VOLUME E (Title 10)

SubChapter C - State Hospital Code

Article 3 - Hospital Operation

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete

Part 720 - Maximum Standard

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 720.1 - General Hospital Accreditation

Section 720.1 General Hospital Accreditation. (a) General hospitals must comply with the operational standards set forth in Part 405 of this Title. The commissioner may accept as evidence of compliance with the minimum operational standards of Part 405 of this Title accreditation by an accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status and which the Commissioner has determined has accrediting standards sufficient to assure the Commissioner that hospitals so accredited are in compliance with such operational standards. The Commissioner can choose to enter into collaborative agreements with such accreditation agencies so that the accreditation agency's accreditation survey can be used in lieu of a Departmental survey. A list of accreditation agencies with which the Department has a collaborative agreement will be posted on the Department's website. These provisions shall apply provided that:

(1) there are no constraints placed upon release of the accreditation agency survey report, plan of correction, interim self-evaluation report, certificate of accreditation, notice on noncompliances, or such other material which the commissioner has accepted under this section; and

(2) the hospital is at all times subject to a survey for compliance with Part 405 of this Title as deemed necessary by the commissioner.

(b) The hospital shall notify the commissioner in writing within seven days of failure to be accredited, re-accredited or the loss of accreditation by the accreditation agency with Centers for Medicare and Medicaid Services deeming status.

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete

Part 721 - Perinatal Regionalization

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.1 - Introduction

Section 721.1 Introduction

(a) All hospital-based perinatal care services shall participate in the statewide perinatal regionalization system. Such system shall coordinate perinatal care within particular geographic areas or among a group of perinatal affiliates.

(b) Each perinatal service within a hospital shall be designated by the Department as providing Level I perinatal care, Level II perinatal care, Level III perinatal care or, the hospital shall be designated as a Regional Perinatal Center (RPC).

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.2 - Definitions

Section 721.2 Definitions

(a) Level I perinatal care service means a comprehensive maternal and newborn service provided by a hospital designated as such by the department for normal low-risk newborns and for women who have been assessed as having a normal, low-risk pregnancy and having a fetus which has been assessed as developing normally and without apparent complications.

(b) Level II perinatal care means a comprehensive maternal and newborn service provided by a hospital designated as such by the department which includes services for moderately high-risk newborns and for women who have been assessed as having the potential or likelihood for a moderately complicated or high-risk delivery and/or bearing a fetus exhibiting the potential for unusual or high-risk development. Such services may also provide services to women requiring care normally provided at Level I perinatal care services.

(c) Level III perinatal care means a comprehensive maternal and newborn service provided by a hospital designated as such by the department and which includes services for women and newborns who have been assessed as high-risk patients and/or are bearing high-risk fetuses , who will require a high level of specialized care. Such programs may also provide services to women and newborns requiring care normally provided at Level I and II perinatal care services.

(d) Regional Perinatal Center (RPC) means a hospital or hospitals housing a perinatal care service which meets the standards for a Level III perinatal care service but which also, includes highly specialized services that may not be available at all Level III hospitals, and designated as such by the department. An RPC serves a geographic area or a group of perinatal affiliates. It provides all aspects of comprehensive maternal and neonatal care, and its functions and responsibilities also include efforts to coordinate and improve quality of perinatal care among its affiliates, attending level consultation regarding patient transfer and clinical management, transport of high-risk patients, outreach to affiliates to determine educational needs, education and training of affiliate hospitals, data collection, evaluation and analysis within that region. If two or more hospitals jointly sponsor an RPC, they must define in a written agreement between or among the hospitals comprising the RPC how the aforementioned functions and responsibilities will be carried out.

(e) Perinatal affiliation agreement shall mean a written fully executed agreement between a Level I, II or III perinatal care hospital, and that hospital's designated RPC. A perinatal affiliation agreement shall include provisions for, at a minimum:

(1) criteria, policies and procedures for transfer of patients, with appropriate consent, to the RPC and from the RPC back to the sending hospital.

(2) criteria and process for attending level subspecialty consultation on a 24-hour basis, including types of consultation processes (i.e., via telephone, telemedicine or in-house consults) acceptable for each subspecialty;

(3) participation in the statewide perinatal data system (SPDS) including the provision of the confidentiality and protection of all data obtained through the SPDS;

(4) cooperation in outreach, education, training and data collection activities; and

(5) authority for one geographically accessible RPC representative or representatives to participate in the affiliate hospital's quality assurance committee and other reviews of the quality of perinatal care provided by the affiliate and to provide recommendations for quality improvement of perinatal services. Each RPC and each affiliate hospital shall take actions necessary, including but not limited to, entering into a perinatal affiliation agreement, to authorize such participation by the RPC's representatives in the affiliate hospital's quality assurance committee and for purposes of such participation, the RPC representative or representatives shall be deemed member(s) of the affiliate's quality assurance committee, shall maintain the confidentiality of all information obtained in such capacity and are subject to the confidentiality restrictions of Public Health Law Section 2805-m.

(6) RPC involvement in the development of written agreements among perinatal affiliates including criteria regarding transport of women and newborns;

(7) timely consultation on treatment plans for women and neonates who develop or exhibit unanticipated conditions which may require transfer to a higher level of care; and,

(8) resolution of disputes or disagreements between the RPC and the perinatal affiliate, including disagreements regarding interpretation of affiliation agreement criteria for consultation and/or transfer. In cases of disputes or disagreement between an affiliate and its RPC, the affiliate and the RPC shall follow the dispute resolution process outlined in their perinatal affiliation agreement. If the dispute is not resolved within sixty days, the parties must request review by the department. The department shall initiate compliance reviews at both sites, advise each facility of its findings, and require corrective action, as indicated, to resolve the dispute. This process shall not interfere with the timely and proper transfer of mothers and newborns.

(f) Transfer agreement shall mean a written agreement between a Level I or II perinatal service and a Level III hospital for the transfer of patients requiring Level III care. Perinatal transfer agreements shall address the provision and/or coordination of all high-risk maternal and newborn transports. The agreements shall reflect the following:

(1) the maximum allowable surface travel time to reach a Level III or RPC hospital shall be two hours under usual weather and road conditions, and the receiving hospital shall be accessible and convenient to the mother's place of residence whenever possible;

(2) mutually agreed criteria for determining when consultation and/or transfer is required;

(3) procedures and responsibility for arranging transport;

(4) requirement for 24-hour availability of appropriately qualified RPC medical staff to respond to calls from affiliates;

(5) policies for obtaining patient or parent/guardian consent for patient transfer and to exchange medical information;

(6) procedures for making arrangements for transfer to another hospital if the receiving hospital is unable to accept the transfer due to capacity/bed limitations;

(7) a provision that an emergency transport shall depart within thirty minutes of the request for transfer;

(8) provisions for the back transfer of newborns who no longer need Level III or RPC care but who need continuing care in a hospital located near their home communities shall be part of the perinatal affiliation and/or transfer agreements between two hospitals; and

(9) higher level hospitals shall inform referring hospitals of major changes in status of transferred patients, with patient's consent or with parental or guardian consent in the case of newborn transfers.

(g) Definitions contained in section 405.21(b) of this Title shall apply to this Part.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.3 - Perinatal Designation of Hospitals

Section 721.3 Perinatal designation of hospitals.

(a) Perinatal services will be designated by the Commissioner based on the following:

(1) each hospital designated as a Level I, Level II or Level III hospital shall enter a written perinatal affiliation agreement with an RPC;

(2) the level of care currently provided by the hospital shall meet the definition, standards and criterion set forth in this Part for a Level I, Level II, Level III perinatal service or RPC;

(3) for level II, Level III and RPCs, the number of births and intensity of neonatal care at the hospital during the previous full calendar year must meet the following minimum volume standards.

(i) a Level II perinatal care hospital shall provide no fewer than 1,200 high-risk newborn patient days annually, and no fewer than 150 high-risk maternal patient days annually;

(ii) a Level III perinatal care hospital shall provide no fewer than 2,000 high-risk newborn patient days annually, and no fewer than 250 high-risk maternal patient days annually;

(iii) RPCs shall provide no fewer than 4,000 high-risk newborn patient days annually, and no fewer than 400 high-risk maternal patient days annually. An RPC shall provide quality improvement services to a group of perinatal affiliates with a minimum total of 8,000 births each year;

(4) the availability of appropriate medical, nursing, and other staffing as described in this Part supportive of the perinatal service at the hospital; and

(5) surface travel time for transfers. The surface travel time to reach a Level II hospital, a Level III hospital, or an RPC within the geographic area or affiliative perinatal network, under usual travel conditions shall be no more than two hours. Transfer decisions must be based on the appropriate level of perinatal care required, and care shall be provided at a hospital offering the appropriate level of care which is accessible and convenient to the mother's place of residence whenever feasible.

(6) the geographic distribution of designated hospitals throughout the state to ensure access to appropriate levels of care throughout the state; and,

(7) such other additional information as the Commissioner may require to make the designation.

(b) Designation process.

(1) Each hospital certified to provide perinatal services shall complete a designation survey by the department and verify specific data about its maternal and newborn discharges. The department shall assess the results of the survey and data in order to assign a designation. The department may require an on-site review of services at a hospital before making a designation, in which case the hospital shall participate and cooperate in the review and provide any additional information requested. A hospital shall receive its designation only after this process is complete and the department has obtained and considered all relevant information to its satisfaction.

(2) The perinatal designation of a hospital shall appear on the hospital's operating certificate.

(3) Perinatal designation on the maternity information leaflet. The hospital's perinatal designation and a brief definition of the Level shall be included in the maternity information leaflet distributed to each prospective maternity patient, pursuant to public health law section 2803-j (1).

(c) Redesignations.

(1) A hospital may apply to change its designation no sooner than one year following its most recent designation.

(2) The department may initiate a review and monitor compliance with the definitions, standards and criteria set forth in this Part by perinatal services and RPCs at any time.

(3) The department may change a designation if it finds that a hospital perinatal service or RPC no longer meets the definition, standards and criterion for its current designation.

(4) Maintenance of minimum volume standards. To ensure that service capability and staff competence are maintained for Level II, Level III, or an RPC, a hospital which fails to meet minimum volume standards and is seeking to maintain its designation, or applying for another designation, shall present evidence that the annual minimum volume standards will be achieved within one year following the decision to allow the hospital to remain at the present level of designation or the initiation of the new designation. Minimum volume standards may be waived by the department if the department determines that a waiver will improve access while maintaining high quality care.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.4 - Patient Care and Patient Transfers

Section 721.4 Patient care and patient transfers.

(a) Each hospital providing perinatal care services shall provide patient care based on the individual needs of the patient and in accordance with the following criteria.

(1) A Level I perinatal care service hospital shall evaluate and stabilize all women and neonates.

(i) For patients needing a higher level of care, it shall consult with a higher level hospital and arrange for timely transfer to a Level III perinatal care service hospital or an RPC that provides the appropriate level of perinatal care.

(ii) For healthy women with an anticipated delivery at 36 weeks gestation or later and for healthy newborns with a birthweight of 2,500 grams or more, it shall provide continuing care until their discharge.

(iii) Except in unusual circumstances, smaller and more premature infants shall be delivered at higher level hospitals; if such an infant is born at a Level I perinatal care hospital, he/she shall be transferred promptly after birth.

(iv) Women and neonates who have relatively minor problems that do not require advanced laboratory, radiologic, or consultation services may remain in the Level I perinatal care hospital.

(v) When it is known that the newborn may require immediate complex care, it shall be delivered at a Level III perinatal care hospital or an RPC whenever possible.

(vi) Level I perinatal care hospitals shall also provide care for convalescing babies who have been transferred from Level II, Level III and RPC perinatal care hospitals.

(2) A Level II perinatal care services hospital shall:

(i) provide the Level I perinatal care services described in paragraph (1) above and be capable of providing care for moderately high-risk women, fetuses and newborns and moderately ill women and newborns who have problems that do not require highly specialized care; and

(ii) stabilize ill women and newborns and women whose fetuses are expected to need complex care, consult with a higher level hospital and arrange for timely transfer to a hospital that provides the appropriate level of perinatal care.

(iii) Level II perinatal care hospitals are qualified to deliver infants with an anticipated delivery at 30 weeks gestation or later and with an anticipated birthweight of 1,250 grams or more.

(iv) Except in unusual circumstances, infants smaller and more premature than is described at subparagraph (iii) of this paragraph shall be delivered at Level III hospitals or RPCs. If an infant who is smaller or a lower gestational age than described in subparagraph (iii) of this paragraph is born at the Level II hospital, he/she shall be transferred promptly after birth.

(3) A Level III perinatal care services hospital shall:

(i) provide Level I and Level II perinatal care services described in paragraphs (1) and (2) of this subdivision and shall care for women, fetuses, and newborns who may require complex care.

(ii) stabilize ill women and newborns prior to transfer, including women whose newborns are expected to need the most complex care, consult with its designated RPC, and transfer if appropriate.

(iii) Women in unstable medical and/or obstetric situations shall be cared for at a Level III hospital or an RPC.

(4) Regional Perinatal Care Centers (RPC) shall provide Level I, Level II and Level III perinatal care services described in paragraphs (1), (2), and (3) of this subdivision and shall also care for women, fetuses, and newborns who require highly specialized services not available at the Level III care hospital, such as sophisticated ventilation techniques (e.g., high-frequency ventilation and extracorporeal membrane oxygenation), cardiac surgery or neurosurgery.

(5) The transfer and consultation criterion included in the affiliation and transfer agreements can be customized to reflect the RPC’s knowledge and the capabilities of each affiliate hospital. Any variation in transfer of patients to a higher level perinatal care service hospital as specified in this Section must be in accordance with generally accepted standards of professional practice and criteria established in the affiliation agreement with each hospital's respective RPC.

(b) Ventilation for distressed newborns. Resuscitation and ventilation of neonates who require cardiorespiratory assistance shall be performed at each Level of perinatal care and in the following ways:

(1) at a Level I perinatal care services hospital the ventilation of distressed newborns shall be immediate resuscitation after birth as appropriate, stabilization, and assisted ventilation of newborns until timely transfer to a hospital that provides a higher level of perinatal care;

(2) at a Level II perinatal care hospital the ventilation of a distressed newborn shall be as described in paragraph (1) above and, in addition, standard short-term mechanical ventilation. A Level II perinatal care hospital may care for infants requiring mechanical ventilation and/or 50% or more oxygen for no more than four days. By the fourth day of a newborn's receipt of

assisted

ventilation or oxygen at 50% or more, the Level II hospital shall consult with its designated RPC regarding the status of the newborn and determine whether to transfer the newborn to a higher level hospital. If after such consultation the neonate stays at the Level II hospital, that hospital may retain the neonate for no more than a total of seven days on assisted ventilation or oxygen at 50% and must then transfer the neonate to a Level III hospital or to an RPC unless the hospital's RPC is consulted and agrees that the neonate's care is appropriate and in accordance with current standards of professional practice and remaining at the Level II hospital is in the best interests of the neonate.

(3) at Level III perinatal care services hospitals and RPCs the ventilation of a distressed newborn shall be as described in paragraphs (1) and (2) of this subdivision and, in addition, may also include long-term standard mechanical ventilation and complex ventilation techniques, such as high-frequency ventilation and extracorporeal membrane oxygenation (ECMO).

(c) Transfers.

(1) All patient care and transfers shall be in accordance with generally accepted professional standards and be consistent with section 405.21(g) and this Part. Requirements for consultation and for transfer to a higher level of perinatal care and transfer back to the referring hospital or other hospital providing a lower level of care, shall be described in any transfer agreement negotiated between Level I, II and III perinatal care hospitals, and in transfer provisions in the perinatal affiliation agreements between Level I, II and III perinatal care hospitals and their RPCs.

(2) When a newborn and/or mother requires transfer, care shall be provided at a hospital providing the appropriate level of perinatal care which is, whenever feasible, accessible and convenient to the mother's place of residence. When mothers and their infants need different levels of care, efforts shall be made to keep the mother-newborn dyad together. Level III hospitals and RPCs shall return a newborn to the sending hospital when the condition has been stabilized and return is medically appropriate.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.5 - Responsibilities and Qualifications of Chiefs of Services At Each Designated Level

Section 721.5 Responsibilities and qualifications of chiefs of services at each designated level. The qualifications and responsibilities for each designated level shall be as follows:

(a) Level I perinatal care service. Care shall be coordinated jointly by the chiefs of obstetrics, pediatrics, family practice, nursing, anesthesia, and midwifery. For facilities that do not have chiefs of service in all such areas, each discipline shall have effective input in care coordination. The coordinators of perinatal care at a Level I perinatal care services hospital shall be responsible for developing policy, maintaining standards of care, and collaborating and consulting with professional staff of hospitals providing Level II and Level III perinatal care services and RPC perinatal care in the region. In hospitals that do not separate maternity and newborn services, one person may be given the responsibility for coordinating perinatal care;

(b) Level II perinatal care service. A board-certified obstetrician with special interest, experience, and expertise in maternal-fetal medicine shall be the chief of the obstetric service at a Level II care hospital. A full-time board-certified pediatrician with subspecialty certification in neonatal medicine or at a minimum has successfully completed a fellowship in neonatal medicine shall be the chief of the neonatal care services. These physicians shall jointly coordinate the hospital's perinatal care services and, in conjunction with the chiefs of anesthesiology, nursing, midwifery, and family practice, and other patient care and administration staff, shall develop policies concerning staffing, procedures, equipment, and supplies; maintaining standards of care; and planning, developing, and coordinating in-hospital professional educational programs;

(c) Level III perinatal care services. The chief of the maternal-fetal medicine service at a hospital providing Level III perinatal care shall be a full-time, board-certified obstetrician with interest, experience and special competence in maternal-fetal medicine; subspecialty certification in maternal-fetal medicine is recommended. The director of a newborn intensive care service at a Level III hospital shall be a full-time, board-certified pediatrician with subspecialty certification in neonatal medicine. These physicians shall jointly coordinate the hospital's perinatal care services in order to ensure provision of a comprehensive continuum of high quality care to mothers and newborns. In conjunction with the chiefs of anesthesiology, nursing, midwifery, and family practice, and other patient care and administrative staff, these physicians shall be responsible for developing policies concerning staffing, procedures, equipment, and supplies; maintaining standards of care; and planning, developing, and coordinating in-hospital professional educational programs;

(d) RPC care. The chief of the maternal-fetal medicine service at an RPC shall be a full-time, board-certified obstetrician with subspecialty certification in maternal-fetal medicine. The chief of a newborn intensive care service at an RPC shall be a full-time, board-certified pediatrician with subspecialty certification in neonatal medicine. These physicians shall jointly coordinate perinatal care services in order to ensure provision of a comprehensive continuum of high quality care to mothers and newborns. In conjunction with the chiefs of anesthesiology , nursing, midwifery, and family practice, and other patient care and administration staff, these physicians shall be responsible for developing policies concerning staffing, procedures, equipment, and supplies; maintaining standards of care; and planning, developing, and coordinating in-hospital professional educational programs. The chiefs of maternal-fetal medicine and neonatology will also be responsible for providing outreach and professional education programs, participating in the evaluation and improvement of perinatal care in the region, and coordinating the services provided at their hospital with those provided at Level I, Level II and Level III care hospitals in the region.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.6 - Qualification and Responsibilities of Physicians and Other Licensed Obstetrical Practitioners At Each Designated Level of Care

Section 721.6 Qualifications and responsibilities of physicians and other licensed obstetrical practitioners at each designated level of care. The qualifications and responsibilities of licensed obstetrical practitioners at each designated level of care shall be:

(a) Level I perinatal care: A physician or licensed midwife with appropriate training and expertise shall attend all deliveries. At least one person capable of initiating neonatal resuscitation shall be present at every delivery. An ultrasound machine shall be readily available to labor and delivery. A radiologist or obstetrician skilled in interpretation of ultrasound scans shall be available within a timeframe appropriate to meet the patient's needs;

(b) Level II perinatal care: A physician or licensed midwife with appropriate training and expertise shall attend all deliveries. At least one person capable of initiating neonatal resuscitation shall be present at every delivery. An ultrasound machine shall be readily available to labor and delivery. A radiologist or obstetrician skilled in interpretation of ultrasound scans shall be available 24 hours a day within a timeframe appropriate to meet the patient's needs. Portable, neonatal-appropriate equipment and appropriately trained personnel to administer the service must be available within a timeframe appropriate to meet the patient's needs. Care for moderately high-risk women and neonates shall be provided by appropriately qualified physicians. General pediatricians and general obstetricians with the expertise to assume responsibility for acute care for infants and women, shall be immediately available within 20 minutes, 24 hours a day to provide needed services. The chief of obstetric anesthesia services shall be board-certified in anesthesia and shall have training and experience in obstetric anesthesia. A neonatologist shall be available on-site within 20 minutes 24 hours a day to provide needed services. The hospital staff shall also include a radiologist skilled in interpretation of ultrasound scans, a clinical pathologist , personnel qualified to administer specialized pharmaceutical services to newborns, and a designated, in-house credentialed person for neonatal resuscitation, all of whom shall be available 24 hours a day. Personnel with credentials to administer obstetric anesthesia shall be readily available. Specialized adult and pediatric medical and surgical consultation shall be readily available;

(c) Level III and RPC perinatal care: A physician or licensed midwife with appropriate training and expertise shall attend all deliveries. At least one person capable of initiating neonatal resuscitation shall be present at every delivery. An ultrasound machine shall be readily available to labor and delivery. A radiologist, obstetrician or maternal-fetal medicine specialist skilled in interpretation of ultrasound scans shall be available in-house 24 hours a day. Portable, neonatal-appropriate equipment and appropriately trained personnel to administer the service must be available within a timeframe appropriate to meet the patient's needs. Maternal-fetal medicine specialists and neonatologists who care for high-risk mothers and newborns in the Level III or RPC hospital shall have qualifications equivalent to those of the chief of their service as described in section 721.5(c) and (d) of this Title or at a minimum will have successfully completed a fellowship in maternal fetal medicine or in neonatal medicine, whichever is appropriate. A maternal-fetal medicine specialist and a neonatologist shall be available on-site within 20 minutes 24 hours a day to provide needed services. Obstetric and neonatal diagnostic imaging, provided by radiologists with special expertise in diagnosis of maternal and neonatal disease and its complications, shall be available 24 hours a day. Pediatric and adult subspecialists in cardiology, neurology, hematology, genetics, nephrology, metabolism, endocrinology, gastroenterology, nutrition, radiology, infectious diseases, pulmonology, immunology, and pharmacology shall be available for consultation. In addition, pediatric surgeons and pediatric surgical subspecialists, e.g., cardiovascular, neurological, orthopedic, ophthalmologic, urologic, and otolaryngological surgeons, shall be available for consultation and care. Pathologists with special competence in placental, fetal, and neonatal disease shall be members of the Level III or regional perinatal center staff. A clinical pathologist shall be available 24 hours a day. A board-certified anesthesiologist with special training or experience in maternal-fetal anesthesia shall be in charge of obstetric anesthesia services at a Level III or regional perinatal center facility, and personnel with credentials in the administration of obstetric anesthesia shall be available for all deliveries. Personnel with credentials in the administration of neonatal and pediatric anesthesia shall be readily available as needed. Personnel qualified to prepare, dispense and administer specialized pharmaceutical services to newborns shall be available 24 hours a day.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.7 - Nursing Care

Section 721.7 Nursing Care. In addition to providing nursing care that meets generally accepted professional standards, hospitals shall meet the following additional nursing requirements at each designated level of care.

(a) Level I perinatal care service hospital. Maternal and newborn nursing care shall be provided under the direct supervision of a registered nurse. All obstetric nursing personnel shall be qualified in interpretation of fetal heart rate monitoring and understand the physiology of labor. All newborn nursing personnel shall be qualified in assessment of the newborn and all aspects of routine monitoring and care, including education and support related to breastfeeding.

(b) Level II care hospital. In addition to the qualifications described in subdivision (a) of this section, direct patient care shall be provided by registered nurses who have education and experience in the care of moderately high-risk women and/or newborns. All nurses caring for ill women or newborns shall demonstrate competence in the observation and treatment of such patients, including cardiorespiratory monitoring. Registered nurses in a Level II perinatal care hospital shall be able to: monitor and support the stability of cardiopulmonary, neurologic, metabolic, and thermal functions; assist with special procedures such as lumbar puncture, endotracheal intubation, and umbilical catheterization; and perform emergency resuscitation.

(c) Level III perinatal care hospital. Responsibilities of registered nurses shall include those defined in subdivisions (a) and (b) of this section. In addition, registered nurses in the Level III perinatal care hospital shall have specialty certification or advanced training and experience in the nursing management of high-risk women, neonates and their families. They shall also be experienced in caring for unstable women and neonates with multi-organ system problems and in specialized care technology. An advanced practice nurse shall be available to the staff for consultation and support on nursing care issues. Assessment and monitoring activities shall remain the responsibility of a registered nurse or advanced practice nurse in obstetric-neonatal nursing, even when personnel with a mixture of skills are used.

(d) RPC. Responsibilities of registered nurses shall include those defined in subdivisions (a), (b), and (c) of this section. In addition, nurses with special training shall participate in regional perinatal center responsibilities such as outreach, training, education and support.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.8 - Ancillary Personnel

Section 721.8 Ancillary personnel. The ancillary personnel requirements for each designated level are as follows:

(a) All designated Level I, II, III perinatal care services and RPCs shall have:

(1) an organized plan of action that includes personnel and equipment for identification and immediate resuscitation of newborns and mothers requiring cardiorespiratory assistance;

(2) personnel who are capable of determining blood type, cross-matching blood, and performing antibody testing and who are available on a 24-hour basis;

(3) infection control personnel responsible for surveillance of infections in women and neonates, as well as for the development of an appropriate environmental control program;

(4) a radiologic technician available 24 hours a day to perform imaging;

(5) at least one staff member with expertise in lactation and breastfeeding management responsible for the hospital's breastfeeding support program, as described in section 405.21(f)(3)(i) of this Title;

(6) at least one staff member with expertise in bereavement responsible for the hospital's bereavement activities, including a systematic approach to ensuring that individuals in need receive such services;

(7) at least one qualified social worker available who has experience with the socioeconomic and psychosocial problems of pregnant women, ill neonates, and their families assigned to the perinatal service. Additional qualified social workers sufficient to meet the needs of women and newborns are required when there is a high volume of medical activity or psychosocial need; and,

(8) licensed practical nurses and other licensed patient care staff with demonstrated knowledge and clinical competence in the nursing care of women, fetuses, and newborns during labor, delivery, and the postpartum and neonatal periods.

(9) The need for other support personnel shall depend on the intensity and level of sophistication of the other support services provided and shall be sufficient to meet the needs of the patients.

(b) Additional requirements for Level II, Level III perinatal care services and RPC designation:

(1) at least one occupational or physical therapist with neonatal expertise;

(2) at least one registered dietician/nutritionist who has special training in perinatal nutrition and can plan diets that meet the special needs of high-risk women and neonates;

(3) appropriate and adequate numbers of the nursing staff who are trained in breastfeeding support for mothers and infants with special needs;

(4) qualified personnel for support services, such as laboratory studies, radiologic studies, and ultrasound examinations, who are available 24 hours a day; and

(5) respiratory therapists or nurses with special training who can manage the mechanical ventilation of neonates with cardiopulmonary disease.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.9 - Regional Quality Improvement Activities

Section 721.9 Regional quality improvement activities.

(a) Quality of care reviews of affiliates. Each hospital with a Level I, Level II or Level III perinatal care service shall enter into and comply with a perinatal affiliation agreement as defined in this Part with an RPC in its geographic area or network of perinatal affiliates. RPC representatives shall participate in the affiliate hospital's quality assurance committee and other reviews of the quality of perinatal care provided by the affiliate and in the provision of recommendations for quality improvement of perinatal services. Each RPC and each affiliate hospital shall take actions necessary, including but not limited to entering into a perinatal affiliation agreement, to authorize such participation by the RPC's representatives in the affiliate hospital's quality assurance committee and for purposes of such participation, the RPC representative or representatives shall be deemed members of the affiliate's quality assurance committee. RPC representatives may only access confidential patient information for quality improvement purposes through their roles on the affiliate hospitals’ quality assurance committees as set forth in the affiliation agreements and these regulations. Members of hospitals’ quality assurance committees must maintain the confidentiality of patient information and are subject to the confidentiality restrictions of Public Health Law Section 2805-m.

(1) The RPC representative(s) shall participate in the review of information and data for quality improvement purposes as described in the affiliation agreement which may include:

(i) statistical data from the statewide perinatal data system or equivalent data available from other sources;

(ii) the affiliate hospital's quality improvement program, policies, and procedures;

(iii) care provided by medical, nursing, and other health care practitioners associated with the perinatal service;

(iv) appropriateness and timeliness of maternal and newborn referrals and transfers and of patients retained at the affiliate hospital who met criteria for transfer to a higher level of care; and

(v) maternal and newborn serious adverse events or occurrences that may include the following:

(a) maternal and newborn fatalities;

(b) maternal and newborn morbidity in circumstances other than those related to the natural course of disease or illness;

(c) maternal and newborn nosocomial infections;

(d) maternal and newborn high-risk procedures; or

(vi) pathology related to all deaths and significant surgical specimens.

(2) The hospital shall implement quality improvement recommendations by its RPC. In the event of a disagreement related to a recommendation, the hospital and the RPC shall follow the dispute resolution process outlined in their perinatal affiliation agreement and section 721.2 of this Title.

(b) Each RPC shall cooperate with the department in regular quality improvement reviews by the department of the RPC's perinatal care, the RPC's internal quality improvement activities, and the services it provides to its perinatal affiliates:

(1) The department's quality of care review of the RPC shall include the elements set forth in section 721.9(a)(1) of this Title.

(2) The department's quality improvement review of an RPC shall include review of the quality of the services it has provided to its perinatal affiliates.

(3) The RPC shall cooperate with the department by providing medical records and other relevant documents and information on a timely basis when requested.

(c) Quality improvement outreach program. Each RPC shall provide professional education and training for physicians, nurses, and other staff at all hospitals in the region or affiliative network for which it provides quality of care review. Education and training shall be designed to update and enhance staff knowledge and familiarity with relevant procedures and technological advances.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Section 721.10 - Perinatal Affiliation Agreements and Tranfer Agreements

Section 721.10 Perinatal affiliation agreements and transfer agreements.

(a) Each hospital with a Level I, II or III perinatal care service shall enter into and comply with a perinatal affiliation agreement with an RPC. Each hospital with a Level I or II perinatal care service may also enter into a transfer agreement with a hospital with a Level III perinatal care service if such an agreement would result in an acceptable level of care and provide a more convenient alternative than transfer to an RPC. All such agreements and amendments to such agreements shall be made available to the department, upon request. The terms of such agreements shall be mutually agreed upon by the affiliating hospitals.

(b) Changes in the identity of the RPC with which a hospital has a perinatal affiliation agreement may not be made more frequently than once annually. Such changes shall require 30 days prior notice to the department.

Effective Date: 
Wednesday, September 14, 2005
Doc Status: 
Complete

Part 722 - Sexual Assault Forensic Examiner (SAFE) Programs

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 2803 and 2805

Section 722.1 - Definition

Section 722.1 Definition.

(a) Upon the request of a qualifying hospital, i.e. hospitals licensed under Article 28 of the Public Health Law that have an emergency department and meet the qualifications specified herein, the Department may designate that hospital as having an approved Sexual Assault Forensic Examiner (SAFE) program. Such hospital program shall meet the standards for treatment of sexual assault victims and maintenance of sexual offense evidence established in subdivision (c) of section 405.9 of this Title and shall also make available to survivors, on a 24-hour per day basis, specially trained Sexual Assault Forensic Examiners. Such programs:

(1) May also be referred to as Sexual Assault Nurse Examiner (SANE) and Sexual Assault Examiner (SAE) programs;

(2) Are comprehensive and designed to meet the needs of survivors of sexual assault by providing not only medical care but also forensic examinations in a private setting conducted by specially trained Sexual Assault Forensic Examiners;

(3) Are designed to provide specialized standards of medical care and evidence collection that support recovery and prevent further injury or illness arising from the trauma for all survivors and may increase the successful prosecution of sex offenders for survivors who choose to report the crime to law enforcement; and

(4) Coordinate an interdisciplinary collaborative effort involving a hospital-based SAFE program, a rape crisis center, law enforcement, the prosecutor's office and other appropriate service agencies. These organizations provide a coordinated response that not only effectively meets the needs of the sexual assault survivor but also can improve the overall community response to sexual assault.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.2 - Application for Designation

Section 722.2 Applications for Designation.

(a) General hospitals may choose to seek designation from the Department as SAFE hospitals. Such hospitals shall complete an application form developed by the Department, which includes but is not limited to, the following information:

(1) The location of the hospital;

(2) The hospital's capacity to provide on-site, comprehensive medical services to survivors of sexual offenses;

(3) The capacity of the hospital to coordinate services for survivors of sexual offenses, including medical treatment, rape crisis counseling, psychological support, law enforcement assistance and forensic evidence collection;

(4) The hospital's capacity to provide access to the sexual assault forensic examination site for individuals with disabilities;

(5) The hospital's existing services for survivors of sexual offenses;

(6) The capacity of the hospital site to collect uniform data and ensure the confidentiality of such data; and

(7) The hospital's commitment to compliance with all applicable state and federal laws, regulations and generally accepted standards of care, including the standards of care and services established in this Part and the approved provider agreement between the hospital and the Department.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.3 - Review and Approval of Applications for Designation

Section 722.3 Review and Approval of Applications for Designation.

(a) The Department shall review applications for designation to ensure that the information supplied is consistent with statutory requirements as well as regulatory program standards and requirements.

(b) The Department or its designee may conduct site visits to resolve any concerns and/or to ensure that the proposed SAFE program is consistent with program requirements.

(c) The Department shall notify applicants of its decision, including reasons for any denial of designation.

(d) Approved designations shall be reflected on the hospital's operating certificate.

Effective Date: 
Tuesday, January 17, 2006
Doc Status: 
Complete

Section 722.4 - Withdrawal of Designation

Section 722.4 Withdrawal of Designation.

(a) The Department may withdraw designation from an approved program if:

(1) It finds and documents a material failure to comply with relevant statutes, regulations, or generally accepted standards of care and services, a failure to provide the Department with accurate and timely reporting, including program data, a failure to permit appropriate Department personnel access to perform program and patient record reviews, or a failure to provide the provider agreement; and

(2) The hospital has been provided ample and reasonable

notice and an opportunity to address any deficiencies identified regarding its SAFE program but has not done so. Reasonable notice and an opportunity to respond will consist of written notice to the program by the Department and an opportunity for the hospital to respond no later than thirty days from the date on which the notice was sent to the hospital by the Department.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.5 - Provider Agreements

Section 722.5 Provider Agreements.

(a) A hospital with a designated SAFE program shall enter into a provider agreement with the Department. Such agreement shall address at least the following:

(1) A description of the proposed SAFE program model that is acceptable to the Department, including adequate availability of appropriately trained and certified SAFE examiners.

(2) Participation by the program in an interdisciplinary/community task force, including:

(i) hospital administration and emergency service representatives;

(ii) the local rape crisis center;

(iii) law enforcement entities; and

(iv) a representative of the district attorney’s office of the county or city in which the hospital is located, including the special sex crimes unit, where available.

(3) The program's organization, including administrative and clinical oversight, designed to provide care to survivors that is consistent with generally accepted standards of care.

(4) A listing of facilities/equipment required of the program, including a private, designated room for the performance of exams, access to a shower and access for individuals with disabilities.

(5) A listing of data required to be maintained by the program and provided to the Department on a quarterly and/or annual basis; and

(6) Other such terms and conditions that may be required by the Department to ensure that the program will comply with relevant statutes, regulations, generally accepted standards of care and the goals of the SAFE program.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.6 - Program Standards

Section 722.6 Program Standards.

(a) The hospital shall ensure that the following minimum requirements are met throughout the period of its designation as a SAFE program.

(1) Appropriate administrative and clinical oversight is provided to the program;

(2) SAFE programs are affiliated with and integrated into the policies and procedures and operations of related areas of the hospital, particularly emergency services;

(3) Initial and ongoing assessment of competency and credentialing of SAFE staff is conducted, including certification of Sexual Assault Forensic Examiners by the Department;

(4) Effective systems to provide triage and assessment are incorporated;

(5) Effective on-call and back-up call schedules have been developed to ensure that the patient is met by a Sexual Assault Forensic Examiner within sixty minutes of patient's arrival in the hospital except

(i) when the patient does not disclose a sexual assault at the time of triage; or

(ii) under exigent circumstances;

(6) The rape crisis center is contacted immediately to ensure that a rape crisis advocate is available to offer services to the patient;

(7) Medical/surgical backup is readily available to the Sexual Assault Forensic Examiner;

(8) An appropriately equipped, private, designated room with access to a shower that can accommodate patients with disabilities is available when needed for sexual assault exams;

(9) Medical treatment and forensic examinations of sexual assault survivors are provided in compliance with all relevant laws and regulations and consistent with generally accepted standards of care, including standards such as those incorporated in the Department's

Protocol for the Acute Care of the Adult Patient Reporting Sexual Assault

(as currently posted on the DOH website at www.health.state.ny.us/nysdoh/sexual_assault/index.htm);

(10) Prophylaxis for sexually transmitted diseases, HIV and hepatitis B, and prophylaxis against pregnancy resulting from a sexual assault (emergency contraception) are provided on site;

(11) The New York State Sexual Offense Evidence Collection Kit is used, unless a patient or person authorized to consent on the patient’s behalf refuses to have evidence collected; and evidence is maintained and collected as required by Public Health Law section 2805-i;

(12) Replacement clothing is provided to the patient, if necessary, before the patient leaves the hospital;

(13) Referral and follow-up regarding medical treatment is provided;

(14) The patient is referred to counseling and support and other needed services;

(15) Safe discharge is reasonably assured for the patient;

(16) Medical and forensic SAFE services are appropriately documented;

(17) Information is collected related to the provision of services to survivors of sexual assault and confidentiality of the data is ensured; and

(18) An effective system of continuous quality improvement is established to ensure SAFE medical and forensic services are in compliance with generally accepted standards of care.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.7 - Responsibilities of Hospital Emergency Staff

Section 722.7 Responsibilities of Hospital Emergency Staff.

(a) Hospital emergency staff shall immediately implement the following protocol upon arrival of a putative sexual assault victim:

(1) Provide triage and assessment in a timely manner;

(2) Contact the Sexual Assault Forensic Examiner when the patient discloses that she or he has been sexually assaulted;

(3) Contact a rape crisis advocate at the same time that contact is made with the Sexual Assault Forensic Examiner;

(4) Be available for consultation and support of the SAFE program and the Sexual Assault Forensic Examiner;

(5) Assist in obtaining necessary tests and medications;

(6) Assist in arranging referrals and follow-up services; and

(7) Ensure the availability of medical/surgical back up as may be needed including, but not limited to: general surgery, obstetrics/gynecology, pediatrics, urology and psychiatry.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.8 - Staffing

Section 722.8 Staffing.

(a) At a minimum, SAFE programs shall maintain the following staff:

(1) A program director who:

(i) reports directly to the emergency service director or the director of nursing;

(ii) if he or she is a clinician, also may provide clinical services to the program, provided administrative responsibilities remain his or her primary duties;

(iii) is responsible for integrating the SAFE program within the hospital's overall administrative structure;

(iv) acts as the liaison with the interdisciplinary/community task force;

(v) has relevant training and experience sufficient to perform his or her duties;

(vi) oversees recruitment, education and continuing education, preceptorships, certification and re-certification of program staff; and

(vii) participates with the interdisciplinary/community task force in development of a community outreach and education plan;

(2) A medical director or, if there is no medical director for the program, one or more hospital designees who ensure that the SAFE program is integrated within the hospital's clinical oversight and quality improvement structure;

(3) Certified Sexual Assault Forensic Examiners sufficient to meet program needs. Such individuals shall:

(i) be registered, certified, or licensed, as appropriate to practice as a nurse, nurse practitioner, physician assistant or physician in the State of New York and perform within his or her statutory scope of practice;

(ii) have a minimum of one year, full-time clinical post-graduate experience;

(iii) have successfully completed at least a forty-hour didactic and clinical training course approved by the Department. Individuals who can demonstrate competence in some or all of the course objectives required for DOH approval may be eligible for exemption from those components of the course;

(iv) have completed a competency-based post-course preceptorship;

(v) have a signed letter from the SAFE program or other provider or institution ensuring qualified medical oversight of the Sexual Assault Forensic Examiner; and

(vi) be re-certified every three years. To qualify for recertification, individuals:

(a) shall have completed a minimum of fifteen hours of continuing education in the field of forensic science in the past three years;

(b) shall have maintained competency in providing sexual assault examinations. Based upon the examiner’s performance of sexual assault exams during the preceding year, the medical director of the SAFE program or other appropriate institution shall attest to the examiner's continuing competency. If the examiner has had more than a one year lapse in service during the three year certification period, the medical director must explain how competency was maintained or updated, i.e., by means of repeating training or by other means; and

(c) must function with qualified clinical oversight as a Sexual Assault Forensic Examiner. A signed letter from the SAFE program or other provider or institution stating that such oversight is provided will satisfy this requirement.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.9 - Treatment of Patients

Section 722.9 Treatment of patients.

(a) Absent exigent circumstances or unless the patient does not disclose a sexual assault at the time of triage, the Sexual Assault Forensic Examiner shall meet the patient within sixty minutes of the patient’s arrival at the hospital. Should circumstances beyond the hospital's control prevent the hospital from meeting this standard, the hospital shall ensure that the patient receives the same care and services that are provided to all such patients in accordance with all applicable State and Federal laws, regulations and generally accepted standards, including but not limited to:

(1) Public Health Law section 2805-i. Treatment of sexual offense patients and maintenance of evidence in a sexual offense;

(2) Subdivision (c) of section 405.9 of this Title. Establishment of hospital protocols and maintenance of sexual offense evidence;

(3) The Sexual Assault Reform Act (SARA), Chapter 1 of the Laws of 2000; and

(4) Generally accepted standards for the treatment of sexual assault victims such as:

(i) the DOH guidance,

HIV Prophylaxis Following Sexual Assault: Guidelines for Adults and Adolescents;

and

(ii) the DOH

Protocol for the Acute Care of the Adult Patient Reporting Sexual Assault

(as currently posted on the DOH website at www.health.state.ny.us/nysdoh/sexual_assault/index.htm).

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Section 722.10 - Continuous Quality Improvement

Section 722.10 Continuous Quality Improvement.

(a) The SAFE program shall develop and implement written policies and procedures establishing an internal quality improvement program to identify, evaluate, resolve and monitor actual and potential problems in patient care. The internal program shall be integrated with the hospital's overall quality improvement plan and shall include, but not be limited to, the following components:

(1) Chart audits performed periodically on a statistically significant number of sexual assault patient records. The hospital must designate one or more individuals to review sexual assault patient records periodically, along with other appropriate information, to determine the following:

(i) length of time the patient waited from arrival to exam commencement;

(ii) availability of appropriately trained staff to examine the patient;

(iii) availability of all of the necessary equipment for the examination;

(iv) if a rape crisis program advocate was contacted to accompany the patient;

(v) if consent was appropriately obtained from the patient or the person authorized to give consent on behalf of the patient;

(vi) if the patient received appropriate medical treatment;

(vii) if HIV prophylaxis was recommended in all cases, when appropriate, pursuant to this DOH protocol (for the most recent version of the HIV guidelines, visit www.hivguidelines.org);

(viii) if HIV prophylaxis was made available on-site to all clients requesting this preventive measure;

(ix) for female patients, whether the patient received appropriate counseling related to pregnancy prophylaxis and whether the patient received on-site pregnancy prophylaxis if the patient requested it;

(x) if the patient received treatment for STDs, including prophylaxis;

(xi) if forensic evidence was collected in a manner consistent with law, regulations and standards, including maintenance of the chain of custody;

(xii) if an appropriate medical and psychosocial referral and follow-up plan were developed for the patient;

(xiii) if safe discharge was assured for the patient; and

(ix) if confidentiality was maintained.

(2) A system for developing and recommending corrective actions to resolve identified problems; and

(3) A follow-up process to assure that recommendations and plans of correction are implemented.

Effective Date: 
Wednesday, January 17, 2007
Doc Status: 
Complete

Part 723 Reserved

Part 724 Reserved

Article 4 - Managed Care

ARTICLE 4Managed Care

PART
732

Workers' Compensation Preferred Provider Organizations

________________________________________________________________________* The Department of Health repealed Articles 4 and 5 of the State HospitalCode in January 1978, and at the same time promulgated a new Article 4 andamendments to sections 700.2 and 704.1, all of this to be effective 60 daysafter filing. The revised material was published in the Official Compilationprior to its effective date. Also prior to the effective date, but afterpublication in the Official Compilation, the Department of Health deferredthe effective date until further action by the State Hospital Review andPlanning Council. Therefore, Articles 4 and 5, and sections 700.2 and 704.1,were reprinted, effective with the August 1978 supplement to the OfficialCompilation, as they appeared prior to January 1978.

Effective Date: 
Wednesday, July 17, 2002
Doc Status: 
Complete

Part 732 - Workers' Compensation Preferred Provider Organizations

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete
Statutory Authority: 
Workers' Compensation Law, Article 10-A

SubPart 732-1 - Provider certification

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete
Statutory Authority: 
Workers' Compensation Law, Article 10-A

Section 732-1.1 - Definitions

Section 732-1.1 Definitions. The following terms, as used in this Part, shall have the following meanings:

(a) "Carrier" or "insurer" shall mean the insuring, risk bearing entity which contracts with the employer and the PPO for the provision of workers' compensation medical and service benefits.

(b) "Chair" shall mean the Chair of the Workers' Compensation Board

(c) "Claimant" shall mean an individual employed by or otherwise covered for workers' compensation benefits by a participating employer and eligible for medical care provided by a PPO who receives treatment for or applies for medical and/or health services for any accidental injury arising out of and in the course of employment or for occupational disease.

(d) "Commissioner" shall mean the Commissioner of Health.

(e) "Emergency or urgent care" shall mean medical care, treatment, services, products or accommodations provided to an injured or ill employee for a sudden onset of a medical condition of such nature that failure to render immediate care would reasonably result in deterioration of the injured employee's medical condition.

(f) "Governing body" shall mean the board of directors or trustees of a not-for-profit corporation, the officers, directors and stockholders of a business corporation, all partners in a partnership or the individual proprietor of a PPO.

(g) "Preferred Provider Organization" or "PPO" shall mean a plan certified pursuant to the requirements of this Subpart owned, operated or administered by an entity that provides or arranges for the coordination and delivery of all services required by subdivision (h) of this section to all persons covered by such plan. No insurer or employer shall have any financial interest in the PPO.

(h) Services provided by a PPO shall include all services provided or arranged for under the Workers' Compensation Law to diagnose, treat and rehabilitate a claimant requiring medical treatment of an occupational disease or an accidental injury arising out of and in the course of employment, which shall include but not be limited to:

(1) inpatient hospital services;

(2) emergency or urgent care services;

(3) primary care physician services;

(4) diagnostic imaging services;

(5) physical therapy, occupational therapy and rehabilitation services;

(6) other therapeutic services;

(7) mental health professional services;

(8) pharmacy services;

(9) specialist services as required by patient conditions and/or authorized under the Workers' Compensation Law.

(10) occupational disease and injury services; and

(11) such other services as may be required by the commissioner to be provided as a condition of certification.

(i) "Service area" shall refer to an area defined on a county by county basis.

(j) "Employer" shall mean an employer covered by the Workers' Compensation Law who is either self-insured or who contracts with an insurer to arrange for coverage for employees for all necessary treatment and care for accidental injury, illness arising out of and in the course of employment or for occupational disease.

(k) "Rural area" shall mean any county not defined as an urban area pursuant to this section.

(l) "Urban area" shall, for the purposes of this Part, mean the following counties: Albany, Bronx, Broome, Chautauqua, Chemung, Dutchess, Erie, Kings, Monroe, Montgomery, Nassau, New York, Niagara, Oneida, Onondaga, Orange, Oswego, Putnam, Queens, Rensselaer, Richmond, Rockland, Saratoga, Schenectady, Suffolk and Westchester.

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-1.2 - Preferred Provider Organization Certification

732-1.2 Preferred Provider Organization Certification.

(a) Any plan, owned, operated or administered by an entity which has the capacity to establish a network of service providers to coordinate and provide all services provided or arranged for under the workers' compensation law to diagnose, treat and rehabilitate a claimant requiring medical treatment of an occupational disease or accidental injury arising out of and in the course of employment, as enumerated in paragraphs (1) to (11) of subdivision (h) of section 732-1.1 of this Subpart and to meet the operating standards established in Subpart 732-2 of this Part may apply to the commissioner for certification as a PPO. Such application shall be on forms provided by the Department of Health and shall be accompanied by a $500 application fee.

(b) Each application for certification as a PPO shall include the following information:

(1) the standards by which the providers participating in the preferred provider organization will be selected;

(2) the names and credentials of all individuals and organizations, and certifications of all hospitals, that will provide service under the preferred provider organization, together with appropriate evidence of workers' compensation board authorizations for such individuals as well as evidence of compliance with all licensing or certification requirements for such individuals or organizations to practice in this State;

(3) a description of any final disposition of professional misconduct charges against any of the individuals or organizations which will provide medical or other health care services under the preferred provider organization program;

(4) a description of the times, places and manner of providing service under the preferred provider organization;

(5) a detailed description of procedures to be followed in meeting the requirements of Subpart 732-2 of this Part for ongoing quality assurance, service utilization review and dispute resolution; including:

(i) procedures for implementing the internal dispute resolution protocol described in paragraph (1) of subdivision (h) of section 732-2.2 of this Part;

(ii) for disputes not resolved through the internal dispute resolution process, a process for determining whether and how to access the Workers' Compensation Board dispute resolution process described in paragraph (2) of subdivision (h) of section 732-2.2 of this Part;

(6) if incorporated, a copy of the applicant's certificate of incorporation, bylaws and, if applicable, certificate of doing business under an assumed name;

(7) if not incorporated, a copy of the applicant's proposed certificate of incorporation, bylaws, partnership agreement, application for authority to do business in New York, and certificate of doing business under an assumed name, as applicable;

(8) a description of the projected service area;

(9) a description of how access to services will be provided to claimants who reside outside the proposed service area;

(10) a description of how the PPO will ensure that at least five medical or health care providers will be made available in each county to claimants in each area of specialization required or offered, OR:

(i) documentation indicating that there are not at least five physicians in a particular specialty in each county within the service area; and

(ii) documentation indicating that there are at least five of the following specialty physicians under contract within each county within the proposed service area: family practice (board certified GP); orthopedic surgery, neurology, internal medicine; physical therapist; chiropractor and surgeon; and

(iii) documentation indicating that there are at least five of the following specialty physicians under contract within a county or counties contiguous to one or more of the other counties which comprise the service area: anesthesiology, physical medicine and rehabilitation; psychiatry; psychology; radiology and dermatology; and

(iv) documentation indicating that there are at least five of the following specialty physicians under contract within the Workers' Compensation Board District Office service area: cardiology; pulmonary disease; ophthalmology; hand surgery; pathology; plastic surgery; urology; podiatrist; occupational therapist, neurological surgery; otolaryngology; thoracic surgeon; allergy and immunology; or

(v) documentation indicating that the standards contained in subparagraphs (i)-(iv) of this paragraph cannot be met along with documentation, acceptable to the chair, in consultation with the commissioner, indicating how the PPO will provide claimants with an equivalent and accessible choice of practitioners;

(11) a description of how the PPO will ensure that a claimant will be able to choose from at least three hospitals within a radius appropriate to the care needs of claimants in the event that hospitalization is necessary; provided that: (i) for urban counties, there shall be at least one hospital available within the county and at least two other hospitals available in counties other than such urban county, which are within the Workers' Compensation Board District Office service area; and

(ii) for rural counties, where there is no hospital affiliated with the PPO within a travel distance from either the work site or claimant's home of forty miles or less, the PPO shall permit the claimant to be treated at the hospital nearest to either the claimant's worksite or home that has the capability to treat the claimant's condition, and shall reimburse such hospital at the established diagnosis related group reimbursement rate, or as otherwise authorized by law;

(12) an independently audited financial statement of the current financial condition of the applicant; and

(13) such other information relating to the certification and operation of the PPO as the commissioner may deem necessary.

(c) An applicant shall demonstrate, to the satisfaction of the commissioner, that the medical director and the members of the board, officers, controlling persons of a corporation, the owners, including individuals, shareholders, and all of the partners of a partnership, are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the proposed PPO in the best interest of the PPO and in the public interest, and to provide proper care for claimants.

(1) In determining the character and competence of the foregoing individuals and controlling person(s), the commissioner shall consider matters including, but not necessarily limited to, criminal convictions, bankruptcy proceedings, and the quality of health-related services provided by such individuals and controlling person(s) and any facility or organization which is or has been affiliated or related to the PPO or its controlling person(s) or with which any officer, member of the board, controlling person, owner, partner or medical director is or has been affiliated. Such determination shall also identify and proscribe any financial interest by the insurer or employer in the PPO.

(2) If a controlling person is an entity already certified by the Department of Health to provide care and services, such entity may not be required to undergo as extensive a character and competence review as a controlling person not so certified.

(d) An applicant shall provide to the commissioner a list of all individuals comprising the governing body with current mailing addresses. An applicant shall demonstrate to the satisfaction of the commissioner that such governing body shall be responsible for establishment and oversight of the PPO's policies, management and overall operation, including responsibility for adoption and enforcement of all policies governing the PPO's management, contracting, health care services delivery, quality assurance and improvement and utilization review programs and all other PPO operations.

(e) The commissioner shall not certify an applicant to operate as a PPO until such applicant has satisfied the commissioner that the application is complete and that the applicant satisfies the criteria set forth in this section and Article 10-A of the Worker's Compensation Law. The commissioner shall review and act upon any complete application within 90 days of receipt of such application.

(f) In the event of a refusal to certify, the commissioner shall provide the applicant with a detailed written statement of the basis or bases for such refusal.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-1.3 - Change in ownership or control of Preferred Provider Organization.

732-1.3 Change in ownership or control of Preferred Provider Organization. The governing body shall provide the commissioner with written notice of any proposed change in the ownership or control of the entity certified to operate as a PPO. If such change requires the prior approval of any other agency, board or officer of this state, or any other state or jurisdiction, the governing body shall provide the commissioner with documentation of such other entity's determination to approve or disapprove such proposed change. No change shall be implemented prior to approval thereof by the commissioner pursuant to the applicable provisions of this Subpart for initial certification and the commissioner shall not issue such approval if the change in ownership results in the insurer or employer having a financial interest in the PPO.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-1.4 - Preferred Provider Organization Decertification

732-1.4 Preferred Provider Organization Decertification.

(a) The commissioner may revoke, suspend or amend the certification of any PPO if the commissioner finds that:

(1) the PPO fails to meet any of the requirements of this Part or Article 10-A of the Workers' Compensation Law, or fails to maintain compliance with the standards set forth in the application for certification.

(i) If the commissioner has reason to believe that such lack of compliance was unintentional and did not have a negative impact on any claimant, he or she may request from the PPO a plan of correction; and

(ii) if such plan of correction is accepted by the Commissioner and implemented, decertification shall not be required; or

(2) the PPO has knowingly provided false or misleading information in its application for certification.

(b) Decertification of a PPO shall preclude the organization and its principals from operating or being affiliated in any manner with a PPO certified pursuant to this Part for a period of not less than three years from the date of decertification.

(c) If the commissioner has reason to believe a medical or other health care provider or physician participating in a certified PPO fails to meet the requirements of Article 10-A of the Workers' Compensation Law or regulations promulgated pursuant thereto, he/she shall promptly provide information and documentation concerning such belief to the chair.

(d) The chair shall notify the commissioner of any providers disqualified from the PPO network under the Worker's Compensation Law.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

SubPart 732-2 - Operations

NOTE: A PPO shall arrange for or provide to claimants services for the diagnosis, treatment and rehabilitation of any accidental injury arising out of and in the course of employment and for occupational disease in accordance with claimant needs. Such care and treatment shall meet generally accepted professional standards and shall be provided by health care professional who are currently licensed, registered or certified as appropriate and are employed by or under contract with the PPO.

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete
Statutory Authority: 
Workers' Compensation Law, Article 10-A

Section 732-2.1 - Organization and administration

Section 732-2.1 Organization and administration.
(a) The PPO shall have a governing body functioning in accordance with the provisions of subdivision (d) of section 732-1.2 of this Part.
(b) The PPO shall employ an administrator who shall be responsible for overseeing all facets of the operation.
(c) The PPO shall employ a medical director responsible for oversight of all aspects of medical care including the quality and appropriate utilization of services and the development, updating and assurance of compliance with medical standards. Individuals providing medical direction shall have training and experience necessary for effective performance and any such individuals who practice medicine in New York State shall comply with licensing, registration and scope of practice requirements of the State Education Department. Medical direction shall also be provided consistent with the requirement that the insurer or employer shall not have a financial interest in the PPO.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.2 - General operating requirements

732-2.2 General operating requirements.

(a) The PPO shall develop, implement, require provider adherence to and make available for inspection by the commissioner quality and treatment standards and protocols, consistent with generally accepted standards of care, which will ensure the coordination, quality and continuity of care for claimants.

(b) The PPO shall ensure that emergency and urgent care are available and accessible to claimants twenty-four hours a day, seven days a week. However, a claimant may access any medical facility during an emergency or urgent care situation.

(c) The PPO shall ensure that first access to initial treatment for all non-emergency care is available to injured employees within 48 hours of a request by a claimant for treatment for any accidental injury arising out of and in the course of employment or for occupational disease and that subsequent referrals are made on a timely basis.

(d) If the PPO cannot provide access to necessary services within the approved provider network within 48 hours of a claimant's request, it shall secure such services from appropriate practitioners outside the approved network within 48 hours of a claimant's request and bear the cost of such services.

(e) The PPO shall develop and implement a system under which employees may obtain information on a 24 hour-a-day basis regarding the availability of necessary medical services including emergency services and other urgently needed medical care.

(f) The PPO shall submit to the commissioner and ensure the conduct of a service utilization review process which indicates what reports are to be produced, the frequency of review, the standards used and the types of corrective action to be taken when problems are identified. Such process shall:

(1) be consistent with the utilization review requirements of Article 49 of the State Insurance Law, Article 49 of the Public Health Law or a generally accepted and nationally recognized utilization review accrediting entity acceptable to the Commissioner; or

(2) be produced by an entity currently certified by the Utilization Review Accreditation Commission.

(g) The PPO shall submit to the commissioner a detailed description of the procedures to be followed for dispute resolution which shall include access to a second opinion for the claimant from another provider within the PPO at any time. The PPO shall comply with such procedures.

(h) The PPO shall submit to the commissioner and implement a grievance procedure consistent with applicable law. Such process shall address the objective and equitable resolution of disputes between the PPO and the employer and the PPO and the insurer.

(1) Grievances and/or disputes which arise between the PPO and the claimant may be handled in accordance with the internal dispute resolution protocol which shall comply with section 4408-A and Article 49 of the Public Health Law, as applicable. The internal dispute resolution protocol shall also address the resolution of disputes between the claimant and any PPO providers, providers and the insurer, the PPO and any providers and the PPO and the insurer.

(2) If a dispute is not resolved through the internal dispute resolution protocol, the parties may avail themselves of the remedies provided by sections 13-g, 13-k, 13-1 and 13-m of the Workers' Compensation Law. Notwithstanding the other requirements of this subdivision regarding the PPO's internal dispute resolution protocol, insurers, providers and PPOs wishing to protect their right to dispute resolution in accordance with this paragraph shall continue to have the right to file notice with the workers' compensation board in accordance with the timeframes established in sections 13-g, 13-k, 13-l and 13-m of the Workers' Compensation Law and have such disputes resolved in accordance with such laws.

(i) Consistent with all applicable statutes regarding the confidentiality of patient medical records, only the PPO shall have access to patient medical records maintained by network providers. The PPO shall provide any information required by the commissioner, the chair and/or the workers' compensation board including evidence of compliance with all regulatory requirements and representations made in the application for certification, on a timely basis and shall provide truthful testimony and supporting documentation including accurate and complete patient medical records to the workers' compensation board, as required by such board, on a timely basis and in accordance with applicable statute and regulation.

(j) An injured employee may continue to receive necessary care for a pre-existing condition in any compensation case from a non-PPO network provider who has been providing ongoing treatment to such employee for the specific work-related injury or illness. Such provider must be authorized pursuant to the workers' compensation law to provide such care. (k) The PPO shall make claimants aware of their right to opt out of PPO care, which shall include:

(1) the right of the claimant to seek medical treatment from outside the PPO only after thirty days have passed since his or her first visit to a PPO provider; and

(2) the right of an employer to require, under such circumstances, a second opinion from a provider within the PPO.

(l) The PPO shall not, by contract, written policy, or written procedure:

(1) prohibit or restrict any provider from disclosing to any claimant or designated representative any information that such provider deems appropriate regarding a condition or course of treatment;

(2) prohibit or restrict any provider from filing a complaint, making a report, or commenting to an appropriate governmental body regarding the policies or practices of the PPO which the provider believes may negatively impact upon the quality of, or access to, claimant care;

(3) prohibit or restrict any provider from advocating to the PPO on behalf of a claimant for a particular course of treatment; or

(4) purport to transfer to the provider, by indemnification or otherwise, any liability relating to activities, actions or omissions of the PPO as opposed to those of the provider.

(m) The PPO shall permit the claimant to choose to obtain treatment for occupational diseases from the New York State Occupational Health Clinics Network. Such treatment shall be specific to the claimant's occupational disease and all other care shall be provided by the PPO.

(n) The PPO shall maintain a return-to-work program in conjunction with the employer, treating physician and carrier to facilitate the return of injured workers to the workplace.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.3 - Quality assurance and improvement

732-2.3 Quality assurance and improvement.

(a) A PPO shall develop and implement on a continuous basis a quality assurance and improvement program that includes organizational arrangements and ongoing procedures for the identification, evaluation and resolution of potential and actual problems in health care administration and delivery to claimants. These organizational arrangements and ongoing procedures shall be fully described in written form, provided to all members of the governing authority, providers and staff, and made available to eligible employees of an affected employer.

(b) The organizational arrangements for the quality assurance and improvement program must be clearly defined and should include, but need not be limited to, the following:

(1) a quality assurance and improvement committee, responsible for quality assurance activities, consisting of the medical director, the administrator, at least one member of the governing body and provider representatives including physicians;

(2) accountability of the committee to the governing body, with requirements for periodic written and oral reports to the governing body;

(3) participation from an appropriate base of providers and support staff;

(4) supervision by the medical director;

(5) regularly scheduled meetings at appropriate intervals but at least quarterly; and

(6) written minutes of the meetings of the quality assurance and improvement committee describing in detail the actions taken by the committee, the medical charts reviewed, problems discussed, recommendations made, and any other pertinent discussions and activities.

(c) The content of the quality assurance and improvement program shall reflect the scope of services provided and address all of the following:

(1) high risk procedures;

(2) sentinel events or occurrences; screens to identify potential failures in quality of care;

(3) development of explicit criteria and protocols for evaluating the quality of care;

(4) review and documentation of all claimant complaints and written evaluations described in paragraph (12) of subdivision (e) of section 732-2.6 of this Subpart and reasons given by those who opt out. Such written evaluations from claimants and any data extracted from such forms shall be made available to the commissioner and chair upon request;

(5) review and assessment of the continuity of care;

(6) review and assessment of the appropriateness and timeliness of referrals;

(7) review of the education and training of all primary treating physicians to ensure their knowledge and training in occupational medicine and Workers' Compensation Law requirements, including but not limited to:

(i) regulatory and reporting requirements under the workers' compensation program; and

(ii) familiarity with workplace hazard causes, restrictions, disability evaluation and rehabilitation; and

(8) review of the adequacy of access to care as demonstrated by records of complaints pertaining to waiting periods for appointments and telephone access.

(d) A PPO shall document the manner by which it examines actual and potential problems in health care administration and delivery to eligible employees. While a variety of methods may be utilized, the following components shall be addressed:

(1) the establishment of procedures for the analysis, monitoring and assessment of the quality of care provided, including review criteria developed in accordance with generally accepted standards of medical practice;

(2) the acquisition of sufficient data to perform a meaningful analysis; for example, through a statistically valid sample size for medical chart review; and

(3) involvement of appropriate clinical personnel, including physicians and other providers, in peer review activities.

(e) The quality assurance and improvement program shall include the development and documentation of timely and appropriate recommendations for addressing problems that are identified in health care administration and delivery to claimants. The PPO shall demonstrate operational mechanisms for responding to those problems.

(f) The PPO shall document the steps taken to follow-up on recommendations made by the quality assurance and improvement committee. The PPO shall be able to demonstrate that recommendations of the committee responsible for quality assurance activities are reviewed and acted upon in a timely manner, in order to:

(1) assure the implementation of appropriate action relative to the recommendations;

(2) assess the results of such action; and

(3) provide for revision of recommendations or actions and continued monitoring when necessary.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.4 - Reimbursement

732-2.4 Reimbursement.

(a) A PPO shall not be required to reimburse for provider services in accordance with the provider fee schedules authorized pursuant to the Workers' Compensation Law.

(b) PPOs shall be eligible for reimbursement on a fee-for-service basis.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.5 - Contracts

732-2.5 Contracts.

(a) PPOs shall have written contracts with all providers in the network.

(1) Such contracts shall be made available for review by the commissioner upon request.

(2) The PPO shall develop and, upon request, make available to prospective providers, written application procedures and minimum qualification requirements which the provider must meet in order to be considered by the PPO.

(3) Unless otherwise specified in contract, a PPO shall not terminate a contract with a provider unless it gives the provider a written explanation of the reasons for the proposed termination and an opportunity for a review or hearing. Either party to a contract, however, may, on sixty day notice, exercise a right of non-renewal at the expiration of the contract period or, for a contract without a specific expiration date, on each January first occurring after the contract has been in effect for at least one year. Such non-renewal shall not constitute a termination.

(4) Unless otherwise specified in contract, a provider may not terminate a contract with a PPO except upon a material breach of contract by the PPO. Such terminations shall be reported to the chair and shall take effect only after arrangements for the continuing care of affected claimants, acceptable to the commissioner and such claimants, are effected.

(b) A PPO may enter into a management contract with an entity to oversee the management of the day to day activities of the PPO with respect to the performance of various services including: management information systems, utilization review, payment and medical dispute resolution and quality assurance. However, a PPO may not enter into a management contract with a self-insured employer, an insurance carrier or with any entity owned or controlled by, or affiliated with such carrier to oversee the management of the day to day activities of the PPO with respect to the performance of the following services: quality assurance and medical dispute resolution. Any such contract shall be effective only with the prior written consent of the commissioner, and shall include the following:

(1) a description of the proposed role of the PPO governing authority during the term of the proposed management contract. The description shall clearly reflect retention by the governing authority of the PPO of ongoing responsibility for statutory and regulatory compliance;

(2) a provision that clearly recognizes that the responsibilities of the governing authority of the PPO are in no way obviated by entering a management contract, and that any powers not specifically delegated to the management contractor through the provisions of the contract remain with the governing authority of the PPO;

(3) a clear acknowledgement of the authority of the commissioner to terminate the contract, when a determination is made that the PPO is not providing adequate care or otherwise assuring the health, safety and/or welfare of the claimants;

(4) a provision that annual reports on the financial operations and any other operational data requested by the governing authority of the PPO, the commissioner or chair, will be provided by the management contractor;

(5) a provision stating that the management contract approved by the department shall be the sole agreement between the management contractor and the governing authority of the PPO for the purpose of management of the PPO and payment to the management contractor for management services, and that any amendments or revisions to the management contract shall be effective only with the prior written consent of the commissioner; and

(6) specification of payment terms that are reasonable and do not jeopardize the financial security of the PPO.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.6 - Records, reports and information requirements

732-2.6 Records, reports and information requirements.

(a) Clinical records shall be made available for review by the commissioner and otherwise afforded confidentiality in accordance with applicable state law, including laws on confidentiality of HIV records, and unwarranted access shall be prevented.

(b) The PPO shall report to the commissioner information regarding disciplinary action against any provider or information regarding professional misconduct.

(c) All other business records and data maintained by the PPO, and relevant to the commissioner's authority to oversee the activities of the PPO and to determine the appropriateness of continued certification, either pursuant to applicable law or in the normal conduct of business, shall be made available to the commissioner and/or chair upon request.

(d) The PPO shall develop a detailed plan for providing affected employees with written notice of the PPO arrangement for the treatment of all workers' compensation injuries and illnesses. Such written notice shall also advise potential claimants where they may obtain a handbook which contains written information about the PPO as described in subdivision (e) of this section.

(e) The PPO shall develop a handbook, a limited number of which shall be distributed by an appropriate party to all participating employers, upon the entering of a contract between the PPO and the carrier. The handbook shall be written in an understandable manner. Employers will be expected to reproduce the handbook in sufficient numbers to provide copies to employees on an as-needed basis. The handbook shall contain:

(1) all information needed by an employee to access services and programs offered by the PPO, including 24 hour emergency care;

(2) the procedures for selecting and changing providers within the PPO network;

(3) a full explanation of all rights and responsibilities of the PPO, employer and employee when services are required;

(4) a detailed description of the policies and procedures of the PPO including service utilization review policies and procedures;

(5) the manner in which medical determinations are made in the PPO/workers' compensation area;

(6) a listing of all participating providers, including address and telephone number, their specialties, any board certification and the means of initiating contact;

(7) a description of how such providers are reimbursed;

(8) a description of the process for obtaining a second opinion, which the claimant may seek from another provider within the PPO at any time, with respect to a proposed medical treatment;

(9) a description of the process for opting out of PPO care which shall include:

(i) the right of the claimant to seek medical treatment from outside the PPO thirty days after his or her first visit to a PPO provider; and

(ii) the right of an employer to require, under such circumstances, a second opinion from a provider within the PPO;

(10) a description of how the PPO addresses the needs of non-English speaking claimants;

(11) the procedure for filing grievances against the PPO, the location and/or phone number where grievances may be filed and the procedure for processing and resolving grievances;

(12) a description of the process by which claimants may participate in a written evaluation of the PPO and thereby influence changes in policies and procedures;

(13) the procedure for filing a complaint with the workers' compensation board and/or the Department of Health;

(14) the procedure for obtaining a referral to the New York State Occupational Health Clinics Network when the claimant chooses to obtain treatment at such clinics for occupational disease; and

(15) general claimant education material which will assist the claimant in obtaining care.

