Title: Section 405.22 - Critical care and special care services

405.22 Critical care and special care services.

(a) General provisions. Critical care and special care services are those services which are organized and provided for patients requiring care on a concentrated or continuous basis to meet special health care needs. Each service shall be provided with a concentration of professional staff and supportive services that are appropriate to the scope of services provided.

(1) The direction of each service, unless otherwise specified in this section, shall be provided by a designated member of the medical staff who has received special training and has demonstrated competence in the service related to the care provided.

(2) The provision of all critical care and special care services shall be in accordance with generally accepted standards of medical practice. The hospital shall ensure that written policies are developed by the medical staff and the nursing service and implemented for all special care and critical care services.

(i) The written policies and procedures shall be reviewed at least annually and revised as necessary and shall include at a minimum the following: infection control protocols, safety practices, admission/discharge protocols and an organized program for monitoring the quality and appropriateness of patient care, with identified problems reported to the hospital-wide quality assurance program and resolved.

(ii) The written protocols for patient admission to and discharge from a critical care or special care unit shall include:

(a) criteria for priority admissions;

(b) alternatives for providing specialized patient care to those patients who require such care but who, due to lack of space, or other specified reasons such as infection or contagious disease, are not eligible for admission according to unit policy; and

(c) guidelines for the timely transfer and referral of patients who require services that are not provided by the unit.

(3) Each critical care unit shall be organized as a physically and functionally distinct entity within the hospital.

(i) Access shall be controlled in order to regulate traffic, including visitors, in the interest of infection control.

(ii) Emergency equipment and an emergency cart within each unit shall contain appropriate drugs and equipment, as determined by the medical staff and pharmacy service.

(4) When critical or special care services are provided to pediatric patients, opportunities shall be provided for education, socialization, and play pertinent to the growth and development needs of these patients, unless medically contraindicated.

(5) Minimum nurse to patient ratios for intensive care and critical care patients. There shall be a minimum of one registered professional nurse assigned to care for every two patients that an attending practitioner determines to require intensive or critical care.

(i) The minimum registered professional nurse-to-patient ratio set forth in this subdivision shall apply whenever the attending practitioner determines that the condition and medical needs of the patient requires admission to an intensive care unit (ICU) or critical care unit (CCU), and considers the continued need for that level of care based on ongoing assessments. The minimum staffing standard or ratio provided to a patient in an ICU or CCU shall be based on patient acuity, as determined by the attending practitioner and not solely based on the location of the patient.

(ii) The minimum staffing requirements of this subdivision shall not apply to a patient when:

(a) the attending practitioner has determined that a patient in the ICU or CCU no longer requires intensive or critical care or the patient is awaiting transfer to a lower level of care unit; or

(b) a patient is placed in the ICU or CCU when an acute care or other inpatient service bed is not available and the attending practitioner has determined that the patient in the ICU or CCU does not require intensive or critical care;

(iii) Complaints of potential violations of this subdivision shall be made to the clinical staffing committee.  Complaints of potential violations of this subdivision, that have first been submitted to the clinical staffing committee, may be made to the department if they remain unresolved by the clinical staffing committee after 90 days have elapsed.

(b) Pediatric Intensive Care Unit (PICU) Services.

(1) Definitions.

(i) PICU. A PICU is a physically separate unit that provides intensive care to pediatric patients (infants, children and adolescents) who are critically ill or injured. A PICU must be staffed by qualified practitioners competent to care for critically ill or injured pediatric patients.

(ii) Qualified practitioner. Qualified practitioner as referred to in this section shall mean a practitioner functioning within his or her scope of practice according to State Education Law who meets the hospital's criteria for competence, credentialing and privileging practitioners in the management of critically ill or injured pediatric patients.

(2) General. (i) A PICU must be approved by the Department. The governing body of a hospital that provides PICU services must develop written policies and procedures for operation of the PICU in accordance with generally accepted standards of medical care for critically ill or injured pediatric patients. The PICU shall:

(a) Provide multidisciplinary definitive care for a wide range of complex, progressive, and rapidly changing medical, surgical, and traumatic disorders occurring in pediatric patients;

(b) Have a minimum average annual pediatric patient number of 200/year;

(c) Have age and size appropriate equipment available in the unit; and

(d) Provide medical oversight for interhospital transfers of critically ill or injured patients during transfer to the receiving PICU.

