Article 2 - Hospitals

Effective Date: 
Thursday, August 6, 2020
Doc Status: 
Complete

Part 405 - Hospitals--Minimum Standards

Effective Date: 
Thursday, August 6, 2020
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 2803, 2805-k, 2805-l, 2805-m, 2805-v, 2805-w, 4351

Section 405.1 - Introduction

Section 405.1 Introduction. (a) General hospitals, hereinafter referred to as hospitals, shall comply with all of the requirements of this Part:

(1) hospitals shall comply with construction standards contained in Article 2 of Subchapter C of this Chapter (Medical Facility Construction); and

(2) the commissioner may accept as evidence of compliance with the minimum operational standards of this Part, 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. Hospitals shall notify the commissioner in writing within seven days after receipt of notice of failure to be accredited, re-accredited or the loss of accreditation by the accreditation agency.

(b) The provisions of Parts 700, except for paragraphs (a) (1), (a)(21)-(22), (b)(25) and (c)(7), (35)-(41) of section 700.2; 702; 703, except for section 703.6; 706; and 707 of Article 1 of this Chapter shall not apply to general hospitals.

(c) Any person, partnership, stockholder, corporation or other entity with the authority to operate a hospital must be approved for establishment by the Public Health Council unless otherwise permitted to operate by the Public Health Law or as provided for by section 405.3 of this Part. For the purposes of this Part, a person, partnership, stockholder, corporation or other entity is an operator of a hospital if it has the decision-making authority over any of the following:

(1) appointment or dismissal of hospital management level employees and medical staff, except the election or removal of corporate officers by the members of a not-for-profit corporation;

(2) approval of hospital operating and capital budgets;

(3) adoption or approval of hospital operating policies and procedures;

(4) approval of certificate of need applications filed by or on behalf of the hospital;

(5) approval of hospital debt necessary to finance the cost of compliance with operational or physical plant standards required by law;

(6) approval of hospital contracts for management or for clinical services; and

(7) approval of settlements of administrative proceedings or litigation to which the hospital is party, except approval by the members of a not-for-profit corporation of settlements of litigation that exceed insurance coverage or any applicable self-insurance fund.

(d) Nothing in subdivision (c) of this section shall require the establishment of any member of a not-for-profit corporation, which operates a hospital, based upon such member's reservation and exercise of the power to require that the hospital operate in conformance with the mission and philosophy of the hospital corporation. (e) The requirements of this Part relating to patient care and services shall apply to patients of all ages, including newborns, pediatric and geriatric patients.

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.2 - Governing body

405.2 Governing body. (a) The established operator shall be legally responsible for the quality of patient care services, for the conduct and obligations of the hospital as an institution and for ensuring compliance with all Federal, State and local law.

(b) Organization and operation. (1) The hospital shall have a governing body legally responsible for directing the operation of the hospital in accordance with its mission. If a hospital does not have an organized governing body, then the person or persons legally responsible for the conduct of the hospital shall carry out the functions specified in this Part that pertain to the governing body. Hospitals operated by governmental organizations, with the exception of those sponsored by the Federal government, shall provide written notification to the commissioner of their designated governing bodies and the legal authority establishing these designations. No contracts/arrangements or other agreements may limit or diminish the responsibility of the governing body in any way.

(2) The governing body, in order to achieve and maintain generally accepted standards of professional practice and patient care services in the hospital, shall establish, cause to implement, maintain and, as necessary, revise its practices, policies and procedures for the ongoing evaluation of the services operated or delivered by the hospital and for the identification, assessment and resolution of problems that may develop in the conduct of the hospital.

(3) All officers, directors, trustees, partners, or sole proprietors of the governing body shall participate in orientation and continuing education programs addressing the mission of the institution, their roles and responsibilities, patients' rights, and the organization, goals and operation of the hospital's quality assurance program.

(4) The governing body shall adopt written bylaws reflecting its legal responsibility and accountability to the patients and its obligation to the community it was established to serve. The bylaws shall specify at least the following:

(i) the role and purpose of the hospital;

(ii) the duties and responsibilities of the governing body;

(iii) the responsibilities of any governing body committees including the requirement that minutes reflect all business conducted, including findings, conclusions and recommendations;

(iv) the relationships and responsibilities of the governing body, hospital administration, and the medical staff, and the mechanism established by the governing body for holding such parties accountable;

(v) the mechanisms for adopting, reviewing and revising governing body bylaws; and

(vi) the mechanisms for formal approval of the organization, bylaws, rules and regulations of the medical staff and its departments in the hospital.

(5) Meetings of the governing body shall be held in order for the governing body to evaluate the conduct of the hospital, including the care and treatment of patients as well as its own performance. Based on these evaluations, the governing body shall take necessary actions sufficient to correct noted problems. A record of all governing body proceedings which reflects all business conducted, including findings, conclusions and recommendations, shall be maintained for review and analysis.

(6) The governing body shall establish and maintain a coordinated program which integrates the review activities of all hospital services for the purpose of enhancing the quality of patient care and identifying and preventing malpractice.

(c) Compliance with Federal, State and local laws. (1) The hospital shall comply with all applicable Federal, State and local laws, including the New York State Public Health Law, Mental Hygiene Law, and the Education Law.

(2) The governing body shall take all appropriate and necessary actions to monitor and restore compliance when deficiencies in the hospital's compliance with statutory and/or regulatory requirements are identified, including but not limited to monitoring the chief executive officer's submission and implementation of all plans of correction.

(d) Chief executive officer. The governing body shall appoint a chief executive officer who is responsible to the governing body for the management of the hospital. This function shall not be delegated to or shared with any organization except under a management authority contract approved by the commissioner pursuant to section 405.3 of this Part.

(1) The chief executive officer shall be qualified for his/her responsibilities through education and experience.

(2) The governing body shall assure the chief executive officer's effective performance through ongoing documented monitoring and evaluation of that performance against written criteria developed for the position. Such criteria shall include the hospital's compliance with statutory and regulatory requirements, the corrective actions required and taken to achieve such compliance, and the maintenance of corrective actions to achieve continued compliance in previously deficient areas.

(e) Medical staff. The governing body shall: (1) determine, in accordance with State law, which categories of health care practitioners are eligible candidates for appointment to the medical staff;

(2) appoint a physician, referred to in this Part as the medical director, who is qualified for membership on the medical staff and who shall be responsible for directing the medical staff organization in accordance with provisions of section 405.4 of this Part. Such appointment shall be made after consultation with the medical staff. In making such appointment the governing body may consider an individual who is a clinical department chairperson, an elected president of the medical staff, a medical staff committee chairperson, or any other person who meets the requirements for appointment set forth in this paragraph. The medical director may carry out his or her duties on either a full or part-time basis and on a salaried or nonsalaried basis as determined by the governing body and may report to the governing body directly, or to the governing body through the chief executive officer or through another route as determined by the governing body;

(3) ensure the implementation of written criteria for selection, appointment and reappointment of medical staff members and the the delineation of their medical privileges. Such criteria shall include standards for individual character, competence, training, experience, judgement, and physical and mental capabilities;

(4) ensure that staff membership or professional privileges in the hospital are not dependent solely upon certification, fellowship, or membership in a speciality body or society;

(5) appoint members of the medical staff after considering the recommendations of the existing members of the medical staff in accordance with written procedures, as established by hospital and medical staff bylaws;

(6) ensure that actions taken on applications for medical staff appointments and reappointments including the delineation of privileges are put in writing;

(7) ensure that the medical staff has written bylaws;

(8) approve medical staff bylaws and any other medical staff rules and regulations;

(9) require that members of the medical staff abide by the rules, regulations and bylaws of the hospital;

(10) ensure that the medical staff is accountable to the governing body for the quality of care provided to patients; and

(11) require that members of the medical staff practice only within the scope of privileges granted by the governing body.

(f) Care of patients. The governing body shall require that the following patient care practices are implemented, shall monitor the hospital's compliance with these patient care practices, and shall take corrective action as necessary to attain compliance:

(1) every patient of the hospital, whether an inpatient, emergency service patient, or outpatient, shall be provided care that meets generally acceptable standards of professional practice;

(2) every patient is under the care of a health care practitioner who is a member of the medical staff;

(3) patients are admitted to the hospital only on the recommendation of a licensed practitioner permitted to admit patients to a hospital;

(4) a physician, or a licensed physician assistant under the general supervision of a physician, or a nurse practitioner in collaboration with a physician, is on duty all times in the hospital except that the Commissioner may approve substitute coverage, for all or part of each day, by each patient's attending physician when these physicians are immediately available to the hospital by telephone, and available in person or by telemedicine within 30 minutes as needed, upon a hospital demonstrating to the Commissioner that:

(i) all patients are medically stable and patients who become medically unstable are promptly transferred to an appropriate receiving hospital in accordance with Section 400.9 of this title;

(ii) the hospital does not operate an emergency service; and

(iii) the entire hospital has less than 25 approved beds.

(5) a physician shall be responsible for the care of each patient with respect to any medical or psychiatric problem that is present on admission or develops during hospitalization;

(6) hospitals which conduct, or propose to conduct, or otherwise authorize human research on patients or other human subjects shall adopt and implement policies and procedures pursuant to the provisions of Public Health Law, article 24-A for the protection of human subjects;

(7) hospitals shall have available at all times personnel sufficient to meet patient care needs; and (8) hospitals shall have in place evidence-based protocols for the early recognition and treatment of patients with severe sepsis and septic shock that are based on generally accepted standards of care as required by subdivision (a) of section 405.4 of this Part.

(g) Physical plant. The governing body is responsible for providing a physical plant equipped and staffed to maintain the needed facilities and services for patients in compliance with construction standards contained in Article 2 of Subchapter C of this Chapter (Medical Facility Construction), and for correcting deficiencies cited by regulatory agencies. (h) Hospital service contracts. The governing body shall be responsible for services furnished in the hospital whether or not they are furnished by outside entities under contracts. The governing body shall ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable codes, rules and regulations.

(1) The governing body shall ensure that the services performed under a contract are provided in a safe and effective manner, in accordance with the requirements of section 400.4 of this Subchapter.

(2) The hospital shall maintain a list of all contracted services, including the scope and nature of the services provided.

(i) As used in this Part to describe the duties or obligations of the governing body of a hospital, the words "assure" or "ensure" shall not affect the standard of liability in damages of a hospital corporation's board of directors, or the board's individual members, beyond the standard set forth in statutory and/or case law applicable in this State.

Effective Date: 
Wednesday, May 17, 2017
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 405.3 - Administration

405.3 Administration. The hospital shall be managed effectively and efficiently in accordance with hospital bylaws and policies and procedures. The daily management and operational affairs of the hospital shall be the responsibility of the chief executive officer.

(a) The chief executive officer shall be responsible for the development, submission and implementation of all plans to correct operational deficiencies identifed by regulatory agencies on a timely basis and shall report to the governing body progress in developing and carrying out plans of correction.

(b) Personnel. The chief executive officer develops and implements personnel policies and practices with regard to at least the following:

(1) the employment of personnel, without regard to sex, race, creed, sexual orientation, disability, or national origin, whose qualifications are commensurate with anticipated job responsiblities;

(2) the identification of all hospital personnel, including students and volunteers, through the use of identification name tags which are clearly visible and are worn at all times;

(3) the orientation of all new employees to the hospital and to hospital and personnel policies;

(4) the development and implementation of a written plan for inservice training, including orientation and training for the governing body;

(5) effective July 1, 1989, the provision, at all times, of intravenous services, phlebotomy services, messenger services, transporter services, nurse aides, housekeeping services and other ancillary support services in a manner sufficient to meet patient care needs and to prevent adverse impact on the delivery of medical and nursing care;

(6) the maintenance of an accurate, current, and complete personnel record for each hospital employee;

(7) the verification of all applicable current licensure/certification;

(8) a periodic performance evaluation, based on a written job description, of each employee;

(9) the provision of employee health services, in consultation with the medical staff; and

(10) the provision for a physicial examination and recorded medical history for all personnel including all employees, members of the medical staff, contract staff, students, and volunteers, whose activities are such that a health impairment would pose a potential risk to patients. The examination 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 hospital is required to provide such examination without cost for all employees who are required to have such examination. For personnel whose activities are such that a health impairment would neither pose a risk to patients nor interfere with the performance of his/her duties, the hospital shall conduct a health status assessment in order to determine that the health and well-being of patients are not jeopardized by the condition of such individuals. The hospital shall require the following of all personnel, with the exception of those physicians who are practicing medicine from a remote location, as a condition of employment or affiliation:

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

(a) 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 thisTitle, demonstrating serologic evidence of rubella antibodies; or

(b) 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

(c) a copy of a document described in (a) or (b) above which comes from a previous employer or the school which the employee attended as a student; and

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

(a) 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

(b) 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

(c) 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

(d) a copy of a document described in (a), (b) or (c) above which comes from a previous employer or the school which the employee attended as a student;

(iii) 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 employee's health, the requirements of (i) and/or (ii) above 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

(iv) 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.

(v) 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.

(11) the reassessment of the health status of all personnel 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;

(12) the provision for emergency health care for all personnel;

(13) the maintenance of medical records for all personnel including the dates, extent and results of all health assessments and physical examinations; the results of laboratory tests and X-ray reports; and records of immunizations, illnesses or injuries;

(14) the requirement that all personnel report immediately to their supervisor any signs or symptoms of personal illness. All personnel making such report shall be referred to an appropriate health care professional for assessment of the potential risk to patients and personnel. Based on this assessment, the hospital shall authorize appropriate measures to be taken, including but not limited to removal, reassignment or return to duty;

(15) the safety and protection of all personnel and advice to personnel concerning the nature of toxic substances which they may encounter in the workplace in the course of their employment or affiliation, in accordance with article 28 of the New York State Labor Law; and

(16) a policy that no hospital employee or member of a hospital medical staff shall be required by the hospital or a member of the hospital staff to participate in an induced termination of pregnancy who has informed the hospital of his or her decision not to participate in such act or acts;

(c) The hospital shall have a written agreement which defines the respective roles and responsibilities of the hospital and any educational program which utilizes the clinical facilities of the hospital for the education of students. Such agreement shall recognize the responsibility of the hospital for activities of the educational program and students which affect the care of patients.

(d) Records and reports. Any information, records or documents provided to the department shall be subject to the applicable provisions of the Public Health Law, Mental Hygiene Law, Education Law, and the Public Officers Law in relation to disclosure. The hospital shall maintain and furnish to the Department of Health, immediately upon written request, copies of all documents, including but not limited to:

(1) all records related to patient care and services;

(2) the certificate of incorporation or the partnership agreement, and the certificate of conducting business under an assumed name as required by General Business Law, section 130;

(3) the reports of hospital inspections and surveys of outside agencies with statements attached specifying the steps taken to correct any hazards or deficiencies or to carry out the recommendations contained therein;

(4) all contracts, leases and other agreements entered into by the governing authority pertaining to the ownership of the land, building, fixtures and equipment used in connection with the operation of the hospital;

(5) all licenses, permits and certificates required by law for the operation of the hospital and also for those departments and staff members, where required;

(6) operating procedure manuals for all services or units of the hospital organization. These manuals shall be reviewed at least biennially by the hospital or more frequently as determined appropriate by each service or unit and be made available to all services and units of the hospital;

(7) all bylaws, rules and regulations of the hospital and all amendments thereto; a listing of the names and addresses and titles of offices held for all members of the governing authority and revisions thereof; a copy of the bylaws, rules and regulations of the medical staff and all amendments of the medical staff and revisions thereof; a copy of the current annual report and financial statements of the hospital;

(8) copies of complaints received regarding patient care and documentation of the follow-up actions taken as a result of the investigation of these complaints;

(9) copies of all incident reports completed pursuant to section 405.8 of this Part;

(10) a listing of the names and titles of the members of each committee of the hospital;

(11) written minutes of each committee's proceedings. These minutes shall include at least the following:

(i) attendance;

(ii) date and duration of the meeting;

(iii) synopsis of issues discussed and actions or recommendations made;

(12) whenever the commissioner determines that there exists an outbreak of a highly contagious communicable disease pursuant to Part 2 of this Title or other public health emergency, such syndromic surveillance data as the commissioner deems appropriate, which the hospital shall submit in the manner and form determined by the commissioner; and

(13) any record required to be kept by the provisions of this Part.

(e) Other reporting requirements. (1) The hospital shall report in writing to the Office of Professional Medical Conduct with a copy to the appropriate area administrator of the department's Office of Health Systems Management within 30 days of the occurrence of denial, suspension, restriction, termination or curtailment of training, employment, association or professional privileges or the denial of certification of completion of training of any physician, registered physician's assistant or registered specialist's assistant licensed/registered by the New York State Department of Education for reasons related in any way to any of the following:

(i) alleged mental or physical impairment, incompetence, malpractice, misconduct or endangerment of patient safety or welfare;

(ii) voluntary or involuntary resignation or withdrawal of association or of privileges with the hospital to avoid the imposition of disciplinary measures;

(iii) the receipt of information concerning a conviction of a misdemeanor or felony. The report shall contain:

(a) the name and address of the individual;

(b) the profession and license number;

(c) the date of the hospital's action;

(d) a description of the action taken; and

(e) the reason for the hospital's action or the nature of the action or conduct which lead to the resignation or withdrawal and the date thereof; and

(iv) the hospital shall establish policies and implement procedures to ensure compliance with these reporting requirements.