(f) If a provider ceases participation in the PPO, or if any provider becomes unavailable to provide services to any claimant, the PPO shall provide written notice to affected claimants within fifteen days from the date that the organization becomes aware of such change in status. Such notice shall also describe:

(1) the procedures for choosing an alternative provider within the PPO network; and

(2) steps to be taken to ensure that medically appropriate continuity of care for the claimant is maintained.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Section 732-2.7 - Notice and approval required to discontinue operation

732-2.7 Notice and approval required to discontinue operation.

(a) No PPO shall voluntarily discontinue operation unless at least 90 days written notice of its intention to do so is sent to each participating carrier or self-insured employer, the commissioner and the chair. Such entities shall communicate this information to other affected employers.

(1) Operations shall not be discontinued until approval to do so is obtained from the commissioner.

(2) The commissioner shall grant such approval when the conditions of subdivision (b) of this section have been met.

(b) A PPO discontinuing operations for any reason, including decertification, shall, preceding discontinuance:

(1) notify the commissioner in writing and make arrangements, subject to the approval of the commissioner, to maintain, store, assure access to and make available upon request, all clinical records for a period of not less than six years after completion of treatment or, for a minor, six years after reaching the age of majority;

(2) provide a written plan, acceptable to the commissioner, for the continuation of care for each claimant; and

(3) comply with all requirements established by the commissioner in any order of decertification.
 

Effective Date: 
Wednesday, July 16, 1997
Doc Status: 
Complete

Article 5 - RESERVED

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Article 6 - Treatment Center and Diagnostic Center Operation

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law section 2803

Part 750 - General Provisions

Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 750.1 - General requirements

Section 750.1 General requirements. (a) As a minimum, all diagnostic and treatment centers shall comply with the rules and regulations as set forth in Part 751 of this Title.
(b) Diagnostic and treatment centers shall comply with the rules and regulations as set forth in Parts 752 through 756 of this Title for each service that is provided at the center.

Doc Status: 
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Part 751 - Organization and Administration

Effective Date: 
Wednesday, July 31, 2013
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 2803, 2803-b, 3612

Section 751.1 - Definition

Section 751.1 Definition. The terms diagnostic center and treatment center, also referred to in this article as a center, shall mean a medical facility with one or more organized health services not part of an inpatient hospital facility or vocational rehabilitation center primarily engaged in providing services and facilities to out-of-hospital or ambulatory patients by or under the supervision of a physician or, in the case of a dental service or dispensary, of a dentist, for the prevention, diagnosis and, in the case of a treatment center, treatment of human disease, pain, injury, deformity or physical condition, not including the individual or group private practice of medicine.
 

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Section 751.2 - Operator

751.2 Operator. The operator shall be responsible for the establishment of policies and the management and operation of the center in compliance with all applicable laws, rules and regulations, including the provisions of this Chapter. The operator shall not enter into any agreement limiting such responsibility. The operator shall be responsible for ensuring that all of the requirements of this Chapter applicable to the center are met. The responsibilities of the operator shall include but not be limited to:

(a) the development of a written statement of the purpose and objectives of the center;

(b) ensuring that all patients receive quality health care and services provided in accordance with generally accepted standards of professional practice;

(c) with regard to not-for-profit and business corporate operators, the adoption of bylaws concerning the organization and management of the corporation, including but not limited to, the selection and the authority and responsibilities of members, directors and officers and the number of members and directors necessary to constitute a quorum for the transaction of business;

(d) except with respect to sole proprietors, the establishment of committees, when appropriate, to assist the operator in meeting its functions and responsibilities;

(e) except with respect to sole proprietors, the provision for regular meetings of the operator which shall occur at least quarterly;

(f) ensuring that the following documents, as applicable, are retained on file in the administrative offices of the center:

(1) a current listing of all directors, officers and members or stockholders of a not-for-profit or business corporate operator and all partners of a partnership operator;

(2) the certificate of incorporation and any certificate of doing business;

(3) the current rules and bylaws of the operator;

(4) the current bylaws or policies and procedures of the medical and dental staff;

(5) the minutes of all meetings of the operator and committees, which shall be retained for a period of at least five years from the date of the meeting;

(6) the minutes of all meetings of the medical and dental staff and committees, which shall be retained for a period of at least five years from the date of the meeting;

(7) the applications for admission to staff privileges of all current medical and dental staff, which shall include for each applicant: a statement of training and experience, all supporting documents, satisfactory evidence of conformity with requisite professional licensing laws and records of actions and recommendations of staff committees of the respective professional staff and of the governing authority; and

(8) the reports of health facility inspections and surveys of outside agencies with statements attached thereto specifying the steps taken to correct any hazards or deficiencies or to carry out the recommendations contained therein, which shall be retained for a period of at least five years from the date of inspection;

(g) the appointment of a medical director;

(h) the appointment of medical and dental staff, the assignment of their clinical privileges and reviews of such appointments at least every two years;

(i) ensuring that medical and dental services are provided at the center only by members of the medical or dental staff of the center;

(j) the appointment of an administrator;

(k) the approval of medical and dental staff bylaws or medical and dental policies and procedures which are kept current and maintained by the center;

(l) the adoption of the center's budgets and control of all assets and funds, including provision of annual audits;

(m) the adoption of the center's operational, management and patient care policies;

(n) establishing and maintaining oversight of the quality assurance program as set forth in section 751.8 of this Part;

(o) the approval of all written agreements and/or contracts;

(p) the adoption of policies for the handling of patient emergencies within the center;

(q) the provision of staff, space, facilities, supplies and equipment for all functions and services adequate to meet the health care and safety needs of its patient population and to facilitate the efficient operation of the center;

(r) ensuring that all equipment is maintained in safe and working order; and (s) the prohibition of the splitting or sharing of fees between a referral agency and the center.
 

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Section 751.3 - Administrator

751.3 Administrator. The operator shall appoint an administrator whose training and experience is related to the services provided at the center, and who shall have executive authority and responsibility for the operation of the center.
 

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Section 751.4 - Medical director

751.4 Medical director. The operator shall appoint a medical director who:

(a) is qualified by training, experience and administrative ability to assume responsibility for the position;

(b) is delegated the authority and is responsible to the operator for the professional, organizational and administrative aspects of the adequacy and quality of care provided to patients in the center;

(c) is a physician licensed by and currently registered with the New York State Education Department. In dental centers, the director shall be a dentist who is licensed by and currently registered with the New York State Education Department;

(d) develops and recommends to the operator policies and procedures governing patient care in accordance with generally accepted standards of professional practice;

(e) develops and recommends to the operator policies and procedures concerning the appointment of medical and dental staff, the assignment of their clinical privileges and reviews of such appointments; and

(f) is responsible for the supervision of the quality assurance program and for reporting the activities of the program to the operator.
 

Doc Status: 
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Section 751.5 - Operating policies and procedures

751.5 Operating policies and procedures. The operator shall ensure:

(a) the development and implementation of policies and procedures written in accordance with prevailing standards of professional practice which include but are not limited to:

(1) the provision of service(s) without regard to age, race, color, sexual orientation, marital status, religion, sex, national origin or sponsor;

(2) provisions for communicating with patients who exhibit a communication barrier;

(3) a method for promptly handling patient complaints;

(4) the provision for continuing care by the same health care practitioner, when ever possible;

(5) ensuring prompt follow-up action on patients with abnormal test results or physical findings;

(6) the referral to a health-care facility or health-care practitioner for service(s) not available at the center;

(7) the prompt transfer of a copy of the pertinent parts of the medical record and other information, with the patient's written consent, when the patient is referred to another health-care facility or health-care practitioner;

(8) the identification, assessment, reporting and referral of cases of suspected child abuse or maltreatment and identification and treatment of victims of domestic violence;

(9) the identification, of patients' medically related personal and social problems which may interfere with the patients' treatment, recovery or rehabilitation;

(10) the establishment and implementation, in consultation with a qualified social worker, of a plan, consistent with available community and center resources, to provide or arrange for the provision of social work, psychological and health educational services that may be necessary to meet the treatment goals of its patients;

(11) if social work services are provided onsite by the center, the service must be under the direction of a qualified social worker and must be provided in accordance with all applicable requirements set forth in section 752.1 of this Title;

(12) the designation of a member of the center staff to be specifically assigned to implement policies and procedures for the coordination of the services of the center with the services of community health facilities and programs and community social agencies;

(13) the operation, maintenance and security of the center;

(14) ensuring that emergency equipment and staff prepared to care for emergencies are provided in accordance with the services provided at the center, and equipment is maintained in working condition;

(15) the granting of access to his/her health-care records to a patient or other qualified person in accordance with the provisions of section 18 of the Public Health Law and Subpart 50-3 of this Title; and

(16) if prenatal services are provided onsite, the center must ensure that the pregnant woman is provided HIV counseling and that voluntary HIV testing is recommended. Counseling and/or testing, if accepted, shall be provided pursuant to Public Health Law Article 27-F. Information regarding the woman's HIV counseling and HIV status must be transferred as part of her medical history to the delivering facility. Women with positive test results shall be referred to the necessary health and social services within a clinically appropriate time.

(b) the center's policies and procedures are available to all center personnel; and

(c) that the center's policies and procedures are reviewed at least annually and revised as necessary.
 

Effective Date: 
Wednesday, May 1, 1996
Doc Status: 
Complete

Section 751.6 - Personnel

751.6 Personnel. The operator shall ensure:

(a) the development and implementation of written policies and procedures, which are reviewed annually and revised as necessary;

(b) the employment of personnel without regard to age, race, color, sexual orientation, religion, sex or national origin;

(c) that the health status of each employee is examined prior to the beginning of employment, which is sufficient in scope to ensure that the employee is free from a health impairment which is of potential risk to patients or which may interfere with the performance of his/her duties;

(d) that a record of the following tests, procedures and examinations is maintained for all employees:

(1) a certificate of immunization against rubella which means:

(i) a document prepared by a physician, physician's assistant, specialist's assistant, nurse practitioner, licensed midwife or laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of rubella antibodies; or

(ii) a document indicating one dose of live virus rubella vaccine was administered on or after the age of twelve months, showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a copy of a document described in (i) or (ii) of this paragraph which comes from a previous employer or the school which the employee attended as a student; and

(2) a certificate of immunization against measles, for all personnel born on or after January 1, 1957, which means:

(i) a document prepared by a physician, physician's assistant, specialist's assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of measles antibodies; or

(ii) a document indicating two doses of live virus measles vaccine were administered with the first dose administered on or after the age of 12 months and the second dose administered more than 30 days after the first dose but after 15 months of age showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a document, indicating a diagnosis of the employee as having had measles disease, prepared by the physician, physician's assistant/ specialist's assistant, licensed midwife or nurse practitioner who diagnosed the employee's measles; or

(iv) a copy of a document described in (i), (ii) or (iii) of this paragraph which comes from a previous employer or the school which the employee attended as a student;

(3) if any licensed physician, physician's assistant/specialist's assistant, licensed midwife or nurse practitioner certifies that immunization with measles or rubella vaccine may be detrimental to the employee's health, the requirements of paragraph (1) and/or (2) of this subdivision relating to measles and/or rubella immunization shall be inapplicable until such immunization is found no longer to be detrimental to such employee's health. The nature and duration of the medical exemption must be stated in the employee's employment medical record and must be in accordance with generally accepted medical standards, (see, for example, the recommendations of the American Academy of Pediatrics and the Immunization Practices Advisory Committee of the U.S. Department of Health and Human Services); and

(4) for all personnel prior to employment or affiliation, except for personnel with no clinical or patient contact responsibilities who are located in a building or site with no patient care services, either tuberculin skin test or Food and Drug Administration (FDA) approved blood assay for the detection of latent tuberculosis infection, prior to employment or affiliation and no less than every year thereafter for negative findings. Positive findings shall require appropriate clinical follow-up but no repeat tuberculin skin test or blood assay. The medical staff shall develop and implement policies regarding positive outcomes; and

(5) an annual, or more frequent if necessary, health status reassessment to assure freedom from a health impairment which is a potential risk to the patients or might interfere with the performance of duties; (6) documentation of vaccination against influenza, or wearing of a surgical or procedure mask during the influenza season, for personnel who have not received the influenza vaccine for the current influenza season, pursuant to section 2.59 of this Title. (e) that a personnel file is maintained for each employee;

(f) that employees are qualified, as applicable, by:

(1) holding professional licensure and demonstrating evidence of current registration from the New York State Education Department or the New York State Department of Health; and/or

(2) meeting the definitional requirements of Parts 20, 94 and 700 of this Title; and/or

(3) demonstrating evidence of current registration or certification from the appropriate agency, association, council or board;

(g) the assignment of duties and functions to each employee that are commensurate with his/her licensure, registration and/or certification, and experience and competence;

(h) that each employee is provided with a copy of policies regarding conditions of employment;

(i) that there is a current written job description for each position which delineates duties, functions, responsibilities, and specific education and experience requirements; (j) that each new employee is provided with a planned orientation to the center's operation and personnel policies;

(k) that each employee, as applicable, receives on-the-job training necessary to perform his/her duties;

(l) that all staff receive education in the identification, assessment, reporting and referral of cases of suspected child abuse or maltreatment and identification and treatment of victims of domestic violence;

(m) the provision of in-service education and continuing education for all professional staff in order to maintain skills and current standards of professional practice;

(n) that a record is maintained for each employee which documents his/her attendance at orientation, on-the-job training and in-service education programs; and

(o) that each person delivering health care services wears identification indicating his/her name and title.

Effective Date: 
Wednesday, July 31, 2013
Doc Status: 
Complete

Section 751.7 - Medical record system

751.7 Medical record system. The operator shall:

(a) maintain a medical record system;

(b) designate a staff member who has overall supervisory responsibility for the medical record system;

(c) ensure that the medical record supervisor receives consultation from a qualified medical record practitioner when such supervisor is not a qualified medical record practitioner;

(d) ensure that the medical record for each patient contains and centralizes all pertinent information which identifies the patient, justifies the treatment and documents the results of such treatment;

(e) ensure that the following are included in the patient's record as appropriate:

(1) patient identification information;

(2) consent forms;

(3) medical history;

(4) immunization and drug history with special notation of allergic or adverse reactions to medications;

(5) physical examination reports;

(6) diagnostic procedures/tests reports;

(7) consultative findings;

(8) diagnosis or medical impression;

(9) medical orders;

(10) psychosocial assessment;

(11) documentation of the services provided and referrals made;

(12) anesthesia record;

(13) progress note(s);

(14) follow-up plans; and

(15) discharge summaries, when applicable;

(f) ensure that entries in the medical record are current, legible, signed and dated by the person making the entry;

(g) ensure that medical, social, personal and financial information relating to each patient is kept confidential and made available only to authorized persons;

(h) ensure that when a patient is treated by an outside health-care provider, and that treatment is relevant to the patient's care, a clinical summary or other pertinent documents are obtained to promote continuity of care. If documents cannot be obtained, the reason is noted in the medical record;

(i) maintain medical records at the center in a safe and secure place which can be locked and which is readily accessible to staff; and

(j) retain medical records for at least six years after the last date of service rendered to a patient or, in the case of a minor, for at least six years after the last date of service or three years after he/she reaches majority whichever time period is longer.
 

Doc Status: 
Complete

Section 751.8 - Quality assurance program

751.8 Quality assurance program. (a) The operator shall ensure the development and implementation of a written quality assurance program that includes a planned and systematic process for monitoring and assessing the quality and appropriateness of patient care and clinical performance on an ongoing basis. The program shall resolve identified problems and pursue opportunities to improve patient care.

(b) The program shall be supervised by the medical director.

(c) There shall be a written plan for the quality assurance program which describes the program's objectives, organization, responsibilities of all participants, scope of the program and procedures for overseeing the effectiveness of monitoring, assessing and problem-solving activities.

(d) The quality assurance process shall define methods for the identification and selection of clinical and administrative problems to be reviewed. The process shall include but not be limited to:

(1) the establishment of review criteria developed in accordance with current standards of professional practice for monitoring and assessing patient care and clinical performance;

(2) regularly scheduled reviews of medical charts, patient complaints and suggestions, reported incidents and other documents pertinent to problem identification;

(3) documentation of all quality assurance activities, including but not limited to the findings, recommendations and actions taken to resolve identified problems; and

(4) the timely implementation of corrective actions and periodic assessments of the results of such actions.

(e) The scope of clinical and administrative problems selected to be reviewed for the purpose of quality assurance shall reflect the scope of services provided and the populations served at the center.

(f) The outcomes of quality assurance reviews shall be used for the revision or development of policies and in granting or renewing staff privileges, as appropriate.

(g) There shall be participation in the program by administrative staff and health-care professionals representing each professional service provided.

(h) The findings, conclusions, recommendations and actions taken as a part of the quality assurance program shall be reported to the operator by the medical director.
 

Doc Status: 
Complete

Section 751.9 - Patients' rights

751.9 Patients' rights. Policies and procedures shall be developed and implemented regarding the patients' rights. The operator shall have in effect a written statement of patients' rights which is prominently posted in patient care areas and a copy of which is given to the patient. Such statement shall include the patients' rights to:

(a) receive service(s) without regard to age, race, color, sexual orientation, religion, marital status, sex, national origin or sponsor;

(b) be treated with consideration, respect and dignity including privacy in treatment;

(c) be informed of the services available at the center;

(d) be informed of the provisions for off-hour emergency coverage;

(e) be informed of the charges for services, eligibility for third-party reimbursements and, when applicable, the availability of free or reduced cost care;

(f) receive an itemized copy of his/her account statement, upon request;

(g) obtain from his/her health care practitioner, or the health care practitioner's delegate, complete and current information concerning his/her diagnosis, treatment and prognosis in terms the patient can be reasonably expected to understand;

(h) receive from his/her physician information necessary to give informed consent prior to the start of any nonemergency procedure or treatment or both. An informed consent shall include, as a minimum, the provision of information concerning the specific procedure or treatment or both, the reasonably foreseeable risks involved, and alternatives for care or treatment, if any, as a reasonable medical practitioner under similar circumstances would disclose in a manner permitting the patient to make a knowledgeable decision;

(i) refuse treatment to the extent permitted by law and to be fully informed of the medical consequences of his/her action;

(j) refuse to participate in experimental research;

(k) voice grievances and recommend changes in policies and services to the center's staff, the operator and the New York State Department of Health without fear of reprisal;

(l) express complaints about the care and services provided and to have the center investigate such complaints. The center is responsible for providing the patient or his/her designee with a written response within 30 days if requested by the patient indicating the findings of the investigation. The center is also responsible for notifying the patient or his/her designee that if the patient is not satisfied by the center response, the patient may complain to the New York State Department of Health's Office of Health Systems Management;

(m) privacy and confidentiality of all information and records pertaining to the patient's treatment;

(n) approve or refuse the release or disclosure of the contents of his/her medical record to any health-care practitioner and/or health-care facility except as required by law or third-party payment contract;

(o) access his/her medical record pursuant to the provisions of section 18 of the Public Health Law, and Subpart 50-3 of this Title;

(p) authorize those family members and other adults who will be given priority to visit consistent with your ability to receive visitors; and

(q) make known your wishes in regard to anatomical gifts. You may document your wishes in your health care proxy or on a donor card, available from the center.

Effective Date: 
Wednesday, September 13, 2006
Doc Status: 
Complete

Section 751.10 - Adverse Event reporting

751.10 Adverse Event Reporting

(a) Any adverse event required to be reported pursuant to subdivision (b) of this section shall be reported to the department within 24 hours or one business day of when the adverse event occurred or when the center has reasonable cause to believe that such an adverse event has occurred. This notification shall be submitted in a format specified by the department and shall at least include: the date, the nature, classification, and location of the adverse event and medical record numbers of all patients directly affected by the adverse event.

(b) Adverse events to be reported are:

(1) patients' deaths in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards;

(2) injuries and impairments of bodily functions, in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards that necessitate additional or more complicated treatment regimens or that result in a significant change in patient status;

(3) equipment malfunction or equipment user error during treatment or diagnosis of a patient which results in death or serious injury of a patient;

(4) patient elopements resulting in death or serious injury;

(5) abduction of a patient of any age;

(6) sexual abuse/sexual assault on a patient or staff member within or on the grounds of a center;

(7) physical assault of a patient or staff member within or on the grounds of a center;

(8) discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person;

(9) patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process;

(10) patient suicide, attempted suicide or self harm resulting in serious injury;

(11) poisoning occurring within the center;

(12) fires or other internal disasters in the center which disrupt the provision of patient care services or cause harm to patients or staff members;

(13) disasters or other emergency situations external to the center environment which affect center operations;

(14) termination of any services vital to the continued safe operation of the center or to the health and safety of its patients and staff members, including but not limited to the termination of telephone, electric, gas, fuel, water, heat, air conditioning, rodent or pest control, laundry services, food, or contract services; and

(15) strikes by staff members.

(c) The center shall conduct an investigation of any adverse events described in paragraphs (1 - 10) of subdivision (b) of this section. Such investigation shall be thorough and credible and occur within thirty days of when the adverse event occurred or when the center has reasonable cause to believe that such an adverse event occurred or upon determination by the department that an investigation is warranted in order to protect patient health and safety. If the center reasonably expects such investigation to extend beyond the thirty day period, the center shall notify the department electronically of such expectation and the reason(s) and shall inform the department of the expected date of completion, not to exceed sixty days. This investigative report shall be thorough and credible and the center shall submit its report electronically, in a format prescribed by the department.

(d) Nothing in this section shall prohibit the department from investigating any adverse event included in subdivision (b) of this section occurring in such centers.

(e) The requirements of this section shall be in addition to and shall not replace other reporting required by this Chapter.

Effective Date: 
Saturday, October 26, 2013
Doc Status: 
Complete

Section 751.11 - Center Accreditation

751.11 Center Accreditation.

(a) Centers must comply with the operational standards set forth in this Article 6 of Subchapter C of Chapter V of this Title. The commissioner may accept as evidence of compliance with the minimum operational standards of this Article 6 of Subchapter C of Chapter V of this Title, accreditation by an accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status and which the Commissioner has determined has accrediting standards sufficient to assure the Commissioner that centers so accredited are in compliance with such operational standards. The Commissioner can choose to enter into collaborative agreements with such accreditation agencies so that the accreditation agency's accreditation survey can be used in lieu of a Departmental survey. A list of accreditation agencies with which the Department has a collaborative agreement will be posted on the Department's website. These provisions shall apply provided that:

(1) there are no constraints placed upon release of the accreditation agency survey report, plan of correction, interim self-evaluation report, certificate of accreditation, notice on noncompliances, or such other material which the commissioner has accepted under this section; and

(2) the center is at all times subject to a survey for compliance with Article 6 of Subchapter C of Chapter V of this Title as deemed necessary by the commissioner.

(b) The center shall notify the commissioner in writing within seven days of failure to be accredited, re-accredited or the loss of accreditation by the accreditation agency.

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete

Section 751.12 - Validity

751.12 Validity. If any clause, sentence, paragraph or section of this Part shall be adjudged by any court of competent jurisdiction to be invalid, such judgment shall not affect, impair or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph or section thereof directly involved in the controversy in which such judgement shall have been rendered.

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete

Part 752 - Center Services

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

SubPart 752-1 - Center Services

Effective Date: 
Friday, April 26, 2002
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 752-1.1 - Professional services

Section 752-1.1 Professional services. Professional services are those health care services provided by individuals licensed pursuant to title 8 of the Education Law, and include, but are not limited to, those services provided by audiologists, certified social workers, dentists, occupational therapists, optometrists, physical therapists, physicians, podiatrists, psychologists, registered professional nurses and speech-language pathologists. For each professional service provided, the operator shall ensure that:

(a) services are provided in accordance with current standards of professional practice;

(b) there is participation by professionals, as appropriate, in the center's quality assurance program in accordance with the requirements set forth in section 751.8 of this Title;

(c) there is a professional person designated to be responsible for the direction of each professional service and the service is within their scope of practice;

(d) treatment is given upon the written order or referral of a physician or dentist for physical therapy and speech-language pathology services and upon written order or a referral of a physician for occupational therapy services; and

(1) a written plan of care and results of treatment is reviewed at least every 30 days by the physician and appropriate professional staff except when an order or referral specifies treatment of a longer duration, in which case the plan of care is reviewed by the physician and appropriate professional staff at least every 90 days;

(2) a qualified occupational therapist or physical therapist provides onsite supervision when certified occupational therapy assistants or physical therapy assistants provide care;

(3) each qualified occupational therapist or physical therapist supervises no more than four certified occupational therapy assistants or physical therapy assistants; and

(4) a qualified occupational therapist or physical therapist countersigns all reports written in the medical record by certified occupational therapy assistants or physical therapy assistants.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-1.2 - Physician's assistants and specialist's assistants

752-1.2 Physician's assistants and specialist's assistants. The services of physician's assistants and specialist's assistants shall be provided in compliance with the requirements of Parts 94 and 707 of this Title.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-1.3 - Diagnostic and therapeutic radiology

752-1.3 Diagnostic and therapeutic radiology. When this service is provided, the operator shall ensure that:

(a) a physician is responsible for the direction of this service;

(b) the services of a qualified specialist in radiology, as defined in section 700.2 of this Title, are provided or arranged for as needed;

(c) the radiographic procedures requiring the use of contrast media or fluoroscopic interpretation and control are performed with the active participation of a qualified specialist in diagnostic radiology or a physician qualified in a medical specialty related to the radiographic procedure and, that emergency equipment and staff trained in its use shall be available for anaphylactic shock reactions;

(d) a qualified specialist in radiotherapy is on the premises at all times when treatments are administered and a qualified radiation physicist is available for consultation when radiotherapeutic services are provided;

(e) the ordering and the interpretation of radiographs is done by a qualified physician, dentist, registered physician's assistant or registered specialist's assistant;

(f) the diagnostic and therapeutic radiological services are provided only where there is an adequate physical plant, adequate equipment and proper safety precautions and the radiological facilities are in compliance with Part 16 of this Title, or for facilities located in New York City, article 175 of the New York City Health Code. Copies of article 175 (Radiation Control) of the New York City Health Code are available from the City of New York, City Books, One Centre Street, Municipal Building, New York, NY 10007. Copies are also available for public inspection and copying at the Records Access Office, New York State Department of Health, Corning Tower, Nelson A. Rockefeller Empire State Plaza, Albany, NY 12237;

(g) radiological and teletherapy equipment is operated only by appropriate persons licensed by the New York State Education Department or the New York State Department of Health, in conformance with Part 89 of this Title; and

(h) the diagnostic and therapeutic radiological services are provided in accordance with current standards of professional practice.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-1.4 - Clinical laboratory

752-1.4 Clinical laboratory. When laboratory services are provided, the operator shall ensure that the laboratory complies with the the certification and permit requirements of article 5, title V of the Public Health Law. If the center makes arrangements for the provision of clinical laboratory services with a laboratory outside the center, the operator shall also ensure that any such laboratory has a current valid laboratory permit as required by article 5, title V of the Public Health Law.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-1.5 - Pharmaceutical provisions

752-1.5 Pharmaceutical provisions. The operator shall ensure that:

(a) when there is a pharmacy onsite, it is registered with the State Education Department and meets applicable sections of Part 80 of this Title:

(1) the pharmacy is under the direction and supervision of a qualified pharmacist;

(2) there is a pharmaceutical services committee which shall include, but need not be limited to, the medical director, administrator, pharmacist and, when nursing services are provided, a registered professional nurse. The committee shall:

(i) meet as necessary but at least once every six months;

(ii) establish and maintain a formulary available to all staff members authorized to prescribe medications; and

(iii) be responsible for the development, implementation and review of policies and procedures for obtaining, dispensing, controlling, storing, administering and utilizing medications and biologicals in the center, and other related pharmaceutical matters;

(b) when medications and biologicals are handled by personnel in the center in the absence of a pharmacy, there shall be consultation from a qualified pharmacist to assist in the development of policies and procedures for providing medications and biologicals;

(c) expired or deteriorated medications and biologicals are destroyed in accordance with professional standards of pharmacy practice;

(d) adverse drug reactions are reported to the practitioner responsible for the patient and documented in the medical record; and

(e) pharmaceutical services are provided in accordance with current standards of professional practice.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

SubPart 752-2 - Up-Graded Diagnostic and Treatment Center Services

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 2803

Section 752-2.1 - Definitions

Section 752-2.1 Definitions. (a) For purposes of this sub-part, an "up-graded diagnostic and treatment center (UD&TC)" shall mean a general hospital that has relinquished its inpatient acute care bed capacity or a diagnostic and treatment center established pursuant to article twenty-eight of the Public Health Law, which possesses a valid operating certificate, is in substantial compliance with all other applicable state and federal requirements and;

(1) complies with the provisions of this section and the provisions of Parts 750, 751 and Parts 752 through 756 of this title, as appropriate;

(2) participates in a rural health network or a central services facility rural health network as defined in paragraph (c) of this subdivision;

(3) has a formal affiliation with a general hospital that complies with all provisions of Part 405 of this Title;

(4) is located in a rural area, defined as any county with less than two hundred thousand persons or any town which has a population of less than two hundred persons per square mile, or if approved by the commissioner, any town which has a population of of less than two hundred fifty persons per square mile.

(5) in addition to primary ambulatory care services, may provide limited emergency care services; and

(6) is designated by the Commissioner of Health to operate as an up-graded diagnostic and treatment center pursuant to guidelines developed by the commissioner and the provisions of Part 710 of this Title as appropriate. The guidelines for designation may be obtained from the commissioner and shall be published in the New York State Register. Upon designation, a UD&TC shall remain subject to all other requirements of this Title and the Public Health Law applicable to hospitals, including those pertaining to operating certificates and which shall also apply to the proposed revocation, suspension, limitation or annulment of a UD&TC designation.

(b) "Limited emergency care services" shall:

(1) include initial diagnostic evaluation, a limited range of procedures compared to those normally available in an emergency room of a general hospital, and the facilities necessary for resuscitation and stabilization;

(2) have a range and scope that responds to locally determined circumstances and is consistent with the clinical skills available through the center and affiliated network providers providing backup support;

(3) be developed within a coordinated network emergency medical services delivery system in a manner that complements and maximizes basic life support (BLS) and advanced life support (ALS) capabilities for the network service area in which the UD&TC operates; and

(4) be provided in a manner consistent with the emergency medical services component of an approved network operational plan or cooperative agreement.

(c) "Rural health network" shall mean an affiliation of health care providers serving a rural area, pursuant to a contract or joint cooperative agreement, which may plan, coordinate, provide or arrange for the provision of health care services to residents of the rural area and/or the provision of administrative services among such health care providers. Such network may also be organized pursuant to the not-for-profit corporation law and established as a central services facility rural health network pursuant to Parts 680 and 408 of this Title.

(d) "Medical control" shall have the meaning set forth in subdivision 15 of section 3001 of the Public Health Law and includes advice and direction provided by or under the direction of a physician to certified first responders, emergency medical technicians or advanced emergency medical technicians who are providing medical care at the scene of an emergency or in route to a health care facility. For the purposes of this Part, medical control shall also involve the implementation of network emergency medical service plans developed in conjunction with the Regional Emergency Medical Advisory Committee(s) responsible for the network's service area specified in a network operational plan or network cooperative agreement.

(e) "Professional" shall mean a person practicing medicine as defined in article 131 of Title 8 of the State Education Law, and may also mean other licensed and currently registered health care practitioners appointed by the governing body, in accordance with State law. The governing body shall determine which categories of health care practitioners are eligible candidates for appointment to the medical staff. The eligible categories may include qualified staff such as registered physician's assistants, registered specialist's assistants, registered professional nurses - nurse practitioners or clinical nurse specialists.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-2.2 - Limited emergency services

752-2.2 Limited emergency services. (a) General.

(1) The operator shall assure that limited emergency services are provided in accordance with this subdivision or subdivisions (b) and (c) of this section as appropriate.

(2) When limited emergency services are provided by an up- graded diagnostic and treatment center, the governing body through its medical/professional staff shall assure:

(i) the availability of limited emergency services on a 24-hour a day basis, seven days a week, within a network-wide emergency medical services (EMS) system as defined by a network operational plan or cooperative agreement; and

(ii) the availability of a 24-hour a day, continuous on-line communications link with its affiliated hospital(s) and other appropriate providers of emergency services, medical backup, consultation, inter-facility transport and medical control.

(3) UD&TCs that do not provide 24-hour a day on-site limited emergency services shall ensure that:

(i) patients in need of emergency care and arriving at the facility during non-operating hours are provided with information necessary to contact center personnel responsible for arranging/providing needed emergency care; and

(ii) EMS/ambulance personnel are able, at all times, to contact center personnel responsible for arranging/providing needed emergency care to facilitate appropriate patient disposition.

(b) Organization. (1) the entity or person established as operator shall ensure:

(i) that its medical/professional staff are sufficient in number and qualified to provide emergency services in accordance with patient needs and the service capabilities of the facility; and

(ii) that the medical/professional staff includes at least one licensed physician and one or more currently licensed or registered health care practitioners including but not limited to registered physician's assistants and nurse practitioners appointed by the operator's governing body, which shall mean the governing authority as defined in subdivision (a) section 600.9 of this Title. The members of the medical/professional staff shall:

(a) provide services in accordance with the UD&TC's policies and procedures;

(b) arrange for, or refer patients to, providers or services not available at the UD&TC as needed;

(c) assure that appropriate patient health records are maintained and transferred as required when patients are referred or transferred; and

(d) participate in the development, implementation and periodic review of the written policies and procedures governing the services of the UD&TC, which shall specify:

(1) the responsibilities of the emergency services unit to evaluate, initially manage and treat, or transfer patients to another facility for treatment;

(2) the organizational structure of the limited emergency service, including lines of administrative authority and delineation of responsibilities for patient services; and

(3) the prohibition of any refusal to treat or transfer patients based on their ability or inability to pay for services.

(2) At a minimum, the UD&TC shall maintain an adequate supply of emergency equipment, supplies, and medication readily available for treating emergency cases. The items available shall include but need not be limited to:

(i) drugs and biologicals commonly used in life-saving procedures such as: analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and oral and IV electrolytes and replacement solutions (adult and pediatric); and

(ii) equipment and supplies commonly used in lifesaving procedures such as: airway control and ventilation devices in adult and pediatric sizes, portable (transport) mechanical ventilators, endotracheal tubes, bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters.

(3) Emergency services shall be coordinated with other services of the UD&TC to facilitate continuity of care and discharge planning when post emergency needs do not require transfer to another facility.

(4) Emergency services shall be coordinated with other appropriate network providers, including ambulance providers serving the pre-hospital delivery system of the network.

(5) UD&TCs shall have an advanced life support (ALS) supported emergency transportation system available on a 24-hour a day on call basis to provide timely inter-facility transport.

(c) General policies and procedures. The UD&TC shall: (1) maintain the location and telephone number of the State Department of Health designated poison control center at the telephone switchboard and in the emergency service area of the center; (2) establish written procedures for screening and assessing patients to determine the most appropriate on-site treatment and for identifying cases beyond the facility's capacity to serve in order to arrange safe transfer to a more appropriate facility; and

(3) in cooperation with other network emergency medical service providers, develop written procedures to permit appropriately trained UD&TC personnel to provide necessary patient care on ambulances in potentially life threatening situations where such assistance is required.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-2.3 - Hospital transfer and emergency medical transport

752-2.3 Hospital transfer and emergency medical transport. The operator shall ensure that:

(a) utilization of protocols in combination with continuous communication with medical control shall be used to determine if the patient:

(1) requires immediate transport to another more appropriate facility;

(2) requires immediate stabilization and subsequent transport to another more appropriate facility;

(3) requires stabilization, observation and possible transfer to another facility; or

(4) may be treated and discharged within a reasonable length of time, as the patient's needs can be met by the resources of the center;

(b) the center, in consultation with medical control, the supporting hospital(s) and other appropriate emergency services providers in the network service area develops written destination and transport protocols for managing patients with medical needs beyond the service capabilities of the center; and

(c) written policies and procedures are implemented for the transfer of patients who develop, after treatment has been initiated, complications that are beyond the capabilities of the center. Such plans and procedures shall include arrangements for ambulance service and, when appropriate, the escort of the patient to the admitting facility by a clinical staff member of the center. Such plans and procedures shall also include but need not be limited to:

(1) guidelines to ensure the timely and orderly transfer of patients to more appropriate levels of care when needed;

(2) standard descriptions of patients, identifying those in need of specialized emergency care beyond the capability of the UD&TC, and the development or amendment of existing written transfer agreements with appropriate full service hospitals;

(3) ensuring that a copy of the medical record accompanies the patient upon transfer to the receiving facility; and

(4) establishing a mechanism for jointly reviewing all transfer patients by the transfer facility and the center as part of the quality assurance program specified in section 752-2.5 of this sub-part.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-2.4 - Administrative requirements

752-2.4 Administrative requirements. When limited emergency care services are offered by an UD&TC the operator shall ensure that:

(a) such care is provided in a specifically designated area of the center that is staffed, equipped, and maintained during posted hours, and that the center is capable of providing care to patients with urgent and limited emergent medical problems and of ensuring that the services of a physician, physician's assistant or nurse practitioner with training and/or experience in emergency care, including Advanced Cardiac Life Support (ACLS), are immediately available by telephone or radio contact as established through written agreement with network providers, and available on site at the center within 30 minutes on a 24-hour a day basis. The UD&TC shall also:

(1) participate in the development and implementation of an EMS plan that shall be a component of the cooperative agreement or operational plan for the network within which the UD&TC operates. The plan must be acceptable to existing local EMS system and to service delivery providers operating within the network service area in order to ensure the provision of the services described above. In addition the operator shall:

(i) post hours of operation publicly in the communities it serves and make them available to the designated medical control facility for the network;

(ii) change posted hours of operation only after a specified notification period to insure the community has had ample warning of such changes;

(iii) install and maintain a radio operated or dedicated phone line (call box) outside the center to provide continuous contact with medical control and appropriate providers of advice and/or emergency transport for patients who may arrive at the center after operating hours; and

(iv) develop written polices and protocols for medical control. Such protocols shall be developed in conjunction with appropriate network providers, entities providing medical control services, consistent with area and regional EMS protocols, and be approved by the area Regional Emergency Medical Advisory Committee (REMAC);

(2) provide initial diagnostic evaluation, a limited range of treatments, necessary resuscitation and stabilization, and initiate transport to an appropriate facility affiliated with the rural health network, or other hospital, for services not offered at the center; and

(3) clearly outline, in a network cooperative agreement or operational plan, treatment and admission criteria for limited emergency cases and integrate the plan with the network's EMS delivery system;

(b) maintain the capacity to handle limited emergency patients in need of immediate stabilization, and arrange for transfer to an appropriate facility;

(c) ensure that specific written operating procedures are established delineating the duties and responsibilities of medical, nursing and other clinical support staff in providing high quality, coordinated, emergency care services;

(d) ensure that the center, in conjunction with other network EMS providers, develops and supports network-wide systems for mutual aid, overlapping coverage, destination protocols, data collection and other aspects requiring coordination to enhance the delivery of emergency medical services; and

(e) ensure that the center participates in a comprehensive, on-line information and data collection system to enable on-going evaluation of the provision of emergency services including medical control, consultation, emergency medical back-up and pre-hospital emergency services.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-2.5 - Medical/professional staff

752-2.5 Medical/professional staff. The operator shall ensure that:

(a) in addition to the requirements set forth in section 751.4 of this Title, the medical director is a licensed and currently registered doctor of medicine or osteopathy who is board-certified, or board-eligible for a period not to exceed five years after the physician first attained board eligibility, in emergency medicine, surgery, internal medicine, pediatrics or family practice, has successfully completed a course and is currently certified in ACLS or has training and experience equivalent to ACLS and is certified in advanced trauma life support (ATLS) and/or pediatric advanced life support (PALS) or has had training and experience equivalent to ATLS and\or PALS;

(b) in addition to the requirements set forth in section 751.6 of this Title, the emergency service will be staffed by a physician's assistant, nurse practitioner or registered professional nurse who has successfully completed a course and is currently certified in ACLS or has training and experience equivalent to ACLS and who preferably is certified in ATLS and/or PALS or has training and experience equivalent to ATLS and/or PALS; and

(c) nursing services are staffed by experienced registered and/or licensed practical nurses to assure that the nursing needs of all emergency patients are met;

(1) patient care responsibilities are delineated in writing for all nursing service personnel;

(2) nursing services are provided in accordance with current standards of professional practice; and

(3) a registered professional nurse with training and current certification in trauma nurse care coordination (TNCC) is in charge of nursing services in the emergency care services unit.

Effective Date: 
Wednesday, April 26, 1995
Doc Status: 
Complete

Section 752-2.6 - Quality assurance and utilization review

752-2.6 Quality assurance and utilization review. In addition to meeting the requirements set forth in section 751.8 of this Title, the quality assurance program of the UD&TC shall be developed and implemented for all services in accordance with the on-going quality assurance program of the affiliated general hospital, at a minimum, and preferably, with a network quality assurance program should one exist.

(a) The UD&TC's quality assurance program shall be coordinated jointly with a general hospital participating in the network. This program should include provisions for risk management, quality improvement, and utilization review involving prospective, concurrent and retrospective analyses.

(b) If there is a network-wide quality assurance program, the center shall coordinate its quality assurance activities with such program to enhance the quality of patient care and to identify and prevent incidents of malpractice, and to implement the required medical malpractice prevention program.

(c) The UD&TC's quality assurance program shall utilize a performance- based approach, as well as:

(1) an established set of written criteria for care, using both process and outcome measures;

(2) a mechanism for tracking patients throughout the provider network and analyzing negative outcomes that result from the lack of access to and/or availability of needed care; such mechanism may include a network-wide patient registry or medical records system; and

(3) a dedicated, continuous on-line information system for linking the UD&TC with the facility or facilities providing network core services and other appropriate primary care and emergency services providers as identified by the governing body of the network.

(d) A UD&TC's utilization review program shall provide for prospective, concurrent and retrospective review processes, as follows:

(1) the prospective review process shall be locally developed by clinicians from the UD&TC and from the facility or facilities providing core hospital services to the network within which the center operates, and shall be based upon the service capabilities of those facilities;

(2) the concurrent review process shall provide for a review of patients treated at the UD&TC under exceptional circumstances (i.e., emergency or other life threatening situations, weather, availability of transport, equipment or staff prohibits transfer to a more appropriate facility) and patients whose service needs have changed after initiation of treatment and exceed the service capabilities of the center;

(3) the retrospective review process shall focus on on-going improvement in care delivery at the network, facility and case levels. The review process shall include case level assessments for patients as set forth in paragraphs (i) through (v) of subdivision (c) of section 752-2.5 and, in cases involving the transfer or referral of a patient to another facility, shall involve a facility level assessment. Case level review of the emergency medical care services of the UD&TC shall include, at a minimum:

(i) the care provided by the medical/nursing and other professional staff and by other health care practitioners employed by or associated with the UD&TC;

(ii) mortalities;

(iii) morbidity in circumstances other than those related to the natural course of disease or illness;

(iv) infections, complications, errors in diagnosis, transfusions and results of treatments; and

(v) medical records, medical care evaluation studies, complaints, incidents and staff suggestions regarding patient care and safety, utilization review findings, patient profile analysis and other pertinent data sources.

(e) In addition to the activities of the quality assurance and utilization review provisions of this sub-part and section 751.8 of this Title, the UD&TC shall:

(1) review emergency service visits made at the UD&TC under exceptional circumstances involving life threatening situations, adverse weather, or non-availability of transport, equipment or staff that prohibits transfer to a more appropriate facility; and

(2) review cases involving transfer to a more service intensive facility.

Effective Date: 
Wednesday, April 26, 1995
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Complete

Part 753 - Family Planning Services

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Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 753.1 - Family planning services

Section 753.1 Family planning services. For purposes of this section, family planning services shall mean the planning and spacing of children by medically acceptable methods, not including the performance of abortions, to achieve pregnancy or to prevent unintended pregnancy. Nothing herein precludes approval of a family planning center to provide abortion services under Part 756 of this Title or limits the ability of a family planning center to offer information and referral services concerning abortion. When family planning services are provided, the operator shall ensure that:

(a) all medically acceptable methods for the prevention of unplanned pregnancy, screening for cervical and breast cancer, the prevention of and screening for sexually transmissible diseases and infertility diagnosis and treatment are made available at the center or by prompt referral to a health care facility or health care practitioner for service(s) not available at the center;

(b) referral is made to other providers of health services as indicated by the patient's needs and documented in the patient's medical record;

(c) information is provided regarding all medically acceptable family planning methods; and

(d) the services provided to each patient upon admission and as medically indicated thereafter shall include as a minimum:

(1) the provision of information of sufficient scope regarding all medically acceptable methods of preventing unplanned pregnancy to enable the patient to give informed consent prior to the initiation of any contraceptive method;

(2) a medical history and examination sufficient to enable the patient to make an informed selection of any appropriate family planning method;

(3) as appropriate, a physical examination including but not limited to, a screening for pregnancy, pelvic abnormality, cervical cancer, sexually transmissible diseases, hypertension, anemia, glycosuria and proteinuria; and

(4) post-examination interview, counseling and instruction regarding the specific contraceptive method of choice;

(e) services are provided in accordance with current standards of professional practice.
 

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Part 754 - Birth Center Services

Effective Date: 
Wednesday, May 1, 1996
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 754.1 - Definitions

Section 754.1 Definitions. (a) A birth center is a diagnostic and treatment center organized to provide care to low-risk patients during pregnancy, labor and delivery who require a stay of less than 24 hours after birth. Services are provided by a physician or licensed midwife to women during a normal and an uncomplicated pregnancy, labor, birth and puerperium. Birth center services are based on a philosophy that promotes a family-centered approach to care and views pregnancy and delivery as a normal physiological process requiring limited technological and pharmacological support. The center services are designed to meet the specific needs of the population being served and promote optimum pregnancy outcomes. The licensed midwife or physician provides care for the low-risk woman during pregnancy and stays with her during labor from the time of admission to the birth center through the immediate postpartum period providing continuous physical and emotional support, evaluating progress, facilitating family interaction and assisting the woman in labor and delivery. Nurse practitioners may provide prenatal and post partum care to birthing center patients. They may also provide supportive care during labor and delivery, but the attending provider for birth must be a physician or licensed midwife.

(b) A patient at low risk means a patient with a normal medical, surgical and obstetrical history and a normal, uncomplicated prenatal course as determined by adequate prenatal care, and prospects. for a normal uncomplicated birth. A pregnant woman, parturient or newborn shall be determined as low risk during the prenatal period, intrapartum and postpartum by the use of standardized criteria based on generally accepted standards of professional practice such as those approved by the department's Prenatal/Perinatal Advisory Council Subcommittee on Birth Centers in Guidelines for Birth Centers in New York State.

Effective Date: 
Wednesday, January 23, 2002
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Section 754.2 - Administrative requirements

754.2 Administrative requirements. When birthing center services are provided the operator shall ensure that:

(a) only those women for whom a prenatal and intrapartum history, physical examination and laboratory screening procedures have demonstrated the expectation of a normal, uncomplicated course of pregnancy and labor are admitted and cared for at the birth center;

(b) written policies, procedures and standard risk assessment criteria for determining low-risk pregnancies based upon generally accepted standards of practice are developed and implemented;

(c) written policies, procedures and protocols for the management of care are implemented in accordance with birth center philosophy;

(d) a physician or licensed midwife reviews the content of the informed consent form with each woman, and a copy is given to the woman before signing;

(e) there is a transfer agreement with a hospital(s) located within 20 minutes' transport time from the birth center to the transfer hospital for medical care of a woman or an infant when complications arise during the antepartum, intrapartum, postpartum or newborn period, written in accordance with section 400.9 of this Title;

(f) support services such as laboratory, radiology and family planning services not provided by the birth center are available by referral;

(g) the birth center services are available 24 hours a day for the admission of women, professional consultation and prompt response to inquiries;

(h) kitchen facilities are available to enable families to store and prepare food brought in for the laboring family; and

(i) the birth center takes action in accordance with the requirements of paragraph 405.21(c)(13) of this Title with respect to a voluntary acknowledgement of paternity for a child born out of wedlock.

Effective Date: 
Wednesday, January 23, 2002
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Section 754.3 - Service restrictions

754.3 Service restrictions. The operator shall ensure that:

(a) only women assessed as being low-risk by application of risk assessment criteria during pregnancy, labor, birth and puerperium are admitted and cared for at the birth center;

(b) surgical procedures are limited to those which may be performed during and after uncomplicated childbirth such as episiotomy and repair. Other surgical procedures, including forceps and vacuum extraction will not be permitted;

(c) general and regional anesthesia are not administered at the center; and (d) labor is not induced, inhibited, stimulated or augmented with pharmacological agents acting directly on the uterus during the first or second stages of labor.
 

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Section 754.4 - Hospital transfer procedures

754.4 Hospital transfer procedures. (a) There are written plans and procedures for the transfer of a woman or an infant to the obstetrical or pediatric services of the transfer hospital(s) when complications arise of an emergency nature. Such plans and procedures shall include arrangements for an ambulance service and, when appropriate, the escort of the patient to the admitting facility by a clinical staff member of the birth center.

(b) The operator, in collaboration with the transfer hospital(s) , shall develop a list of indicators necessitating transfer and a written procedure for automatic acceptance of such transfers by the transfer hospital.

(c) There shall be a system to ensure that a copy of the medical record accompanies the patient upon transfer to the hospital.

(d) There shall be an established mechanism for jointly reviewing all transfer cases by the transfer hospital(s) and the center as part of the quality assurance program specified in section 754.9 of this Part.
 

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Section 754.5 - Medical director and medical consultants

754.5 Medical director and medical consultants. The operator shall:

(a) appoint a medical director who:

(1) is a qualified specialist, as defined in section 700.2 of this Title, in obstetrics/gynecology or family practice;

(2) has obstetrical privileges that include admission and care of maternity patients at the hospital(s) used for transfer. In the absence of obstetrical privileges at the transfer hospital(s), there must be formal arrangements for the provision of obstetrical care at the transfer hospital(s);

(3) approves all policies, procedures and protocols for the medical management of care;

(4) approves standardized criteria for admission screening and monitoring the risk status of each mother during pregnancy, labor, birth and postpartum; and (5) is available for consultation and referral or has made arrangements with a qualified physician for these services;

(b) appoint a consultant physician who:

(1) is a qualified specialist, as defined in section 700.2 of this Title, in pediatrics or family practice and who has pediatric privileges that include admission and care of newborns at the transfer hospital(s). In the absence of pediatric privileges, there must be formal arrangements for the provision of pediatric care at the transfer hospital(s); and

(2) is available for consultation and referral.
 

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Section 754.6 - Clinical staff

754.6 Clinical staff. The operator shall ensure that:

(a) a licensed midwife or an obstetrician or a family practitioner attends each woman in labor from the time of admission, during labor, during the birth and through the immediate postpartum period. Such attendance may be delegated only to another licensed midwife or physician;

(b) a second staff person is also present at each birth who:

(1) is under the supervision of the licensed midwife or physician in attendance;

(2) has specialized training in labor and delivery techniques and care of the new born; and

(3) receives planned and ongoing training as needed to perform assigned duties effectively;

(c) if the center employs licensed midwives, a licensed midwife is appointed as director of midwifery services who is responsible for the development of policies and procedures for such services.

Effective Date: 
Wednesday, January 23, 2002
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Section 754.7 - Services for the care of mothers and newborns

754.7 Services for the care of mothers and newborns. The operator shall ensure that the birth center provides at least the following:

(a) admission screenings to assure that only low risk women are admitted to the birth center;

(b) active participation by women and families in their own health care plan to include but not be limited to:

(1) orientation to the birth center services and its philosophy and goals preceding registration; and

(2) attendance at prenatal education classes approved by the clinical staff which address, as a minimum, labor and delivery, infant care and feeding, parenting, nutrition, the effects of smoking, alcohol and other drugs on the fetus, what to expect if transferred, and the newborn screening program with the distribution of newborn screening educational literature;

(c) prenatal and intrapartum care including:

(1) a plan of care developed according to accepted professional standards;

(2) selection of pediatric services by the woman for follow-up care of the infant;

(3) providing HIV counseling and recommending voluntary testing to pregnant women during a prenatal visit. Counseling and/or testing, if accepted, shall be provided pursuant to Public Health Law Article 27-F. Information regarding the woman's HIV counseling and HIV status must be transferred as part of her medical history to the labor and delivery site. Women with positive test results shall be referred to the necessary health and social services within a clinically appropriate time;

(4) continuous risk assessment of the woman and fetus; and

(5) labor support and professional attendance at birth for the mother and her family;

(d) postpartum care including:

(1) care in the birth center to be provided for a minimum of four hours and a maximum of 24 hours after the third stage of labor is complete;

(2) a physical assessment of the newborn with the required eye prophylaxis in accordance with section 12.2 of this Title and newborn screening tests in accordance with Part 69 of this Title;

(3) birth registration in accordance with section 4130 of the Public Health Law;

(4) a physical assessment of the mother in accordance with established protocols including the evaluation of Rh status, need for Rh prophylaxis and the mother's ability to feed the infant prior to discharge from the center; and

(5) the transfer to the newborn's medical record of a mother's HIV test result, if one exists.

(e) discharge and follow-up including:

(1) maternal and newborn home visits the following day after discharge and upon the third day after discharge unless arrangements have been made for the infant to be seen by his/her physician. The home visits may be performed by professional nursing staff from the birth center, if the facility is approved under article 36 of the Public Health Law, or through an arrangement with a certified or licensed home health agency, to include an assessment of the mother-child relationship, an evaluation of the nutritional status of the infant and the physical and psychological status of the mother, performance of a hematocrit, rubella vaccination and Rh prophylaxis, if indicated, and newborn screening blood collection in accordance with Part 69 of this Title;

(2) assurance of immediate and ongoing pediatric care;

(3) provision of family planning counseling or arrangements for family planning services, if desired by the patient; and

(4) arrangements for follow-up visits at the birth center within a six-week period following the birth.
 

Effective Date: 
Saturday, February 1, 1997
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Section 754.8 - Medical records

754.8 Medical records. The operator shall ensure that, in addition to meeting the requirements in section 751.7 of this Title:

(a) The medical record for each woman admitted to the birth center shall contain the following information:

(1) results of physical and risk assessments;

(2) maternal history, to include medical, surgical, gynecological and psychosocial history;

(3) informed consent for birth center services;

(4) ongoing assessments of fetal growth and development;

(5) periodic evaluations of maternal health;

(6) results of laboratory tests;

(7) labor and birth information;

(8) newborn physical assessment, including APGAR scores, maternal-newborn interaction, ability to feed, eye prophylaxis, vital signs and accommodation to extrauterine life;

(9) postpartum assessment;

(10) discharge and follow-up plans;

(11) home visit reports;

(12) birth center follow-up visit report; and

(13) documentation of family planning counseling and the arrangements made for family planning services, if any.

(b) The medical record for each newborn shall be cross-referenced with the mother's medical record and contain the following information:

(1) copy of the newborn physical assessment;

(2) results from newborn screening tests;

(3) discharge summary with follow-up plans; and

(4) home visit report.
 

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Section 754.9 - Quality assurance

754.9 Quality assurance. In addition to meeting the requirements set forth in section 751.8 of this Title, the operator shall ensure that there is a review of all mother and/or newborn hospital transfers, with reasons for such transfers documented. Findings from these reviews shall be used in the development and revision of policies and in the consideration of renewing or granting staff privileges.
 

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Section 754.10 - Emergency care

754.10 Emergency care. The operator shall ensure that:

(a) emergency equipment and supplies approved by the medical director are available for use and include at least the following:

(1) intravenous therapy equipment;

(2) infant warmer;

(3) infant transport equipment;

(4) oxygen and oxygen administration equipment for mother and infant;

(5) airways and manual breathing bags for mother and infant;

(6) suction machine and equipment for mother and infant;

(7) infant laryngoscope and endotracheal tubes; and

(8) medications and intravenous fluids with supplies and equipment for administration;

(b) center staff are trained in resuscitation and other emergency procedures; and

(c) a physician or registered professional nurse and another staff member, both trained in emergency procedures, are on duty in the center when a mother is in the birth center.
 

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Section 754.11 - Validity

754.11 Validity. If any clause, sentence, paragraph or section of this Part shall be adjudged by any court of competent jurisdiction to be invalid, such judgment shall not affect, impair or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph or section thereof directly involved in the controversy in which such judgment shall have been rendered.

Effective Date: 
Wednesday, May 1, 1996
Doc Status: 
Complete

Part 755 - Free-Standing and Off-Site Hospital Based Ambulatory Surgery Services

Effective Date: 
Wednesday, February 22, 2012
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 755.1 - Ambulatory surgery definition

Section 755.1 Ambulatory surgery definition. An ambulatory surgery service is a service organized to provide those surgical procedures which need to be performed for safety reasons in an operating room on anesthetized patients requiring a stay of less than 24 hours' duration. These procedures do not include those outpatient surgical procedures which can be performed safelyin a private physician's office or an outpatient treatment room. Ambulatory surgery services may be provided in a free-standing ambulatory surgery center or a hospital-based ambulatory surgery center. Hospital-based ambulatory surgery centers may be on-site or off-site, as described in section 405.20 of this Title. The provisions of this Part shall be applicable to free-standing ambulatory surgery centers and off-site hospital-based ambulatory surgery centers.

Effective Date: 
Wednesday, March 11, 1998
Doc Status: 
Complete

Section 755.2 - Administrative requirements

755.2 Administrative requirements. When ambulatory surgery services are provided, the operator shall ensure that:

(a) there is a documented plan and procedure for the transfer of patients to a nearby hospital when hospitalization is indicated. Such plans shall include arrangements for an ambulance service and, when appropriate, escort of the patient to the hospital by clinical staff member of the ambulatory surgery service;

(b) the specific ambulatory surgical procedures which each physician and dentist is qualified and competent to perform are delineated in writing, reviewed on an ongoing basis by the medical staff and revised as necessary;

(c) the medical staff develops, maintains and reviews at least biannually a list of surgical procedures which may be performed in this service;

(d) each member of the medical staff practicing at the center with three or fewer physicians in any one specialty has an appointment with equivalent delineated privileges at one or more hospitals in the area. When there are four or more physicians in any one specialty practicing at the center, such appointments are not required;

(e) the medical staff adopts, with the operator's approval, bylaws which provide formal procedures for the evaluation of the application and credentials of registered physician's assistants and registered specialist's assistants applying for employment or privileges in the facility for the purpose of providing medical services under the supervision of a physician; and (f) evidence of compliance with operational standards, as set forth in Section 751.11 of this Title, shall apply. New facilities shall obtain accreditation from an accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status and which the Commissioner has determined has accrediting standards sufficient to assure the Commissioner that ambulatory surgery services so accredited are in compliance with ambulatory surgery services operational standards under this Chapter within two full years of operation.

Effective Date: 
Wednesday, February 22, 2012
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Section 755.3 - Surgery services

755.3 Surgery services. The operator shall ensure that:

(a) a surgeon or anesthesiologist who meets the definition of a qualified specialist, and is licensed by and currently registered with the New York State Education Department, is responsible for the surgery service and may fulfill the requirement for medical director;

(b) all surgical procedures are performed in accordance with current standards of professional practice;

(c) all tissues removed during surgery are examined by a qualified pathologist, except for those exempted by the operator on recommendation of the medical staff consistent with current standards of professional practice; and

(d) blood and blood products are maintained and used in accordance with Subpart 58-2 of this Title and are administered by only physicians or registered professional nurses.
 

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Section 755.4 - Anesthesia services

755.4 Anesthesia services. The operator shall ensure that:

(a) an anesthesiologist, licensed by and currently registered with the New York State Education Department, and who meets the definition of a qualified specialist, is responsible for the anesthesia services and may fulfill the requirement for medical director;

(b) administration of anesthesia is in accordance with current standards of professional practice;

(c) anesthesia is administered by only a qualified anesthesiologist, or a physician or dentist qualified to administer anesthesia, or a certified registered nurse anesthetist;

(d) when nonphysicians administer anesthesia, the anesthetist must be under the direct personal supervision of a qualified physician, who may be the operating surgeon;

(e) the person administering the anesthesia, other than local anesthesia, is not the operating surgeon; and

(f) a physician examines each patient immediately prior to surgery to evaluate the risk to anesthesia and the procedure to be performed.
 

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Section 755.5 - Nursing services

755.5 Nursing. The operator shall ensure that:

(a) nursing services are staffed to assure that the nursing needs of all patients are met;

(b) patient care responsibilities are delineated in writing for all nursing service personnel;

(c) nursing services are provided in accordance with current standards of professional practice;

(d) a registered professional nurse is in charge of the nursing services in the operating room; and

(e) only registered professional nurses function as circulating nurses in the operating room.
 

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Section 755.6 - Patient admission and discharge

755.6 Patient admission and discharge. The operator shall ensure that:

(a) patients shall be admitted only under the care of a licensed and currently registered physician or dentist, who shall be a member of the staff. The patient's condition and provisional diagnosis shall be established on admission by the patient's physician or dentist;

(b) the patient receives a history and physical examination and preoperative studies. The data and information are incorporated into the medical record prior to surgery;

(c) informed consent of the patient or, if applicable, the patient's representative, is obtained before surgery;

(d) each patient is evaluated by a physician or by an individual qualified to administer anesthesia as set forth in subdivision (c) in Section 755.4 of this Part for proper anesthesia recovery, and discharged upon the written order of a physician;

(e) verbal instructions understandable to the patient, confirmed by written instructions, are provided to each patient at discharge, and include at least the following:

(1) information about complications that may arise;

(2) telephone number(s) to be used by the patient should complications or questions arise;

(3) directions for medications prescribed, if any;

(4) date, time and location of the follow-up visit or return visit; and

(5) designated place to go for treatment in the event of emergency; and

(f) all patients who have received anesthesia are discharged in the company of a responsible adult, unless exempted by a physician.
 

Effective Date: 
Wednesday, December 29, 2010
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Section 755.7 - Medical record system

755.7 Medical record system. In addition to the requirements of section 751.7 of this Title, the medical record shall contain the following information:

(a) a history, physical examination, pertinent preoperative diagnostic studies and a preoperative diagnosis incorporated into the medical record prior to surgery;

(b) a record of any allergies and abnormal drug reactions;

(c) evidence of the appropriate written informed consent for surgery;

(d) preoperative and post-operative instructions;

(e) anesthesia record;

(f) an operative report describing surgical procedures performed and findings, completed by the individual performing the operation;

(g) post-operative follow-up report, including any post-operative abnormalities or complications;

(h) pathology reports on anatomical parts and tissues removed during surgery;

(i) a discharge diagnosis; and

(j) follow-up plans.
 

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Section 755.8 - Emergency care

755.8 Emergency care. The operator shall ensure that:

(a) emergency supplies and equipment are provided in accordance with the scope of surgical services provided at the facility, and include at least the following:

(1) an emergency call system;

(2) oxygen;

(3) airways, manual breathing bag and ventilator;

(4) cardiac defibrillator;

(5) cardiac monitoring equipment;

(6) thoracotomy set;

(7) tracheostomy set;

(8) laryngoscope and endotracheal tubes;

(9) suction equipment; and

(10) emergency drugs and supplies as specified by the medical staff; and

(b) an anesthesiologist or other physician and a registered professional nurse who are qualified in resuscitative techniques and emergency care are present and available until all patients have been discharged from the service.
 

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Section 755.9 - Quality assurance

755.9 Quality assurance. In addition to the requirements set forth in section 751.8 of this Title, the operator shall ensure that there are reviews of the appropriateness and necessity of procedures performed, operative complications and circumstances leading to hospitalization.
 

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Section 755.10 - Data requirements

755.10 Data requirements. (a) All facilities having freestanding ambulatory surgery services shall submit to the department, for each patient visit to the service, the following information: permanent facility identifier number assigned by the department; an identity-shielded patient record number; the patient's birthdate, sex and ZIP code; the date of the visit; the hour of the admission and discharge for the visit; operating room time used; principal diagnosis code; principal procedure code; other procedure code; primary reimbursement code; county of the patient's residence; the disposition of the patient on discharge; and physician's or dentist's license number; and method of anesthesia and such additional elements as are approved by the commissioner upon finding that they are recommended by the National Uniform Billing Committee and the National Committee on Vital and Health Statistics or are necessary for permitted uses of SPARCS data under section 400.18(e) of this Title.

(b) Facilities which are using their own computer facilities to process and maintain such data, and those with contracted services for the processing of such data, shall submit such data in computer-readable format according to specifications provided by the commissioner. Resulting reports and any hospital owner magnetic media will be returned to the facility after use by the department.

(c) Facilities certified to provide freestanding ambulatory surgery services shall submit such data within 30 days of the end of each calendar quarter. Data will be submitted in the form and manner prescribed by the commissioner.

(d) Facilities which do not submit corrected data within 30 days of receipt of the department's error report concerning such data will not be reimbursed under section 86-1.41 of this Title until compliance with this section is certified by the commissioner or his designee.

(e) Requests for deniable individual or aggregate data or data reports based on data submitted pursuant to this section shall be processed pursuant to section 400.18(e) of this Title.
 

Effective Date: 
Wednesday, January 5, 1994
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Part 756 - Abortion Services

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Statutory Authority: 
Public Health Law, Section 2803

Section 756.1 - General Requirements

756.1 General requirements. When abortion services are provided, the operator shall ensure that:

(a) the center complies with the requirements set forth in section 755.3(b)-(d) and, if there are anesthesia services, section 755.4, and also complies with sections 755.6 through 755.8 of this Title;

(b) there is a documented plan and procedure for the transfer of patients to a nearby hospital when hospitalization is indicated. Such plans shall include arrangements for an ambulance service and, when appropriate, escort of the patient to the hospital by a clinical staff member of the abortion service; and (c) services are provided in accordance with current standards of professional practice.

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Section 756.2 - Medical director

756.2 Medical director. In addition to the requirements set forth in section 751.4 of this Title, if the medical director is not an obstetrician/gynecologist who meets the definition of a qualified specialist as set forth in section 700.2 of this Title, there shall be consultation from an obstetrician/gynecologist in the development of policies and procedures governing the provision of abortion services.
 

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Section 756.3 - Patient management

756.3 Patient management. The operator shall ensure that:

(a) prior to performing the procedure, the patient receives a complete physical examination, with appropriate tests for a positive pregnancy diagnosis and sonography if there is a question of gestational age, and the results are documented in the patient's medical record;

(b) after the procedure, an evaluation of the physical and emotional status of the patient is made and documented in the patient's medical record;

(c) information and counseling about alternative methods of birth control are made available by a health care professional to all patients who want such information;

(d) referral is made to another facility for family planning services, if not available at the center, and if desired by the patient; and

(e) the determination of blood group and Rh type is made prior to the termination of pregnancy. The patient is evaluated for the risk of sensitization to Rho(D) antigen and, if the use of Rh immune globulin is indicated and the patient consents, an appropriate dosage is administered within 72 hours after the termination of pregnancy.
 

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Section 756.4 - Physician services

756.4 Physician services. The operator shall ensure that:

(a) physicians performing abortions at the center are qualified through training and experience; and

(b) at least one physician has admitting privileges at a hospital in order to ensure the necessary back-up for care.
 

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Section 756.5 - Nursing services

756.5 Nursing services. The operator shall ensure that:

(a) nursing services are staffed to assure that the nursing needs of all patients are met;

(b) patient care responsibilities are delineated in writing for all nursing service personnel;

(c) as a minimum, a licensed nurse is present in each treatment room when an abortion procedure is being performed;

(d) the recovery area is staffed to allow for continual observation of post-procedure patients;

(e) if abortions are performed in operating rooms, a registered professional nurse is in charge of the nursing services in the operating rooms;

(f) if there are rooms for post-operative recovery of patients, a registered professional nurse is in charge of the nursing services for the recovery rooms to ensure continual observation of post-operative patients; and

(g) only registered professional nurses function as circulating nurses in the operating room.
 

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Section 756.6 - Quality assurance

756.6 Qualify assurance. In addition to the requirements set forth in section 751.8 of this Title, the operator shall ensure that there is a review of any abortion procedure complication with the use of these findings in the development and revision of policies and in consideration of renewing or granting staff privileges.
 

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Part 757 - Chronic Renal Dialysis Services

Effective Date: 
Wednesday, November 18, 2015
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 757.1 - Codes and standards

Section 757.1 Codes and standards.

Operators of chronic renal dialysis centers shall comply with the codes and standards referred to in this section. Nothing herein shall preclude the operator of a chronic renal dialysis center from exceeding any codes and standards relating to the quality of care set forth in this Part. If a conflict occurs between the codes and standards set forth herein, or between them and regulations found elsewhere in this Chapter, the operator of a chronic renal dialysis center shall comply with the more restrictive requirement. The following codes and standards are hereby incorporated by reference, with the same force and effect as if fully set forth at length herein. Copies of such codes and standards are available for inspection and copying at the Regulatory Affairs Unit, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237. Copies are also available from the publisher or issuing organization at the addresses listed below.

(a) Title 42 of the Code of Federal Regulations, Part 494, Conditions for Coverage for End-Stage Renal Disease Facilities, 2008 edition, including all standards incorporated therein. These regulations are published by the Office of the Federal Register National Archives and Records Administration. Copies may be obtained from the Superintendent of Documents, United States Government Printing Office, Washington, D. C. 20402.

(b) In the document entitled "Guidelines for the Prevention of Intravascular Catheter Related Infections", the provisions entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children", Parts I -IV; and "Central Venous Catheters, Including PICCs, Hemodialysis and Pulmonary Artery Catheters in Adult and Pediatric Patients", pages 16 through 18, Morbidity and Mortality Weekly Report, volume 51, number RR-10, August 9, 2002. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration, United States Government Printing Office, Washington, D. C. 20402.

(c) "Recommendation for Preventing Transmission of Infections Among Chronic Hemodialysis Patients", developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration, United States Government Printing Office, Washington, D. C. 20402.

Effective Date: 
Wednesday, November 18, 2015
Doc Status: 
Complete

Section 757.2 - Additional requirements for chronic renal dialysis centers

Section 757.2 Additional requirements for chronic renal dialysis centers.