(ii) Organization and Direction. The PICU shall be directed by a board certified pediatric medical, surgical, or anesthesiology critical care/intensivist physician who shall be responsible for the organization and delivery of PICU care and has specialized training and demonstrated competence in pediatric critical care. Such physician in conjunction with the nursing leadership responsible for the PICU shall participate in administrative aspects of the PICU. Such responsibilities shall include development and annual review of PICU policies and procedures, oversight of patient care, quality improvement activities, and staff training and development.

(a) All hospitals with PICUs must have a physician, notwithstanding emergency department staffing, in-house 24 hours per day who is available to provide bedside care to patients in the PICU. Such physician shall be at least a post graduate year three in pediatrics or anesthesiology. This physician must be skilled in and be credentialed by the hospital to provide emergency care to critically ill or injured children.

(b) The PICU shall have, at a minimum, a physician at the level of post graduate year two or above and/or physician assistant and/or nurse practitioner with specialized training in pediatric critical/intensive care assigned to the unit 24 hours/day, 7 days/week with an attending pediatric, medical, surgical or anesthesiology critical care/intensivist available within 60 minutes.

(c) An attending pediatric medical, surgical, or anesthesiology critical care/intensivist physician shall be responsible for the oversight of patient care at all times.

(d) The PICU shall provide registered professional nursing staffing sufficient to meet critically ill or injured pediatric patient needs, ensure patient safety and provide quality care, and that meets the ICU clinical staffing plan requirements in subdivision (c) of this section.

(e) PICU physician and nursing staff shall have successfully completed a course and be current in pediatric advanced life support (PALS) or have current equivalent training and/or experience to PALS.

(iii) Quality Performance. The hospital shall have an organized quality assessment performance improvement (QAPI) program for PICU services. Such program shall require participation by all clinical members of the PICU team and include: monitoring of volume and outcomes, morbidity and all case mortality review, regular multidisciplinary conferences including all health professionals involved in the care of PICU patients.

(iv) Closure. Failure to meet one or more regulatory requirements or inactivity in a program for a period of 12 months or more may result in actions, including, but not limited to, the Department's withdrawal of approval for the hospital to serve as a PICU.

(v) Voluntary closure. The hospital must give written notification, including a closure plan acceptable to the department, at least 90 days prior to planned discontinuance of PICU services. No PICU shall discontinue operation without first obtaining written approval from the department.

(vi) Notification of significant changes. A hospital must notify the department in writing within 7 days of any significant changes in its PICU services, including, but not limited to: (a) any temporary or permanent suspension of services or (b) difficulty meeting staffing or workload requirements.

(c) Reserved.

(d) Burn unit/center. (1) Personnel and staffing.

(i) A burn unit/center shall designate a director who is a board-certified or board-admissible general or plastic surgeon with one additional year of specialized training in burn therapy or equivalent experience in burn patient care.

(ii) Staff for the burn unit/center shall be in accordance with the annual clinical staffing plan established under paragraph (8) of subdivision (a) of section 405.5 of this Title and shall include:

(a) a head nurse of the facility who is a registered professional nurse, with two years intensive care unit or equivalent training and a minimum of six months burn experience;

(b) one registered professional nurse for every two intensive care patients at all times;

(c) one registered professional nurse for every three nonintensive care patients at all times;

(d) on staff, or through formal arrangement, a physical therapist and occupational therapist with a minimum of three months training or six months experience in burn treatment available as needed;

(e) staff or through formal arrangement a registered dietician available as needed;

(f) on staff, or through formal arrangement, a medical social worker responsible for referral and follow-up care and individual and group counseling available as needed; and

(g) a psychologist and/or psychiatrist available as needed.

(iii) The burn unit/center shall be responsible for training facility staff and other personnel within the service area on emergency treatment procedures, assessment of total body surface area affected, and the classification of burns and triage protocols.

(2) Operation and service delivery.

(i) Each burn unit/center shall have a minimum of six beds.

(ii) Each burn unit/center shall treat a minimum of 50 patients with major burn injury to moderate uncomplicated burn injury per year.