(2) The hospital shall furnish to the Department of Education or the Department of Health for individuals licensed by the Department within 30 days of occurrence, a written report of any denial, withholding, curtailment, restriction, suspension or termination of any membership or professional privileges in, employment by, or any type of association with a hospital relating to an individual who is a health profession student serving in a clinical clerkship, an unlicensed health professional serving in a clincial fellowship or residency, or an unlicensed health professional practicing under a limited permit or a state licensee, such as an audiologist, licensed master social worker (LMSW), licensed clinical social worker (LCSW), dental hygienist, dentist, medical laboratory technologist, nurse, occupational therapist, ophthalmic dispenser, optometrist, pharmacist, physical therapist, podiatrist, psychologist, radiologic technologist, radiologist assistant, respiratory therapist, respiratory therapy technician or speech-language pathologist for reasons related in any way to any of the following reasons:

(i) alleged mental or physical impairment, incompetence, malpractice, misconduct or endangerment of patient safety or welfare;

(ii) voluntary or involuntary resignation or withdrawal of association, employment or privileges with the hospital to avoid imposition of disciplinary measures; and

(iii) the receipt of information concerning a conviction of a misdemeanor or felony. The report shall contain:

(a) the name and address of the individual;

(b) the profession and license number;

(c) the date of the hospital's action;

(d) a description of the action taken; and

(e) the reason for the hospital's action or the nature of the action or conduct which lead to the resignation or withdrawal and the date thereof.

(3) At the time that a physician on a hospital's staff is granted admitting privileges or before or at the time the physician admits his or her first patient, each hospital shall furnish to such physician the following notice, which each physician on the hospital staff must sign and date. The signed notices shall be kept on file by the hospital. The notice to physicians shall state:

"Notice to physicians. Payment to hospitals for inpatient services is based in part on each patient's principal and secondary diagnoses and the major procedures performed on the patient, and for neonates, upon birthweight or admission weight as well. This data must be documented by the patient's medical record. Anyone who misrepresents, falsifies, or conceals this information may be subject to fine, imprisonment, or civil penalty under applicable Federal and New York State laws."

(4) at the time of discharge, for categories of patients determined by the commissioner, the chief executive officer shall provide the department information in a manner and on a form specified by the department.

(f) Hospital management contracts. (1) For the purposes of this Part, a management contract is an agreement between a hospital 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 facility or a defined patient care unit of the facility. A management contract shall not include:

(i) a contract solely for the provision of professional clinical services;

(ii) an employment contract; or

(iii) a contract for the provision of administrative services to a defined patient care unit of a facility where all of the following factors are present:

(a) the hospital retains responsibility for the day-to-day operations of the defined patient care unit;

(b) the contracting entity has no authority to hire or fire any hospital employee;

(c) the contracting entity does not maintain and control the books and records of the defined patient care unit;

(d) the contracting entity has no authority to incur any liability on behalf of the facility; and

(e) the contracting entity has no authority to adopt or enforce policies regarding the operation of the defined patient care unit.

(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 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;

(ii) A provision that clearly recognizes that the responsibilities of the facility'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 body; and

(iii) a plan for assuring maintenance of the fiscal stability, the level of services provided and the quality of care rendered by the facility during the term of the management contract.

(3) 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 authority:

(i) direct independent authority to appoint and discharge the chief executive officer or other key management employees;

(ii) independent control of the books and records;

(iii) authority over the disposition of assets and the authority to incur on behalf of the facility liabilities not normally associated with the day-to-day operation of a facility; and

(iv) independent adoption of policies affecting the delivery of health care services.

(4) A governing body wishing to enter into a management contract shall submit a proposed written contract to the department, a least 60 days prior to the intended effective date, unless a shorter period is approved in writing by the commissioner, due to extraordinary circumstances. In addition, the governing body 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) documentation of the goals and objectives of the management contracts including a mechanism for periodic evaluation by the governing body of effectiveness of the arrangement in meeting those 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 pricipals, officers and directors, is satisfactory, including evidence that all facilities it has managed in New York State have provided a substantially consistent high level of care in accordance with section 600.2 of this Title, during the term of their management contract or operating certificate; and

(v) evidence that it is financially feasible for the facility to enter into the proposed management contract for the term of the contract and for a period of one year following expiration, recognizing that the costs of the contract are subject to all applicable provisions of Part 86 of this Title. To demonstrate evidence of financial feasibility, the facility shall submit projected operating and capital budgets for the required periods. Such budgets shall be consistent with previous certified financial statements and be subject to future audits.

(5) During the period between a facility's submission of a request for initial approval of a management contract and disposition of that request, a facility 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) The term of a management contract shall be limited to three years and may be renewed for additional periods not to exceed three years only when authorized by the commissioner. The commissioner shall approve an application for renewal provided that 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 time frames;

(ii) that the quality of care provided by the facility during the term of the contract has been maintained or has improved; and

(iii) that the level of service to meet community needs and patient access to care and services has been maintained or improved.

(7) A contract for which an application for renewal has been submitted on a timely basis to the commissioner may be extended on an interim basis until the commissioner approves or disapproves the application for renewal.

(8) A facility's governing body shall, within the terms of the contract, retain the authority to discharge the managing authority and its employees from their positions at the facility with or without cause on not more than 90 days' notice. In such event, the facility shall notify the department in writing at the time the managing authority is notified. The facility's governing body shall provide a plan for the operation of the facility subsequent to the discharge to be submitted with the notification to the department.

(g) Whenever the commissioner determines that there exists an outbreak of a highly contagious communicable disease pursuant to Part 2 of this Title or other public health emergency, the commissioner may direct general hospitals, as defined in Article 28 of the public health law, and consistent with the federal Emergency Medical Treatment and Labor Act (EMTALA), to accept patients pursuant to such procedures and conditions as the commissioner may determine appropriate.

 

Effective Date: 
Friday, June 5, 2020
Doc Status: 
Complete

Section 405.4 - Medical staff

405.4 Medical staff. The hospital shall have an organized medical staff that operates under bylaws approved by the governing body.

(a) Medical staff accountability. The medical staff shall be organized and accountable to the governing body for the quality of the medical care provided to all patients.

(1) The medical staff shall establish objective standards of care and conduct to be followed by all practitioners granted privileges at the hospital. Those standards shall:

(i) be consistent with prevailing standards of medical and other licensed health care practitioner standards of practice and conduct; and

(ii) afford patients their rights as patients in accordance with the provisions of this Part.

(2) The medical staff shall establish mechanisms to monitor the ongoing performance in delivering patient care of practitioners granted privileges at the hospital, including monitoring of practitioner compliance with bylaws of the medical staff and pertinent hospital policies and procedures.

(3) The medical staff shall review and, when appropriate, recommend to the governing body, the limitation or suspension of the privileges of practitioners who do not practice in compliance with the scope of their privileges, medical staff bylaws, standards of performance and policies and procedures, and assure that corrective measures are developed and put into place, when necessary.

(4) The medical staff shall adopt, implement, periodically update and submit to the Department evidence-based protocols for the early recognition and treatment of patients with severe sepsis and septic shock ("sepsis protocols") that are based on generally accepted standards of care. Sepsis protocols must include components specific to the identification, care and treatment of adults, and of children, and must clearly identify where and when components will differ for adults and for children. These protocols must include the following components:

(i) a process for the screening and early recognition of patients with sepsis, severe sepsis and septic shock;

(ii) a process to rapidly identify and document individuals appropriate for treatment through severe sepsis and septic shock protocols, including explicit criteria defining those patients who should be excluded from the protocols, such as patients with certain clinical conditions or who have elected palliative care;

(iii) guidelines for hemodynamic support, including monitoring, therapeutic endpoints and timeframe goals;

(iv) for infants and children, guidelines for fluid resuscitation with explicit timeframes for vascular access and fluid delivery consistent with current, evidence-based guidelines for severe sepsis and septic shock with defined therapeutic goals for children; and

(v) a procedure for identification of infectious source and delivery of early antibiotics with timeframe goals.

(5) The medical staff shall ensure that professional staff with direct patient care responsibilities and, as appropriate, staff with indirect patient care responsibilities, including, but not limited to laboratory and pharmacy staff, are periodically trained to implement sepsis protocols required pursuant to paragraph (4) of this subdivision. Medical staff shall ensure updated training when the hospital initiates substantive changes to the protocols.

(6) Hospitals must update sepsis protocols required pursuant to paragraph (4) of this section based on newly emerging evidence-based standards. Protocols are to be submitted to the Department at the request of the Department.

(7) Collection and Reporting of Sepsis Measures.

(i) The medical staff shall be responsible for the collection, use, and reporting of quality measures related to the recognition and treatment of severe sepsis for purposes of internal quality improvement and hospital reporting to the Department. Such measures shall include, but not be limited to, data sufficient to evaluate each hospital's adherence to timeframes and implementation of all protocol components for adults and children.

(ii) Hospitals shall submit data specified by the Department to permit the Department to develop risk-adjusted severe sepsis and septic shock mortality rates in consultation with appropriate national, hospital and expert stakeholders.  Hospitals shall submit data to the Department or the Department’s designee in the form and format, and according to such specifications as may be required by the Department. 

(iii) Such data shall be reported annually, or more frequently at the request of the Department, and shall be subject to audit at the discretion of the Department.

(8) Definitions. Sepsis is a life threatening medical emergency that requires early recognition and intervention.  For the purposes of hospital data collection, the following terms shall have the following meanings:

(i) sepsis shall mean a confirmed or suspected infection accompanied by two systemic inflammatory response syndrome (SIRS) criteria;

(ii) severe sepsis shall mean sepsis complicated by organ dysfunction; and

(iii) for adults, septic shock shall mean sepsis-induced hypotension persisting despite adequate IV fluid resuscitation and/or evidence of tissue hypoperfusion; for pediatrics, septic shock shall mean sepsis and cardiovascular organ dysfunction.

(b) Organization. (1) The medical staff shall be organized in a manner appropriate to the size of the institution and the services provided.

(2) The responsibility for organization and conduct of the medical staff shall be developed and defined in writing in consultation with the medical staff and assigned to the medical director who is a physician appointed by the governing body in accordance with section 405.2(e)(2) of this Part, based upon written qualifications for the position.

(3) The medical staff shall be composed of persons practicing medicine as defined in article 131 of title 8 of the State Education Law, and may also be composed of other licensed and currently registered health care practitioners appointed by the governing body.

(4) The medical staff shall examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with the provisions of this Part and the New York State Public Health Law. Following the initial appointment of medical staff members, the medical staff shall conduct periodic reappraisals of its members, on at least, a biennial basis.

(5) Medical staff appointments, and reappointments shall be made in accordance with the privilege review procedures of the hospital's quality assurance committee, as contained in section 405.6 of this Part.

(6) In order that the working conditions and working hours of physicians and postgraduate trainees promote the provision of quality medical care, the hospital shall establish the following limits on working hours for certain members of the medical staff and postgraduate trainees:

(i) In hospitals with over 15,000 unscheduled visits to an emergency service per year, assignment of postgraduate trainees and attending physicians shall be limited to no more than twelve consecutive hours per on-duty assignment in the emergency service. The Commissioner may approve alternative schedule limits of up to fifteen hours for attending physicians in a hospital emergency service upon a determination that:

(a) the alternative schedule contributes to the hospital's ability to meet its community's need for quality emergency services;

(b) the volume of patients examined and treated during the extended period is substantially less than for other hours of the day; and

(c) adequate rest time is provided between assignments and during each week to prevent fatigue.

(ii) Effective July 1, 1989, schedules of postgraduate trainees with inpatient care responsibilities shall meet the following criteria:

(a) the scheduled work week shall not exceed an average of eighty hours per week over a four week period;

(b) such trainees shall not be scheduled to work for more than twenty-four consecutive hours; and

(c) for departments other than anesthesiology, family practice, medical, surgical, obstetrical, pediatric or other services which have a high volume of acutely ill patients, and where night calls are infrequent and physician rest time is adequate, the medical staff may develop and document scheduling arrangements other than those set forth in clauses (a) and (b) of this subparagraph; and

(d) "on call" duty in the hospital during the night shift hours by trainees in surgery shall not be included in the twenty-four limit contained in clause (b) of this subparagraph and the eighty-hour limit contained in clause (a) of this subparagraph if:

(1) the hospital can document that during such night shifts postgraduate trainees are generally resting and that interruptions for patient care are infrequent and limited to patients for whom the postgraduate trainee has continuing responsibility;

(2) such duty is scheduled for each trainee no more often than every third night;

(3) a continuous assignment that includes night shift "on call" duty is followed by a non-working period of no less than sixteen hours; and

(4) policies and procedures are developed and implemented to immediately relieve a postgraduate trainee from a continuing assignment when fatigue due to an unusually active "on call" period is observed.

(iii) The medical staff shall develop and implement policies relating to postgraduate trainee schedules which prescribe limits on the assigned responsibilities of postgraduate trainees, including but not limited to, assignment to care of new patients, as the duration of daily on-duty assignments progress.

(iv) In determining limits on working hours of postgraduate trainees as set forth in subparagraphs (i) and (ii) of this paragraph, the medical staff shall require that scheduled on-duty assignments be separated by not less than eight non-working hours. Post-graduate trainees shall have at least one twenty-four period of scheduled non-working time per week.

(v) Hospitals employing postgraduate trainees shall adopt and enforce specific policies governing dual employment. Such policies shall require at a minimum, that each trainee notify the hospital of employment outside the hospital and the hours devoted to such employment. Post-graduate trainees who have worked the maximum number of hours permitted in subparagraphs (i)-(iv) of this paragraph shall be prohibited from working additional hours as physicians providing professional patient care services.

(c) Medical staff bylaws. The medical staff shall adopt and enforce bylaws to carry out its responsibilities. The bylaws shall at a minimum:

(1) be approved by the governing body;

(2) include a statement of the obligations and prerogatives of each category of medical staff membership;

(3) describe the organization of the medical staff;

(4) describe the qualifications and performance standards to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body;

(5) set forth criteria and procedures for recommending the privileges to be granted to individual practitioners, contain a procedure for applying the criteria and procedures to individuals requesting privileges, and be consistent with the requirements contaned in section 405.6 of this Part;

(6) set forth criteria and procedures for determining the need for consultation with a specialist physician to provide for the diagnosis and treatment of patient conditions in accordance with generally accepted standards of patient care. Such criteria and procedures shall not preclude postgraduate trainees, nurses, or other health care practitioners involved in the care of the patient from requesting such consultations in an emergency;

(7) describe the responsibilities of members of the medical staff for participation in the malpractice prevention program and the quality assurance program;

(8) exempt from the requirement to obtain medical staff privileges those practitioners from outside organ procurement organizations designated by the Secretary, U.S. Department of Health and Human Services, engaged solely at the hospital in the harvesting of tissues and/or other body parts for transplantation, therapy, research or educational purposes pursuant to the Federal Anatomical Gift Act and the requirements of section 405.25 of this Part;

(9) exempt from liability by the hospital any physican who shall inform a patient that he or she refuses to give advice with respect to, or participate in, any induced termination of pregnancy; and

(10) set forth criteria and procedures that ensure appropriate and confidential use of electronic or computer transmissions and authentications, including the identification of those categories of practitioners and hospital personnel who are authorized to utilize electronic or computer generated transmissions, if the hospital elects to utilize an electronic or computer system for transmitting or authenticating medical records entries, orders and/or other patient specific records.

(d) Dental services. (1) The attending dentist shall be responsible for the admission, management and discharge of dental patients, including all related written documentation.

(2) The admission history and physical examination for dental patients shall be completed by a dentist qualified to perform a history and physical examination or by another member of the medical staff so qualified. A dentist qualified to perform a history and physical examination shall mean a dentist who:

(i) has successfully completed a postgraduate program of study incorporating training in physical diagnosis at least equivalent to that received by one who has successfully completed a postgraduate program of study in oral and maxillofacial surgery accredited by a nationally recognized body approved by the United States Education Department; and

(ii) as determined by the medical staff, is currently competent to conduct a complete history and physical examination to determine a patient's ability to undergo a proposed dental procedure.

(3) Dental patients with medical comorbidites or complications present upon admission or arising during hospitalization shall be referred to appropriate medical staff for consultation and/or management.

(e) Registered physician's assistants and registered specialist's assistants. Hospitals employing or extending privileges to registered physician's assistants or registered specialist's assistants shall comply with the provisions of this subdivision and Part 94 of this Title.

(1) General standards. Hospitals shall:

(i) employ or extend privileges only to registered physician's assistants and registered specialist's assistants who are currently registered with the New York State Education Department;

(ii) designate in writing the licensed and currently registered staff physician or physicians responsible for the supervision and direction of each registered physician's assistant and registered specialist's assistant employed or extended privileges:

(a) no physician shall be designated to supervise and direct more than six registered physician's assistants or registered specialist's assistants or a combination thereof;

(b) when more than one physician is designated as responsible for registered physician's assistants or registered specialist's assistants, written policies and procedures shall delineate the specific physician charged with supervision of care of each patient for whom the registered physician's assistant or registered specialist's assistant is to render care;

(iii) employ or extend privileges only to registered physician's assistants and registered specialist's assistants whose training and experience are within the scope of practice for which the physician or physicians to whom they are assigned are qualified; and

(iv) be approved for providing the specialized medical services for which the registered specialist's assistant is employed or extended privileges and employ and extend privileges only to registered specialist's assistants whose training and experience are appropriate to the delivery of the specialized service.