(a) Whenever referred to in this Part, the following definitions shall have the following meanings:

(1) Dialysis station means an individual patient treatment area that accommodates the dialysis equipment and the routine and emergency care indicated, and is sufficiently separate from other dialysis stations to afford protection from cross-contamination with blood-borne pathogens. A hemodialysis station shall be equipped with a chair or a bed, a hemodialysis machine, and access to a purified water source and dialysate concentrates.

(2) End-Stage Renal Disease (ESRD) network means entities contracted with the federal government that collect and share data and other information with the Centers for Medicare and Medicaid Services (CMS), New York State and chronic renal dialysis centers within a specific geographic area.

(3) Chronic renal dialysis center means an ambulatory care facility approved by CMS to provide chronic renal dialysis services and licensed by the New York State Department of Health to provide such services.

(4) Home dialysis means dialysis provided at home by a patient or care partner who is trained by a registered professional nurse to deliver dialysis (peritoneal or hemodialysis) treatments at the patient’s place of residence. The nurse responsible for home dialysis training must be a registered professional nurse who meets the licensure and practice requirements of New York State, has 12 months experience providing nursing care and 3 months experience working
as a nurse in the specific dialysis modality (peritoneal or hemodialysis).

(5) Dialysate means aqueous fluid containing electrolytes and, usually, dextrose, which is intended to exchange solutes with blood during hemodialysis. It is the fluid made from water and concentrates delivered to the dialyzer by the
dialysate supply system.

(6) Product water means water produced by a water treatment system or by an individual component of a system.

(b) Operators of chronic renal dialysis centers shall comply with Parts 751 and 752 of this Subchapter.

(c) The operator of a chronic renal dialysis center that provides pediatric services on other than an emergency basis, shall obtain pediatric nephrology consultation services with one or more board certified pediatric nephrologists. Such board certified pediatric nephrologist(s) shall follow current evidence based professionally accepted clinical practice standards for evaluating and monitoring the pediatric dialysis patients.

(d) Each chronic renal dialysis center certified for home dialysis services must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to patients who receive such services at the chronic renal dialysis center, and meet all applicable requirements contained in Title 42 of the Code of Federal Regulations, Part 494, Conditions for Coverage for End-Stage Renal Disease Facilities, 2008 edition.

(e) Each chronic renal dialysis center shall ensure that its water treatment and dialysate supply systems protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in water and improperly prepared dialysate. Each chronic renal dialysis center shall develop, implement and comply with policies and procedures related to water treatment, dialysate, and reuse that are understandable and include the following:

(1) sample of product water and a sample of dialysate shall have a microbiological examination at least once every month;

(2) sample of product water shall have a chemical examination at least once every three months; and

(3) water samples shall be examined by a laboratory licensed pursuant to Section 502 of the Public Health Law that is approved by the Department for the analysis of potable water.

(f) Each chronic renal dialysis center shall ensure that dialysis stations meet the requirements set forth in subdivision (a) (1) of this section.

(g) Each chronic renal dialysis center shall collaborate with its ESRD network, suppliers, utility service providers and the Department for surveys and for emergency preparedness, and shall also collaborate with other chronic renal dialysis centers to ensure that lifesaving dialysis services are available in the event of an emergency or disaster. The chronic renal dialysis center shall develop written policies and procedures that detail the actions it shall take and plan to be implemented in the event of an emergency or disaster.

Effective Date: 
Wednesday, November 18, 2015
Doc Status: 
Complete

Section 757.3 - Chronic renal dialysis service staffing

Section 757.3 Chronic renal dialysis service staffing.

(a) In addition to other requirements that may be applicable to the operator as set forth in this Chapter, the operator of chronic renal dialysis center shall ensure that the center is adequately staffed with qualified personnel as described in and in accordance with this section.

(1) Registered Professional Nurses. All registered professional nurses (RNs) working in a chronic renal dialysis center shall hold an active New York State license to practice in accordance with Article 139 of the Education Law and its implementing regulations. At least one RN shall be present, on duty, and available to provide nursing services including nursing supervisory duties at all times when patients are present at the center.

(2) Licensed Practical Nurse. All licensed practical nurses (LPNs) working in a chronic renal dialysis center shall hold an active New York State license to practice in accordance with Article 139 of the Education Law and its implementing regulations. LPN responsibilities shall be consistent with the authorization and training provided by the center. In addition, LPNs practicing in a chronic renal dialysis center who have received training and demonstrated the competencies required by such chronic renal dialysis center may, if authorized by the LPNs’ supervising RN, access and provide care to patients with central venous catheters. A supervising RN shall, in his or her sole discretion, determine whether an LPN has received the appropriate training and demonstrated competencies as required by the center to provide care to patients with central venous catheters. All LPNs who are authorized to perform intravenous therapy procedures shall perform such procedures in accordance with the provisions set forth in Section 400.15 of this Title.

(3) Qualified Social Worker. The operator of chronic renal dialysis center shall have on staff, a qualified social worker who is licensed and registered by the New York State Education Department to practice as a licensed master social worker (LMSW) or licensed clinical social worker (LCSW) as defined in and in accordance with Article 154 of the Education Law.

(4) Patient Care (Dialysis) Technicians. The operator of a chronic renal dialysis center shall ensure that all unlicensed staff who have responsibility for direct patient care meet or exceed the center's written policies and procedures that define the minimum experience and training qualifications of patient care technicians(PCTs) and perform such patient care only under the direction of an RN. The operator of a chronic renal dialysis center shall ensure that all PCTs that provide patient care at its center are certified by a CMS approved national commercial dialysis technician certification organization within 18 months post hire. Such PCTs must, under the direction of an RN, complete a training program approved by the medical director of the chronic renal dialysis center.

(b) The operator of chronic renal dialysis center shall comply with the following requirements and shall annually review, approve and implement policies and procedures that include or address the following:

(1) Non-catheter patient assessment and documentation must be completed by the RN within sixty (60) minutes of initiation of dialysis.

(2) Catheter patient assessment and documentation must be completed by the RN within forty-five (45) minutes of initiation of dialysis;

(3) All supervising RNs must be thoroughly familiar with and clearly understand the training and qualifications of LPNs under their supervision as well as the types of tasks that may be delegated to such LPNs at the chronic renal dialysis center. Supervising RNs shall determine, at their discretion, whether to delegate such tasks to the LPNs.

(4) All unlicensed staff that has patient care responsibilities must be supervised by RNs.

(5) Training, qualifications, practice, supervision and other requirements for all LPNs that may access central venous catheters. LPNs that may access central venous catheters must successfully complete an initial and thereafter an annual training program for central venous access which includes successful completion of a written examination and competency demonstration. This training must be approved by the operator’s governing body and the medical director. Documentation of such training must be maintained by the chronic renal dialysis center and made available to the Department upon request. LPNs who access central venous catheters must provide such care under the direction of an RN.

(6) The chronic renal dialysis center shall clearly define the minimum experience and training qualifications of all patient care technicians (PCTs) who provide services in such center and services that PCTs are authorized to perform. The operator of a chronic renal dialysis center shall maintain documentation that demonstrates that PCTs in its center have, within 18 months post hire, and maintain certification by a CMS approved national commercial dialysis technician certification organization.

Effective Date: 
Wednesday, November 18, 2015

Part 758 - Outpatient Rehabilitation Services For Persons With Head Injury

Effective Date: 
Monday, April 1, 1991
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 758.1 - Definition of services

758.1 Definition of services. Outpatient head injury rehabilitation services shall mean comprehensive services provided on an outpatient basis to persons with traumatic head injuries, who have residual cognitive and behavioral deficits and functional disabilities. The facility shall provide services which include goal-directed assessment, treatment and support services for the purpose of preventing or minimizing chronic disabilities, restoring the individual to the optimal level of physical, cognitive and behavioral functioning, or maintaining optimal functional abilities. These services are a necessary part of a continuum of care of rehabilitative services which are provided to persons with head injuries who no longer are in need of inpatient rehabilitative services, but who are still in need of care and services provided in an ambulatory setting. Services shall be provided in accordance with the requirements set forth in this Part and in Parts 751 and 752 of this Chapter. Outpatient services may be provided on a full day, half day or less than half day basis, depending on the needs of the individuals.
 

Effective Date: 
Monday, April 1, 1991
Doc Status: 
Complete

Section 758.2 - General requirements

758.2 General requirements. The operator shall ensure: (a) that in addition to the requirements in section 751.5 of Part 751, policies and procedures shall include the program goals and objectives, a description of the program, the type of patients served, admission criteria used to determine the appropriateness of an applicant and discharge criteria;

(b) that services shall be provided in an environment which is consistent with the behavior and cognitive limitations of individuals with head injuries and shall be provided in accordance with current standards of professional practice;

(c) distraction-free treatment rooms shall be available for all treating services;

(d) there is ongoing inservice training, and that continuing education shall be conducted on a regular basis for all personnel caring for such patients;

(e) the development and consistent application of written admission and discharge criteria for this service which include but are not limited to:

(1) patients admitted have traumatically-acquired head injuries or have diffuse brain damage caused by such factors as anoxia, toxic poisoning, cerebral vascular accident, or encephalitis which resulted in residual cognitive and behavioral deficits and functional disabilities, and who have been considered appropriate for an outpatient head injury rehabilitation program;

(2) patients admitted have potential for functional improvement or need to minimize chronic disability or are in need of diagnostic assessment;

(3) services offered by the program must be appropriate and necessary to meet the patients' needs and level of recovery or functioning; and

(4) patients admitted must not be in need of inpatient rehabilitative care.

(f) that the facility shall participate with the commissioner or his designee in a program of patient care and services monitoring which shall include but not be limited to review of admissions, care and services provided, continued stays, and discharge planning. The facility shall furnish such records and reports at such frequency as the commissioner or his designee may require and shall make available members of the interdisciplinary patient care team for case conferences as the commissioner or his designee deems necessary.
 

Effective Date: 
Monday, April 1, 1991
Doc Status: 
Complete

Section 758.3 - Management and staffing

.sc 758.3 758.3 Management and staffing. The operator shall ensure that: (a) an individual shall be designated as program director who has administrative responsibility for the outpatient head injury program;

(b) an individual with experience and training in the treatment of head injured individuals shall be designated as having clinical management responsibility and for ensuring appropriateness and quality and continuity of care provided by the head injury program. If this is not the medical director of the facility, the individual shall be accountable to the medical director for quality of care;

(c) assessment and treatment shall be provided by an interdisciplinary care team who have training and experience in treatment of individuals with head injuries, as needed to manage the functional, behavioral and cognitive needs of individuals served and to carry out the goals and objectives of the program;

(d) the service shall provide or make formal arrangements for vocational rehabilitation, special education, rehabilitation engineering or other services as needed;

(e) case management shall be provided which shall:

(1) ensure the coordination of treatment;

(2) provide ongoing contact with third-party payors;

(3) advocate for the patient and provide linkage to support services in the community, communicate with other agencies and insure an appropriate plan for follow-up care;

(4) serve as liaison among patient, family and staff to ensure that patient and family concerns are addressed; and

(5) include documented follow-up after discharge at three, six and twelve months to assess the patient's response to the discharge plan.

(f) education and counselling services shall be made available and offered to patients and families as needed.
 

Effective Date: 
Monday, April 1, 1991
Doc Status: 
Complete

Section 758.4 - Interdisciplinary care planning

758.4 Interdisciplinary care planning. The operator shall ensure that: (a) each patient is assessed upon admission by the physician to determine appropriateness for admission, care to be rendered and services needed. The assessment shall include a physical examination, medical history, medication review, summary of treatment to date, assessment of current conditions and the patient's response to therapeutic interventions;

(b) an initial functional assessment of the patient is performed by the interdisciplinary team members within two weeks of admission; and

(c) a written comprehensive care plan for each patient, based upon initial and ongoing interdisciplinary assessments, which establishes rehabilitation goals and objectives, and which specifies which professional staff are responsible for care consistent with their scope of practice and expertise, including timeframes for accomplishment of goals, shall be developed and implemented. The care plan shall be reviewed at least every thirty days and modified by the team according to the patient's needs. The care plan shall address at a minimum the following areas: medical assessment, physical function, cognitive function, psychosocial function, independent living skills, vocational and educational information and discharge planning.
 

Effective Date: 
Monday, April 1, 1991
Doc Status: 
Complete

Part 759 - Adult Day Health Care Services for Registrants with AIDS and other high-need populations

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sec. 2803

Section 759.1 - Definitions

Section 759.1 Definitions. As used in this Part, unless the context otherwise requires:

(a) For purposes of this Part, AIDS shall mean acquired immune deficiency syndrome and other human immunodeficiency virus (HIV) related illnesses.

(b) Registrant means a person who either has AIDS or HIV-related illness or is otherwise considered to be part of a high-need population that, regardless of HIV status and in the discretion of the Commissioner, would benefit from receiving adult day health care services and:

(1) who is not a resident of a residential health care facility, is functionally impaired and not homebound, and requires certain preventive, diagnostic, therapeutic, rehabilitative or palliative care or services but does not require the continuous 24-hour-a-day inpatient care and services provided by a general hospital, or residential health care facility;

(2) whose assessed social and health care needs can satisfactorily be met, in whole or in part, by the delivery of appropriate services in the community setting; and

(3) who has been accepted by an adult day health care program based on an authorized practitioner's order or a referral from a managed care organization or care coordination model and a comprehensive assessment conducted by the adult day health care program or by the managed care organization or care coordination model.

(c) Adult day health care program or program, means an approved adult day health care program that is provided in a licensed diagnostic and treatment center, a residential health care facility or an approved extension site of either.

(d) Adult day health care services, or services, means care and services provided to a registrant under the medical direction of a physician by personnel of the adult day health care program.  Such care and services are required to be in accordance with a comprehensive assessment of care needs and individualized health care plan to maintain or improve a registrant’s health status and enable the registrant to remain in the community.

(e) Managed care organization means a managed care plan or a managed long-term care plan.

(f) Operating hours for an adult day health care program means the period of time that the program must be open, operational and providing services to registrants in accordance with the approval granted by the Department.  Each approved adult day health care session must operate for a minimum of five hours duration, not including time spent in transportation, and must provide, at a minimum, nutritional services in the form of at least one meal and necessary supplemental nourishment and planned activities. In addition, an ongoing assessment must be made of each registrant's health status by the adult day health care program or by the managed care organization or care coordination model that referred the registrant to the adult day health care program in order to provide coordinated care planning, case management and other health care services as determined by the registrant's needs.

(g) Visit means an individual episode of attendance by a registrant at an adult day health care program during which the registrant receives adult day health care services in accordance with his or her comprehensive care plan.  Registrants referred by a managed care organization or care coordination model will receive services as ordered by those entities in conformance with those entities’ comprehensive assessment after discussion and consultation with the adult day health care program.  

(h) Registrant capacity means the total number of registrants approved by the Department for each session in a 24-hour day.

(i) Operator of an adult day health care program, or operator, means the operator of a diagnostic and treatment center or a residential health care facility that is approved by the Department to be responsible for all aspects of the adult day health care program.

(j) Practitioner means a physician, nurse practitioner, or a physician’s assistant with physician oversight.

(k) Department means the New York State Department of Health.

(l) Commissioner means the Commissioner of the New York State Department of Health.

(m) Care coordination model means a program model that meets guidelines specified by the Commissioner that supports coordination and integration of services pursuant to section 4403-f of the Public Health Law.

(n) Comprehensive assessment means an interdisciplinary comprehensive assessment of a registrant completed in accordance with section 759.5 of this Part by the adult day health care program or an interdisciplinary comprehensive assessment, approved by the Department, completed by the managed care organization or care coordination model that referred the registrant to the adult day health care program.

(o) Care plan means the comprehensive care plan developed in accordance with section 759.6 of this Part by the adult day health care program.

(p) Unbundled Services/Payment Option means the ability of an adult day health care program to provide less than the full range of adult day health care services to a functionally impaired individual referred by a managed care organization or care coordination model based on the registrant’s comprehensive assessment.  The full range of adult day health care services as described in Part 759 shall be available to all registrants enrolled in the adult day health care program.

 

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete

Section 759.2 - Applicability

759.2 Applicability.

(a)(1) The operator of a diagnostic and treatment center or a residential health care facility may provide adult day health care services to registrants when approved pursuant to Part 710 of this Title.

(2) A diagnostic and treatment center or a residential health care facility which has been approved by the department to operate an adult day health care program at its primary site may provide adult day health care services at an extension site approved by the department under the provisions of section 710.1 of this Title.

(3) A diagnostic and treatment center or a residential health care facility which does not operate an adult day health care program at its primary site may provide such a program at an extension site approved by the department in accordance with section 710.1 of this Title if there is not sufficient suitable space within the center or residential health care facility to accommodate a full range of adult day health care program activities and services. The department may conduct an on-site survey of the extension clinic or offsite location of the residential health care facility to determine whether the facility space and/or location is suitable for an adult day health care program.

(b) Prior to operation of the facility's adult day health care program, the operator shall apply to the department for approval in accordance with Part 710 of this Chapter and shall submit a description of the proposed program, including but not limited to:

(1) need for the program, including statements on philosophy and objectives of the program;

(2) range of services provided;

(3) methods of delivery of services;

(4) transportation arrangements for registrants;

(5) physical space and use thereof;

(6) number and expected characteristics of registrants to be served;

(7) personnel participating in the program, including qualifications;

(8) case management services and use of and coordination with existing community resources, including designated AIDS Centers, health homes and other licensed health facilities, alcohol and substance abuse programs and rehabilitation facilities as appropriate;

(9) financial policies and procedures;

(10) program budget;

(11) methods for program evaluation; and

(12) proximity to an identified number of potential registrants.

 

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete

Section 759.3 - Changes in existing program

759.3 Changes in existing program.

(a) Applications for approval of changes in the program, including but not limited to substantial changes in the physical plant, space and utilization thereof, the extent and type of services provided, and the program's registrant capacity, must be submitted to the Department in writing and must conform to the provisions of Part 710 of this Title.

(b) Written requests for additional program sessions must be based on the number and need of registrants and be approved by the Department.

(c) An operator may not discontinue the operation of services to registrants without:

(1) receiving written approval from the Commissioner in accordance with Part 710 of this Title.  The application to discontinue services must set forth the specific intended date of discontinuance and the intended plans for alternate services to registrants;

(2) notifying each registrant and coordinating with the registrant’s managed care organization, care coordination model, or primary care physician regarding the development of suitable plans for alternate services for each registrant; and

(d) The operator must notify the Department of the program’s election of the Unbundled Services/Payment Option in writing thirty days before commencement of this option.

Effective Date: 
Wednesday, June 14, 2017

Section 759.4 - General requirements

759.4 General requirements. The operator shall have and implement written policies and procedures which shall provide for:

(a) An operator must:

(1) provide services to registrants consistent with the requirements of this Title and Part and other applicable statutes and regulations;

(2) provide appropriate staff, equipment, supplies and space as needed for the administration of the adult day health care program in accordance with the requirements of this Part. Such staff are to be experienced in the care and management of persons with AIDS or HIV-related illness as well as in the care and management of other high-need populations that may be registrants of the program.  Equipment and space are to be sufficient to meet the assessed needs of registrants, including sufficient bath and toilet facilities, pursuant to Part 714 of this Title;

(3) provide each registrant with a copy of a bill of rights specific to the operation of the adult day health care program.  These rights include, but are not limited to:

(i) confidentiality, including confidential treatment of all registrant records;

(ii) freedom to voice grievances about care or treatment without discrimination or reprisal;

(iii) protection from physical and psychological abuse;

(iv) participation in developing the comprehensive care plan;

(v)  receiving written notification by the program at admission and following the continued stay evaluation of the services the registrant shall receive while attending the adult day health care program; and

(vi) freedom to decide whether or not to participate in any given activity.

(b) Administration.  Without limiting its responsibility for the operation and management of the program, the operator must designate a person responsible for:

(1) coordinating services for registrants with services provided by other community-based agency programs, including but not limited to, certified home health agencies, social service agencies, clinics and hospital outpatient departments and services; provided, however, with respect to registrants referred to the adult day health care program by a managed care organization or care coordination model, the coordination of such services shall be the responsibility of the managed care organization or care coordination model; and

(2) day-to-day direction, management and administration of the adult day health care services; such person must be a practitioner who has experience in the care and clinical management of persons with AIDS or HIV-related illness and other high-need populations that enroll as registrants, including but not limited to:

(i) assigning adequate and appropriately licensed personnel to be on-duty at all times when the program is in operation to ensure safe care of the registrants;

(ii) assigning and supervising activities of all personnel to ensure that registrants receive assistance in accordance with their comprehensive care plans, including nursing services under the supervision of a registered professional nurse with experience in the care and management of persons with AIDS or HIV-related illness and other high-need populations that enroll as registrants;

(iii) ensuring supervision of direct care staff in accordance with state rules and regulation;

(iv) developing and implementing or arranging for in-service orientation, training and staff development, staff counseling and supportive services, and infection control specific to AIDS and HIV-related illness and other high-need populations that enroll as registrants; and

(v) maintaining records in accordance with provisions of sections 400.2, 415.3(d)(1), 425.20 and 751.9(m)–(o) of this Title.

(c) Policies and procedures for service delivery.  The operator must:

(1) establish and implement written policies and procedures, consistent with the approved application for operation of the adult day health care program, concerning the rights and responsibilities of registrants, the program of services provided to registrants, use of physical structures and equipment, and the number and qualifications of staff members and their job classifications and descriptions;

(2) ensure that written policies and procedures, consistent with current professional standards of practice, are developed and implemented for each service and are reviewed and revised as necessary;

(3) develop protocols for each involved professional discipline to indicate when the service of such discipline should be included in the registrant assessment;

(4) ensure that professional personnel are fully informed of and encouraged to refer registrants to other health and social community resources that may be needed to maintain the registrant in the community; provided, however, with respect to registrants referred to the adult day health care program by a managed care organization or care coordination model, such referrals shall be the responsibility of the managed care organization or care coordination model;

(5) establish and implement written policies for the storage, cleaning and disinfection of medical supplies, equipment and appliances;

(6) establish and implement written policies and procedures governing medications brought to the program site by registrants;

(7) establish and implement written policies and procedures concerning refunds and prepayment for basic services in accordance with existing rules and regulations;

(8) establish and implement written policies and procedures concerning transfer and affiliation agreements covering registrants that are consistent with the standards specified in section 400.9 of this Title;

(9) provide in such agreement(s) reasonable assurance of assistance to each registrant in transferring to inpatient or resident status in a residential health care facility whenever the registrant is deemed by a practitioner to be medically appropriate for such care; and

(10) establish and implement a written affiliation agreement with a designated AIDS center or other hospital for the transfer of registrants requiring emergency care, acute inpatient care services and clinical, sub-specialty clinical, and ancillary services.

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete

Section 759.5 - Admission, continued stay, and registrant assessment

759.5 Admission, continued stay, and registrant assessment.

(a) The operator shall:

(1) select and admit to and retain in the adult day health care program only those persons for whom adequate care and needed services can be provided and who, according to the comprehensive assessment, can benefit from the services provided on the basis of at least one (1) visit per week to the program;

(2) assess each applicant, unless the assessment was conducted by a managed care organization or care coordination model that referred the applicant to the adult day health care program, utilizing an assessment instrument provided by the department as part of the admission review process, which assessment shall include, at a minimum, the following:

(i) medical needs, including the determination that the applicant is expected to need continued service for a period of 30 or more days from the date of the completion of the comprehensive assessment;

(ii) use of medication and required treatment;

(iii) nursing care needs;

(iv) functional status;

(v) mental/behavioral health status;

(vi) sensory impairments;

(vii) rehabilitation therapy needs, including a determination regarding the specific need for physical therapy, occupational therapy, and speech language pathology services;

(viii) family and other informal supports;

(ix) home environment;

(x) psycho-social needs;

(xi) financial status;

(xii) nutritional status

(xiii) ability to tolerate the duration and method of transportation to the program;

(xiv) evidence of any substance abuse problem; and

(xv) need for HIV risk reduction counseling.

(3) register each applicant only upon recommendation from the applicant's physician and after completion of a personal interview by qualified personnel with the applicant, next of kin and/or sponsor;

(4) register each applicant only after determining that the applicant is not receiving the same services from any other facility or agency;

(5) determine whether the applicant is receiving primary medical care and, if so, where the care is provided;

(6) admit an applicant to the service only after execution of a written agreement which shall include but not be limited to a requirement that:

(i) the applicant agrees to a medical examination at a physician's office, the facility or other appropriate site, within six weeks prior to or seven days after admission; and

(ii) the operator provides to the applicant, next of kin and/or sponsor a written list of basic services furnished by the facility to registrants and paid for as part of the registrant visit at daily, weekly or monthly rates;

(7) record all financial arrangements with the applicant or designated representative, with copies executed by and furnished to each party;

(8) make no arrangement for prepayment for basic services exceeding one month; and

(9) comply with the provision of financial policies as set forth in the applicable section of this Title;

(b) An individual may be registered in an adult day health care program only if his or her comprehensive assessment indicates that the program can adequately and appropriately care for the physical and emotional health needs of the individual.

(c) No applicant suffering from a communicable disease that constitutes a danger to other registrants or staff may be registered or retained for services on the premises unless a physician certifies that the registrant presents no significant risk to any person.

(d)  The operator may admit, on any given day, up to 10% over the approved capacity for that program.  The average annual capacity, however, may not exceed the approved capacity of the operator’s program.

 

Effective Date: 
Wednesday, June 14, 2017
Doc Status: 
Complete

Section 759.6 - Comprehensive care planning

759.6 Comprehensive care planning. (a) The operator shall:

(1) develop a comprehensive care plan based on the comprehensive assessment required by this Part and, when applicable, a transfer or discharge plan, for each registrant within five visits or within 30 days after registration, whichever is earlier.  The adult day health care program and the referring managed care organization or care coordination model must be sure to coordinate with each other regarding the development of a registrant’s comprehensive care plan;

(2) designate staff members to ensure the completion of the comprehensive care plan with the participation of consultants in the medical, social, paramedical and related fields as appropriate;

(3) ensure that the comprehensive registrant care plan includes for each registrant:

(i) designation of a professional person to be responsible for coordinating the comprehensive care plan;

(ii) the registrant’s pertinent diagnoses, including mental health status; types of equipment and services required; case management; frequency of planned visits; prognosis; rehabilitation potential; functional limitations; planned activities; nutritional requirements; medications and treatments; necessary measures to protect against injury; instructions for discharge or referral if applicable; orders for therapy services, including the specific procedures and modalities to be used and the amount, frequency, and duration of such services; and any other appropriate item;

(iii) the medical and nursing goals and limitations anticipated for each registrant and, as appropriate, the nutritional, social, rehabilitative and leisure time goals and limitations;

(iv) the registrant's potential for remaining in the community;

(v) transportation arrangements; and

(vi)  a description of all services to be provided to the registrant by the program, informal supports and other community resources pursuant to the comprehensive care plan, and how such services will be coordinated;

(4) ensure that development and modification of the comprehensive care plan is coordinated with other health care providers outside the program who are involved in the registrant's care.

(b) Designated staff members, with the participation of consultants in the medical, social, paramedical and related fields, as appropriate, shall:

(1) record in the clinical record changes in the registrant's status which require alterations in the registrant comprehensive care plan;

(2) modify the comprehensive care plan accordingly;

(3) review the comprehensive care plan at least once every six months and whenever the registrant’s condition warrants and document each such review in the clinical record; and

(4) promptly alert the registrant’s authorized practitioner of any significant changes in the registrant’s condition which indicate a need to revise the comprehensive care plan.

Effective Date: 
Wednesday, June 14, 2017
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Section 759.7 - Registrant continued stay evaluation

759.7 Registrant continued stay evaluation. The operator, directly or through the managed care organization or care coordination model that referred the registrant to the adult day health care program, must ensure that a written comprehensive assessment and evaluation is completed pursuant to section 759.5 of this Part at least once every six months for each registrant, addressing the appropriateness of the registrant's continued stay in the program.  Such assessment and evaluation is to address, at a minimum:

(a) a reassessment of the registrant's needs, including an interdisciplinary evaluation of the resident's need for continued services;

(b) the appropriateness of the registrant's continued stay in the program;

(c) the necessity and suitability of services provided; and

(d) the potential for transferring responsibility for or the care of the registrant to other more appropriate agencies or service providers.

Effective Date: 
Wednesday, June 14, 2017

Section 759.8 - Registrant services

759.8 Registrant services. The operator must provide or arrange for services appropriate to each registrant in accordance with the comprehensive assessment conducted and comprehensive care plan developed by the adult day health care program or by the managed care organization or care coordination model that referred the registrant to the adult day health care program.  The following registrant services shall be provided on-site, as appropriate, to each registrant in accordance with the individual's multidisciplinary assessment of needs and comprehensive care plan:

(a) medical services provided by the operator, which, without limiting its responsibility for the operation and management of the program, must:

(1) assign to the operator's medical board, medical advisory committee, medical director or consulting practitioner the following responsibilities regarding registrants of the program:

(i) developing and amending clinical policies;

(ii) supervising medical services;

(iii) advising the operator regarding medical and medically related problems;

(iv) establishing procedures for emergency practitioner coverage, records and consultants; and

(v) establishing professional relationships with other institutions and agencies, such as general hospitals, rehabilitation centers, residential health care facilities, home health agencies, hospital outpatient departments, clinics and laboratories;

(2) ensure that medical services, including arranging for necessary consultation services, are provided to registrants of the program in accordance with the registrant’s managed care organization or care coordination model;

(3) provide or arrange for the personnel, staff or other designated practitioner to obtain a medical history and a physical examination of each registrant, including diagnostic laboratory and x-ray services, as medically indicated, within six weeks before or seven days after admission to the program;

(4) ensure that the practitioner record, date and authenticate significant findings of the medical history, physical examination, diagnostic services, diagnoses and orders for treatment in the registrant's clinical records;

(5) ensure that orders for treatment include orders for medication, diet, permitted level of physical activity and, when indicated, special orders or recommendations for rehabilitative therapy services and other adult day health care services;

(b) case management services;

(c) food and nutrition services provided by the operator, which must:

(1) provide meals and nutritional supplements, including modified diets when medically prescribed, to registrants who are on the premises at scheduled meal times and, where appropriate, to registrants in their homes in accordance with the identified needs included in registrant comprehensive care plans;

(2) ensure that nutrition services are under the direction of a qualified dietitian;

(i) A qualified dietician is one who is qualified based on:

(a) registration by the Commission on Dietetic Registration of the American Diabetes Association;

(b) education, training, and experience in identification of dietary needs, planning, and implementation of dietary program; or

(c) certification as a certified dietician or certified nutritionist in accordance with Article 157 of the Education Law;

(3) ensure that dietary service records for the adult day health care service are maintained;

(d) social services provided by the operator must:

(1) be under the supervision and direction of a licensed clinical social worker;

(2) be provided through the use of a full or part-time licensed mental health professional in conformance with the approved application for operation and regular access may be directly with a master’s prepared or licensed mental health professional;

(3) either directly or through the managed care organization or care coordination model that referred the registrant to the adult day health care program, ensure that psychosocial needs are assessed, evaluated and recorded, and that services are provided to meet the identified needs of the registrant as part of the comprehensive care plan; and

(4) ensure that staff members arrange for the use of and/or access to other community resources as needed and coordinate the needs of the registrants with services provided by the adult day health care program and other health care providers, community social agencies and other resources; provided, however, with respect to registrants referred to the adult day health care program by a managed care organization or care coordination model, this shall be the responsibility of the managed care organization or care coordination model.

(e) assistance and/or supervision with activities of daily living, such as toileting, feeding, ambulation, bathing including routine skin care, care of hair and nails, and oral hygiene, and supervision and monitoring of personal safety, restorative rehabilitative and maintenance therapy services, and instrumental activities of daily living;

(f) rehabilitation therapy services provided or arranged by the operator, either directly or through the managed care organization or care coordination model that referred the registrant to the adult day health care program, in conformance with the registrant’s needs identified during the comprehensive assessment;

(g) an activities program, provided by the operator either directly or through the managed care organization or care coordination model that referred the registrant to the adult day health care program, which must involve community, interpersonal and self-care functions appropriate and sufficient in scope to the needs and interests of each registrant to sustain physical and psychosocial functioning and must:

(1) ensure that activities are an integral part of the program and reflect the registrants' individual interests and cultural backgrounds;

(2) ensure that activities are designed to enhance registrant participation in the program, home life and the community;

(3) involve appropriate volunteers and volunteer groups in the program, unless prohibited by law;

(4) provide sufficient equipment and supplies for the operation of the activity program;

(5) provide or arrange for transportation to and from community events and outings; and

(6) ensure that activities are included as part of each registrant's comprehensive care plan;

(h) nursing services, provided by the operator, directly or through the managed care organization or care coordination model that referred the registrant to the adult day health care program, must be based on the care needs of the registrant as specified in the comprehensive care plan and be provided by a registered professional nurse.  A licensed practical nurse, acting within his or her lawful scope of practice under Title VIII of the Education Law, may provide the on-site services when a registered professional nurse is available at the sponsoring licensed facility to provide immediate direction or consultation;

(1) in addition to providing nursing services as specified in the registrant comprehensive care plan, the operator must ensure that a registered professional nurse is available to conduct sick call triage assessments to registrants presenting with new problems or symptoms that result in consultation with the registrant’s primary care physician or the managed care organization in which the registrant is enrolled or, as necessary, immediate transfer to an emergency department;

(i) pastoral counseling, either provided directly or arranged for by the operator;

(j) counseling for HIV risk reduction;

(k) pharmaceutical services;

(l) substance abuse services;

(m) mental health and psychiatric services;

(n) ancillary services, commensurate with the level of care delivered on-site; and

(o) referrals for dental services and sub-specialty care that are in conformance with the needs identified during the comprehensive assessment.

Effective Date: 
Wednesday, June 14, 2017
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Section 759.9 - Medical record system

759.9 Medical record system. The operator must:

(a) maintain a medical record system that contains a record, including a current comprehensive care plan for each registrant, in accordance with accepted professional standards of practice and the medical records system section of this Title. Each registrant's medical record shall contain, as a minimum:

(1) identification and admission information, including:

(i) all details of the referral and registration;

(ii)  identification of next of kin, family and sponsor;

(iii)  the person or persons to be contacted in the event of emergency;

(iv)  accident and incident reports;

(v)  non-medical correspondence and papers pertinent to the registrant’s participation in the program; and

(vi)  a fiscal record including copies of all agreements or contracts;

(2) documentation of medical examinations, progress notes and discharge summaries; and

(3) all other pertinent information related to the resident's care including record of attendance;

(b) develop and implement policies and procedures to ensure the confidentiality of all medical records.

Effective Date: 
Wednesday, June 14, 2017
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Complete

Section 759.10 - General records system

759.10  General records system.  The operator must:

(a) maintain on the premises of the program or facility the following written records, which must be easily retrievable and must include, but not be limited to, the following:

(1) a chronological admission register consisting of a daily chronological listing of registrants admitted by name with relevant clinical and social information about each, including as a minimum, name, address, next of kin, attending practitioner, principal diagnosis, and the place from which each registrant was admitted;

(2) a chronological discharge register consisting of a daily chronological listing of registrants discharged by name, the reason for discharge and the place to which the registrant was discharged; and

(3) a daily census record consisting of a summary report of the daily registrant census with cumulative figures for each month and each year.

(b) maintain as public information, available for public inspection, records containing copies of all financial and inspection reports pertaining to the adult day health care services that have been filed with or issued by any governmental agency for six years from the date such reports are filed or issued.

Effective Date: 
Wednesday, June 14, 2017

Section 759.11 - Confidentiality of records

759.11  Confidentiality of records. The operator shall keep confidential and make available only to authorized persons all medical, social, personal and financial information relating to each registrant.

Effective Date: 
Wednesday, June 14, 2017

Section 759.12 - Quality assessment and assurance

759.12  Quality assessment and assurance. The facility shall establish and maintain a coordinated quality assessment and assurance program that integrates the review activities of facility services to enhance the quality of life and registrant care and treatment.

(a) Facility-wide quality assurance. Quality assurance shall be the responsibility of all staff, at every level, at all times. Supervisory personnel alone cannot ensure quality of care and services. Such quality must be a part of each individual's approach to his or her daily responsibilities.

(b) Quality assessment and assurance committee. The facility shall maintain a quality assessment and assurance committee consisting of at least the following:

(1) the program director;

(2) the licensed master social worker;

(3) a registered nurse designated by the facility;

(4) at least three other members of facility staff.

(c) Committee functions. The quality assessment and assurance committee shall:

(1) meet at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary;

(2) have a written plan for the quality assessment and assurance program which describes the program's objectives, organization, responsibilities of all participants, scope of the program, procedures for overseeing the effectiveness of monitoring, assessing and problem-solving activities. Such plan shall also provide for the development and implementation of quality improvement initiatives designed to advance the quality of life, care and services in the facility;

(3) define methods for identification and selection of clinical and administrative problems to be reviewed. The process shall include but not be limited to:

(i) the establishment of review criteria developed in accordance with current standards of professional practice for monitoring and assessing registrant care and clinical performance;

(ii) regularly scheduled reviews of clinical records, resident complaints and suggestions, reported incidents and other documents pertinent to problem identification;

(iii) consultation, on at least a quarterly basis with the Consumer Advisory Board, to seek recommendations on quality improvements;

(iv) documentation of all quality assessment and assurance activities, including but not limited to, the findings, recommendations and actions taken to resolve identified problems; and

(v) the timely implementation of corrective actions and periodic assessments of the results of such actions;

(4) ensure that the outcomes of quality assurance reviews are shared with appropriate staff to be used for the revision or development of facility policies and practices and in granting or renewing staff privileges, as appropriate; and

(5) facilitate participation in the program by administrative staff and health-care professionals representing each professional service provided; and

(6) report its activities, findings and recommendations to the governing body as often as necessary, but no less than 4 times a year.

 

 

 

 

Effective Date: 
Wednesday, June 14, 2017

Section 759.13 - Program evaluation

759.13 Program evaluation.

(a) Quality improvement. The operator must develop and implement a quality improvement process that provides for an annual or more frequent review of the operator's program. Such evaluation must include a profile of the characteristics of the registrants admitted to the program, the services and degree of services most utilized, the length of stay and use rate, registrant need for care and services, and disposition upon discharge. The process must:

(1) include an evaluation of all services in order to enhance the quality of care and to identify actual or potential problems concerning service coordination and clinical performance;

(2) review accident and incident reports, registrant complaints and grievances and the actions taken to address problems identified by the process;

(3) develop and implement revised policies and practices to address problems found and the immediate and systematic causes of those problems; and

(4) assess the impact of the revisions implemented to determine if they were successful in preventing recurrence of past problems.

(b) The results of the quality improvement process must be reported to the chief executive officer, program director, or governing body.

Effective Date: 
Wednesday, June 14, 2017
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Section 759.14 - Payment

759.14  Payment

(a) Payments to adult day health care programs by State government agencies. A program may only bill for one visit per registrant per day.  

(b) Payments to adult day health care programs by managed care organizations or care coordination models:

(1) Payments shall be made in accordance with the negotiated agreement between the adult day health care program and the managed care organization or care coordination model.

(2) The full range of adult day health care services shall be available to registrants with a documented need for such services. Based on a registrant’s individual needs, as determined in the comprehensive assessment, the managed care organization or care coordination model may order less than the full range of adult day health care services. Nothing shall prohibit adult day health care programs and managed care organizations or care coordination models from agreeing to reimbursement terms that reflect a registrant’s receipt of less than the full range of adult day health care services.

Effective Date: 
Wednesday, June 14, 2017

Article 7 - Certified Home Health Agencies and Licensed Home Care Services Agencies

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Part 760 - Certified Home Health Agency Establishment

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Statutory Authority: 
Public Health Law, Sections 3606, 3611, 3612

Section 760.1 - Definitions

Section 760.1 Definitions. For purposes of this Part, unless the context indicates otherwise, the following terms shall have the following meanings.

(a) Sponsor means:

(1) any governmental subdivision, a sole proprietor, a partnership and each member thereof, a corporation and the officers and principal stockholders thereof, or other operator that is requesting or has received approval to operate a certified home health agency; and

(2) any controlling person as defined in this section.

(b) Person means an individual, corporation, governmental subdivision or other legal entity, including a joint venture or any combination of the foregoing acting in concert.

(c) Controlling person means a person which either directly or indirectly, or through one or more intermediaries, possesses the ability to direct or cause the direction of the actions, management or policies of a person, whether through the ownership of voting securities or voting rights, by contract (except a commercial contract for goods or nonmanagement services) or otherwise; but no person shall be deemed to control another person solely by reason of his being a corporate officer or director of such other person (providing such officer or director is not acting in concert with others to represent another corporation). Control shall be presumed to exist if any person directly or indirectly owns, controls or holds with the power to vote 10 percent or more of the voting securities or voting rights of any other person or is a member of a not-for-profit corporation which member is other than a natural person.

(d) Principal stockholder means any person or organization that owns, holds or has the power to vote 10 percent or more of the issued and outstanding voting shares of stock of a corporation.

(e) Parent corporation means a corporation which directly or indirectly, or through one or more intermediaries, possesses or will possess the ability to direct or cause the direction of the actions, management or policies of any partnership or corporation, any of the members of which are not natural persons, or any corporation, any of the stock of which is owned by another corporation, which is applying for approval to operate or which already operates a certified home health agency or a licensed home care services agency.

(f) Health-related subsidiary corporation means a corporation which:

(1) is approved to operate a health care facility or program under either article 28, 33, 36, 40 or 44 of the Public Health Law or which is approved to operate a facility or program under the Mental Hygiene Law; or

(2) operates a facility or program outside the State of New York which, if located within New York, would be subject to approval under either article 28, 33, 36, 40 or 44 of the Public Health Law or the provisions of the Mental Hygiene Law; and

(3) is, or will be, either directly or indirectly, or through one or more intermediaries:

(i) controlled by any partnership or corporation, any of the members of which are not natural persons, or any corporation, any of the stock of which is owned by another corporation, which is applying for approval to operate or which already operates a certified home health agency or a licensed home care services agency; or

(ii) controlled by any parent corporation of any such partnership or corporation described in subparagraph (i) of this paragraph, through the ability to direct or cause the direction of such health-related subsidiary's actions, management or policies.

(g) Special pilot program home health agency means an agency established to meet the needs of a defined population group and service area in accordance with section 760.5(e)(1)(ii) of this Part.
 

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Section 760.2 - Applications for establishment

760.2 Applications for establishment. (a) An application to the Public Health Council for its approval, as required by law, shall be in writing on application forms provided by the department and subscribed by the chief executive officer duly authorized by the board of a corporate applicant, a general partner or proprietor of the proposed certified home health agency, or, where an application is to be submitted by a governmental subdivision as the applicant, the president or chairman of the board of the proposed agency of the chief executive officer if there is no board and accompanied by a certified copy of a resolution of the board of a corporate applicant authorizing the undertaking which is the subject of the application, and the subscribing and submission thereof by an appropriate designated individual. In the event that an application is to be submitted by an entity which necessarily remains to be legally incorporated, it shall be subscribed and submitted by one of the proposed principal stockholders or directors. If a local government applicant submitting an application has not designated a president, chairman or chief executive officer for the proposed agency, the application shall be subscribed by the chairman or president of the local legislature or board of supervisors having jurisdiction, or other appropriate executive officer. An original application and eight copies thereof shall be prepared and filed with the Public Health Council through the Project Management Unit in the department's central office in Albany which shall transmit one copy to the health systems agency having jurisdiction.

(b) Applications to the council shall contain information and data as applicable with reference to:

(1) the public need for the existence of the certified home health agency or proposed agency at the time and place and under the circumstances proposed;

(2) the character, experience, competence and standing in the community of the proposed persons, incorporators, directors, controlling persons, officers, principal stockholders, sponsors, or partners of the applicant or of any parent or health-related subsidiary corporation, as applicable. The application shall include copies of personal qualifying, financial and disclosure information, as appropriate, as may be required by the council with regard to any such individual or organization;

(i) the applicant shall be responsible for providing information necessary for the determination by the council of character, competence and standing in the community where information adequate to make such determination is not available to the council or the commissioner in the records of the department;

(ii) disclosure information shall include, but not be limited to, a list of health care, adult care, or mental health facilities, programs or agencies controlled or operated in the United States by an individual or organization specified in this paragraph; the name and address of each such facility, program or agency; and the dates of control or operation of each such facility, program or agency;

(iii) in the event that any such health care, adult care, or mental health facility, program or agency while under the control or operation of an individual or organization specified in this paragraph, has been subjected to financial penalties, or suspension or revocation of its operating certificate, license, or certification because of a failure to comply with provisions governing the conduct and operation of the facility, program, or agency, then information must be provided which describes the nature of the violation, the agency or body enforcing the violation (including its name and mailing address), the steps taken by the facility, program or agency to remedy the violation or violations, and an indication of whether the suspension, revocation or accreditation has since been restored;

(3) the financial resources and sources of future revenue of the certified home health agency to be operated by the applicant;

(4) the ability of the applicant to operate the certified home health agency in compliance with applicable Federal and State statutes and regulations.

(c) The following documents shall be filed as attachments to the application:

(1) where the applicant will be operating the certified home health agency under an assumed name, a photocopy of the applicant's existing or executed proposed certificate of doing business;

(2) where the applicant is a partnership, full and true copies of all partnership agreements, which shall include the following language:

"By signing this agreement, each member of the partnership created by the terms of this agreement acknowledges that the partnership and each member thereof has a duty to report to the New York State Department of Health any proposed changes in the membership of the partnership. The partners also acknowledge that the prior written approval of the Public Health Council is necessary for such change before such change is made, except that a change resulting from an emergency caused by the severe illness, incompetency or death of a member of the partnership shall require immediate notification to the New York State Department of Health of such fact and application shall be made for the approval by the Public Health Council of such change within 30 days of the commencement of such emergency. The partners also acknowledge that they shall be individually and severally liable for failure to make the aforementioned reports and/or applications"; and (3) where the applicant or operator has or proposes to have a controlling person or a parent corporation, or is affiliated with a health-related subsidiary corporation, full and true copies of any such corporation's bylaws, certificate of incorporation and any existing or proposed amendments thereto, all agreements between the applicant and any such controlling person or parent corporation relating to the manner and mechanisms by which any such controlling person or parent corporation controls or will control the applicant and/or all agreements by which the applicant is affiliated with any health-related subsidiary corporation, and a detailed description of such control or affiliation relationships;

(4) where an applicant corporation is formed pursuant to the requirements of section 3611 of the Public Health Law, documentation demonstrating the designation of an agent for service of process pursuant to section 305 of the Business Corporation Law or section 305 of the Not-For-Profit Corporation Law, as applicable; and

(5) such additional pertinent information or documents necessary for the council's consideration, as requested.
 

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Section 760.3 - Requirements for approval

760.3 Requirements for approval. (a) The application must be complete and in proper form. It shall provide all the information essential for the Public Health Council's consideration.

(b) The applicant must satisfactorily demonstrate to the council:

(1) that there is a public need for the certified home health agency;

(2) that there are adequate finances and sources of future revenue to properly establish and operate the certified home health agency;

(3) (i) if a not-for-profit corporation, that the controlling persons and sponsors, if any, the members of the board of directors and officers of the corporation are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the corporation in the best interests of the agency and in the public interest and to provide proper care for those to be served by the certified home health agency;

(ii) if a proprietary business, that the owner, or all the partners of a partnership, are persons of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the business in the best interests of the agency and in the public interest and to provide proper care for those to be served by the certified home health agency;

(iii) if a business corporation, that the controlling persons and sponsors, if any, the members of the board of directors, the officers and the principal stockholders of the corporation or, in the case of an application solely for a change in the principal stockholder(s), that the proposed new principal stockholder(s) of the corporation are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the corporation in the best interests of the agency and in the public interest and to provide proper care for those to be served by the certified home health agency;

(iv) with respect to any parent corporation or health-related subsidiary corporation, that the directors, sponsors, controlling persons and principal stockholders of any such corporation, insofar as applicable, are of such character, competence and standing in the community as to give reasonable assurance that, to the extent they have or will have the ability through control or influence to direct or cause the direction of the actions, management or policies of the applicant, such control or influence will be exercised in the best interest of the applicant and in the public interest in order to ensure the provision of proper care for those to be served by the certified home health agency;

(v) with respect to an application solely for the acquisition of control of an operator of a certified home health agency by a controlling person or a change of a controlling person, that such new controlling person, insofar as applicable, is of such character, competence and standing in the community as to give reasonable assurance that, to the extent it has or will have the ability to direct or cause the direction of the actions, management or policies of the applicant, such control or influence will be exercised in the best interest of the applicant and in the public interest in order to ensure the provision of proper care for those to be served by the certified home health agency;

(vi) if a public or government agency, that the governing authority of the governmental subdivision applying to operate the agency has provided reasonable assurance of its ability to conduct the affairs of the agency in the best interest of the agency and in the public interest and to provide proper care for those to be served by the certified home health agency.

(c) In conducting a character and competence review, the Public Health Council shall, as applicable, evaluate any parent or health-related subsidiary corporation, the controlling persons, sponsors, members of the board of directors, the officers and principal stockholders, if any, of a corporate applicant, any sole proprietor, all partners in a partnership, or, in the case of a governmental subdivision as the applicant, the governmental subdivision and the governing body thereof as a whole rather than the individual elected or appointed members thereof, by:

(1) reviewing the findings of inspection reports, patient care reviews, complaint investigations and any other pertinent information relating to the operation of any health care, adult care or mental health facility, program or agency located in New York approved to operate by the Department of Health, Department of Social Services or the Department of Mental Hygiene or, if located outside New York, would require the approval to operate by any one of such agencies if located in New York, with which an individual, corporation, other organization, or governmental subdivision has been affiliated as a director, sponsor, controlling person, principal stockholder, sole proprietor, partner or governmental operator; (2) reviewing whether such individual, corporation, other organization or governmental subdivision exercised supervisory responsibility of the facility/agency operation to assure a consistent pattern of compliance with applicable standards and to prevent conditions which could result in harm to the health, safety or welfare of patients/residents;

(3) determining that if a violation of applicable standards did occur, the applicant investigated the circumstances surrounding the violation and took steps appropriate to the gravity of the violation which a reasonably prudent operator would take to promptly correct and to prevent the reoccurrence of the violation; and

(4) considering such other pertinent matters relating to the character, competence and standing in the community of the applicant(s) .

(d) The applicant must supply:

(1) Any additional information requested by the department within 30 days of such request, or must obtain from the department an extension of time in which to provide such information. Any requests for such extension of time shall set forth the reasons why such information could not be obtained within the prescribed time. The granting of such extension of time shall be at the discretion of the commissioner, provided such extensions are not for more than 30 days and the commissioner is satisfied as to the reasons why such information could not be obtained within the prescribed time. The commissioner is authorized to deny a request for an extension of time. Failure to provide such information within the time prescribed shall constitute an abandonment and withdrawal of the application by the applicant.

(2) Any authorization the department requests in order to verify any information contained in the application or to obtain additional information which the department finds is pertinent to the application. Failure to provide such authorization shall constitute an abandonment and withdrawal of the application.
 

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Section 760.4 - Amendments to applications

760.4 Amendments to applications. (a) An application made to the Public Health Council pursuant to this Part may be amended while the matter is pending before the council. Such amendments shall be made on appropriate forms supplied by the department.

(b) Any amendment to an application which constitutes a substantial change in the information contained in the original application, or any prior amendments thereto, must be accompanied by a satisfactory written explanation as to the reason such information was not contained in the original application.

(c) Prior to the issuance of a certificate of approval, any change as set forth in this subdivision shall constitute an amendment to the application and the applicant shall submit appropriate documentation as may be required in support of such amendment. The amended application shall be referred to the health systems agency having geographic jurisdiction and the State Hospital Review and Planning Council for their reevaluation and recommendations. The approval of the Public Health Council must be obtained for any amended application. Each of the following shall constitute an amendment:

(1) any change of five percent or more in the agency's proposed annual operating budget;

(2) any change in the proposed patient case capacity;

(3) any change in the types of services to be provided;

(4) any change in the agency's proposed service area;

(5) any change in the principals of the applicant as considered by the council.

(d) Failure to disclose an amendment prior to the issuance of a certificate of approval shall constitute sufficient grounds for the revocation, limitation or annulment of the approval of establishment.
 

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Section 760.5 - Determinations of public need

760.5 Determinations of public need.

(a) (1) The following methodology shall be utilized in the evaluation of applications involving the establishment and/or construction of certified home health agencies, excluding long-term home health care programs, in order to determine the need for such agencies. It is intended that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Title, which are also applicable to the determination of need for certified home health agencies and which are incorporated herein, represent a statement of basic principles and planning/decisionmaking tools for guiding and directing the development and expansion of certified home health agencies throughout the State. The methodology is conceptually based on the application of uniform planning objectives at the health systems agency and/or State level. Its purpose is to provide guidance, to permit flexibility and to assist the health systems agencies, the State Hospital Review and Planning Council, the Public Health Council, the commissioner and potential applicants in determining the estimated need for certified home health agencies. The objective of the methodology is to ensure that an adequate supply of certified home health agency capacity is available and accessible, while at the same time avoiding the proliferation of unneeded agencies. The application of the methodology is expected to result in reducing the need for institutional acute and long-term care by developing and expanding the availability of certified home health agency services which may serve as appropriate alternatives to institutional care.

(2) In making determinations of public need under this section prior to January 1, 1988, calculations of total projected need, projections of met need, and determinations of standard agency case capacity shall be based on agencies that have reported nursing cases by age and sex cohorts in diagnostic categories to the department on forms provided by the department regardless of whether such cases were admissions of the reporting agency or admissions of another agency for which the reporting agency provided services through contract arrangement.

(b) (1) The commissioner shall designate certified home health agency planning areas within each health systems agency region among which the need estimates calculated pursuant to this section will be allocated. The commissioner shall designate each county as a separate planning area unless, with the advice of the State Hospital Review and Planning Council, he has approved a proposal by a health systems agency to designate two or more contiguous counties as a planning area.

(2) A health systems agency may submit a proposal to the commissioner to designate two or more contiguous counties as a planning area. Factors which shall be considered by a health systems agency in proposing, the State Hospital Review and Planning Council in providing advice regarding, and the commissioner in designating two or more contiguous counties as a planning area shall include, but need not be limited to, the following:

(i) provider travel patterns including driving time and availability of public transportation;

(ii) the availability of existing certified home health agency case capacity; and

(iii) other factors identified by the health systems agencies.

(c) Certified home health agency need estimates.

(1) (i) Certified home health agency need estimates shall be calculated at least once every three years using the most currently available and analyzed data. The factors and methodology to be utilized by the Public Health Council and/or the commissioner, as appropriate, in estimating the public need for certified home health agencies shall include, but need not be limited to, the development of statewide normative use rates, and consideration of the local characteristics and demographics of the planning area. Prior to January 1, 1986, the normative use rates shall be calculated on the basis of reported certified home health agency nursing cases. A case is defined as an admission or readmission to a certified home health agency during a given calendar year. Such cases shall include those reported in the noninfective disease and disability categories, the infective and parasitic diseases categories (excluding tuberculosis and venereal disease and all disease contacts) and the ill without diagnosis category (symptoms, signs and ill-defined conditions) or comparable categories as listed on the department form. Subsequent to December 31, 1985, the calculation of normative use rates shall also include consideration of certified home health agency cases which represent admissions or readmissions during a calendar year directly to therapy services.

(ii) The number of reported cases shall be adjusted by the department to remove reported cases from the data base which represent either nursing assessments solely to determine an individual's eligibility to participate in the personal care program administered by the Department of Social Services, or reporting errors and inconsistencies. In the absence of explicit data, such adjustments shall be determined by the department based on the statewide distribution of nursing visits per case reported by certified home health agencies as follows: (a) the ratio of reported nursing visits to reported cases for each agency shall be computed; and

(b) the reported nursing visits of an agency divided by the statewide mean of the visit to case ratios minus one standard deviation shall be computed to derive adjusted cases.

(2) The statewide normative use rates shall be derived using the lower of the reported cases as described in subparagraph (1) (i) of this subdivision or the adjusted cases as determined under subparagraph (1) (ii) of this subdivision for each county for the following age/sex cohorts:

(i) male, 0-18 years;

(ii) male, 20-44 years;

(iii) male, 45-64 years;

(iv) male, 65-74 years;

(v) male, 75-84 years;

(vi) male, 85+ years;

(vii) female, 0-19 years;

(viii) female, 20-44 years;

(ix) female, 45-64 years;

(x) female, 65-74 years;

(xi) female, 75-84 years; and

(xii) female, 85+ years.

(3) The cases for each age/sex cohort for each county shall be expressed as a use rate in cases per 1,000 population and ranked from the lowest to the highest with the use rates for the same cohort for all other counties. Outliers shall be removed from the high end of each of the 12 age/sex cohort rankings. A use rate shall be considered an outlier if it is the highest use rate in an age/sex cohort ranking and is more than 20 percent higher than the next highest use rate in such ranking. After deletion of any outliers, the average of the 10 highest use rates for each of the 12 age/sex cohort rankings shall be determined. Such average for each cohort ranking shall represent the statewide normative use rate for its respective cohort for purposes of estimating need. The statewide normative use rates are then applied to the most current New York State Department of Commerce population figures for each county projected five years into the future to derive an estimate of need, expressed as cases per year.

(4) A health systems agency may submit a plan to the Public Health Council and the commissioner which proposes adjustments to the need estimates for a planning area within its region. The Public Health Council and/or the commissioner, as appropriate, with the advice of the State Hospital Review and Planning Council, may reject or approve all or a portion of the proposed adjustments based upon consideration of pertinent factors, including, but not necessarily limited to the following:

(i) whether the proposed adjustments reflect consistency with the objectives and requirements of this section and section 709.1 of this Title;

(ii) whether the proposed adjustments take into consideration the number of patients on alternate care status in hospitals serving the planning area; and

(iii) whether the proposed adjustments identify special populations in need of certified home health agency services.

(d) (1) To estimate unmet need for certified home health agencies in a planning area, the projected need as determined pursuant to subdivision (c) of this section, together with any adjustments thereto, shall be compared to the case capacity of approved certified home health agencies in such planning area projected five years into the future. Estimates of projected capacity of certified home health agencies shall be calculated at least once every three years using the most currently available and analyzed data.

(2) The projected capacity of a certified home health agency that has reported case data to the department for at least two calendar years shall be the number of annual adjusted cases projected to grow for five years at an annual rate equal to the average annual statewide case growth rate for all such certified home health agencies in the State for the two most recent calendar years for which case data has been analyzed pursuant to this section, or the average annual case growth rate for all such certified home health agencies in the agency's planning area for the two most recent calendar years for which case data has been analyzed pursuant to this section, whichever is less.

(3) The projected case capacity for a certified home health agency that has reported case data for one year only or that was not operational during the most recent reporting year shall be no greater than:

(i) the adjusted cases reported for the most recently completed and analyzed calendar year of operation, if any; or

(ii) the standard agency case capacity for the population density category of the agency's planning area, whichever is higher.

(4) The standard agency case capacity of a planning area shall be determined based on the population density category of that planning area. For each population density category, the standard agency case capacity shall be defined as the mean of the adjusted cases for all certified home health agencies reporting cases for at least two calendar years in that population density category reduced by one standard error of the mean. In determining the standard agency case capacity, an agency's cases shall be excluded if its inclusion would result in a shift in the standard agency case capacity greater than 15 percent. Such exclusions shall be limited to one agency at the lower and upper end of the range of adjusted cases. If a certified home health agency's reported cases in planning areas in more than one population density category, the cases shall be counted in the population density category having the plurality of cases. For purposes of such determination, planning areas shall be grouped into the following population density categories: (i) areas with a population density no greater than 200 persons per square mile;

(ii) areas with a population density greater than 200 but no greater than 800 persons per square mile;

(iii) areas with a population density greater than 800 but no greater than 5,000 persons per square mile; or

(iv) areas with a population density greater than 5,000 persons per square mile.

(5) A health systems agency may submit a proposal to the Public Health Council and the commissioner which recommends adjustments to reduce the estimates of projected met need for a planning area within its region. The Public Health Council and/or the commissioner, as appropriate, with the advice of the State Hospital Review and Planning Council, may reject or approve all or a portion of the proposed adjustments based upon consideration of pertinent factors, including, but not necessarily limited to, documentation indicating that one or more approved agencies within its planning area will not attain or retain the growth rates projected for such area.

(6) The sum of the projected case capacities for a planning area shall be the estimate of projected met need for certified home health agency capacity for such area.

(e) (1) Notwithstanding that need may otherwise have been determined to be met under this section, the Public Health Council and/or the commissioner, as appropriate, may recognize the need for additional certified home health agencies or agency case capacity where:

(i) an applicant proposes to provide services to patients that would otherwise require care in a facility or program licensed by the Office of Mental Health or the Office of Mental Retardation and Developmental Disabilities when the appropriate office documents the number of individuals in the applicant's planning area that are eligible for care in a facility or program licensed by such office who would also be eligible for and would benefit from certified home health agency services, the nature of the certified home health agency services required by such individuals, the expected length of time such individuals would require certified home health agency services and the inability of existing certified home health agencies to provide such services. The Office of Mental Health or the Office of Mental Retardation and Developmental Disabilities shall provide the necessary documentation to the department before an application to provide care for such individuals may be acted on. The certified home health agency case capacity approved to serve any special population under this subparagraph shall not be counted as part of the available resources to satisfy public need for certified home health agency case capacity otherwise estimated under this section; or

(ii) an applicant proposes to be established as a special pilot program home health agency; and:

(a) has demonstrated how the direct provision of home health agency services by the applicant will improve continuity of care, access to services, cost effectiveness and efficiency;

(b) has identified and described a particular population group and any special needs of such group, and has estimated the number of people therein to be served and the geographic area where the services will be provided;

(c) has demonstrated how the applicant will be better able than other home health agencies in the service area to meet any special needs of the defined population group; and

(d) has agreed to, and if approved shall, prepare and file an annual report to the commissioner and the State Hospital Review and Planning Council on meeting the program's objectives, including reaching its approved case capacity, enhancing quality assurance and access to services, and improving cost effectiveness and efficiency.

(2) The commissioner shall:

(i) specifically limit the case capacity and service area of a special pilot program home health agency, approved pursuant to subparagraph (1) (ii) of this subdivision, consistent with the program scope as set forth in the application; and

(ii) approve no more than 10 such special pilot program home health agencies.

(3) An agency program approved pursuant to this subdivision shall be exempt from the requirements relating to minimum annual case capacity and serving an entire certified home health agency planning area as set forth in subdivisions (g) and (h) of this section.

(4) An agency program approved pursuant to this subdivision shall not have a case capacity that exceeds 10 percent of the entire certified home health agency planning area's projected need.

(f) (1) The need estimates for each planning area together with any approved adjustments determined under this section shall constitute the estimate of the public need for certified home health agency case capacity in the planning area. (2) Public need shall be deemed satisfied for each planning area when the projected case capacity of approved certified home health agencies meets the estimate of public need for the planning area.

(g) Approval of new agencies.

(1) (i) Except as provided below, the number of new agencies which may be approved in a certified home health agency planning area shall not exceed the nearest rounded number derived from dividing the unmet need by the standard agency case capacity for the planning area's population density category.

(ii) Where there is not sufficient remaining unmet need to approve a new agency under subparagraph (i) of this paragraph, a new agency may be approved to meet such unmet need if the Public Health Council determines that such need will not otherwise be met and such unmet need is sufficient to sustain an efficiently operated agency.

(2) Where there is remaining unmet need, an agency may be approved to serve more than one planning area without meeting the standard agency case capacity for each such planning area provided that the agency's total proposed case capacity among all planning areas to be served by it is no less than the standard agency case capacity for the planning area to be served by such agency with the greatest population density.

(h) In addition to meeting the other applicable provisions of this section, an applicant for initial certification shall be approved as meeting public need only if the applicant:

(1) agrees to serve the entire certified home health agency planning area. Pursuant to the procedure set forth in section 709.1(c) of this Title, exceptions to serving the entire planning area may be permitted under special circumstances, including but not limited to those set forth below, provided that the agency agrees to serve the entire alternate service area designated for such agency. Such circumstances include:

(i) geographic barriers and/or travel time which may impede service delivery to the entire planning area provided that the remaining portion of the planning area is adequately served;

(ii) proposals in which an applicant will focus its program of care in specific underserved areas which form only a portion of a planning area; and

(iii) other factors identified by the local health systems agency; and

(2) agrees to serve general hospital inpatients on alternate care status that would be suitable to receive home care;

(3) agrees to serve population groups in the planning area that have difficulty gaining access to appropriate certified home health agency care due to minority status, age, medical history, case complexity, or payment source; and

(4) ensures the provisions of charity care in each fiscal year of the agency in an amount no less than two percent of the projected total annual operating costs of the agency in that fiscal year for not-for-profit and for-profit agencies and agencies operated by public benefit corporations and 3-1/3 percent of projected total annual operating costs of the agency for public agencies. Charity care is care provided at no charge or reduced charge for the services the agency it certified to provide to patients who are unable to pay full charges, are not eligible for covered benefits under title XVIII or XIX of the Social Security Act, are not covered by private insurance and whose household income is less than 200 percent of the Federal poverty level. Adjustments to the required percentages of charity care may be made by the department upon recommendation of the appropriate health systems agency to reflect significant county variations from the State average with respect to the proportion of indigent and medically uninsured persons to the total population; and

(5) demonstrates an ability and willingness to attain a minimum annual case capacity no less than the standard agency case capacity for its planning area population density category, or the remaining need, whichever is less, within three years of the date of issuance of its certificate of approval.

(i) For initial certification of home health agencies and where public need is established herein, priority consideration will be given to applicants who demonstrate that they will:

(1) reduce the utilization of general hospital and residential health care facilities in the planning area;

(2) provide charity care in excess of that specified in paragraph (h) (4) of this section; or

(3) provide, in addition to the minimum services required by this Subchapter, three or more of the following which include social work, occupational therapy, physical therapy, speech/language pathology and nutrition services.

(j) Any application wherein a determination of public need is made pursuant to this section shall be subject to the following: (1) (i) The Public Health Council and/or the commissioner, as appropriate, may, during the processing of an application, propose to disapprove the application solely on the basis of a determination of public need in advance of the consideration of the other review criteria required by article 36 of the Public Health Law without, however, waiving the right to consider such other criteria at a later date.

(ii) The local health systems agency may, during its review process, determine to recommend disapproval of an application solely on the basis of a determination of public need.

(2) In the event the Public Health Council and/or the commissioner proposes to disapprove an application on the basis of a lack of public need and the applicant requests a hearing, the Public Health Council and/or the commissioner, as appropriate, may direct the completion of the other reviews required by article 36 of the Public Health Law. The application shall then be returned to the Public Health Council and/or the commissioner as appropriate, to consider such reviews, the results of which may then be included as grounds for the proposed disapproval to be considered at the hearing. If the Public Health Council and/or the commissioner, as appropriate, directs the completion of such reviews, a copy of the report containing the results of the reviews shall be mailed to the applicant at least 60 days prior to the date set for hearing.

(3) In the processing of an establishment application, the commissioner may recommend disapproval based on a review limited to a determination of public need. In the event the Public Health Council does not concur with the commissioner's recommendation of disapproval, it shall return the application to the department at which time all other required reviews shall be completed. When all other reviews are completed, the application shall be returned to the Public Health Council for action.

(k) The provisions of this section shall be evaluated by the department and the health systems agencies by January 1, 1988 to assure that projected need for certified home health agencies is adjusted to reflect changes in health care delivery and medical practice patterns, including but not limited to general hospital prospective payment, residential health care facility case mix reimbursement, improved facility discharge planning procedures, increased utilization of ambulatory care, and uniform patient assessment of potential home care recipients. This evaluation shall include an examination of the standard agency case capacity, planning areas and other factors utilized in this section.

Effective Date: 
Monday, July 2, 2012
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Section 760.6 - Withdrawals of applications

760.6 Withdrawals of applications. An application made to the Public Health Council may, on written request of the applicant, be withdrawn prior to decision by the council at any time without prejudice to resubmission.
 

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Section 760.7 - Decisions

760.7 Decisions. (a) Copies of the resolution of the Public Health Council approving or disapproving an application shall be transmitted to the applicant, the State Hospital Review and Planning Council, the appropriate health systems agency and the Commissioner of Health.
(b) Copies of a notice that the council is considering the disapproval of an application or action contrary to the recommendation of the State Hospital Review and Planning Council or a health systems agency and affording an opportunity to request a public hearing shall be transmitted to the applicant, the State Hospital Review and Planning Council, the appropriate health systems agency and the Commissioner of Health.

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Section 760.8 - Failure to implement an application

760.8 Failure to implement an application. The failure, neglect or refusal of an applicant for the establishment of a new certified home health agency to obtain a certificate of approval and commence operation of the certified home health agency within one year of issuance of the Public Health Council's approval or contingent approval of the application shall constitute an abandonment of the application by the applicant and any approval or contingent approval issued by the Public Health Council shall be deemed cancelled and withdrawn without further action of such council.
 

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Section 760.9 - Revocation, limitation or annulment of approvals of establishment

760.9 Revocation, limitation or annulment of approvals of establishment. (a) An approval of establishment may be revoked, limited or annulled by the Public Health Council if the council finds that:

(1) the established operator has been guilty of fraud or deceit in procuring such approval of establishment, has made statements or furnished information in support of the application which were not true, accurate, or complete in any material respect or has failed to make services available to the population groups or in the service area as proposed in the application as approved;

(2) the agency's certificate of approval has been revoked, limited or annulled pursuant to the applicable provisions of law;

(3) the established operator has failed to comply with the applicable provisions of article 36 of the Public Health Law or the rules and regulations promulgated thereunder which threatened, or resulted in, direct significant harm to the health, safety or welfare of patients;

(4) the established operator has been convicted in a court of competent jurisdiction, either within or outside of the State, of a crime; or

(5) the established operator has transferred ownership interest in the operation of the agency or the operator has terminated participation in the operation of the agency without obtaining prior Public Health Council approval, or a controlling person has exercised control of the operator of such agency without obtaining Public Health Council prior approval.

(b) For purposes of this section, established operator shall include any person, partnership, or partner thereof, or governmental subdivision, and any corporation or principal stockholder, officer or director thereof, actual or proposed, whose application for establishment has been approved, regardless of whether a certificate of approval has been issued.