(iii) The burn unit/center shall refer patients for whom there are no available beds to another burn unit/center which can provide the care needed.

(iv) Each burn unit/center shall have available, either through direct control or through a network of clearly identified relationships, a system of land and/or air transport which will bring severe burn victims to the unit/center.

(v) Each burn unit/center shall have a designated area for providing specialized intensive care and an operating room easily accessible within the hospital.

(vi) Reviews of each patient with major burn injury or moderate uncomplicated burn injury shall be undertaken on a weekly basis by the burn care team.

(e) Alternate level of care. (1) Organization and staffing.

(i) Patients on each service of the hospital who have been assigned alternate level of care status shall be congregated on a single care unit when there are 10 or more such persons on the service. Patients for whom discharge is anticipated within 14 days and patients whose identified needs cannot be safely and effectively met on this unit need not be transferred to the congregate unit and shall not be counted in the 10-patient threshold.

(ii) If the hospital can demonstrate to the department that it can fully meet the needs of patients assigned alternate level of care status without congregating such patients, it may provide such services in accordance with a plan approved by the department in lieu of meeting the requirements of subparagraph (i) of this paragraph.

(iii) The hospital shall appoint a staff person who has administrative responsibility for the delivery of patient care services to patients assigned alternate level of care status and for the supervision of the services whether or not they are provided by congregate care units.

(iv) The appointed staff person shall monitor and evaluate the quality and appropriateness of care provided to alternate level of care patients and shall ensure that identified problems are resolved and are reported, as appropriate, to the hospital-wide quality assurance program.

(2) Delivery of services. (i) The hospital shall provide each patient assigned to alternate level of care status care and services in accordance with a multidisciplinary assessment of needs in order to promote the patient's independence and health.

(a) A written individualized, comprehensive care plan based upon the patient's assessed needs shall include, but not be limited to:

(1) medical and nursing care;

(2) assistance and/or supervision, when required, with activities of daily living, such as toileting, feeding, ambulation, bathing including routine skin care, care of hair and nails, and oral hygiene;

(3) rehabilitation therapy services as the patient's needs indicate;

(4) an activities program appropriate to the needs and interest of each patient to sustain physical and psychosocial functioning; and

(5) other clinical care and supportive services to meet the needs of patients.

(b) The written individualized comprehensive care plan shall be developed and implemented by all of the qualified professionals whose services are required by the patient under the supervision and coordination of the patient's attending physician and with the involvement of the patient and the family to the extent possible, in accordance with the patient's wishes.

(c) The comprehensive care plan shall establish realistic and measurable goals for short- and long-term care needs, and shall identify the type, amount and frequency of care and services needed to maintain, restore and/or promote the patient's functioning and health within stated time frames for achievement.

(f) Acquired immune deficiency syndrome (AIDS) centers. (1) Definition. An AIDS center shall mean a hospital approved by the commissioner pursuant to Part 710 of this Title as a provider of designated, comprehensive and coordinated services for AIDS patients in accordance with the requirements of this section. These services shall include inpatient, outpatient, community and support services for the screening, diagnosis, treatment, care and follow-up of patients with AIDS.

(2) Administrative requirements. The hospital shall ensure that:

(i) integrated and comprehensive services are provided onsite to include, as a minimum, the following:

(a) a designated patient care unit for AIDS patients, except that the commissioner may waive this requirement, under a plan acceptable to the commissioner for placing patients in other than a designated unit, if the AIDS center meets all other requirements of this section and the hospital can demonstrate:

(1) that it is unable, due to structural or space limitations, to place the AIDS patients in a designated unit; or

(2) specific programmatic or operational reasons why it is preferable not to use a designated unit or not practicable to have a designated unit for AIDS patients;

(b) an outpatient clinic program for screening, diagnostic and treatment services for AIDS patients; and

(c) emergency services, available 24 hours a day, for treatment of AIDS patients;

(ii) other health care services, as appropriate, are provided directly or through contract for AIDS patients, to include at least the following:

(a) home health care, provided through a home care services agency licensed or certified under article 36 of the Public Health Law, made available 24 hours a day, 7 days a week;

(b) personal care services;