(2) Medical staff responsibility. The medical staff shall adopt, with governing body approval, bylaws, rules and regulations:

(i) 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

(ii) which set forth in writing, the mechanism or mechanisms by which the supervising physicians shall exercise continuous supervision over the registered physician's assistants or registered specialist's assistants for whom he or she is responsible.

(f) Postgraduate trainees. Patient care services may be provided by physicians in post graduate training programs accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association or an equivalent accrediting agency approved by the New York State Education Department, only if the following conditions are met:

(1) all post graduate trainees prior to entering a postgraduate training program, have received adequate and appropriate medical education as defined in subparagraphs (i) and (ii) of this paragraph:

(i) effective January 1, 1986 and thereafter, hospitals shall permit only the following to be assigned into a postgraduate training position:

(a) a graduate of a medical school offering a medical program accredited by the Liaison Committee on Medical Education or the American Osteopathic Association or registered with the New York State Education Department or by an accrediting organization acceptable to the New York State Education Department; or

(b) a graduate of a foreign medical school who has been certified by the Educational Commission for Foreign Medical Graduates (ECFMG) as meeting the requirements of the ECFMG and has been awarded the ECFMG certificate;

(ii) except for individuals eligible for licensure under section 6528 of the State Education Law, a graduate of a foreign medical school who enrolled in such medical school after October 1, 1983 shall have completed the clinical component of a program of medical education which:

(a) included no more than 12 weeks of clinical clerkships in a country other than the country in which the medical school is located;

(b) included clinical clerkships of greater than 12 weeks in a country other than the country in which the medical school is located if the clinical clerkships were offered by a medical school approved by the State Education Department for the purposes of clinical clerkships;

(2) the medical staff shall review the licensure, education, training, physical and mental capacity, and experience of individuals in approved postgraduate medical training programs in relation to the patient care services to be provided by such individuals in such training programs where such individuals do not otherwise have active medical staff privileges.

(i) such individuals may provide patient care services only as part of a training program accredited by the Accreditation Council for Graduate Medical Education or American Osteopathic Association, or an equivalent training program approved by the State Education Department;

(ii) the medical staff shall, based on written criteria, recommend privileges that are specific to treatments/procedures for each individual in such program prior to delivery of patient care services;

(iii) the medical staff shall develop and implement written policies and procedures which set forth a clear set of principles governing medical practice by postgraduate trainees, including guidelines on circumstances requiring supervision and consultation;

(iv) post graduate trainee privileges, regardless of whether the individual is full-time, part-time, or rotating status, shall be modified based upon written criteria and individual review and approval of each trainee;

(v) the specific treatments/procedures that each individual is authorized to perform shall be stated in writing and that authorization shall specify:

(a) those treatments/procedures that may be performed under the general control and supervision of the patient's attending physician or another physician credentialed to provide the specific treatment/procedures; and

(b) those that may only be performed under direct visual supervision of the patient's attending physician or another physician credentialed to provide the specific treatment/procedures; and

(3) the medical staff monitors and supervises postgraduate trainees assigned patient care responsibilities as part of an approved medical training program, including:

(i) providing written documentation of privileges granted to such individuals to appropriate medical and other hospital patient care staff;

(ii) continuously monitoring patient care services provided by such individuals to assure provision of quality patient care services within the scope of privileges granted;

(iii) effective July 1, 1989 for postgraduate trainees in the acute care specialties of anesthesiology, family practice, medicine, obstetrics, pediatrics, psychiatry, and surgery, supervision shall be provided by physicians who are board certified or admissible in those respective specialties or who have completed a minimum of four postgraduate years of training in such specialty. There shall be a sufficient number of these physicians present in person in the hospital 24 hours per day seven days per w eek to supervise the postgraduate trainees in their specific specialities to meet reasonable and expected demand. In hospitals that can document that the patients' attending physicians are immediately available by telephone and readily available in person when needed, the on-site supervision of routine hospital care and procedures may be carried out in accordance with paragraph (2) of this subdivision by postgraduate trainees who are in their final year of postgraduate training, or who have completed at least three years of postgraduate training;

(iv) supervision by attending physicians of the care provided to surgery patients by postgraduates in training must include as a minimum:

(a) personal supervision of all surgical procedures requiring general anesthesia or an operating room procedure;

(b) preoperative examination and assessment by the attending physician; and

(c) postoperative examination and assessment no less frequently than daily by the attending physician;

(v) taking disciplinary action and other corrective measures against the individual providing service and/or the attending/supervising physician when services provided exceed scope of privileges granted; and

(vi) taking disciplinary action or other corrective measures against any individual providing service in violation of the physicians' working hour limits set forth in subparagraph (iv) of paragraph (6) of subdivision (b) of this section.

(g) Unlicensed physicians. Patient care services may be provided by unlicensed physicians only under the following circumstances:

(1) physicians not licensed by New York State but who practice within the exemptions authorized by section 6526 of the State Education Law; or

(2) physicians who possess limited permits to practice medicine issued by the New York State Education Department pursuant to section 6525 of the State Education Law if such physicians are under the supervision of a physician licensed and currently registered to practice medicine in the State of New York and if the physicians possessing limited permits are:

(i) graduates of medical school offering a medical program accredited by the Liaison Committee on Medical Education or the American Osteopathic Association, or registered with the State Education Department or accredited by an accrediting organization acceptable to the State Education Department, and have satisfactorily completed one year of graduate medical education in a postgraduate training program accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, their predecessors or successors or an equivalent accrediting agency acceptable to the State Education Department;

(ii) graduates of a foreign medical school and have satisfactorily completed three years of graduate medical education in a postgraduate training program accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, their predecessors or successors or an equivalent accrediting agency acceptable to the State Education Department; or

(iii) graduates of a foreign medical school who have satisfactorily completed three years in a postgraduate training program and who are receiving advanced training as part of an official exchange visitor program approved by the United States Information Agency and the Educational Commission for Foreign Medical Graduates (ECFMG);

(3) the medical staff shall:

(i) review the licensure, education, training, physical and mental capacity, and experience of individuals practicing under the provisions of this subdivision;

(ii) based on written criteria, recommend privileges that are specific to treatments/procedures for each individual prior to delivery of patient care services;

(iii) continuously monitor patient care services provided by such individuals to assure provision of quality patient care services within the scope of privileges granted; and

(iv) take disciplinary action or other corrective measures against the individual providing service and/or the attending/supervising physician when services provided exceed the scope of privileges granted.

(h) Medical students. Medical students, in the course of their educational curriculum, may take patient histories, perform complete physical examinations and enter findings in the medical record of the patient with the approval of the patient's attending physician. All medical student entries must be countersigned within 24 hours by an appropriately privileged physician. Medical students may be assigned and directed to provide additional patient care services under the direct in person supervision of an attending physician or authorized postgraduate trainee. The hospital, in cooperation with the medical staff and the medical school, shall provide such appropriate supervision and documentation of all procedures performed by medical students. In addition, specific identified procedures may be performed by medical students under the general supervision of an attending physician or authorized senior postgraduate trainee provided that the medical staff and the medical school affirm in writing each individual student's competence to perform such procedures. Documentation of supervision and competence of medical students shall be incorporated into the quality assurance program of the hospital and its affiliation agreement with the medical school. In all such patient care contacts, the patient shall be made aware that the individual performing the procedure is a student.

(i) Autopsies. The medical staff shall attempt to secure permission for autopsies in all cases of unusual deaths and deaths of medical-legal and educational value. The mechanism for documenting permission to perform an autopsy shall be defined in writing. There shall be a system for notifying the medical staff, and specifically the attending physician, when an autopsy is to be performed.

Effective Date: 
Wednesday, November 14, 2018
Doc Status: 
Complete

Section 405.5 - Nursing services

405.5 Nursing services. The governing body shall ensure that the hospital has an organized nursing service that provides 24-hour services and that meets the care needs of all patients in accordance with established standards of nursing practice. The nursing services for all patients shall be provided or supervised by a registered professional nurse who is on duty and available at all times.

(a) Organization and staffing. (1) The hospital shall have a written nursing service plan of administrative authority and delineation of responsibilities. The director of the nursing service shall be a licensed registered professional nurse who is qualified by training and experience for such position. He or she shall be responsible for the operation of the service, including developing a plan to be approved by the hospital for determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

(2) The hospital shall employ licensed and currently registered professional nurses, licensed practical nurses, and other personnel to provide nursing care to all patients as needed. The hospital shall provide supervisory and staff personnel for each department or nursing unit to ensure, when needed in accordance with generally accepted standards of nursing practice, the immediate availability of a registered professional nurse for bedside care of any patient.

(3) Job descriptions for each position classification of registered professional nurses and ancillary nursing personnel shall specify standards of performance and delineate the functions, responsibilities, and specific qualifications of each classification.

(4) A written evaluation of the performance, credentials, and competence of registered professional nurses and ancillary nursing personnel shall be conducted on at least a biennial basis.

(5) When nursing services are provided by nursing students, nurses with limited permits, or by personnel from outside sources, the hospital shall retain full responsibility for the quality of nursing care rendered in the hospital.

(i) Nursing students, nurses with limited permits, and registered professional nurses from outside sources who are working in the hospital shall adhere to the policies and procedures of the hospital.

(ii) The director of nursing services shall provide for the supervision and evaluation of the clinical activities of all nursing personnel.

(6) All nursing services personnel, including nursing students and nonemployee licensed nurses who are working in the hospital, shall receive a basic orientation to prepare them for their specific duties and responsibilities prior to performing any nursing functions within a patient care area. For employee nurses and nursing students, the hospital shall provide or arrange for the provision of training programs to augment their knowledge of pertinent new developments in patient care. The hospital shall also require that nonemployee licensed nurses obtain education and training pertinent to the clinical duties to which they are assigned.

(7) Nursing services personnel employed in specialty areas, including, but not limited to, emergency services, must complete training and education specific to the specialty area.  Nursing services personnel must be periodically reevaluated for competency and ongoing education and training provided to maintain competency in the specialty area.

(b) Delivery of services. (1) There shall be working relationships among medical staff, nursing staff and staff of other departments or services to assure that all patient care needs are met.

(i) Nursing services personnel shall execute the orders of physicians and other practitioners, authorized by the governing body to order such services.

(ii) Registered professional nurses shall confer with the responsible practitioner relative to patient care on an ongoing basis and relative to significant changes in the patient's condition as necessary.

(iii) The hospital shall develop and implement policies and procedures for prompt review and correction, as necessary, of health care practitioner orders which have, or have the likely potential for having, negative impact on patient care and safety and which should not be carried out.

(2) There shall be continuous review and evaluation of the adequacy and appropriateness of nursing care provided for patients.

(i) Nursing care policies and procedures shall be written and consistent with generally accepted standards of nursing practice.

(ii) A registered professional nurse shall plan, supervise, and evaluate the nursing care for each patient. A registered professional nurse shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and competence of such other nursing personnel.

(3) Written nursing care plans shall be kept current. Such plans shall indicate what nursing care is needed, how it is to be provided, and the methods, approaches and mechanisms for ongoing modifications necessary to ensure the most effective and beneficial results for the patient. Patient education and patient/family knowledge of care requirements shall be included in the nursing plan.  The nursing care plan may be integrated into the overall interdisciplinary plan of care.

(4) Nursing documentation shall describe the nursing care given and include information and observations of significance so that they contribute to the continuity of patient care. Nursing interventions and patient responses shall be documented.

(c) Administration of drugs. All drugs and biologicals shall be administered in accordance with the orders of the practitioner or practitioners responsible for the patient's care as specified under section 405.2 of this Part, and generally accepted standards of practice. They shall be administered by a licensed physician or a registered professional nurse, or other personnel in accordance with applicable licensing requirements of title 8 of the New York State Education Law, except for the self-administration of medications as set forth in paragraphs (4) and (5) of this subdivision, and in accordance with hospital policies and procedures.  For purposes of this subdivision, “self-administration” means administration by the patient or the patient’s caregiver, including but not limited to a caregiver pursuant to section 2994-ii(3) of the Public Health Law, or a designated caregiver pursuant to section 3360(5) of the Public Health Law.

(1) All orders for drugs and biologicals shall be authenticated by the practitioner or practitioners responsible for the care of the patient as specified under section 405.2 of this Part.

(2) Blood transfusions and intravenous medications shall be administered in accordance with approved medical staff and nursing service policies and procedures. If blood transfusions and intravenous medications are administered by personnel other than physicians, such personnel shall have completed specific training to prepare them for this duty.

(3) There shall be a hospital procedure and nursing policies and procedures for the reporting and review of transfusion reactions, adverse drug reactions, and errors in administration of drugs.

(4) Hospitals, in accordance with hospital policies and procedures, may authorize hospital-issued prescription and non-prescription medications to be self-administered, provided that:

(i) a practitioner responsible for the care of the patient in the hospital has issued an order permitting self-administration;

(ii) the capacity of the patient or the patient’s caregiver to administer the medication has been assessed;

(iii) the patient or the patient’s caregiver has been given instructions for the safe and accurate administration of the medication;

(iv) the security of the medication is addressed; and

(v) documentation is made of the administration of each medication in the patient’s record, as reported by the patient or the patient’s caregiver.

(5) Hospitals, in accordance with hospital policies and procedures, may authorize a patient to bring in his or her own medications, including prescription medications, non-prescription medications and medical marihuana as defined in section 3360(8) of the Public Health Law, and self-administer such medications, provided that:

(i) a practitioner responsible for the care of the patient in the hospital has issued an order permitting self-administration of the medication the patient brought into the hospital, and in the case of medical marihuana, upon presentation of the patient or designated caregiver’s registry identification card issued pursuant to section 3363 of the Public Health Law;

(ii) the capacity of the patient or the patient’s caregiver to administer the medication has been assessed;

(iii) a determination is made concerning whether the patient or the patient’s caregiver needs instruction on the safe and accurate administration of the medication;

(iv) the medication is identified and visually evaluated for integrity;

(v) the security of the medication is addressed;

(vi) documentation is made of the administration of each medication in the patient’s record, as reported by the patient or the patient’s caregiver; and

(vii) if a patient dies in the hospital, any unused prescription medication shall be destroyed or disposed of in accordance with all applicable state and federal laws and regulations. Such prescription medications may not be turned over to the patient’s caregiver.  In the case of medical marihuana, it may be turned over to the deceased patient’s designated caregiver or to appropriate law enforcement for destruction or disposal.

(d) Nasogastric tube feedings. Following consideration of possible alternatives for short term nutritional therapy, nasogastric tubes and feeding formulations may be used for feeding purposes when determined clinically appropriate by the attending practitioner. Nasogastric tube feedings shall be used to promote a therapeutic program to maintain adequate nutrition and hydration and include a plan to help the patient develop or regain eating skills.

(1) Nasogastric tube feeding formulations shall be given in accordance with the manufacturer's instructions or at a rate appropriate to the physical size of the resident and the amount of fluid and nutrients necessary to meet the assessed caloric and fluid needs of the patient.

(2) To minimize patient discomfort, nasogastric tubes used for patient feeding purposes shall:

(i) be the smallest gauge appropriate for the patient and shall not exceed 3.96 millimeters (#12 French) in outside diameter unless medically indicated;

(ii) be made of a soft, flexible material such as medical grade polyurethane or silicone; and

(iii) be specifically manufactured for nasogastric feeding purposes.

(3) Patients receiving nasogastric tube feedings shall be periodically evaluated for the ability to return to normal feeding function. If nasogastric feedings are to be continued longer than three months, permanent enteral feeding procedures such as surgical gastrostomy or jejunostomy shall be considered. If the nasogastric feeding is continued, the reasons for continuation shall be documented in the patient's medical record.

(4) The facility shall develop and implement policies and procedures for inpatient nasogastric tube feedings which are written in accordance with prevailing standards of professional practice and in consultation with the medical, nursing, dietary and pharmacy services of the facility. Medical practitioners shall be informed of such policies and procedures governing the use of nasogastric tubes for patient feeding. The policies and procedures shall address as a minimum:

(i) types and sizes of nasogastric tubes and the various types of feeding formulations available at the facility;

(ii) the need to assess each patient's clinical and nutritional status to determine the size of the nasogastric tube and type of feeding appropriate for that individual;

(iii) standard techniques for inserting a nasogastric tube and confirming the correct placement of the tube;

(iv) procedures for administering nasogastric feedings including positioning the patient and the need for patient observation and monitoring before, during and following the feeding; and

(v) infection control practices related to tube feedings.

(e) Quality assurance. The nursing service shall monitor and evaluate the quality and appropriateness of patient care and the resolution of identified problems. This process shall be integrated with the quality assurance committee in accordance with hospital policies and procedures.

(1) Nursing service personnel shall meet as often as necessary to identify and resolve problems and potential problems in the provision of nursing care, taking into consideration the findings from relevant nursing care monitoring and evaluation activities.

(2) Documentation of such reviews shall include findings, conclusions, recommendations and actions taken in conjunction with the hospital-wide quality assurance program and shall be maintained for review and analysis.