(c) No establishment approval shall be revoked, limited or annulled under this section without first offering the established operator the opportunity for a public hearing.

(d) The Public Health Council shall not revoke, limit or annul establishment approval due solely to the operator's failure to attain minimal annual case capacity pursuant to subdivision (h) of section 760.5 of this Part.
 

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Section 760.10 - Hearings

760.10 Hearings. (a) Necessary hearings shall be conducted by the Public Health Council, a committee of the council, or a person designated by the council.

(b) Requests for hearings by applicants shall be made within 20 days after notification that such request may be made. If such request is made by the State Hospital Review and Planning Council or by a health systems agency, it must be made within 10 days subsequent to the meeting of such council or agency which took place after notification that such request may be made.
 

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Section 760.11 - Establishment of not-for-profit corporations

760.11 Establishment of not-for-profit corporations. A not-for-profit corporation seeking the approval of the Public Health Council as the operator of a certified home health agency shall provide, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) a photocopy of the executed existing or proposed applicable corporate certificate which shall in all respects conform to the applicable provisions of the New York State Not-for-Profit Corporation Law and which includes corporate powers and purposes adequate to encompass the ownership and operation of a home care services agency or agencies; and

(b) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 760.12 - Establishment of business corporations

760.12 Establishment of business corporations. A business corporation seeking the approval of the Public Health Council as the operator of a certified home health agency shall provide, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) a photocopy of the executed existing or proposed applicable corporate certificate which shall in all respects conform to the applicable provisions of the New York State Business Corporation Law and which contains corporate powers and purposes adequate to encompass the ownership and operation of a home care services agency or agencies;

(b) a statement identifying all proposed principal stockholders, the number of voting shares to be owned by each and the percentage of issued and outstanding voting stock represented by such shares; and

(c) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 760.13 - Transfers of interest by persons or partnerships

760.13 Transfers of interest by persons or partnerships. Any change in the person who or partnership which is the operator of a certified home health agency must receive the prior approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Part. In the event such change is occasioned by the death of an operator, the department shall be notified immediately and application shall be made for approval of such change within 30 days of such death. A person or partnership seeking Public Health Council approval for the transfer of all or part of the ownership of the business shall file, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) a photocopy of the applicant's existing or executed proposed certificate of doing business;

(b) a photocopy of any corporate applicant's executed existing or proposed applicable corporate certificate;

(c) where the applicant is a partnership, full and true copies of all partnership agreements;

(d) a declaration of the percentage of the business to be transferred;

(e) a financial statement setting forth the purchase price of the interest in the business being sold and the financial resources available to make such purchase, or the basis on which such transfer is to be financed;

(f) where any transfer is to be by gift, a statement of the relationship between the donor and the donee; and

(g) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 760.14 - Transfers of stock

760.14 Transfers of stock. (a) Any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder of a corporation which is the operator of a certified home health agency, or any transfer, assignment or other disposition of the stock or voting rights thereunder of such a corporation which results in the ownership or control of more than 10 percent of the stock or voting rights thereunder of such corporation by any person must receive the prior approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Part. In the event such change is occasioned by the death of a stockholder, the department shall be notified immediately and application shall be made for approval of such change within 30 days of such death. An applicant who proposes to acquire stock or voting rights thereunder in a business corporation, the transfer of which requires the approval of the Public Health Council, shall file, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(1) a statement identifying the number of shares of stock or voting rights thereunder to be acquired, the percentage of the total issued and outstanding stock represented by such shares, the name and address of the transferror and the purchase price of the shares to be transferred;

(2) the financial resources available for the acquisition of the shares to be transferred, or the basis on which such transfer is to be financed;

(3) if such transfer of stock is to be by gift, a statement of the relationship between the donor and the donee; and

(4) such additional pertinent information or documents necessary for the Public Health Council's consideration, as requested.

(b) Any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder to the corporation, or any transfer, assignment or other disposition of the stock or voting rights thereunder which results in the ownership or control of more than 10 percent of the stock or voting rights thereunder by the corporation, or any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder by the corporation shall be subject to the prior approval by the Public Health Council in accordance with the applicable requirements of this Part and this section.
 

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Section 760.15 - Acquisition of control of the operator of an agency

760.15 Acquisition of control of the operator of an agency. This section relates to changes in the control of an operator of a certified home health agency not covered in section 760.13 or 760.14 of this Part. Changes covered in section 760.13 or 760.14 of this Part shall require the prior approval of the Public Health Council.

(a) (1) Any change in the controlling person(s) of the operator of a not-for-profit or proprietary certified home health agency other than a change subject to prior approval pursuant to section 760.13 or 760.14 of this Part, shall be subject to the approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Part. A person seeking approval as a controlling person of the operator of a certified home health agency shall file an application for Public Health Council approval within 30 days of becoming a controlling person in accordance with the applicable requirements of this Part.

(2) Pending a decision by the Public Health Council, an applicant shall refrain from exercising control over the certified home health agency by directing or causing the direction of the actions, management or policies of the agency whether through voting securities or voting rights thereunder, electing or appointing directors, the direct or indirect determination of policies, or otherwise. The applicant shall submit, as part of the application, an affidavit whereby the applicant affirms that it will not exercise control over the agency pending a decision by the council.

(b) If the Public Health Council disapproves an application to become a controlling person under subdivision (a) of this section, the applicant shall divest himself of the controlling interest over the operator of the certified home health agency within 30 days of the council's final decision.

(c) Notwithstanding any other provision of this section, the prior approval of the Public Health Council must be obtained, pursuant to the applicable requirements of article 36 of the Public Health Law and this Part, if a person who proposes to become a controlling person of the operator of a certified home health agency is not able to refrain from exercising control over the agency upon becoming a controlling person as required by subdivision (a) of this section.

(d) (1) Upon request of an applicant under this section, the commissioner, on behalf of the Public Health Council, may issue a determination that the taking of some control action or proposed control action by the applicant does not constitute the applicant becoming a controlling person of the operator of a certified home health agency as contemplated by this Part and that Public Health Council approval is not required.

(2) The commissioner may revoke or modify his determination that an applicant is not or will not become a controlling person when, based on additional information or documentation not provided to the commissioner at the time of his initial determination, it is found that the applicant will exercise or has exercised control over the operator of a certified home health agency to the extent of directing or causing the direction of the actions, management or policies of the operator of such agency.

(3) When the commissioner determines that a person will exercise or is exercising control over an operator of a certified home health agency as a controlling person, such person shall refrain from exercising or continuing to exercise such control until Public Health Council approval is obtained.
 

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Section 760.16 - Limitation on transfer

760.16 Limitation on transfer. Any transfer pursuant to section 760.13 or 760.14 of this Part shall be completed within 90 days of issuance by the Public Health Council of its approval for such transfer unless extended by the council and the council shall be notified of the transfer within 10 days after completion. Any request for an extension of time shall set forth the reasons why such transfer could not be completed within the prescribed time. Failure to complete a transfer within the prescribed time or as extended by the council or failure to notify the council within the time prescribed shall constitute an abandonment and withdrawal of the application and any council approval.
 

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Part 761 - Certified Home Health Agency, Long Term Home Health Care Program and AIDS Home Care Program Certification and Authorization

Effective Date: 
Wednesday, March 23, 1994
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Statutory Authority: 
Public Health Law, sections 3612(5)

Section 761.1 - Applicability

Section 761.1 Applicability.

(a) This Part shall apply to certified home health agencies, long term home health care programs and AIDS home care programs, hereafter also referred to in this Part as the agency.

(b) Certified home health agencies must be established by the Public Health Council and possess a certificate of approval issued by the Commissioner, hereafter referred to in this Part as an operating certificate.

(c) Long term home health care programs must be approved by the Commissioner and possess a certificate of authorization issued by the Commissioner, hereinafter referred to as an operating certificate. If a long term home health care program is authorized by the Commissioner to provide an AIDS home care program, the long term home health care program operating certificate shall state such authorization.

(d) An AIDS home care program provided by an AIDS Center Hospital shall be approved by the Commissioner and shall possess a certificate of authorization issued by the Commissioner, hereafter referred to as an operating certificate.
 

Effective Date: 
Wednesday, March 23, 1994
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Section 761.2 - Operating certificates

761.2 Operating certificates.

(a) The Commissioner shall issue an operating certificate to any home care services agency qualified to participate as a home health agency under titles XVIII and XIX of the Federal Social Security Act and which agrees to participate in such programs, applying therefore, and which complies with the provisions of Article 36 of the Public Health Law and the applicable provisions of this Title. No home care services agency shall hold itself out to be a certified home health agency, long term home health care program, or AIDS home care program unless it possesses such valid operating certificate.

(b) The operating certificate shall be posted conspicuously at the principal administrative office of the agency and shall state the health care services the agency is approved to provide; the geographic service area; and for long term home health care programs, a designated patient capacity and whether the long term home health care program is authorized to provide an AIDS home care program.

(c) An operating certificate may be revoked, suspended, limited or annulled by the Commissioner according to the provisions of Article 36 of the Public Health Law on proof that the agency has failed to comply with the provisions of the statute or the rules and regulations promulgated for the establishment, approval and/or operation of such agencies.
 

Effective Date: 
Wednesday, March 23, 1994
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Section 761.3 - Action required upon surrender or loss of an operating certificate

761.3 Action required upon surrender or loss of an operating certificate. An agency shall notify each patient concerned, the patient's family and the patient's physician, at least 30 days prior to the voluntary surrender of the operating certificate or as directed in an order of revocation, suspension, limitation or annulment issued by the Commissioner.
 

Effective Date: 
Wednesday, March 23, 1994
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Section 761.4 - Notice and approval required to discontinue operation

761.4 Notice and approval required to discontinue operation.

(a) No agency shall discontinue operation or surrender its operating certificate unless at least 90 days' written notice of its intention to do so and a plan for the continuation of care for each of the patients on its roster are given to the Commissioner and prior written approval is obtained. The Commissioner shall not approve an agency to discontinue operation unless he is satisfied as to the adequacy of the plan for the continuation of the care of patients and the agency has complied with the requirements of subdivision (c) of this section concerning clinical records.

(b) An operating certificate shall be surrendered promptly to the department when revoked, suspended, limited or annulled by the Commissioner, or when the agency terminates service.

(c) In the event that an agency discontinues operation for any reason, the governing authority, immediately preceding the discontinuance of the operation of the agency, shall make effective arrangements to maintain, store, assure access to and make available upon request, all clinical records for a period of not less than six years after discharge from the agency or program and, in the case of a minor, six years after discharge from the agency or program or three years beyond majority, whichever period is longer. The governing authority shall notify the department in writing as to the arrangements made for the clinical records and the address where such records will be stored and made available.
 

Effective Date: 
Wednesday, March 23, 1994
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Part 762 - Approval of Home Care Programs and Program Changes

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
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Statutory Authority: 
Public Health Law, section 3612

Section 762.1 - Long term home health care program and AIDS home care program approval

Section 762.1 Long term home health care program and AIDS home care program approval.

(a) A long term home health care program may be provided by a certified home health agency or by a residential health care facility or hospital possessing a valid operating certificate issued under article 28 of the Public Health Law.

(b) An AIDS home care program may be provided by a long term home health care program or an AIDS Center as defined in Part 405 of this Title specifically authorized pursuant to Article 36 of the Public Health Law to provide an AIDS home care program.

(c) An AIDS home care program provided by an AIDS Center shall mean a long term home health care program which is authorized only to provide an AIDS home care program and which shall comply with the standards of organization and administration for a long term home health care program set forth in Part 763 of this Chapter.

(d) No agency or facility shall provide a long term home health care program or an AIDS home care program as defined in part 700 of this chapter without a written authorization of the Commissioner to provide such a program, in accordance with the provisions of Article 36 of the Public Health Law.

(e) A long term home health care program that does not obtain authorization to provide an AIDS home care program shall not be precluded from providing services within its existing authority to patients who are diagnosed as having AIDS, or are deemed by a physician, within his or her judgement, to be infected with the etiologic agent of acquired immune deficiency syndrome, and who have an illness, infirmity or disability which can be reasonably ascertained to be associated with such infection.

(f) A hospital, residential health care facility, or certified home health agency seeking authorization to provide a long term home health care program shall transmit to the Commissioner an application setting forth the scope of the proposed program. Such application shall be on forms provided by the Commissioner.

(1) The Commissioner shall transmit the application to the State Hospital Review and Planning council and to the health systems agency having geographic jurisdiction of the area where the proposed program is to be located.

(2) The State Hospital Review and Planning Council and health systems agency shall have an opportunity to recommend approval or disapproval of the application by the Commissioner.

(g) A long term home health care program or AIDS Center seeking approval of an AIDS home care program shall transmit to the Commissioner an application setting forth the scope of the proposed program. Such application shall be on forms provided by the Commissioner.

(h) The Commissioner's written approval of the application shall constitute authorization to provide a long term home health care program or AIDS home care program. In making his authorization, the Commissioner shall specify the maximum number of persons which a provider of a long term home health care program may serve. Such number shall not include persons who are receiving services from an AIDS home care program. If the Commissioner proposes to disapprove the application, he shall notify the applicant in writing, stating the reasons for disapproval, and afford the applicant an opportunity for a public hearing.
 

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
Complete

Section 762.2 - Certified home health agency, long term home health care program construction

762.2 Certified home health agency, long term home health care program and AIDS home care program construction.

(a) Certified home health agency or long term home health care program construction as defined in section 3602(12) of the Public Health Law shall require the prior approval of the Commissioner in accordance with the provisions of Article 36 of the Public Health Law.

(b) For purposes of this Part:

(1) Total project costs shall include total costs for construction contracts, if any, including, but not limited to costs for demolition work, site preparation, actual construction and contingencies, total costs for real property, for fixed and movable equipment, architectural and/or engineering fees, capitalized amounts of working capital and construction loan interest costs, and other financing, professional and ancillary fees and charges. Such costs shall include the cost of all capital items associated with an acquisition, lease arrangement and/or construction. If any acquisition is to be effectuated through a leasing arrangement, the relevant cost shall be the cost of the asset, if purchased, or fair market value, whichever is greater, not the lease amount.

(2) Annual operating costs shall include the total costs incurred in conducting the operation of a certified home health agency or long term home health care program during the agency's fiscal year, including but not limited to depreciation, rent utilities, salaries, supplies and equipment.

(c) Any proposal for any of the following purposes shall constitute construction and shall be the subject of an application submitted for review pursuant to the requirements of this Part and Article 36 of the Public Health Law, including a review by the State Hospital Review and Planning Council:

(1) the addition or deletion of a certified home health agency service, regardless of cost. For purposes of this Part, such services include physical therapy, occupational therapy, speech pathology, social work services, respiratory therapy, nutrition, personal care services and physician services;

(2) a change in the agency's or program's geographic service area;

(3) a change in the method of providing a service if the total project cost or increase in annual operating cost, including any capital component thereof, generated by such proposal, exceeds $400,000;

(4) the erection, building or substantial acquisition or alteration of a physical structure or equipment if the total project cost or increase in annual operating cost, including the capital component thereof, generated by such proposal, exceeds $400,000; or

(5) a change in long term home health care program patient capacity, other than for an AIDS home care program.

(d) Notwithstanding the review requirements contained in subdivision (c) of this section, an AIDS home care program sponsored by an AIDS center hospital which proposes construction in accordance with paragraphs (2), (3) or (4) of subdivision (c) of this section, shall have such construction subject to a review only by the Commissioner of Health.

(e) The operator of an agency shall submit to the department, in writing, a request for approval of any proposed change in the name of a business corporation, not-for-profit corporation, partnership or governmental subdivision or initial use of, or change in, an assumed name of a business corporation, not-for-profit corporation, partnership, governmental subdivision or sole proprietor, ninety (90) days prior to the proposed name change.

(1) Such request for approval shall include the following:

(i) a photocopy of the executed proposed certificate of amendment of the certificate of incorporation or application for authority to conduct business in the State of New York, or a certificate or amended certificate of conducting business under an assumed name;

(ii) the current and proposed names and an explanation of the nature of, and the reasons for, the requested name change; and

(iii) such other pertinent information and documents necessary for the department's consideration, as requested.

(2) The approval by the department of a proposed name or assumed name shall be withheld if the proposed name or assumed name indicates or implies that the corporation, partnership, governmental subdivision or individual is authorized to engage in activities for which it is not authorized, provide a level of care it is not authorized to provide, is misleading, causes confusion with the identity of another home care agency, or violates any provision of law.

(f) The governing authority of an agency shall notify the department of any proposed change in address or office site location which does not require construction approval under this Part at least 10 days prior to effecting such changes.

(g) An application for certified home health agency or long term home health care program construction may be administratively approved by the Commissioner with prior notice to, but without the recommendation of, the State Hospital Review and Planning Council, if the council declines to make a recommendation and if the health systems agency having jurisdiction has recommended approval. (h) A construction application must be submitted on forms provided by the department and shall provide all the information essential for the Commissioner's consideration.

(i) If the Commissioner proposes to disapprove an application for construction, he shall afford the applicant an opportunity to request a public hearing and, if so requested, a public hearing shall be held.

(j) For certified home health agency or long term home health care program construction, the Commissioner shall not take any action contrary to the advice of the health systems agency until he affords an opportunity to the health systems agency to request a public hearing and, if so requested, a public hearing shall be held.

(k) The Commissioner, on his own motion, may hold a public hearing on an application for certified home health agency or long term home health care program construction.

(l) The governing authority of a certified home health agency, long term home health care program or AIDS home care program shall implement an approved application within 90 days of receipt of the Commissioner's approval of the application, unless a longer implementation period is granted by the Commissioner as part of such approval. Upon request of the applicant, the Commissioner may grant an initial extension of the timeframes specified in the approved application not to exceed 90 days and, upon another request of the applicant, the Commissioner may grant a final extension not to exceed 90 days. Any request for an extension shall be in writing and shall set forth the reasons why the application could not be implemented within the prescribed time. Failure to implement an approved application within the prescribed time as determined by the department shall constitute an abandonment of the application by the applicant and an expiration of the Commissioner's approval.
 

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
Complete

Part 763 - Certified Home Health Agencies, Long Term Health Care Programs and AIDS Home Care Programs Minimum Standards

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete
Statutory Authority: 
Public Health Law Sec. 3612 and Social Services Law, Sec. 367-M

Section 763.1 - General

Section 763.1 General. This Part establishes minimum requirements and operating standards for certified home health agencies, long term home health care programs and AIDS home care programs. For the purposes of this Part, these entities shall be referred to as "agency" unless the regulation specifies otherwise.
 

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
Complete

Section 763.2 - Patients' rights

763.2 Patients' rights.

(a) The governing authority shall develop and implement written policies and procedures regarding the rights of the patient. These rights, policies and procedures shall afford each patient the right to:

(1) be informed of these rights, and the right to exercise such rights, in writing prior to the initiation of care, as evidenced by written documentation in the clinical record;

(2) be given a statement of the services available from the agency and related charges;

(3) be advised before care is initiated of the extent to which payment for agency services may be expected from any third party payors and the extent to which payment may be required from the patient.

(i) The agency shall advise the patient of any changes in information provided under this paragraph or paragraph (2) of this subdivision as soon as possible, but no later than 30 calendar days from the date the agency becomes aware of the change.

(ii) All information required by this paragraph shall be provided to the patient both verbally and in writing;

(4) be informed of all treatments prescribed, when and how services will be provided, and the name and functions of any person and affiliated agency providing care and services;

(5) participate in the planning of his or her care and be advised in advance if any changes to the plan of care are warranted;

(6) refuse care and treatment after being fully informed of and understanding the consequences of such actions;

(7) submit patient complaints about care and services provided or not provided and complaints concerning lack of respect for property by anyone furnishing services on behalf of the agency, to be informed of the procedure for filing such complaints, and to have such complaints investigated by the agency in accordance with the provisions of paragraph (8) of subdivision (a) of section 763.11 of this Part;

(8) voice complaints and recommend changes in policies and services to agency personnel, the New York State Department of Health or any outside representative of the patient's choice. The expression of such complaints by the patient or his/her designee shall be free from restraint, interference, coercion, discrimination or reprisal;

(9) be treated with consideration, respect and full recognition of his or her dignity and individuality;

(10) privacy, including confidential treatment of patient records, and refusal of their release to any individual outside the agency except in the case of the patient's transfer to a health care facility, or as required by law or third-party payment contract;

(11) be advised in writing of the availability of the Department of Health toll-free hotline, the telephone number, the hours of its operation and that the purpose of the hotline is to receive complaints or answer questions about home care agencies; and

(12) refuse consent to advanced tasks performed by an advanced home health aide, in which case the agency shall provide for the performance of such tasks by a registered professional nurse.

(b) The governing authority shall make all personnel providing patient care services on behalf of the agency aware of the rights of patients and the responsibility of personnel to protect and promote the exercise of such rights.

(c) If a patient lacks capacity to exercise these rights, the rights shall be exercised by an individual, guardian or entity legally authorized to represent the patient.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 763.3 - Patient care

763.3 Patient care.

(a) The governing authority shall ensure that a comprehensive array of services is available and provided as needed.

(1) For a certified home health care agency, such services shall include, as a minimum, the following services which are of a preventive, therapeutic, rehabilitative, health guidance and/or supportive nature to persons at home: nursing services; home health aide services; medical supplies, equipment and appliances suitable for use in the home; and at least one additional service which may include, but not be limited to, the provision of physical therapy, occupational therapy, speech/language pathology, nutritional services and social work services.

(2) For a long term home health care program or AIDS home care program, such services shall include as a minimum: nursing services; home health aide services; medical supplies, equipment and appliances; physical therapy; occupational therapy; respiratory therapy; speech-language pathology; audiology; medical social work; nutritional services; personal care; homemaker and housekeeper services.

(b) An agency shall provide at least one of the services identified in paragraph (1) of subdivision (a) of this section directly, while any other services may be provided directly or by contract arrangement. For purposes of this Part, the direct provision of services includes the provision by employees compensated by the agency or individuals under contract with the agency, but does not include the provision of services through contract arrangements with other agencies or facilities.

(c) The agency shall assist the patient with obtaining, from other facilities, agencies or individuals, any of the services in subdivision (a) of this section that are not provided by the agency and which are needed by the patient.

(d) An agency must ensure the availability 24 hours a day, seven days a week of:

(1) professional telephone consultation for patients or caregivers; and

(2) part time, intermittent nursing and home health aide visits in the home as the needs of the patient dictate. If personal care or homemaker services are provided by the agency, such services must also be available on a part time, intermittent basis, 24 hours a day, seven days a week.

(e) If the agency is providing only personal care services to a patient, such services shall be provided in accordance with the regulations in this Article applicable to licensed home care services agencies.
 

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 763.4 Policies and procedures of service delivery

763.4 Policies and procedures of service delivery. The agency shall ensure that:

(a) written policies and procedures, consistent with current professional standards of practice, are developed and implemented for each service and are reviewed and revised as necessary;

(b) protocols are developed for each professional discipline to indicate when that service should be included in the patient assessment;

(c) any nursing or therapeutic services, procedures or treatments, not previously carried out in the home by that agency, are first reviewed by the professional advisory committee before being provided regularly. If a patient needs such service, procedure or treatment, it may be provided prior to review by the professional advisory committee, if:

(1) medical consultation has been obtained regarding safety and appropriateness; and

(2) personnel have been trained to provide that specific service, procedure or treatment;

(d) professional personnel are fully informed of, and encouraged to refer patients to, other health and social community resources which may be needed to maintain patients in the home;

(e) policies and procedures for the storage, cleaning and disinfection of medical supplies, equipment and appliances are established;

(f) persons providing care in the home display proper and current identification, including name, title and current photograph of care provider and name of agency providing the service. Such identification shall be returned to the agency upon termination of employment;

(g) supervisory personnel are employed by the agency to assure quality of patient care services. Such supervision shall include:

(1) ongoing review of cases and delegation of assignments;

(2) in-home visits to direct, demonstrate and evaluate the delivery of patient care;

(3) provision of clinical consultation; and

(4) professional guidance on agency policies and procedures; and

(h) all personnel delivering care in patient homes are adequately supervised. The department shall consider the following factors as evidence of adequate supervision:

(1) supervision of nursing personnel is conducted by a supervising community health nurse;

(2) personnel regularly provide services at the frequencies specified in the patient's plan of care, and in accordance with the policies and procedures of their respective services;

(3) personnel are assigned to the care of patients in accordance with their licensure, as appropriate, and their training, orientation and demonstrated skills;

(4) clinical records are kept complete, and changes in patient condition, adverse reactions, and problems with informal supports or home environment are charted promptly and reported to supervisory personnel;

(5) plans of care are revised as needed by the patient, and changes are reported to the authorized practitioner and other personnel providing care to the patient;

(6) supervision of a home health aide or personal care aide is conducted by a registered professional nurse or licensed practical nurse or by a therapist if the aide carries out simple procedures as an extension of physical therapy, occupational therapy or speech/language pathology;

(7) in-home supervision, by professional personnel, of home health aides and personal care aides takes place:

(i) to demonstrate to and instruct the aide in the treatments or services to be provided, with successful re-demonstration by the aide during the initial service visit, or where there is a change in personnel providing care, if the aide does not have documented training and experience in performing the tasks prescribed in the plan of care;

(ii) where any of the changes in paragraph (4) of this subdivision occur, to evaluate the change and initiate any revision in the plan of care which may be needed; and

(iii) to instruct the aide as to the observations and written reports to be made to the supervising community health nurse or therapist;

(8) direct supervision of an advanced home health aide is conducted by a registered professional nurse who:

(i) provides training, guidance, direction and oversight, and evaluation related to the performance of advanced tasks by the advanced home health aide;

(ii) assigns advanced tasks to be performed by the advanced home health aide after completing a nursing assessment to determine the patient’s current health status and care needs;

(iii) provides case specific training to the advanced home health aide to verify and ensure the advanced home health aide can safely and competently perform the advanced tasks for the patient;

(iv) provides written, patient specific instructions for performing advanced tasks, including the criteria for identifying, reporting, and responding to problems, errors or complications;

(v) conducts a comprehensive medication review including evaluation of the patient’s current medication use, and prescribed drug regimen and identifies and resolves any discrepancies prior to assigning the advanced home health aide to administer medications;

(vi) determines direct supervision of the advanced home health aide based on the complexity of advanced tasks, the skill and experience of the advanced home health aide assigned to perform the advanced tasks, and the health status of the patient for whom the advanced tasks are being performed;

(vii) while on duty is continuously available to communicate with the advanced home health aide by phone or other means;

(viii) conducts home visits or arranges for another qualified registered professional nurse whenever necessary to protect the health and safety of the patient;

(ix) performs an initial and ongoing assessments of the patient’s needs; and

(x) conducts a home visit at least every two weeks and more frequently as determined by the registered professional nurse, to observe, evaluate, and oversee services provided by the advanced home health aide;  

(9) a process is in place to document the limitation or revocation of the assignment of advanced tasks by an advanced home health aide when deemed appropriate by a supervising registered professional nurse and to ensure that such information is available to other registered professional nurses that may supervise such aide; and

(10) any failure by a supervising registered professional nurse to comply with the requirements of paragraph eight of this subdivision shall be reported to the department.

 

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 763.5 - Patient referral, admission and discharge

763.5 Patient referral, admission and discharge. The governing authority shall ensure that decisions regarding patient referral, admission and discharge are made based on the patient's assessed needs and the agency's ability to meet those needs in a manner that protects and promotes the patient's health and safety and does not jeopardize the safety of personnel. Such decisions shall reflect a commitment to providing authorized practitioner ordered care and services while honoring the patient's expressed needs and choices to the extent practicable and shall be made in accordance with the provisions of this section. For the purposes of this Part, authorized practitioner shall refer to a doctor of medicine, a doctor of osteopathy, a doctor of podiatry or any other practitioner authorized under Federal and State law and applicable rules and regulations to provide medical care and services to the patient.

(a) The initial patient visit shall be made within 24 hours of receipt and acceptance of a community referral or return home from institutional placement unless:

(1) the patient's authorized practitioner orders otherwise; or

(2) there is written documentation that the patient or family refuses such a visit.

(b) A patient shall be admitted to the agency after an assessment, using a form prescribed or approved by the department, is performed during the initial patient visit, which indicates that the patient's health and supportive needs can be met safely and adequately at home and that the patient's condition requires the services of the agency.

(1) In determining whether a prospective patient's health and supportive needs can be met safely at home, the agency shall consider for admission a prospective patient who meets at least one of the following criteria: is self-directing; is able to call for help; can be left alone; or has informal supports or other community supports who are willing, able and available to provide care and support for the patient in addition to the services being provided by the agency. For purposes of this section:

(i) A self-directing patient means an individual who is capable of making choices about his/her clinical care and activities of daily living, understanding the impact of the choice and assuming responsibility for the results of the choice, or has informal supports willing and able to provide advise and/or direction on behalf of the patient, if needed, in accordance with State law;

(ii) A patient who is able to call for help means an individual who is physically, mentally and cognitively capable of initiating effective communication to individuals outside the immediate presence of the patient who can provide timely assistance to the patient;

(iii) A patient who can be left alone means an individual who, based on his/her physical, mental and cognitive capability, does not require the continuous presence of another individual to meet his/her minimal ongoing health and safety requirements; and

(iv) Informal supports or other community supports means friends, relatives or associates of the patient, whether compensated or not, unaffiliated with the agency, who are able, available and willing to provide needed care, support and other services to the patient during the periods agency personnel are not present. Such supports may include personnel of an adult care facility in which the patient resides.

(2) The agency shall not be required to admit a patient:

(i) who does not meet any of the criteria of paragraph (1) of this subdivision;

(ii) when conditions are known to exist in or around the home that would imminently threaten the safety of personnel, including but not limited to:

(a) actual or likely physical assault which the individual threatening such assault has the ability to carry out;

(b) presence of weapons, criminal activity or contraband material which creates in personnel a reasonable concern for personal safety; or

(c) continuing severe verbal threats which the individual making the threats has the ability to carry out and which create in personnel a reasonable concern for personal safety;

(iii) when the agency has valid reason to believe that agency personnel will be subjected to continuing and severe verbal abuse which will jeopardize the agency's ability to secure sufficient personnel resources or to provide care that meets the needs of the patient; or

(iv) who, based on previous experience with the delivery of care from the agency, is known to repeatedly refuse to comply with a plan of care or others interfere with the patient's ability to comply with a plan of care agreed upon, as appropriate, by: the patient; the patient's family; any legally designated patient representative; the patient's physician; agency personnel and/or any case management entity, and such non-compliance will: (a) lead to an immediate deterioration in the patient's condition serious enough so that home care will no longer be safe and appropriate; or

(b) make the attainment of reasonable therapeutic goals impossible.

(3) The assessment shall be conducted by a registered professional nurse, except in those instances where physical therapy or speech/language pathology is the sole service prescribed by the patient's physician and the agency elects to have the therapist conduct the assessment.

(c) At the time a determination is made to deny a patient admission based on the criteria listed in paragraph (2) of subdivision (b) of this section, the agency shall determine whether the patient appears to be eligible for services from the local Protective Services for Adults program in accordance with the criteria set forth in subdivision (b) of section 457.1 of 18 NYCRR.

(1) If the patient appears to be eligible for such services, the agency shall make a referral to the appropriate local Protective Services for Adults program. Such referral shall indicate the patient's ongoing care needs and the reason for the decision not to admit.

(2) If the local Protective Services for Adults program accepts the referral, takes action to address the problems preventing admission and notifies the agency that such problems have been resolved, the agency shall reassess the patient to determine whether admission has become appropriate or remains inappropriate.

(d) Any patient who is assessed or reassessed as inappropriate for agency services shall be assisted by the agency, in collaboration with the discharge planner, the local Social Service Department and other case management entity, as appropriate, with obtaining the services of an alternate provider, if needed, and the patient's authorized practitioner shall be so notified. If alternate services are not immediately available, and the local Protective Services for Adults program, the Office of Mental Retardation and Developmental Disabilities, the Office of Mental Health or other official agency requests that home care services be provided on an interim basis, the agency may provide home care services which address minimally essential patient health and safety needs for a period of time agreed upon by the agency and the requesting entity, provided that the patient and family or informal supports, as appropriate, have been fully informed of the agency's intent to transfer the patient to an alternate service, when available, and have been consulted in the development of an interim plan of care.

(e) Services which the agency provides shall be available to all persons without regard to age, race, color, creed, sex, national origin, disability, service need intensity, location of patient's residence in the service area, or source of payment.

(f) Services shall not be diminished or discontinued solely because of the change in the patient's source of payment or the patient's inability to pay for care.

(g) A discharge plan shall be initiated prior to agency discharge to assure a timely, safe and appropriate transition for the patient.

(h) A patient may be discharged by the agency only after consultation, as appropriate, with the patient's authorized practitioner, the patient, the patient's family or informal supports, any legally designated patient representative and any other professional personnel including any other case management entity involved in the plan of care. If the agency determines that the patient's health care needs can no longer be met safely at home due to the circumstances specified in paragraphs (4) and (5) of this subdivision, the agency must continue to provide home health services only to the extent necessary to address minimally essential patient health and safety needs until such time as an alternative placement becomes available and such placement is made or the patient or the patient's legal representative, who has the authority to make health care decisions on behalf of the patient, makes an informed choice to refuse such placement. As appropriate, the patient and family or informal supports, any legally designated patient representative and any other professional personnel including any case management entity involved, shall be fully informed of the agency's intent to discharge the patient to an alternate service, when available, and shall be consulted in the development of an interim plan of care. Discharge shall be appropriate when:

(1) therapeutic goals have been attained and the patient can function independently or with other types of community support services;

(2) conditions in the home imminently threaten the safety of the personnel providing services or jeopardize the agency's ability to provide care as described in subparagraphs (ii) and (iii) of paragraph (2) of subdivision (b) of this section;

(3) all agency services are terminated by the patient; (4) the patient, the patient's family, informal supports or any legally designated patient representative is non-compliant or interferes with the implementation of the patient's plan of care and the scope and effect of such non-compliance or interference:

(i) has led to or will lead to an immediate deterioration in the patient's condition serious enough that home care will no longer be safe and appropriate; or

(ii) has made attainment of reasonable therapeutic goals at home impossible; and

(iii) the likely outcome of such non-compliance or interference has been explained to the patient, or the patient's legally designated patient representative, family or informal supports, and any case management entity, as appropriate, and the patient continues to refuse to comply with, or others continue to interfere with the implementation of, the plan of care; or

(5) the availability of home health services or community support services is no longer sufficient to meet the patient's changing care needs and to assure the patient's health and safety at home and the patient requires the services of a health care institution or an alternate health care provider. An agency may determine that the patient's health care needs can no longer be met safely at home by the agency if none of the criteria or circumstances of paragraph (1) of subdivision (b) of this section apply any longer to the patient.

(i) If a patient is to be discharged in accordance with subdivision (h) of this section, and the agency believes there will continue to be a substantial risk to the patient's health and safety subsequent to discharge, a referral shall be made to the appropriate local Protective Services for Adults program or other official agency, as appropriate, at the time the discharge determination is made.

(1) If the local Protective Services for Adults program or other official agency to which the patient has been referred accepts the referral, takes action to address adequately the problems leading to the discharge determination and notifies the home care agency that such problems have been resolved, the agency shall reassess the patient.

(2) After reassessment, the home care agency shall determine whether action to discharge the patient should be discontinued or the discharged patient should be readmitted.
 

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
Complete

Section 763.6 - Patient assessment and plan of care

763.6 Patient assessment and plan of care.

(a) A comprehensive interdisciplinary patient assessment shall be completed, involving, as appropriate, a representative of each service needed, the patient, the patient's family or legally designated representative and patient's authorized practitioner. Such assessment shall address, at a minimum, the medical, social, mental health and environmental needs of the patient.

(b) A plan of care shall be developed within 10 days of admission to the agency and approved by the patient based on the comprehensive interdisciplinary patient assessment. The plan shall designate a professional person employed by the agency to be responsible for coordinating care which includes but is not limited to:

(1) coordination of all services provided directly or by contract to the patient by the agency, informal supports and other community resources to carry out the agency's plan of care;

(2) cooperation with other health, social and community organizations providing or coordinating care;

(3) consultation with the patient's authorized practitioner, the local social services representative and discharge planner, if applicable. If an authorized practitioner has referred a patient under a plan of care that cannot be completed until after an evaluation visit, the authorized practitioner shall be consulted to approve additions or modifications to the original plan; and

(4) responsibility for maintaining current clinical records, conducting case reviews and completing required patient-specific records and reports, as appropriate.

(c) The plan of care shall cover all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, need for palliative care, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and any other appropriate items.

(d) Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration of such services.

(e) The plan of care shall be reviewed as frequently as required by changing patient conditions but at least every 60 days.

(1) Each review shall be documented in the clinical record; and

(2) Agency professional personnel shall promptly alert the patient's authorized practitioner to any significant changes in the patient's condition that indicate a need to alter the plan of care.
 

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 763.7 - Clinical records

763.7 Clinical records.

(a) The agency shall maintain a confidential clinical record for each patient admitted to care or accepted for service to include:

(1) identifying patient data;

(2) source of patient referral, including, where applicable, name and type of institution from which discharged, discharge summary and plan of care and date of discharge;

(3) medical orders and nursing diagnoses to include all diagnoses, medications, treatments, prognoses, and need for palliative care. Such orders shall be:

(i) signed by the authorized practitioner within 12 months after admission to the agency, or prior to billing, whichever is sooner;

(ii) signed by the authorized practitioner within 12 months after issuance of any change in medical orders or prior to billing, whichever is sooner, to include all written and oral changes and changes made by telephone by such practitioner; and

(iii) renewed by the authorized practitioner as frequently as indicated by the patient's condition but at least every 60 days;

(4) the comprehensive interdisciplinary patient assessment;

(5) the individualized plan of care;

(6) signed and dated progress notes, following each patient contact by each professional person providing care, which shall include a summary of patient status and response to plan of care and, if applicable, contacts with family, informal supports and other community resources, and a brief summary of care provided at the termination of each service;

(7) observations and reports made to the registered professional nurse, licensed practical nurse or supervising therapist by the advanced home health aide, home health aide or personal care aide, including activity sheets;

(8) documentation of accidents and incidents;

(9) documentation of the patient's receipt of information regarding his/her rights; and

(10) a discharge summary, completed by appropriate personnel when the patient is discharged from the agency, including but not limited to:

(i) documentation of discharge planning preparation;

(ii) notification to the patient's authorized practitioner;

(iii) reasons for discharge and date of discharge;

(iv) summary of care given and patient's progress;

(v) patient status upon discharge including a description of any remaining needs for patient care and supportive services;

(vi) patient or family ability to self-manage in relation to any remaining problems; and

(vii) recommendations and referral for any follow-up care, if needed.

(b) In addition to meeting the clinical record requirements of subdivision (a) of this section, clinical records for long term home health care programs and AIDS home care programs shall include an evaluation of the medical, mental health, social and environmental needs of the patient, on forms prescribed by the Commissioner, which shows that the patient is medically eligible for placement in a hospital or residential health care facility were this program not available.

(c) Each patient's clinical records shall be be kept securely for not less than six years after discharge from the agency and made available to the department upon request. In the case of minors, records are to be kept for not less than six years after discharge, or three years after they reach majority (18 years), whichever is the longer period.

(d) Each agency shall maintain written policies and procedures which:

(1) safeguard clinical records against loss or unauthorized access; and

(2) govern use, removal and release of information.

(e)(1) For agency patients who require placement in a nursing home or health-related facility, the SCREEN as contained in section 400.12 and the Hospital/Community PRI as contained in section 400.13 of this Title shall, as appropriate, be completed by personnel qualified and trained in accordance with section 86-2.30 and section 400.12 of this Title.

(2) Each agency shall have a sufficient number of trained, qualified and approved assessors and screeners to meet H/C PRI and SCREEN requirements and to attest to the accuracy of such patient review forms.

(3) The Commissioner may waive the requirements of this subdivision or any part thereof for recognized demonstration projects to effect the development of additional knowledge and experience in different types of assessments for long term care patients.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 763.8 Reserved

Section 763.9 Reserved

Section 763.10 Reserved

Section 763.11 - Governing authority

763.11 Governing authority. (a) The governing authority of the agency shall be responsible for the management, operation and evaluation of the agency and shall:

(1) ensure compliance of the agency with the applicable federal, state and local statutes, rules and regulations;

(2) ensure adequate personnel resources to:

(i) effectively conduct administrative functions of the agency; and

(ii) provide care in the home, based on the needs of the persons served as specified in the plan of care;

(3) adopt the agency's budget, control assets and funds, and provide for annual fiscal audits;

(4) prohibit personnel paid directly by the agency from being reimbursed by any party other than the agency for services provided by the agency;

(5) prohibit the splitting or sharing of fees between a referral agency, facility, individual or other home care services agency and the agency;

(6) adopt and amend policies regarding management and operation of the agency and the provision of patient care services;

(7) enter into agreements and contracts, where applicable, to provide agency services or to assure services needed by the agency;

(8) ensure the development and implementation of a patient complaint procedure to include:

(i) documentation of receipt, investigation and resolution of any complaint, including maintenance of a complaint log indicating the dates of receipt and resolution of all complaints received by the agency;

(ii) review of each complaint, with a written response to all written complaints or oral complaints, if requested by the individual making the oral complaint, to be provided within 15 days of receipt of such complaint:

(a) describing the complaint investigation findings and the decisions rendered to date by the agency; and

(b) advising the complainant of the right to appeal the outcome of the agency's complaint investigation and the appeal procedure to be followed;

(iii) an appeals process with review by a member or committee of the governing authority within 30 days of receipt of the appeal; and

(iv) notification to the patient or his or her designee that if the patient is not satisfied by the agency's response, the patient may complain to the Department of Health's Office of Health Systems Management;

(9) provide an office facility or facilities equipped and sufficient in size to permit efficient conduct of business, including access to patient records by all personnel providing care and prompt telephone contact to and from patients, referral agencies or facilities, and other home care services agencies;

(10) ensure the development of a written emergency plan which is current and includes procedures to be followed to assure health care needs of patients continue to be met in emergencies which interfere with delivery of services and orientation of all employees to their responsibilities in carrying out such a plan;

(11) for certified home health agencies only, ensure the provision of charity care in each fiscal year of the agency in an amount no less than two percent (2%) of the total operating costs of the agency in that fiscal year for not-for-profit and for-profit agencies and agencies operated by public benefit corporations and three and one-third percent (3-1/3%) of total operating costs of the agency for public agencies. Charity care is care provided at no charge or reduced charge for the services the agency is certified to provide to patients who are unable to pay full charges, are not eligible for covered benefits under title XVIII or XIX of the Social Security Act, are not covered by private insurance, and whose household income is less than two hundred percent (200%) of the federal poverty level. Adjustments to the required percentages of charity care may be made by the department upon recommendation of the appropriate health systems agency to reflect significant county variations from the state average with respect to the proportion of indigent and medically uninsured persons to the total population; and

(12) ensure continuous quality improvement initiatives, by establishing and maintaining a coordinated quality assessment and assurance program which integrates the review activities of all home care services provided by the agency to enhance the quality of care and treatment. Quality improvement shall be the responsibility of all personnel, at every level, at all times. Supervisory personnel alone cannot ensure quality of care and services. Such quality must be part of each individual's approach to his or her daily responsibilities.

(13) appoint a group of professional personnel, which includes one or more physicians, registered professional nurses, and representatives of the professional therapeutic services provided by the agency to perform the activities required in subparagraph (ii) of this paragraph. The findings and recommendations of this group shall be integrated into the agency's quality assessment and assurance program described in paragraph 12 of this subdivision. (i) At least one member of the group shall be neither an owner nor an employee compensated by the agency.

(ii) The group of professional personnel shall participate in the annual evaluation of the agency's program and shall meet at least quarterly to:

(a) review policies pertaining to the delivery of the health care and services provided by the agency and, when revisions are indicated, recommend such policies to the governing authority for adoption;

(b) make recommendations to the governing authority on professional issues, including the adequacy and appropriateness of services based on an assessment of health care resources in the community, patients' needs, available reimbursement mechanisms and availability of qualified personnel;

(c) assist the agency in maintaining liaison with other health care providers in the community;and

(d) review a sample of both active and closed clinical records to determine whether established policies are followed in furnishing services directly or under arrangement; and

(14) ensure that, at least annually, an overall evaluation of the agency's program is conducted.

(i) Such evaluation shall be conducted by all of the following:

(a) the group of professional personnel (or a committee thereof) as described in paragraph (13) of this subdivision;

(b) agency personnel; and

(c) consumers or other professional persons outside the agency working in conjunction with consumers.

(ii) Such evaluation shall include but not be limited to:

(a) an overall policy and administrative review to include the extent to which the agency:

(1) meets service area needs, including underserved geographic areas;

(2) meets the needs of special populations, including persons with intense service needs; mentally, cognitively or physically disabled persons, and financially indigent persons; and

(3) coordinates patient care services with services provided by other community agencies and organizations; and

(b) a review of the results and outcomes of the clinical record review as specified in clause (d) of subparagraph (ii) of paragraph (13) of this subdivision.

(b) To assist the governing authority with executing the responsibilities specified in subdivision (a) of this section, the governing authority shall:

(1) appoint an administrator responsible for the day-to-day management of the agency.

(i) The administrator, who may also be the supervising physician or registered nurse, as specified in paragraph (2) of this subdivision, shall be responsible for the organization and direction of the agency's ongoing functions through, but not limited to:

(a) implementation of an effective budgeting and accounting system;

(b) determination of the number and types of personnel needed to meet the agency's responsibilities and recruitment of qualified personnel;

(c) ensuring a planned orientation of new personnel and provision for appropriate, regularly scheduled in-service education related to personnel responsibilities;

(d) ensuring an annual evaluation of personnel performance;

(e) maintenance of ongoing liaison among the governing authority, the group of professional personnel appointed as specified in paragraph (13) of subdivision (a) of this section, and agency personnel; and

(f) ensuring availability of public information concerning the health care services which the agency provides, the geographic area in which these services are made available, the charges for the various types of services and the payment sources which may be available to pay for such services;

(ii) For long term home health care programs or AIDS home care programs, administrative responsibilities may be assumed by the administrator of the sponsoring certified home health agency, hospital or nursing home;

(2) employ a director of patient services on a full time or part time basis who is responsible for clinical direction and supervision of patient care services. This person, or a qualified alternate, shall be available at all times during operating hours and shall participate in all activities relevant to the professional services furnished, including development of qualifications and the assignment of personnel; and

(3) delineate in writing the organizational lines of responsibility and accountability of the administrator, the supervising community health nurse or physician, the group of professional personnel appointed as specified in paragraph 13 of subdivision (a) of this section, other committees and agency personnel.

(c) Except when a management contract has been approved pursuant to this section, the governing authority may not delegate its responsibility for the operation of the agency to another organization, a parent or subsidiary corporation or through a managing authority contract. An improper delegation may be found to exist where the governing authority no longer retains authority over the operation and management of the agency, including but not limited to such areas as: (1) authority to hire or fire the administrator;

(2) authority for the maintenance and control of the books and records;

(3) authority over the disposition of assets and the incurring of liabilities on behalf of the agency; or

(4) authority over the adoption and enforcement of policies regarding the operation of the agency.

(d) If the governing authority enters into a management contract, the requirements of this subdivision shall be met.

(1) For the purpose of this section, a management contract is an agreement between an agency's governing authority and a managing authority for the purpose of managing the day-to-day operation of the agency of any portion thereof.

(2) Management contracts shall be effective only with the prior written consent of the Commissioner, and shall include the following:

(i) a description of the proposed roles of the governing authority and managing authority during the period of the proposed management contract. The description shall clearly reflect retention by the governing authority of ongoing responsibility for statutory and regulatory compliance;

(ii) a provision that clearly recognizes that the responsibilities of the agency's governing authority are in no way obviated by entering into the management contract, and that any powers not specifically delegated to the managing authority through the provisions of the contract remain with the governing authority;

(iii) a clear acknowledgement of the authority of the Commissioner to void the contract pursuant to paragraph (9) of this subdivision;

(iv) a plan for assuring maintenance of the fiscal stability, the level of service provided and the quality of care rendered by the agency during the term of the management contract;

(v) an acknowledgement that the costs of the contract are subject to all applicable provisions of Part 86 of this Title;

(vi) a requirement that the reports described in paragraph (10) of this subdivision will be provided to the department and to the governing authority annually for the term of the management contract;

(vii) an express representation that any management contract approved by the Commissioner is the sole agreement between the managing authority and the governing authority for the purpose of managing the day-to-day operation of the agency or any portion thereof, and that any amendments or revisions to the management contract shall be effective only with the prior written consent of the Commissioner; and

(viii) a provision that includes the terms of paragraph (8) of this subdivision.

(3) No management contract shall be approved if the governing authority does not retain sufficient authority and control to discharge its responsibility as the certified operator. The following elements of control shall not be delegated to a managing authority;

(i) direct independent authority to hire or fire the administrator;

(ii) independent control of the books and records;

(iii) authority over the disposition of assets and the authority to incur on behalf of the agency liabilities not normally associated with the day-to-day operation of an agency; and

(iv) independent adoption of policies affecting the delivery of health care services.

(4) In addition to a proposed written contract complying with the provisions of paragraph (2) of this subdivision, a governing authority seeking to enter into a management contract shall submit to the department, at least 60 days prior to the intended effective date, unless a shorter period is approved by the Commissioner due to extraordinary circumstances, the following:

(i) documentation indicating that the proposed managing authority holds all necessary approvals to do business in New York State;

(ii) documentation of the goals and objectives of the management contract, including a mechanism for periodic evaluation of the effectiveness of the arrangement in meeting these goals and objectives;

(iii) evidence of the managing authority's financial stability.

(iv) information necessary to determine that the character and competence of the proposed managing authority, and its principals, officers and directors, are satisfactory, including evidence that all agencies or health care facilities managed or operated, in or outside of New York State, have provided a high level of care; and

(v) evidence that it is financially feasible for the agency to enter into the proposed management contract, recognizing that the costs of the contract are subject to all applicable provisions of Part 86 of this Title.

(5) During the period between an agency's submission of a request for approval of a management contract and disposition of that request, an agency may not enter into any arrangement for management contract services other than a written interim consultative agreement with the proposed managing authority. Any interim agreement shall reflect consistency with the provisions of this section, and shall be submitted to the department no later than five days after its effective date. (6) The term of a management contract shall be limited to three years and may be renewed only when authorized by the Commissioner, provided compliance with this section and the following provisions can be demonstrated:

(i) that the goals and objectives of the contract have been met within specified timeframes;

(ii) that the quality of care provided by the agency during the term of the contract has been maintained or has improved; and

(iii) that the reporting requirements contained in paragraph (10) of this subdivision have been met.

(7) Any application for renewal shall be submitted at least 90 days prior to the expiration of the existing contract.

(8) An agency's governing authority shall, within the terms of the contract, retain the authority to discharge the managing authority and its employees from their positions at the agency with or without cause on not more than 90 days' notice. In such event, the agency shall notify the department in writing at the time the managing authority is notified. The agency's governing authority shall provide a plan for the operation of the agency subsequent to the discharge, to be submitted with the notification to the department.

(9) A management contract shall terminate and be deemed cancelled, without financial penalty to the governing authority, not more than 60 days after notification to the parties by the department of a determination that the management of the agency is so deficient that the health and safety of patients would be threatened by continuation of the contract.

(10) Each managing authority shall submit annual reports to the department and the governing authority providing measurements of agency performance in the following areas:

(i) financial operations, including a balance sheet, any change in financial position, and a statement of revenues and expenses sufficient to determine liquidity, working capital, net operating margin and age, extent and type of payables and receivables;

(ii) personnel; and

(iii) services delivered.

(e) Franchise agreements. (1) For purposes of this subdivision, a franchise agreement means a contract or agreement between an agency's governing authority (franchisee) and a franchisor by which:

(i) the governing authority is granted the right to engage in the business of offering home care services under a marketing plan or system developed in substantial part by a franchisor, and the governing authority is required to pay, directly or indirectly, a franchise fee; or

(ii) the governing authority is granted the right to engage in the business of offering home care services associated substantially with the franchisor's trademark, service mark, trade name, logotype, advertising, or other commercial symbol designating the franchisor or its affiliate, and the governing authority is required to pay, directly or indirectly, a franchise fee.

(2) A governing authority may enter into a franchise agreement if the requirements of this subdivision are met. A franchise agreement which has been approved by the department prior to the effective date of this subdivision need not be amended further in order to meet the specific requirements of this subdivision. A franchise agreement entered into on or after the effective date of this subdivision shall be effective only with the prior written consent of the Commissioner. A governing authority seeking to enter into a franchise agreement shall submit to the department a copy of the proposed agreement complying with the provisions of this section at least 60 days prior to the intended effective date, unless a shorter period is approved by the Commissioner due to extraordinary circumstances. The department shall review proposals expeditiously and shall notify the governing authority of any changes that must be made. Such agreements shall include the following:

(i) a description of the proposed roles of the governing authority and franchisor during the period of the proposed agreement. The description shall reflect clearly the governing authority's ongoing responsibility for the operation and management of the agency and for compliance with all statutory and regulatory requirements;

(ii) a provision which recognizes clearly that the responsibilities of the agency's governing authority are in no way lessened by entering into the agreement and that the governing authority has full legal authority over the operation and management of the agency, and that the governing authority retains the right and authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations; (iii) a provision which recognizes that the policies, standards, procedures, manuals and other documents developed by the franchisor which relate to the operating standards, policies and procedures for the agency shall be available for inspection and copying by the department in accordance with the department's statutory and regulatory authority. Such documents, when received by the department, shall be subject to the relevant provisions of the Freedom of Information Law including, if applicable, provisions relating to excepting from disclosure documents which are trade secrets or are maintained for the regulation of commercial enterprise which if disclosed would cause substantial injury to the competitive position of the subject enterprise.

(iv) an express representation that any franchise agreement approved by the Commissioner is the sole franchise agreement between the franchisor and the governing authority for the agency, or any portion thereof, relating to the geographic service area that is covered by the franchise agreement.

(3) A franchise agreement shall not be approved if the governing authority does not retain sufficient authority and control to discharge its responsibilities as the agency operator. The following elements of control shall not be delegated to a franchisor:

(i) authority to hire of fire agency personnel;

(ii) control of the agency's books and records;

(iii) authority over the disposition of assets or the authority to incur liabilities on behalf of the agency; and

(iv) sole authority for the independent adoption of policies and procedures affecting the delivery of health care services. Although the governing authority may agree to adopt and utilize policies and procedures developed by the franchisor, the governing authority must retain authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations.

(4) An agreement which contains elements of both a franchise agreement and a management contract shall be subject to the applicable provisions of this subdivision and subdivisions (c) and (d) of this section. (f) Health Provider Network Access and Reporting Requirements. The governing authority of an agency shall obtain from the Department’s Health Provider Network (HPN), HPN accounts for each agency it operates and ensure that sufficient, knowledgeable staff will be available to and shall maintain and keep current such accounts. At a minimum, twenty-four hour, seven-day a week contacts for emergency communication and alerts, must be designated by each agency in the HPN Communications Directory. A policy defining the agency’s HPN coverage consistent with the agency’s hours of operation shall be created and reviewed by the agency no less than annually. Maintenance of each agency’s HPN accounts shall consist of, but not be limited to, the following: (1) sufficient designation of the facility’s HPN coordinator(s) to allow for HPN individual user application; (2) designation by the governing authority of an agency of sufficient staff users of the HPN accounts to ensure rapid response to requests for information by the State and/or local Department of Health; (3) adherence to the requirements of the HPN user contract; and (4) current and complete updates of the Communications Directory reflecting changes that include, but are not limited to, general information and personnel role changes as soon as they occur, and at a minimum, on a monthly basis.

Effective Date: 
Wednesday, November 2, 2005
Doc Status: 
Complete

Section 763.12 - Contracts

763.12 Contracts.

(a) The governing authority may enter into contracts with individuals, organizations, agencies or facilities, when necessary, to provide or obtain those services required by patients. Such contracts shall specify:

(1) the contracting parties' agreements, including, but not limited to:

(i) the services to be provided;

(ii) the manner in which services will be supervised and evaluated;

(iii) charges, reimbursement and other financial arrangements; and

(iv) any provisions made for indemnification between the agency and the contract provider;

(2) that contracted personnel meet the personnel requirements as set forth in section 763.13 of this Part, which can be verified by written documented evidence and examined by the agency and the department on request;

(3) that services provided to the patient by contract shall be in accordance with the plan of care developed by the agency in consultation with all providers of care, as appropriate, and that the contracting party agrees to abide by the patient care policies established by the agency;

(4) that nurses or therapists providing care and services under individual contract with the agency or as personnel of another contracted agency maintain liaison to assure that care planning and service delivery provided by such individuals is coordinated, supervised and integrated effectively into the patient services responsibilities required by this Part;

(5) that the agency to which the patient is admitted retains ultimate responsibility for coordination and provision of patient care;

(6) that the contracting party agrees to permit any personnel providing patient care to participate in patient care conferences upon request of the agency;

(7) that the contracting party submits patient clinical record entries, progress notes, visit schedules and periodic patient evaluations to the agency as frequently and promptly as necessary but at least within 12 calendar days of each visit to reflect:

(i) the current condition and progress of the patient; and

(ii) effective reporting and coordination of patient care between the agency and contract personnel; and

(8) the following terms and conditions: "Notwithstanding any other provisions in this contract, the agency remains responsible for:

(i) ensuring that any service provided pursuant to this contract complies with all pertinent provisions of Federal, State and local statutes, rules and regulations;

(ii) planning, coordinating and ensuring the quality of all services provided; and

(iii) ensuring adherence to the plan of care established for patients."

(b) The agency shall retain sole authority for the admission and discharge of patients. (c) A certified home health agency shall provide to a sub-contracting licensed home care services agency all information to allow such licensed home care services agency to meet the financial and statistical reporting requirements of section 766.12(c)(1) of this Part.
 

Effective Date: 
Wednesday, June 4, 2008
Doc Status: 
Complete

Section 763.13 - Personnel

763.13 Personnel. The agency shall ensure for all personnel:

(a) the development and implementation of written personnel policies and procedures, which are reviewed and revised as necessary;

(b) (1) that qualifications as specified in section 700.2 of this Title are met; (i) that the information required by Public Health Law section 3613(3)(a)-(f) has been entered into the home care services worker registry in accordance with Part 403 of this Title; and (ii) a criminal history record check to the extent required by section 400.23 and Part 402 of this Title.

(c) that the health status of all new personnel is assessed prior to assuming patient care duties. The assessment shall be of sufficient scope to ensure that no person shall assume his/her duties unless he/she is free from a health impairment which is of potential risk to the patient or which might interfere with the performance of his/her duties, including the habituation or addiction to depressants, stimulants, narcotics, alcohol or other drugs or substances which may alter the individual's behavior. The agency shall require the following of all personnel prior to assuming patient care duties:

(1) a certificate of immunization against rubella which means:

(i) a document prepared by a physician, physician's assistant, specialist's assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of rubella antibodies, or

(ii) a document indicating one dose of live virus rublella vaccine was administered on or after the age of twelve months, showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization, or

(iii) a copy of the document described in subparagraph (i) or (ii) of this paragraph which comes from a previous employer or the school which the individual attended as a student; and

(2) a certificate of immunization against measles for all personnel born on or after January 1, 1957, which means:

(i) a document prepared by a physician, physician's assistant, specialist's assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of measles antibodies; or

(ii) a document indicating two doses of live virus measles vaccine were administered with the first dose administered on or after the age of 12 months and the second dose administered more than 30 days after the first does but after 15 months of age showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a document, indicating a diagnosis of the person as having had measles disease prepared by the physician, physician's assistant/specialist's assistant, licensed midwife or nurse practitioner who diagnosed the person's measles; or

(iv) a copy of the document described in subparagraph (i), (ii) or (iii) of this paragraph which comes from a previous employer or the school which the person attended as a student;

(3) if any licensed physician, physician's assistant, specialist's assistant, licensed midwife or nurse practitioner certifies that immunization with measles and/or rubella vaccine may be detrimental to the person's health, the requirements of paragraphs (1) and (2) of this subdivision relating to measles and/or rubella immunization shall be inapplicable until such immunization is found no longer to be detrimental to such person's health. The nature and duration of the medical exemption must be stated in the individual's personnel record and must be in accordance with generally accepted medical standards (for example, the recommendations of the American Academy of Pediatrics and the Immunization Practices Advisory Committee of the U.S. Department of Health and Human Services); and

(4) either tuberculin skin test or Food and Drug Administration (FDA) approved blood assay for the detection of latent tuberculosis infection, prior to assuming patient care duties and no less than every year thereafter for negative findings. Positive findings shall require appropriate clinical follow-up but no repeat tuberculin skin test or blood assay. The agency shall develop and implement policies regarding follow-up of positive test results;

(5) documentation of vaccination against influenza, or wearing of a surgical or procedure mask during the influenza season, for personnel who have not received the influenza vaccine for the current influenza season, pursuant to section 2.59 of this Title.

(d) that the health status of all personnel be reassessed as frequently as necessary, but no less than annually, to ensure that personnel are free from health impairments which pose potential risk to patients or personnel or which may interfere with the performance of duties;

(e) that a record of all tests, examinations, health assessments and immunizations required by this section is maintained for all personnel who have direct patient contact;

(f) that personal identification is produced by each applicant for employment and verified by the agency prior to hiring of an applicant by the agency;

(g) that prior to patient contact, employment histories from previous employers, if applicable, and recommendations from other persons unrelated to the applicant if not previously employed, are verified;

(h) that personnel records include, as appropriate, records of professional licenses and registrations; verifications of employment history and qualifications for the duties assigned; signed and dated applications for employment; records of physical examinations and health status assessments; performance evaluations; dates of employment, resignations, dismissals, and other pertinent data, provided that all documentation and information pertaining to an employee's medical condition or health status, including such records of physical examinations and health status assessments shall be maintained separate and apart from the non-medical personnel record information and shall be afforded the same confidential treatment given patient medical records under section 763.7 of this Part;

(i) that time and payment records are maintained for all personnel;

(j) that there is a current written job description for each position which delineates responsibilities and any specific education, licensure and experience requirements;

(k) that an annual assessment of the performance and effectiveness of each person is conducted and documented in writing, including at least one home visit to observe performance if the person provides services in the home; and

(l) that all personnel receive orientation to the policies and procedures of the agency operation, inservice education necessary to perform his/her responsibilities and continuing programs for development and support. At a minimum:

(1) home health aides shall participate in 12 hours of inservice education per year;

(2) personal care aides shall participate in six hours of inservice education per year; and

(3) advanced home health aides must participate in 18 hours of in-service education per year, which must include medication management, infection control, and injection safety, and which must be directly supervised by a registered professional nurse.

(m)(1) that a program is implemented for the prevention of personnel or patients/clients becoming exposed to significant risk body substances which could put them at significant risk of HIV or other blood-borne pathogen infection as defined in sections 63.1 and 63.9 of this Title. Such a program shall include:

(i) use of scientifically accepted protective barriers during job-related activities which involve, or may involve, exposure to significant risk body substances. Such preventive action shall be taken by personnel with each patient/client and shall constitute an essential element for the prevention of bi-directional spread of HIV or other blood-borne pathogen;

(ii) use of scientifically accepted preventive practices during job-related activities which involve the use of contaminated instruments or equipment which may cause puncture injuries;

(iii) training at the time of employment and yearly personnel development programs on the use of protective equipment, preventive practices, and circumstances which represent a significant risk for all personnel whose job-related tasks involve, or may involve, exposure to significant risk body substances;

(iv) provision of personal protective equipment for personnel which is appropriate to the tasks being performed;

(v) a system for monitoring preventive programs to assure compliance and safety.

(2) that policies and procedures are implemented and enforced for the counseling, support and health care management of individuals who are exposed to significant risk body substances under circumstances which constitute significant risk of transmitting or contracting HIV or other blood-borne pathogen infection. They shall include:

(i) a system for reporting to a designated individual in the agency exposure thought to be a circumstance which constitutes significant risk of transmitting or contracting HIV or other blood-borne pathogen infection.

(ii) evaluation of the circumstances of a reported exposure and services for providing follow-up of the exposed individual which includes:

(a) medical and epidemiological assessment of the individual who is the source of the exposure, where that individual is known and available;

(b) if indicated epidemiologically, HIV or other blood-borne pathogen counseling and voluntary testing of the source individual. Disclosure of the HIV status of the source individual can be made with the express written consent of the protected individual, or a person authorized pursuant to law to consent to health care for the protected individual if such person lacks capacity to consent, or pursuant to court order, if the HIV status is not known to the exposed individual;

(c) appropriate medical follow-up of the exposed individual;

(iii) ensuring protection of confidentiality for those involved in reported exposures.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 763.14 - Records and reports

763.14 Records and reports.

(a) The governing authority shall ensure that:

(1) copies of the following current records are retained on file at the principal administrative office of the agency within its approved geographic service area:

(i) the certificate of incorporation and any amendments thereto, the partnership agreement and the certificate of doing business under an assumed name, if applicable;

(ii) the operating certificate;

(iii) all contracts and other agreements pertaining to the operation of the agency;

(iv) rules and bylaws of the governing authority and/or other authority, if applicable;

(v) operating policies and procedures and relevant determinations and interpretations;

(vi) a patient roster;

(vii) a listing of all personnel;

(viii) copies of all notices and documents required to be filed with the Securities and Exchange Commission; and

(ix) any other licenses, permits and certificates required by law for the operation of the agency;

(2) copies of the documents required under subparagraphs (1)(v), (vi) and (vii) of this subdivision are retained at each branch office of the agency. The listing of personnel and patients should be specific to each branch office;

(3) the following reports and records are retained by the agency and copies are furnished to the department immediately upon request:

(i) minutes of the meetings of the governing authority and the committees thereof which shall be retained for three years from the date of the meeting;

(ii) records of all financial transactions which shall be retained eight years from the date of the transaction;

(iii) personnel records, which shall be retained six years from the date of termination or resignation;

(iv) records of grievances, complaints and appeals, which shall be retained three years from resolution;

(v) all records related to patient care and services; and

(vi) other such records and reports as may be required by the department.

(4) all records required by paragraph (3) of this subdivision to be retained are maintained in hard copy or electronic form. If electronic storage is maintained, such records shall:

(i) be secure from unwarranted access;

(ii) have confidentiality protected, when appropriate; and

(iii) be immediately available to the agency and the department in hard copy format upon request.

(b) The agency shall furnish annually to the department a copy of:

(1) the listing of charges for all services offered;

(2) statistical summaries of all services provided, including patient specific information and discharge summary data;

(3) if a for-profit corporation, a list of the directors, officers and principal shareholders and the number and percent of the total issued and outstanding shares of the corporation held by each, duly certified by the secretary of the corporation as to completeness and accuracy;

(4) if a not-for-profit corporation, a list of corporate members, directors and officers; and

(5) other such records and reports as may be required by the department.
 

Effective Date: 
Wednesday, March 23, 1994
Doc Status: 
Complete

Part 764 Reserved

Part 765 - Approval and Licensure of Home Care Services Agencies

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 3605, 3611, 3612

SubPart 765-1 - Approval of Home Care Services Agencies

Effective Date: 
Monday, February 17, 1986
Doc Status: 
Complete

Section 765-1.1 - Definitions

Section 765-1.1 Definitions. For purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings: (a) Sponsor means:

(1) each officer of a corporation that is requesting or has received approval to operate a licensed home care services agency; and

(2) any controlling person, as defined in this section.

(b) Person means an individual, corporation, governmental subdivision or other legal entity, including a joint venture, or any combination of the foregoing acting in concert.

(c) Controlling person means a person which, either directly or indirectly, or through one or more intermediaries, possesses the ability to direct or cause the direction of the actions, management or policies of a person, whether through the ownership of voting securities or voting rights, by contract (except a commercial contract for goods or nonmanagement services) or otherwise; but no person shall be deemed to control another person solely by reason of his being a corporate officer or director of such other person (providing such officer or director is not acting in concert with others to represent another corporation). Control shall be presumed to exist if any person, directly or indirectly, owns, controls or holds with the power to vote 10 percent or more of the voting securities or voting rights of any other person or is a member of a not-for-profit corporation which member is other than a natural person.

(d) Principal stockholder means any person or organization that owns, holds or has the power to vote 10 percent or more of the issued and outstanding voting shares of stock of a corporation.

(e) Parent corporation means a corporation which, directly or indirectly, or through one or more intermediaries, possesses or will possess the ability to direct or cause the direction of the actions, management or policies of any partnership or corporation, any of the members of which are not natural persons, or any corporation any of the stock of which is owned by another corporation, which is applying for approval to operate or which already operates a certified home health agency or a licensed home care services agency.

(f) Health-related subsidiary corporation means a corporation which:

(1) is approved to operate a health care facility or program under either article 28, 33, 36, 40 or 44 of the Public Health Law, or which is approved to operate a facility or program under the Mental Hygiene Law; or

(2) operates a facility or program outside the State of New York which, if located within New York, would be subject to approval under either article 28, 33, 36, 40 or 44 of the Public Health Law or the provisions of the Mental Hygiene Law; and

(3) is, or will be, either directly or indirectly, or through one or more intermediaries:

(i) controlled by any partnership or corporation, any of the members of which are not natural persons, or any corporation any of the stock of which is owned by another corporation, which is applying for approval to operate or which already operates a certified home health agency or a licensed home care services agency; or

(ii) is controlled by any parent corporation of any such partnership or corporation described in subparagraph (i) of this paragraph, through the ability to direct or cause the direction of such health-related subsidiary's actions, management or policies.
 

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Section 765-1.2 - Applications for licensure

765-1.2 Applications for licensure. (a) An application to the Public Health Council for its approval, as required by law, shall be in writing on application forms provided by the department and subscribed by the chief executive officer duly authorized by the board of a corporate applicant, a general partner or proprietor of the proposed licensed home care services agency, or, where an application is to be submitted by a governmental subdivision as the applicant, the president or chairman of the board of the proposed agency or the chief executive officer if there is no board; and accompanied by a certified copy of a resolution of the board of a corporate applicant authorizing the undertaking which is the subject of the application, and the subscribing and submission thereof by an appropriate designated individual. In the event that an application is to be submitted by an entity which necessarily remains to be legally incorporated, it shall be subscribed and submitted by one of the proposed principal stockholders or directors. If a local government applicant submitting an application has not designated a president, chairman or chief executive officer for the proposed agency, the application shall be subscribed by the chairman or president of the local legislature or board of supervisors having jurisdiction, or other appropriate executive officer. An original application and five copies thereof shall be prepared and filed with the Public Health Council through the project management unit in the department's central office in Albany, which shall transmit one copy to the health systems agency having jurisdiction.