(iii) all reasonable efforts are made to provide or arrange for the following services and programs to meet the needs of the AIDS patients:

(a) residential health care;

(b) hospice services provided through a hospice certified under article 40 of the Public Health Law; and

(c) residential living programs;

(iv) diagnostic and therapeutic radiology services and other specialized services are made available to meet the needs of AIDS patients;

(v) inservice education programs which address the medical, psychological and social needs spedific to AIDS patients are conducted for all hospital personnel caring for AIDS inpatients;

(vi) infection control policies and procedures pertinent to AIDS are developed and implemented as an integral part of the hospital-wide infection control program;

(vii) a quality assurance program, which includes a review of the appropriateness of care for patients with AIDS, is developed and implemented as an integral part of the overall quality assurance program;

(viii) at the request of the department, it shall participate in clinical research programs approved by the hospital's institutional review board/human research review committee;

(ix) resource information about AIDS shall be available to the public, and educational programs are provided for particular high-risk populations in their service area; and

(x) a crisis intervention program shall be made available in coordination with other existing community services.

(3) Patient referral, admission and discharge. The hospital shall ensure that:

(i) policies and procedures are developed and implemented which address admission criteria for AIDS patients, referral mechanisms and coordinated discharge planning;

(ii) only patients who meet the admission criteria for AIDS are admitted to the designated patient care unit;

(iii) services which the center provide are available to all persons regardless of age, race, color, creed, sex, sexual orientation, disability, national origin or ability to pay;

(iv) there are transfer agreements in effect with other hospitals in accordance with section 400.9 of this Title for the acceptance of referrals or the transfer of AIDS patients in need of specialized services available at the center; and

(v) professional staff responsible for planning patient discharges, referrals or transfers shall have available current information regarding home care programs, institutional health care providers and other support services within the hospital's primary service area.

(4) Patient management plan. The hospital shall ensure that:

(i) a multidisciplinary team, whose composition reflects inpatient and outpatient care services, operating in conjunction with the attending physician:

(a) shall be responsible for each AIDS patient;

(b) shall include, as appropriate to the needs of the AIDS patient, health care professionals from nursing, nutritional, mental health and social work services; and

(c) whenever practicable, the AIDS patient is assigned to the same multidisciplinary team;

(ii) a comprehensive patient management plan is developed by the multidisciplinary professional team, the patient, and when appropriate, home health care or other nonacute long-term care representatives, in consultation with the patient's family and other individuals with significant personal ties to the patients, which:

(a) shall reflect the ongoing psychological, social, functional and financial needs of the patient and is oriented to posthospital, ambulatory care and community support services;

(b) shall be based on the patient's illness, prescribed treatments and the individual patient's needs and choices;

(c) shall be reviewed and updated to reflect the patient's changing needs and current status;

(d) shall include transfer or discharge and follow-up plans coordinated by the multidisciplinary team or the case manager;

(e) shall be forwarded with the patient upon discharge or transfer for posthospital care; and

(f) shall evaluate the extent to which the patient or patient's personal support system can provide or arrange to provide for identified care needs of the patient in the home situation;

(iii) a case manager shall be designated from the multidisciplinary team to be responsible for coordinating the health care services and plan for each AIDS patient; and

(iv) a mechanism shall be established to assure periodic reviews and updates of the patient management plan in conjunction with other agencies involved with, or responsible for, the care of the AIDS patient;

(5) Medical director. The hospital shall appoint a physician who:

(i) shall be a qualified physician with special training in infectious diseases, oncology or other appropriate subspecialty;

(ii) shall direct and coordinate all medical services provided in the AIDS center;

(iii) shall ensure the implementation of the quality assurance program as specified in subparagraph (2)(vii) of this subdivision;

(iv) shall ensure that all members of the health care team participate in the quality assurance program;

(v) shall ensure that interdisciplinary rounds that include the health care professionals responsible for the patient's total care are made on a timely and sufficiently frequent basis as determined by each patient's needs;

(vi) shall ensure that other qualified physician specialists are available for consultation as indicated by the patient's condition; and

(vii) shall ensure that routine dental services are available for AIDS patients.