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 405.6 - Quality assurance program

405.6 Quality assurance program. The governing body shall establish and maintain a coordinated quality assurance program which integrates the review activities of all hospital services to enhance the quality of patient care and identify and prevent medical, dental and podiatric malpractice.

(a) The governing body shall establish a quality assurance committee, at least one member to be a member of the governing body of the hospital and who is not otherwise affiliated with the hospital in an employment or contractual capacity. The quality assurance committee shall report its activities, findings and recommendations to the governing body as often as necessary, but no less often than four times a year. The quality assurance committee shall:

(1) develop a written plan which details:

(i) the establishment and implementation of a medical, dental and podiatric malpractice prevention program;

(ii) the manner in which the committee will relate to the medical staff executive committee, if any, the hospital governing body and the chief executive officer;

(iii) the manner in which the medical, dental and podiatric malpractice program will relate to other hospital administrative mechanisms and procedures;

(iv) the role and responsibility of each service or department in the quality assurance process; and

(v) the authority of the committee regarding recommendation or implementation of corrective action;

(2) administer the hospital quality assurance program to assure:

(i) the identification of actual or potential problems concerning patient care and clinical performance;

(ii) the assessment of the cause and scope of problems identified;

(iii) the development and recommendation of proposed courses of action to address problems identified;

(iv) the use, in the revision of hospital policies and procedures, of information gathered regarding problems identified;

(v) the implementation, through established mechanisms, of actions necessary to correct the identified problems;

(vi) the monitoring and evaluation of actions taken and the implementation of remedial action to ensure effectiveness; and

(vii) the documentation of all measures taken pursuant to this section in the quality assurance program.

(b) The activities of the quality assurance committee shall involve all patient care services and shall include, as a minimum:

(1) review of the care provided by the medical and nursing staff and by other health care practitioners employed by or associated with the hospital. Such review shall include a determination that the hospital is admitting only those patients for whom it has appropriate staff, resources and equipment and transferring those patients for whom the hospital does not have the capability to provide care, except under conditions of disasters and/or emergency surge that may require admissions to provide care to those patients;

(2) review of mortalities;

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

(4) review of infections, complications, errors in diagnosis, tranfusions and results of treatments;

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

(6) the maintenance and continuous collection of information concerning the hospital's experience with negative health care outcomes and incidents injurious to patients, patient grievances, professional liability premiums, settlements, awards, costs incurred by the hospital for patient injury prevention and safety improvement activities; and

(7) the committee shall oversee and coordinate the following:

(i) the establishment of a medical, dental and podiatric staff privileges review procedure through which credentials, physical and mental capacity, and competence in delivering health care services are reviewed at least biennially as part of an evaluation of staff privileges and in accordance with section 405.4 of this Part. These procedures shall include the collection of the following information from a physician, dentist or podiatrist prior to granting or renewing professional privileges or association in any capacity with the hospital:

(a) the name of any hospital or facility with which the physician, dentist or podiatrist has had any association, employment, privileges or practice and, if such association, employment, privileges or practice have been suspended, restricted, terminated, curtailed or not renewed, the reasons for such action;

(b) the substance of any pending malpractice actions or professional misconduct proceedings in this or any other state and any report made pursuant to section 405.3(e) of this Part;

(c) any judgment or settlement of any professional malpractice action and any finding of professional misconduct in this or any other state; and

(d) any information relative to findings pertinent to violations of patients' rights as set forth in section 405.7 of this Part; (ii) upon initial application for or renewal of hospital staff privileges, the receipt of a waiver by the physician, dentist or podiatrist of any confidentiality provisions concerning the information set forth in subparagraph (i) of this paragraph and a sworn statement by the physician, dentist or podiatrist that the information is complete, true and accurate;

(iii) prior to granting or renewing privileges or association to any physician, dentist, or podiatrist, or hiring a physician, dentist or podiatrist, the hospital shall request from: (a) any hospital with or at which such physician, dentist or podiatrist, has or had privileges, was associated or was employed during at least the preceding 5 years the following information concerning the physician, dentist or podiatrist:

(1) any pending professional misconduct proceedings or any professional malpractice actions in New York or another state; (2) any judgment or settlement of a malpractice action and any finding of professional misconduct in New York or another state; and

(3) any information required to be reported by hospitals pursuant to section 405.3(e) of this Part; and (b) the National Practitioner Data Bank or any successor database, any information available concerning: (1) payments for the benefit of the physician, dentist or podiatrist in settlement of, or in satisfaction of, in whole or in part, a claim or a judgment against such physician, dentist or podiatrist for medical malpractice; (2) licensure actions by any medical or professional board relating to the physician, dentist, or podiatrist; (3) adverse actions affecting clinical privileges of the physician, dentist or podiatrist; and (4) other actions or information relevant to the professional competence and conduct of the physician, dentist or podiatrist.

(iv) The provision by the hospital, within 45 days, in response to requests from any other hospital or facility performing credentials review for medical staff appointment or reappointment, of information related to the physician's, dentist's or podiatrist's professional practice within the facility for at least 5 years;

(v) the maintenance of a file on each physician, dentist and podiatrist granted privileges or otherwise associated with the hospital which shall contain the information collected pursuant to subparagraphs (i) through (iii) of this paragraph, to be updated at least on a biennial basis, and all other relevant information gathered in accordance with the hospital's quality assurance program and as required by this section;

(vi) a biennial review of credentials, physical and mental capacity and competence in delivering health care services of all clinical staff who are employed or associated with the hospital which for physicians, dentists and podiatrists shall include a comprehensive review of the information maintained in accordance with subparagraph (v);

(vii) a procedure for the prompt resolution of grievances by patients or their representatives related to accidents, injuries, treatment and other events that may result in claims of medical, dental or podiatric malpractice;

(viii) education programs dealing with patient safety, patients' rights, injury prevention, staff responsibility to report professional misconduct, legal aspects of patient care, improved communication with patients and causes of malpractice claims for staff personnel engaged in patient care activities; and

(ix) continuing education programs for medical, dental and podiatric staff in their areas of speciality.
 

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.7 - Patients' rights

405.7 Patients' rights. The hospital shall ensure that all patients including inpatients, outpatients and emergency service patients, are afforded their rights as set forth in subdivision (b) of this section. The hospital's responsibility for assuring patients' rights includes both providing patients with a copy of these rights as set forth in subdivision (c) of this section and providing assistance to patients to understand and exercise these rights. Each general hospital patient who has been removed but not discharged from a hospital for the mentally ill operated or licensed under the Mental Hygiene Law shall maintain his or her status and rights as a patient pursuant to article 9 of the State Mental Hygiene Law and 14 NYCRR part 527 (Rights of Patients).

(a) Procedural requirements. In order to assure that patients are made aware of, understand and can exercise their rights, the hospital shall meet the following requirements:

(1) each patient or the patient representative shall be given a copy of their rights as set forth in subdivision (c) of this section at the time of admission;

(2) for outpatients and emergency service patients, copies of these rights shall be provided to each patient or his/her representative;

(3) a copy of these rights shall also be posted in clearly viewed areas of the hospital, at readable heights, including the admitting office, patient floors and outpatient department and the emergency service waiting areas;

(4) inservice training shall be provided to all patient care staff to assure their knowledge and understanding of patients' rights requirements;

(5) the hospital shall communicate effectively to each inpatient or patient representative after admission an explanation of those rights and provide information on how these rights can be exercised. Patients shall be offered a choice at admission to have or to decline an in-person explanation of these rights. The hospital shall maintain documentation of such communication;

(6) the hospital shall make available designated staff to answer questions regarding patients' rights for outpatients and emergency service patients. Patients shall be notified of the availability of these services; and

(7) the hospital shall develop a Language Assistance Program to ensure meaningful access to the hospital’s services and reasonable accommodation for all patients who require language assistance. Program requirements shall include:

(i) the designation of a Language Assistance Coordinator who shall report to the hospital administration and who shall provide oversight for the provision of language assistance services;

(ii) policies and procedures that assure timely identification and ongoing access for patients in need of language assistance services;

(iii) the development of materials that will be made available for patients and potential patients that summarize the process and method to access free language assistance services;

(iv) ongoing education and training for administrative, clinical and other employees with direct patient care contact regarding the importance of culturally and linguistically competent service delivery and how to access the hospital’s language assistance services on behalf of patients;

(v) signage, as designated by the Department of Health, regarding the availability of free language assistance services in public entry locations and other public locations;

(vi) identification of language of preference and language needs of each patient upon initial visit to the hospital;

(vii) documentation in the medical record of the patient’s language of preference, language needs, and the acceptance or refusal of language assistance services;

(viii) a provision that family members, friends, or non-hospital personnel may not act as interpreters, unless:

(a) the patient agrees to their use;

(b) free interpreter services have been offered by the hospital and refused; and

(c) issues of age, competency, confidentiality, or conflicts of interest are taken into account. Any individual acting as an interpreter should be 16 years of age or older; individuals younger than 16 years of age should only be used in emergent circumstances and their use documented in the medical record.

(ix) management of a resource of skilled interpreters and persons skilled in communicating with vision and/or hearing impaired individuals;

(a) interpreters and persons skilled in communicating with vision and/or hearing impaired individuals shall be available to patients in the inpatient and outpatient setting within 20 minutes and to patients in the emergency service within 10 minutes of a request to the hospital administration by the patient, the patient’s family or representative or the provider of medical care. The Commissioner of Health may approve time limited alternatives to the provisions of this subparagraph regarding interpreters and persons skilled in communicating with vision and/or hearing impaired individuals for patients of rural hospitals; which:

(1) demonstrate that they have taken and are continuing to take all reasonable steps to fulfill these requirements but are not able to fulfill such requirements immediately for reasons beyond the hospital’s control; and

(2) have developed and implemented effective interim plans addressing the communications needs of individuals in the hospital service area.

(x) an annual needs assessment utilizing demographic information available from the United State Bureau of the Census, hospital administrative data, school system data, or other sources, that will identify limited English speaking groups comprising more than one percent of the total hospital service area population. Translations/transcriptions of significant hospital forms and instructions shall be regularly available for the languages identified by the needs assessment; and

(xi) reasonable accommodation for a family member or patient’s representative to be present to assist with the communication assistance needs for patients with mental and developmental disabilities.

(b) Hospital responsibilities. The hospital shall afford to each patient the right to:

(1) exercise these rights regardless of the patient's language or impairment of hearing or vision. Skilled interpreters shall be provided to assist patients in using these rights;

(2) treatment without discrimination as to race, color, religion, sex, gender identity, national origin, disability, sexual orientation, age, or source of payment;

(3) considerate and respectful care in a clean and safe environment;

(4) receive emergency medical care as indicated by the patient's medical condition upon arrival at the hospital;

(5) limit the use of physical restraints to those patient restraints authorized in writing by a physician after a personal examination of the patient, for a specified and limited period of time to protect the patient from injury to himself or to others. In an emergency, the restraint may be applied only by or under the supervision of and at the direction of a registered professional nurse who shall set forth in writing the circumstances requiring the use of restraints. In such emergencies, a physician shall be immediately summoned and pending the arrival of the physician, the patient shall be kept under continuous supervision as warranted by the patient's physical condition and emotional state. At frequent intervals while restraints are in use the patient's physical needs, comfort and safety shall be monitored. An assessment of the patient's condition shall be made at least once every 30 minutes or at more frequent intervals if directed by a physician;

(6) the name of the medical staff member who has the responsibility for coordinating his/her care and the right to discuss with his/her practitioner the type of care being rendered;

(7) the name, position and function of any person providing treatment to the patient;

(8) obtain from the responsible medical staff member complete current information concerning his/her diagnosis, treatment and prognosis in terms the patient can be reasonably expected to understand. The patient shall be advised of any change in health status, including harm or injury, the cause for the change and the recommended course of treatment. The information shall be made available to an appropriate person on the patient's behalf and documented in the patient's medical record, if the patient is not competent to receive such information;

(9) receive 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 specific procedure or treatment or both, the reasons for it, the reasonably foreseeable risks and benefits involved, and the alternatives for care or treatment, if any, as a reasonable practitioner under similar circumstances would disclose. Documented evidence of such informed consent shall be included in the patient's medical record;

(10) refuse treatment to the extent permitted by law and to be informed of the reasonably forseeable consequences of such refusal;

(11) receive from the responsible medical staff or designated hospital representatives information necessary to give informed consent prior to the withholding of medical care and treatment;

(12) privacy consistent with the provision of appropriate care to the patient;

(13) confidentiality of all information and records pertaining the the patient's treatment, except as otherwise provided by law;

(14) a response by the hospital, in a reasonable manner, to the patient's request for services customarily rendered by the hospital consistent with the patient's treatment;

(15) be informed by the responsible medical staff member or appropriate hospital staff of the patient's continuing health care requirements following discharge, and before any transfer to another facility, all relevant information about the need for and all reasonable alternatives to such a transfer;

(16) prior to discharge, receive an appropriate written discharge plan and a written description of the patient discharge review process available to the patient under Federal or State law;

(17) the identity of any hospital personnel including students that the hospital has authorized to participate in the patient's treatment and the right to refuse treatment, examination and/or observation by any personnel;

(18) refuse to participate in research and human experimentation in accordance with Federal and State law;

(19) examine and receive an explanation of his/her bill, regardless of source of payment;

(20) be informed of the hospital rules and regulations that apply to a patient's conduct;

(21) be admitted to a nonsmoking area;

(22) register complaints and recommend changes in policies and services to the facility's staff, the governing authority and the New York State Department of Health without fear of reprisal;

(23) express complaints about the care and services provided and to have the hospital investigate such complaints. The hospital shall provide the patient or his/her designee with a written response if requested by the patient indicating the findings of the investigation. The hospital shall notify the patient or his/her designee that if the patient is not satisfied with the hospital's oral or written response, the patient may complain to the New York State Department of Health's Office of Health Systems Management. The hospital shall provide the telephone number of the local area office of the Health Department to the patient;

(24) obtain access to his /her medical record pursuant to the provisions of Part 50 of this Title. The hospital may impose reasonable charges for all copies of medical records provided to patients, not to exceed costs incurred by the hospital. A patient shall not be denied a copy of his/her medical record solely because of inability to pay; and

(25) receive supportive services to meet the changing care needs of the patient and the patient's family/representative provided by qualified individuals who collectively have expertise in assessing the special needs of hospital patients and their families.

(c) Patient's Bill of Rights. For purposes of subdivision (a) of this section, the hospital shall utilize the following Patients' Bill of Rights:

Patients' Bill of Rights

As a patient in a hospital in New York State, you have the right, consistent with law, to:

(1) Understand and use these rights. If for any reason you do not understand or you need help, the hospital must provide assistance, including an interpreter.

(2) Receive treatment without discrimination as to race, color, religion, sex, gender identity, national origin, disability, sexual orientation, age, or source of payment.

(3) Receive considerate and respectful care in a clean and safe environment free of unnecessary restraints.

(4) Receive emergency care if you need it.

(5) Be informed of the name and position of the doctor who will be in charge of your care in the hospital.

(6) Know the names, positions, and functions of any hospital staff involved in your care and refuse their treatment, examination or observation.

(7) Identify a caregiver who will be included in your discharge planning and sharing of post-discharge care information or instruction.

(8) Receive complete information about your diagnosis, treatment and prognosis.

(9) Receive all the information that you need to give informed consent for any proposed procedure or treatment. This information shall include the possible risks and benefits of the procedure or treatment.

(10) Receive all the information you need to give informed consent for an order not to resuscitate. You also have the right to designate an individual to give this consent for you if you are too ill to do so. If you would like additional information, please ask for a copy of the pamphlet "Deciding About Health Care - A Guide for Patients and Families."

(11) Refuse treatment and be told what effect this may have on your health.

(12) Refuse to take part in research. In deciding whether or not to participate, you have the right to a full explanation.

(13) Privacy while in the hospital and confidentiality of all information and records regarding your care.

(14) Participate in all decisions about your treatment and discharge from the hospital. The hospital must provide you with a written discharge plan and written description of how you can appeal your discharge.

(15) Review your medical record without charge and obtain a copy of your medical record for which the hospital can charge a reasonable fee. You cannot be denied a copy solely because you cannot afford to pay.

(16) Receive an itemized bill and explanation of all charges.

(17) View a list of the hospital’s standard charges for items and services and the health plans the hospital participates with.

(18) Challenge an unexpected bill through the Independent Dispute Resolution process.

(19) Complain without fear of reprisals about the care and services you are receiving and to have the hospital respond to you and if you request it, a written response. If you are not satisfied with the hospital's response, you can complain to the New York State Health Department. The hospital must provide you with the Health Department telephone number.

(20) Authorize those family members and other adults who will be given priority to visit consistent with your ability to receive visitors.

(21) Make known your wishes in regard to anatomical gifts. Persons sixteen years of age or older may document their consent to donate their organs, eyes and/or tissues, upon their death, by enrolling in the NYS Donate Life Registry or by documenting their authorization for organ and/or tissue donation in writing in a number of ways (such as health care proxy, will, donor card, or other signed paper). The health care proxy is available from the hospital.