(b) Applications to the council shall contain information and data as applicable with reference to the character, experience, competence and standing in the community of the proposed persons, incorporators, directors, controlling persons, officers, principal stockholders, sponsors, governmental subdivisions, individual operators or partners of the applicant or of any parent or health-related subsidiary corporation as applicable. The application shall include copies of personal qualifying and disclosure information, as appropriate, as may be required by the council with regard to any such individual or organization.

(1) Disclosure information shall include, but not be limited to, a list of health care, adult care or mental health facilities, programs or agencies controlled or operated in the United States by an individual or organization specified in this subdivision; the name and address of each such facility, program or agency; and the dates of control or operation of each such facility, program or agency.

(2) In the event that any such health care, adult care or mental health facility, program or agency, while under the control or operation of an individual or organization specified in this subdivision, has been subjected to financial penalties, or suspension or revocation of its operating certificate, license or certification because of a failure to comply with provisions governing the conduct and operation of the facility, program or agency, then information must be provided which describes the nature of the violation, the agency or body enforcing the violation (including its name and mailing address), the steps taken by the facility, program or agency to remedy the violation or violations, and an indication of whether the suspension, revocation or accreditation has since been restored.

(c) The following documents shall be filed as attachments to the application: (1) where the applicant will be operating the licensed home care services agency under an assumed name, a photocopy of the applicant's existing or executed proposed certificate of doing business;

(2) where the applicant is a partnership, full and true copies of all partnership agreements, which shall include the following language:

"By signing this agreement, each member of the partnership created by the terms of this agreement acknowledges that the partnership and each member thereof has a duty to report to the New York State Department of Health any proposed changes in the membership of the partnership. The partners also acknowledge that the prior written approval of the Public Health Council is necessary for such change before such change is made, except that a change resulting from an emergency caused by the severe illness, incompetency or death of a member of the partnership shall require immediate notification to the New York State Department of Health of such fact, and application shall be made for the approval by the Public Health Council of such change within 30 days of the commencement of such emergency. The partners also acknowledge that they shall be individually and severally liable for failure to make the aforementioned reports and/or applications."

(3) where the applicant or licensed operator has or proposes to have a controlling person or a parent corporation, or is affiliated with a health-related subsidiary corporation, full and true copies of any such corporation's bylaws, certificate of incorporation and any existing or proposed amendments thereto, all agreements between the applicant and any such controlling person or parent corporation relating to the manner and mechanisms by which any such controlling person or parent corporation controls or will control the applicant and/or all agreements by which the applicant is affiliated with any health-related subsidiary corporation, and a detailed description of such control or affiliation relationship; (4) where an applicant corporation is formed pursuant to the requirements of section 3611 of the Public Health Law, documentation demonstrating the designation of an agent for service of process pursuant to section 305 of the Business Corporation Law or section 305 of the Not-for-Profit Corporation Law, as applicable; and

(5) such additional pertinent information or documents necessary for the council's consideration, as requested.
 

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Section 765-1.3 - Requirements for approval

765-1.3 Requirements for approval. (a) The application must be complete and in proper form. It shall provide all the information essential for the Public Health Council's consideration.

(b) The applicant must satisfactorily demonstrate to the council:

(1) if a not-for-profit corporation, that the controlling persons and sponsors, if any, the members of the board of directors and the officers of the corporation are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the corporation in the best interests of the agency and in the public interest, and to provide proper care for those to be served by the licensed home care services agency;

(2) if a proprietary business, that the owner, or all the partners of a partnership, are persons of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the business in the best interests of the agency and in the public interest, and to provide proper care for those to be served by the licensed home care services agency;

(3) if a business corporation, that the controlling persons and sponsors, if any, the members of the board of directors, the officers and the principal stockholders of the corporation or, in the case of an application solely for a change in the principal stockholder(s), that the proposed new principal stockholder(s) of the corporation, are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the corporation in the best interests of the agency and in the public interest, and to provide proper care for those to be served by the licensed home care services agency;

(4) with respect to any parent corporation or health-related subsidiary corporation, that the directors, sponsors, controlling persons and principal stockholders of any such corporation, insofar as applicable, are of such character, competence and standing in the community as to give reasonable assurance that, to the extent they have or will have the ability, through control or influence, to direct or cause the direction of the actions, management or policies of the applicant, such control or influence will be exercised in the best interests of the applicant and in the public interest, in order to ensure the provision of proper care for those to be served by the licensed home care services agency;

(5) with respect to any application solely for the acquisition of control of an operator of a licensed home care services agency by a controlling person or a change of a controlling person, that such new controlling person, insofar as applicable, is of such character, competence and standing in the community as to give reasonable assurance that, to the extent it has or will have the ability to direct or cause the direction of the actions, management or policies of the applicant, such control or influence will be exercised in the best interests of the applicant and in the public interest, in order to ensure the provision of proper care for those to be served by the licensed home care services agency; or

(6) if a public or government agency, that the governing authority of the governmental subdivision applying to operate the agency has provided reasonable assurance of its ability to conduct the affairs of the agency in the best interests of the agency and in the public interest, and to provide proper care for those to be served by the licensed home care services agency.

(c) In conducting a character and competence review, the Public Health Council shall, as applicable, evaluate any parent or health-related subsidiary corporation, the controlling persons, sponsors, members of the board of directors, the officers and principal stockholders, if any, of a corporate applicant, any sole proprietor, all partners in a partnership or, in the case of a governmental subdivision as the applicant, the governmental subdivision and the governing body thereof as a whole rather than the individual elected or appointed members thereof, by:

(1) reviewing the findings of inspection reports, patient care reviews, complaint investigations and any other pertinent information relating to the operation of any health care, adult care or mental health facility, program or agency located in New York approved to operate by the Department of Health, Department of Social Services or the Department of Mental Hygiene or, if located outside New York, would require the approval to operate by any one of such agencies if located in New York, with which an individual, corporation, other organization or governmental subdivision has been affiliated as a director, sponsor, controlling person, principal stockholder, sole proprietor, partner or governmental operator; (2) reviewing whether such individual, corporation, other organization or governmental subdivision exercised supervisory responsibility of the facility/agency operation to assure a consistent pattern of compliance with applicable standards and to prevent conditions which could result in harm to the health, safety or welfare of patients/residents;

(3) determining that, if a violation of applicable standards did occur, the applicant investigated the circumstances surrounding the violation and took steps appropriate to the gravity of the violation which a reasonably prudent operator would take to promptly correct and to prevent the reoccurrence of the violation; and

(4) considering such other pertinent matters relating to the character, competence and standing in the community of the applicant(s) .

(d) The applicant must supply:

(1) any additional information requested by the department within 30 days of such request, or must obtain from the department an extension of the time in which to provide such information. Any request for such extension of time shall set forth the reasons why such information could not be obtained within the prescribed time. The granting of such extension of time shall be at the discretion of the commissioner, provided such extensions are not for more than 30 days and the commissioner is satisfied as to the reasons why such information could not be obtained within the prescribed time. The commissioner is authorized to deny a request for an extension of time. Failure to provide such information within the time prescribed shall constitute an abandonment and withdrawal of the application by the applicant.

(2) any authorization the department requests in order to verify any information contained in the application or to obtain additional information which the department finds is pertinent to the application. Failure to provide such authorization shall constitute an abandonment and withdrawal of the application.
 

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Section 765-1.4 - Amendments to applications

765-1.4 Amendments to applications. (a) An application made to the Public Health Council pursuant to this Subpart may be amended while the matter is pending before the council. Such amendments shall be made on appropriate forms supplied by the department.

(b) Any amendment to an application which constitutes a substantial change in the information contained in the original application, or any prior amendments thereto, must be accompanied by a satisfactory written explanation as to the reason such information was not contained in the original application.

(c) Prior to the issuance of a license, any change as set forth in this subdivision shall constitute an amendment to the application and the applicant shall submit appropriate documentation as may be required in support of such amendment. The amended application shall be referred to the health systems agency having geographic jurisdiction and the State Hospital Review and Planning Council for their comments. The approval of the Public Health Council must be obtained for any amended application. Each of the following shall constitute an amendment:

(1) any change in the types of licensed services to be provided; and/or

(2) any change in the principals of the applicant as considered by the council.
 

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Section 765-1.5 - Withdrawals of applications

765-1.5 Withdrawals of applications. An application made to the Public Health Council may, on written request of the applicant, be withdrawn prior to decision by the council at any time without prejudice to resubmission.
 

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Section 765-1.6 - Decisions

765-1.6 Decisions. (a) Copies of the resolution of the Public Health Council approving or disapproving an application shall be transmitted to the applicant, the State Hospital Review and Planning Council, the appropriate health systems agency and the Commissioner of Health.

(b) Copies of a notice that the council is considering the disapproval of an application and affording the applicant an opportunity to request a public hearing shall be transmitted to the applicant and the Commissioner of Health.
 

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Section 765-1.7 - Failure to implement an application

765-1.7 Failure to implement an application. The failure, neglect or refusal of an applicant for licensure as a home care services agency to obtain a license and commence operation of the licensed home care services agency within one year of issuance of the Public Health Council's approval or contingent approval of the application shall constitute an abandonment of the application by the applicant and any approval or contingent approval issued by the Public Health Council shall be deemed cancelled and withdrawn without further action of such council.
 

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Section 765-1.8 - Revocation, limitation or annulment of Public Health Council approval

765-1.8 Revocation, limitation or annulment of Public Health Council approval. (a) An approval may be revoked, limited or annulled by the Public Health Council if the council finds that:

(1) the approved operator has been guilty of fraud or deceit in procuring such approval or has made statements or furnished information in support of the application which were not true, accurate or complete in any material respect;

(2) the agency's license has been revoked, limited or annulled pursuant to the applicable provisions of law;

(3) the approved operator has failed to comply with the applicable provisions of article 36 of the Public Health Law or the rules and regulations promulgated thereunder which threatened, or resulted in, direct significant harm to the health, safety or welfare of patients;

(4) the approved operator has been convicted, in a court of competent jurisdiction, either within or without the State, of a crime; or

(5) the approved operator has transferred ownership interest in the operation of the agency or the operator has terminated participation in the operation of the agency without prior approval of the Public Health Council, or a controlling person has exercised control of the operator of such agency without obtaining Public Health Council prior approval.

(b) For purposes of this section, approved operator shall include any person, partnership or partner thereof, governmental subdivision, and any corporation or principal stockholder, officer or director thereof, actual or proposed, whose application for licensure has been approved, regardless of whether a license has been issued.

(c) No approval shall be revoked, limited or annulled under this section without first offering the approved operator the opportunity for a public hearing.
 

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Section 765-1.9 - Hearings

765-1.9 Hearings. (a) Necessary hearings shall be conducted by the Public Health Council, a committee of the council, or a person designated by the council.

(b) Requests for hearings by the applicant shall be made within 20 days after notification that such request may be made.
 

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Section 765-1.10 - Approval of not-for-profit corporations

765-1.10 Approval of not-for-profit corporations. A not-for-profit corporation seeking the approval of the Public Health Council as the operator of a licensed home care services agency shall provide, in addition to meeting the other applicable requirements of this Subpart, information, documents and data as follows:

(a) a photocopy of the executed existing or proposed applicable corporate certificate which shall, in all respects, conform to the applicable provisions of the New York State Not-for-Profit Corporation Law and which includes corporate powers and purposes adequate to encompass the ownership and operation of a home care services agency or agencies; and

(b) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 765-1.11 - Approval of business corporations

765-1.11 Approval of business corporations. A business corporation seeking the approval of the Public Health Council as the operator of a licensed home care services agency shall provide, in addition to meeting the other applicable requirements of this Subpart, information, documents and data as follows:

(a) a photocopy of the executed existing or proposed applicable corporate certificate which shall, in all respects, conform to the applicable provisions of the New York State Business Corporation Law and which contains corporate powers and purposes adequate to encompass the ownership and operation of a home care services agency or agencies;

(b) a statement identifying all proposed principal stockholders, the number of voting shares to be owned by each and the percentage of issued and outstanding voting stock represented by such shares; and

(c) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 765-1.12 - Transfers of interest by persons or partnerships

765-1.12 Transfers of interest by persons or partnerships. Any change in the person who or partnership which is the operator of a licensed home care services agency must receive the prior approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Subpart. In the event such change is occasioned by the death of an operator, the department shall be notified immediately and application shall be made for approval of such change within 30 days of such death. A person or partnership seeking Public Health Council approval for the transfer of all or part of the ownership of the business shall file, in addition to meeting the other applicable requirements of this Subpart, the applicable information, documents and data as follows:

(a) a photocopy of the applicant's existing or executed proposed certificate of doing business;

(b) a photocopy of any corporate applicant's executed existing or proposed applicable corporate certificate;

(c) where the applicant is a partnership, full and true copies of all partnership agreements;

(d) a declaration of the percentage of the business to be transferred; and

(e) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 765-1.13 - Transfers of stock

765-1.13 Transfers of stock. (a) Any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder of a corporation which is the operator of a licensed home care services agency, or any transfer, assignment or other disposition of the stock or voting rights thereunder of such a corporation which results in the ownership or control of more than 10 percent of the stock or voting rights thereunder of such corporation by any person, must receive the prior approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Subpart. In the event such change is occasioned by the death of a stockholder, the department shall be notified immediately and application shall be made for approval of such change within 30 days of such death. An applicant who proposes to acquire stock or voting rights thereunder in a business corporation, the transfer of which requires the approval of the Public Health Council, shall file, in addition to meeting the other applicable requirements of this Subpart, information, documents and data as follows:

(1) a statement identifying the number of shares of stock or voting rights thereunder to be acquired and the percentage of total issued and outstanding stock represented by such shares; and

(2) such additional pertinent information or documents necessary for the Public Health Council's consideration, as requested.

(b) Any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder to the corporation, or any transfer, assignment or other disposition of the stock or voting rights thereunder which results in the ownership or control of more than 10 percent of the stock or voting rights thereunder by the corporation, or any transfer, assignment or other disposition of 10 percent or more of the stock or voting rights thereunder by the corporation, shall be subject to the prior approval by the Public Health Council in accordance with the applicable requirements of this Subpart and this section.
 

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Section 765-1.14 - Acquisition of control of the operator of an agency

765-1.14 Acquisition of control of the operator of an agency. This section relates to changes in the control of an operator of a licensed home care services agency not covered in section 765-1.12 or 765-1.13 of this Subpart. Changes covered in section 765-1.12 or 765-1.13 shall require prior approval of the Public Health Council.

(a) (1) Any change in the controlling person(s) of the operator of a not-for-profit or proprietary licensed home care services agency, other than a change subject to prior approval pursuant to section 765-1.12 or 765-1.13 of this Subpart, shall be subject to the approval of the Public Health Council in accordance with the applicable requirements of article 36 of the Public Health Law and this Subpart. A person seeking approval as a controlling person of the operator of a licensed home care services agency shall file an application for Public Health Council approval within 30 days of becoming a controlling person, in accordance with the applicable requirements of this Subpart.

(2) Pending a decision by the Public Health Council, an applicant shall refrain from exercising control over the licensed home care services agency by directing or causing the direction of the actions, management or policies of the agency, whether through voting securities or voting rights thereunder, electing or appointing directors, the direct or indirect determination of policies, or otherwise. The applicant shall submit, as part of the application, an affidavit whereby the applicant affirms that it will not exercise control over the agency pending a decision by the council.

(b) If the Public Health Council disapproves an application to become a controlling person under subdivision (a) of this section, the applicant shall divest himself of the controlling interest over the operator of the licensed home care services agency within 30 days of the council's final decision.

(c) Notwithstanding any other provision of this section, the prior approval of the Public Health Council must be obtained, pursuant to the applicable requirements of article 36 of the Public Health Law and this Part, if a person who proposes to become a controlling person of the operator of a licensed home care services agency is not able to refrain from exercising control over the agency upon becoming a controlling person as required by subdivision (a) of this section.

(d) (1) Upon request of an applicant under this section, the commissioner, on behalf of the Public Health Council, may issue a determination that the taking of some control action or proposed control action by the applicant does not constitute the applicant becoming a controlling person of the operator of a licensed home care services agency as contemplated by this Part and that Public Health Council approval is not required.

(2) The commissioner may revoke or modify his determination that an applicant is not or will not become a controlling person when, based on additional information or documentation not provided to the commissioner at the time of his initial determination, it is found that the applicant will exercise or has exercised control over the operator of a licensed home care services agency to the extent of directing or causing the direction of the actions, management or policies of the operator of such agency.

(3) When the commissioner determines that a person will exercise or is exercising control over an operator or a licensed home care services agency as a controlling person, such person shall refrain from exercising or continuing to exercise such control until Public Health Council approval is obtained.
 

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Section 765-1.15 - Limitation on transfer

765-1.15 Limitation on transfer. Any transfer pursuant to section 765-1.12 or 765-1.13 of this Subpart shall be completed within 90 days of issuance by the Public Health Council of its approval for such transfer unless extended by the council, and the council shall be notified of the transfer within 10 days after completion. Any request for an extension of time shall set forth the reasons why such transfer could not be completed within the prescribed time. Failure to complete a transfer within the time prescribed or as extended by the council or failure to notify the council within the time prescribed shall constitute an abandonment and withdrawal of the application and any council approval.
 

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SubPart 765-2 - Issuance of Home Care Services Agency License

Effective Date: 
Wednesday, December 12, 2018
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Section 765-2.1 - Issuance of a license

765-2.1 Issuance of a license. (a) No home care services agency, other than those exempt from licensure requirements as provided in subdivision (c) of this section, shall provide nursing, advanced home health aide, home health aide, or personal care services to persons in their home unless it has been approved by the Public Health and Health Planning Council and has been issued a license pursuant to the provisions of article 36 of the Public Health Law and this Part.

(b) A license shall not be issued by the commissioner unless he finds that the agency's equipment, personnel, standards of care and provision of service are in compliance with article 36 of the Public Health Law and all applicable codes, rules and regulations.

(c) The following are exempt from licensure under this Part and article 36 of the Public Health Law:

(1) a certified home health agency, long term home health care program, AIDS home care program, or hospice to the extent of providing home care to its hospice patients;

(2) an agency which provides personal care services or home care services exclusively to individuals pursuant to a program administered, operated or regulated by another State agency;

(3) an organization licensed and operating exclusively as a nurses' registry pursuant to article 11 of the General Business Law;

(4) sole practitioners of nursing licensed pursuant to article 139 of the Education Law; and

(5) a medical facility, approved under article 28 of the Public Health Law, to provide chronic renal dialysis services, to the extent such facility provides chronic renal dialysis services to patients at home.

(d) The following criteria shall be used to determine whether an organization or group of individuals are subject to licensure as a home care services agency:

(1) accountability for the services provided as evidenced by responsibility for:

(i) making admission and discharge decisions;

(ii) the provision of, or arranging for, patient care;

(iii) the establishment of standards and policies relating to the provision of care; and

(iv) determining charges for services provided;

(2) employment relationship, if any, of the staff to the operational entity; and

(3) extent and scope of service delivery and functions of staff.

(e) An application for licensure as a home care services agency shall be made to the department on forms provided by the department.

Effective Date: 
Wednesday, December 12, 2018
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Section 765-2.2 - Amendment of a license

765-2.2 Amendment of a license. (a) After issuance of an initial license, in order for the department to determine compliance with applicable statutes, rules and regulations, any licensed home care services agency seeking to add nursing, home health aide or personal care services shall submit an application to the department at least 90 days prior to the anticipated start of service and obtain written approval from the department prior to commencing the service. Such application shall be acted upon by the department within 90 days of receipt.

(b) The operator of a licensed home care services agency shall submit to the department, in writing, a request for approval of any proposed change in the name of a business corporation, not-for-profit corporation, partnership, sole proprietor or governmental subdivision or initial use of or change in an assumed name of a business corporation, not-for-profit corporation, partnership, sole proprietor or governmental subdivision, at least ninety (90) days prior to the proposed name change.

(1) Such request for approval shall include the following:

(i) a photocopy of the executed proposed certificate of amendment of the certificate of incorporation or application for authority to conduct business in the State of New York, or a certificate or amended certificate of conducting business under an assumed name;

(ii) the current and proposed names and an explanation of the nature of, and the reasons for, the requested name change; and

(iii) such other pertinent information and documents necessary for the department's consideration, as requested.

(2) The approval by the department of a proposed name or assumed name shall be withheld if the proposed name or assumed name indicates or implies that the corporation, partnership, governmental subdivision or individual is authorized to engage in activities for which it is not authorized, provide a level of care it is not authorized to provide, is misleading, causes confusion with the identity of another home care agency, or violates any provision of law.

(c) After issuance of an initial license, a licensed home care services agency shall notify the department in writing at least 30 days prior to commencing or discontinuing physical therapy, occupational therapy, speech/language pathology, nutrition services, social work, respiratory therapy, physician services, or medical supplies, equipment and appliances.

(d) A licensed home care services agency shall notify the department, in writing, of any proposed change in address or office site location at least 10 days prior to effecting such change.
 

Effective Date: 
Wednesday, November 1, 1995
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Section 765-2.3 - Discontinuation, revocation, suspension, limitation or annulment of a license

765-2.3 Discontinuation, revocation, suspension, limitation or annulment of a license. (a) No licensed home care services agency shall discontinue operation of the agency, discontinue the provision of nursing, home health aide or personal care services or surrender its license unless 30 days' written notice of its intention to do so, and a plan for the continuation of care for the patients on its roster and a plan for maintenance and safekeeping of the patient records are provided to the commissioner and written approval obtained. Such plan shall include referral of patients in need of such services to an alternate provider, if available.

(b) A home care services agency shall notify each patient concerned, the patient's family, and the patient's physician, if any, at least 30 days prior to the voluntary surrender of a license or as directed in an order of revocation, suspension, limitation or annulment.

(c) A license of a home care services agency may be revoked, suspended, limited or annulled by the commissioner on proof that it has failed to comply with the provisions of article 36 of the Public Health Law or the rules and regulations promulgated thereunder.

(d) No such license shall be revoked, suspended, limited, annulled or denied without a hearing. However, a license may be temporarily suspended or limited without a hearing for a period not in excess of 30 days upon written notice to the agency following a finding by the department that the public health or safety is in imminent danger.

(e) The commissioner shall fix a time and place for the hearing. A copy of the charges, together with the notice of the time and place of the hearing, shall be served in person or mailed by registered or certified mail to the agency at least 21 days before the date fixed for the hearing. The agency shall file with the department not less than eight days prior to the hearing, a written answer to the charges.

(f) All orders or determinations hereunder shall be subject to review as provided in article 78 of the Civil Practice Law and Rules. Application for such review must be made within 60 days after service in person or by registered or certified mail of a copy of the order or determination upon the application or agency.

(g) A home care services agency license shall be promptly surrendered to the department when revoked, suspended, limited or annulled by the commissioner, or when the agency terminates services.
 

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Part 766 - Licensed Home Care Services Agencies--Minimum Standards

Effective Date: 
Wednesday, December 12, 2018
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Statutory Authority: 
Public Health Law, Sections 576, 2164, 2500-a, 2522(6), 2528, 2904, 2904-b, 3612, 3612(6), 4175; SSL Sections 364(2), 365-a)

Section 766.1 - Patient rights

Section 766.1 Patient rights. (a) The governing authority shall establish written policies regarding the rights of the patient and shall ensure the development of procedures implementing such policies. These rights, policies and procedures shall afford each patient the right to:

(1) be informed of these rights, and the right to exercise such rights, in writing prior to the initiation of care, as evidenced by written documentation in the clinical record;

(2) be given a statement of the services available by the agency and related charges;

(3) be advised before care is initiated of the extent to which payment for agency services may be expected from any third party payors and the extent to which payment may be required from the patient.

(i) The agency shall advise the patient of any changes in information provided under this paragraph or paragraph (2) of this subdivision as soon as possible, but no later than 30 calendar days from the date the agency becomes aware of the change.

(ii) All information required by this paragraph shall be provided to the patient both orally and in writing;

(4) be informed of all services the agency is to provide, when and how services will be provided, and the name and functions of any person and affiliated agency providing care and services;

(5) participate in the planning of his or her care and be advised in advance of any changes to the plan of care;

(6) refuse care and treatment after being fully informed of and understanding the consequences of such actions;

(7) be informed of the procedures for submitting patient complaints;

(8) voice complaints and recommend changes in policies and services to agency staff, the New York State Department of Health or any outside representative of the patient's choice. The expression of such complaints by the patient or his/her designee shall be free from interference, coercion, discrimination or reprisal;

(9) submit patient complaints about the care and services provided or not provided and complaints concerning lack of respect for property by anyone furnishing service on behalf of the agency, to be informed of the procedure for filing such complaints, and to have the agency investigate such complaints in accordance with the provisions of subdivision (j) of section 766.9 of this Part. The agency is also responsible for notifying the patient or his/her designee that if the patient is not satisfied by the response the patient may complain to the Department of Health's Office of Health Systems Management;

(10) be treated with consideration, respect and full recognition of his/her dignity and individuality;

(11) privacy, including confidential treatment of patient records, and to refuse release of records to any individual outside the agency except in the case of the patient's transfer to a health care facility, or as required by law or third-party payment contract; and

(12) refuse consent to advanced tasks performed by an advanced home health aide, in which case the agency shall provide for the performance of such tasks by a registered professional nurse.

(b) The governing authority shall make all personnel providing patient care services on behalf of the agency aware of the rights of patients and the responsibility of personnel to protect and promote the exercise of such rights.

(c) If a patient lacks capacity to exercise these rights, the rights shall be exercised by an individual, guardian or entity legally authorized to represent the patient.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.2 - Patient service policies and procedures

766.2 Patient service policies and procedures. (a) The governing authority shall ensure for each health care service provided that:

(1) written policies and procedures consistent with current professional standards of practice are developed and implemented for each service and are reviewed and revised as necessary;

(2) that the delivery of each service is documented in the clinical record;

(3) to the extent possible, services are provided by the same personnel to the same patient;

(4) persons providing care in the home display proper and current identification, including name, title and current photograph of care provider and name of agency providing the service, to be returned to the agency upon termination of employment;

(5) written policies and procedures for the storage, cleaning and disinfection of medical supplies, equipment and appliances are established;

(6) professional staff evaluate the appropriateness, cleanliness and safety of equipment prescribed;

(7) any nursing or therapeutic service, procedure or treatment not previously provided in homes by the agency is first reviewed by the quality improvement committee as described in section 766.9 of this Part before being provided routinely. If the needs of a patient require such a service, procedure or treatment, it may be implemented prior to review by the quality improvement committee if:

(i) medical consultation has been obtained regarding safety and appropriateness; and

(ii) staff have been trained to provide that specific service, procedure or treatment;

(8) a discharge plan is initiated prior to agency discharge of the patient in order to assure a timely, safe and appropriate transition for the patient; and

(9) a patient is discharged by the agency after notification of the authorized practitioner, as defined in subdivision (b) of section 766.4 of this Part, and consultation with the patient and any other professional staff involved in coordinating the plan of care, no less than 48 hours prior to patient discharge.

(b) For purposes of this Part, health care services shall include nursing, advanced home health aide services, home health aide services, personal care, physical therapy, occupational therapy, speech/language pathology, nutrition services, social work, respiratory therapy, physician services and medical supplies, equipment and appliances.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.3 - Plan of care

766.3 Plan of care. The governing authority or operator shall ensure that:

(a) all patients are accepted for health care services only after a determination has been made by a registered professional nurse or by an individual directly supervised by a registered professional nurse that the patient's needs can be safely and adequately met by the agency;

(b) a plan of care is established for each patient based on a professional assessment of the patient's needs and includes pertinent diagnosis, prognosis, need for palliative care, mental status, frequency of each service to be provided, medications, treatments, diet regimens, functional limitations and rehabilitation potential;

(c) orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration of such services; and

(d) the plan of care is reviewed and revised as frequently as necessary to reflect the changing care needs of the patient, but no less frequently than every six months;

(1) each review shall be documented in the clinical record; and

(2) agency professional personnel shall promptly alert the patient's authorized practitioner and other affected care providers to any significant changes in the patient's condition that indicate a need to alter the plan of care.
 

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 766.4 - Medical orders

766.4 Medical orders.(a) The governing authority or operator shall ensure that an order from the patient's authorized practitioner is established and documented for the health care services the agency provides to those patients who:

(1) are being actively treated by an authorized practitioner for a diagnosed health care problem;

(2) have a health care need or change in physical status requiring medical intervention; or

(3) are advanced home health aide, home health aide, or personal care services patients of a certified home health agency.

(b) For purposes of this Part, authorized practitioner shall refer to a doctor of medicine, a doctor of osteopathy, a doctor of podiatry, a licensed midwife or a nurse practitioner authorized under federal and state law and applicable rules and regulations to provide medical care and services to the patient except as may be limited by third party contract.

(c) Such orders shall be reviewed and revised as the needs of the patient dictate but no less frequently than every six months, except where an authorized practitioner, as part of an authorization, orders personal care services for up to one year for a Medicaid patient.

(d) Medical orders shall reference all diagnoses, medications, treatments, prognoses, need for palliative care, and other pertinent patient information relevant to the agency plan of care; and

(1) shall be authenticated by an authorized practitioner within 12 months after admission to the agency; and

(2) when changes in the patient's medical orders are indicated, orders, including telephone orders, shall be authenticated by the authorized practitioner within 12 months.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.5 - Clinical supervision

766.5 Clinical supervision. The governing authority shall ensure for all health care services that:

(a) sufficient numbers of appropriately trained and oriented supervisory staff are available to ensure the quality of patient care services provided by the agency. Such supervision shall include:

(1) ongoing review of cases and delegation of assignments by appropriate health care professionals;

(2) in-home visits to direct, demonstrate and evaluate the delivery of patient care;

(3) provision of clinical consultation; and

(4) professional consultation on agency policies and procedures;

(b) all staff delivering care in patient homes are adequately supervised. The department shall consider the following factors as evidence of adequate supervision:

(1) staff regularly provide services at the times and frequencies specified in the patient's plan of care and in accordance with the policies and procedures of their respective services;

(2) staff are assigned to the care of patients in accordance with their licensure, and their training, orientation, and demonstrated skills;

(3) clinical records are kept complete and changes in patient condition, adverse reactions, and problems with informal supports or home environment are charted promptly and reported to supervisory staff; and

(4) plans of care are revised as needed and changes are reported to the patient's authorized practitioner, other staff providing care to the patient, and other agencies which authorize payment for services, as appropriate and necessary;

(c) home health aides or personal care aides are supervised, as appropriate, by a registered professional nurse, or a therapist if the aide carries out simple procedures as an extension of physical therapy, occupational therapy or speech/language pathology;

(d) in-home supervision by professional staff of home health aides and personal care aides occurs:

(1) to demonstrate to and instruct the aide in the treatments or services to be provided with successful re-demonstration by the aide during the initial service visit or where there is a change in personnel providing care, if the aide does not have documented training and experience in performing the tasks prescribed in the plan of care;

(2) where any of the conditions set forth in paragraph (3) of subdivision (b) of this section occur, to evaluate the condition and initiate any revision in the plan of care which may be needed; and

(3) to instruct the aide as to the observations and written reports to be made to the supervising nurse or therapist; and

(e) direct supervision of an advanced home health aide is conducted by a registered professional nurse who:

(i) provides training, guidance, direction and oversight, and evaluation related to the performance of advanced tasks by the advanced home health aide;

(ii) assigns advanced tasks to be performed by the advanced home health aide after completing a nursing assessment to determine the patient’s current health status and care needs;

(iii) provides case specific training to the advanced home health aide to verify and ensure the advanced home health aide can safely and competently perform the advanced tasks for the patient;

(iv) provides written, patient specific instructions for performing advanced tasks, including the criteria for identifying, reporting, and responding to problems, errors or complications;

(v) conducts a comprehensive medication review including evaluation of the patient’s current medication use, and prescribed drug regimen and identifies and resolves any discrepancies prior to assigning the advanced home health aide to administer medications;

(vi) determines direct supervision of the advanced home health aide based on the complexity of advanced tasks, the skill and experience of the advanced home health aide assigned to perform the advanced tasks, and the health status of the patient for whom the advanced tasks are being performed;

(vii) while on duty is continuously available to communicate with the advanced home health aide by phone or other means;

(viii) conducts home visits or arranges for another qualified registered professional nurse whenever necessary to protect the health and safety of the patient;

(ix) performs an initial and ongoing assessments of the patient’s needs; and

(x) conducts a home visit at least every two weeks and more frequently as determined by the registered professional nurse, to observe, evaluate, and oversee services provided by the advanced home health aide;

(f) a process is in place to document the limitation or revocation of the assignment of advanced tasks by an advanced home health aide when deemed appropriate by a supervising registered professional nurse and to ensure that such information is available to other registered professional nurses that may supervise such aide; and

(g) any failure by a supervising registered professional nurse to comply with the requirements of paragraph (e) of this subdivision shall be reported to the department.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.6 - Patient care record

766.6 Patient care record. (a) The agency shall maintain a confidential record for each patient admitted to care to include:

(1) identifying patient data;

(2) medical orders, if applicable;

(3) nursing assessments conducted to provide services;

(4) an individualized plan of care;

(5) signed and dated progress notes following each patient visit or phone contact by all professional personnel providing care which include a summary of patient status and response to the plan of care and any contacts with family, informal supports and other community resources that are relevant to the patient's condition and treatment;

(6) supervisory reports of the registered professional nurse, licensed practical nurse or the therapist, if applicable, of the advanced home health aide, home health aide, or personal care aide;

(7) observations and reports made to the registered professional nurse, licensed practical nurse or therapist by the advanced home health aide, home health aide, or personal care aide, including activity sheets;

(8) documentation of accidents and incidents;

(9) documentation of the patient's receipt of information regarding his/her rights; and

(10) a discharge summary when the patient is discharged from the agency including:

(i) documentation of discharge planning preparation;

(ii) notification to the patient's authorized practitioner;

(iii) reasons for discharge and date of discharge;

(iv) summary of care given and patient's progress;

(v) patient status upon discharge including a description of any remaining needs for patient care and supportive services;

(vi) patient or family ability to self-manage in relation to any remaining problems; and

(vii) recommendations and referral for any follow-up care, if needed.

(b) Each patient's record shall be kept securely for not less than six years after discharge from the licensed home care services agency and available to the department upon request.

(c) In the case of minors, records are to be kept for not less than six years after discharge, or three years after they reach majority (18 years), whichever is the longer period.

(d) In the event that an agency discontinues operation for any reason, the governing authority, immediately preceding the discontinuance of the operation, shall make effective arrangements to maintain, store, assure access to and make available to the patient and the department upon request, all clinical records for a period consistent with the requirements of subdivisions (b) and (c) of this section. The governing authority shall notify the department in writing as to where the clinical records will be stored and how they will be made available to former patients.

(e) Each agency shall maintain written policies and procedures which:

(1) safeguard clinical records against loss or unauthorized access; and

(2) govern use, removal and release of information.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.7 RESERVED

Section 766.8 RESERVED

Section 766.9 - Governing authority

Section 766.9 Governing authority. The governing authority or operator, as defined in Part 700 of this Title, of a licensed home care services agency shall:

(a) be responsible for the management and operation of the agency;

(b) ensure compliance of the home care services agency with all applicable Federal, State and local statutes, rules and regulations;

(c) ensure the development of a written emergency plan which is current and includes procedures to be followed to assure health care needs of patients continue to be met in emergencies that interfere with delivery of services, and orientation of all employees to their responsibilities in carrying out such a plan;

(d) adopt and approve amendments to written policies regarding the management and operation of the home care services agency and the provision of health care services;

(e) make available to the public information concerning the services which it offers, the geographic area in which these services are made available, the charges for the various types of service and the payment mechanisms which may be available for such services;

(f) provide an office facility or facilities equipped and sufficient in size to permit the efficient conduct of business including access to patient records by all professional staff providing care and prompt telephone contact to and from patients, referral agencies or facilities, and other home care services agencies;

(g) employ or contract for a sufficient number of staff to coordinate, direct and deliver services to patients accepted for care in accordance with prevailing standards of professional practice;

(h) employ at least one licensed and currently registered professional nurse whose educational and experiential qualifications are deemed appropriate by the employing agency for the duties assigned, to be responsible for the direction and supervision of all patient care services and other health care activities of the agency;

(i) accept and retain for services only those persons whose health care needs can be safely and adequately met by the agency according to criteria specified in written agency policies;

(j) ensure the development and implementation of a patient complaint procedure to include:

(1) documentation of receipt, investigation and resolution of any complaint, including the maintenance of a complaint log indicating the dates of receipt and resolution of all complaints received by the agency;

(2) review of each complaint with a written response to all written complaints and to oral complaints, if requested by the individuals making the oral complaint:

(i) explaining the complaint investigation findings and the decisions rendered to date by the agency within 15 days of receipt of such complaint; and

(ii) advising the complainant of the right to appeal the outcome of the agency's complaint investigation and the appeal procedure to be followed;

(3) an appeals process with review by a member or committee of the governing authority within 30 days of receipt of the appeal; and

(4) notification to the patient or his or her designee that if the patient is not satisfied by the agency's response, the patient may complain to the Department of Health's Office of Health Systems Management;

(k) ensure continuous quality improvement initiatives, by establishing and maintaining a coordinated quality assessment and improvement program which integrates the review activities of all home care programs and services to enhance the quality of care and treatment. Quality improvement shall be the responsibility of all staff, at every level, at all times. Supervisory personnel alone cannot ensure quality of care and services. Such quality must be part of each individual's approach to his or her daily responsibilities;

(l) appoint a quality improvement committee to establish and oversee standards of care. The quality improvement committee shall consist of a consumer and appropriate health professional persons. The committee shall meet at least four times a year to:

(1) review policies pertaining to the delivery of the health care services provided by the agency and recommend changes in such policies to the governing authority for adoption;

(2) conduct a clinical record review of the safety, adequacy, type and quality of services provided which includes:

(i) random selection of records of patients currently receiving services and patients discharged from the agency within the past three months; and

(ii) all cases with identified patient complaints as specified in subdivision (j) of this section;

(3) prepare and submit a written summary of review findings to the governing authority for necessary action; and

(4) assist the agency in maintaining liaison with other health care providers in the community. (m) ensure that any management contract complies with the following:

(1) For purposes of this section, a management contract is an agreement between a licensed home care services agency's governing authority and a managing authority for the purpose of managing the day-to-day activities of the agency or any portion thereof. The following shall not be considered management contracts:

(i) a contract solely for the provision of professional or other health care services;

(ii) an employment contract; or

(iii) a contract for the provision of administrative, consulting or support services if all of the following factors are present:

(a) the agency's governing authority retains responsibility for the day-to-day operations of the home care agency;

(b) the contracting entity has no authority to hire or fire any agency personnel;

(c) the contracting entity does not maintain and control the books and records of the agency;

(d) the contracting entity has no authority to dispose of assets or to incur any liability on behalf of the agency; and

(e) the contracting entity has no authority to adopt or enforce policies regarding the operation of the agency.

(2) A governing authority may enter into a management contract if the requirements of this subdivision are met. A management contract which has been approved by the department prior to the effective date of this subdivision need not be amended further in order to meet the specific requirements of this subdivision. A management contract entered into on or after the effective date of this subdivision shall be effective only with the prior written consent of the commissioner. Management contracts shall include the following:

(i) a description of the proposed roles of the governing authority and managing authority during the period of the proposed management contract. The description shall clearly reflect retention by the governing authority of ongoing responsibility for compliance with all statutory and regulatory requirements;

(ii) a provision which recognizes clearly that the responsibilities of the agency's governing authority are in no way lessened by entering into the management contract, that the governing authority retains full legal authority over the operation of the agency, and that any powers not delegated specifically to the managing authority through the provisions of the contract remain with the governing authority;

(iii) a provision which states that notwithstanding any other provision of the contract, the governing authority retains:

(a) direct, independent authority to hire or fire the agency's administrator or manager;

(b) independent control of the agency's books and records;

(c) authority over the disposition of assets and the authority to incur on behalf of the agency liabilities not associated normally with the day-to-day operation of the agency; and

(d) authority for the independent adoption and enforcement of policies affecting the delivery of health care services;

(iv) an express representation that any management contract approved by the commissioner is the sole agreement between the managing authority and the governing authority for the purpose of managing the day-to-day activities of the agency, or any portion thereof, relating to the geographic service area that is covered by the management contract, and that any amendments or revisions to the management contract which increase the amount or extent of authority delegated to the managing authority shall be effective only with the prior written consent of the commissioner.

(3) A management contract shall not be approved if the governing authority does not retain sufficient authority and control to discharge its responsibilities as the agency operator. The elements of control set forth in subparagraph (iii) of paragraph (2) of this subdivision shall not be delegated to a managing authority. The governing authority must retain authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations.

(4) A governing authority wishing to enter into a management contract shall submit a proposed written contract to the department at least 60 days prior to the intended effective date, unless a shorter period is approved in writing by the commissioner due to extraordinary circumstances. The department shall review proposals expeditiously and shall notify the governing authority of any changes that must be made. The governing authority shall also submit, within the same time frame, the following: (i) documentation demonstrating that the proposed managing authority holds all necessary approvals to do business in New York State;

(ii) information necessary to determine that the character and competence of the proposed managing authority, and its principals, officers and directors, is satisfactory, including evidence that all agencies or health care facilities it has managed or operated, in or outside of New York State, have provided a high level of care.

(5) During the period between an agency's submission of a request for approval of a management contract and disposition of that request, an agency may not enter into any arrangement for management contract services other than a written interim consultative agreement with the proposed managing authority. Any interim agreement shall be consistent with the provisions of this section, and shall be submitted to the department no later than five days after its effective date.

(6) An agency's governing authority shall retain the authority to terminate the contract and discharge the managing authority and its employees from their positions at the agency for cause on not more than 60 days' notice. In such event, the agency shall notify the department in writing at the time the managing authority is notified. The agency's governing authority shall provide a plan for the operation of the agency subsequent to the termination and discharge, to be submitted with the notification to the department.

(n) ensure that any franchise agreement complies with the following:

(1) For purposes of this section, a franchise agreement means a contract or agreement between a licensed home care services agency's governing authority (franchisee) and a franchisor by which:

(i) the governing authority is granted the right to engage in the business of offering home care services under a marketing plan or system developed in substantial part by a franchisor, and the governing authority is required to pay, directly or indirectly, a franchise fee, or

(ii) the governing authority is granted the right to engage in the business of offering home care services associated substantially with the franchisor's trademark, service mark, trade name, logotype, advertising, or other commercial symbol designating the franchisor or its affiliate, and the governing authority is required to pay, directly or indirectly, a franchise fee.

(2) A governing authority may enter into a franchise agreement if the requirements of this subdivision are met. A franchise agreement which has been approved by the department prior to the effective date of this subdivision need not be amended further in order to meet the specific requirements of this subdivision. A franchise agreement entered into on or after the effective date of this subdivision shall be effective only with the prior written consent of the commissioner. A governing authority seeking to enter into a franchise agreement shall submit to the department a copy of the proposed agreement complying with the provisions of this section at least 60 days prior to the intended effective date, unless a shorter period is approved by the commissioner due to extraordinary circumstances. The department shall review proposals expeditiously and shall notify the governing authority of any changes that must be made. Such agreements shall include the following:

(i) a description of the proposed roles of the governing authority and franchisor during the period of the proposed agreement. The description shall reflect clearly the governing authority's ongoing responsibility for the operation and management of the agency and for compliance with all statutory and regulatory requirements;

(ii) a provision which recognizes clearly that the responsibilities of the agency's governing authority are in no way lessened by entering into the agreement and that the governing authority has full legal authority over the operation and management of the agency, and that the governing authority retains the right and authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations;

(iii) a provision which recognizes that the policies, standards, procedures, manuals and other documents developed by the franchisor which relate to the operating standards, policies and procedures for the agency shall be available for inspection and copying by the department in accordance with the department's statutory and regulatory authority. Such documents, when received by the department, shall be subject to the relevant provisions of the Freedom of Information Law including, if applicable, provisions relating to excepting from disclosure documents which are trade secrets or are maintained for the regulation of commercial enterprise which if disclosed would cause substantial injury to the competitive position of the subject enterprise. (iv) an express representation that any franchise agreement approved by the commissioner is the sole franchise agreement between the franchisor and the governing authority for the agency, or any portion thereof, relating to the geographic service area that is covered by the franchise agreement.

(3) A franchise agreement shall not be approved if the governing authority does not retain sufficient authority and control to discharge its responsibilities as the agency operator. The following elements of control shall not be delegated to a franchisor:

(i) authority to hire or fire agency staff;

(ii) control of the agency's books and records;

(iii) authority over the disposition of assets or the authority to incur liabilities on behalf of the agency; and

(iv) sole authority for the independent adoption of policies and procedures affecting the delivery of health care services. Although the governing authority may agree to adopt and utilize policies and procedures developed by the franchisor, the governing authority must retain authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations.

(4) An agreement which contains elements of both a franchise agreement and a management contract shall be subject to the applicable provisions of this subdivision and subdivision (m) of this section.
(o) Health Provider Network Access and Reporting Requirements. The governing authority or operator of an agency shall obtain from the Department’s Health Provider Network (HPN), HPN accounts for each agency that it operates and ensure that sufficient, knowledgeable staff will be available to and shall maintain and keep current such accounts. At a minimum, twenty-four hour, seven-day a week contacts for emergency communication and alerts, must be designated by each agency in the HPN Communications Directory. A policy defining the agency’s HPN coverage consistent with the agency’s hours of operation shall be created and reviewed by the agency no less than annually. Maintenance of each agency’s HPN accounts shall consist of, but not be limited to, the following: (1) sufficient designation of the agency’s HPN coordinator(s) to allow for HPN individual user application; (2) designation by the governing authority or operator of an agency of sufficient staff users of the HPN accounts to ensure rapid response to requests for information by the State and/or local Department of Health; (3) adherence to the requirements of the HPN user contract; and (4) current and complete updates of the Communications Directory reflecting changes that include, but are not limited to, general information and personnel role changes as soon as they occur, and at a minimum, on a monthly basis.

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 766.10 - Contracts

766.10 Contracts. (a) The governing authority or operator may enter into contracts with individuals, organizations, agencies and facilities when necessary, to obtain or provide patient care services.

(b) No licensed home care service may be provided by arrangement without a written contract which specifies:

(i) services to be provided,

(ii) manner in which services will be supervised and evaluated,

(iii) charges and other financial arrangements; and

(iv) any provisions made for indemnification between the agency and the contract providers.

(c) Contract personnel shall meet the personnel requirements as set forth in section 766.11 of this Part, which can be verified by written documented evidence and examined by the agency and the department.

(d) Contractual arrangements pursuant to subdivision (a) of this section, shall not diminish the licensed home care services agency's responsibility for maintaining adequacy of services provided by the agency and shall specify the following terms and conditions:

Notwithstanding any other provisions in this contract, the licensed home care services agency remains responsible for:

(1) ensuring that any service provided pursuant to this contract complies with all pertinent provisions of Federal, State and local statutes, rules and regulations;

(2) ensuring the quality of all services provided by the agency; and

(3) ensuring adherence by agency staff to the agency plan of care established for patients.

(e) Nurses or therapists providing care and service under individual contract with the agency or as personnel of another contracted agency shall maintain liaison to assure that care planning and service delivery provided by such individuals are coordinated, supervised and integrated effectively into the patient services responsibilities required by this Part;

(f) If the licensed home care services agency contracts to provide personal care services with a local social services district, the physician's orders and nursing and social assessment may, pursuant to the contract and consistent with the provisions set forth in this Part, be maintained by the local social services district purchasing the services, provided that the local social services district furnishes such written documentation and information, including copies of the physician's orders and nursing assessment, and access to its staff, as may be required by the department or by the licensed agency to assure compliance with applicable statutes, rules and regulations. Nothing herein shall be construed to diminish the responsibilities of the local social services district under applicable State or Federal statutes, rules and regulations.

(g) If a licensed home care services agency contracts with a certified home health agency, long term home health care program, AIDS home care program or hospice, to provide personal care or home health aide services, the patient assessment, plan of care, clinical record entries, supervision of such services and the obtaining of medical orders may, pursuant to the contract and consistent with the provisions set forth in this Part, be conducted and documentation maintained by the agency purchasing the service, provided that the certified home health agency, long term home health care program, AIDS home care program or hospice, furnishes such written documentation and information and access to its staff, as required by the licensed agency, to permit the licensed home care services agency to assure compliance by its employees with applicable statutes, rules and regulations.
(h) If a licensed home care services agency contracts with a certified home health agency, the administrative and general costs of such licensed home care services agency shall not exceed the annual statewide average administrative and general limitation applied to certified home health agencies in accordance with subdivision (7) of section 3614 of the public health law.

Effective Date: 
Wednesday, June 4, 2008
Doc Status: 
Complete

Section 766.11 - Personnel

766.11 Personnel. The governing authority or operator shall ensure for all health care personnel:

(a) the development and implementation of written personnel policies and procedures, which are reviewed at least annually and revised as necessary;

(b) (1) that qualifications for advanced home health aides, home health aides, and personal care aides as specified in section 700.2 of this Title are met; and

(2) that the information required by Public Health Law section 3613(3)(a)-(f) has been entered into the home care services worker registry in accordance with Part 403 of this Title.

(c) that the health status of all new personnel is assessed and documented prior to assuming patient care duties. The assessment shall be of sufficient scope that no person shall assume his/her duties unless he/she is free from a health impairment which is of potential risk to the patient or which might interfere with the performance of his/her duties, including the habituation or addiction to depressants, stimulants, narcotics, alcohol or other drugs or substances which may alter the individual's behavior;

(d) that a record of the following tests, examinations or other required documentation is maintained for all personnel who have direct patient contact:

(1) a certificate of immunization against rubella which means:

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of rubella antibodies; or

(ii) a document indicating one dose of live virus rubella vaccine was administered on or after the age of twelve months, showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a copy of the document described in subparagraph (i) or (ii) of this paragraph which comes from a previous employer or the school which the individual attended as a student;

(2) a certificate of immunization against measles for all personnel born on or after January 1, 1957, which means:

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of measles antibodies; or

(ii) a document indicating two doses of live virus measles vaccine were administered with the first dose administered on or after the age of 12 months and the second dose administered more than 30 days after the first dose but after 15 months of age showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a document indicating a diagnosis of the person as having had measles disease prepared by the physician, physician assistant, specialist assistant, licensed midwife or nurse practitioner who diagnosed the person's measles; or

(iv) a copy of the document described in subparagraph (i), (ii), or (iii) of this paragraph which comes from a previous employer or the school which the person attended as a student;

(3) a written statement, if applicable, from any licensed physician, physician assistant, specialist assistant, licensed midwife or nurse practitioner, which certifies that immunization with measles and/or rubella vaccine may be detrimental to the person's health. The requirements of paragraphs (1) and (2) of this subdivision relating to measles and/or rubella immunization shall be inapplicable until such immunization is found no longer to be detrimental to such person's health. The nature and duration of the medical exemption must be stated in the individual's personnel record and must be in accordance with generally accepted medical standards (for example, the recommendations of the American Academy of Pediatrics and the Immunization Practices Advisory Committee of the U.S. Department of Health and Human Services);

(4) either tuberculin skin test or Food and Drug Administration (FDA) approved blood assay for the detection of latent tuberculosis infection, prior to assuming patient care duties and no less than every year thereafter for negative findings. Positive findings shall require appropriate clinical follow up but no repeat tuberculin skin test or blood assay. The agency shall develop and implement policies regarding follow-up of positive test results; and

(5) an annual, or more frequent if necessary, health status assessment to assure that all personnel are free from any health impairment that is of potential risk to the patient, family or to employees or that may interfere with the performance of duties; (6) documentation of vaccination against influenza, or wearing of a surgical or procedure mask during the influenza season, for personnel who have not received the influenza vaccine for the current influenza season, pursuant to section 2.59 of this Title. (e) that personal identification is produced by each applicant and verified by the agency prior to retention of an applicant by the agency;

(f) (i) that prior to patient contact, employment history from previous employers, if applicable, and recommendations from other persons unrelated to the applicant if not previously employed, are verified; and (ii) a criminal history record check to the extent required by Part 402 of this Title.

(g) that personnel records include verifications of employment history and qualifications for the duties assigned and, as appropriate, signed and dated applications for employment; records of professional licenses and registrations; records of physical examinations and health status assessments; performance evaluations; dates of employment, resignations, dismissals, and other pertinent data provided that all documentation and information pertaining to an employee's medical condition or health status, including such records of physical examinations and health status assessment shall be maintained separate and apart from the non-medical personnel record information and shall be afforded the same confidential treatment given patient medical records under section 766.6 of this Part;

(h) that time and payment records are kept for all personnel;

(i) that all personnel receive orientation to the policies and procedures of the home care services agency operation and in-service education necessary to perform his/her responsibilities. At a minimum:

(1) home health aides must participate in 12 hours of in-service education per year;

(2) personal care aides must participate in six hours of in-service education per year; and

(3) advanced home health aide must participate in 18 hours of in-service education per year which must include medication management, infection control, and injection safety, and must be directly supervised by a registered professional nurse;

(j) that there is a current written job description for each position which delineates responsibilities and specific education and experience requirements; and

(k) that an annual assessment of the performance and effectiveness of all personnel is conducted including at least one in-home visit to observe performance, if applicable.

(l)(1) that a program is implemented and enforced for the prevention of circumstances which could result in an employee or patient/client becoming exposed to significant risk body substances which could put them at significant risk of HIV or other blood-borne pathogen infection during the provision of services, as defined in sections 63.1 and 63.9 of this Title. Such a program shall include:

(i) use of scientifically accepted protective barriers during job-related activities which involve, or may involve, exposure to significant risk body substances. Such preventive action shall be taken by the employee with each patient/client and shall constitute an essential element for the prevention of bi-directional spread of HIV or other blood-borne pathogen;

(ii) use of scientifically accepted preventive practices during job-related activities which involve the use of contaminated instruments or equipment which may cause puncture injuries;

(iii) training at the time of employment and yearly staff development programs on the use of protective equipment, preventive practices, and circumstances which represent a significant risk for all employees whose job-related tasks involve, or may involve, exposure to significant risk body substances;

(iv) provision of personal protective equipment for employees which is appropriate to the tasks being performed;

(v) a system for monitoring preventive programs to assure compliance and safety.

(2) that a policy/procedure is implemented and enforced for the management of individuals who are exposed to significant risk body substances under circumstances which constitute significant risk of transmitting or contracting HIV or other blood-borne pathogen infection. The policy/procedure shall include:

(i) a system for reporting to a designated individual in the agency exposure thought to represent a circumstance which constitutes significant risk of transmitting or contracting HIV or other blood-borne pathogen infection;

(ii) evaluation of the circumstances of a reported exposure and services for providing follow-up of the exposed individual which includes:

(a) medical and epidemiological assessment of the individual who is the source of the exposure, where that individual is known and available;

(b) if indicated epidemiologically, HIV or other blood-borne pathogen counseling and voluntary testing of the source individual. Disclosure of the HIV status of the source individual can be made with the express written consent of the protected individual, or a person authorized pursuant to law to consent to health care for the protected individual if such person lacks capacity to consent, or pursuant to court order, if the HIV status is not known to the exposed individual;

(c) appropriate medical follow-up of the exposed individual; and

(iii) assurances for protection of confidentiality for those involved in reported exposures.

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Section 766.12 - Records and reports

766.12 Records and reports. (a) The governing authority or operator shall ensure the prompt submission of all records and reports required by the department and that:

(1) copies of the following records are retained on file at the principal administrative office in New York State of the home care services agency and available to the department upon request:

(i) the license issued by the department to operate as a home care service agency;

(ii) the certificate of incorporation and any amendments thereto, if applicable;

(iii) partnership agreement, if applicable;

(iv) certificate of doing business under an assumed name, if applicable;

(v) contracts and other agreements related to delivery of patient care entered into by the operator;

(vi) rules and bylaws of the governing authority and quality assurance committees, if applicable;

(vii) current written operating policies and procedures;

(viii) a current patient roster; and

(ix) listing of all personnel;

(2) copies of the following records are retained on file at each branch office of the home care services agency:

(i) the agency's policies and procedures;

(ii) a listing of all of the branch office's personnel; and

(iii) a current patient roster of all patients receiving care from the branch office and a copy of the patient care record of each such patient;

(3) at a minimum, the following reports and records are retained by the home care services agency and available to the department upon request:

(i) minutes of the meetings of the governing authority and the committees thereof which shall be retained for three years from the date of the meeting;

(ii) records of all financial transactions directly related to delivery of patient care which shall be retained three years from the date of the transaction;

(iii) personnel records, which shall be retained three years from the date of employee termination or resignation;

(iv) records of grievances and complaints which shall be retained for three years from the date of resolution;

(v) all records related to patient care and services; and

(vi) any other records required to be kept by this Part or Part 765.

(b) All records required by subdivision (a) of the section to be retained shall be maintained in hard copy or electronic form. If electronic storage is maintained, such records shall;

(1) be secure from unwarranted access;

(2) have confidentially protected, when appropriate; and

(3) be immediately available to the agency and the department in hard copy format upon request.

(c) The home care services agency shall furnish annually to the department a copy of:

(1) statistical summaries of all health care services, including the type, frequency and reimbursement for services provided, including reimbursement from federal and state governmental agencies, on forms provided by the department;

(2) if a for-profit corporation, a list of the principal stockholders and the number and percent of the total issued and outstanding shares of the corporation held by each, duly certified by the secretary of the corporation as to completeness and accuracy;

(3) if a not-for-profit corporation, a list of directors, officers and corporate members, if such members number 10 or fewer; and

(4) other such records and reports as may be legally required by the department.

(d) The agency shall furnish simultaneously to the department copies of all notices and documents required to be filed with the Securities and Exchange Commission.
 

Effective Date: 
Wednesday, June 4, 2008
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Part 767 Reserved

Part 768 - Respite Demonstration Projects

Effective Date: 
Monday, February 17, 1986
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Statutory Authority: 
Public Health Law, Section 3617

Section 768.1 - Definitions

Section 768.1 Definitions. (a) Respite shall mean the provision of infrequent and temporary substitute care or supervision of frail or disabled adults on behalf of and in the absence of the care-giver, for the purpose of providing relief from the stresses or responsibilities concomitant with providing constant care, so as to enable the care-giver to maintain a normal routine. Respite shall be limited to periods of three consecutive hours or longer, but not to exceed six weeks in any calendar year for any individual.

(b) Care-giver shall mean the family member or other natural person who normally provides the daily care or supervision of a frail or disabled adult. Such care-giver may, but need not, reside in the same household as the frail or disabled adult.
 

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Section 768.2 - Applicability

768.2 Applicability. (a) Certified home health agencies shall be permitted, with the prior approval of the commissioner, to participate in respite demonstration projects pursuant to section 131-p of the Social Services Law.
 

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Section 768.3 - Review of applications

768.3 Review of applications. (a) The commissioner's review of applications for respite demonstration projects submitted to the State Department of Social Services pursuant to section 131-p of the Social Services Law in regard to any certified home health agency participant shall include, but not be limited to, a review of the following with respect to such participant:

(1) findings of the department from inspections performed pursuant to subdivision 1, section 3612 of article 36 of the Public Health Law to determine the adequacy of care rendered patients; and

(2) findings of the department from inspections performed to determine conformance with applicable Federal statutes and regulations for certification of the agency for provider agreements issued pursuant to title XVIII and/or title XIX of the Social Security Act.

(b) The commissioner shall notify the State Department of Social Services of the results of the review of applications as described in subdivision (a) of this section.

(c) Written approval by the State Department of Social Services of an application for a respite demonstration project submitted pursuant to section 131-p of the Social Services Law shall constitute authorization for such project.
 

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Section 768.4 - Governing authority

768.4 Governing authority. The governing authority of any certified home health agency participating in an approved respite demonstration project pursuant to section 131-p of the Social Services Law shall:

(a) appoint a staff member as coordinator of respite services who shall have, in addition to other agency duties, the responsibility for the coordination of respite services with other patient services provided by the agency; and

(b) provide respite services in such agency only to persons medically eligible for admission to such agency.
 

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Article 8 Reserved

Article 9 - Hospice Operation

Effective Date: 
Wednesday, December 12, 2018
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Part 790 - Hospice Establishment

Effective Date: 
Friday, March 23, 1984
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Statutory Authority: 
Public Health Law, Section 4004

Section 790.1 - Applications for establishment

Section 790.1 Applications for establishment. (a) An application to the Public Health Council for its approval, as required by law, shall be in writing on application forms provided by the department and subscribed by the chief executive officer duly authorized by the board of a corporate applicant, a general partner or proprietor of the hospice or the proposed hospice, or, where an application is to be submitted by a local government applicant, the president or chairman of the board of the proposed hospice or the chief executive officer if there is no board; and accompanied by a certified copy of a resolution of the board of a corporate applicant authorizing the undertaking which is the subject of the application, and the subscribing and submission thereof by an appropriate designated individual. In the event that an application is to be submitted by an entity which necessarily remains to be legally incorporated, it shall be subscribed and submitted by one of the proposed stockholders or directors. If a local government applicant submitting an application has not designated a president, chairman or chief executive officer for the proposed hospice, the application shall be subscribed by the chairman or president of the local legislature or board of supervisors having jurisdiction, or other appropriate executive officer. An original application and eight copies thereof shall be prepared. The original and eight copies shall be filed with the Public Health Council through the Project Management Unit in the department's central office in Albany which shall transmit one copy to the health systems agency having jurisdiction.

(b) Applications to the council shall contain information and data with reference to:

(1) the public need for the existence of the hospice or proposed hospice at the time and place and under the circumstances proposed;

(2) the character, experience, competency and standing in the community of the proposed incorporators, directors, officers, stockholders, sponsors, individual operators or partners:

(3) the financial resources and sources of future revenue of the hospice or proposed hospice to be operated by the applicant; and

(4) the fitness and adequacy of the premises and equipment to be used by the applicant for the hospice or proposed hospice.

(c) The following documents shall be filed as attachments to the application:

(1) where the applicant will be operating the hospice under an assumed name, a photocopy of the applicant's executed proposed certificate of doing business;

(2) where the applicant is a partnership, full and true copies of all partnership agreements, which shall include the following language:

"By signing this agreement, each member of the partnership created by the terms of this agreement acknowledges that the partnership and each member thereof has a duty to report to the New York State Department of Health any proposed changes in the membership of the partnership. The partners also acknowledge that the prior written approval of the Public Health Council is necessary for such change before such change is made, except that a change resulting from an emergency caused by the severe illness, incompetency or death of a member of the partnership shall require immediate notification to the New York State Department of Health of such fact and application shall be made for the approval by the Public Health Council of such change within 30 days of the commencement of such emergency. The partners also acknowledge that they shall be individually and severally liable for failure to make the aforementioned reports and/or applications"; and

(3) such additional pertinent information or documents necessary for the council's consideration, as requested.
 

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Section 790.2 - Requirements for approval

790.2 Requirements for approval. (a) The application must be complete and in proper form. It shall provide all the information essential for the Public Health Council's consideration.

(b) The applicant must satisfactorily demonstrate to the council:

(1) that there is a public need for the hospice or the proposed new hospice;

(2) (i) if a not-for-profit corporation, that the members of the board of directors and the officers of the corporation are of such character, experience, competence and standing as to give reasonable assurance of their ability to conduct the affairs of the corporation in its best interests and in the public interest and to provide proper care for those to be served by the hospice or the proposed hospice;

(ii) if a proprietary business, that the owner, or all the partners of a partnership, are persons of such character, experience, competence and standing as to give reasonable assurance of their ability to conduct the affairs of the business in its best interests and in the public interest and to provide proper care for those to be served by the hospice or the proposed hospice;

(iii) if a business corporation, that the members of the board of directors, the officers and the stockholders of the corporation or, in the case of an application solely for a change in the principal stockholder(s), that the proposed new principal stockholder(s) of the corporation are of such character, experience, competence and standing as to give reasonable assurance of their ability to conduct the affairs of the corporation in its best interest and in the public interest and to provide proper care for those to be served by the hospice or the proposed hospice; and

(3) that there are adequate finances and sources of future revenue to properly establish and conduct the hospice or the proposed hospice.

(c) The applicant must supply:

(1) any additional information requested by the department within 3O days of such request, or must obtain from the department an extension of the time in which to provide such information. Any request for such extension of time shall set forth the reasons why such information could not be obtained within the prescribed time. The granting of such extension of time shall be at the discretion of the commissioner, providing such extensions are not for more than 30 days and the commissioner is satisfied as to the reasons why such information could not be obtained within the prescribed time. The commissioner is authorized to deny a request for an extension of time. Failure to provide such information within the time prescribed shall constitute an abandonment and withdrawal of the application.

(2) any authorization the department requests in order to verify any information contained in the application or to obtain additional information which the department finds is pertinent to the application. Failure to provide such authorization shall constitute an abandonment and withdrawal of the application.

(d) Whenever any applicant proposes to lease premises in which a hospice residence or the inpatient component of a hospice is to be provided, the lease agreement shall include the following language:

"The landlord acknowledges that its rights of reentry into the premises set forth in this lease do not confer on it the authority to operate a hospital or hospice as defined in articles 28 and 40, respectively, of the Public Health Law on the premises and agrees to provide the New York State Department of Health, Mayor Erastus Corning 2nd Tower, The Governor Nelson A. Rockefeller Empire State Plaza, Albany, N.Y. 12237, with notification by certified mall of its intent to reenter the premises or to initiate dispossess proceedings or that the lease is due to expire, at least 30 days prior to the date on which the landlord intends to exercise a right of reentry or to initiate such proceedings or at least 60 days before expiration of the lease."

(e) No lease covering the hospice office site or the premises in which a hospice residence or the inpatient component of a hospice as defined in article 40 of the Public Health Law is to be conducted, and no lease covering any equipment used in the operation of a hospice, may contain any provision whereby rent, or any increase therein is based upon the Consumer Price Index or any other cost of living index. In the event the lease covering such hospice premises or equipment contains provisions whereby it is the lessor's responsibility to pay necessary expenses associated with such premises or equipment, such as real estate taxes, utilities, heat, insurance, maintenance and operating supplies, such lease may contain provisions which allow adjustments to the rent only to the extent necessary to compensate the lessor for changes in such expenses.

(f) For purposes of this Article, principal stockholder means any person who owns or has the power to vote 10 percent or more of the issued and outstanding stock of a corporation which is requesting or has received approval to operate a hospice pursuant to article 40 of the Public Health Law.

Effective Date: 
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Section 790.3 - Amendments to applications

790.3 Amendments to applications. (a) An application made to the Public Health Council pursuant to this Part may be amended while the matter is pending before the council. Such amendments shall be made on appropriate forms supplied by the department, and submitted to the council through the department's central office in Albany which received the application.

(b) Any amendment to an application which constitutes a substantial change in the information contained in the original application, or any prior amendments thereto, must be accompanied by a satisfactory written explanation as to the reason such information was not contained in the original application.

(c) Prior to the issuance of a certificate of approval, any substantial alteration of the method of financing, or of the terms of a lease of the land, building or equipment, or change of the principals as considered by the council, shall constitute an amendment.

(d) Failure to disclose an amendment prior to the issuance of a certificate of approval shall constitute sufficient grounds for the revocation, limitation or annulment of the approval of establishment.
 

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Section 790.4 - Withdrawals of applications

790.4 Withdrawals of applications. An application made to the Public Health Council in accordance with this Part may, on written request of the applicant, be withdrawn prior to decision by the council at any time without prejudice to resubmission.
 

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Section 790.5 - Revocation, limitation or annulment of approvals of establishments

790.5 Revocation, limitation or annulment of approvals of establishment (a) An approval of establishment may be revoked, limited or annulled by the Public Health Council if the council finds that:

(1) the established operator has been guilty of fraud or deceit in procuring such approval of establishment or has made statements or furnished information in support of the application which were not true, accurate, or complete in any material respect;

(2) the hospice certificate of approval has been revoked, limited or annulled pursuant to the applicable provisions of law;

(3) the hospice has failed to comply with the provisions of article 40 of the Public Health Law or the rules and regulations promulgated thereunder;

(4) the established operator has had such a change in financial condition or in the fiscal aspects of the hospice since the approval of establishment as to render the project economically unfeasible or render unsatisfactory the financial resources of the hospice and its sources of future revenue;

(5) the established operator has been convicted in a court of competent jurisdiction, either within or without the State, of a crime;

(6) the established operator is a habitual drunkard or is addicted to the use of morphine, cocaine or other drugs having similar effect, or has become mentally disabled;

(7) the established operator has transferred ownership interest in the operation of the hospice without Public Health Council approval, or that such person has terminated participation in the operation of the hospice;

(8) the established operator has granted any person convicted of a crime relating to hospice or hospital activities the authority to direct or cause the direction of the operations, management or policies of the hospice; or

(9) another corporation has been granted or has obtained ownership of stock or the voting rights thereunder, of the hospice corporation.

(b) For purposes of this section, established operator shall include any person, partnership, or partner thereof, and any corporation or stockholder, officer or director, thereof, actual or proposed, whose application for establishment has been approved, regardless of whether a certificate of approval has been issued.
 

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Section 790.6 - Hearings

790.6 Hearings. (a) Necessary hearings shall be conducted by the Public Health Council, a committee of the council, or a person designated by the council.

(b) Requests for hearings by applicants shall be made within 20 days after notification that such request may be made. If such request is made by the State Hospital Review and Planning Council or by a health systems agency, it must be made within 10 days subsequent to the meeting of such council or agency which took place after notification that such request may be made.
 

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Section 790.7 - Decisions

790.7 Decisions. (a) Copies of the resolution of the Public Health Council approving or disapproving an application shall be transmitted to the applicant, the State Hospital Review and Planning Council, the appropriate health systems agency and the Commissioner of Health.

(b) Copies of a notice that the council is considering the disapproval of an application or action contrary to the recommendation of the State Hospital Review and Planning Council or a health systems agency and affording an opportunity to request a public hearing shall be transmitted to the applicant, to the State Hospital Review and Planning Council, the appropriate health systems agency and the Commissioner of Health.
 