(6) Quality assurance monitoring. (i) The commissioner shall monitor and evaluate the quality and appropriateness of care provided to AIDS patients by the AIDS center through mechanisms which include, but are not limited to, the monitoring and evaluation of patient management plans, utilization reviews and quality assurance programs.

(ii) The department and its AIDS Institute shall develop criteria for assessing the effectiveness of AIDS centers in providing care that meets the special needs of AIDS patients.

(7) Construction requirements. The designated patient care unit shall be a discrete unit which complies with the requirements of section 712.2 of this Title, except as modified by the following:

(i) maximum patient room capacity shall be two beds, except that more than two beds per room may be allowed under a protocol based on patient diagnosis and approved by the commissioner;

(ii) patient room temperature shall be capable of being maintained between 70 and 80 degrees F. Individual room air-conditioning units may be used; and

(iii) each patient care unit shall have at least one functional dayroom with space commensurate with the needs of the patients.

(g) Comprehensive and extended screening and monitoring services for epilepsy. (1) Definition. (Comprehensive and extended screening and monitoring services for epilepsy) shall mean a planned combination of services including inpatient and outpatient care which shall include, but not be limited to: electroencephalographic monitoring, selection of appropriate anticonvulsant medication through neuropharmacological monitoring, surgical interventions, if indicated, and management of a patient's psychological and social needs through a coordinated interdisciplinary team approach. For purposes of this section, extended screening and monitoring services are considered rehabilitative care.

(2) Comprehensive and extended screening and monitoring services for epilepsy shall be provided in a hospital approved by the commissioner pursuant to Part 710 of this Title as a provider of such services. The purpose of these services is to treat and rehabilitate patients with uncontrolled seizures in order to restore and promote them to their optimal level of functioning.

(3) Administrative requirements. The hospital shall ensure that:

(i) policies and procedures be developed and implemented which address the provision and coordination of care between the inpatient unit and the outpatient unit for comprehensive and extended screening and monitoring services for patients with epilepsy;

(ii) a physician is appointed to direct the service, who is a qualified neurologist and who has demonstrated competence in the services and care provided to patients with epilepsy;

(iii) an interdisciplinary team of health care professionals with training and experience in the treatment of epilepsy shall be responsible for assessing patients and planning, providing and coordinating care. The interdisciplinary team shall include as a minimum the following types of health care professionals: neurologist, neurosurgeon, registered professional nurse, pharmacist, psychiatrist with training in neuropsychiatry, psychologist with training in neuropsychology, social worker, dietician, physical therapy, occupational therapist, and dentist;

(iv) consultative services of a neurologist with experience in pediatrics shall be made available as needed;

(v) the service shall provide or make formal arrangements for vocational rehabilitation services and special education services for patients who can benefit from such services;

(vi) comprehensive and extended screening and monitoring services for epilepsy shall include clinical services with staff specialized in electroencephalography, cable telemetry and neuropharmacological monitoring of anticonvulsant drugs; and

(vii) as part of the hospital's quality assurance program, the comprehensive epilepsy service shall implement a system for evaluating the quality and appropriateness of patient care and patient outcomes. Reports summarizing the outcomes from the quality assurance program for these services shall be submitted to the department on an annual basis.

(h) Pediatric and maternal human immunodeficiency virus (HIV) services.

(1) Applicability.

(i) AIDS centers designated in accordance with subdivision (g) of this section which have pediatric and/or maternity services shall provide specialized services for infants, children, adolescents, and pregnant women who are infected with human immunodeficiency virus (HIV) or who are HIV antibody positive and comply with the pertinent provisions of this subdivision as well as those in subdivision (g).

(ii) Hospitals not designated as AIDS centers in accordance with subdivision (g) may be approved to provide specialized services for infants, children, adolescents, and pregnant women who are infected with human immunodeficiency virus (HIV) or who are antibody positive, if the hospital:

(a) is in an area of high prevalence of HIV infection in children and women as evidenced by the hospital's newborn HIV seropositivity rate and the hospital's discharge rate for pediatric and maternal HIV related disorders;

(b) provided care in the past to pediatric and maternal HIV patients;

(c) demonstrates that it is unable to meet the requirements for full designation under subdivision (g) of this section; and

(d) complies with the requirements of this subdivision and subdivision (g) of this section, except for the definition of AIDS center in paragraph (g)(1) and except for the administrative requirement regarding designated patient care units in clause (g)(2)(i)(a).