(d) Each hospital shall be required to post in a conspicuous place and provide a pediatric patient's parent or other medical decision maker with a copy of a Parent's Bill of Rights advising that, at a minimum and subject to laws and regulations governing confidentiality, that in connection with every hospital admission or emergency room visit:

(1) The hospital must ask each patient or the patient's representative for the name of his or her primary care provider, if known, and shall document such information in the patient's medical record.

(2) The hospital may admit pediatric patients only to the extent consistent with their ability to provide qualified staff, space and size appropriate equipment necessary for the unique needs of pediatric patients.

(3) To the extent possible given the patient's health and safety, the hospital shall allow at least one parent/guardian to remain with the patient at all times.

(4) All test results completed during the patient's admission or emergency room visit will be reviewed by a physician, physician assistant or nurse practitioner who is familiar with the patient's presenting condition.

(5) Patients may not be discharged from the hospital or the emergency room until any tests that could reasonably be expected to yield "critical value" results – results that suggest a life-threatening or otherwise significant condition such that it requires immediate medical attention – are reviewed by a physician, physician assistant (PA) and/or nurse practitioner (NP) and are communicated to the patient, his or her parents or other decision-makers, as appropriate.

(6) Patients may not be discharged until they receive a written discharge plan, which will also be verbally communicated to patients, their parents or other medical decision-makers, which will identify critical value results of laboratory or other diagnostic tests ordered during the patient's stay and identify any other tests that have not yet been concluded.

(7) The communication of critical value results and the discussion of the discharge plan must be accomplished in a manner that reasonably assures that the patient, their parents or other medical decision makers understand the health information provided in order to make appropriate health decisions.

(8) Hospitals shall provide all lab results to the patient's primary care provider, if known.

(9) A patient, his or her parent or other medical decision maker has the right to request information about the diagnosis, possible diagnoses that were considered and complications that could develop as well as information about any contact that was made with the patient's primary care provider.

(10) On discharge, the hospital must provide a patient, his or her parent or other medical decision maker a phone number that the patient, his or her parent or other medical decision maker could call for advice in the event that complications or questions arise.

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 405.8 - Adverse Event Reporting

405.8 Adverse Event Reporting

(a) Any adverse event required to be reported pursuant to subdivision (b) of this section shall be reported to the department. Hospitals shall report such adverse events, as defined in subdivision (b) of this section, within 24 hours or one business day of when the adverse event occurred or when the hospital has reasonable cause to believe that such an adverse event has occurred. This report to the department shall be submitted in a format specified by the department and shall at a minimum 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 general hospital;

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

(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 hospital;

(12) fires or other internal disasters in the hospital 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 hospital environment which affect hospital operations;

(14) termination of any services vital to the continued safe operation of the hospital 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 hospital shall conduct an investigation of adverse events described in paragraphs (1-10) of subdivision (b) of this section. Such investigations shall be thorough and credible and occur within thirty days of when the adverse event occurred or when the hospital 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 hospital reasonably expects such investigation to extend beyond the thirty day period, the hospital 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. For adverse events described in paragraphs (1- 10) of subdivision (b) of this section, the hospital shall submit its investigative report electronically, in a format prescribed by the department. The investigative report shall document all hospital efforts to identify and analyze the circumstances surrounding the adverse event and to develop and implement appropriate measures to prevent recurrence and improve the overall quality of patient care. This report shall be credible and thorough and contain all information in a format specified by the department.

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

(e) Nothing in this section shall prohibit the department from investigating any adverse event occurring in general hospitals.

Effective Date: 
Wednesday, May 29, 2013
Doc Status: 
Complete

Section 405.9 - Admission/discharge

405.9 Admission/discharge.

(a) General.

(1) The governing body shall establish and implement written admission and discharge policies to protect the health and safety of the patients and shall not assign or delegate the functions of admission and discharge to any referral agency and shall not permit the splitting or sharing of fees between a referring agency and the hospital.

(b) Admission. (1) Each patient shall be advised of their rights pursuant to section 405.7 of this Part and, as appropriate, the criteria for Medicaid eligibility.

(2) No person shall be denied admission to the hospital because of race, creed, national origin, sex, disability within the capacity of the hospital to provide treatment, sexual orientation or source of payment.

(3) Except in emergencies, patients shall be admitted only upon referral and under the care of a licensed and currently registered practitioner who is granted admitting privileges by the governing body. The patient's condition and provisional diagnosis shall be established on admission by the patient's admitting practitioner and shall be noted in the patient's medical record.

(4) Except in emergencies, a hospital shall admit as patients only those persons who require the type of medical services authorized by the hospital's operating certificate.

(5) Except as provided in section 405.2(f)(4) of this Part, the hospital shall have a licensed and currently registered physician, or a registered physician's assistant under the general supervision of a physician, or a nurse practitioner in collaboration with a physician, available on the premises at all times who shall be responsible for receiving patients for care in accordance with policies established by the hospital and for the appropriate disposition of requests to admit patients.

(6) Insofar as it is practicable, the admitting practitioner shall request of each person being admitted, information concerning signs or symptoms of recent exposure to communicable diseases as defined in Part 2 of this Title. Whenever there are positive findings of exposure to such communicable disease, the patient shall be isolated and managed in accordance with the hospital's infection control policies and the provisions of Part 2 of this Title.

(7) Pediatrics. (i) The hospital shall admit pediatric patients consistent with its ability to provide qualified staff, space and size appropriate equipment necessary for the unique needs of pediatric patients. The hospital shall establish a separate pediatric unit if the hospital regularly has 16 or more pediatric patients at one time or if pediatric patients cannot be adequately and safely cared for in other than separately certified pediatric beds. If a hospital cannot meet these requirements the hospital must develop criteria and policies and procedures for transfer of pediatric patients.

(ii) Hospitals maintaining certified pediatric beds shall assure that admisison to those beds is limited to patients who have not yet reached their 21st birthday except in instances when there are no other available beds within the hospital. In such instances, the hospital shall afford priority admission to the pediatric bed to patients 20 years of age or younger.

(iii) Children under the age of 14 shall not be admitted to a room with patients 21 years of age or over except with the knowledge and agreement of the child's attending practitioner and parent or guardian and the concurrence of the other patients occupying the room and their attending practitioners.

(iv) In the event a separate unit is not available, arrangements for the admission of all children shall be made consistent with written policies and procedures to ensure the safety of each patient.

(v) The hospital shall develop policies and procedures enabling parents/guardians to stay with pediatric patients. To the extent possible given the patient's health and safety, the hospital shall allow at least one parent/guardian to remain with the patient at all times.

(8) The hospital shall require that a member of the medical staff who has privileges to admit patients shall assume the principal obligation and responsibility for managing the patient's medical care. Postgraduate trainees and supervising physicians shall consult with and be directed by the attending practitioner with regard to therapeutic decisions and changes in patient status. Direct patient care may be provided by postgraduate trainees and medical students, within their permitted scope of responsibility and privileges with supervision as required in section 405.4 of this Part with the concurrence of the attending practitioner. Occurrence of urgent or emergent situations may preclude the attending or admitting practitioner from direct participation in decision-making regarding patient care. In such circumstances, the supervising physician shall concur in the decision, and the attending practitioner shall be notified as soon as possible. Responsibility for such decisions made in the absence of consultation with the responsible attending practitioner resides with the involved postgraduate trainees and supervising physicians.

(9) The hospital shall provide for the assignment, management, and disposition of patients who are not admitted as private patients of members of the medical staff. The hospital shall develop and implement policies and procedures which provide for the continuity of care of such patients and shall include a procedure by which each patient is assigned to a member of the medical staff, who shall be the personal practitioner to the patient and assume professional responsibility for his/her care in the hospital and for a proper plan of care after discharge.

(10) No hospital shall be required to admit any patient for the purpose of performing an induced termination of pregnancy, nor shall any hospital be liable for its failure or refusal to participate in any such act, provided that the hospital shall inform the patient of its decision not to participate in such an act or acts. The hospital in such event shall inform the patient of appropriate resources for services or information.

(11) A complete and permanent record shall be maintained of all patients admitted, including but not limited to the date and time of admission, name and address, date of birth, the next of kin or sponsor, veteran status (insofar as these are obtainable), the admitting diagnosis, condition, the name of the referring practitioner, the hospital attending practitioner or service, and as to discharge, the date and time, condition and principal diagnosis.

(i) If a patient is identified as a veteran, the hospital shall notify such veteran of the possible availability of services at a hospital operated by the Veteran's Administration. For the purposes of this paragraph, a veteran shall be defined as a person who served in the United States Military, who received a discharge other than a dishonorable discharge and who is eligible for benefits provided by the Veteran's Administration.

(ii) If a patient eligible for transfer to a hospital operated by the Veteran's Administration requests such transfer, hospital staff shall make such arrangements. Transfer shall be effected in accordance with paragraph (h)(7) of this section.

(12) Every patient shall have a complete history and physical examination performed by an appropriately credentialed practitioner within thirty days before or 24 hours after admission. If recorded in the patient's medical record by an individual other than the attending practitioner, the history and physical examination shall be reviewed and countersigned by the attending practitioner. When the history and physical is completed within the thirty days prior to admission, an examination, to update any changes in the patient's health status, must be completed and documented in the patient's medical record within 24 hours after admission.

(i) Such examination shall include a screening uterine cytology smear on women 21 years of age and over, unless such test is medically contraindicated or has been performed within the previous three years, and palpation of breast, unless medically contraindicated, for all women over 21 years of age. These examinations shall be recorded in the medical record.

(ii) Insofar as it is possible to identify patients who may be susceptible to sickle cell anemia, all such presumptively susceptible patients, including infants over six months of age, shall be examined for the presence of sickle cell hemoglobin unless such test has been previously performed and the results recorded in the patient's medical record or otherwise satisfactorily recorded, such as on an identification card.

(13) No patient 18 years of age or older shall be detained in a hospital against his will, nor shall a minor be detained against the will of his parent or legal guardian, except as authorized by law. This provision shall not be construed to preclude or prohibit attempts to persuade a patient to remain in the hospital in his/her own interest, nor the temporary detention of a mentally disturbed patient for the protection of himself/herself or others, pending prompt legal determination of his/her rights. In no event shall a patient be detained solely for nonpayment of his/her hospital bill or practitioner's statement for medical services.

(14) the hospital shall adopt and make public the following admission notices to be provided to all patients receiving inpatient hospital care. Medicare patients shall be given the notice set forth in subparagraph (i) and all other inpatients shall be given the notice set forth in subparagraph (ii) of this paragraph.

(i) Hospital Admission Notice for Medicare Patients

You have the following rights under the New York State law:

Before you are discharged, you must receive a written Discharge Plan. You or your representative have the right to be involved in your discharge planning.

Your written Discharge Plan must describe the arrangements for any future health care that you may need after discharge. You may not be discharged until the services required in your written Discharge Plan are secured or determined to be reasonably available.

If you do not agree with the Discharge Plan or believe the services are not reasonably available, you may call the New York State Health Department to investigate your complaint and the safety of your discharge. The hospital must provide you with the Health Department's telephone number if you ask for it.

For important information about your rights as a Medicare patient, see the "IMPORTANT MESSAGE FROM MEDICARE," which you must receive when admitted to a hospital.

(ii) Hospital Admission Notice

An Important Message Regarding Your Rights as a Hospital Inpatient

Your Rights While a Hospital Patient

You have the right to receive all of the hospital care that you need for the treatment of your illness or injury. Your discharge date is determined only by YOUR health care needs, not by your DRG category or your insurance.

You have the right to be fully informed about decisions affecting your care and your insurance coverage. ASK QUESTIONS. You have the right to designate a representative to act on your behalf.

You have the right to know about your medical condition. Talk to your doctor about your condition and your health care needs. If you have questions or concerns about hospital services, your discharge date or your discharge plan, consult your doctor or a hospital representative (such as the nurse, social worker, or discharge planner).

Before you are discharged you must receive a written DISCHARGE NOTICE and a written DISCHARGE PLAN. You and/or your representative have the right to be involved in your discharge planning.

You have the right to appeal the written discharge plan or notice you receive from the hospital.

IF YOU THINK YOU ARE BEING ASKED TO LEAVE THE HOSPITAL TOO SOON

Be sure you have received the written notice of discharge that the hospital must give you. You need this discharge notice in order to appeal.

This notice will say who to call and how to appeal. To avoid extra charges you must call to appeal by 12 noon of the day after you receive the notice. If you miss this time you may still appeal. However, you may have to pay for your continued stay in the hospital, if you lose your appeal.

DISCHARGE NOTICE

In addition to the right to appeal, you have the right to:

Receive a written discharge plan that describes the arrangements for any future health care you may need after discharge. You may not be discharged until the services required in your written discharge plan are secured or determined by the hospital to be reasonably available. You also have the right to appeal this discharge plan.

PATIENTS' RIGHTS

A general statement of your additional rights as a patient must be provided to you at this time.

FOR ASSISTANCE/HELP

The Independent Professional Review Agent (IPRA) for your area and your insurance coverage is:

(Hospitals are permitted to use a checklist to indicate the IPRA that the patient should contact.)

(15) In conjunction with the requirements for complete history and physical examination as established in this section, hospitals approved by the Office of Alcoholism and Substance Abuse Services (OASAS) or the Division of Alcoholism and Alcohol Abuse, a predecessor agency, shall provide a Health Intervention Services (HIS) program to screen all admitted patients for signs of alcoholism or alcohol abuse that may relate to the condition requiring hospital admission. Specifically, such hospitals shall:

(i) maintain a dedicated staff that are adequate in number and trained, including continuing education and inservice training, to perform all the activities required of the HIS program;

(ii) identify patients who exhibit signs of alcoholism or alcohol abuse through a comprehensive screening protocol; and

(iii) offer patients intervention and referral services consistent with their assessed needs.

(16) The hospital shall ask each patient for the name of his or her primary care provider, if known, on admission and shall document such information in the patient’s medical record.

(c) Treatment of sexual offense survivors and maintenance of sexual offense evidence.

(1) Treatment of survivors. Hospitals shall:

(i) maintain current protocols regarding the care of patients reporting sexual assault;

(ii) provide to patients who are suspected or confirmed victims of sexual offenses appropriate assessment, emergency treatment and referrals to meet the health care needs of such individuals, to provide emotional support to them and to minimize further trauma;

(iii) advise patients of the availability of services provided by a local rape crisis or victim assistance organization and, unless the patient declines such services, contact such organization with information concerning the age and sex of the victim, language spoken by the victim if other than English , and any other information that may impact the assignment of a victim advocate, such as mental retardation, etc., so that a representative may offer the patient the services that the organization provides;

(iv) as provided by the Department and consistent with current standards of professional practice, provide to patients written and verbal information necessary to make an informed choice in regard to treatment options, including pregnancy prophylaxis;

(v) provide to patients, upon request, prophylaxis against pregnancy, sexually transmitted diseases, hepatitis B and HIV, as medically indicated;

(vi) discuss with patients the option of reporting the sexual offense to the police, and upon consent of the patient, report the offense to the local law enforcement agency; and

(vii) reasonably assure patients an appropriate and safe discharge.

(2) Maintenance of sexual offense evidence. The hospital shall provide for the maintenance of evidence of sexual offenses. The hospital shall establish and implement written policies and procedures that are consistent with requirements of this section and that shall apply to all service units of the hospital which treat victims of sexual offenses, including, but not limited to, medicine, surgery, emergency, pediatric and outpatient services.

(i) The sexual offenses subject to the provisions of this subdivision shall be sexual misconduct, rape, sodomy, sexual abuse and aggravated sexual abuse as defined in Article 130 of the Penal Law.

(ii) The sexual offense evidence shall include, as appropriate to the injuries sustained in each case, slides, cotton swabs, clothing or portions thereof, hair combings, fingernail scrapings, photographs, and other items specified by the local police agency and forensic laboratory in each particular case.

(iii) The hospital shall preserve items of sexual offense evidence and ensure that clothes and samples or swabs are dried, stored in paper bags and labeled, and shall mark and log each item of evidence with a code number corresponding to the patient's medical record number.

(iv) Privileged sexual offense evidence shall mean evidence collected or obtained from the patient during the hospital examination and treatment of injuries sustained as a result of a sexual offense.

(v) Sexual offense evidence that is not privileged shall mean evidence which is obtained from victims of suspected child abuse or maltreatment, and that derived from other alleged crimes, attendant to or committed simultaneously with the sexual offense, which are required to be reported to a police agency, such as bullet or gunshot wounds, powder burns, burn injuries, which may also be required to be reported to the state fire administrator, or other injuries arising from or caused by the discharge of a gun or firearm, or wounds which may result in death and which are inflicted by a knife, ice pick or other sharp or pointed instrument in accordance with sections 265.25 and 265.26 of the Penal Law. Nothing in this paragraph shall prevent the reporting of diseases or medical condition required by law to be reported to health authorities.

(vi) Upon admission of a patient who is an alleged sexual offense survivor, the hospital shall seek patient consent, or consent of the person authorized to act on the patient's behalf, for collection and storage of the sexual offense evidence and shall explain the specific rights of the patient and obligations of the hospital as outlined in this paragraph. The hospital shall store the sexual offense evidence in a locked, separate and secure area for not less than thirty days unless:

(a) the patient or person authorized to act on the patient's behalf signs a statement directing the hospital not to collect and keep privileged evidence; or

(b) such evidence is privileged and the patient or person authorized to act on the patient's behalf signs a statement directing the hospital to surrender the evidence to the police before the thirty day period has expired; or

(c) the evidence is not privileged and the police request its surrender before the thirty day period has expired;

(vii) If none of the above acts have occurred within thirty days from commencement of treatment, the evidence shall be discarded and the patient's possessions shall be returned upon the patient's request.