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Section 790.8 - Governing authority or operator

790.8 Governing authority or operator. (a) The governing authority or operator is the party responsible for the operation of a hospice.

(b) The governing authority or operator shall mean:

(1) the policy-making body of a government agency;

(2) the officers and the board of directors or trustees of a not-for-profit corporation;

(3) the officers, board of directors and stockholders of a business corporation; and

(4) the proprietor or proprietors of a proprietary hospice.

(c) An individual, partnership, corporation, organization or agency which has not received establishment approval may not participate in the total gross income or net revenue of a hospice.
 

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Section 790.9 - Agents, nominees and fiduciaries

790.9 Agents, nominees and fiduciaries. Agents, nominees and fiduciaries, whether testamentary or inter vivos, shall not own or have the power to control any interest in the operation of a hospice nor shall they be considered proper applicants for establishment or transfer of interest in, or ownership of, stock in a corporation that operates a hospice.
 

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Section 709.10 Reserved

Section 790.10 - Establishment of not-for-profit corporations

790.10 Establishment of not-for-profit corporations. A not-for-profit corporation seeking Public Health Council approval to be established as the operator of a hospice shall comply with the other applicable provisions of this Part and, in addition, shall furnish the council with a photocopy of its executed proposed corporate certificate.
 

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Section 790.11 - Establishment of business corporations

790.11 Establishment of business corporations. Only a natural person may own, hold or have the power to vote the stock in a corporation that operates a hospice. Persons seeking the approval of the Public Health Council for the formation of a business corporation to be established as the operator of a hospice shall provide, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) A photocopy of the executed proposed certificate of incorporation which shall, in all respects, conform to the applicable provisions of the Business Corporation Law and all other pertinent laws of the State of New York. Such certificate of incorporation shall contain provisions to the following effect:

(1) The corporate powers and purposes shall be limited to the ownership and operation, or operation, of a hospice or hospices specifically named and the location or locations of which are specifically designated by city, town, village and county; provided, however, that the corporate powers and purposes may also include the ownership and operation, or operation, of a hospital or hospitals, as defined in article 28 of the Public Health Law, or of a certified home health agency or licensed home care services agency or agencies as defined in article 36 of the Public Health Law, or a health maintenance organization as defined in article 44 of the Public Health Law; if the corporation has received all approvals required under such law to own and operate such hospital or hospitals, home care services agency or agencies or health maintenance organization.

(2) The location of the principal office of the corporation which shall be at the same address as a hospice, hospital, home care services agency or health maintenance organization which is to be operated by the corporation in the State of New York.

(3) No person shall own or have the power to vote 10 percent or more of the issued and outstanding stock of the corporation unless the Public Health Council has approved such ownership or control.

(4) All stock certificates of the corporation shall bear on the face thereof the following:

(i) No person shall own or control 10 percent or more of the stock or voting rights thereunder of the corporation unless the Public Health Council has first approved such ownership or control.

(ii) Any transfer, assignment or other disposition of the stock or voting rights thereunder of the corporation which results in the ownership or control of 10 percent or more of the stock or voting rights thereunder of the corporation by any person shall be subject to the prior approval by the Public Health Council.

(iii) No stock or voting rights thereunder of the corporation may be owned or controlled by another corporation.

(5) Stock shall consist of one class of common stock only.

(b) An affidavit from each applicant setting forth:

(1) that the applicant is to be the sole beneficial owner of the voting shares of the corporation of which the applicant is to be the holder of record;

(2) the number of voting shares in the corporation of which the applicant is to be the holder of record; and

(3) that all stock authorized by the certificate of incorporation will be issued and outstanding.

(c) A copy of the proposed stock certificate bearing imprinted on the face thereof the following:

(1) No person shall own or control 10 percent or more of the stock or voting rights thereunder of the corporation unless the Public Health Council has first approved such ownership or control.

(2) Any transfer, assignment or other disposition of the stock or voting rights thereunder of the corporation which results in the ownership or control of 10 percent or more of the stock or voting rights thereunder of the corporation by any person shall be. subject to the prior approval by the Public Health Council.

(3) No stock or voting rights thereunder of the corporation may be owned or controlled by another corporation.

(d) Such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 790.12 - Reporting by business corporations

790.12 Reporting by business corporations. Within 30 days after the approval of establishment, the corporation shall furnish to the department a list of the names of all of the shareholders and the number and percent of the total issued and outstanding shares of the corporation held by each, duly certified by the secretary of the corporation as to completeness and accuracy, and shall thereafter furnish such a certified list at annual intervals. Failure to comply with the provisions of this section shall constitute sufficient grounds for the revocation, limitation or annulment of the approval of establishment.
 

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Section 790.13 - Transfers of interest by sole proprietors or partnerships

790.13 Transfers of interest by sole proprietors or partnerships. An individual or partnership seeking Public Health Council approval for the transfer of all or part of the ownership of the business shall file, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) a photocopy of the applicant's executed proposed certificate of doing business;

(b) where the applicant is a partnership, full and true copies of all partnership agreements;

(c) a declaration of the percentage of the business to be transferred;

(d) a financial statement setting forth the purchase price of the interest in the business being sold and the financial resources available to make such purchase, or the basis on which such transfer is to be financed;

(e) where any transfer is to be by gift, a statement of the relationship between the donor and the donee; and

(f) such additional pertinent information or documents necessary for Public Health Council consideration, as requested.
 

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Section 790.14 - Transfers of stock

790.14 Transfers of stock. An individual who proposes to become a principal stockholder in a business corporation shall file, in addition to meeting the other applicable requirements of this Part, information, documents and data as follows:

(a) a copy of the document giving approval for the incorporation of the hospice business;

(b) an affidavit from each applicant setting forth:

(1) that the applicant is to be the sole beneficial owner of the voting shares of the corporation of which the applicant is to be the holder of record; and

(2) the number of voting shares of the corporation of which the applicant is to be the holder of record;

(c) an affidavit from the transferor of the stock setting forth the transferor's name and address and stating:

(1) the number of voting shares of the corporation which the transferor proposes to transfer to the applicant; and

(2) the purchase price of the shares to be transferred to the applicant;

(d) the financial resources available for the acquisition of the stock to be transferred, or the basis on which such transfer is to be financed;

(e) if such transfer of stock is to be by gift, a statement of the relationship between the donor and the donee; and

(f) such additional pertinent information or documents necessary for the Public Health Council's consideration, as required.
 

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Section 790.15 - Limitation on transfer

790.15 Limitation on transfer. Any transfer pursuant to section 790.13 or 790.14 of this Part shall be completed within 90 days of issuance by the Public Health Council of its approval for such transfer unless extended by the council and the council is notified of the transfer within 10 days thereafter. Any request for an extension of time shall set forth the reasons why such transfer could not be completed within the prescribed time. Failure to complete a transfer within the time prescribed or as extended by the council or failure to notify the council within the time prescribed shall constitute abandonment and withdrawal of the application.
 

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Section 790.16 - Determinations of public need for hospice

790.16 Determinations of public need for hospice. (a) The following methodology will be utilized in the evaluation of applications involving the establishment and/or construction of a hospice and the need for hospice care and services. It is intended that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Title, which are also applicable to the determination of need for hospice and which are incorporated herein, represent a statement of basic principles and planning/decisionmaking tools for guiding and directing the development and expansion of hospice care and services throughout the State. The methodology is conceptually based on the application of uniform planning objectives at the health systems agency and/or State level. Its purpose is to provide guidance, to permit flexibility and to assist the health systems agencies, the State Hospital Review and Planning Council, the Public Health Council, the commissioner and potential applicants in determining the future need for hospice care and services. The objective of the methodology is to ensure that an adequate supply of hospice care and services is available and accessible, while at the same time avoiding the proliferation of unneeded hospices and hospice services.

(b) The commissioner shall designate hospice planning areas within each health systems agency region among which the need estimates calculated pursuant to this section will be allocated. Such areas may include a single county or two or more contiguous counties. In developing hospice planning areas, the commissioner shall seek the advice and recommendations of the health systems agencies and the State Hospital Review and Planning Council. Factors which shall be considered by each health systems agency and the council in making recommendations and by the commissioner in designating hospice planning areas shall include, but need not be limited to, the following:

(1) provider and patient travel patterns, including driving time and availability of public transportation;

(2) the availability of existing hospice care and services; and

(3) other factors identified by the health systems agencies.

(c) The factors and methodology to be utilized by the Public Health Council and/or the commissioner as appropriate, in estimating the public need for hospice, shall include, but need not be limited to, the following:

(1) An estimate shall be made of the number of cancer and noncancer terminally ill patients who would seek and be appropriate for hospice care in each planning area. Estimates will be based on the most current cancer mortality data compiled by the department's Bureau of Vital Statistics.

(2) The department shall estimate the number of cancer patients appropriate for hospice, based on the number of annual cancer deaths and the projection that 40 percent of such patients would seek and be appropriate for hospice.

(3) A number equal to 10 percent of the number of cancer patients determined appropriate for hospice care in paragraph (2) of this subdivision shall be added to such number of cancer patients to determine the total number of patients appropriate for hospice for each planning area. This total number will then be projected five years into the future based on the most current New York State Department of Commerce population projections to estimate the number of individuals who would seek and be appropriate for hospice. For purposes of this methodology, it is assumed that cancer deaths per year per 1,000 population will remain constant for the period of the projection. This number will represent the number of projected hospice cases. A hospice case is defined as an individual admitted to a hospice.

(4) The total number of projected hospice cases shall be multiplied by 63 days to reflect the expected average length of stay in a hospice, in order to provide the expected number of patient days of hospice care. This number is then divided by 365 (days) to arrive at the expected average daily hospice caseload capacity to meet the need for hospice.

(5) The estimated need for hospice inpatient beds or dually certified hospice residence beds shall be equal to a number no greater than 20 percent of the expected average daily hospice caseload capacity divided by 0.85 to reflect an expected occupancy rate for hospice beds.

(d) A health systems agency may submit a plan to the department which proposes adjustments to hospice need estimates within its area. The Public Health Council and/or commissioner, as appropriate, with advice of the State Hospital Review and Planning Council, may reject or approve and implement all or a portion of the proposed adjustments based upon consideration of pertinent factors, including but not necessarily limited to the following:

(1) whether the proposed adjustments reflect consistency with the objectives and requirements of this section and section 709.1 of this Title; and (2) whether the proposed adjustments identify special populations.

(e) (1) The hospice need estimates for each planning area, together with any approved adjustments determined under this section, shall constitute the estimate of public need for hospice for the defined area.

(2) Public need shall be deemed satisfied for a planning area when the daily average caseload capacity of existing and approved hospices is adequate to meet the estimate of public need for hospice for the planning area.

(f) In addition to meeting the other applicable provisions of this section, an applicant for initial certification shall be approved as meeting public need only if the applicant:

(1) agrees to serve the entire hospice planning area. Pursuant to the procedure set forth in section 709.1(c) of this Title, exceptions to serving the entire planning area may be permitted under special circumstances, including but not limited to those set forth in subparagraphs (i)-(iii) of this paragraph, provided that the hospice agrees to serve the entire alternate service area designated for such hospice. Such circumstances include:

(i) geographic barriers and/or travel time which may impede service delivery to the entire planning area;

(ii) proposals in which an applicant will focus its program of care in specific underserved areas which form only a portion of a planning area; and

(iii) other factors identified by the local health systems agency;

(2) agrees to serve population groups in the planning area that have difficulty gaining access to appropriate hospice care due to minority status, age, medical history, case complexity or payment source; and

(3) agrees to provide charity care to medically indigent persons. For the purpose of this paragraph, charity care to the medically indigent shall mean the provision of hospice care and services at no charge or reduced charge to patients who are unable to pay full charges or any charges, are not eligible for covered benefits under title XVIII or XIX of the Social Security Act, are not covered by private insurance and whose household income is less than 200 percent of the Federal poverty level.

(g) For initial certification of proposed hospices and when public need is established herein, priority consideration will be given to applicants who demonstrate that they will maximize the use of appropriate hospice home care, outpatient and other communitybased services.

Effective Date: 
Wednesday, June 6, 2007
Doc Status: 
Complete

Part 791 - Approval of Hospice Construction

Effective Date: 
Thursday, March 22, 1984
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4010

Section 791.1 - Definitions

Section 791.1 Definitions. (a) For purposes of this Part, construction shall mean a change in a hospice's geographic service area, the erection, building or substantial acquisition or alteration of a hospice inpatient facility or unit, hospice residence or equipment, or a substantial change in the method of providing hospice inpatient or hospice residence services.

(b) For purposes of this Part, total project cost shall mean total costs for construction contracts, if any, including, but not limited to costs for demolition work, site preparation, actual construction and contingencies, total costs for real property, for fixed and movable equipment, architectural and/or engineering fees, construction loan interest costs, and other financing, professional and ancillary fees, charges and allowances. Such costs shall include the cost of all capital items associated with an acquisition, lease arrangement and/or construction. If any acquisition is to be effectuated through a leasing arrangement or by a donation, the relevant cost shall be the cost of the asset if purchased.

Effective Date: 
Wednesday, July 17, 2002
Doc Status: 
Complete

Section 791.2 - General provisions

791.2 General provisions. (a) Hospice construction shall require the prior approval of the commissioner, except that the following shall not constitute construction for purposes of this Part and Article 40 of the Public Health Law and shall not require the submission of an application for approval:

(1) the repair, maintenance, alteration or acquisition of equipment when total project cost does not exceed $500,000;

(2) the relocation of an administrative office site, or repair, maintenance, alteration, acquisition, erection or building of an administrataive office site when total project cost does not exceed $500,000, provided that the governing authority of the hospice shall notify the department of any proposed change in an administrative office site location, which does not require construction approval under this Part, at least 10 days prior to effecting such change; and

(3) the repair, maintenance or alteration of a facility or unit used for hospice inpatient or hospice residence care and services when total project cost does not exceed $250,000, except that proposals for the alteration of systems for facility water supply, fixed dietary, solid waste disposal or fire protection, and structural, mechanical and electrical changes affecting safety and/or sanitary conditions shall require approval.

(b) Any of the following proposals shall constitute construction and shall be the subject of an application submitted for review pursuant to the requirements of this Part and Article 40 of the Public Health Law;

(1) the addition of any Article 40 certified hospice inpatient or hospice residence beds, regardless of cost;

(2) a change in the method of, or arrangement for, providing hospice inpatient or hospice residence care and services, regardless of cost;

(3) a change in the hospice's geographic service area;

(4) the repair, maintenance, alteration or acquisition of equipment when the total project cost exceeds $500,000;

(5) the relocation of any administrative office site or the repair, maintenance, alteration, acquisition, erection or building of an administrative office site when the total project cost exceeds $500,000;

(6) the repair, maintenance or alteration of a facility or unit used for hospice inpatient or hospice residence care and services when the total project cost exceeds $250,000, except that proposals for the alteration of systems for facility water supply, fixed dietary, solid waste disposal or fire protection, and structural, mechanical and electrical changes affecting safety and/or sanitary conditions shall require approval regardless of project cost;

(7) the acquisition, erection or building of a facility or portion thereof used for hospice inpatient or hospice residence care and services, regardless of cost; or (8) the approval of any dually certified hospice residence beds, regardless of cost.
(c) An application may be administratively approved by the commissioner on notice to, but without recommendation of, the State Hospital Review and Planning Council if the health systems agency having jurisdiction has recommended approval and if the application proposes:

(1) a change in the hospice's geographic service area;

(2) the repair, maintenance, alteration or acquisition of equipment when total project cost exceeds $500,000, but does not exceed $1,000,000;

(3) the relocation of an administrative office site or the repair, maintenance, alteration, acquisition, erection or building of an administrative office site when total project cost exceeds $500,000, but does not exceed $1,000,000;

(4) the repair, maintenance or alteration of a facility or unit used for hospice inpatient or hospice residence care and services when total project cost exceeds $250,000, but does not exceed $1,000,000; or

(5) the acquisition, erection or building of a facility or portion thereof used for hospice inpatient or hospice residence care and services when total project cost does not exceed $250,000.

(d) A full review of an application pursuant to the requirements of this Part and Article 40 of the Public Health Law, including a review by the State Hospital Review and Planning Council, shall be required prior to a decision by the commissioner when the application proposes:

(1) a change in the method of or arrangement for providing hospice inpatient or hospice residence care and services;

(2) the addition of any Article 40 certified hospice inpatient or hospice residence beds;

(3) the repair, maintenance, alteration or acquisition of equipment when total project cost exceeds $1,000,000;

(4) the relocation of an administrative office site or the repair, maintenance, alteration, erection or building of an administrative office site when total project cost exceeds $1,000,000;

(5) the repair, maintenance or alteration of a facility or unit used for hospice inpatient or hospice residence care and services when total project cost exceeds $1,000,000; or
(6) the acquisition, erection or building of a facility or portion thereof used for hospice inpatient or hospice residence care and services when total project cost exceeds $250,000; or (7) the approval of any dually certified hospice residence beds, regardless of cost. (e) If a general hospital, residential health care facility or certified home health agency, as defined in Articles 28 and 36, respectively, of the Public Health Law, with which a hospice has or proposes to have an arrangement for the provision of hospice inpatient beds, hospice residence beds or services, or hospice home care services, proposes to undertake any activity which requires construction approval under Article 28 or 36, such approval must be obtained.

Effective Date: 
Wednesday, June 6, 2007
Doc Status: 
Complete

Section 791.3 - Application

791.3 Application.

(a) (1) The applicant shall submit the the department an original and seven copies of the application for construction, in a format determined by the department.

(2) As part of the application, the applicant shall give the following assurances as appropriate:

(i) that the applicant will obtain the approval of the commissioner of all required plan submissions for any hospice inpatient facility or unit, or hospice residence, which shall conform to the applicable standards of construction and equipment of this Subchapter;

(ii) that, prior to contracting for construction, the applicant will obtain the approval of the commissioner of the final working drawings and specifications for any hospice inpatient facility or unit, or hospice residence, which shall conform to the applicable standards of construction and equipment of this Subchapter;

(iii) that the applicant will cause the project to be completed in accordance with the application and approved plans and specifications;

(iv) that the applicant will provide and maintain competent and adequate architectural or engineering supervision and inspection at the construction site to insure that the completed work conforms with the approved plans and specifications;

(v) that all hospice services will be provided, and the hospice inpatient facility or unit, or hospice residence, will be operated and maintained, in accordance with the standards prescribed by law; and

(vi) that the applicant will adequately equip and staff the hospice inpatient facility or unit, or hospice residence, and all hospice programs of service to assure their proper operation.

(b) All applications shall contain the following information and documentation:

(1) a narrative description of the proposed construction, including the following information when relevant to the proposal:

(i) the location and type of construction;

(ii) a description of the proposed program of services;

(iii) a description of the inpatient facility and identification of bed capacity;

(iv) an outline of the hospice's long-range plans;

(v) the need for the proposed project, including its relative priority when compared with other needed equipment, facilities, services or programs of the operator;

(vi) the proposed plan for the organization and operation of the hospice;

(vii) the number and types of personnel to be employed;

(viii) any special or unusual services, programs or equipment to be provided, including a description of educational involvements; and

(ix) a demonstration that the proposed project is feasible and adequate in terms of both short-range and long-range goals;

(2) an analysis demonstrating the need for the proposed construction;

(3) an analysis of equipment, facilities or services which may currently serve as alternatives or substitutes for the whole or any part of the proposed construction;

(4) an outline of the proposed financing of the construction and an analysis demonstrating the financial feasibility of the project including all costs and expenses and sources of revenue, and a line item operating budget; and

(5) such other information and documentation as the commissioner, State Hospital Review and Planning Council or the health systems agency may require.

(c) When the governing authority of a hospice proposes to repair, maintain, alter, acquire, erect or build a physical structure or part thereof to be used for the direct provision of hospice inpatient or hospice residence care and services, the applicant shall also submit five copies of the following information and documentation in a format determined by the department:

(1) an architectural program for the project, including, where applicable:

(i) a list in outline form of the rooms, allocated spaces and service areas;

(ii) a description of the interrelationships that each service area has to another;

(iii) the size of the facility, indicating the total number of beds proposed, the type of rooms, the number of each, and the patient capacity of the facility upon completion of construction;

(iv) a general outline of the type of construction proposed;

(v) a description of proposed alterations or additions to existing structures;

(vi) a statement of the period of time estimated to be required for completion of construction after issuance by the commissioner of approval of the application;

(vii) a general outline description of the energy sources, and the type and location of engineering systems which will be used for heating, cooling, ventilation and electrical distribution;

(viii) a general description of the proposed method of transport of clean and soiled materials and wastes;

(ix) a general outline description of the intended dietary service;

(x) a general description of methods for water supply and sewerage; (xi) cost estimates; and

(xii) such other information as the commissioner may require;

(2) acceptable concept sketches, consisting of single line free hand sketches of each floor in an appropriate scale, showing the relationship of the various services to each other. The major exit corridors and exit stair locations and circulation shall be indicated, along with existing buildings if additions or alterations are part of the project.

(d) An applicant may be given 30 days in which to supply additional information or correct any deficiencies relating to the application, unless such time period is extended by the department. The failure to supply the information requested or correct the deficiencies in the time specified shall constitute an abandonment of the application by the applicant and result in the withdrawal of the application.

Effective Date: 
Wednesday, July 17, 2002
Doc Status: 
Complete

Section 791.4 - Determination by the commissioner

791.4 Determination by the commissioner. After receipt and review of the application and after the State Hospital Review and Planning Council and local health systems agency have had an opportunity to submit their recommendations, as required, the commissioner shall make his determination. If the application is approved, the applicant shall be notified that he is to proceed to implement the project in accordance with the application, the assurances given, the approval granted and the requirements of this Chapter.
 

Doc Status: 
Complete

Section 791.5 - Implementation of an approved application

791.5 Implementation of an approved application. Upon receipt of approval for construction, the governing authority of the hospice shall:

(a) Implement an approved construction application for the addition of any Article 40 certified hospice inpatient or hospice residence beds or a change in the method of, or arrangement for, providing hospice inpatient or hospice residence care and services if no physical construction is required; a change in the hospice's geographic service area; the repair, maintenance, alteration or acquisition of equipment; or the repair, maintenance, alteration, acquisition, erection or building of an administrative office facility that does not provide hospice inpatient or hospice residence care and services within 90 days of receipt of the commissioner's approval of the application, unless such time period is extended by the commissioner. Upon request of the applicant, the commissioner may grant an initial extension not to exceed 60 days and, upon another request of the applicant, the commissioner may grant a final extension not to exceed 30 days. Any request for an extension shall be in writing and shall set forth the reasons why the application could not be implemented within the prescribed time.

(b) Proceed with architectural plans and actual construction to implement an approved construction application for the repair, maintenance, alteration, acquisition, erection or building of a hospice inpatient facility or unit, or hospice residence, or part thereof in accordance with the following:

(1) The applicant shall submit to the department two sets of the design development plans containing the following:

(i) plans of each floor, showing the room arrangement with the designation of each room and area;

(ii) such sections as are applicable to show the structural system;

(iii) site plan indicating proposed and existing roads, service and entrance courts, boundaries of the property, parking and orientation of the buildings and all outside utilities;

(iv) an outline specification, including a general description of construction;

(v) design of heating, cooling, ventilation and electrical systems;

(vi) design of sewage disposal system and all potential air pollution sources;

(vii) design of food service area;

(viii) design of water supply system;

(ix) cost estimates; and

(x) such other information as the commissioner may require.

(2) The applicant shall submit to the department two sets of the final drawings and specifications, including cost estimates.

(3) All drawings and specifications shall bear the seal and signature of an architect or engineer licensed to practice in New York State.

(4) The applicant shall not contract for construction until he has been notified in writing of the approval of final drawings, specifications and cost estimates.

(5) All construction in or of a hospice inpatient facility or unit, or hospice residence, shall be under the supervision of an architect or engineer licensed to practice in New York State.

(6) Upon approval of design development plans and upon the applicant's request and adequate justification, the commissioner may consider giving permission to start early construction of specifically identified phases, such as demolition, excavation, foundations and/or the structural shell. Such construction shall be at the applicant's risk and contingent upon submission of approvable final plans and specifications within a time period specified in the applicant's request. In no case shall phases of construction, other than those specifically identified in the commissioner's approval, start before approval of final plans and specifications.

(7) Prior written approval of any changes relating to the project, the project costs or major items of equipment proposed during construction must be obtained from the commissioner.

(8) Upon completion of the project, an on-site inspection of the construction and equipment will be made to assure that such are in accordance with the prior approval of the commissioner. The applicant shall notify the area administrator requesting such inspection two months prior to the anticipated completion date.

Effective Date: 
Wednesday, July 17, 2002
Doc Status: 
Complete

Section 791.6 - Abandonment of an application and the expiration, withdrawal and annulment of prior approvals

791.6 Abandonment of an application and the expiration, withdrawal and annulment of prior approvals. (a) The failure, neglect or refusal of an applicant to implement in a timely manner an approved application for construction that must be implemented within the time limits set forth in section 791.5(a) of this Part or, with respect to such application, to comply with the provisions of paragraph (1), (7), (8) or (9) of subdivision (b) of this section shall constitute an abandonment of the application by the applicant and result in the expiration, withdrawal and annulment of the commissioner's approval.

(b) The failure, neglect or refusal of an applicant who has received approval for the repair, maintenance, alteration, acquisition, erection or building of a hospice inpatient facility or unit, or hospice residence, or part thereof to conform to the following requirements within the prescribed times, unless otherwise authorized in writing by the commissioner, shall constitute an abandonment of the application by the applicant and result in the expiration, withdrawal and annulment of the commissioner's approval:

(1) amending the application to supply or correct any and all deficiencies in any of the matters required to be set forth therein and to file same within 3O days after issuance of notice of such deficiencies;

(2) obtaining and having such estate or interest in the site, including necessary easements and rights-of-way, sufficient to assure use and possession for the purpose of the construction and operation of the facility;

(3) completing and filing design development drawings and revised project cost estimates within 120 days after approval of the project by the commissioner;

(4) completing and filing final drawings and specifications, including cost estimates within 150 days after issuance of favorable review of design development drawings and revised project cost estimates;

(5) securing approval of final drawings, specifications and cost estimates prior to contracting for construction;

(6) after issuance of the approval of final drawings, specifications and cost estimates:

(i) Initiating construction within 120 days;

(ii) proceeding therewith at a reasonable rate; and

(iii) completing and equipping the project within the completion time specified;

(7) securing approval of any change relating to the project, the project costs, the terms of any permanent financing arrangement or any major item or items of equipment during construction;

(8) applying for a certificate of approval within 30 days after issuance of approval of the completed project when applicable; and

(9) maintaining the assurances given pursuant to section 791.3(a)(2) of this Part.

Effective Date: 
Wednesday, July 17, 2002
Doc Status: 
Complete

Section 791.7 - Nonallowance of costs

791.7 Nonallowance of costs. Costs relating to any proposal, project or application, or any amendment or change thereto, for which approval is required under this Part and for which such approval was not obtained, shall not be considered allowable costs for reimbursement pursuant to any of the Subparts contained within Part 86 of this Title.
 

Doc Status: 
Complete

Section 791.8 - Determination of public need

791.8 Determination of public need. The factors and methodology for determining public need with respect to a hospice construction application shall, as applicable, include, but need not be limited to, the criteria and methodology set forth in section 790.16 of this Title.
 

Doc Status: 
Complete

Part 792 - Certification of Hospices

Effective Date: 
Thursday, March 22, 1984
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 4004, 4010

Section 792.1 - Certificate of approval

Section 792.1 Certificate of approval. (a) The commissioner shall not issue a certificate of approval to any hospice unless it complies with the provisions of article 40 of the Public Health Law and the rules and regulations promulgated pursuant thereto, and is qualified to participate as a hospice under title XVIII of the Federal Social Security Act; provided, however, that the commissioner shall issue a certificate of approval to a hospice if he is satisfied that the hospice cannot qualify to participate as a hospice under title XVIII of the Federal Social Security Act solely because it proposes to provide nursing services by arrangement with a certified home health agency.

(b) No person, partnership or organization shall hold itself out as a hospice unless it possesses a valid certificate of approval.

(c) A certificate of approval shall specify the service area of the hospice and shall be posted conspicuously on the premises of the principal office of the hospice located within its approved service area.

(d) A certificate of approval shall remain in force until revised, limited, annulled, revoked, suspended or surrendered, unless an expiration date is specified in the operating certificate as a result of a determination that a subsequent evaluation is necessary to ensure that the facility is operating in compliance with Public Health Law Article 40 and the rules and regulations promulgated thereunder.

(e) A certificate of approval may be revoked, suspended, limited or annulled by the commissioner on proof that the hospice has failed to comply with the provisions of article 40 of the Public Health Law, this Article or any other applicable provision of law.

(f) A certificate of approval shall be surrendered promptly to the State Department of Health when revoked, suspended, limited or annulled by the commissioner, or when the organization terminates service.
 

Effective Date: 
Wednesday, April 2, 1997
Doc Status: 
Complete

Part 793 - Patient/Family Care Services

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4010

Section 793.1 - Patient rights

Section 793.1 Patient rights. (a) The governing authority shall establish written policies regarding the rights and responsibilities of the patient and shall ensure the development of procedures implementing such policies to ensure that, as a minimum, the patient has a right to: 

(1) be fully informed of these rights prior to or at the time of admission, verbally and in writing, in a language and manner that the patient understands, as evidenced by written acknowledgment of receipt signed by the patient or the patient’s representative, pursuant to subdivision (b) of this section; 

(2) be given a statement of the services provided by the hospice and covered under the hospice benefit, including any limitations on those services, and of related charges including charges for services not covered by third-party payors or not covered by the hospice basic rate; 

(3) be fully informed of the patient's medical condition; 

(4) adequate, appropriate and timely care and services, including effective pain management and symptom control for conditions relating to the patient’s terminal illness, for the duration of the illness for which hospice was elected; 

(5) be involved in developing his or her hospice plan of care; 

(6) choose his or her attending physician; 

(7) refuse to participate in experimental research; 

(8) refuse medication, care and treatment after being fully informed of and understanding the consequences of such actions; 

(9) voice complaints and recommend changes in policies and services to hospice staff, the New York State Department of Health or any outside representative of the patient's choice. The expression of such complaints by the patient or his/her designee shall be free from restraint, interference, coercion, discrimination or reprisal; 

(10) express complaints about the care and services provided and to have the program investigate such complaints as specified in section 794.1(l) of this Title. The program is responsible for notifying the patient or his/her designee that if the patient is not satisfied by the response the patient may complain to the Department of Health; 

(11) be treated with consideration, respect and full recognition of the patient’s dignity and individuality; 

(12) make independent personal decisions and have knowledge of available choices; 

(13) be assured of confidential treatment of patient records in accordance with applicable state and federal laws; 

(14) be informed of the name and function of any person and/or agency providing care and services;  

(15) receive services and/or continue to receive services without regard to age, race, color, creed, gender, national origin, sexual orientation, disability or source of payment; 

(16) receive services without discontinuation or diminishment because of the inability to pay for care; 

(17) receive written information and assistance with executing advance directives as set forth in Article 29-CC of the Public Health Law and implementing regulations, as well as applicable federal regulations; 

(18) exercise his or her rights without fear of discrimination or reprisal;

(19) have his or her person and property treated with respect and to be free from mistreatment, neglect, or verbal, mental, sexual and/or physical abuse, including injuries of unknown source, and misappropriation of property; and

(20) refuse consent to advanced tasks performed by an advanced home health aide, in which case the hospice shall provide for the performance of such tasks by a registered professional nurse. 

(b) If a patient lacks capacity to exercise these rights, the rights shall be exercised by an individual, guardian or entity legally authorized to represent the patient. 

(c) The governing authority must: 

(1) ensure that all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property, by anyone furnishing services on behalf of the hospice, are reported immediately by hospice employees and contracted staff to the hospice administrator; 

(2) immediately investigate all alleged violations involving anyone furnishing services on behalf of the hospice and immediately take action to prevent further potential violations while the alleged violation is being verified. Investigations and/or documentation of all alleged violations must be conducted in accordance with established procedures; 

(3) take appropriate corrective action in accordance with state law if the alleged violation is verified by the hospice administration or an outside body having jurisdiction, such as the Department of Health or local law enforcement agency; and 

(4) ensure that verified violations are reported to State and local bodies having jurisdiction including the Department of Health within 5 working days of becoming aware of the violation. 

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 793.2 - Eligibility, Election, Admission and Discharge

793.2 Eligibility, Election, Admission and Discharge.  

The governing authority shall ensure that: 

(a) except as prohibited by Article 45 of the Public Health Law or any other law or regulation, a patient referred to a hospice may be accepted from any source; 

(b) policies and procedures for admission and discharge are developed and implemented; 

(c) any individual admitted to hospice is certified as being terminally ill consistent with state and/or federal definitions. Written certification of terminal illness is required for each election period defined in paragraph (d)(4) of this section. If the hospice cannot obtain the written certification within 2 calendar days after the election period begins, it must obtain an oral certification within 2 calendar days and the written certification before it submits a claim for payment.  

(1) Initial certification of terminal illness must be obtained from either the medical director of the hospice or the physician member of the hospice interdisciplinary group provided for in section 793.4 of this Part, and also from the individual's attending physician, if the individual has an attending physician. In connection with the initial certification, the medical director or physician designee must consider the following: 

(i) diagnosis of the primary terminal condition, along with any supporting current clinically relevant information;  

(ii) related diagnoses, if any, along with any supporting current clinically relevant information;  

(iii) current subjective and objective medical findings;  

(iv) current medication and treatment orders; and  

(v) information about the medical management of any of the patient’s conditions unrelated to the terminal illness.  

(2) Subsequent certifications of terminal illness are obtained from the medical director of the hospice or the physician member of the hospice interdisciplinary group and must be based on the certifying individual’s clinical judgment regarding the normal course of the individual’s illness. 

(3) All certifications must: 

(i) specify that the individual's prognosis is for a life expectancy consistent with applicable state and federal statutes for purposes of payment;  

(ii) include clinical information and other documentation that support the medical prognosis; and  

(iii) be filed in the clinical record.  

(d) an individual who meets the hospice eligibility requirements files an election statement with a particular hospice. If the individual is physically or mentally incapacitated, his or her representative as provided for in subdivision (b) of section 793.1 of this Part may file the election statement;  

(1) The election statement shall remain in effect as long as the individual remains in the care of a hospice unless the individual revokes the election in accordance with paragraph 3 of this subdivision or is discharged from the hospice in accordance with subdivision (e) of this section. He/she may at any time file an election if again eligible for hospice care. 

(2) The signed election statement must:  

(i) identify the hospice that will provide care; 

(ii) include the individual's or representative's acknowledgment that he or she has been given a full understanding of the palliative rather than curative nature of hospice care; and 

(iii) include the effective date of the election, which may be the first day of hospice care or a later date, but no earlier than the date of the election statement. 

(3) An individual or representative may revoke the election of hospice care at any time by filing a signed and dated revocation statement with the hospice. This statement must include the effective date for the revocation. 

(4) An individual may elect to receive hospice care during one or more of the following election periods, which are available in the order listed and may be selected separately at different times: 

(i) an initial 90-day period; 

(ii) a subsequent 90-day period;  

(iii) an unlimited number of subsequent 60-day periods. 

(e) a patient is discharged only if: 

(1) the patient moves out of the hospice's service area or transfers to another hospice; 

(2) the hospice determines that the patient no longer meets the eligibility criteria set forth in subdivision (c) of this section; or 

(3) the hospice determines, under a policy set by the hospice for the purpose of addressing discharge for cause that the patient's (or other persons in the patient's home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the hospice to operate effectively is seriously impaired.  

(i) The hospice must do the following before it seeks to discharge a patient for cause: 

(a) advise the patient that a discharge for cause is being considered; 

(b) make a serious effort to resolve the problem(s) presented by the patient's behavior or situation; 

(c) ascertain that the patient's proposed discharge is not due to the patient's use of necessary hospice services; and 

(d) document the problem(s) and efforts made to resolve the problem(s) and enter this documentation into the clinical record. 

(ii) prior to discharging a patient, a written discharge order must be obtained from the hospice medical director. If a patient has an attending physician involved in his or her care, this physician should be consulted before discharge and his or her review and decision included in the discharge note. 

(iii) prior to discharging a patient or transferring the patient from one hospice to another, continuing care and services shall be arranged and a discharge summary completed as specified in section 794.4 of this Title. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 793.3 - Initial and Comprehensive Assessment

793.3 Initial and Comprehensive Assessment. (a) The hospice registered nurse, as a member of the interdisciplinary group identified in section 793.4 of this Part, must complete an initial assessment within 48 hours after the election of hospice care in accordance with section 793.2 of this Part unless the physician, patient, or representative requests that the initial assessment be completed in less than 48 hours. Initial assessment means an evaluation of the patient’s physical, psychosocial and emotional status related to the terminal illness and related conditions to determine the patient’s immediate care and support needs. 

(b) The hospice interdisciplinary group, in consultation with the individual’s attending physician (if any), shall conduct and document in writing a patient-specific comprehensive assessment no later than 5 calendar days after the election of hospice care. Comprehensive assessment means a thorough evaluation of the patient's physical, psychosocial, emotional and spiritual status related to the terminal illness and related conditions including the caregiver's and family's willingness and capability to care for the patient. 

(c) The comprehensive assessment must take into consideration the following factors: 

(1) the nature and condition causing admission (including the presence or lack of objective data and subjective complaints); 

(2) complications and risk factors that affect care planning; 

(3) functional status, including the patient’s ability to understand and participate in his or her own care; 

(4) imminence of death; 

(5) severity of symptoms; 

(6) a review of all of the patient’s prescription and over-the counter drugs, herbal remedies and other alternative treatments that could affect drug therapy. This includes, but is not limited to, identification of the following: 

(i) effectiveness of drug therapy; 

(ii) drug side effects; 

(iii) actual or potential drug interactions; 

(iv) duplicate drug therapy; and  

(v) drug therapy currently associated with laboratory monitoring; 

(7) an initial bereavement assessment of the needs of the patient’s family and other individuals focusing on the social, spiritual, and cultural factors that may impact their ability to cope with the patient’s death. Information gathered from the initial bereavement assessment must be incorporated into the plan of care and considered in the bereavement plan of care; and 

(8) the need for referrals and further evaluation by appropriate health professionals. 

(d) The comprehensive assessment must include data elements that allow for measurement of outcomes. The data elements must: 

(1) take into consideration aspects of care related to hospice and palliation; 

(2) be measured and documented in the same way for all patients; 

(3) be an integral part of the comprehensive assessment and documented in a systematic and retrievable way for each patient; 

(4) be used in individual patient care planning and in the coordination of services; and  

(5) be used in the aggregate for the hospice’s quality assessment and performance improvement program. 

(e) The hospice interdisciplinary group must update the comprehensive assessment in collaboration with the individual’s attending physician, if any, as frequently as the condition of the patient requires, but no less frequently than every 15 days. The update must consider changes that have taken place since the initial assessment and include information on the patient’s progress toward desired outcomes, as well as a reassessment of the patient’s response to care. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 793.4 - Patient Plan of Care, Interdisciplinary Group and Coordination of Care

793.4 Patient Plan of Care, Interdisciplinary Group and Coordination of Care. The governing authority must: 

(a) designate an interdisciplinary group or groups composed of individuals who work together to meet the physical, medical, psychosocial, emotional, and spiritual needs of the hospice patients and families facing terminal illness and bereavement. The members of the interdisciplinary group are responsible for providing the care and services offered by the hospice, and the group must collectively supervise the care and services.  

(1) The interdisciplinary group must include, but is not limited to:  

(i) a doctor of medicine or osteopathy (who is an employee or under contract with the hospice); 

(ii) a registered nurse; 

(iii) a social worker; and 

(iv) a pastoral or other counselor. 

(2) The governing authority must designate a registered nurse who is a member of the interdisciplinary group to coordinate care and ensure continuous assessment of each patient’s and family’s needs and implementation of the interdisciplinary plan of care;  

(b) if the hospice has more than one interdisciplinary group, specifically designate an interdisciplinary group to establish policies governing the day-to-day provision of hospice care and services;  

(c) ensure that all hospice care and services furnished to patients and their families follow an individualized written plan of care established by the interdisciplinary group in collaboration with the patient's attending physician, if any, and, if they so desire, the patient or representative and the primary caregiver. The plan of care shall indicate for each patient/family how palliative and supportive care is to be achieved including: 

(1) goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments; 

(2) all services necessary for the palliation and management of the terminal illness and related conditions and the individual(s) who will provide those services, including: 

(i) interventions to manage pain and symptoms; 

(ii) a detailed statement of the scope and frequency of services necessary to meet the specific patient and family needs; 

(iii) measurable outcomes anticipated from implementing and coordinating the plan of care; 

(iv) drugs, biologicals, treatments, medical supplies, appliances and durable medical equipment that must be provided by the hospice while the patient is under hospice care; 

(v) identification of the registered nurse responsible for coordinating care; and 

(vi) documentation in the clinical record of the patient’s or representative’s level of understanding, involvement, and agreement with the plan of care, in accordance with the hospice’s own policies; 

(d) ensure that the hospice interdisciplinary group confers with an individual educated and trained in drug management to ensure that drugs and biologicals meet each patient’s needs;  

(e) ensure that each patient and the primary caregiver(s) receives education and training regarding their responsibilities for the care and services identified in the plan of care followed by an assessment of their ability to provide care including their ability to self-administer drugs and biologicals; 

(f) ensure discussion and written instructions are provided to the patient/family regarding the management and disposal of controlled drugs in the home when controlled drugs are initially ordered and documentation of such in the clinical record;  

(g) ensure that the hospice interdisciplinary group reviews, revises and documents the individualized plan as frequently as the patient’s condition requires, but no less frequently than every 15 calendar days. A revised plan of care must include information from the patient’s updated comprehensive assessment, must note the patient’s progress toward the outcomes and goals specified in the plan of care, and must be documented in the clinical record; and 

(h) develop and maintain a system of communication and integration, in accordance with the hospice’s own policies and procedures, to: 

(1) ensure that the interdisciplinary group maintains responsibility for directing, coordinating, and supervising the care and services provided by all hospice and non-hospice healthcare providers; 

(2) ensure that care and services provided are based on all assessments of the patient and family needs; 

(3) provide for and ensure the ongoing sharing of information between all disciplines providing care and services in all settings, whether the care and services are provided directly or under arrangement; and 

(4) provide for an ongoing sharing of information with other non-hospice healthcare providers furnishing services unrelated to the terminal illness and related conditions. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 793.5 - Quality Assessment and Performance Improvement

793.5 Quality Assessment and Performance Improvement  

The governing authority must ensure that the hospice:  

(a) develops, implements, and maintains an ongoing, effective, hospice-wide data-driven program for quality assessment and performance improvement, which shall be evaluated annually. The program must:  

(1) reflect the complexity of the hospice organization and services;  

(2) involve all hospice services, including those services furnished under contract or arrangement, and all locations;  

(3) include the use of quality indicator data in the design of the program, which focuses on improved palliative and end of life outcomes;  

(4) take actions to demonstrate improvement in hospice performance;  

(5) address priorities for improved quality of care and patient safety; and  

(6) be capable of showing measurable improvement in indicators related to improved palliative outcomes and hospice services.  

(b) maintains documentary evidence of the program, and be capable of demonstrating its operation;  

(c) designates one or more individual(s) responsible for operating the program;  

(d) designates a committee which includes licensed professionals, representative of the services provided by the hospice, and administrative personnel to participate in and make recommendations to the governing authority regarding the quality program and perform other quality management activities including:  

(1) review of quality assessment and performance improvement efforts, at least annually, and in collaboration with the hospice interdisciplinary group recommend revisions to the governing authority, as necessary, of policies and procedures;  

(2) review of patient care records for appropriateness of admission, adequacy of assessment of patient/family needs and quality and quantity of services provided;  

(3) review of complaints and other investigations; and 

(4) review of the effectiveness of the hospice’s infection control program, including appropriate identification of infection and communicable disease transmission and control problems and plans for appropriate corrective action, improvement and subsequent prevention.  

(e) measures, analyzes, and tracks quality indicators, including adverse patient events and/or potentially avoidable events and other aspects of performance, in the frequency and detail approved by the governing authority. The data shall include patient care data and other relevant data reflective of the hospice operation, the quality of all services provided and all activities that may impact patient care and must enable the hospice to:  

(1) assess processes of care, hospice services, and operations;  

(2) monitor the effectiveness and safety of services and quality of care; and  

(3) identify opportunities and priorities for improvement.  

(f) develops, implements and evaluates performance improvement projects conducted annually, sufficient in number and scope to reflect the hospice’s population, internal organizational needs, and scope, complexity and past performance of services and operation, using quality indicator data collected. These projects must:  

(1) focus on high risk, high volume, or problem-prone areas;  

(2) consider incidence, prevalence, and severity of problems in those areas;  

(3) take actions aimed at performance improvement in palliative outcomes, patient safety, and quality of care;  

(4) measure the success of such actions and track performance to ensure that improvements are sustained; 

(5) track and analyze the cause of any adverse patient event;  

(6) implement preventive actions and mechanisms that include feedback and learning throughout the hospice; and 

(7) be documented by the hospice including the reasons for conducting the project and the measurable progress achieved. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 793.6 - Infection Control

793.6 Infection Control. The hospice must: 

(a) implement and enforce an agency wide program for the surveillance, identification, prevention, control and investigation of infectious and communicable diseases, which could result in staff, volunteers, visitors, or patients and family members becoming exposed to such communicable diseases or infections. Such a program shall include: 

(1) policies and procedures for maintaining and documenting an effective infection control program in all settings where patients reside, including but not limited to protocols for addressing patient care issues and prevention of infection related to airborne pathogens, infusion therapy, urinary tract care, respiratory tract care, wound care and multi-drug resistant organisms;  

(2) following accepted standards of practice to prevent transmission of infections and communicable disease;  

(3) monitoring staff for compliance with hospice policies and procedures related to infection control;  

(4) protocols for educating staff, contracted personnel, patients, families and other caregivers in infectious disease transmission, standard precautions and the prevention and control of infection; and 

(5) a specific program for protecting patients, staff and families from bi-directional spread of HIV and other blood borne pathogens, as specified in subdivision (b) of this section. 

(b) assure that a program be implemented and enforced for the prevention of circumstances which could result in staff, including housekeeping, direct care staff and volunteers, or patients and family members becoming exposed to significant risk body substances which could put them at significant risk of HIV infection, as defined in section 63.1 of this Title, or other blood borne pathogen infection, during the provision of services. Such a program shall include: 

(1) use of scientifically accepted protective barriers during job-related activities which involve, or may involve, exposure to significant risk body substances. Such preventative action shall be taken by the staff with each patient and shall constitute an essential element for the prevention of bi-directional spread of HIV or other blood borne pathogens.  

(2) use of scientifically accepted preventive practices during job-related activities which involve the use of contaminated instruments or equipment which may cause puncture injuries; 

(3) training at the time of employment and yearly staff development programs on the use of protective equipment, preventive practices, and circumstances which represent a significant risk for all employees whose job-related tasks involve, or may involve, exposure to significant risk body substances; 

(4) provision of personal protective equipment for staff which is appropriate to the tasks being performed; and 

(5) a system for monitoring preventive programs to assure compliance and safety. 

(c) implement and enforce a policy/procedure for the management of individuals who are exposed to significant risk body substances under circumstances which constitute significant risk of transmitting or contracting HIV or other blood borne pathogen infection. The policy/procedure shall include: 

(1) a system for reporting to a designated individual in the hospice any exposure thought to represent a circumstance which constitutes significant risk of transmitting or contracting HIV or other blood-borne pathogen infection; 

(2) evaluation of the circumstances of a reported exposure and services providing follow-up of the exposed individual which includes: 

(i) medical and epidemiological assessment of the individual who is the source of the exposure, where that individual is known and available; 

(ii) if indicated epidemiologically, HIV or other blood-borne pathogen counseling and voluntary testing of the source individual. Disclosure of the HIV status of the source individual can be made, consistent with Article 27-F of Public Health Law and Part 63 of this Title, with the express written consent of the protected individual, or a person authorized pursuant to law to consent to health care for the protected individual if such person lacks capacity to consent, or pursuant to court order, if the HIV status is not known to the exposed individual;  

(iii) appropriate medical follow-up of the exposed individual; and 

(iv) assurances for protection of confidentiality for those involved in reported exposures. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 793.7 - Staff and services

793.7 Staff and services. (a) At a minimum, hospice staff shall be composed of: 

(1) a hospice administrator who is appointed by the governing authority and is an employee of the hospice who works a minimum of half-time for the hospice. The administrator is responsible for the day-to-day management of the hospice. 

(2) a hospice medical director who is:  

(i) a doctor of medicine or osteopathy who is licensed and registered to practice in New York State or maintains a current license and who is an employee or is under contract with the hospice. When the medical director is not available, a physician designated by the hospice shall assume the same responsibilities and obligations as the medical director; and  

(ii) responsible for supervision of all physician employees and physicians under contract; 

(3) a hospice nurse coordinator; 

(4) a hospice social worker; 

(5) a pastoral care coordinator; and 

(6) a coordinator of volunteer services, whose responsibilities shall include:  

(i) ensuring implementation of policies and procedures related to volunteer services; 

(ii) providing and documenting volunteer orientation and training;  

(iii) ensuring that volunteers are used in defined administrative or direct patient care roles under the supervision of a designated hospice employee; 

(iv) ongoing efforts to recruit and retain volunteers; and  

(v) demonstrating and documenting cost savings achieved through the use of volunteers including: 

(a) identification of each position that is occupied by a volunteer and his or her work time; and 

(b) estimates of the dollar costs that the hospice would have incurred if paid employees occupied the positions. Volunteers must provide services in an amount that, at a minimum, equals 5 percent of the total patient care hours of all paid hospice employees and contract staff.  

(b) As the needs of the patient dictate, the hospice shall provide the following services: 

(1) core services, which include nursing, physician, medical social services, dietary, bereavement and spiritual or pastoral care counseling; and  

(2) non-core services which include physical therapy, occupational therapy, speech and language pathology, audiology, respiratory therapy, psychological, drugs and biologicals, laboratory, medical supplies, equipment and appliances, home health aide, personal care, housekeeper, homemaker, and inpatient services. 

(c) With the exception of physician services, core services must routinely be provided directly by hospice employees. A hospice may use contracted staff only if necessary to supplement hospice employees in order to meet the needs of patients under extraordinary or other non-routine circumstances such as unanticipated periods of high patient loads, staffing shortages due to illness or other short-term temporary situations that interrupt patient care such as natural disasters and temporary travel of a patient outside the hospice’s service area. 

(d) Non-core services as specified in subdivision (b) of this section may be provided directly by the hospice or under contractual arrangements made by the hospice as specified in section 794.2 of this Title.  

(e) Physician, nursing, medical social services counseling and volunteer services shall be provided by the same health care practitioners to the same patient and family, whenever possible. 

(f) Nursing services, physician services and drugs and biologicals must be routinely available on a 24-hour basis, 7 days a week. Other services must be available on a 24-hour basis when reasonable and necessary to meet the needs of the patient and family.  

(g) The hospice medical director, physician employees, and contracted physician(s) of the hospice, in conjunction with the patient’s attending physician, must assume responsibility for the palliation and management of the terminal illness and conditions related to the terminal illness. If the attending physician is unavailable, the medical director, contracted physician, and/or hospice physician employee is responsible for meeting the medical needs of the patient. 

(h) Nursing care and services must be provided by or under the supervision of a registered nurse in accordance with patient assessments and plans of care:  

(1) Nursing services in the home shall be provided by or under the direction of hospice personnel who meet the requirements of community health nurse as defined in section 700.2 of this Title.  

(2) Highly specialized nursing services that are provided so infrequently that the provision of such services by direct hospice employees would be impracticable and prohibitively expensive, may be provided under contract. 

(3) Registered nurses certified as nurse practitioners may treat and write orders for hospice patients to the extent permitted by New York State Education Law. 

(i) Medical social services must be provided by a qualified social worker, under the direction of a physician. Medical social services must be based on the patient’s psychosocial assessment and the patient’s and family’s needs and acceptance of services. 

(j) Counseling services must be available to the patient and family to assist the patient and family in minimizing the stress and problems that arise from the terminal illness, related conditions, and the dying process. Counseling services must include, but are not limited to: 

(1) an organized program of bereavement counseling furnished under the supervision of a qualified professional with experience or education in grief or loss counseling. Bereavement services shall be available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient;  

(2) dietary counseling performed by a qualified individual, which include dietitians as well as nurses and other individuals who are able to address and assure that the dietary needs of the patient are met; and  

(3) spiritual counseling which is provided in accordance with the patient’s and family’s acceptance of this service, and in a manner consistent with patient and family beliefs and desires. All reasonable efforts should be made to facilitate visits by local clergy, pastoral counselors, or other individuals who can support the patient’s spiritual needs to the best of their ability. 

(k) All aide services must be provided by individuals who:  

(1) have successfully completed a home health aide training and competency evaluation program as required by paragraph (9) of subdivision (b) of section 700.2 or this Part or an advanced home health aide training program as required by paragraph (54) of subdivision (b) of section 700.2 of this Part; and  

(2) are currently listed in good standing on the Home Care Registry in the State. 

(l) Aide services must be ordered by a member of the interdisciplinary team, included in the plan of care and consistent with training and tasks permitted to be performed by home health aides, including but not limited to personal care and simple procedures as an extension of nursing or therapies or, in the case of advanced home health aide services, ordered by a physician, assigned by the supervising registered professional nurse, included in the plan of care and consistent with training and advanced tasks permitted to be performed by advanced home health aides.  

(m) A registered nurse who is a member of the interdisciplinary group must make patient assignments, prepare written patient care instructions and provide supervision of aides.  

(n) A registered nurse must make an on-site visit to the patient’s home no less frequently than every 14 days to assess the quality of care and services provided by the aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient’s needs. 

(1) The aide should be present during the registered nurse’s on-site visit periodically, but no less frequently than every ninety days, or more frequently if an area of concern is noted by the supervising nurse. 

(2) If an area of concern is verified by the nurse during the on-site visit, then the hospice must conduct, and the aide must successfully complete a competency evaluation.  

(3) The supervising nurse must assess an aide’s ability to demonstrate initial and continued satisfactory performance in meeting outcome criteria that include, but are not limited to:  

(i) following the patient’s plan of care for completion of tasks assigned to the aide by the registered nurse;  

(ii) creating successful interpersonal relationships with the patient and family;  

(iii) demonstrating competency with assigned tasks;  

(iv) complying with infection control policies and procedures;  

(v) reporting changes in the patient’s condition; and 

(vi) completing appropriate records and documentation of care provided. 

(o) The hospice must ensure that staff are adequately supervised. The department shall consider the following factors as evidence of adequate supervision: 

(1) supervision of nursing personnel is conducted by a supervising nurse; 

(2) personnel regularly provide services at the frequencies specified in the patient's plan of care, and in accordance with the policies and procedures of their respective services; 

(3) personnel are assigned to the care of patients in accordance with their licensure, as appropriate, and their training, orientation and demonstrated skills; 

(4) clinical records are kept complete, and changes in patient condition, adverse reactions, and problems with informal supports or home environment are charted promptly and reported to supervisory personnel; 

(5) plans of care are revised as determined by patient condition, and changes are reported to the authorized practitioner and other personnel providing care to the patient; 

(6) in-home visits are made by supervisory personnel to direct, demonstrate and evaluate the delivery of patient care and to provide clinical consultation; 

(7) professional guidance on agency policies and procedures is provided; 

(8) supervision of a home health aide is conducted by a registered professional nurse;  

(9) in-home supervision, by professional personnel, of home health aides takes place:

(i) to demonstrate to and instruct the aide in the treatments or services to be provided, with successful re-demonstration by the aide during the initial service visit, or where there is a change in personnel providing care, if the aide does not have documented training and experience in performing the tasks prescribed in the plan of care;

(ii) to evaluate changes in patient condition reported by the aide and initiate any revision in the plan of care which may be needed; and

(iii) to instruct the aide as to the observations and written reports to be made to the supervising nurse; and

(10) direct supervision of an advanced home health aide is conducted by a registered professional nurse who:

(i) provides training, guidance, direction and oversight, and evaluation related to the performance of advanced tasks by the advanced home health aide;

(ii) assigns advanced tasks to be performed by the advanced home health aide after completing a nursing assessment to determine the patient’s current health status and care needs;

(iii) provides case specific training to the advanced home health aide to verify and ensure the advanced home health aide can safely and competently perform the advanced tasks for the patient;

(iv) provides written, patient specific instructions for performing advanced tasks, including the criteria for identifying, reporting, and responding to problems, errors or complications;

(v) conducts a comprehensive medication review including evaluation of the patient’s current medication use, and prescribed drug regimen and identifies and resolves any discrepancies prior to assigning the advanced home health aide to administer medications;

(vi) determines direct supervision of the advanced home health aide based on the complexity of advanced tasks, the skill and experience of the advanced home health aide assigned to perform the advanced tasks, and the health status of the patient for whom the advanced tasks are being performed;

(vii) while on duty is continuously available to communicate with the advanced home health aide by phone or other means;

(viii) conducts home visits or arranges for another qualified registered professional nurse whenever necessary to protect the health and safety of the patient;

(ix)  performs an initial and ongoing assessments of the patient’s needs; and

(x) conducts a home visit at least every two weeks and more frequently as determined by the registered professional nurse, to observe, evaluate, and oversee services provided by the advanced home health aide;

(11) a process is in place to document the limitation or revocation of the assignment of advanced tasks by an advanced home health aide when deemed appropriate by a supervising registered professional nurse and to ensure that such information is available to other registered professional nurses that may supervise such aide; and

(12) any failure by a supervising registered professional nurse to comply with the requirements of paragraph ten of this subdivision shall be reported to the department.

(p) Homemaker services shall be provided to assist in patient care. A qualified homemaker is an individual who has successfully completed hospice orientation and training in the tasks to be performed.  

(1) Homemaker services must be assigned, coordinated and supervised by a member of the interdisciplinary group.  

(2) Homemakers must report all concerns about the patient or family to the member of the interdisciplinary group and complete appropriate documentation of care provided. 

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Part 794 - Organization and Administration

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4010

Section 794.1 - Governing authority

Section 794.1 Governing authority. The governing authority, as defined in Part 790 of this Title shall: 

(a) be responsible for the management and fiscal operations of the hospice, the provision of all hospice services, and continuous quality assessment and performance improvement; 

(b) ensure compliance with all applicable Federal, State and local laws, rules and regulations; 

(c) provide for coordinated, interdisciplinary inpatient and home care services, 24 hours a day, 7 days a week; 

(d) ensure adequate staff and resources to provide continuity of care based on the needs of the persons served; 

(e) adopt, amend and implement bylaws regarding the responsibilities, functions and activities of the governing body; 

(f) adopt the hospice budgets, control assets and funds, and provide for annual fiscal audits; 

(g) prohibit any employee of the hospice to be reimbursed by any party other than the hospice for service provided as part of the hospice program, or the splitting or sharing of fees between a referral agency/facility or individual and the hospice; 

(h) ensure the prompt submission of all records and reports required by the department; 

(i) ensure compliance with the pertinent provisions regarding the discontinuance of operations of a medical facility, as set forth in section 401.3 of this Chapter, in the event the hospice discontinues operation for any reason; 

(j) negotiate agreements with other patient care facilities/agencies for the referral and acceptance of hospice patients; 

(k) adopt and amend policies and procedures regarding management and operation of the hospice and the provision of patient care services;  

(l) ensure the development and implementation of a patient complaint procedure to include: 

(1) documentation of receipt, investigation and resolution of any complaint, including maintenance of a complaint log indicating the dates of receipt and resolution of all complaints received by the program; 

(2) review of each complaint with a written response to all written complaints and to oral complaints, if requested by the individual making the oral complaint, explaining the complaint investigation findings and the decisions rendered to date by the program within 15 days of receipt of such complaint; and 

(3) an appeals process with review by a member or committee of the governing authority within 30 days of receipt of the appeal. 

(m) ensure the development, implementation and annual review of a written emergency plan which is current and includes hospice emergency contact information, current staff call down list, and community partners contact list and procedures to be followed to assure health care needs of patients continue to be met in emergencies that interfere with the delivery of services, and orientation of all employees to their responsibilities in carrying out such a plan;  

(n) obtain, from the Department’s Health Commerce System (HCS), accounts for each hospice it operates and ensure that sufficient, knowledgeable staff maintain and keep current such accounts. At a minimum, twenty-four hour, seven-day a week contacts for emergency communication and alerts must be designated by each hospice in the HCS Communications Directory. A policy defining the hospice’s HCS coverage consistent with the hospice’s hours of operation shall be created and reviewed by the hospice no less than annually. Maintenance of each hospice’s HCS accounts shall consist of, but not be limited to, the following: 

(1) sufficient designation of the hospice’s HCS coordinator(s) to allow for HCS individual user application; 

(2) designation by the governing authority of the hospice of sufficient staff users of the HCS accounts to ensure rapid response to requests for information by the State and/or local Department of Health; 

(3) adherence to the requirements of the HCS user contract; and  

(4) current and complete updates of the Communications Directory reflecting changes that include, but are not limited to, general information and personnel role changes as soon as they occur, and at a minimum, on a monthly basis. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 794.2 - Contracts

794.2 Contracts. (a) The governing authority may enter into contracts with appropriate qualified individuals, organizations, agencies and/or facilities, when necessary, to provide for those services required by patients/families when the hospice itself does not have sufficient staff or necessary equipment available to render such services directly.  

(1) Such contracts shall meet all applicable State and Federal requirements and shall specify: 

(i) each party's responsibilities, functions, objectives, financial arrangements and charges, including responsibility for supervision; 

(ii) that personnel meet the personnel requirements as set forth in section 794.3 of this Part, which can be verified by written documented evidence accessible to the hospice or department on request;  

(iii) that services provided by contract to the patient shall be authorized by the hospice in accordance with the plan of care developed by the hospice and that the contract provider agrees to abide by the patient care policies established by the hospice for its patients; 

(iv) that the contracting provider agrees to participate in patient/family care planning conferences as requested by the hospice; 

(v) that contracting providers who are licensed professionals agree to participate in: 

(a) the coordination of all aspects of the patient’s hospice care, including ongoing interdisciplinary comprehensive assessments, developing and evaluating the plan of care, and contributing to patient and family counseling and education; 

(b) the hospice’s quality assessment and performance improvement program; and 

(c) hospice sponsored in-service training. 

(vi) any provisions made for indemnification between the hospice and contracting providers; and 

(vii) the following terms and conditions: "Notwithstanding any other provision in this contract, the hospice remains responsible for (a) ensuring that any service provided pursuant to this contract complies with all pertinent provisions of Federal, State and local statutes, rules and regulations; (b) planning, coordinating and ensuring the quality of all services provided; and (c) ensuring adherence to the plan of care established for patients." 

(2) When a contract is with a licensed medical facility or certified home health agency, the service provided must be in compliance with the applicable provisions of Article 28 or 36 of the Public Health Law, respectively, and the applicable rules and regulations promulgated thereunder. If such statutory and regulatory provisions are inconsistent with the provisions of Article 40 of the Public Health Law or the regulations promulgated thereunder, then the contracting provider shall comply with the applicable provisions of Article 40 of the Public Health Law and the regulations promulgated thereunder. 

(3) When a contract is between the hospice and a Skilled Nursing Facility (SNF) /Intermediate Care Facility (ICF) to provide hospice services to residents of the SNF/ICF, the provisions of section 794.8 of this Part related to contracts shall also apply.  

(b) Except when a management contract has been approved pursuant to this section, the governing authority may not delegate its responsibility for the operation of the hospice to another organization, a parent or subsidiary corporation or through a managing authority contract. An improper delegation may be found to exist where the governing authority no longer retains authority over the operation and management of the hospice, including but not limited to such areas as:  

(1) authority to hire or fire the administrator; 

(2) authority for the maintenance and control of the books and records; 

(3) authority over the disposition of assets and the incurring of liabilities on behalf of the hospice; or 

(4) authority over the adoption and enforcement of policies regarding the operation of the hospice. 

(c) If the governing authority enters into a management contract, the requirements of this subdivision shall be met. 

(1) For the purpose of this section, a management contract is an agreement between a hospice's governing authority and a managing authority for the purpose of managing the day-to-day operation of the hospice or any portion thereof. 

(2) Management contracts shall be effective only with the prior written consent of the Commissioner, and shall include the following: 

(i) a description of the proposed roles of the governing authority and managing authority during the period of the proposed management contract. The description shall clearly reflect retention by the governing authority of ongoing responsibility for statutory and regulatory compliance; 

(ii) a provision that clearly recognizes that the responsibilities of the hospice's governing authority are in no way obviated by entering into the management contract, and that any powers not specifically delegated to the managing authority through the provisions of the contract remain with the governing authority; 

(iii) a clear acknowledgment of the authority of the Commissioner to void the contract pursuant to paragraph (9) of this subdivision; 

(iv) a plan for assuring maintenance of the fiscal stability, the level of service provided and the quality of care rendered by the hospice during the term of the management contract; 

(v) an acknowledgment that the costs of the contract are subject to all applicable provisions of Part 86 of this Title; 

(vi) a requirement that the reports described in paragraph (10) of this subdivision will be provided to the department and to the governing authority annually for the term of the management contract; 

(vii) an express representation that any management contract approved by the Commissioner is the sole agreement between the managing authority and the governing authority for the purpose of managing the day-to-day operation of the hospice or any portion thereof, and that any amendments or revisions to the management contract shall be effective only with the prior written consent of the Commissioner; and 

(viii) a provision that includes the terms of paragraph (8) of this subdivision. 

(3) No management contract shall be approved if the governing authority does not retain sufficient authority and control to discharge its responsibility as the certified operator. The following elements of control shall not be delegated to a managing authority; 

(i) direct independent authority to hire or fire the administrator; 

(ii) independent control of the books and records; 

(iii) authority over the disposition of assets and the authority to incur on behalf of the hospice liabilities not normally associated with the day-to-day operation of a hospice; and 

(iv) independent adoption of policies affecting the delivery of health care services. 

(4) In addition to a proposed written contract complying with the provisions of paragraph (2) of this subdivision, a governing authority seeking to enter into a management contract shall submit to the department, at least 60 days prior to the intended effective date, unless a shorter period is approved by the Commissioner due to extraordinary circumstances, the following: 

(i) documentation indicating that the proposed managing authority holds all necessary approvals to do business in New York State; 

(ii) documentation of the goals and objectives of the management contract, including a mechanism for periodic evaluation of the effectiveness of the arrangement in meeting these goals and objectives; 

(iii) evidence of the managing authority's financial stability; 

(iv) information necessary to determine that the character and competence of the proposed managing authority, and its principals, officers and directors, are satisfactory, including evidence that all agencies or health care facilities managed or operated, in or outside of New York State, have provided a high level of care; and 

(v) evidence that it is financially feasible for the hospice to enter into the proposed management contract, recognizing that the costs of the contract are subject to all applicable provisions of Part 86 of this Title. 

(5) During the period between a hospice's submission of a request for approval of a management contract and disposition of that request, a hospice may not enter into any arrangement for management contract services other than a written interim consultative agreement with the proposed managing authority. Any interim agreement shall reflect consistency with the provisions of this section, and shall be submitted to the department no later than five days after its effective date.  

(6) The term of a management contract shall be limited to three years and may be renewed only when authorized by the Commissioner, provided compliance with this section and the following provisions can be demonstrated: 

(i) that the goals and objectives of the contract have been met within specified timeframes; 

(ii) that the quality of care provided by the hospice during the term of the contract has been maintained or has improved; and 

(iii) that the reporting requirements contained in paragraph (10) of this subdivision have been met. 

(7) Any application for renewal shall be submitted at least 90 days prior to the expiration of the existing contract. 

(8) A hospice’s governing authority shall, within the terms of the contract, retain the authority to discharge the managing authority and its employees from their positions at the hospice with or without cause on not more than 90 days notice. In such event, the hospice shall notify the department in writing at the time the managing authority is notified. The hospice's governing authority shall provide a plan for the operation of the hospice subsequent to the discharge, to be submitted with the notification to the department. 

(9) A management contract shall terminate and be deemed cancelled, without financial penalty to the governing authority, not more than 60 days after notification to the parties by the department of a determination that the management of the hospice is so deficient that the health and safety of patients would be threatened by continuation of the contract. 