(iii) A patient shall be eligible for services if the patient is an infant, child, adolescent or a pregnant woman who is infected with HIV or is HIV antibody positive, whether or not the patient has progressed to symptomatic HIV related illness.

(iv) For purposes of these regulations, family shall include the patient's immediate kin, legal guardian or anyone with significant personal ties to and who resides with the patient.

(2) Organization of services. The hospital shall ensure that:

(i) patients who require HIV related services are identified and referred for care by the pediatric and maternal HIV services;

(ii) obstetrical, pediatric and medical services develop and implement procedures to coordinate the clinical care of pediatric and maternal HIV patients to ensure the voluntary identification of potentially affected patients and family members and the delivery of appropriate services;

(iii) an organizational plan and policies and procedures are developed and implemented which address interdepartmental relationships and communications between the pediatric and maternal HIV services;

(iv) patient care services are provided through a coordinated interdisciplinary team approach. Inpatient and outpatient services shall be organized to preclude unnecessary hospitalization and to ensure continuity of care. A member of the interdisciplinary team managing the patient shall be designated as the individual patient's and family's case manager and shall be responsible for serving as a liaison among patient, family, staff and resources in the community and responsible for coordinating the comprehensive family management plan;

(v) services are family-centered and, in addition to the inpatient services, include the following ambulatory care and community support services: dental, substance abuse treatment, family planning, infusion therapy, mental health, neurodevelopmental evaluation, nutrition, rehabilitation therapies, prenatal care and primary care services;

(vi) other health and related human services are provided or arranged for as appropriate to meet the personal, social, educational, developmental and financial needs of these patients, including as a minimum:

(a) personal services such as caregiver support, day care, homemaker, housekeeper, transitional residential living programs, respite and transportation to and from needed services;

(b) referral for legal services as appropriate to the needs of the patient;

(c) identification and referral of children and adolescents in need of foster care and adoption services;

(d) financial services such as emergency support, food stamps, housing assistance, medical assistance, public assistance, Social Security Disability, Supplemental Security Income and Special Supplemental Food Program for Women, Infants and Children; and

(e) education and developmental services such as early intervention and therapeutic day care services.

(vii) a comprehensive family management plan is developed and implemented to address the medical, nursing, nutritional, functional, developmental, educational, psychological, social and financial needs of the patient and family, which plan:

(a) integrates the patient management plans as specified in subdivision (g) of this section with plans addressing the needs of the family; and

(b) documents the assessment and the monitoring of the patient's and family's needs with reassessment as necessary.

(3) Patient referral, admission and discharge. The hospital shall ensure that:

(i) services begin at the time of the patient's entry into the pediatric and maternal HIV service program and continue until the patient chooses not to participate in the pediatric and maternal HIV service; or relocates outside the pediatric and maternal HIV service catchment area; or transfers to another AIDS center or pediatric and maternal HIV service; or expires;

(ii) admission criteria include provisions for the assignment of pediatric and adolescent patients to a unit appropriate for the developmental needs of the patient; and

(iii) written policies and procedures are established and implemented for the pediatric and maternal HIV service to include voluntary HIV counseling and testing.

(i) Secure units for tuberculosis patients including detainees.

(1) Definition. (Secure unit for tuberculosis patients including detainees) shall mean a designated patient care unit specifically designed to treat patients who have been diagnosed with active tuberculosis. Hospitals shall provide such patients with safe and adequate care within such unit in accordance with procedures approved by the Commissioner. Patients eligible for admission to such units shall include:

(i) patients who have been found to be noncompliant with medical regimens and legally remanded to such unit who shall receive priority admission to and retention in such unit. The rights of such patients to leave such units shall be restricted in accordance with the order legally remanding them to such units; and

(ii) other patients requiring acute care for active tuberculosis, but not legally remanded for treatment, including intensified treatment for those individuals with multiple drug resistant tuberculosis. Such patients shall retain rights to voluntary egress from and entrance to such units in accordance with generally accepted medical practice and consistent with the rights of patients in other units of the hospital.