(viii) The hospital shall designate a staff member to coordinate the required actions and to contact the local police agency and forensic laboratory to determine their specific needs and requirements for the maintenance of sexual offense evidence.

(d) Child abuse and maltreatment. The hospital shall provide for the identification, assessment, reporting and management of cases of suspected child abuse and maltreatment. The hospital shall establish and implement written policies and procedures which are consistent with the requirements of this section and which shall apply to all service units of the hospital which treat victims of child abuse and maltreatment, including but not limited to medicine, surgery, emergency, pediatrics and outpatient services.

(1) The hospital shall provide orientation and continuing education to the nursing, medical and social work personnel of, at least, the hospital's emergency, pediatric and outpatient services in the recognition of indicators of domestic violence and suspected child abuse and maltreatment and in the individual's responsibilities in dealing with such case.

(2) A staff member shall be designated to coordinate the required reporting to the New York State Central Register of Child Abuse and Maltreatment and the hospital's actions taken with respect to such cases in accordance with procedures set forth in article 6, title 6 of the State Social Services Law.

(e) Domestic violence. The hospital shall provide for the identification, assessment, treatment and appropriate referral of cases of suspected or confirmed domestic violence victims. The hospital shall establish and implement written policies and procedures consistent with the requirements of this section which shall apply to all service units of the hospital.

(f) Individuals with Substance Use Disorders.  The hospital shall develop and maintain written policies and procedures for inpatient and outpatient care of individuals with documented substance use disorders or who appear to have or be at risk for substance use disorders, as that term is defined in section 1.03 of the Mental Hygiene Law.  Such policies and procedures shall, at a minimum, meet the following requirements:   

(1) Policies and procedures shall provide for the use of an evidence-based approach to identify and assess individuals for substance use disorders, and to refer individuals with documented substance use disorders or who appear to have or be at risk for substance use disorders;

(2) Upon admission, treatment, or discharge of an individual with a documented substance use disorder or who appears to have or be at risk for a substance use disorder, including discharge or transfer from the emergency service of the hospital or assignment to observation services pursuant to paragraph (2) of subdivision (e) of section 405.19 of this Part, the hospital shall inform the individual of the availability of the substance use disorder treatment services that may be available to him or her through a substance use disorder services program. Such information may be provided verbally and/or in writing as appropriate;

(3) During discharge planning, the hospital shall provide to each individual with a documented substance use disorder or who appears to have or be at risk for a substance use disorder with educational materials, identified by the Office of Alcoholism and Substance Abuse Services in consultation with the Department and provided to the hospital pursuant to subdivision 1 of section 2803-u of the Public Health Law;

(4) Except where an individual has come into the hospital under section 22.09 of the Mental Hygiene Law, and where the hospital does not directly provide substance use disorder services, the hospital shall refer individuals in need of substance use disorder services to and coordinate with appropriate substance use disorder services programs that provide behavioral health services, as defined in section 1.03 of the Mental Hygiene Law; and

(5) The hospital shall establish and implement training, in addition to current training programs, for all individuals licensed or certified pursuant to title eight of the education law who provide direct patient care regarding the policies and procedures established in this paragraph.

(g) Human Trafficking.  The hospital shall provide for the identification, assessment, and appropriate treatment or referral of individuals who are suspected to be human trafficking victims, as that term is defined in section 483-aa of the Social Services Law and used in Article 10-D of the Social Services Law.  The hospital shall establish and implement written policies and procedures, which shall apply to all service units of the hospital and, at a minimum, shall meet the following requirements:

(1) Policies and procedures shall provide for the identification, assessment, and appropriate treatment or referral of individuals who are suspected to be human trafficking victims;

(2) In the case of individuals who are suspected to be human trafficking victims and are under eighteen years old, policies and procedures shall provide for the reporting of such persons as an abused or maltreated child if required under Title 6 of Article 6 of the Social Services Law;

(3) The hospital shall inform individuals who are suspected to be human trafficking victims of services that may be available, including those referenced in Article 10-D of the Social Services Law.  Referrals also may be made to other health care providers, appropriate state agencies, and/or other providers of services as appropriate.  Such information may be provided verbally and/or in writing as appropriate;

(4) The hospital shall post the human trafficking hotline poster issued by the National Human Trafficking Resources Center, or a variation of such poster created by the Office of Temporary and Disability Assistance (OTDA) consistent with section 483-ff of the Social Services Law, whichever OTDA makes available on its website.  Posters shall be placed in conspicuous locations near primary public entrances and where other posters and notices are posted; and

(5) The hospital shall establish and implement training, which may be incorporated into current training programs, for all individuals licensed or certified pursuant to Title 8 of the Education Law who provide direct patient care, and for all security personnel, regarding the policies and procedures established pursuant to this subdivision. Such training shall include training in the recognition of indicators of a human trafficking victim and the responsibilities of such personnel in dealing with persons suspected as human trafficking victims.

(h) Discharge. (1) The hospital shall ensure that each patient has a discharge plan which meets the patient's post-hospital needs. No patient who requires continuing health care services in accordance with such patient discharge plan may be discharged until such services are secured or determined by the hospital to be reasonably available to the patient.

(2) The hospital shall have a discharge planning coordinator responsible for the coordination of the hospital discharge planning program. The discharge planning coordinator shall be an individual with appropriate training and experience as determined by the hospital to coordinate the hospital discharge planning program.

(3) The hospital shall ensure:

(i) that discharge planning staff have available current information regarding home care programs, institutional health care providers, and other support services within the hospital's primary service area, including their range of services, admission and discharge policies and payment criteria;

(ii) the utilization of written criteria as part of a screening system for the early identification of those patients who may require post-hospital care planning and services. Such criteria shall reflect the hospital's experience with patients requiring post-hospital care and shall be reviewed and updated annually;

(iii) that upon the admission of each patient, information is obtained as required to assist in identifying those patients who may require post-hospital care planning;

(iv) that each patient is screened as soon as possible following admission in accordance with the written criteria described in subparagraph (ii) of this paragraph and that this screening is coordinated with the utilization review process;

(v) that each patient identified through the screening system as potentially in need of post-hospital care is assessed by those health professionals whose services are appropriate to the needs of the patient to determine the patient's post-hospital care needs. Such assessment shall include an evaluation of the extent to which the patient or patient's personal support system can provide or arrange to provide for identified care needs while the patient continues to reside in his/her personal residence;

(vi) that for each patient determined to need assistance with post-hospital care, the health professionals whose services are medically necessary, together with the patient and the patient's family/representative shall develop an individualized comprehensive discharge plan consistent with medical discharge orders and identified patient needs;

(vii) that each patient determined to need assistance with post-hospital care and the patient's family/representative receive verbal and written information regarding the range of services in the patient's community which have the capability of assisting the patient and the patient's family/representative in implementing the patient's individualized discharge plan which is appropriate to the patient's level of care needs;

(viii) that the patient and the patient's family/representative shall have the opportunity to participate in decisions regarding the selection of post-hospital care consistent with and subject to any limitations of Federal and State laws. Planning for post-hospital care shall not be limited to placement in residential health care facilities for persons assessed to need that level of care, but shall include consideration of noninpatient services such as home care, long-term home health care, hospice, day care and respite care;

(ix) that when residential health care facility placement is indicated, the patient and the patient's family/representative shall be afforded the opportunity, consistent with and subject to any limitation of Federal and State laws, to participate in the selection of the residential health care facilities to which applications for admission are made.

(x) that contact with appropriate providers of health care and services is made as soon as possible, but no later than the day of assignment of alternate level of care status and that each patient's record contains a record of all such contacts including date of contact and provider response as well as a copy of any standard assessment form, including but not limited to any hospital/community patient review instrument as contained in section 400.13 of this Title and any home health assessment, completed by the hospital for purposes of post-hospital care;

(xi) that relevant discharge planning information is available for the utilization review committee; and

(xii) the development and implementation of written criteria for use in the hospital emergency service indicating the circumstances in which discharge planning services shall be provided for a person who is in need of post emergency care and services but not in need of inpatient hospital care.

(4) The hospital shall establish and implement written policies an d procedures governing the admissions and discharge process which ensure compliance with State and Federal antidiscrimination laws which apply to the operator. Such laws include, but need not be limited to, the applicable provisions of this Part; Public Health Law, section 2801-a(9); the New York State Civil Rights Law, sections 40 and 40-c; article 15 (Human Rights Law) of the State Executive Law, sections 291, 292 and 296; and title 42 of the United States Code, sections 1981, 2000a, 2000a-2, 2000d, 3602, 3604 and 3607. Copies of the cited State and Federal statutes are available from West Publishing Company, P.O. Box 64526, St. Paul, MN 55164-0526, the publisher of McKinney's Consolidated Laws of New York annotated and the United States Code annotated. Copies of such statutes are also available for public inspection and copying at the Records Access Office, New York State Department of Health, Corning Tower Building, Governor Nelson A. Rockefeller Empire State Plaza, Albany, New York 12237.

(5) Discharge planners shall inform each patient and his/her family of the admission policies of the residential health care facilities to which they are referred.

(6) The requirements of this subdivision relating to a patient's family/representative participating in the discharge planning process and in receiving an explanation of the reason for a patient's transfer or discharge shall not apply in the following circumstances:

(i) when a competent adult patient objects to such participation by, or to an explanation regarding transfer or discharge being given to, any family/representative. Any such objections shall be noted in the patient's medical record; or

(ii) when the hospital has made a reasonable effort to contact a patient's family/representative in order to provide an opportunity to participate in the discharge planning process or to explain the reason for transfer or discharge, and the hospital is unable to locate a responsible family member/representative, or, if located, such individual refuses to participate. The reasons a patient's family/representative did not participate in the discharge planning process or did not receive an explanation of the reason for a patient's transfer or discharge shall be noted in the patient's medical record. A reasonable effort shall include, but not be limited to, attempts to contact a patient's family/representative by telephone, telegram and/or mail.

(7) The hospital shall ensure that no person presented for medical care shall be removed, transferred or discharged from a hospital based upon source of payment. Each removal, transfer or discharge shall be carried out after a written order made by a physician that, in his/her judgment, such removal, transfer or discharge will not create a medical hazard to the person or that such removal, transfer or discharge is considered to be in the person's best interest despite the potential hazard of movement. Such a removal, transfer or discharge shall be made only after explaining the need for removal, transfer or discharge to the patient and to the patient's family/representative and prior notification to the medical facility expected to receive the patient.

(i) The hospital shall maintain a record of all removals, discharges and transfers from the hospital, including the date and time of the hospital reception or admission, name, sex, age, address, presumptive diagnosis, treatment provided, clinical condition, reason for removal, transfer or discharge and destination. A copy of such information shall accompany any person transferred or discharged to a health care facility or a certified or licensed home care services agency and, where applicable, become a part of the person's medical record.

(ii) Patients discharged from the hospital by their attending practitioner shall not be permitted to remain in the hospital without the consent of the chief executive officer of the hospital except in accordance with provisions of subdivision (i) of this section.

(iii) In the absence of a written order of an attending practitioner discharging a patient, with respect to a patient who insists upon discharging himself from the hospital, the hospital shall obtain, where practicable, a written release from the patient absolving the hospital and the patient's attending practitioner of liability and damages resulting from such discharge.

(8) Unless otherwise provided by law, the hospital shall ensure that a minor shall be discharged only in the custody of his parent, a member of his immediate family or his legal guardian or custodian, unless such parent or guardian shall otherwise direct.

(9) A dead body, including a stillborn infant or fetus estimated by an attending physician to have completed 20 weeks of gestation, shall be delivered only to a licensed funeral director or undertaker or his/her agent. If, at the time of death, the patient was diagnosed as having a specific communicable or infectious disease, including but not limited to those diseases designated in Part 2 of this Title, a written report of such disease shall accompany the body when it is released to the funeral director or his/her agent.

(10) The hospital shall develop and implement written policies and procedures pertaining to the review and communication of laboratory and diagnostic test/service results ordered for a patient while admitted or receiving emergency services to the patient. If the patient lacks medical decision-making capacity, the communication shall be to the patient's medical decision-maker. The results shall also be provided to the patient’s primary care provider, if known. Such policies and procedures shall be reviewed and updated as necessary and at a minimum shall include:

(i) a requirement that all laboratory and other diagnostic tests/service results be reviewed upon completion by a physician, physician assistant or nurse practitioner familiar with the patient’s presenting condition;

(ii) a requirement that all laboratory and other diagnostic test services results be forwarded to the patient's primary provider, if known, after review by a physician, physician assistant or nurse practitioner;

(iii) provisions to include in the discharge plan information regarding the patient's completed and pending laboratory and other diagnostic test/service results, medications, diagnoses, and follow-up care and to review such information with the patient or, if the patient is not legally capable of making decisions, the patient's parent, legal guardian or health care agent, or surrogate, as appropriate, subject to all applicable confidentiality laws and regulations;

(iv) a requirement that patients may not be discharged from the hospital or the emergency room until any tests that could reasonably be expected to yield "critical value" results – results that suggest a life-threatening or otherwise significant condition such that it requires immediate medical attention – are reviewed by a physician, physician assistant (PA) and/or nurse practitioner (NP);

(v) a requirement that before a patient is discharged, any critical laboratory test results are communicated to the patient or, if the patient is not legally capable of making decisions, the patient's parent, legal guardian or health care agent, or surrogate, as appropriate, subject to all applicable confidentiality laws and regulations;

(vi) a requirement that all information be presented to the patient or if the patient is not legally capable of making decisions, the patient's parent, legal guardian or health care agent, or surrogate, as appropriate, subject to all applicable confidentiality laws and regulations, in a manner that reasonably assures that the patient, their parents or other medical decision makers understand the health information provided in order to make appropriate health decisions.

(i) Hospital inpatient discharge review program. (1) A hospital inpatient discharge review program applicable to all patients other than beneficiaries of title XVIII of the Federal Social Security Act (Medicare) shall be established in accordance with this subdivision. No hospital inpatient subject to the provisions of this subdivision may be discharged on the basis that inpatient hospital service in a general hospital is no longer medically necessary and that an appropriate discharge plan has been established unless a written notice of such determinations and a copy of the discharge plan have been provided to the patient or the appointed personal representative of the patient. The patient or the appointed personal representative of the patient shall have the opportunity to sign the notice and a copy of the discharge plan and receive a copy of both signed documents. Every hospital shall use the common notice set forth in paragraph (9) of this subdivision. The patient, or the appointed personal representative of the patient may request a review of such determinations by the appropriate independent professional review agent or review agent in accordance with paragraph (4) of this subdivision. Notwithstanding that the patient discharge review process provided in accordance with Federal law and regulation shall apply to beneficiaries of title XVIII of the Federal Social Security Act (Medicare), a written copy of the discharge plan, and discharge notice shall be provided to the beneficiary or the appointed personal representative of the beneficiary. The beneficiary or the appointed personal representative of the beneficiary shall have the opportunity to sign the documents and receive a copy of the signed documents.

(2) (i) For patients eligible for payments by state governmental agencies for hospital inpatient services as the patient's primary payor an independent professional review agent shall mean the commissioner or his designee. In conducting hospital inpatient discharge reviews in accordance with this paragraph, the commissioner may utilize the services of department personnel or other authorized representatives, including a review agent approved in accordance with subparagraph (ii) of this paragraph.

(ii) For patients who are not beneficiaries of title XVIII of the Federal Social Security Act (Medicare) nor eligible for payments by state governmental agencies as the patient's primary payor, an independent professional review agent shall mean a third-party payor of hospital services or other corporation approved by the commissioner in writing for purposes of conducting hospital inpatient discharge reviews in accordance with this subdivision. For a third-party payor of hospital services or other corporation to be approved as an independent professional review agent in accordance with this subparagraph, such third-party payor or other corporation must meet the following approval criteria:

(a) the review agent shall employ or otherwise secure the services of adequate medical personnel qualified to determine the necessity of continued inpatient hospital services and the appropriateness of hospital discharge plans;

(b) the review agent shall demonstrate the ability to render review decisions in a timely manner as provided in this subdivision;

(c) the review agent shall agree to provide ready access by the commissioner to all data, records and information it collects and maintains concerning its review activities under this subdivision;

(d) the review agent shall agree to provide to the commissioner such data, information and reports as the commissioner determines necessary to evaluate the review process provided pursuant to this subdivision;

(e) the review agent shall provide assurances that review personnel shall not have a conflict of interest in conducting a discharge review for a patient based on hospital or professional affiliation; and

(f) the review agent meets such other performance and efficiency criteria regarding the conduct of reviews pursuant to this subdivision established by the commissioner.

The commissioner may withdraw approval of an independent professional review agent where such review agent fails to continue to meet approval criteria established pursuant to this subparagraph.