(10) Each managing authority shall submit annual reports to the department and the governing authority providing measurements of hospice performance in the following areas: 

(i) financial operations, including a balance sheet, any change in financial position, and a statement of revenues and expenses sufficient to determine liquidity, working capital, net operating margin and age, extent and type of payables and receivables; 

(ii) personnel; and 

(iii) services delivered. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 794.3 - Personnel

794.3 Personnel. The governing authority shall ensure for all personnel, which includes direct employees, contract staff and volunteers: 

(a) the development and implementation of written personnel policies and procedures, which are reviewed annually and revised as necessary; 

(b) that personnel are qualified as specified in section 700.2 of this Title;  

(c) that the health status of all new personnel is assessed prior to the beginning of patient/family contact. The assessment shall be of sufficient scope to ensure that no person shall assume his/her duties unless he/she is free from a health impairment that is of potential risk to the patient/family or to employees or that may interfere with the performance of his/her duties including the habituation or addiction to depressants, stimulants, alcohol, or other drugs or substances which may alter the individual’s behavior; 

(d) that a record of the following tests and examinations is maintained for all employees, and those volunteers who have direct patient/family contact: 

(1) a certificate of immunization against rubella which means: 

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating a serologic evidence of rubella antibodies, or 

(ii) a document indicating one dose of live virus rubella vaccine was administered on or after the age of twelve months, showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization, or 

(iii) a copy of a document described in (i) or (ii) of this paragraph which comes from a previous employer or the school which the employee attended as a student; 

(2) a certificate of immunization against measles, for all personnel born on or after January 1, 1957, which means: 

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of measles antibodies, or 

(ii) a document indicating two doses of live virus measles vaccine were administered with the first dose administered on or after the age of 12 months and the second dose administered more than 30 days after the first dose but after 15 months of age showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization, or 

(iii) a document, indicating a diagnosis of the employee as having had measles disease, prepared by the physician, physician assistant/specialist assistant or nurse practitioner who diagnosed the employee's measles, or 

(iv) a copy of a document described in (i), (ii) or (iii) of this paragraph which comes from a previous employer or the school which the employee attended as a student; 

(3) if any licensed physician, physician assistant/specialist assistant or nurse practitioner certifies that immunization with measles or rubella vaccine may be detrimental to the employee's health, the requirements of paragraph (1) and/or (2) of this subdivision relating to measles and/or rubella immunization shall be inapplicable until such immunization is found no longer to be detrimental to such employee's health. The nature and duration of the medical exemption must be stated in the employee's employment medical record and must be in accordance with generally accepted medical standards (see, for example, the recommendations of the American Academy of Pediatrics and the Immunization Practices Advisory Committee of the U.S. Department of Health and Human Services);  

(4) either tuberculin skin test or Food and Drug Administration (FDA) approved blood assay for the detection of latent tuberculosis infection, prior to employment or voluntary service, and no less than every year thereafter for negative findings. Positive findings shall require appropriate clinical follow-up but no repeat tuberculin skin test or blood assay. The hospice shall develop and implement policies regarding follow-up of positive test results;  

(5) documentation of any immunization(s) required by the Department;  

(6) documentation of vaccination against influenza, or wearing of a surgical or procedure mask during the influenza season, for personnel who have not received the influenza vaccine for the current influenza season, pursuant to section 2.59 of this Title; and 

(7) an annual, or more frequent if necessary, health status assessment to assure that all personnel are free from health impairment that is of potential risk to the patient/family or to employees or that may interfere with the performance of his/her duties; 

(e) that a record of all tests, examinations, health assessments and immunizations required by this section is maintained for all personnel who have direct patient contact; 

(f) that personal identification is produced by each applicant and verified by the program prior to retention of an applicant by the program; 

(g) that prior to patient contact, employment history from previous employers, if applicable, and recommendations from other persons unrelated to the applicant if not previously employed, are verified; 

(h) that personnel records include, as appropriate, records of professional licenses and registrations; verifications of employment history and qualifications for the duties assigned; signed and dated applications for employment; records of pre-employment physical examinations and health status assessments; criminal background check; performance evaluations; time and payroll records; dates of employment, resignations, dismissals, inservice training and other pertinent data; provided that all documentation and information pertaining to an employee's medical condition or health status, including such records of physical examinations and health status assessments shall be maintained separate and apart from the non-medical personnel record information and shall be afforded the same confidential treatment given patient clinical records under section 794.4 of this Part;  

(i) that time and payment records are maintained for all personnel; 

(j) that there is a current written job description for each position which delineates responsibilities and specific education and experience requirements;  

(k) that all personnel, including hospice employees, volunteers and contract staff with direct patient and family contact, receive orientation to the concept of hospice care, his or her specific job duties, and the policies and procedures for the hospice operation, inservice education necessary to perform his/her responsibilities and continuing programs for development and support.

(1) At a minimum home health aides shall participate in 12 hours of in-service education per year, which may occur while the aide is furnishing care. In-service may be offered by any organization and must be supervised by a registered nurse; and

(2) advanced home health aides shall participate in 18 hours of in-service education per year which must include medication management, infection control, and injection safety, and must be directly supervised by a registered professional nurse.

(l) that employees providing care in the home display proper and current identification, including name, title and current photograph of care provider and name of the program providing the service, to be returned to the program upon termination of employment; and 

(m) that an annual assessment of the performance and effectiveness of all personnel is conducted. Such assessment shall include an assessment of skills and competence of individuals providing care including volunteers and include: 

(1) written policies and procedures describing the methods of competency assessment, which shall be implemented; and  

(2) training and education to personnel to improve competency in areas identified by the assessment process as requiring such improvement. 

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 794.4 - Clinical record

794.4 Clinical record. The governing authority shall ensure that:  

(a) there is a standardized clinical record system which is maintained in conformance with generally accepted medical record practices; 

(b) a clinical record containing past and current findings is maintained for each hospice patient. The clinical record must contain correct clinical information that is available to the patient's attending physician and hospice staff including:  

(1) initial assessment, comprehensive assessments and updated comprehensive assessments; 

(2) initial plan of care and updated plans of care;  

(3) clinical notes. A clinical note means a notation of a contact with the patient and/or the family that is written and dated by any person providing services and that describes signs and symptoms, treatments and medications administered, including the patient's reaction and/or response, any changes in physical, emotional, psychosocial or spiritual condition during a given period of time;  

(4) signed copies of the notice of patient rights pursuant to section 793.1 of this Title and election statement pursuant to section 793.2 of this Title; 

(5) responses to medications, symptom management, treatments and services;  

(6) outcome measure data elements; 

(7) physician certification and recertification of terminal illness;  

(8) any advance directive; 

(9) physician orders;  

(10) documentation regarding instructions and written information provided to patients and families on the use, management and disposal of controlled substances and durable medical equipment and supplies; and  

(11) a discharge summary if the patient is discharged from hospice, completed by appropriate personnel, including but not limited to:  

(i) reason for discharge and date; 

(ii) a summary of the hospice care given including treatments, symptoms and pain management; and 

(iii) patient status upon discharge including a description of any remaining needs. 

(c) the clinical record for each patient is in a form that can be summarized for transferral of information for inpatient care, home care services, and bereavement services, as appropriate; 

(d) the clinical record meets the following requirements as applicable: 

(1) all entries shall be current;  

(2) all entries shall be legible and recorded in dark ink to facilitate photocopying;  

(3) all entries shall be signed and dated, including the time of day and authenticated; and  

(4) all records shall be kept in a place convenient to and easily retrievable by the hospice staff; 

(e) the clinical record, whether hard copy or in electronic form, is readily available on request by an appropriate authority; 

(f) the clinical record, its contents and the information contained is safeguarded against loss or unauthorized use. The hospice must be in compliance with state and federal requirements, including section 18 of the Public Health Law, governing the disclosure of personal health information.  

(g) each patient’s clinical record shall be retained by the hospice for at least a six-year period after death or discharge from the hospice. In the case of a minor who is discharged from the hospice, clinical records shall be retained for at least a six-year period after death or discharge or, if the minor attains majority (18 years), for a three-year period thereafter, whichever period is longer. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 794.5 Short-term Inpatient Service

Section 794.5 Short-term Inpatient Service.  

(a) Part 702 of this Title, section 717.3 of this Title and Part 14 of the Sanitary Code shall apply to hospice inpatient settings as applicable. 

(b) The hospice may provide short-term inpatient services for respite and for pain control and management of symptoms related to the terminal illness in a free-standing hospice facility, a skilled nursing facility or a general hospital. 

(c) The provision of inpatient services shall be consistent with applicable Federal requirements and with the definition of hospice as defined in section 700.2 of this Title, and shall include, but not be limited to: 

(1) 24-hour nursing services that meet the needs of all patients and are furnished in accordance with the patient’s plan of care, including the services of a registered professional nurse if a hospice patient has been admitted to inpatient services for other than respite care. Each patient must receive all nursing services as prescribed and must be comfortable, clean, well groomed, and protected from accident, injury and infection;  

(2) accommodations to enable families to store and prepare food brought in by the family; 

(3) accommodations to enable families to remain with the patient throughout the night; 

(4) flexible visitation policies which include 24-hour a day visiting privileges regardless of age of visitor; 

(5) provision of adequate and wholesome food and supplemental nourishments under the direction of a dietician; 

(6) flexibility in meal times and in selection of food based on individual needs of patients; 

(7) accommodations for recreational and religious activities; 

(8) adequate space for private small group interactions; 

(9) retention and use of personal possessions as space and safety permits; 

(10) a telephone accessible to the patient; and 

(11) oxygen available to each patient, as necessary. 

(d) In addition to meeting the provisions of section 794.2 of this Part and any applicable State and Federal requirements, contractual arrangements with a facility for inpatient services must include a written agreement describing the arrangements and the agreement shall specify that:  

(1) a member of the hospice interdisciplinary care group shall conduct onsite reviews of the inpatient services provided to ensure conformance with the established plan of care, at least weekly; 

(2) the hospice supplies the inpatient provider with a copy of the patient’s plan of care and specifies the inpatient services to be furnished; 

(3) the inpatient provider has established patient care policies consistent with those of the hospice and agrees to abide by the palliative care protocols and plan of care established by the hospice for its patients; 

(4) the hospice patient’s inpatient clinical record includes a record of all inpatient services furnished and events regarding care that occurred at the facility;  

(5) upon discharge from the inpatient service, a copy of the discharge summary and if requested a copy of the inpatient medical record will be forwarded to the hospice and retained as part of the hospice clinical record; 

(6) the inpatient facility has identified an individual within the facility who is responsible for the implementation of the provisions of the agreement; 

(7) the hospice retains responsibility for ensuring that the training of personnel who will be providing the patient’s care in the inpatient facility has been provided and that a description of the training and the names of those giving the training are documented; and 

(8) a method for verifying that the requirements in paragraphs (d)(1) through (d)(6) of this section are met. 

(e) The hospice that provides inpatient care directly in its own facility must demonstrate compliance with all of the following standards: 

(1) ensuring that staffing for all services reflects its volume of patients, their acuity, and the level of intensity of services needed to ensure that plan of care outcomes are achieved and negative outcomes are avoided; 

(2) providing 24-hour nursing services that meet the nursing needs of all patients and are furnished in accordance with each patient’s plan of care;  

(3) providing pharmacy services under the direction of a licensed pharmacist responsible for evaluating the patient’s response to drug therapy, identification of potential drug reactions and recommend corrective action; 

(4) having a written policy for dispensing drugs accurately and maintaining records of receipt and disposition of controlled drugs; 

(5) maintaining a safe physical environment free of hazards for patients, staff, and visitors which includes: 

(i) addressing real or potential threats to health and safety of patients, others and property; 

(ii) having a written disaster plan in effect for managing power failures, natural disasters and other emergencies affecting the ability to provide care. The plan must be periodically reviewed and rehearsed with staff; 

(iii) developing and implementing procedures for routine storage and prompt disposal of trash and medical waste; light, temperature and ventilation/air exchanges; emergency gas and water supply; and scheduled and emergency maintenance and repair of all equipment;  

(6) ensuring that patient areas are designed to preserve the dignity, comfort, and privacy of patients; and 

(7) developing and implementing policies that meet federal standards for use of seclusion and restraints. 

Effective Date: 
Wednesday, August 31, 2016

Section 794.6 Hospice Residence Service

Section 794.6 Hospice Residence Service. (a) Part 702 of this Title, section 717.4 of Part 717 of this Title and Part 14 of the Sanitary Code shall apply to all hospice residence settings, as applicable. 

(b) Hospice residence as defined in Part 702 of this Title shall mean a hospice operated home which is residential in character and physical structure, and operated for the purpose of providing more than two hospice patients, but not more than sixteen hospice patients, with hospice care. 

(c) Hospice residence service shall include, but not be limited to:  

(1) the provision of services as specified in section 794.5(c)(2), (3), (4), (6), (7), (8), (9), (10) and (11) of this Part.  

(2) the provision of either home health aide, licensed practical nurse or registered nurse services, as appropriate, to address the medical needs and ensure the safety and well-being of residents on a 24-hour a day basis; 

(3) the provision of adequate and wholesome food and supplemental nutrition under the direction of a dietician. The hospice residence must: 

(i) store, prepare, distribute and serve food under sanitary conditions in accordance with the sanitary requirements of Part 14 (Service Food Establishments) of Chapter 1 (State Sanitary Code) of this Title; 

(ii) offer each resident at least three meals, or their equivalent, each day at regular times, with not more than 14 hours between a substantial evening meal and breakfast; and  

(iii) prepare and serve therapeutic diets, prescribed by a physician, and planned and supervised by a professionally qualified dietitian; and 

(4) routine and emergency drugs and biologicals, provided either directly to residents, or obtained under contract as described in section 794.2 of this Part, in accordance with Article 33 of the Public Health Law and Part 80 of this Title. 

Effective Date: 
Wednesday, August 31, 2016

Section 794.7 - Leases

Section 794.7 Leases. (a) Whenever a hospice leases premises in which the inpatient component of a hospice or a hospice residence is to be provided, the hospice shall ensure that the lease contains the following language: 

"The landlord acknowledges that its rights of reentry into the premises set forth in this lease do not confer on it the authority to operate a hospital or hospice as defined in Articles 28 and 40, respectively, of the Public Health Law on the premises and agrees to provide the New York State Department of Health with notification by certified mail of intent to reenter the premises or to initiate dispossess proceedings or that the lease is due to expire, at least 30 days prior to the date on which the landlord intends to exercise a right of reentry or to initiate such proceedings or at least 60 days before expiration of the lease." 

(b) Upon receipt of notice from the landlord of its intent to exercise its right of reentry or upon the service of process in dispossess proceedings and 60 days prior to the expiration of the lease, the hospice shall immediately notify by certified mail the New York State Department of Health of receipt of such notice or service of such process or that the lease is about to expire. 

(c) No lease covering the administrative office site or the premises in which the inpatient component of a hospice or a hospice residence as defined in Article 40 of the Public Health Law is to be conducted and no lease covering any equipment used in the operation of a hospice may contain any provision whereby rent, or any increase therein, is based upon the Consumer Price Index or any other cost of living index. In the event the lease covering such hospice premises or equipment contains provisions whereby it is the lessor's responsibility to pay necessary expenses associated with such premises or equipment, such as real estate taxes, utilities, heat, insurance, maintenance and operating supplies, such lease may contain provisions which allow adjustments to the rent only to the extent necessary to compensate the lessor for changes in such expenses. 

Effective Date: 
Wednesday, August 31, 2016
Doc Status: 
Complete

Section 794.8 Hospice care provided to residents of a Skilled Nursing Facility (SNF) or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID)

Section 794.8 Hospice care provided to residents of a Skilled Nursing Facility (SNF) or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID).  

(a) A hospice that provides hospice care to residents of a SNF or ICF/IID, hereafter referred to as the facility, must assume responsibility for professional management of the hospice services provided to the resident, in accordance with the hospice plan of care, including assessing, planning, monitoring, directing and evaluating the patient’s/resident’s hospice care across all settings. 

(b) The hospice and the facility must have a written agreement for the provision of hospice services between the two entities signed by an authorized representative of the hospice and the facility. The written agreement must include the following provisions:  

(1) the manner in which the facility and the hospice are to communicate with each other and document such communications to ensure that the needs of patients are addressed and met 24 hours a day;  

(2) that the facility immediately notifies the hospice if:  

(i) a significant change in a patient’s physical, mental, social, or emotional status occurs;  

(ii) clinical complications appear that suggest a need to alter the plan of care;  

(iii) a need to transfer a patient from the facility arises, and the hospice makes arrangements for, and remains responsible for, any necessary continuous care or inpatient care necessary which is related to the terminal illness and related conditions; or  

(iv) a patient dies;  

(3) that the hospice is responsible for determining the appropriate course of hospice care, including the determination to change the level of services provided;  

(4) that the facility is responsible for furnishing 24-hour room and board care; and for meeting the personal care and nursing needs that would have been provided by the primary caregiver at home and at the same level of care provided before hospice care was elected;  

(5) a delineation of the hospice’s responsibilities, which include, but are not limited to providing: 

(i) medical direction and management of the patient; 

(ii) core services including nursing and counseling (including spiritual, dietary and bereavement), as well as medical social services; medical supplies, durable medical equipment and drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions; and all other hospice services that are necessary for the care of the resident’s terminal illness and related conditions; and 

(iii) services at the same level and to the same extent as those services would be provided if the resident were in his or her own home;  

(6) that the hospice may use the facility nursing personnel where permitted by State and Federal law and as specified by the SNF or ICF/IID to assist in the administration of prescribed therapies included in the plan of care only to the extent that the hospice would routinely use the services of a hospice patient’s family in implementing the plan of care;  

(7) that the hospice must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by anyone unrelated to the hospice to the facility administrator within 24 hours of the hospice becoming aware of the alleged violation; and  

(8) a delineation of the responsibilities of the hospice and the SNF or ICF/IID to provide bereavement services to facility staff.  

(c) A written hospice plan of care must be established and maintained in consultation with facility representatives.  

(1) The hospice plan of care must identify the care and services that are needed and specifically identify which provider is responsible for performing the respective functions that have been agreed upon and included in the hospice plan of care.  

(2) The hospice plan of care should reflect the participation of the hospice, the facility staff, and the patient and family to the extent possible.  

(3) Based on collaboration between the hospice and the facility, the hospice plan of care should reflect: 

(i) a common problem list;  

(ii) palliative interventions;  

(iii) palliative outcomes;  

(iv) responsible discipline;  

(v) responsible provider; and  

(vi) patient goals.  

(4) The hospice must approve any changes in the hospice plan of care before implementation and discuss such changes with the patient or representative, and facility representatives.  

(d) For each patient, the hospice must designate a member of the interdisciplinary group who will be responsible for:  

(1) providing overall coordination of the hospice care of the resident with the facility representatives and communicating with facility representatives and other health care providers and physicians participating in the provision of care;  

(2) providing the facility, for each hospice patient, with:  

(i) the most recent hospice plan of care;  

(ii) the hospice election form and any advance directives;  

(iii) the physician certification and recertification of the terminal illness;  

(iv) the names and contact information for hospice personnel involved in hospice care;  

(v) hospice medication information;  

(vi) hospice physician and attending physician (if any) orders; and  

(vii) instructions on how to access the hospice’s 24-hour on-call system;  

(e) Hospice staff must orient facility staff furnishing care to hospice patients to the hospice philosophy; hospice policies and procedures regarding methods of comfort, pain control, and symptom management; principles about death and dying and individual responses to death; patient rights; appropriate forms; and record keeping requirements.  

Effective Date: 
Wednesday, August 31, 2016

Section 794.9 Records and reports

Section 794.9 Records and reports. (a) The governing authority shall ensure that: 

(1) the following records are retained on file at the principal office of the hospice within its approved geographic service area and available to the Department upon request: 

(i) the certificate of incorporation, if applicable; 

(ii) the certificate of approval; 

(iii) all current contracts, leases and other agreements entered into by the hospice; 

(iv) current operating policies and procedures; and 

(v) a current patient/family roster; 

(2) copies of the documents under subparagraphs (1)(iv) and (v) of this subdivision are retained on file at each suboffice of the hospice, if applicable; 

(3) the following reports and records are retained by the hospice and available to the department upon request: 

(i) minutes of the meetings of the hospice governing authority and the quality assurance committee which shall be retained for three years from the date of the meeting; 

(ii) the reports of hospice surveys and inspections by outside agencies with statements attached thereto specifying the steps taken to correct any deficiencies or to carry out the recommendations contained therein which shall be retained for five years from the date of such survey or inspection; 

(iii) records of all financial transactions which shall be retained eight years from the date of the transaction; 

(iv) personnel records, which shall be retained six years from the date of employee termination or resignation;  

(v) records of complaints and appeals, which shall be retained three years from resolution; and 

(vi) records of tracking, receipt and resolution of accident and incidents. 

(b) The hospice shall furnish annually to the department a copy of: 

(1) the current annual report submitted to its governing body; and  

(2) other such data, records and reports as may be required by the department. 

Effective Date: 
Wednesday, August 31, 2016

Chapter VI - State Emergency Medical Services Code

Effective Date: 
Wednesday, July 20, 2016
Doc Status: 
Complete

Part 800 - Emergency Medical Services

Effective Date: 
Wednesday, July 20, 2016
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Art. 30, Section 3002(2)

GENERAL

Section 800.1 - Title

GENERAL

Section 800.1 Title. This chapter shall be known and may be cited as the "State Emergency Medical Services Code".
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.2 - Applicability of other laws, codes, rules and regulations

800.2 Applicability of other laws, codes, rules and regulations. Except as otherwise provided in this chapter, ambulance services shall comply with all pertinent Federal laws, State laws, and those provisions of county, city, town and village charters, special and local laws, ordinances and any codes, rules or regulations promulgated thereunder having general application thereto.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.3 - Definitions

800.3 Definitions. The following definitions shall apply to this Chapter unless the context otherwise requires:

(a) Department means the New York State Department of Health.

(b) Commissioner means the State Commissioner of Health.

(c) Person means an individual, partnership, association, corporation or any other legal entity whatsoever.

(d) Emergency medical service means a service engaged in providing initial emergency medical assistance including, but not limited to, the treatment of trauma, burns and respiratory, circulatory and obstetrical emergencies.

(e) Ambulance means a motor vehicle, airplane, boat or other form of transport especially designed and equipped to provide emergency medical services during transit.

(f) Ambulance service means a person engaged in providing emergency medical services and the transportation of sick, disabled or injured persons by motor vehicle, aircraft or other form of transportation to facilities providing hospital services.

(g) Voluntary ambulance service means an ambulance service (i) operating not for financial profit and (ii) no part of the assets or income of which is distributable to, or enures to the benefit of, its members, directors or officers except to the extent permitted under article 30.

(h) Municipal ambulance service means an ambulance service operated by a municipality or agency thereof and staffed by municipal employees or an ambulance service operated by a county or agency thereof and staffed by county employees.

(i) Hospital ambulance service means an ambulance service owned and operated by a hospital as defined in article 28 of the Public Health Law.

(j) Certified ambulance service means an ambulance service having an ambulance service certificate issued by the department pursuant to section 3005 or 3006 of the Public Health Law.

(k) Certificate of inspection means a windshield sticker affixed to the lower right hand corner of the windshield of the ambulance. The sticker signifies that the vehicle has been inspected and approved by the department for operation in a certified ambulance service.

(l) New vehicle means a vehicle of recent manufacture placed in service for the first time.

(m) Emergency ambulance service Vehicle means a vehicle that is owned or operated by an ambulance service that is used to transport emergency medical personnel and equipment to sick or injured persons.

(n) Certified first responder means a person certified pursuant to these regulations as a first responder.

(o) Emergency medical technician means a person certified pursuant these regulations as an emergency medical technician.

(p) Advanced emergency medical technician means a person certified pursuant to these regulations as an advanced emergency medical technician, an emergency medical technician-critical care, or an emergency medical technician-paramedic.

(q) State Council means the New York State Emergency Medical Services Council established pursuant to section 3002 of article 30 of the Public Health Law.

(r) Regional council means a regional emergency medical services council established pursuant to section 3003 of article 30 of the Public Health Law.

(s) Certified instructor coordinator means a person certified pursuant to these regulations to serve as the lead instructor for courses leading to certification as a certified first responder, emergency medical technician or advanced emergency medical technician. Certified instructor coordinators must be certified, pursuant to these regulations, at or above the level at which they seek to instruct.

(t) Certified laboratory instructor means a person certified pursuant to these regulations to instruct, in psychomotor skills, candidates in courses leading to certification as an emergency medical technician or certified first responder or advanced emergency medical technician.

(u) Advanced life support system means a method for the provision of initial emergency medical assistance under medical direction and supervision including, but not limited to, one or more of the following services:

(1) administration of intravenous fluids;

(2) administration of drugs;

(3) intubation;

(4) manual defibrillation; and

(5) and other services as approved by the commissioner and council.

(v) Primary territory means that area listed on an ambulance or advanced life support first response service certificate in which the service may treat or receive (pick up) patients.

(w) Continuous Practice means a certified individual having:

(1) actively provided prehospital patient care during their period of certification, at or below their level of certification; and

(2) been a current, active member or employee of an EMS agency recognized by the department, during their period of certification.

(x) Course Sponsor means a person approved by the department to conduct EMS Educational Programs as one or more of the following specific types of course sponsor:

(1) Basic Life Support Course Sponsor - a course sponsor authorized by the department to conduct original and refresher CFR and EMT courses.

(2) Advanced Life Support Course Sponsor - a course sponsor authorized by the department to conduct all basic life support courses, AEMT and EMT-CC original and refresher courses, and the EMT-P original and refresher courses.

(3) Continuing Education Course Sponsor - a course sponsor authorized by the department to conduct one or more of the following courses, including, but not limited to: Certified Instructor Coordinator, Certified Lab Instructor, Certified Instructor Update, or other continuing education courses developed by the department. Approval as a continuing education course sponsor is specific to the EMS educational programs that the sponsor is authorized to offer and not all sponsors will be approved to offer all types of courses.

(y) Learning Contract means a written agreement between a student and a course sponsor which specifies requirements to complete the course and the policies of the sponsor.

(z) "DNR bracelet" means an item meeting the Department of Health specification in section 800.90 of this Part which may be worn by a person who has been issued a valid non-hospital order not to resuscitate.

(aa) Automated External Defibrillation (AED) means defibrillation by a certified first responder, emergency medical technician or advanced emergency medical technician using an external defibrillator that incorporates an electronic rhythm analysis system that limits the delivery of an electrical counter shock to a rhythm for which defibrillation is medically indicated. The external defibrillator may be either a fully automatic or semiautomatic (shock-advisory) type.

(ab) "Mutual aid agreement" means a written agreement, entered into by two or more ambulance services or advanced life support first response services for the organized, coordinated and cooperative reciprocal mobilization of personnel, equipment, services or facilities for back-up or support upon request as required pursuant to a written mutual aid plan.

(ac) "Call receipt interval" means the elapsed time from receipt of a request for emergency assistance by the service or its dispatch agency to the time a staffed ambulance or ALSFR vehicle is en route to the reported location of the incident.

(ad) "Advanced life support (ALS) care" means definitive acute medical care provided under medical control, by advanced emergency medical technicians within an advanced life support system.

(ae) "Advanced life support first responder (ALSFR) service" means any person or organization which provides advanced life support care, but does not transport patients.

(af) "Advanced life support first response (ALSFR) vehicle" means a designated vehicle or conveyance operated by an ALSFR service, which brings advanced life support equipment and personnel authorized to provide ALS care to a location to provide such care.

(ag) "Quality improvement program" means a system which seeks to improve and enhance the quality and appropriateness of patient care and clinical performance of the service.

(ah) "Governing authority" means in the case of a fire district, the board of fire commissioners; or in the case of a municipality, the municipality's legislative body; or in the case of a corporation, the board of directors; or in the case of a hospital, the governing body; or in the case of a partnership, each of the partners; or in the case of a sole proprietorship, the proprietor; or in the case of an unincorporated association, all the members of the association.

(ai) "EMS service" means an ambulance service or an advanced life support first response service.

(aj) "Authorized EMS response vehicle" means any vehicle, conveyance, boat or aircraft meeting the requirements of this part authorized by the governing authority and operated by an EMS service for the purpose of providing certified personnel and equipment to an event dispatched as an EMS response.

(ak) Criminal offense means, except in exceptional circumstances as determined by the agency, convictions in any jurisdiction for felonies involving murder, manslaughter, assault, sexual abuse, theft, robbery, fraud, embezzlement, drug abuse, or sale of drugs.

(al) Incompetence means a lack of, or loss of, skill or knowledge to practice the profession, and/or practicing with negligence, as negligence is defined in this part, on one or more occasions while treating a patient.

(am) Negligence means a failure to perform, on one or more EMS calls, as an ordinary, reasonable, similarly situated certificate holder certified at the same level would, based upon the standard of care in the region, as delineated in controlling protocols, curricula, and policies, and as demonstrated by an ordinary, reasonable certificate holder’s general standards of practice.

(an) Non-criminal offense means findings of inappropriate conduct or misconduct not constituting a criminal offense in any jurisdiction, including, but not limited to, findings by either a designated governmental authority or a court of law of patient abuse, neglect, mistreatment, or misappropriation of patient property; Family Court findings of spousal and/or intimate partner violence; Family Court or other designated governmental entity findings of child abuse, neglect or abandonment; vehicle and traffic findings involving reckless and/or aggressive driving; findings by any governmental entity of diversion of controlled substances from any health care facility, health care provider, or pharmacy; and any governmental findings involving dishonesty and/or other unethical conduct evincing unfitness to serve the public.

(ao) Patient Abandonment means a certificate holder’s willful termination of patient contact prior to delivering the patient for medical evaluation and/or treatment, or securing a proper refusal of medical attention in accordance with applicable protocol. Patient abandonment may be effected through means including, but not limited to, leaving a patient unattended after establishing patient contact, leaving a patient to the care of an EMT certified at a lower level when the certificate holder knew or should have known that the patient required a higher level of care, and/or encouraging the patient and/or bystanders to reject transport to a hospital by ambulance unless it occurs within an organized multi patient/agency response.

(ap) Patient abuse means any inappropriate and/or offensive physical, sexual or verbal contact or interaction with a patient, irrespective of whether the certificate holder is specifically acting in his/her capacity as an EMT when (s)he engages in the abuse, including but not limited to the following:

(1) Physical abuse means conduct by a certificate holder which causes, by physical contact, physical injury, or serious or protracted impairment of the physical, mental or emotional condition of a patient, or which causes the likelihood of such injury or impairment. Such conduct may include, but shall not be limited to, slapping, hitting, kicking, biting, chocking, smothering, shoving, dragging, pinching, punching, shaking, sitting upon, burning, cutting, strangling, striking, using corporal punishment, or throwing objects at a patient. Physical abuse shall not include reasonable emergency interventions necessary to protect the safety of any person.

(2) Psychological abuse means verbal or non-verbal conduct by a certificate holder, directed to a patient, which insults, denigrates, humiliates, shocks, mocks, threatens, harasses, or alarms the patient. Psychological abuse shall not include verbal or non-verbal conduct which has medical or therapeutic purpose or justification.

(3) Sexual abuse means conduct by a certificate holder, which subjects a patient to any offense defined in article one hundred thirty, two hundred forty-five of the penal law; or any conduct or communication by a certificate holder that allows, permits, uses or encourages a patient to engage in any act described in two hundred sixty-three of the penal law. Offensive sexual contact or conduct may include, but shall not be limited to, engaging in, or facilitating sexual contact, exposure, performances, photography or any other form of sexual image collection and/or dissemination, irrespective of the patient’s receptiveness to the conduct.

(aq) Patient contact means that the certificate holder has assessed, the patient and the circumstances in which the patient is found, when responding to a request for emergency medical services and that the patient has either accepted care or the patient’s acceptance of care is implied from the circumstances or from his (her) inability to respond.

(ar) Statutory and/or regulatory violation means any finding or determination by a court or governmental agency holding jurisdiction to adjudicate allegations of violations of EMS laws, regulations and/or protocols.

(as) Scope of practice means the psychomotor skills and knowledge necessary for the minimum competence for each level of New York State EMT certification as approved by the Commissioner.

(at) State-approved protocols means Basic Life Support (BLS) patient care protocols which apply throughout New York State and which are distributed to every certificate holder certified at every level, and protocols established by the Regional Emergency Medical Advisory Committees (REMACs) which are approved and distributed to every certificate holder credentialed by the REMAC.

(au) Treatment means the pre-hospital administration or application of a remedy or remedies by a certificate holder to a patient for a condition, disease or injury when rendering emergency medical services.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.4 - Signs and advertisements

800.4 Signs and advertisements. (a) The word "ambulance" may not be displayed on a vehicle, aircraft, or boat except on a vehicle, aircraft, or boat registered with the department as an ambulance except to comply with 800.21 (e).

(b) Services desiring to advertise the operation of aircraft and boats shall comply with the requirements of this Part.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

ADVANCED LIFE SUPPORT SYSTEMS

Section 800.5 - Requirements for an advanced life support system

ADVANCED LIFE SUPPORT SYSTEMS

800.5 Requirements for an advanced life support system. (a) An advanced life support system must meet the following requirements:

(1) designation of a qualified physician to provide medical supervision and direction; and

(2) integration with a hospital emergency service, or intensive care, coronary care, or other appropriate hospital unit.

(b) An ambulance or advanced life support first response service, when providing advanced life support services, must meet the requirements of Sections 800.23 and 800.24 of this Part and utilize a treatment record provided by or approved by the department, including submission of such record for use in quality assurance programs.

(c) An advanced life support system providing prehospital Advanced EMT care must include the following:

(1) voice communications to receive medical direction;

(2) equipment and supplies to provide prehospital advanced care; and

(3) staffing by a certified advanced emergency medical technician, emergency medical technician-critical care, or or emergency medical technician-paramedic, as appropriate.

(d) An advanced life support system providing prehospital EMT-critical care and/or EMT-paramedic services must include the following:

(1) voice communications to receive medical direction;

(2) biomedical telemetry;

(3) equipment and supplies to provide pre-hospital critical care and/or EMT-paramedic services;  

(4) a current class 3(c) institutional dispenser limited license, in accordance with Article 33 of the Public Health Law and section 80.136 of this Title, unless exempt as an ALS agency owned and operated by a hospital, to purchase, possess, deliver and administer controlled substance medications to treat patients, in accordance with applicable State-approved regional protocols developed pursuant to sections 3002-a and 3004-a of the Public Health Law; and

(5) staffing by a certified emergency medical technician-critical care or emergency medical technician-paramedic, as appropriate.

 

Effective Date: 
Wednesday, July 20, 2016
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 3002

EMERGENCY MEDICAL SERVICES PERSONNEL

Section 800.6 - Initial certification requirements

EMERGENCY MEDICAL SERVICES PERSONNEL

800.6 Initial certification requirements. To qualify for initial certification, an applicant shall:

(a) file with the department a completed department-approved application form bearing the applicant’s original signature in ink, or an electronic application approved by the department;
(b) be at least 18 years of age prior to the last day of the month in which he/she is scheduled to take the written certification examination for the course in which they are enrolled, except that an applicant for a certified first responder must be at least 16 years of age prior to the last day of the month in which he/she is scheduled to take the written certification examination;

(c) satisfactorily complete the requirements of a State-approved course given by a State-approved course sponsor in emergency medical care at one of the following levels for which certification is available:

(1) certified first responder (CFR);

(2) emergency medical technician (EMT);

(3) advanced emergency medical technician;

(4) emergency medical technician-critical care (EMT-CC);

(5) emergency medical technician-paramedic (EMT-P);

(6) certified laboratory instructor (CLI); or

(7) certified instructor coordinator (CIC). (d) pass the State practical skills examination for the level at which certification is sought within one year of the scheduled written examination date for the course;

(e) after passing the practical skills examination, pass the State written certification examination for the level at which certification is sought within one year of the scheduled written examination date for the course, except at the certified instructor coordinator level and certified lab instructor level; (f) if the applicant has been convicted of one or more criminal offenses, as defined in §800.3(ak), be found eligible after a balancing of the factors set out in Article 23-A of Corrections Law. In accordance with that Article, no application for a license shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of this certificate or (ii) certifying the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the agency will look at the eight factors listed under New York State Corrections Law Section 753; and (g) not have been found guilty or in violation, in any jurisdiction, of any other non-criminal offense or statutory and/or regulatory violation, as those terms are defined in Section 800.3 of this Part, relating to patient safety unless the department determines such applicant would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.7 - Reexaminations - applicants for initial certification

800.7 Reexaminations - applicants for initial certification. (a) Candidates who have failed the practical skills examination must complete a refresher or an original certification course for the level of certification sought prior to being admitted to another practical skills examination at the same level of certification. Such candidates may be admitted once to a practical skills examination at a lower level of certification within one year after the last attempt at the level originally sought.

(b) Candidates who have failed the written certification exam after two attempts must complete a refresher or original certification course at the appropriate level prior to being admitted to another written certification exam at the same level of certification. Such candidates may be admitted once to a written certification examination at a lower level of certification, within one year after the last attempt at the level originally sought.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.8 - Recertification requirments

800.8 Recertification requirements. Applicants for recertification must comply with either section 800.8 or 800.9. To qualify for recertification under this section, an applicant shall: (a) file with the department a completed department-approved application form bearing the applicant's original signature in ink or an electronic application approved by the department;

(b) have previously held New York State certification at or above the level at which recertification is sought except as provided in section 800.18 of these regulations;

(c) enroll in a recertification course provided by an approved course sponsor (800.20) and complete the requirements for recertification at the level at which recertification is sought;
(d) pass the State practical skills examination for the level at which recertification is sought within one year of the scheduled written examination date for the course;

(e) after passing the practical skills examination, pass the State written certification examination for the level at which certification is sought within one year of the scheduled written examination date for the course, except at the certified instructor coordinator level and certified lab instructor level; (f) if the applicant has been convicted of one or more criminal offenses, as defined in §800.3(ak), be found eligible after a balancing of the factors set out in Article 23-A of Corrections Law. In accordance with that Article, no recertification shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of this certificate or (ii) recertification of the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the agency will look at the eight factors listed under New York State Corrections Law Section 753; and (g) not have been found guilty or in violation, in any jurisdiction, of any other non-criminal offense or statutory and/or regulatory violation, as those terms are defined in Section 800.3 of this Part, relating to patient safety unless the department determines such applicant would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.9 - Continuing medical education recertification

800.9 Continuing medical education recertification.

(1) Continuing Medical Education program. Recertification applicants who have demonstrated competence in applicable behavioral and performance objectives, and who have demonstrated completion of appropriate continuing medical education may, if qualified as set forth in 2 below, have their certification renewed without being required to successfully complete a state practical skills and written examination.

(2) To qualify for recertification using continuing medical education, an applicant shall:

(a) be currently certified at the certification level they are seeking;

(b) be a current active member or employee of an agency already registered in the program and authorized to provide the level of care for which the participant is seeking recertification;

(c) be in continuous practice as defined in Section 800.3;

(d) file with the department a completed department-approved application form bearing the applicant’s signature in ink, or an electronic application approved by the department;

(e) submit the completed application, through the EMS agency, for recertification postmarked at least 45 days, but not more than 9 months, prior to their current certification expiration date;

(f) if the applicant has been convicted of one or more criminal offenses, be found eligible after a balancing of the factors set out in Article 23-A of Corrections Law. In accordance with that Article, no recertification shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and the duties required of this certification or (ii) recertifying the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the agency will look at the eight factors listed under New York State Corrections Law Section 753; and

(g) not have been found guilty or in violation, in any jurisdiction, of any other non-criminal offense or statutory and/or regulatory violation, as those terms are defined in Section 800.3 of this Part, relating to patient safety unless the department determines such applicant would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.10 - Reexaminations - applicants for recertification

800.10 Reexaminations - applicants for recertification. (a) Candidates who have failed the practical skills examination must complete a refresher or original certification course for the level of certification sought prior to being admitted to another practical skills examination at the same level of certification. Such candidates may be admitted once to a practical skills examination at a lower level of certification within one year after the last attempt at the level of certification originally sought.

(b) Candidates who have failed the written certification exam after two attempts must complete a refresher or original certification course for the level of certification sought prior to being admitted to another written certification exam at the same level of certification. Such candidates may be admitted once to a written certification examination at a lower level of certification within one year after the last attempt at the level of certification initially sought.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.11 - Advanced emergency medical technician certification

800.11 Advanced emergency medical technician certification. (a) A candidate, to qualify for initial certification at any level above emergency medical technician-defibrillation, in addition to meeting the requirements set forth in section 800.6 of this Part, shall:

(1) have current certification as an emergency medical technician-basic at the time of the written certification examination; and

(2) submit documentation of satisfactory completion of an internship approved by the course sponsor for any course for which an internship is described in the curriculum.

(b) No person certified pursuant to these regulations or required to be certified (see Article 30 of the Public Health Law) shall practice above the level of emergency medical technician-basic except as part of an advanced life support system.
 

Effective Date: 
Wednesday, November 8, 1995
Doc Status: 
Complete

Section 800.12 - Reciprocal certification requirements

800.12 Reciprocal certification requirements. (a) To qualify for New York State certification based on out-of-state emergency medical responder, emergency medical technician, advanced emergency medical technician, emergency medical technician-critical care, emergency medical technician-paramedic, emergency medical services instructor certification or emergency medical services training credentials, a person must be currently certified or licensed by another state, the United States Military, or the National Registry of Emergency Medical Technicians, based on an out-of-state training program. The out-of-state training must be equivalent to or more stringent than New York State training and examination requirements.

(b) The applicant must:

(1) demonstrate a need for certification, such as New York State residence or employment opportunity;

(2) have successfully completed a course that meets or exceeds a curriculum based on the current department EMS certification guidelines;

(3) have successfully completed

(i) an out-of-state recognized or National Registry of Emergency Medical Technicians practical skills and written examination within 18 months of the date the application is received by the department; or

(ii) if a member or veteran of the United States Military, an approved medical training program from the Army, Navy, Air Force, Marines or Coast Guard that meets or exceeds current national emergency medical services education guidelines within three (3) years of the date the application is received by the department;

(4) submit a complete application for reciprocal certification on forms provided by the department;

(5) submit the filing fee of $25 for emergency medical responder or emergency medical technician certification or $50 for all other level of certification;

(6) if the applicant has been convicted of one or more criminal offenses, as defined in section 800.3(ak) of this part, be found eligible after a balancing of the factors set out in Article 23-A of the Correction Law. In accordance with that Article, no application for a license shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of this certificate or (ii) certifying the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the department will look at all factors listed under New York State Correction Law Section 753;

(7) not have been found guilty or in violation, in any jurisdiction, of any other non-criminal offense or statutory and/or regulatory violation, as those terms are defined in section 800.3 of this Part, relating to patient safety unless the department determines such applicant would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public; and

(8) be at least eighteen years of age.
 

Effective Date: 
Wednesday, July 6, 2016
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 3002

Section 800.13 - Certification

800.13 Certification. The department: (a) shall grant reciprocal certification to any qualified person with out-of-state certification or licensure, provided that there are no outstanding violations or charges of violations of the rules or laws governing emergency medical services in the state(s) in which the person holds certification or licensure.

(1) Such certification shall expire on the same date as the applicant's out-of-state certification, except that such certification shall be for no more than three years.

(2) Candidates who are required to pass both the written and practical skills examinations as part of this process shall have the expiration of their certifications determined by section 800.17.

(b) May require the candidate to pass the written or practical skills examinations in order to determine the equivalency of training; and

(c) Shall keep the processing fee, even if the application for certification is denied.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.14 - Emergency medical technicians certified by states bordering New York

800.14 Emergency medical technicians certified by states bordering New York. Emergency medical technicians certified by Vermont, Massachusetts, Connecticut, New Jersey, or Pennsylvania may practice in New York State without New York State certification, while (a) transferring a patient across the border between New York State and the certifying state or (b) providing emergency medical care in New York State pursuant to a mutual aid agreement with a New York State-certified or registered ambulance service. The mutual aid agreement must be in writing, signed by an authorized officer of both ambulance services, and must delineate the protocols to be adhered to by the out-of-state emergency medical technicians and shall be on file with the department.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.15 - Required conduct

800.15 Required conduct. Every person certified at any level pursuant to this Part or Article 30 of the Public Health Law shall:

(a) comply with prehospital practice standards, applicable for the geographic region of the State in which the individual is practicing, as established by:

(1) State-approved training curricula and State-approved training standards, in accordance with section 800.20 of this Part;

(2) State-approved protocols developed by State and/or Regional Medical Advisory Committees pursuant to sections 3002-a and 3004-a of the Public Health Law; and

(3) Scope of Practice as defined in Section 800.3; and

(b) maintain, at all times, the confidentiality of any and all patient information to which the certificate holder has access concerning patients alive or deceased, including, but not limited to, patient names, conditions, treatments, descriptions, communications, images or other identifying features, irrespective of whether the patient’s name is included, which may be transmitted by electronic or other media, except:

(1) when a certificate holder is acting as part of an organized pre-hospital emergency medical service, the certificate holder responsible for patient care shall accurately complete a pre-hospital care report in a department-approved format for each patient with whom the certificate holder makes patient contact, and shall provide a copy to the hospital receiving the patient and/or to the department’s authorized agent for use in the State’s quality assurance program; or

(2) when authorized by the patient and/or the patient’s representative, the certificate holder may reveal patient information to the extent necessary to collect insurance payments due; or

(3) when and to the extent otherwise authorized by law; and

(c) comply with the terms of a Medical Order of Life Sustaining Treatment (MOLST), as defined by Article 29-CC of the Public Health Law, form or a non-hospital Do Not Resuscitate (DNR) form, when the patient, family, or other caretaker or person on the scene provides such an order issued on a standard department-issued form, or, when the patient is wearing on his/her person a department-developed DNR bracelet or necklace identifying the patient as one for whom a non-hospital DNR order has been issued, with the following exceptions:

(1) emergency medical services personnel may disregard a non-hospital Do Not Resuscitate (DNR) order as defined by Article 29-B of the Public Health Law, when:

(i) possessed of a good faith belief that the order has been revoked or that the order has been canceled; or

(ii) family members or others on the scene, excluding emergency medical services personnel, object to the order and a physical confrontation appears likely; and

(2) Hospital emergency service physicians may direct emergency medical services personnel to disregard a non-hospital Do Not Resuscitate (DNR) order if other significant and exceptional medical circumstances warrant disregarding the order; and

(d) not be subjected to criminal prosecution or civil liability, or be deemed to have engaged in unprofessional conduct, for honoring reasonably and in good faith pursuant to subdivision (c) of this section, a non-hospital order not to resuscitate (non-hospital DNR), for disregarding such order pursuant to paragraph (1) or (2) of subdivision (c) of this section, or for other actions reasonably taken in good faith pursuant to subdivision (c) of this section.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.16 - Suspension or revocation of certification

800.16 Suspension or revocation of certification.

(a) Any certification issued pursuant to this Part or Article 30 of the Public Health Law may be suspended for a fixed period, revoked or annulled, and the certificate holder may be censured, reprimanded, or fined in accordance with section 12 of the Public Health Law, after a hearing conducted pursuant to section 12-a of the Public Health Law, if the department finds that the certificate holder:

(1) has failed to comply with the requirements of Section 800.15 of this Part;

(2) has been negligent in the performance of his/her EMS duties and practice, as negligence is defined in Section 800.3 of this Part;

(3) has been incompetent in the performance of his/her EMS duties and practice, as incompetence is defined in Section 800.3 of this Part;

(4) has abused a patient, as patient abuse is defined in Section 800.3 of this Part;

(5) has been convicted of one or more criminal offenses, as that term is defined in § 800.3(ak) of this Part, unless, in accordance with Article 23-A of the Corrections Law, the department determines, that (i) there is not a direct relationship between one or more of the criminal offenses and the duties required of this certificate or (ii) allowing the certificate holder to retain his/her certificate would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the agency will look at the eight factors listed under New York State Correctional Law Section 753;

(6) has been found guilty, in any jurisdiction, of any non-criminal offense or statutory and/or regulatory violation, as those terms are defined in Section 800.3 of this Part, relating to patient safety and/or has had any other professional license and/or certification suspended and/or revoked in any jurisdiction, unless the Department determines such certificate holder would not involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public;

(7) has procured, or has attempted to procure, his/her certification or re-certification through any form of fraud or deceit, including, but not limited to, the intentional false representation or misrepresentation, either expressly or by omission, on his/her application for emergency medical services certification or re-certification, of information pertaining to prior convictions, offenses, regulatory violations and actions against other professional licenses and certification held by the certificate holder or having received certification without having completed all the specified requirements;

(8) has responded to a call, provided patient care, or driven an ambulance or other emergency medical response vehicle while under the influence of alcohol or any other drug or substance which has affected the certificate holder’s physical coordination or intellectual functions;

(9) has falsified a patient record and/or misrepresented and/or concealed pertinent information during a patient care investigation, including, but not limited to making deliberate omissions of material fact;

(10) has misappropriated any money or any property from any source during the course of any EMS duty and/or practice, irrespective of whether such misappropriation is prosecuted as a crime;

(11) has abandoned a patient, as patient abandonment is defined in Section 800.3 of this Part;

(12) has knowingly aided or abetted another in practice as an emergency medical technician who is not certified as such;

(13) has held him/herself out as being certified at a higher level than actually certified, or has exceeded his/her authorized scope of practice, as that term is defined in Section 800.3 of this Part; or

(14) has procured certification or recertification without having met the requirements of Sections 800.6, 800.8, or 800.9 of this Part, or Article 30 of the Public Health Law, as applicable.

(b) Notwithstanding subdivision (a), the Commissioner may summarily suspend any certification issued pursuant to this Part 800 or Article 30 of the Public Health Law in accordance with the summary action provisions of Public Health Law Section 16 and State Administrative Procedure Act Section 401.

Effective Date: 
Wednesday, May 6, 2015
Doc Status: 
Complete

Section 800.17 - Period of certification

800.17 Period of certification. (a) Expiration of initial certification. A candidate's initial certification shall expire at 11:59 p.m. on the last day of the month 37 months following the month in which the candidate passed the written certification examination.

(b) Expiration of subsequent certifications.

(1) A candidate who completes the requirements of section 800.8 during the last nine months of his or her certification shall have his or her certification extended for an additional thirty-six months;

(2) The certification of a candidate who completes the requirements of section 800.8 at any other time while certified shall expire at 11:59 p.m. on the last day of the month 37 months following the month in which the candidate passed the written certification examination.

(3) The certification of a candidate who recertifies pursuant to section 800.18 shall expire at 11:59 p.m. on the last day of the month 37 months following the month in which the candidate passes the written certification examination.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.18 - Lapsed certification

800.18 Lapsed certification. (a) During the twelve months immediately following the expiration of certification, a candidate may recertify by meeting the requirements of section 800.8.

(b) After the first day of the thirteenth month immediately following the expiration of certification, a candidate may recertify by completing the requirements of section 800.8 and by successfully completing a refresher course and corresponding practical skills and written certification examinations at or below the level at which certification was held.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.19 - Demonstration projects

800.19 Demonstration projects. (a) Purpose. The state emergency medical services council may authorize, after review by the appropriate regional emergency medical services council and subject to the approval of the commissioner, demonstration projects of a limited duration for the purpose of demonstrating either:

(1) new skills not currently practiced by CFRs, EMTs or AEMTs, or

(2) the appropriateness of moving a skill to another level.

(b) Requirements of demonstration projects.

(1) The commissioner shall specify the duration of the project and the requirements for evaluation of the project.

(2) The State Emergency Medical Services Council shall recommend the training requirements for each project, including the knowledge and skill objectives, subject to the approval of the commissioner.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.20 - Course sponsors

800.20 Course Sponsors.

(a) Approval of course sponsors.

(1) When applying for original approval or re-approval, every course sponsor shall file a completed application on a form provided by the Department.

(2) Approval of a course sponsor shall be for no more than two years. Approvals shall expire on July 1. One half the approvals of sponsors conducting courses on the effective date of this part shall expire on the next succeeding July 1 and the other half shall expire on the second succeeding July 1.

(3) Original and renewal sponsorship applications shall be reviewed by the appropriate regional emergency medical services council, which shall forward its recommendation to the department within 45 days of receiving the application. If the regional council is a course sponsor, it shall consider only the capability of the sponsor to meet the requirements of this part. If the regional council is not a course sponsor, it may also consider the size of the potential student pool and the impact of an additional sponsor on the ability of existing sponsors to sustain a student body of adequate size. The department, when making a determination with regard to original and renewal sponsorship applications, shall consider the capability of the sponsor to meet the requirements of this part, the size of the potential student pool and the impact of an additional sponsor on the ability of existing sponsors to sustain a student body of adequate size.

(4) The application for approval shall include the names of all certified instructor coordinators and certified lab instructors who will be providing instructional services.

(b) Course planning. Each course sponsor shall on or before July 1 and January 1 of each year submit to the appropriate regional emergency medical services councils and the department a projected schedule of courses for the next six months, including the course type, tentative dates and locations, and proposed certified instructor coordinators.

(c) All course sponsors shall meet the following requirements:

(1) Administration. Course sponsors shall comply with the following administrative requirements:

(i) The course sponsor shall file applications for courses by the deadline included in a schedule supplied by the Department;

(ii) The course sponsor shall not admit students who do not meet the age requirements for certification in accordance with this Part, or who do not meet the requirements for entry into a refresher course (i.e., previous completion of an original course);

(iii) The course sponsor shall submit student applications, in accordance with a schedule supplied by the department;

(iv) The course sponsor shall certify to the department those students who have met the requirements of the curriculum approved by the department and the State Emergency Medical Services Council.

(2) Equipment and Supplies. Supplies and equipment adequate for the provision of instruction shall be available consistent with the curriculum and sufficient for the number of students enrolled.

(3) Instructional Faculty. Every course except continuing education courses shall have a Certified Instructor Coordinator. Each continuing education course shall be conducted by faculty who have completed an instructor training course, conducted by the Department, for that specific course. The lab faculty of all courses except continuing education courses shall include one or more certified laboratory instructors.

(4) Admission Policies and Procedures. Admission of students shall be made in accordance with clearly defined and published policies of the course sponsor, which shall be available to the department on request. Specific academic, health related, and technical requirements for admission shall also be clearly defined and published. The standards and prerequisites for admission shall be made known to all individuals expressing an interest in enrollment.

(5) Curricula. The minimum curricula for courses are listed below. A course sponsor offering a particular course must adhere to the minimum curriculum specified for that course. The course sponsor may exceed the minimum instructional hours (consistent with the needs of students) and minimum content as long as the course does not exceed the scope of practice for the certification level.

(i) The following course curricula, which pertain to the courses specified and which are contained in the publications listed below, are hereby incorporated by reference with the same force and effect as if set forth at length herein. The publications are available for public inspection and copying at the Records Access Office, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New York 12237. Copies are also available from the publishers, Health Education Services, P.O. Box 7126, Albany, New York 12224. (a) Certified First Responder (original course) Certified First Responder Course Curriculum: Course Guide, Instructor Lesson Plans (August 1991)

(b) Certified First Responder (refresher course) Certified First Responder Refresher Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (1989)

(c) Emergency Medical Technician (original course)

(1) Instructor's Lesson Plan For Emergency Medical Technicians (Basic) (Revised June 1985) (Appendices dated April 1989 and July 1989).

(2) The Expanded Primary Assessment/Resuscitation: Standard Curriculum (1989)

(3) Instructor's Slide Script: Hazardous Materials, Lesson #22, Section #2 (First Edition)

(d) Emergency Medical Technician (refresher course) Certified Emergency Medical Technician - Refresher Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (1990)

(e) Emergency Medical Technician - Defibrillation (original course) Emergency Medical Technician - Defibrillation: Course Content and Outline (Automatic/Semi-automatic Only) (January 1991)

(f) Emergency Medical Technician - Intermediate (original course). Certified Emergency Medical Technician - Intermediate EMT - 1 Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (April 1989)

(g) Emergency Medical Technician - Intermediate (refresher course). Certified Emergency Medical Technician - Intermediate EMT - 1 Refresher Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (November 1990)

(h) Emergency Medical Technician - Critical Care (original course). Emergency Medical Technician - Critical Care Course Curriculum: Course Guide and Instructor's Content Outline (January 1992)

(i) Emergency Medical Technician - Critical Care (refresher course). Outline for Refresher Training For Advanced Emergency Medical Technicians Category 3 and Basic Emergency Medical Technician (July 1, 1981)

(j) Emergency Medical Technician - Paramedic (refresher course). Certified Emergency Medical Technician - Paramedic Refresher Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (November 1989)

(k) Critical Trauma Care (CTC) (continuing education course) Critical Trauma Care, "A Continuing Education Course for Basic EMT's": Instructor Outline (1987)

(l) Ambulance Accident Prevention Seminar (continuing education course). Ambulance Accident Prevention Seminar, "A Continuing Education Course for EMT's": Instructor Outline (1989)

(m) Combined EMT refresher/CTC (continuing education course)

(1) Certified Emergency Medical Technician - Refresher Course Curriculum: Standard Course Guide and Instructor's Lesson Plans (1990)

(2) Critical Trauma Care, "A Continuing Education Course for Basic EMT's": Instructor Outline (February 1987)

(n) Certified Instructor Coordinator Certified Instructor Coordinator Course: Standard Curriculum (1989)

(o) Certified Lab Instructor Certified Lab Instructor Course: Standard Curriculum (1989)

(p) Certified Instructor Upstate Certified Instructor Update: Regional Faculty Manual (1990/1991)

(q) Prehospital Pediatric Care Course (continuing education course) Prehospital Pediatric Care Course, "A continuing Education Course For EMT's": Instructor Outline (1990)

(r) EMS Dispatcher Course (continuing education course) Emergency Medical Services Dispatcher: National Standard Curriculum: Standard Course Guide and Instructor's Lesson Plans (Second Edition 1983)

(s) Crash Victim Extrication (continuing education course) Crash Victim Extriction Training Course, Emergency Medical Technician: Instructor's Manual (Revised April 1979)

(t) Emergency Vehicle Operator

(1)Training Program for Operation of Emergency Vehicles: Course Guide (1978)

(2) Training program for Operation of Emergency Vehicles: Instructor's Lesson Plans (1978)

(u) Infection Control Workshop (continuing education course) Protecting Yourself From AIDS and Other Infectious Diseases: Instructor Guide (June, 1991)

(ii) The following course curricula, which pertain to the courses specified and which are contained in the publications listed below, are hereby incorporated by reference with the same force and effect as if set forth at length herein. The publications are available for public inspection and copying at the Records Access Office, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New York 12237. Copies are also available from the publisher, Association for Medical Emergency Information, Inc., 21155 Woodfield Road, Gaithersburg, Md. 20882. (a) Emergency Medical Technician - Paramedic (original course)

(1) Emergency Medical Technician - Paramedic: National Standard Curriculum: Course Guide (1985)

(2) Emergency Medical Technical - Paramedic: National Standard Curriculum: Instructor's Lesson Plans (1985)

(6) Evaluation. Evaluation of students shall be conducted on a recurring basis and with sufficient frequency to provide the student, course medical director and certified instructor coordinator with valid and timely indicators of the student's progress toward and the achievement of the competencies and objectives stated in the curriculum. In order to ensure effectiveness of student evaluation, the test instruments and evaluation methods shall undergo at least annual review. When appropriate, reviews shall result in the update, revision, or formulation of more effective test instruments or evaluation methods. The reviewers shall include at least a certified instructor coordinator.

(7) Identification. Students at clinical or internship sites shall be clearly identified by name and student status, using nameplate, uniform, or other apparent means to distinguish them from other personnel.

(8) Fair Operational Practices. Announcements and advertising shall accurately reflect the program offered. Student and faculty recruitment, student admission, and faculty employment practices shall be non-discriminatory with respect to race, color, creed, sex, age and national origin. The course sponsor shall have written policies which shall be approved by the department as being consistent with the curriculum, equitable in their treatment of students and in compliance with the requirements of this Part. Such policies shall be issued to all students at the first course session or earlier covering each of the following subjects:

(i) course goals and objectives,

(ii) interim testing requirements and pass/fail criteria,

(iii) interim exam retesting,

(iv) attendance requirements and make-up procedure,

(v) requirements regarding personal conduct and ethics,

(vi) emergency class cancellation procedure,

(vii) course termination/expulsion and appeal procedure,

(viii) textbooks required,

(ix) tuition refund schedule, and

(x) a student-course sponsor learning contract for all refresher courses.

(9) Record keeping.

(i) The course sponsor shall maintain for a period of at least five years, files which contain the following documentation on individual students. There shall be a system for accessing individual information.

(a) individual attendance record,

(b) signed student-course sponsor learning contract if applicable,

(c) interim examination results,

(d) practical skills examination sheets, and

(e) clinical experience documentation and field internship experience documentation which show the student achieved the objectives of the clinical and field internship experiences and who evaluated the student's performance.

(ii) The course sponsor shall maintain on file for a period of at least five (5) years individual course files which shall contain the following documentation:

(a) for state funded courses, financial records showing all sources of funding and all expenditures for each course,

(b) a list of the names of each faculty member,

(c) the certification exam grades and other documentation received from the department pertaining to each individual course,

(d) a copy of each interim examination administered, or a record of where it can be found and

(e) a copy of the course application, schedule and course approval from the department.

(iii) The course sponsor shall maintain the names, last known addresses, business telephone numbers, and qualifications of all faculty. This information shall be maintained on file for the duration of the faculty member's working association with the sponsor plus 5 years.

(10) Sponsor's Medical Director. Each course sponsor shall have a physician medical director, who shall be responsible for assuring the medical accuracy and medical appropriateness of the educational program and supervising all advanced life support course clinical and internship programs. The sponsor's medical director may delegate the medical direction of a specific course to another physician, provided that the department is notified in writing at least thirty days prior to the start of the course.

(11) Practical Skills Examinations. The course sponsor shall follow the administrative procedures issued by the department for conducting the practical skills examination.

(d) The following requirements apply to advanced life support course sponsors and accredited paramedic course sponsors: (1) Clinical Resources. Clinical affiliations shall be established and confirmed in written affiliation agreements with institutions and agencies that provide clinical experience under appropriate medical direction and clinical supervision. Students shall have access to patients who present common problems encountered in the delivery of advanced emergency care so that the students may meet the clinical objectives. Supervision in the clinical setting shall be provided by program instructors or hospital personnel, such as nurses or physicians, if they have been approved by the program to function in such roles. The ratio of instructors to students in the clinical facilities shall be no greater than 1:6.

(2) Fair Operational Practices. Each sponsor shall have written policies which shall be approved by the department as being consistent with the curriculum, equitable in their treatment of students and in compliance with the requirements of this Part. Such policies shall be issued to all students at the first course session, or earlier, covering each of the following subjects:

(i) clinical experience requirements and objectives,

(ii) field internship experience requirements and objectives.

(3) Evaluation. The annual review of test instruments and evaluation methods shall be conducted by the sponsor's medical director and one or more certified instructor coordinators.

Effective Date: 
Wednesday, December 30, 1992
Doc Status: 
Complete

CERTIFIED AMBULANCE SERVICES

Section 800.21 - General requirements

CERTIFIED AMBULANCE SERVICES

800.21 General requirements. An ambulance service shall:

(a) have a valid Department of Health certificate of inspection and Department of Motor Vehicles certificate of inspection on each vehicle at all times while it is in service;

(b) withdraw from service any ambulance or emergency ambulance service vehicle which is not in compliance with requirements of this part, or not in compliance with requirements of the Department of Motor Vehicles. Any vehicle with holes (from rust, poor gaskets, etc.) into the patient compartment must also be withdrawn from service;

(c) notify the department in writing when any ambulance or emergency ambulance service vehicle is permanently removed from service. Such vehicles must have removed all departmental certification stickers and logos;

(d) display an out-of-service sticker supplied by the department on any vehicle taken temporarily out of service in accordance with the departmental procedures currently in effect;

(e) display on the exterior of both sides and the back of all ambulances and emergency ambulance service vehicles the name of the service in letters not less than 3 inches in height and clearly legible. The logo provided by the department shall also be displayed on both sides and the back of every ambulance and shall be removed upon sale or transfer of the vehicle;

(f) maintain an ambulance which shall conform to the standards set forth in this Part;

(g) equip any ambulance or emergency ambulance service vehicle placed in service with the minimum equipment set forth in this Part;

(h) have on each call at least one attendant who is a certified emergency medical technician in attendance with the patient at all times except for transfers between hospitals. Another licensed health care provider specifically authorized in writing by a physician may serve as the patient care attendant on transfers between hospitals. The ambulance service shall maintain the physician's order for three years. A licensed driver shall drive the ambulance;

(i) transport all patients in the patient compartment except in extenuating circumstances documented on the record of the call;

(j) make available for inspection, with or without notice, to representatives of the department all vehicles, materials, equipment, personnel records, procedures, and facilities;

(k) maintain current and accurate personnel files for all drivers, certified first responders, emergency medical technicians, and advanced emergency medical technicians, showing qualifications, training and certifications, and health records, including immunization status. Employee health records shall be maintained separately and in compliance with all applicable requirements. Information contained in such personnel files shall be reviewed annually, and may be disclosed only to authorized individuals. Training records must include at a minimum:

(1) copies of state issued certifications;

(2) all records of additional or specialized training; and

(3) all records or any in-service and continuing education programs.

(l) maintain a record of each ambulance call in accordance with the provisions of section 800.32 of this Part;

(m) maintain adequate and safe storage facilities for equipment, clean supplies and linen, soiled linen and waste at the place where the ambulance is based;

(n) maintain the interior of the vehicles and equipment in a clean and sanitary condition;

(o) operate only within its primary territory except:

(1) when receiving a patient which it initially delivered to a facility outside its primary territory; or

(2) in response to a request for mutual aid from another certified or registered ambulance service; or

(3) in response to a mutual aid plan implemented by a central dispatch agency on behalf of a certified or registered ambulance service or on behalf of a county or city emergency management office; or

(4) if a voluntary service, when transporting a patient who is a resident of the primary operating territory; or

(5) by approval of the department or the appropriate regional emergency medical services council for up to 60 days if the expansion of territory is necessary to meet an emergency need.

(p) have and enforce written policies concerning:

(1) mutual aid, including any required authorizations and agreements, to request the response of the nearest, appropriate, available EMS service(s). The written plan shall consider the incident location and access to it, location of the mutual aid agency, primary service territory, authorized level of service, staff availability and any other pertinent information when identifying the mutual aid agency;

(2) coverage of the ambulance service's response area when it is unable to respond to emergency calls for assistance;

(3) the maximum call receipt interval for all emergency calls for assistance, except for MCI or disaster situations; (4) actions to be taken if the maximum call receipt interval determined in (3) is exceeded and an ambulance has not yet started toward the incident location;

(5) authorization and protocols for a central dispatch agency to send a mutual aid service when the service does not or cannot respond;

(6) minimum qualifications and job descriptions for all patient care providers, drivers and EMS dispatchers;

(7) physical, health and immunization requirements for all patient care providers and drivers, including provisions for biennial review and updating of such requirements;

(8) preventive maintenance requirements for all authorized EMS response vehicles and patient care equipment;

(9) cleaning and decontamination of authorized EMS response vehicles and equipment;

(10) equipping and inspection of all authorized EMS response vehicles;

(11) reporting by the agency of suspected:

(i) crimes;

(ii) child abuse;

(iii) patient abuse; and/or

(iv) domestic violence, including any directed toward elderly persons;

(12) responsibilities of patient care providers when:

(i) a patient cannot be located;

(ii) entry can not be gained to the scene of an incident;

(iii) a patient judged to be in need of medical assistance refuses treatment and/or transportation;

(iv) patients seek transportation to a hospital outside the area in which the service ordinarily transports patients;

(v) a receiving hospital requests that a patient be transported to another facility before arrival at the hospital;

(vi) treating minors;

(vii) treating or transporting patients with reported psychiatric problems; and/or

(viii) confronted with an unattended death.

(13) infection control practices and a system for reporting, managing and tracking exposures and ensuring the confidentiality of all information that is in compliance with all applicable requirements;

(14) by July 1, 1995 have a response plan for hazardous material incidents. Participation in a county or regional plan will meet this requirement;

(15) by July 1, 1996 have a response plan for multiple casualty incidents. Participation in a county or regional MCI plan will meet this requirement.

(q) upon discovery by or report to the governing authority of the ambulance service, report to the Department's Area Office by telephone no later than the following business day and in writing within 5 working days every instance in which:

(1) a patient dies, is injured or otherwise harmed due to actions of commission or omission by a member of the ambulance service;

(2) an EMS response vehicle operated by the service is involved in a motor vehicle crash in which a patient, member of the crew or other person is killed or injured to the extent requiring hospitalization or care by a physician;

(3) any member of the ambulance service is killed or injured to the extent requiring hospitalization or care by a physician while on duty;

(4) patient care equipment fails while in use, causing patient harm;

(5) it is alleged that any member of the ambulance service has responded to an incident or treated a patient while under the influence of alcohol or drugs while on duty.

(r) on or in a form approved by the department, maintain a record of all unexpected authorized EMS response vehicle and patient care equipment failures that could have resulted in harm to a patient and the corrective actions taken. A copy of this record shall be submitted to the department with the EMS service's biennial recertification application.
 

Effective Date: 
Wednesday, November 8, 1995
Doc Status: 
Complete

Section 800.22 - Requirements for certified ambulance vehicle construction

800.22 Requirements for certified ambulance vehicle construction. All ambulances shall:

(a) have the following headroom:

(1) if placed in-service after January 1, 1980 have a minimum of 54 inches headroom in the patient compartment measured from floor to ceiling, or

(2) if placed in-service on or before January 1, 1980, have a minimum of 48 inches headroom in the patient compartment, measured from floor to ceiling;

(b) have a clear interior width to accommodate two recumbent patients with adequate room for an attendant to provide patient care;

(c) have a patient compartment, longer at the head and foot than the patient-carrying device, and must have adequate space to allow an attendant to work at the head of the patient;

(d) have seat belts on all seats in the driver's and patient compartments, including the squad bench;

(e) have two-way voice communication equipment to provide communication with hospital emergency departments directly or through a dispatcher, throughout the duration of an ambulance call within their primary operating area. It shall be licensed by the Federal Communications Commission in other than the Citizens Band. Alternate communication systems are subject to approval of the department as being equivalent in capability.

(f) have a curbside door large enough to allow for removal of a recumbent patient on a stretcher or cot;

(g) have all ambulances built after July 1, 1990, equipped with a heating, ventilation and air conditioning system which maintains the patient compartment at approximately 75 degrees Fahrenheit regardless of outside temperature; and

(h) have all cots and devices used to transport patients secured while in motion. Such capability shall be demonstrated to the department upon inspection. These shall be crash resistant.
 

Effective Date: 
Wednesday, January 15, 1992
Doc Status: 
Complete

Section 800.23 - General requirements related to equipment

800.23 General requirements related to equipment.

(a) All equipment shall be clean, sanitary and operable.

(b) The emergency medical technician must be able to operate all equipment on board the ambulance or emergency ambulance service vehicle within the scope of his/her certification.

(c) Any volume of liquid in excess of 249 milliliters stored in the ambulance must be in plastic containers.

(d) Insofar as practical, all equipment in every vehicle shall be secured to the vehicle whenever the vehicle is in motion.

(e) All pressurized gas cylinders shall be secured and in compliance with Federal DOT hydrostatis test expiration dates.

(f) If controlled substances, drugs or needles are carried, there shall be a securely locked cabinet in which these items are stored when not in use.
 

Effective Date: 
Wednesday, January 15, 1992
Doc Status: 
Complete

Section 800.24 - Equipment requirements for certified ambulance service

800.24 Equipment requirements for certified ambulance service. All ambulances in a certified ambulance service shall be equipped with the following unless exempted pursuant to section 800.25:

(a) Patient transfer equipment consisting of:

(1) wheeled ambulance cot capable of supporting the patients in the Fowlers position;

(2) a device capable of carrying a second recumbent patient;

(3) a device enabling ambulance personnel to carry a sitting patient over stairways and through narrow spaces where a rigid litter cannot be used. The requirements of paragraphs (2) and (3) of this subdivision may be satisfied by use of one combination device capable of both operations;

(4) all litters and cots used to transport patients shall be secured using crash resistant fasteners. The ambulance shall be equipped with securing devices such that two patient carrying devices can be simultaneously secure; and

(5) ambulance cots and other patient carrying devices shall be equipped with at least two, two-inch wide web straps with fasteners to secure the patient to the device and the cot.