(2) Staffing and operation. A secure unit for tuberculosis patients including detainees shall:

(i) maintain staff that are adequate in number and trained, including continuing education and inservice training, to perform all necessary activities related to the treatment and care of such patients with tuberculosis;

(ii) implement procedures to identify, diagnose and treat patients who exhibit signs and symptoms of infectious disease including the use of appropriate isolation practices;

(iii) consist of an environmentally sound physical plant in accordance with current, generally accepted standards of infection control practices specifically relating to tuberculosis. Such practices shall address ventilation, air dilution, and the provision of adequate and appropriate isolation facilities; and

(iv) provide adequate and effective personal protective devices to any persons at risk of exposure to infectious tuberculosis. Such protective devices shall be utilized and monitored through a respiratory program which shall ensure training, proper use and/or fit of such appropriate devices in accordance with generally accepted standards of practice.

(3) Approval. Hospitals wishing to operate secure units for tuberculosis patients including detainees, for which construction approval pursuant to Part 710 is not otherwise required, shall apply to the Commissioner of Health for approval to operate such units pursuant to section 710.1(c)(5) of such Part specifically requiring a limited review.

(j) Tuberculosis treatment center - for legally detained tuberculosis patients.

(1) Definition. (Tuberculosis treatment center for legally detained tuberculosis patients) shall mean a designated patient unit or site specifically designed to treat and contain those patients who have been remanded pursuant to applicable statute, for treatment, care, and observation for active tuberculosis. Hospitals shall be equipped and staffed with safeguards approved by the commissioner as adequate to contain these patients and prevent elopement or escape.

(2) Admission, transfer and discharge.

(i) Patients shall be admitted to such center only when:

(a) such patients require a reduced level of medical care with such care needs expected to continue for an extended period of time;

(b) such patients do not require the greater intensity of services provided by a secure unit for tuberculosis patients as defined in subdivision (j) of this section; and

(c) such center has the capability to meet the ongoing medical, nursing and psycho-social needs of the patient.

(ii) Patients shall be transferred from such center to a secure unit for tuberculosis patients at a hospital operating such unit when:

(a) a change in the patient's medical condition necessitates movement to a unit providing more intense services;

(b) security for the legally remanded patient during transfer can be assured; and

(c) the patient and the patient's designated representative have been notified of the pending transfer. Such notification shall be given as soon as possible after the need for transfer has been documented.

(iii) Patients shall be discharged from such center only when treatment goals have been met in accordance with the order legally remanding them to the center.

(3) Staffing and Operation. A tuberculosis treatment center for legally detained tuberculosis patients shall:

(i) maintain staff that are adequate in number and qualifications to perform all necessary activities related to the care and treatment of such patients with active tuberculosis. The staff shall be from those disciplines that provide the training necessary to meet the medical/nursing and psycho-social aspects of the care necessary for these patients;

(ii) implement procedures to diagnose, treat and monitor patients who exhibit signs and symptoms of infectious disease, including the use of appropriate isolation practices;

(iii) consist of an environmentally sound physical plant in accordance with current, generally acceptable standards of infection control specifically relating to tuberculosis. Such plant design shall include adequate dilutional ventilation, safe exhaust/discharge of potentially contaminated air, and the provision of adequate isolation facilities with appropriate directional air flow;

(iv) provide adequate and effective security control systems which will safely contain the legally detained patient and prevent elopement or escape of such patient;

(v) provide adequate and effective personal protective devices to any persons at risk of exposure to an infectious tuberculosis patient. Such protective devices shall be utilized and monitored through a respiratory program which shall adequately train individuals in the proper use and/or fit of such appropriate devices in accordance with generally accepted standards of practice;

(vi) monitor employees for tuberculosis infection on an ongoing basis and review aggregate results of such monitoring; and

(vii) monitor environmental controls to ensure proper functioning.

(4) Approval. Hospitals wishing to operate a tuberculosis treatment center for legally detained tuberculosis patients for which construction approval pursuant to Part 710 is not otherwise required, shall apply to the Commissioner of Health for approval to operate such centers pursuant to section 710.1(c)(5) of such Part, which provides for a limited review.