(iii) Each hospital shall enter into contracts with one or more independent professional review agents approved by the commissioner in accordance with subparagraph (ii) of this paragraph for purposes of conducting hospital inpatient discharge reviews in accordance with this subdivision for patients, including uncompensated care patients, who are not beneficiaries of title XVIII of the Federal Social Security Act (Medicare) nor eligible for payments by State governmental agencies as the patient's primary payor; provided, however, a payor of hospital service authorized under article 43 of the State Insurance Law or certified as health maintenance organizations under article 44 of the Public Health Law, may designate the review agent for their subscribers or beneficiaries or enrolled members and shall reimburse such designated review agent for costs of the discharge review program.

(3) (i) If a hospital and the attending physician agree that inpatient hospital service in a hospital is no longer medically necessary for a patient, other than a beneficiary of title XVIII of the Federal Social Security Act (Medicare), and an appropriate discharge plan has been established for such patient, at that time the hospital shall provide the patient or the appointed personal representative of the patient with a written discharge notice and a copy of the discharge plan, meeting the requirements of paragraph (1) of this subdivision.

(ii) If a hospital has determined that inpatient hospital service in a hospital is no longer medically necessary for a patient, other than a beneficiary of title XVIII of the Federal Social Security Act (Medicare), and an appropriate discharge plan has been established for such patient but the attending physician has not agreed with the hospital's determinations, the hospital may request by telephone a review of the validity of the hospital's determinations by the appropriate independent professional review agent. Such review agent shall conduct a review of the hospital's determinations and prior to the conclusion of the review shall provide an opportunity to the treating physician and an appropriate representative of the hospital to confer and provide information which may include the patient's clinical records if requested by the review agent. Such review agent shall notify the hospital of the results of its review not later than one working day after the date the review agent has received the request, the records required to conduct such review, and the date of such conferring and receipt of an additional information requested. The hospital shall provide notice to the attending physician of the results of the review. If the review agent concurs with the hospital's determinations, the hospital shall provide the patient or his appointed personal representative with a written notice of such determinations and notice that the patient shall be financially responsible for continued stay, and with a copy of the proposed discharge plan. The patient or the appointed personal representative of the patient shall have the opportunity to sign the notice and a copy of the proposed discharge plan and receive a copy of both signed documents. Every hospital shall use the notice set forth in paragraph (10) of this subdivision which shall indicate the determinations made, shall state the reasons therefor and that the patient's attending physician has disagreed, and shall state that the patient or the appointed personal representative of the patient may request a review of such determinations by the appropriate review agent.

(4) A patient in a hospital, or the appointed personal representative of the patient, who receives a written notice in accordance with subparagraph (3)(i) or (3)(ii) of this subdivision, may request a review by the appropriate review agent of the determinations set forth in such notice related to medical necessity of continued inpatient hospital service, the appropriateness of the discharge plan and the availability of required continuing health care services.

(i) If a patient while still hospitalized or while no longer an inpatient, or the appointed personal representative of such patient, requests a review by the appropriate review agent, the hospital shall promptly provide to the review agent the records required to review the determinations. Such request for a patient no longer an inpatient shall take place no later than 30 days after receipt of a notice provided in accordance with paragraph (3) of this subdivision or seven days after receipt of a complete bill for all inpatient services rendered, whichever is later. The review agent shall conduct a review of such determinations, and shall provide the treating physician and an appropriate representative of the hospital with an opportunity to confer and provide information prior to the conclusion of the review. The review agent shall provide written notice to the patient, or the appointed personal representative of the patient, and the hospital of the results of the review within three working days of receipt of the requests for review and the records required to review the determinations. The hospital shall provide notice to the attending physician of the results of the review.

(ii) If a patient while still an inpatient in the hospital, or the appointed personal representative of the patient, requests a review by the appropriate review agent not later than noon of the first working day after the date the patient, or the appointed personal representative of the patient, receives the written notice, the hospital shall provide to the appropriate review agent the records required to review the determinations by the close of business of such working day. The appropriate review agent shall conduct a review of such determinations and provide written notice to the patient, or the appointed representative of the patient, and the hospital of the results of the review not later than one full working day after the date the review agent has received the request for review and such records. The hospital shall provide notice to the attending physician of the results of the review.

(5) If the appropriate review agent, upon any review conducted pursuant to subparagraph (3)(ii) or pursuant to paragraph (4) of this subdivision does not concur in the determinations, continued stay in a hospital shall be deemed necessary and appropriate for the patient for purposes of payment for such continued stay.

(6) If a patient eligible for payment for inpatient hospital services under the case-based payment per discharge system or the appointed personal representative of the patient, requests a review by the appropriate review agent in accordance with subparagraph (4)(ii) of this subdivision, the hospital may not demand or request any payment for additional inpatient hospital services provided to such patient subsequent to the proposed time of discharge and prior to noon of the day after the date the patient or the appointed personal representative of the patient receives notice of the results of the review by the review agent except deductibles, copayments, or other charges that would be authorized for a patient for whom inpatient hospital services in a hospital continue to be necessary and appropriate.

(7) In any review conducted pursuant to subpargraph (3)(ii) or pursuant to paragraph (4) of this subdivision, the review agent shall solicit the views of the patient involved, or the appointed personal representative of the patient, and the attending physician.

(8) Each patient, or the appointed personal representative of the patient, provided a notice by a hospital in accordance with paragraph (3) of this subdivision shall be provided at such time by the hospital with a notice of such patient's right to request a discharge review in accordance with this subdivision. The patient or the appointed personal representative of the patient shall have the opportunity to sign this form and receive a copy of the signed form.

(9) Notice that inpatient hospital service is no longer medically necessary. For purposes of subparagraph (i) of paragraph (3) of this subdivision, the hospital shall utilize the following notices:

(i) The following form shall be used for patients covered under the case payment system:

DISCHARGE NOTICE

Date:/__________/________________

READ THIS LETTER CAREFULLY-IT CONCERNS YOUR PRIVATE INSURANCE BENEFITS OR MEDICAID BENEFITS OR IF YOU ARE UNINSURED

PATIENT NAME: ___________________________________ PRIMARY PAYOR

AT DISCHARGE:___________________________________________________

ATT. PHYS: __________________ MR #: ________________

ADM. DATE:________________________________________

Dear Patient:

Your doctor and the hospital have determined that you no longer require care in the hospital and will be ready for discharge on:

______________________       _____/_____/_____

Day of Week                                         Date

IF YOU AGREE with this decision, you will be discharged. Be sure you have already received your written discharge plan which describes the arrangements for any future health care you may need.

IF YOU DO NOT AGREE and think you are not medically ready for discharge or feel that your discharge plan will not meet your health care needs, you or your representative may request a review. Contact the review agent indicated on the reverse side of this letter if you would like a review of the discharge decision.

IF YOU WOULD LIKE A REVIEW, you should immediately, but not later than noon of _____________________________ (Day and Date) call the telephone number checked off on the reverse side of this page.

IF YOU CANNOT REQUEST THE REVIEW YOURSELF, and you do not have a family member or friend to help you, you may ask the hospital representative at extension __________________, who will request the review for you.

IF YOU REQUEST A REVIEW, the following will happen:

1. The review agent will ask you or your representative why you or your representative think you need to stay in the hospital and also will ask your name, admission date and telephone number where you or your representative can be reached.

2. After speaking with you or your representative and your doctor and after reviewing your medical record, the review agent will make a decision which will be given to you in writing.

3. While this review is being conducted, you will not have to pay for any additional hospital days until you have received the review agent's decision.

IF THE REVIEW AGENT AGREES WITH THE DISCHARGE DECISION, you will be financially responsible for your continued stay after noon of the day after you or your representative has been notified of the review agent's decision.

IF THE REVIEW AGENT AGREES THAT YOU STILL NEED TO BE IN THE HOSPITAL: for Medicaid patients, Medicaid benefits will continue to cover your stay; for private health insurance patients, coverage for your continued stay is limited to the scope of your private health insurance policy.

NOTE: If you miss the noon deadline mentioned on the first page of this notice, you may still request a review. However, if the review agent disagrees with you, you will be financially responsible for the days of care beginning with the proposed discharge date.

If you would like a review of your hospital stay after you have been discharged, you may request a review by the review agent within thirty (30) days of the receipt of this notice or seven days after receipt of a complete bill from the hospital, whichever is later, by writing to the review agent.

I have received this notice on behalf of myself as the patient or as the representative of the patient:

______________________                 _______/________/_______              _________________

Signature                                                      Date                                              Time

 

_____________________

Relationship

(ii) The following form shall be used for patients covered under a per diem reimbursement system:

DISCHARGE NOTICE

DATE  _____/_____/_____

 

READ THIS LETTER CAREFULLY-IT CONCERNS YOUR PRIVATE INSURANCE BENEFITS OR MEDICAID BENEFITS OR IF YOU ARE UNINSURED

PATIENT NAME: ______________________________________PRIMARY PAYOR

AT DISCHARGE:________________________________

ATT. PHYS:______________________ MR #:____________________

ADM. DATE:_____________ /____________________ /__________________

Dear Patient:

Your doctor and the hospital have determined that you no longer require care in the hospital and will be ready for discharge on:

___________________    _____/_____/_____

Day of Week                                Date

IF YOU AGREE with this decision, you will be discharged. Be sure you have already received your written discharge plan which describes the arrangements for any health care you may need when you leave the hospital.

IF YOU DO NOT AGREE and think you are not medically ready for discharge or feel that your discharge plan will not meet your health care needs, you or your representative may request a review of the discharge decision by contacting your review agent indicated on the reverse side of this page.

IMPORTANT NOTICE ABOUT THE PAYMENT FOR YOUR CARE

o If your hospital care is covered by private health insurance, you may be charged directly while you remain in the hospital while the discharge review is being conducted. Whether you have to pay during this period will depend on your private health insurance benefits and if the review agent agrees with you that you need to stay in the hospital.

o If your hospital care is covered under the Medicaid program, Medicaid will pay for the days you remain in the hospital while the discharge review is being conducted.

IF YOU WOULD LIKE A REVIEW, you should immediately, but not later than noon of (Day and Date) call the telephone number checked off on the reverse side of this page.

IF YOU CANNOT REQUEST THE REVIEW YOURSELF, and you do not have a family member or friend to help you, you may ask the hospital representative at extension, who will request the review for you.

IF YOU REQUEST A REVIEW, the following will happen:

1. The review agent will ask you or your representative why you or your representative think you need to stay in the hospital and also will ask your name, admission date and telephone number where you or your representative can be reached.

2. After speaking with you or your representative and your doctor and after reviewing your medical record, the review agent will make a decision which will be given to you in writing.

IF THE REVIEW AGENT AGREES WITH THE DISCHARGE DECISION, you will be financially responsible for your continued stay after noon of the day you or your representative has been notified of the review agent's decision.

IF THE REVIEW AGENT AGREES THAT YOU STILL NEED TO BE IN THE HOSPITAL: for Medicaid patients, Medicaid benefits will continue to cover your stay; for private health insurance patients, coverage for your continued stay is limited to the scope of your private health insurance policy.

NOTE: If you miss the noon deadline mentioned on the first page of this notice, you may still request a review. However, if the review agent disagrees with you, you will be financially responsible for the days of care beginning with the proposed discharge date.

If you would like a review of your hospital stay after you have been discharged, you may request a review by the review agent within thirty (30) days of the receipt of this notice or seven days after receipt of a complete bill from the hospital, whichever is later, by writing to the review agent.

I have received this notice on behalf of myself as the patient or as the representative of the patient:

___________________              _____/_____/_____                     ______________

Signature                                                Date                                          Time

______________________

Relationship

(10) Notice that inpatient hospital services is no longer medically necessary. For purposes of subparagraph (3)(ii) of this subdivision, a hospital shall utilize the following notice:

HOSPITAL LETTERHEAD

DATE/______/_______

CONTINUED STAY DISCHARGE NOTICE

(ATTENDING PHYSICIAN AGREES/REVIEW AGENT AGREES)

READ THIS LETTER CAREFULLY-IT CONCERNS YOUR INSURANCE

BENEFITS OR MEDICAID BENEFITS

PATIENT NAME: ________________ PRIMARY PAYOR: ____________________

ADDRESS: _________________________________________________________________

ATT. PHYS.: ____________ MR NO.: _____________

ADM. DATE: ___________/_______________/____________________

Dear Patient:

After careful review of your medical record and consideration of your own views regarding medical condition, the (name of review agent) (the review agent approved by the Department of Health) has agreed with the hospital that you no longer require care in the hospital because you are ready for discharge.

IF YOU AGREE with this decision, you should discuss with your doctor the arrangements for any further health care you may need. This means if you have health insurance benefits or Medicaid benefits, these benefits will no longer pay for any additional hospital days as of:

______________________                 ______/______/______

Day of Week                                                       Date

__________________________________________________________________________

IF YOU DO NOT AGREE THAT YOU ARE READY FOR DISCHARGE, IMMEDIATELY AFTER RECEIPT OF THIS NOTICE YOU OR YOUR REPRESENTATIVE MAY CALL THE (name of review agent) AT (phone no.) TO REQUEST AN IMMEDIATE REVIEW OF YOUR MEDICAL RECORD.

__________________________________________________________________________

If you cannot request the reconsideration yourself and you do not have a representative to help you, you may notify the hospital representative at extention ___________ to request the reconsideration to you. In either case, the individual review agent approved by the Department of Health will request your name, admission date, and telephone number where you or your representative can be reached. If the individual review agent approved by the Department of Health did not ask your views before, it must do so now.

IF YOU REQUEST A REVIEW, the following will happen:

(1) You or your representative will be informed in writing of the results of the review.

(2) IF THE REVIEW AGENT AGREES WITH THE HOSPITAL'S DECISION that you are ready for discharge or that your condition could be safely treated in another setting and you have health insurance benefits or Medicaid benefits, your health insurance benefits or Medicaid benefits will PAY FOR YOUR STAY ONLY UNTIL NOON OF THE NEXT DAY AFTER YOU OR YOUR REPRESENTATIVE HAVE BEEN NOTIFIED.

(3) If the review agent determines that you still need to be in the hospital, for purposes of payments under health insurance or Medicaid benefits, your continued stay will be considered necessary and appropriate.

IN EITHER CASE (2 OR 3), YOU WILL NOT HAVE TO PAY FOR ANY ADDITIONAL HOSPITAL DAYS UNTIL YOU HAVE BEEN NOTIFIED OF THE REVIEW AGENT DETERMINATION.

NOTE: If you miss the noon deadline mentioned on the reverse side of this notice, you may still request a review during your hospital stay. However, if the review agent rules against you, you will be financially responsible starting on the date you receive the notice. Of course, if the review agent determination is in your favor, you are not liable for payment for the extra days.

If you would like a review of your hospital stay after you have been discharged, you may request an individual review agent review within 30 days of receipt of this notice or seven days after receipt of a complete bill from the hospital, whichever is later, by writing to the review agent.

(REVIEW AGENT NAME/ADDRESS)

____________________________________       _____/_____/_____                 ___________

(Hospital Representative Signature)                                   (Date)                                   (Time)

If your hospital stay is not covered under the per case payment system, you may still request a discharge review. However, you will continue to be charged for hospital services during the review process.

IF YOU HAVE ANY DIFFICULTY UNDERSTANDING THIS NOTICE OR IF YOU NEED MORE INFORMATION, YOU MAY CALL THE REVIEW AGENT DIRECTLY

AT: _____________________

(Telephone No.)

I have received this notice on behalf of myself as the patient or as a representative of the patient to whom it is addressed:

________________________                   ______/______/______                   _____________

Signature                                                                  Date                                           Time

________________________

Relationship

cc: Attending PhysicianHospital Billing Office

(11) The provisions of this subdivision shall apply to hospital inpatients admitted on and after January 1, 1988.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 405.10 - Medical records

405.10 Medical records. The hospital shall have a department that has administrative responsibility for medical records. An accurate, clear, and comprehensive medical record shall be maintained for every person evaluated or treated as an inpatient, ambulatory patient, emergency patient or outpatient of the hospital.

(a) General requirements. (1) Medical records shall be legibly and accurately written, complete, properly filed, retained and accessible in a manner that does not compromise the security and confidentiality of the records.

(2) The hospital shall establish, implement and monitor an effective system of author identification for medical records and/or medical orders to ensure the integrity of the authentication and protect the security of all transmissions, records and record entries. This system shall identify those categories of practitioners and personnel who are authorized to utilize electronic or computer authentication systems.

(3) The hospital shall ensure that all medical records are completed within 30 days following discharge.

(4) Medical records shall be retained in their original or legally reproduced form for a period of at least six years from the date of discharge or three years after the patient's age of majority (18 years), whichever is longer, or at least six years after death.

(5) The hospital shall have a system of coding and indexing medical records. The system shall allow for timely retrieval by diagnosis and procedure, in order to support quality assurance studies.

(6) The hospital shall ensure the confidentiality of patient records. Original medical records, information from or copies of records shall be released only to hospital staff involved in treating the patient and individuals as permitted by Federal and State laws.

(7) The hospital shall allow patients and other qualified persons to obtain access to their medical records and to add brief written statements which challenge the accuracy of the medical record documentation to become a permanent part of the medical record, in accordance with the provisions of Part 50 of Chapter II of this Title and the provisions of Public Health Law, section 18(4).

(b) Content. (1) The medical record shall contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services.