(b) Airway, ventilation, oxygen and suction equipment consisting of:

(1) a manually operated self-refilling adult-size bag valve mask ventilation device capable of operating with oxygen enrichment, and clear adult-size masks with air cushion;

(2) four oropharyngeal airways in adult sizes;

(3) portable oxygen with a minimum 350 liter capacity (medical "D" size) with pressure gauge, regulator and flow meter and one spare cylinder, medical "D" size or larger. The oxygen cylinders must contain a minimum of 1000 PSI pressure;

(4) an in-ambulance oxygen system with a minimum 1200 liter capacity (two medical "E" size) with yoke(s), or CDC fitting, pressure gauges, regulators and flow meters capable of delivering oxygen to two patients at two different flow rates of up to 15 liters per minute simultaneously.

(5) four each, non-rebreather oxygen masks, and four nasal cannulae;

(6) portable suction equipment capable, according to the manufacturer's specifications, of producing a vacuum of over 300 millimeters of mercury when the suction tube is clamped. This will meet the 800.24(b)(7) requirement if equipped to operate off the ambulance electrical system;

(7) installed adjustable suction capable of producing a vacuum of over 300 millimeters of mercury when tube is clamped; and

(8) two plastic Yankauer-type wide bore pharyngeal tips individually wrapped.

(c) Immobilization equipment consisting of:

(1) one full size (at least 72 inches long and 16 inches wide) backboard with necessary straps capable of immobilizing the spine of a recumbent patient;

(2) one half length spinal immobilization device with necessary straps capable of immobilizing the spine of a sitting patient;

(3) one traction splinting device for the lower extremity; and

(4) two of each of the following size padded boards, with padding at least 3/8 inches thick:

(i) 4 1/2 feet by 3 inches

(ii) 3 feet by 3 inches or equivalent device

(iii) 15 inches by 3 inches or equivalent device

(5) one set of rigid extrication collars capable of limiting movement of the cervical spine. The set shall include large, medium and small adult-size rigid extrication collars which permit access to the patient's anterior neck; and

(6) a device or devices capable of immobilizing the head of a patient who is secured to a long backboard.

(d) Bandaging and dressing supplies consisting of:

(1) twenty-four sterile gauze pads 4 inches by 4 inches;

(2) three rolls of adhesive tape in two or more sizes;

(3) ten rolls of conforming gauze bandages in two or more sizes;

(4) two sterile universal dressings approximately 10 inches by 30 inches;

(5) ten large sterile dressings 5 inches by 9 inches minimum;

(6) one pair bandage shears;

(7) two sterile bed-size burn sheets;

(8) six triangular bandages;

(9) one liter of sterile normal saline in plastic container(s) within the manufacturer's expiration date; and

(10) roll of plastic or aluminum foil or equivalent sterile occlusive dressing.

(e) Emergency childbirth supplies in a kit, consisting of the following sterile supplies:

(1) disposable gloves;

(2) scissors or scapel;

(3) umbilical clamps or tape;

(4) bulb syringe;

(5) drapes; and

(6) 1 individually wrapped sanitary napkin.

(f) Miscellaneous and special equipment in clean and sanitary condition consisting of:

(1) linen and pillow on wheeled ambulance cot and spare pillow, two sheets, two pillow cases, and two blankets;

(2) four cloth towels;

(3) one box facial tissues;

(4) two emesis containers;

(5) one adult-size blood pressure cuff with gauge;

(6) stethoscope;

(7) carrying case for essential emergency care equipment and supplies; (8) four chemical cold packs;

(9) one male urinal;

(10) one bed pan;

(11) two sets masks and goggles or equivalent;

(12) two pair disposable rubber or plastic gloves;

(13) one liquid glucose or equivalent;

(14) six sanitary napkins individually wrapped; and

(15) one pen light or flashlight.

(g) Safety equipment consisting of:

(1) six flares or three U.S. Department of Transportation approved reflective road triangles;

(2) one battery lantern in operable condition; and

(3) one Underwriters' Laboratory rated five pound U.L.-rated ABC chemical fire extinguisher or any extinguisher having a U.L. rating of 10BC.

(h) Pediatric equipment consisting of:

(1) pediatric bag valve mask, equipped with oxygen reservoir system;

(2) clear face masks in newborn, infant and child sizes, inflatable rim (or mask with minimal under-mask volume) to fit above;

(3) two each nasal cannula, and two each oxygen masks including non-rebreather in the pediatric size;

(4) two each oropharyngeal newborn, infant and child size airways;

(5) sterile suction catheters, two each in sizes 5, 8 and 10 french;

(6) two sterile DeLee type suction catheters #10 or modified suction traps, or two small bulb syringes;

(7) one sterile single-use disposable oxygen humidification setup;

(8) child and infant size blood pressure cuffs with gauge(s);

(9) one rigid extrication collar in pediatric size;

(10) one pediatric stethoscope (interchangeable type acceptable);

(11) one commercially prepared infant swaddler.
 

Effective Date: 
Wednesday, January 15, 1992
Doc Status: 
Complete

Section 800.25 - Special use vehicles

800.25 Special use vehicles. A vehicle used exclusively for a special purpose, such as the transportation of neonates, may be authorized by the commissioner, pursuant to a written application by the service, to not carry specific items of equipment otherwise required by these regulations if the equipment is shown to be unnecessary for the special use proposed.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

Section 800.26 - Equipment requirements for emergency ambulance service vehicles other than an ambulance

800.26 Equipment requirements for emergency ambulance service vehicles other than an ambulance.

The governing authority of any ambulance service which, as a part of its response system, utilizes emergency ambulance service vehicles other than an ambulance to bring personnel and equipment to the scene, must have policies in effect for equipment, staffing, individual authorization, dispatch and response criteria, and maintain appropriate insurance coverage. (a) A waiver of the equipment requirements for emergency ambulance service vehicles may be granted by the Department when the service provides an acceptable plan to the Department demonstrating how appropriate staff, equipment and vehicles will respond to a call for emergency medical assistance. The affected Regional EMS Councils will be solicited for comment on the service's waiver request. (b) Any emergency ambulance service vehicle other than an ambulance shall be equipped and supplied with emergency care equipment consisting of:

(1) 12 sterile 4 inches x 4 inches gauze pads;

(2) adhesive tape, three rolls assorted sizes;

(3) six rolls conforming gauge bandage, assorted sizes;

(4) two universal dressings, minimum 10 inches x 30 inches;

(5) six 5 inches x 9 inches (minimum size) sterile dressings or equivalent;

(6) one pair of bandage shears;

(7) six triangular bandages;

(8) sterile normal saline in plastic container (1/2 liter minimum) within manufacturer's expiration date;

(9) one air occlusive dressing;

(10) one liquid glucose or equivalent;

(11) disposable sterile burn sheet;

(12) sterile obstetric kit;

(13) blood pressure sphygmomanometers cuff in adult and pediatric sizes and stethoscope;

(14) three rigid extrication collars capable of limiting movement of the cervical spine. These collars shall include small, medium and large adult sizes; and

(15) carrying case for essential equipment and supplies.

(c) Oxygen and resuscitation equipment consisting of:

(1) portable oxygen with a minimum 350 liter capacity with pressure gauge, regulator and flow meter medical "D" size or larger. The oxygen cylinder must contain a minimum of 1000 pounds per square inch; (2) manually operated self-refilling bag valve mask ventilation devices in pediatric and adult sizes with a system capable of operating with oxygen enrichment and clear adult, and clear pediatric-size masks with air cushion;

(3) four individually wrapped or boxed oropharyngeal airways in a range of sizes for pediatric and adult patients;

(4) two each: disposable non-rebreather oxygen masks, and disposable nasal cannula individually wrapped;

(5) portable suction equipment capable, according to the manufacturer's specifications, of producing a vacuum of over 300 m.m. Hg when the suction tube is clamped and including two plastic large bore rigid pharyngeal suction tips, individually wrapped; and

(6) pen light or flashlight.

(d) A two-way voice communications enabling direct communication with the agency dispatcher and the responding ambulance vehicle on frequencies other than citizens band.

(e) Safety equipment consisting of:

(1) six flares or three U.S. Department of Transportation approved reflective road triangles;

(2) one battery lantern in operable condition; and

(3) one Underwriters' Laboratory-rated five pound ABC fire extinguisher or any extinguisher having a UL rating of 10BC.

(f) Extrication equipment consisting of:

(1) one short backboard or equivalent capable of immobilizing the cervical spine of a seated patient. The short backboard shall have at least two 2 inches x 9 feet long web straps with fasteners unless straps are affixed to the device; and

(2) one blanket.

Effective Date: 
Wednesday, November 3, 2004
Doc Status: 
Complete

AIRCRAFT AND BOATS

Section 800.27 - Aircraft and boats

AIRCRAFT AND BOATS

800.27 Aircraft and boats. (a) Ambulance services desiring to operate aircraft and boats to transport emergency patients shall file with the commissioner all forms required of a certified ambulance service and will be governed by all sections of this Part referring to a certified ambulance service.

(b) When the condition of the mode of transport and the configuration of the aircraft or boat provides a hardship, a variance may be obtained from the regulations by petitioning the commissioner for said variance.
 

Effective Date: 
Wednesday, November 14, 1990
Doc Status: 
Complete

NONHOSPITAL ORDERS NOT TO RESUSCITATE

Section 800.90 - Non-hospital orders not to resuscitate

800.90 Non-hospital orders not to resuscitate. (a) A non-hospital order not to resuscitate shall consist of a form issued by the department bearing the name of the person to whom the order applies, that person's date of birth, the issuing physician's signature and a hand-printed or typewritten name and license number, and the date of issuance.

(b) A DNR bracelet shall consist of a piece of metal no less than 1.5 inches in length and no less than one-half inch in width with the symbol commonly referred to as the caduceus on the obverse and the words Do Not Resuscitate in letters of no less than 16 point size on the reverse. The ends of the piece of metal shall be linked to one another with material of sufficient strength as to be serviceable for ordinary use. A caduceus is a representation of a staff with one entwined snake and one wing at the top.

(c) DNR bracelets may be sold for use only by persons who have been issued a valid nonhospital order not to resuscitate.
 

Effective Date: 
Wednesday, March 24, 1993
Doc Status: 
Complete

Part 801 - Availability of Resuscitation Equipment in Certain Public Places

Effective Date: 
Wednesday, October 20, 2004
Doc Status: 
Complete

Section 801.1 - Definitions

801.1 Definitions. For the purposes of this Part, the following terms shall be defined as follows:

(a) “Accessible Area” means any area, which can be easily identified by, and is readily accessible to, patrons. “Accessible areas” may include but shall not be limited to the following: bar area, service counter area, host/hostess station, registration desk, and concession stand.

(b) “Bar” means any establishment which is devoted to the sale and service of alcoholic beverages for on-premises consumption and in which the service of food, if served at all, is incidental to the consumption of such beverages.

(c) “Health Club” means any commercial establishment offering instruction, training or assistance and/or the facilities for the preservation, maintenance, encouragement or development of physical fitness or well-being. “Health Club” as defined herein shall include, but not be limited to, health spas, health studios, gymnasiums, weight control studios, martial arts and self-defense schools or any other commercial establishment offering a similar course of physical training.

(d) “Owner or Operator” means the owner, manager, operator or other person having control of an establishment.

(e) “Package” means the sealed manufacturer-provided packaging containing an exhaled air resuscitation mask.

(f) “Public place” means a restaurant, bar, theater or health club.

(g) “Restaurant” means any commercial eating establishment with is devoted, wholly or in part, to the sale of food for on-premises consumption.

(h) “Resuscitation equipment” means:

(1) an adult exhaled air resuscitation mask, for which the Federal Food and Drug Administration has granted permission to market, accompanied by a pair of disposable gloves; and

(2) a pediatric exhaled air resuscitation mask, for which the Federal Food and Drug Administration has granted permission to market, accompanied by a pair of disposable gloves.

(i) “Suitable location” means any location where the resuscitation equipment is readily available to the public for use at all times.

(j) “Theater” means a motion picture theater, concert hall, auditorium or other building used for, or designed for. the primary purpose of exhibiting movies, stage dramas, musical recitals, dance or other similar performances.

Effective Date: 
Wednesday, October 20, 2004
Doc Status: 
Complete

Section 801.2 - Requirement

801.2 Requirement. The owner or operator of a public place as defined in section 801.1(a) of this Part shall have available, in an accessible area of such public place, resuscitation equipment sufficient to assure that patrons and/or staff can access it for use and bring it to the victim within 3 minutes of onset of an incident, and, in any event, no less than two (2) adult exhaled air resuscitation masks, two (2) pediatric exhaled air resuscitation masks, all in their original package, and four (4) pairs of disposable gloves. Exhaled air resuscitation masks and gloves shall be discarded after a single use and replaced within 96 hours.

Effective Date: 
Wednesday, October 20, 2004
Doc Status: 
Complete

Section 801.3 - Labeling Requirements

801.3 Labeling Requirements.

(a) The following written statement shall be stored with the resuscitation equipment or affixed to the envelope or container in which such equipment is stored:

IN THE EVENT OF AN EMERGENCY, REQUEST ASSISTANCE BY DIALING 911

DO NOT ATTEMPT TO USE UNLESS TRAINED IN CARDIOPULMONARY RESUSCITATION (CPR) AND IN THE USE OF EXHALED AIR RESUSCITATION MASKS

RESUSCITATION EQUIPMENT CONTENTS INCLUDE:

TWO ADULT EXHALED AIR RESUSCITATION MASKS

TWO CHILD EXHALED AIR RESUSCITATION MASKS

FOUR PAIRS DISPOSABLE GLOVES

DISCARD MASK AND GLOVES AFTER ONE USE

REPLACE EQUIPMENT AS INDICATED

(b) The written statement shall be presented in a manner which is readily visible. Lettering on the statement shall not be less than ½ inch in height.

Effective Date: 
Wednesday, October 20, 2004
Doc Status: 
Complete

Section 801.4 - Required Notice

801.4 Required Notice.

(a) The owner or operator of a public place shall provide clear and conspicuous notice to all patrons which indicates that resuscitation equipment for emergency use is available, its location, and information on how to receive cardiopulmonary resuscitation (CPR) training. This notice shall be in the form of a sign, or shall be included as part of an information brochure, as long as the owner or operator provides the opportunity for all patrons to read the notice upon entering or shortly after being seated, and to do so without incurring a monetary charge.

(b) The notice shall include the following statements:

(1) In the event of an emergency, call 911 or (insert name of the local Emergency Medical Services (EMS)) at (insert phone number of local EMS system).

(2) Resuscitation masks and disposable gloves are available at (insert

name of location(s) where resuscitation equipment is provided).

(3) Learn CPR. For information contact – (insert name(s) of

organization(s) qualified to offer CPR training, which may include but are not limited to the American Red Cross and American Heart Association).

(c) Lettering and Graphics. The lettering on signs or informational handouts shall be of sufficient size so that all information is clear, conspicuous, and easily read. Signs and informational handouts shall be printed on durable material with a light-colored background. The required information on signs and informational handouts shall be highly visible color, with lettering on signs a minimum of 5/16 inches in height, and the lettering on informational handouts a minimum of 1/16 inch in height.

Effective Date: 
Wednesday, October 20, 2004
Doc Status: 
Complete

Chapter VII - Life Care Communities

Effective Date: 
Thursday, July 12, 2001
Doc Status: 
Complete

Part 900 - Certificate of Authority

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4602(2)(g)

Section 900.1 - Definitions

Section 900.1 Definitions. For purposes of this Part, unless the context indicates otherwise, the following definitions shall apply:

(a) Adult care facility shall mean an adult home or an enriched housing program established pursuant to Article 7 of the Social Services Law which provides long-term residential care and services to adults who, though not requiring continual medical and nursing care as provided by facilities licensed or operated pursuant to article 28 of the Public Health Law or articles 19, 23, 29 and 31 of the Mental Hygiene Law, are, by reason of physical or other limitations associated with age, physical or mental disabilities or other factors, unable or substantially unable to live independently.

(b) Application fee shall mean a sum of money other than an entrance fee deposit or entrance fee collected from an individual upon application for admission to the community.

(c) Board shall mean the provision of meals consisting of food and drink appropriate for the physical needs and medical conditions of residents, including the provision of therapeutic diets appropriate for the individual resident.

(d) Certificate or certificate of authority shall mean an authorization in writing, approved by the Life Care Community Council and issued by the Commissioner of Health, for an operator to operate a life care community and to enter into life care contracts pertaining to such community.

(e) Commissioner shall mean the Commissioner of Health.

(f) Contracts or agreements shall mean life care contracts as defined in this section.

(g) Controlling person shall mean a person who, either directly or indirectly, or through one or more intermediaries, possesses the ability to direct or cause the direction of the actions, management or policies of a person, whether through the ownership of voting securities or voting rights, by contract (except a commercial contract for goods or non-management services) or otherwise; but no person shall be deemed to control another person solely by reason of his or her being a corporate officer or director of such other person (providing such officer or director is not acting in concert with others to represent another corporation). Control shall be presumed to exist if any person, directly or indirectly, owns, controls or holds with the power to vote ten percent or more of the voting securities or voting rights of any other person or is a member of a not-for-profit corporation which member is other than a natural person.

(h) Council shall mean the Life Care Community Council, established pursuant to Section 4602 of Article 46 of the Public Health Law.

(i) Entrance fee shall mean an initial or deferred transfer to an operator, as defined in this section, of a sum of money, made or promised to be made by an individual or individuals entering into a life care contract, for the purpose of ensuring services pursuant to such a contract.

(j) Facility shall mean any place in which an operator provides a resident with the services of a life care community, pursuant to a contract, whether such place is constructed, owned, leased, rented or otherwise contracted for by the operator.

(k) Home health care shall mean services and items provided to residents of the community in other than nursing home beds, either directly or through a contract arrangement. Such services shall be provided under a plan established and periodically reviewed by a physician and shall include, but not be limited to, part-time or intermittent nursing care by or under the supervision of a registered professional nurse (R.N.), physical therapy, occupational therapy, speech-language pathology, medical social services, medical supplies, equipment and appliances and home health aide services.

(l) Life care contract shall mean a single contract to provide an individual, for the duration of such individual's life, the services provided by the life care community. Payment for services provided under the life care contract can be made:

(1) fully through the entrance fee and monthly fees; or

(2) through the entrance fee, monthly fees and under an arrangement in which the costs of the resident's nursing facility and/or home health care services are paid for in whole or in part by long term care insurance or medical assistance payments in accordance with the Long Term Care Security Program for Long Term Care pursuant to section 367-f of the Social Services Law, section 3229 of the Insurance Law and section 4623 of the Public Health Law.

(m) Life care community or community shall mean a facility or facilities established to provide, pursuant to a life care contract, a comprehensive, cohesive living arrangement for the elderly, oriented to the enhancement of the quality of life and which at a minimum:

(1) provides independent living units;

(2) provides board including the availability of three meals per day, payment for which is subject to the terms specified in the life care contract; (3) provides a range of health care and social services, subject to such terms as may be included within the contract which shall include, but not be limited to home health care, nursing care, and the services of an on-site or affiliated nursing home;

(4) provides access to specialized rehabilitative services such as physical therapy, occupational therapy, speech-language pathology and audiology;

(5) provides access to physician services; and

(6) provides access to prescription drugs.

(n) Life care, health care and/or adult care operation shall mean:

(1) any community which requires or would require, if located in New York State, approval by the Life Care Community Council;

(2) any facility or program which requires or would require if located in New York State, establishment approval by the Public Health Council; or

(3) any facility or program which requires or would require if located in New York State, approval by the New York State Department of Social Services, the New York State Office of Mental Health or the New York State Office of Mental Retardation and Developmental Disabilities.

(o) Living unit or independent living unit shall mean an apartment, room, cottage, or other area within a community set aside for the exclusive use of one or more residents exclusive of a room in the nursing home, adult care facility or other specialized unit within the community.

(p) Monthly care fee shall mean the monthly cost to a resident for the prepayment of any services, including rent, rendered pursuant to a contract, exclusive of entrance fees or other prepayments, and any other regular periodic charges to the resident, determined on a monthly basis, pursuant to the provisions of a contract.

(q) Nursing home, also referred to in this Part and Part 901 as a residential health care facility or nursing facility, shall mean a facility, institution, or portion thereof subject to Article 28 of the New York State Public Health Law, providing therein, lodging for twenty-four or more consecutive hours to three or more nursing home residents who are not related to the operator by marriage or by blood within the third degree of cosanguinity, who need regular nursing services or other professional services but who shall not need the services of a general hospital.

(r) Operator shall mean a legal entity operating a life care community pursuant to a certificate of authority.

(s) Parent corporation means a corporation which, directly or indirectly, or through one or more intermediaries, possesses the ability to direct or cause the direction of the actions, management or policies of any partnership or corporation which is applying for approval to operate or which already operates a life care community.

(t) Person shall mean an individual, corporation, governmental subdivision or other legal entity, including a joint venture or any combination of the foregoing acting in concert.

(u) Principal stockholder means any person or organization that owns, holds or has the power to vote ten percent or more of the issued and outstanding voting shares of stock of a corporation.

(v) Qualified consulting actuary shall mean an individual who either:

(1) is a member of the American Academy of Actuaries and has, based on the Academy's qualification standards, the necessary, training and experience pertaining to life care communities; or

(2) demonstrates to the satisfaction of the Superintendent that based on his/her knowledge, training and experience that he/she has the necessary knowledge pertaining to life care communities.

(w) Resident shall mean any individual who, pursuant to a contract, is entitled to reside in and receive services from a life care community.

(x) Social services shall mean those services which may include, but not be limited to counseling, case management, and information and referral.

(y) Superintendent shall mean the Superintendent of Insurance.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 900.2 - Applicability of other laws and regulations

900.2 Applicability of other laws and regulations. (a) Except as otherwise indicated in this section, the activities of life care communities shall be subject to any other laws governing such activities including, but not limited to, Articles 28 and 36 of the Public Health Law and Article 7 of the Social Services Law and regulations promulgated thereunder.

(b) In applying the provisions of section 2801-a of the Public Health Law to life care communities:

(1) the first one thousand nursing home beds proposed as components of communities shall be exempt from the consideration of public need pursuant to section 2801-a(3) and Part 670 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York;

(2) the prohibition against establishment of a residential health care facility to be operated by a limited partnership, or by a partnership any of the members of which are not natural persons, pursuant to section 2801-a(4)(d), shall not apply;

(3) the prohibition against establishment of a residential health care facility to be operated by a corporation any of the stock of which is owned by another corporation pursuant to section 2801-a(4)(e), shall not apply;

(4) the prohibition against contracting for management services with a party which has not received establishment approval pursuant to Section 600.9(d) of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, shall not apply;

(5) the requirements for establishment of business corporations pursuant to section 620.1 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York except as specifically noted herein shall be superseded by those of this Part;

(6) the requirements regarding the transfer, assignment or other disposition of ten percent or more of the stock or voting rights pursuant to section 2801-a(4)(c) and section 620.3 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply to the community as a whole (to which the provisions of this Part regarding controlling persons apply), but shall apply to any nursing home component which is to be operated by the life care community operator; and

(7) the requirements regarding the review of the character, competence and standing in the community of any principal stockholders pursuant to section 2801-a(3) and section 600.2 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply to the community as a whole (to which the provisions of this Part regarding controlling persons apply), but shall apply to any nursing home component to be operated by the life care community operator.

(c) In applying the provisions of Article 36 of the Public Health Law to life care communities:

(1) any certified home health agency established as part of a life care community shall not be exempt from the determination of public need pursuant to section 3606(2) and section 760.3 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York;

(2) the requirements regarding the review of the character, competence and standing in the community of any principal stockholders pursuant to sections 3605(4) and 3606(2) of the Public Health Law and sections 760.2, 765-1.2 and 765-1.3 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply to the community as a whole (to which the provisions of this Part regarding controlling persons apply), but shall apply to any home care services agency,subject to Article 36 of the Public Health Law, which is to be operated by the life care community operator; and

(3) the requirements regarding the transfer, assignment or other disposition of ten percent or more of the stock or voting rights pursuant to section 3611-a(2) of the Public Health Law and sections 760.14 and 765-1.13 of Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply to the community as a whole (to which the provisions of this Part regarding controlling persons apply), but shall apply to any home care services agency, subject to Article 36 of the Public Health Law, which is to be operated by the life care community operator.

(d) In applying the provisions of Article 7 of the Social Services Law to life care communities:

(1) any adult care facility beds established as part of a life care community shall not be exempt from the determination of public need pursuant to section 485.6 of Chapter II, Title 18 (Social Services) of the Official Compilation of Codes, Rules and Regulations of the State of New York; (2) the prohibition against establishment by certain non-natural persons and business corporations pursuant to section 461-b(1)(a) of the Social Services Law and section 485.5 of Chapter II, Title 18 (Social Services) of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply; and

(3) the requirements regarding the review of character, competence and standing the community of any principal stockholders pursuant to section 485.6 of Chapter II, Title 18 of the Official Compilation of Codes, Rules and Regulations of the State of New York shall not apply to the community as a whole but shall apply to any adult home component established as part of a life care community.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 900.3 - Application for certificate of authority

Section 900.3 Application for certificate of authority. (a) An application to the Life Care Community Council for its approval to operate a life care community shall be in writing on application forms provided by the department and subscribed by the chief executive officer duly authorized by the board of a corporate applicant, a general partner or proprietor of the proposed life care community, or, where an application is to be submitted by a governmental subdivision as the applicant, the president or chairman of the board of the proposed community or the chief executive officer if there is no board; and accompanied by a certified copy of a resolution of the board of a corporate applicant authorizing the undertaking which is the subject of the application, and the subscribing and submission thereof by an appropriate designated individual. In the event that an application is to be submitted by an entity which necessarily remains to be legally incorporated, it shall be subscribed and submitted by one of the proposed principal stockholders or directors. If a local governmental applicant submitting an application has not designated a president, chairman or chief executive officer for the proposed community, the application shall be subscribed by the chairman or president of the local legislature or board of supervisors having jurisdiction, or other appropriate executive officer. An original application and eleven copies thereof shall be prepared and submitted to the Commissioner.

(b) Applications to the council shall contain information and data with reference to:

(1) the need for the existence of the proposed community at the time and place and under the circumstances proposed;

(2) the character, experience, competence and standing in the community of the controlling persons, if any, of the applicant, managers, if any, the sole proprietor applicant, the general partners of a partnership applicant, the proposed directors and officers of a corporation, corporate general partner, parent corporation or management corporation, and governmental subdivisions. The application shall include copies of personal and disclosure information, as appropriate, as may be required by the council with regard to any such individual or organization; and

(3) the applicant's ability to organize, market, manage, promote and operate the community in a financially feasible and capable manner and its ability to meet its expected obligations.

(c) The following documents shall be filed as part of the application:

(1) a feasibility study defined as follows:

(i) the study shall be in the form of a financial forecast subject to an examination by an independent certified public accountant including a statement by the accountant that the examination was conducted in accordance with generally accepted accounting principles (GAAP);

(ii) the financial forecast shall include:

(a) prospective financial statements covering a period of five years beginning with the calendar year in which the application is made;

(b) a market analysis including the demographic characteristics of the population to be served as a basis for judging whether the proposed community is likely to achieve acceptable occupancy rates; and

(c) an opinion by a qualified consulting actuary as to the acturial assumptions used in developing the financial forecast; and

(iii) the examination of the financial forecast included in the application may be in draft form provided that the final examination be submitted to the department upon financing of the community;

(2) the rates and rating system, if any, consisting of a detailed formula or formulas to be applied by the operator in the calculation of future entrance fees and monthly care fees;

(3) where the applicant will be operating the life care community under an assumed name, a photocopy of the applicant's existing or executed proposed certificate of doing business;

(4) a copy of the proposed life care contract between the community and its residents;

(5) copies of any contracts for the provision of nursing home services, home health care services or adult care facility services to the community;

(6) copies of all applicable executed and proposed deeds, leases, and rental agreements or executed option contracts related to the community's real property interests;

(7) complete details of any agreements between the community and licensed insurers, including copies of the proposed contracts requiring the insurer to assume, wholly or in part, the cost of medical or health related service to be provided to the residents of the community;

(8) a copy of each of the basic organizational documents and agreements of the applicant and all participating entities including, as applicable: by-laws, partnership agreements, articles of incorporation, articles of association or other membership agreements, or their substantial equivalents; (9) where the applicant has a parent corporation or a controlling person, copies of any such entity's bylaws, certificate of incorporation and any existing or proposed amendments thereto, all agreements between the applicant and any such controlling person or parent corporation relating to the manner and mechanisms by which any such controlling person or parent corporation controls or will control the applicant and a detailed description of such control relationship;

(10) architectural program and sketches of the community including the following:

(i) site plans;

(ii) schematic architectural and engineering design drawings and single line sketches of each floor in an appropriate scale showing the relationship of various buildings to each other, room configurations, major exit corridors, exit stair locations, and circulation along with existing buildings if additions or alterations are part of the project;

(iii) outline specifications for the type of construction proposed including a description of energy sources, type and location of engineering systems proposed for heating, cooling, ventilation and electrical distribution, dietary systems, water supply and sewage; and

(iv) for an on-site nursing home component:

(a) a description of the functional and locational relationships among each related but discrete component; and

(b) in those cases where those systems and services specified in Section 711.3(g)(3), Chapter V, Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York are located at the first or basement level or where any floor level is located below the 100-year flood crest level, a description of the site, including a topographic map, U.S. Geological Survey, published by the U.S. Department of Interior Geological Survey, 7 1/2 minute series, unless not published for such site, in which case 15 minute series shall be acceptable;

(11) construction timetable;

(12) information on the ownership of the property interests in the community including the following:

(i) the name and address and a description of the interest held, or proposed to be held, by each of the following persons:

(a) any person who, directly or indirectly, beneficially owns any interest in the land on which the community is located;

(b) any person who, directly or indirectly, beneficially owns any interest in the buildings in which the community is located;

(c) any person who, directly or indirectly, beneficially owns any interest in any mortgage, note, deed of trust or other obligations secured in whole or in part by the equipment used in the community, or by the land on which or the buildings in which the community is located;

(d) any person who, directly or indirectly, has any interest as lessor or lessee in any lease or sublease of the land on which or the buildings in which the community is located; and

(ii) if any person named in response to paragraph (i) of this subdivision is a partnership, then the name and address of each general partner;

(iii) if any person named in response to paragraph (i) of this subdivision is a corporation, then the name and address of each controlling person, director and officer of such corporation;

(iv) if any corporation named in response to paragraph (i) of this subdivision is a corporation whose shares are traded on a national securities exchange or are regularly quoted in an over-the-counter market or which is a commercial bank, savings bank or savings and loan association, then the name and address of the principal executive officers and each member of the board of directors of such corporation;

(v) such additional pertinent information and documents necessary for the council's consideration, as requested;

(13) a copy of the agreement, if any, executed or to be executed between the operator and a manager;

(14) an initial disclosure statement which shall include, but not be limited to:

(i) the following statement printed in bold twelve point type on the cover or on top of the first page: "This matter involves a substantial financial investment and a legally binding contract. In evaluating the disclosure statement and the contract prior to any commitment, it is recommended that you consult with an attorney and financial advisor of your choice, if you so elect, who can review these documents with you.";

(ii) the name and business address of the operator and a statement of whether the operator is an individual, partnership, corporation or other legal entity;

(iii) all of the information required by regulation to be in the life care contract unless a copy of the actual contract is attached and incorporated as part of the disclosure statement; (iv) a description of the community including the number of independent living units, nursing home beds, adult care facility beds, if any, as well as the location, size and anticipated completion date and a description of other social and health services provided by the community;

(v) a list of life care, health care and/or adult care operations owned or operated by any controlling person(s) of the applicant(s), each sole proprietor applicant, each general partner of a partnership applicant, each corporate applicant and each officer and member of the board of directors of a corporate applicant or corporate general partner, or by entities with which the members of the board are affiliated including the address and dates of ownership or operation of each such operation;

(vi) in the event that any life care, health care and/or adult care operation specified pursuant to subparagraph (v) above has been subjected to a limitation, withdrawal, disapproval or refusal to grant an operating certificate or other equivalent authority to operate because of failure to comply with standards governing the conduct and operation of the life care, health care and/or adult care operation, information describing the nature of the violation, the name and address of the agency or body enforcing the standard, the steps taken by the life care, health care and/or adult care operation to remedy the violation, and an indication of whether any authority to operate has since been restored or limitation removed;

(vii) a statement as to whether any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, corporate general partner, management corporation, parent corporation, or health-related subsidiary corporation:

(a) has been convicted of a crime or plead nolo contendre to a felony charge, or been held liable or enjoined in a civil action by final judgement if the criminal or civil action involved fraud, embezzlement, fraudulent conversion, or misappropriation of property;

(b) had a prior discharge in bankruptcy or was found insolvent in any court action;

(c) is or was subject to a currently effective order or federal or state administrative order relating to business activity or health care as a result of an action by a public agency or department, including, without limitation, actions affecting a license to operate a life care, health care and/or adult care operation. This statement shall set forth the court or agency, date of conviction or judgement, the penalty imposed or damages assessed, and the date, nature and issuer of the order;

(viii) if any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, corporate general partner, management corporation, parent corporation or health-related subsidiary maintains a ten percent interest or greater in any professional service, firm, association, foundation, trust, partnership, corporation, or other entity or if such entity maintains a ten percent interest or greater in the applicant, and such entity will or may provide goods, leases, or services to the community, the value of which is five hundred dollars or more within any one year, the name and address of the entity shall be disclosed together with a description of the goods, leases or services and the probable or anticipated cost to the community;

(ix) if the community is to be operated by a manager:

(a) the name and address of other life care, health care and/or adult care operations, if any, managed by the manager;

(b) a summary of the agreement, including the fee, executed or to be executed between the operator and manager, with a full copy to be made available upon request;

(c) if the manager is incorporated or established and operated on a for-profit basis the name and address of all controlling persons, officers and members of the board of directors of the management corporation;

(d) the method by which the manager was chosen. If the manager was chosen due to a condition in a mortgage commitment, the name and address of the mortgagee imposing the condition;

(x) a statement indicating whether the applicant is or has been affiliated, or has or had a contractual arrangement with a religious, charitable or other non-profit organization and if so, the extent of such affiliation or contractual arrangement including the extent to which the non-profit organization will be responsible for the financial and contractual obligations of the applicant; (xi) if the applicant operates one or more life care communities within or outside of the state, a statement for each such community describing the changes in the entrance fees and the monthly care fees as well as any changes in the care and services provided under the life care contract during the past five years or less for communities which have been in operation for less than five years. This disclosure shall include tables indicating the frequency and average dollar amounts of the fee increases for each community during such time period;

(xii) if the applicant is a corporate subsidiary or affiliate of another corporation, disclosure of the parent or affiliate corporation including the name and address of the parent or affiliate, the primary activities of the parent or affiliate, the interest in the applicant held by the parent or affiliate and the extent to which the parent will be responsible for the financial and contractual obligations of the subsidiary;

(xiii) the most recent financial statement of the applicant prepared in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis and certified by an independent certified public accountant, including a balance sheet as of the end of the applicant's last fiscal year and income statements for the past two fiscal years, or such shorter period of time as the operator has been in operation;

(xiv) if construction, lease, rental or purchase of the community has not been completed, a statement indicating the anticipated source and application of the funds to be used in such purchase, lease, rental or construction which shall include but not be limited to:

(a) an estimate of the cost of purchasing, leasing, renting, constructing and equipping the community, including at a minimum, related costs such as financing expenses, legal expenses, land costs, occupancy development costs, and all other similar costs which the operator will incur or become obligated for prior to the occupancy of the community; (b) a projection of the estimated operating expenses of the community, including a description of the assumptions used in calculating the expenses and separate allowances, if any, for the replacement of equipment and furnishings and any anticipated major structural repairs or additions;

(c) an estimate of any funds which are anticipated to be required to fund start-up losses and to assure full performance of all obligations of the operator pursuant to the life care contracts including, but not limited to the reserves required to be maintained pursuant to the applicable regulations of the New York State Department of Insurance;

(d) an estimate of the total entrance fees to be received upon completion of occupancy;

(e) a projection of estimated income from fees and charges other than entrance fees, a description of the individual rates to be charged, and the assumptions used in calculating the estimated occupancy rate of the community;

(f) the anticipated terms and costs of any mortgage loan or other long term financing of the community; and

(g) a statement of actual and anticipated assets pledged as collateral for any purpose; and

(15) such additional pertinent information or documents necessary for the council's consideration, as requested.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 900.4 - Requirements for approval

900.4 Requirements for approval. (a) The application must be complete and in proper form. It shall provide all the information essential for the Life Care Community Council's consideration.

(b) The council shall not act upon an application for a certificate of authority unless all approvals and consents required by law have been obtained including:

(1) approval by the Superintendent of Insurance as to:

(i) the actuarial principles involved;

(ii) the financial feasibility of the facility;

(iii) the form and content of the proposed life care contract between the community and its residents;

(iv) the form and content of any agreements between the community and licensed insurers requiring the insurers to assume, wholly or in part, the cost of medical or health related services to be provided pursuant to the life care contract; and

(v) the rates and rating system, if any, including detailed formula or formulas to be applied by the operator in the calculation of future entrance fees and monthly care fees;

(2) approval by the Commissioner of Social Services of those components of the application pertaining to adult care facility beds, if any;

(3) approval by the Public Health Council as to the establishment of a nursing home or other facilities and services which require the Public Health Council's approval e.g., diagnostic and treatment center, certified home health agency or licensed home care services agency; and

(4) approval by the commissioner as to the construction of a nursing home or other facilities and services which require the commissioner's approval e.g., diagnostic and treatment center, certified home health agency or licensed home care services agency.

(c) The applicant must satisfactorily demonstrate to the council:

(1) that the proposed community will meet a need and will fulfill the purposes of Article 46 of the Public Health Law;

(2) that the applicant has satisfied all of the requirements of Article 46 of the Public Health Law and this part;

(3) that the controlling person of the applicant, the manager, the sole proprietor applicant, general partners of a partnership applicant and the officers and the members of the board of directors of a corporate applicant, management corporation or parent corporation are of such character, experience, competence and standing in the community as to give reasonable assurance of their ability to conduct the affairs of the community in the best interests of the community and in the public interest and to provide proper care for those to be served by the community;

(4) in the case of a public or government agency, that the governing authority of the governmental subdivision applying to operate the life care community has provided reasonable assurance of its ability to conduct the affairs of the life care community in the best interests of the community and in the public interest, and to provide proper care for those to be served by the community; and

(5) that the applicant has the capability to organize, market, manage, promote and operate the community in a financially feasible and capable manner and its ability to meet its obligations pursuant to Article 46 of the Public Health Law; and

(6) the applicant has demonstrated that the combined total number of beds for the nursing facility component and the adult care facility component, if any, is reasonably related to the number of independent living units proposed for the community.

(d) In conducting a character and competence review, the council shall, as applicable, evaluate any controlling persons of the applicant, any sole proprietor applicant, any general partners of a partnership application and any officers and members of the board of directors of a corporate applicant, corporate general partner, parent corporation and in the case of a governmental subdivision as the applicant, the governmental subdivision and the governing body thereof as a whole rather than the individual elected or appointed members thereof, by:

(1) reviewing the findings of inspection reports, resident care reviews, complaint investigations and any other pertinent information relating to the operation of any life care, health care and/or adult care operation located in New York or elsewhere with which the individual has been affiliated as a controlling person, sole proprietor, general partner or governmental operator during the past ten years;

(2) reviewing whether such individual, partnership, corporation, other organization or governmental subdivision exercised supervisory responsibility of the life care, health care and/or adult care operation to assure a consistent pattern of compliance with applicable standards and to prevent conditions which could result in harm to the health, safety or welfare of the residents; (3) determining that, if a violation of applicable standards did occur, that the individual, partnership, corporation, other organization or governmental subdivision implemented an acceptable plan of correction; and

(4) with respect to a manager who will be responsible for the day-to-day operations of the proposed community, the information required pursuant to this subdivision for any life care, health care, and/or adult care operation for which the manager was responsible under a management contract;

(5) considering such other pertinent matters relating to the character, competence and standing in the community of the applicant.

(e) The department may request any additional information required by the council or any of the reviewing agencies. Such information shall be provided to the department within thirty days of the request, unless an extension has been granted. Any request for such extension of time shall set forth the reasons why such information could not be obtained within the prescribed time. The granting of such extension of time shall be at the discretion of the commissioner, provided such extensions are not for more than thirty days and the commissioner is satisfied as to the reasons why such information could be not obtained within the prescribed time. Failure to provide such information within the time prescribed shall constitute an abandonment and withdrawal of the application by the applicant. The commissioner is authorized to deny a request for an extension of time.

(f) The applicant must also supply any authorization the Commissioner requests in order to verify any information contained in the application or to obtain additional information which the Commissioner finds is pertinent to the application. Failure to provide such authorization shall constitute an abandonment and withdrawal of the application.

(g) The council shall have sixty days from the date of the last approvals required under subdivision (b) of this section to either approve or disapprove the application.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 900.5 - Amendments to applications

900.5 Amendments to applications. (a) An application made to the Life Care Community Council, may be amended while the application is pending before the council. Such amendments shall be made on appropriate forms supplied by the department.

(b) Any amendment to an application which constitutes a substantial change in the information contained in the original application, or any subsequent amendments thereto, must be accompanied by a satisfactory written explanation as to the reason such information was not contained in the original application.

(c) Changes which constitute an amendment include, but are not limited to:

(1) any substantive changes to the life care contract or the disclosure statement;

(2) changes in the construction timetable;

(3) changes in the proposed operator; and

(4) in the case of a community which contracts for management services, changes in this contracted management entity.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 900.6 - Withdrawals of applications

900.6 Withdrawals of applications. An application made to the Life Care Community Council may, upon written request of the applicant to the Commissioner, be withdrawn prior to a decision by the council at any time without prejudice to resubmission.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 900.7 - Decisions

900.7 Decisions. (a) The Life Care Community Council shall by majority vote either approve or disapprove the application.

(b) Copies of the resolution of the council approving or disapproving an application shall be transmitted to the applicant.

(c) If the council disapproves the application, the commissioner shall provide notice to the applicant of the opportunity to request a public hearing.

(1) The applicant shall have thirty days from such notice to request a public hearing.

(2) Any public hearing held pursuant to this section shall be conducted by the council, a committee of the council, or by any individual designated by the council.

(d) If the council approves the application, the commissioner shall issue a certificate of authority to the applicant.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 900.8 - Certificate of authority

900.8 Certificate of authority. (a) The certificate of authority shall authorize an approved applicant:

(1) to operate a life care community and to enter into life care contracts pertaining to such community;

(2) to prepare and publicize information that details the terms of the life care contract relating to the approved community;

(3) to advertise the approved community and related services that will be provided; and

(4) to offer and execute contracts including the collection of application fees, entrance fees and deposits.

(b) Upon issuance of a certificate of authority, the commissioner, in consultation with the council, may authorize an operator to provide, for a period not to exceed seven years, nursing home services to persons, who are not residents of the community, provided, however, that the operator shall not discriminate in the admissions, retention or care of any such persons because such person is or will be eligible for or receives or will receive, medical assistance benefits pursuant to Title 11 of Article 5 of the Social Services Law. The operator may seek an extension of this authorization at the end of the seven year period upon written application to the commissioner.

(c) Upon issuance of a certificate of authority, the Commissioner of Social Services, in consultation with the council, may authorize an operator to provide for a period not to exceed seven years, adult care facility services to persons who are not residents of the community, provided, however that the operator shall not discriminate in the admission, retention or care of any such person because such person is or will be eligible for or receives or will receive, medical assistance benefits pursuant to Title II of Article 5 of the Social Services Law or supplemental security income benefits pursuant to Title 16 of the Federal Social Security Act and any additional state payments made under Title 6 of Article 5 of the Social Services Law. The operator may seek an extension of this authorization at the end of the seven year period upon written application to the Commissioner of Social Services.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 900.9 - Fees

900.9 Fees. (a) Upon receipt of a certificate of authority, the approved operator shall submit to the commissioner a fee in the amount of fifty dollars per approved independent living unit within thirty days of receipt of the certificate of authority.

(b) The approved operator shall submit thereafter to the commissioner an annual fee in the amount of fifty dollars per approved independent living unit upon submission of the annual statement.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 900.10 - Authorization to begin construction

900.10 Authorization to begin construction. (a) Upon issuance of a certificate of authority, the operator may begin construction of the model units and a sales office.

(b) Construction of the community may begin upon written authorization of the commissioner. Such authorization shall be granted upon:

(1) proof of execution of contracts for at least fifty percent of all living units or approved phase of living units accompanied by a deposit of at least ten percent of the entrance fee. Such proof shall consist of a listing certified by the operator which includes the names, addresses and phone numbers of prospective residents and amounts of the deposits paid;

(2) obtaining all applicable permits and approvals; and

(3) satisfaction of all certificate of authority contingencies.
 

Effective Date: 
Wednesday, September 18, 1991
Doc Status: 
Complete

Section 900.11 - Long term care security program for long term care model

900.11 Long term care security program for long term care model.

(a) The Life Care Community Council may approve an application for a certificate of authority and the Commissioner may issue a certificate of authority for the establishment and operation of a life care community under an arrangement which otherwise complies with the requirements of Article 46 except that the costs of each resident's nursing facility or home health care services are paid for in whole or in part by long term care insurance obtained and paid for by the resident or by medical assistance payments in accordance with the Long Term Care Security Program for Long Term Care pursuant to Section 367(f) of the Social Services Law and Section 3229 of the Insurance Law.

(b) With regard to nursing home or home health care services provided as part of the life care contract, any elimination or waiting periods and any deductibles, co-payments, or other amounts not paid for by such long term care insurance or medical assistance payments shall be the responsibility of the life care community. The resident shall not be liable to pay any such amounts.

(c) The life care community operator shall not require that long term care insurance be purchased from a specified insurer or group of insurers and the life care community operator shall not specify a minimum acceptable benefit level in excess of that established under the Long Term Care Security Program for Long Term Care.

(d) Entrance fees and monthly care fees shall reflect that the cost of resident's nursing home and home health care services are or will be paid for in whole or in part through a long term care insurance policy and medical assistance payments.

(e) If a resident fails to maintain minimum long term care insurance coverage in accordance with the Long Term Care Security Program for Long Term Care, the life care community operator shall purchase, if possible, such coverage on behalf of and at the expense of the resident and may require an appropriate adjustment in the monthly fees paid by the resident to the life care community operator.

(1) If the life care community operator cannot purchase such long term care insurance coverage, the operator may require an adjustment in the resident's monthly fees, subject to the approval of the Superintendent, to fund the additional risk to the facility.

(2) If the resident fails to maintain such long term care insurance coverage and the life care community operator has not purchased such coverage, the operator shall be responsible for any expenses which would have been covered under the long term care insurance policy which the resident failed to maintain. The operator may add the amount of such expenses to the resident's monthly fees.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Part 901 - Organizations and Administration

Effective Date: 
Wednesday, April 29, 2009
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 4602(2)(g)

Section 901.1 - Pre-contract disclosure

Section 901.1 Pre-contract disclosure. (a) Prior to the execution of a contract, or before the transfer of any money other than a refundable priority reservation application fee or a priority reservation fee to the operator by or on behalf of a prospective resident, whichever occurs first, the operator shall deliver to the person with whom the contract is to be entered into or the person's legal representative:

(1) the most recent annual statement required pursuant to Section 901.8 of this Part; and

(2) an initial disclosure statement including the information contained in the contract unless the contract is attached to and made part of the initial disclosure statement. Such disclosure statement shall be prepared in accordance with subdivision 900.3(c)(14) of Part 900.

(b) The operator shall designate knowledgeable personnel to be available to prospective residents to provide information and answer questions regarding the community and its operation, the disclosure statement, the life care contract and the annual statement.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 901.2 - Life care contract

901.2 Life care contract. (a) The life care contract shall be written in plain language and printed in no less than twelve point type. In addition, the following statement shall be printed in bold twelve point type on the cover or top of the first page: "This matter involves a substantial financial investment and a legally binding contract. In evaluating the disclosure statement and the contract prior to any commitment, it is recommended that you consult with an attorney and financial advisor of your choice, if you so elect, who can review these documents with you."

(b) The life care contract shall include, but not be limited to, all of the following information:

(1) the amount of all money transferred or to be transferred, including, but not limited to, donations, subscriptions, deposits, fees, and any other amounts paid or payable by, or on behalf of, the resident or residents;

(2) a description of all services which are to be provided to the resident. The contract must clearly identify those services which are provided as part of the entrance fee and those services which are provided as part of the monthly care fee and those which are not included in such fees and in the case of a Long Term Care Security Program for Long Term Care model community, those services which are paid in whole or in part through a long term care insurance policy and medical assistance payments;

(3) a description of the entrance fee, monthly care fee and any other fees provided for in the contract and the conditions under which any of the fees may be adjusted, provided that an operator shall not charge a non-refundable application fee to a prospective resident who has already paid a non-refundable priority reservation agreement application fee;

(4) a description of any late penalties which will be imposed and the grace period, if any, during which no penalties will be imposed, due to late payment of monthly care fees, and the community's policies and procedures regarding non-payment of the monthly care fees;

(5) the community's policies and procedures, including dollar amounts and terms, regarding the subsequent entry of a spouse into the community and the consequences of the spouse's failure to meet the entrance criteria;

(6) the terms and conditions under which the contract may be cancelled by the operator or by the resident;

(7) the entrance fee refund policy which must be consistent with the provisions set forth in section 901.4 of this Part;

(8) the conditions under which an independent living unit will be determined to be vacant either due to the resident's permanent transfer to the community's nursing home, adult care facility or other specialized facility within the community or due to the permanent transfer of the resident to a hospital or other facility outside of the community, provided that nothing therein shall relieve the community of its obligations to provide or to insure provision of lifetime care;

(9) a statement of the community's liability in the event that a resident's chronic condition requires placement in a more specialized chronic care facility that provides services beyond those provided by the community's nursing home. The liability of the community shall be equal to the excess of the community's nursing home private pay per diem over the resident's monthly care fee on a per diem basis. In the event that the community's nursing home is no longer serving the outside community, a reasonable cost based per diem shall be established for the community's nursing home for the purpose of establishing the community's liability;

(10) a statement indicating that in the event that a resident dies prior to occupancy in the community, or due to illness, injury or incapacity is no longer eligible for occupancy in the community under the terms of the contract, the contract is automatically rescinded upon written notice to the sponsor by the prospective resident or his or her legal representative and the resident or his or her legal representative shall receive a full refund of all moneys paid to the community, except for those costs specifically incurred by the community at the request of the resident and set forth in writing in a separate addendum, signed by the parties to the contract. In the event of a multiple party contract, the contract may remain in effect at the option of the remaining prospective residents subject to the terms of of the contract;

(11) a statement of the community's policy regarding advance notice to be provided to the resident of any changes in fees or charges or scope of care or services. Such notice must be made at least sixty days in advance of such change;

(12) a statement that no act, agreement or statement of any resident, or of an individual purchasing care for a resident under any agreement to furnish care to the resident, shall constitute a valid waiver of any provision of Article 46 of the Public Health Law or of any rules and regulations enacted pursuant thereto intended for the benefit or protection of the resident or the individual purchasing care for the resident; (13) a description of the community's reinstatement policy in the event that the contract is cancelled by the community or the resident;

(14) a statement indicating that internal procedures have been established to address and resolve disputes and grievances of the residents and that a copy of such procedures shall be provided to each resident;

(15) a statement of Medicare Parts A and B and supplement coverage requirements which shall specify that:

(i) the resident shall, if eligible, enroll in and continue to maintain Medicare Parts A and B coverage or the equivalent and Medicare supplement coverage as defined by the New York State Insurance Department pursuant to sections 52.11 and 52.22 of Part 52 of Title 11 of the Official Compilation of Codes, Rules and Regulations of the State of New York;

(ii) the community shall maintain a system to monitor residents' coverage and if the resident fails to maintain or is ineligible for Medicare Parts A and B and supplement coverage, and the resident fails to purchase the equivalent of such coverage, the community shall purchase such coverage on behalf of and at the expense of the resident and shall have the authority to require appropriate adjustment to the resident's monthly care fee;

(iii) if the community cannot purchase such coverage, the community shall have the authority to require an adjustment to the resident's monthly care fee, subject to the approval of the Superintendent of Insurance, to fund the additional risk to the community; and

(iv) the community shall be responsible for any expense incurred which would have been covered by Medicare Parts A and B and Medicare supplement or equivalent coverage during a lapse in coverage due to failure or inability of the resident and the community to secure coverage. The community may add the amount of such expenses to the resident's monthly care fee if the community has not funded this additional risk pursuant to subparagraph (iii) of this paragraph;

(16) If the community is operated as a Long Term Care Security Program for Long Term Care model, a statement of the community's policies regarding that program which must include the following:

(i) with regard to any nursing home or home health care services provided pursuant to the life care contract, any elimination or waiting periods and any deductibles, co-payments or other amounts not paid for through a long term care insurance policy or medical assistance payment shall be the responsibility of the community, and the resident shall not be liable for such amounts;

(ii) the operator shall not require that the long term care insurance policy be purchased from a specific insurer or group of insurers and shall not require a minimum benefit level in excess of that required pursuant to Section 367(f) of the Social Services Law and Section 3229 of the Insurance Law; and

(iii) the community shall maintain a system to monitor residents' coverage and if the resident fails to maintain the minimum required coverage, the operator shall purchase, if possible, such coverage on behalf and at the expense of the resident and may require an appropriate adjustment to the resident's monthly fees to reflect the cost of the coverage.

(a) If the operator cannot purchase such coverage, the operator may require an adjustment of the resident's monthly fees to fund the additional risk to the community, subject to the Superintendent's approval.

(b) If the resident fails to maintain the required coverage and the operator has not purchased such coverage, the operator shall be responsible for any expenses which would have otherwise been covered under such a policy. The operator may add the amount of actual expenses incurred to the resident's monthly fees.

(17) a statement that any amendment to the contract and any change in entrance and/or monthly care fees other than those within the guidelines of a previously approved rating system or which do not exceed the change in the consumer price index, or other index as determined by the Superintendent of Insurance, must be approved by the Superintendent;

(18) a statement that property may not be substituted as payment for either the entrance fee or the monthly care fee; and

(19) a statement of the conditions under which a resident will be admitted to or discharged from the various components of the community.
 

Effective Date: 
Wednesday, July 27, 1994
Doc Status: 
Complete

Section 901.3 - Entrance fee escrow account

901.3 Entrance fee escrow account. (a) In order to advertise and collect refundable entrance fees and deposits subsequent to the issuance of a certificate of authority but prior to substantial completion of construction or purchase of the community or approved phase of the community, issuance of an occupancy permit and the availability of the unit for occupancy, the operator shall:

(1) establish a federally insured interest-bearing account with a New York bank, New York savings and loan association or New York trust company for the deposit of such fees and deposits; and

(2) enter into an escrow agreement with the bank, savings and loan association or trust company which shall state that:

(i) the purpose of the agreement is for the protection of the prospective resident; and

(ii) the escrow agent shall release all or portions of the funds on deposit including interest accrued or earned from investment of funds at prevailing rates to the operator or resident as directed pursuant to subdivisions (e)-(g) of this section or upon order of a court of competent jurisdiction.

(b) All checks, drafts and money orders for deposit from prospective residents or their legal representatives shall be made payable to the escrow agent only.

(c) All funds deposited in the escrow account shall remain the property of the prospective residents or their representatives until release of such funds to the operator pursuant to subdivision (e) of this section, and the funds shall not be subject to any liens or charges by the escrow agent or judgements, garnishments or creditor's claims against the operator or community.

(d) The escrow agent shall issue a statement indicating the status of the escrow account upon request of the operator, the Commissioner of Health, the Superintendent of Insurance or the resident.

(e) The escrowed funds including earned interest shall be released by the escrow agent to the operator upon order of a court of competent jurisdiction or upon notice by the Commissioner. Such notice shall be provided upon presentation to the Commissioner of evidence of compliance with the following conditions:

(1) substantial completion of the construction or purchase of the community or phase of the community if the community was approved by the Life Care Community Council to be established in phases;

(2) issuance of an occupancy permit covering all of the living units in the community or in an approved phase of the community by the local government having authority to issue such permits; and

(3) availability for occupancy of the specific living units for which deposits have been collected.

(f) The escrowed funds shall be released by the escrow agent to the person who paid the fee upon order of a court of competent jurisdiction or upon receipt of notice from the operator that such person or his or her representative is entitled to a refund pursuant to section 901.4 of this Part. The interest income earned on such funds shall be returned to the person who paid the fee or his or her representative.

(g) If the funds are not released to the operator due to revocation, suspension or annulment of the certificate of authority pursuant to section 901.16 of this Part then such funds shall be returned by the escrow agent to the persons who made payments to the operator upon notification to the escrow agent by the Commissioner of such revocation, suspension or annulment.

(h) Any nonrefundable application fee that has been so designated in the contract shall not be subject to the provisions of this section.
 

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.4 - Refunds

901.4 Refunds. Any funds paid by or on behalf of a resident or prospective resident shall be refundable as follows:

(a) An application fee or other similarly designated processing fee shall be subject to the refund provisions specified in the contract.

(b) Entrance fee deposits shall be refundable as follows:

(1) Entrance fee deposits shall be fully refundable if the contract is cancelled within seventy two hours of its execution.

(2) If the prospective resident dies or through illness, injury or incapacity is precluded from becoming a resident under the terms of the contract, the contract is automatically rescinded and the prospective resident or his or her legal representative shall receive a full refund of all moneys paid to the operator, except for those costs specifically incurred by the community at the request of the prospective resident or representative and set forth in writing in a separate addendum to the contract, signed by both parties to the contract. In the event of a multiple party contract, the contract may remain in effect at the option of the remaining prospective residents, subject to the terms of the contract.

(3) If the contract includes more than one resident, and one of the prospective residents dies or through illness, injury or incapacity is precluded from being a resident under the terms of the contract, the remaining resident(s) may cancel the contract and shall receive a full refund of all moneys paid to the operator, except for those costs specifically incurred by the community at the request of the prospective resident(s) or representative(s) and set forth in writing in a separate addendum to the contract, signed by all parties to the contract.

(4) If the community is not substantially complete as evidenced by meeting the requirements of subdivision (e) (1-3) of Section 901.3 of this part within six months of the completion date specified in the initial disclosure statement which was issued to the prospective resident or his or her legal representative the resident or representative shall have the option of cancelling the contract. In this case, the resident or representative shall receive a full refund of all moneys paid including earned interest, except for those costs specifically incurred by the community at the request of the resident or representatives and set forth in writing in a separate addendum to the contract, signed by both parties to the contract.

(c) Subsequent to occupancy, the contract shall be cancelled upon death of a resident in a singly occupied unit; or at least a thirty day written notice by certified mail by the resident or his or her representative for any reason; or by the operator if the resident has willfully mismanaged assets needed for payment of monthly care fees. The resident may not be discharged for inability to pay the monthly care fee except where the operator can demonstrate willful mismanagement of assets needed to pay the monthly care fee by the resident. Upon receipt of the required notice or upon the death of the resident, the operator shall provide for refund of any funds received as follows:

(1) If the required notice is received or if the death of a resident in a singly occupied unit occurs within the first ninety days of occupancy, the refund shall be at least equal to the entry fee and any other prepayment less the actual cost of any services rendered and the actual cost of refurbishing the living unit for resale;

(2) If the required notice is received or if the death of a resident in a singly occupied unit occurs after the first ninety days of occupancy, any refund shall be not less than the entrance fee, except that the operator may retain no more than two percent per month of occupancy by the resident of such fee and no more than a four percent fee for processing; and

(3) Any refund made subsequent to occupancy must be made within thirty days of the resale of the living unit, but in no event later than one year after the unit has been vacated.

(d) Subsequent to occupancy, if a resident who is party to a multiple resident contract either dies or otherwise vacates the unit, the contract shall remain in effect at the option of the remaining resident(s), subject to the terms of the contract. In the event that the remaining resident(s) cancel the contract, refunds shall be provided subject to the provisions of subdivision (c) of this section..

(e) Any refund provisions not herein specified, shall be subject to the terms of the life care contract.
 

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.5 - Rate increases

901.5 Rate increases. (a) Any increases in the entrance fees or monthly care fees subsequent to the issuance of the certificate of authority shall require the prior written approval of the Superintendent of Insurance except under the following conditions:

(1) the increase has been calculated in accordance with a rating system which has been approved by the Superintendent; or

(2) the increase does not exceed a relevant cost index or indices which reflect all components of life care including the cost associated with provision of health care as determined and promulgated at least annually by the Superintendent.

(b) The Superintendent shall be notified of all fee increases, including those not requiring approval, prior to the implementation of the increase.

(c) No individual resident's monthly care fee may be increased due to the increased needs for services of that resident.
 

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.6 - Advertisements

901.6 Advertisements. (a) For purposes of this section, advertisements shall mean any financial statement, pamphlet, circular, form letter, or other sales literature or advertising communication intended for or directed to prospective residents of the community or the general public.

(b) The applicant or any employee, agent or representative of the applicant shall not publish or cause to be published, circulated or disseminated any advertisement prior to the issuance of a certificate of authority.

(c) No advertisement shall contain statements or illustrations that are untrue, deceptive, misleading or omit material facts.

(d) Advertisements that refer to a specific entrance fee shall state the full entrance fee as well as any periodic charges, assessments or costs to the purchaser.

(e) Advertisements shall not refer to any community that is not in operation unless that fact is prominently stated in the advertisement and the proposed date of completion is contained therein.

(f) Advertisements shall not state that items or services are free when the cost of such items or services is included in the monthly care fee.

(g) Advertisements shall not contain photographs, sketches or artist's conceptions of proposed facilities unless that fact is prominently noted directly on or adjacent to the photographs, sketches or artist's conceptions.

(h) Advertisements shall not refer in wording, photograph, sketch or artist's conception to any recreational, medical, social, shopping or other facility that is not located within the life care community unless so stated and the approximate distance from the community is set forth.

(i) Advertisements shall not refer to an imminent price increase unless the amount and date of the increase is indicated.

(j) Advertisements that require attendance or submission to a sales promotion shall clearly state such requirements.

(k) Any model unit that is used as part of a promotional plan shall be in substantial conformance with the units that are subsequently constructed unless otherwise stated in the contract.
 

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.7 - Reserves and supporting assets

901.7 Reserves and supporting assets. After release of funds held in escrow pursuant to Section 901.3 of this Part, the operator shall maintain reserves in accordance with the requirements established by the Superintendent of Insurance and as set forth in Part 350 of Chapter XIII, Title 11 (Insurance) of the Official Compilation of Codes, Rules and Regulations of the State of New York.
 

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.8 - Periodic reporting requirements

901.8 Periodic reporting requirements. (a) At an interval of every six months following the issuance of a certificate of authority and continuing until the community achieves an independent living unit occupancy rate of ninety percent, the operator shall file with the Commissioner a report indicating the construction status and marketing status of the community.

(b) The operator shall file an annual statement with the Commissioner of Health and Superintendent of Insurance within four months following the close of the operator's fiscal year.

(1) If the operator's fiscal year ends within six months following the issuance of the certificate of authority, the first annual statement shall not be required until the end of the next fiscal year.

(2) The operator may request an extension of time to file the annual report. A request for extension of filing time must be submitted in writing to the Commissioner within sixty days prior to the original due date.The Commissioner shall issue an approval or disapproval in writing within thirty days of receipt of the request. A formal request shall be required for each year in which an extension is required.

(3) If the annual statement is not received by the original due date or extended due date a late fee in the amount of one dollar per approved independent living unit per day may be charged.

(4) The annual statement must be accompanied by a certification by the operator of a proprietary community, a officer of a voluntary community, or the public official responsible for the operation of a public community.

(5) The annual statement shall show the condition of the community as of the last day of the preceding fiscal year and shall include, at a minimum, the following information in a format prescribed by the Council:

(i) a change in status of any of the following information submitted with the original application pursuant to paragraphs (3-9) and (11-14) of subdivision (c) of section 900.3 of Part 900:

(a) certificate of doing business;

(b) the life care contract;

(c) any contracts for the provision of nursing home services, home health care services or adult care facility services to the community;

(d) all executed and proposed deeds, leases, and rental agreements or executed option contracts related to the community's real property interests;

(e) any agreements or contracts between the community and licensed insurers requiring the insurer to assume, wholly or in part, the cost of medical or health related service to be provided to the residents of the community;

(f) the basic organizational documents and agreements including, as applicable: by-laws, partnership agreements, articles of incorporation, articles of association or other membership agreements, or their substantial equivalents;

(g) any bylaws, certificates of incorporation of a parent corporation or controlling person and any agreements with such an entity relating to the manner and mechanisms by which any such controlling person or parent corporation will exercise control;

(h) the ownership of the property interests in the community;

(i) the management contract, if any;

(j) the initial disclosure statement;

(ii) Financial statements prepared in accordance with the most current generally accepted accounting principles and audited by an independent certified public accountant which shall contain, for two or more periods, if the community has been in existence that long, the following:

(a) the accountant's opinion;

(b) a balance sheet;

(c) statement of income and expenses

(d) a statement of equity or fund balances;

(e) a statement of changes in financial position; and

(f) notes to the financial statements considered customary or necessary to ensure full disclosure of the financial statements, financial condition and operation.

(iii) a detailed listing of the assets supporting the reserves required pursuant to section 901.7 of this Part and Part 350 of Chapter XIII, Title 11 (Insurance) of the Official Compilation of Codes, Rules and Regulations of the State of New York;

(iv) an actuarial review of the community including an opinion of a qualified consulting actuary, as to the current and projected soundness of the community; and

(v) such other reasonable financial and other information as the council may require with respect to the operator or the community, or its directors, controlling persons, trustees, members, branches, subsidiaries or affiliates to determine the financial status of the community and the management capabilities of the operator.

(c) Sixty days before the official opening date and in subsequent years the commencement of each fiscal or calendar year, whichever applies, the operator shall file with the Commissioner and the Superintendent a computation of the annual long-term debt service and a projected annual revenue and expense summary for the next ten years.

Effective Date: 
Wednesday, July 1, 1992
Doc Status: 
Complete

Section 901.9 - Other notice and submission requirements

901.9 Other notice and submission requirements. (a) Notice of changes in the following shall be submitted to the Commissioner as they occur unless already submitted to the Commissioner pursuant to section 901.8 of this Part:

(1) the life care contract;

(2) the initial disclosure statement;

(3) changes in the construction timetable which extend the completion date six months beyond the current approved completion date; and

(4) the entrance fee and monthly care fees.

(b) Changes to the life care contract which result in a change in the package of services provided under the contract shall require the prior approval of the Superintendent.

(c) Changes in the construction timetable that result in the extension of the completion date beyond one year of the current approved completion date shall require the approval of the Commissioner, with the advice and consent of the Superintendent and, if required, the advice and consent of the Attorney General.

(d) any substantive changes to the initial disclosure statement shall require the prior approval of the Commissioner.

(e) Any increase of the entrance fees or monthly care fees shall require the prior approval of the Superintendent except when such increase has been calculated within a previously approved rating system or does not exceed the current relevant cost index as promulgated by the New York State Department of Insurance pursuant to Section 901.5 of this Part. (f) Any physical restructuring of the community which results in an addition or loss in the number of independent living units, adult care facility units or residential health care facility beds previously approved under the community's Certificate of Authority shall require only the prior approval of the Commissioner, with the advice and consent of the Superintendent, and, if required, the advice and consent of the Attorney General; provided, however, that any change in the number of previously approved adult care facility units or residential health care facility beds must receive all required Department approvals prior to approval of the Commissioner. Establishment of a residential health care facility component and/or an adult care facility component, not previously approved under the community’s Certificate of Authority, shall require the prior approval of the Continuing Care Retirement Community Council.

Effective Date: 
Wednesday, April 29, 2009
Doc Status: 
Complete

Section 901.10 - Management contracts

901.10 Management contracts. (a) For the purposes of this Part, a management contract is an agreement between a life care community's governing body and a contracting entity for the contracting entity to assume the primary responsibility for managing the day-to-day operations of an entire community or component thereof.

(b) A management contract shall contain the following information:

(1) a description of the proposed role of the governing body during the period of the proposed management contract. The description shall clearly reflect retention by the governing authority of ongoing responsibility for statutory and regulatory compliance;

(2) a provision that clearly recognizes that the responsibilities of the community's governing body are in no way obviated by entering into a management contract and that any powers not specifically delegated to the contracting entity through the provisions of the contract remain with the governing authority;

(3) a provision that states that the community's governing body shall retain the authority to discharge the managing entity and its employees at the community with or without cause; and

(4) a plan for assuring maintenance of the fiscal stability and the level and quality of services provided by the community during the term of the management contract.

(c) The governing body shall retain sufficient authority and control to discharge its responsibility under this Part. The following elements of control shall not be delegated to a managing entity:

(1) direct independent authority to appoint and discharge the chief executive officer or other key management employees above the department head level;

(2) independent control of the books and records;

(3) authority over the disposition of assets and the authority to incur on behalf of the community liabilities not normally associated with the day-to-day operation of a facility; and

(4) independent adoption of policies affecting the delivery of life care community services.

(d) A governing body wishing to enter into a management contract shall submit a proposed written contract to the department upon submission of a Certificate of Authority application in accordance with section 900.3(c)(13) or a governing body entering a new management contract or revising a management contract subsequent to the issuance of a certificate of authority shall submit a copy of the contract with the submission of the disclosure statement in accordance with section 901.9(a)(2). In addition, the governing body shall also submit, within the same time frame, the following:

(1) a statement as to whether the manager or managing entity has been convicted of a crime or pleaded nolo contendre to a felony charge, or been held liable or enjoined in a civil action by final judgement if the criminal or civil action involved fraud, embezzlement, fraudulent conversion or misappropriation of property;

(2) a statement as to whether the manager or managing entity had a prior discharge in bankruptcy or was found insolvent in any court action; and

(3) a statement as to whether the manager or managing entity is or was