(2) All records shall document, as appropriate, at least the following:

(i) evidence of a physical examination, including a health history, performed no more than thirty days prior to admission or within 24 hours after admission and a statement of the conclusion or impressions drawn;

(ii) admitting diagnosis;

(iii) results of all consultative evaluations of the patient and findings by clinical and other staff involved in the care of the patient;

(iv) documentation of all complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia;

(v) properly executed consent forms for procedures and treatments;

(vi) all practitioners' diagnostic and therapeutic orders, nursing documentation and care plans, reports of treatment, medication records, radiology, and laboratory reports, vital signs and other information necessary to monitor the patient's condition;

(vii) discharge summary with outcome of hospitalization, disposition of case and provisions for follow-up care; and

(viii) final diagnosis.

(c) Authentication of medical records, record entries and medical orders.

(1) Upon completion of ordering or providing or evaluating patient care services, each such action shall be recorded and promptly entered in the patient medical record. All entries shall be legible and complete and shall be authenticated by the person entering, ordering or completing such action. Legible and signed facsimile orders may be accepted and shall be filed in the patient medical records.

(2) Written signatures, or initials and electronic signatures or computer generated signature codes shall be acceptable as authentication when utilized in accordance with hospital policy.

(3) Each electronic or computer entry, order or authentication shall be recorded in the medical record as to date, time, category of practitioner, mode of transmission and point of origin.

(4) Safeguards to ensure security and confidentiality shall include but not be limited to:

(i) the assignment, as appropriate, of a unique identifier that is assigned in a confidential manner;

(ii) the certification in writing by the hospital's designee and the user that each identifier assigned is confidential and is available and accessible only to the person authorized to use the electronic or computer authentication system;

(iii) policies and procedures to ensure the security of electronic or computer equipment from unwarranted access;

(iv) policies and procedures that restrict access to information and data to those individuals who have need, reason and permission for such access; and

(v) the implementation of an audit capability to track access by users.

(5) Hospitals shall implement an ongoing verification process to ensure that electronic communications and entries are accurate, including but not limited to:

(i) protocols for ensuring that incomplete entries or reports or documents are not accepted or implemented until reviewed, completed and verified by the author; and

(ii) a process implemented as part of the hospital's quality assurance activities that provides for the sampling of records for review to verify the accuracy and integrity of the system.

(6) Written notice from the author shall be required should the author/user wish to terminate participating in the electronic or computer authentication system.

(7) The hospital shall have procedures in place to modify or terminate use of any assigned identifier in cases of abuse or misuse or if practice privileges are suspended, restricted, terminated or curtailed or employment or affiliation ends.

(8) The hospital shall implement policies and procedures regarding the use and authentication of verbal orders, including telephone orders.  Such policies and procedures must:

(i) Specify the process for accepting and documenting such orders;

(ii) Ensure that such orders will be issued only in accordance with applicable scope of practice provisions for licensed, certified or registered practitioners, consistent with Federal and State law; and

(iii) Specify that such orders must be authenticated by the prescribing practitioner, or by another practitioner responsible for the care of the patient and authorized to write such orders and the time frame for such authentication.

(9) All orders for controlled substances shall be carried out in accordance with provisions of Part 80 of this Title.

Effective Date: 
Wednesday, May 17, 2017
Doc Status: 
Complete

Section 405.11 - Infection control

405.11 Infection control. The hospital shall provide a sanitary environment to avoid sources and transmission of nosocomial infections and of communicable diseases which may lead to morbidity or mortality in patients and hospital personnel. The hospital shall establish an effective infection control program for the prevention, control, investigation and reporting of all communicable disease and increased incidence of infections, including nosocomial infections, consistent with current acceptable standards of professional practice. The hospital-wide infection control program shall be reviewed as frequently as necessary but not less than once per year, and updated as necessary to promote optimal effectiveness.

(a) Organization. The hospital shall designate an infection control professional who is responsible for the development and implementation of a hospital-wide infection control program. This individual shall be qualified by training in infection surveillance, prevention and control and also have knowledge or job experience in epidemiological principles, infectious diseases and infection control procedures.

(b) Nosocomial surveillance, prevention and control. The hospital-wide infection control program shall include processes designed to reduce the risk of endemic and epidemic nosocomial infections and communicable diseases in patients and hospital personnel. Such processes shall include methods to:

(i) collect and analyze surveillance data including case findings and identification of epidemiologically important nosocomial infections and communicable disease;

(ii) prevent or reduce the risk of nosocomial infections; and

(iii) control the spread of infection and communicable diseases and epidemiologically important organisms.

(c) Reporting of infections and communicable diseases. There shall be written policies and procedures for identifying, reporting and investigating infections, and communicable disease of patients and hospital personnel, both community acquired and nosocomial. The professional responsible for the hospital-wide infection control program shall report to the Department of Health, in a manner specified by the Commissioner of Health, any increased incidence of nosocomial infections, as designated in section 2.2 of this Title and defined by the department, or nosocomially acquired communicable disease designated in section 2.1 of this Title. This individual shall also report, immediately, the presence of any communicable disease as defined in section 2.1 of this Title, to the city, county, or district health officer.

(d) Integration with the quality assurance program. The professional responsible for the hospital-wide infection control program shall ensure that all hospital infection control activities are integrated with the quality assurance program required by section 405.6 of this Part, including identification, assessment and correction of problems related to infection and communicable disease control.

(e) Infection control education. The hospital shall require compliance with written requirements for orientation and ongoing education programs that are relevant to the hospital's infection control program for all personnel whose activities are such that they are at risk of directly or indirectly contributing to the transmission of infection or communicable disease from or to patients, other health care personnel or themselves.

(f) Corrective action plans. The hospital shall be responsible for the implementation of acceptable corrective action plans related to infection control and resulting from problems identified through quality assurance or regulatory oversight activities and the professional responsible for the hospital-wide infection control program shall report to the chief executive officer progress in correcting identified problems.

(g) (i) The hospital shall possess and maintain a supply of all necessary items of personal protective equipment (PPE) sufficient to protect health care personnel, consistent with federal Centers for Disease Control guidance, for at least 60 days by August 31, 2020, and at least 90 days by September 30, 2020, at rate of usage equal the average daily rate that PPE was used between April 13, 2020 and April 27, 2020; provided, however, that upon request the Department may grant an extension of the deadline to October 30, 2020, at its sole and exclusive discretion for having at least a 90 day supply of PPE where the hospital demonstrates, to the Commissioner’s satisfaction, that:

(A) the hospital’s inability to meet this deadline is solely attributable to supply chain issues that are beyond the hospital’s control and purchasing PPE at market rates would facilitate price gouging by PPE vendors; or

(B) the seven-day rolling average of new COVID-19 infections in New York State remains below one and a half percent (1.5%) of the total seven-day rolling average of COVID-19 tests performed over the same period; and there are ten or less states in the United States that have a seven-day rolling average of new COVID-19 infections exceeding five thousand cases.

(ii) Failure to possess and maintain such a supply of PPE may result in the revocation or suspension of the hospital’s license; provided, however, that no such revocation or suspension shall be ordered unless the Department has provided the hospital with a fourteen day grace period, solely for a hospital’s first violation of this section, to achieve compliance with the requirement set forth herein.

Effective Date: 
Tuesday, July 21, 2020
Doc Status: 
Complete

Section 405.12 - Surgical services

405.12 Surgical services. If surgical services are provided, the hospital shall develop and keep current and implement effective written policies and procedures regarding staff privileges consistent with provisions set forth in section 405.4 of this Part, the performance of surgical procedures, the maintenance of safety controls and the integration of such services with other related services of the hospital to protect the health and safety of the patients in accordance with generally accepted standards of medical practice and patient care. Such policies and procedures shall be reviewed and updated as necessary, but at a minimum biennially.

(a) Organization and direction. The surgical service shall be directed by a physician who shall be responsible for the clinical aspects of organization and delivery of all inpatient and ambulatory surgical services provided to hospital patients. That physician or another individual qualified by training and experience shall direct administrative aspects of the service.

(1) The operating room shall be supervised by a registered professional nurse or physician who the hospital finds qualified by training and experience for this role.

(i) Nursing personnel shall be on duty in sufficient number for the surgical suite in accordance with the needs of patients and the complexity of services they are to receive.

(ii) A registered professional nurse qualified by the hospital and by training and experience in operating room nursing shall be present as the circulating nurse in any and each separate operating room where surgery is being performed for the duration of the operative procedure. Nothing in this section precludes a circulating nurse from leaving the operating room as part of the operative procedure, leaving the operating room for short periods; or, in accordance with employee rules or regulations, being relieved during an operative procedure by another circulating nurse assigned to continue the operative procedure. (iii) Licensed practical nurses and surgical technologists may perform scrub functions and may assist in circulating duties under the supervision of the circulating nurse who is present in the operating room for the duration of the procedure, in accordance with policies and procedures established by the medical staff and the nursing service and approved by the governing body.

(2) Surgical privileges shall be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner as required by section 405.4 of this Part. The surgical service shall maintain a roster of practitioners specifying the surgical privileges of each practitioner. The hospital shall assure that the privileges of the practitioner are commensurate with his or her training and experience.

(3) In accordance with written policies and procedures developed and implemented by the medical staff and approved by the governing body, in any procedure presenting unusual hazard to life based on the individual patient risk factors and complexity of the procedure, there shall be present and scrubbed as first assistant a physician designated by the medical staff and the governing body as being qualified to assist in major surgery.

(4) The surgical service policies shall clearly outline requirements for orientation and continuing education programs for all staff and compliance with such requirements shall be considered at the time of performance evaluation. Such training or continuing education programs will be established that are relevant to care provided, but will, at a minimum include instruction in safety precautions, equipment usage and inspections, infection control requirements, cardiopulomonary resucitation and patients' rights requirements pertaining to surgical/anesthesia consents.

(5) The director shall, in conjunction with the medical staff, monitor the quality and appropriateness of patient care and ensure that identified problems are reported to the quality assurance committee and are resolved.

(6) Precautions shall be clearly identified in written policies and procedures specific to the department and the post anesthesia care unit (PACU) and include but are not limited to:

(i) safety regulations posted;

(ii) routine inspection and maintenance of equipment;

(iii) availability in the operating room suites and PACU of appropriate resuscitation, airway and monitoring equipment including a resuscitation cart with age and size appropriate medications, equipment and supplies; and

(iv) control of traffic in and out of the operating room suites and accessory services to eliminate through traffic.

(b) Operation and service delivery. Policies governing surgical services shall be designed to assure the achievement and maintenance of generally accepted standards of medical practice and patient care. The policies shall assure that service and equipment routinely available in the operating suite and PACU are age and size appropriate.

(1) The operating room register shall be kept complete and up-to-date.

(2) There shall be a complete history and physical work-up in the chart of every patient prior to any surgery except emergency surgery. Each record shall document a review of the patient's overall condition and health status prior to any surgery including the identification of any potential surgical problems and cardiac problems. If this has been dictated, but not yet recorded in the patient's chart, there shall be a statement to that effect and an admission note in the chart by the practitioner who admitted the patient. Such reports shall be signed to attest to the adequacy and currency of the history and physical or countersigned by the attending surgeon, prior to surgery.

(3) Informed consent shall be obtained from the patient, and a properly executed informed consent form for the operation that includes the identification of the practitioner(s) performing the surgical procedure(s) shall be in the patient's chart before surgery except in emergencies in accordance with section 405.7 of this Part.

(4) An operative report describing techniques, findings, complications, tissues removed or altered and the general condition of the patient shall be written or dictated immediately following surgery and signed by the surgeon. (5) Findings of any pathology reports shall be recorded in the patient's medical record and a procedure established and implemented for reporting unusual findings to the patient's attending practitioner or surgeon.

(6) All infections of clean surgical cases shall be recorded and reported to the infection control officer. A procedure shall be developed and implemented for the investigation of such cases.

(c) Voluntary termination of pregnancy. (1) No termination of pregnancy shall be performed until a woman has had a complete physical examination with appropriate tests for a positive pregnancy and a determination of gestational age including the use of sonography where there is a question of gestational age.

(2) The standards for preprocedure examination, post-procedure evaluation, counseling for family planning services and birth control options, evaluation, treatment, and determination of blood group and Rh type established in section 756.3 of this Title shall be applicable to all terminations of pregnancy performed in hospitals.

(3) When a patient is admitted for an induced termination of pregnancy, the determination of blood group and Rh type shall have been made prior to the admission and shall have been recorded in the patient's chart. If not done, such determination shall be made as soon after admission as practicable, and prior to the termination of pregnancy. The patient shall be 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 thereof shall be administered to her as soon as possible within 72 hours after the termination of pregnancy.
 

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.13 - Anesthesia services

405.13 Anesthesia services. If anesthesia services are provided within a hospital, the hospital shall develop, implement and keep current effective written policies and procedures regarding staff privileges consistent with provisions set forth in section 405.4 of this Part, the administration of anesthetics, the maintenance of safety controls and the integration of such services with other related services of the hospital to protect the health and safety of the patients in accordance with generally accepted standards of medical practice and patient care. Such policies and procedures shall be reviewed and updated as necessary, but at a minimum biennially. Hospitals providing living liver donor transplants shall also comply with the provisions contained in Section 405.31(p)(2). (a) Organization and direction. Anesthesia services shall be directed by a physician who has responsibility for the clinical aspects of organization and delivery of all anesthesia services provided by the hospital. That physician or another individual qualified by education and experience shall direct administrative aspects of the service.

(1) The director shall be responsible, in conjunction with the medical staff, for recommending to the governing body privileges to those persons qualified to administer anesthetics, including the procedures each person is qualified to perform and the levels of required supervision as appropriate. Anesthesia shall be administered in accordance with their credentials competencies and privileges by the following:

(i) anesthesiologists;

(ii) physicians granted anesthesia privileges;

(iii) dentists, oral surgeons, or podiatrists who are qualified to administer anesthesia under State law;

(iv) certified registered nurse anesthetists (CRNA's) under the supervision of an anesthesiologist who is immediately available as needed or under the supervision of the operating physician who has been found qualified by the governing body and the medical staff to supervise the administration of anesthetics and who has accepted responsibility for the supervision of the CRNA; or

(v) a student enrolled in a school of nurse anesthesia accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs may administer anesthesia as related to such course of study under the direct personal supervision of a certified registered nurse anesthetist or an anesthesiologist.

(2) Anesthesia service policies shall clearly outline requirements for orientation and continuing education programs for all staff, and staff compliance with such requirements shall be considered at the time of reappointment or performance evaluation. Such training clinical competencies and continuing education programs shall be established that are relevant to care provided but must, at a minimum, include instruction in safety precautions, equipment usage and inspections, infection control requirements and any patients' rights requirements pertaining to surgical/anesthesia consents.

(3) The director shall, in conjunction with the medical staff, monitor the quality and appropriateness of anesthesia related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved.

(b) Operation and service delivery. Policies governing anesthesia services shall be designed to ensure the achievement and maintenance of generally accepted standards of medical practice and patient care.

(1) All anesthesia machines shall be numbered and reports of all equipment inspections and routine maintenance shall be included in the anesthesia service records. Policies and procedures shall be developed and implemented regarding notification of equipment disorders/malfunctions to the director, to the manufacturer and, in accordance with section 405.8 of this Part, to the department.

(2) Written policies regarding anesthesia procedures shall be developed and implemented which shall clearly delineate pre-anesthesia and post-anethesia responsibilities. These policies shall include, but not be limited to, the following elements:

(i) Pre-anesthesia physical evaluations shall be performed by an individual qualified to administer anesthesia and recorded within 48 hours, prior to surgery.

(ii) Routine checks shall be conducted by the anesthetist prior to every administration of anesthesia to ensure the readiness, availability, cleanliness, sterility when required, and working condition of all equipment used in the administration of anesthetic agents.

(iii) All anesthesia care shall be provided in accordance with generally accepted standards of practice and shall ensure the safety of the patient during the administration, conduct of and emergence from anesthesia. The following continuous monitoring is required during the administration of general and regional anesthetics. Such continuous monitoring is not required during the administration of anesthetics administered for analgesia or during the administration of local anesthetics unless medically indicated.

(a) An anesthetist shall be continuously present in the operating room throughout the administration and the conduct of all general anesthetics, regional anesthetics, and monitored anesthesia care. If there is a documented hazard to the anesthetist which prevents the anesthetist from being continuously present in the operating room, provision must be made for monitoring the patient. (b) All patients must be attended by the anesthetist during the emergence from anesthesia until they are under the care of qualified post-anesthesia care staff or longer as necessary to meet the patient's needs.

(c) During all anesthetics, the heart sounds and breathing sounds of all patients shall be monitored through the use of a precordial or esophogeal stethoscope. Such equipment or superior equipment shall be obtained and utilized by the hospital.

(d) During the administration and conduct of all anesthesia services the patient's oxygenation shall be continuously monitored to ensure adequate oxygen concentration in the inspired gas and the blood through the use of a pulse oximeter or superior equipment that is age and size appropriate. During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in the patient's breathing system shall be measured by an oxygen analyzer with a low oxygen concentration limit alarm.

(e) All patients' ventilation shall be continuously monitored during the conduct of anesthesia. During regional anesthesia, monitored anesthesia care and general anesthesia with a mask, the adequacy of ventilation shall be evaluated through the continual observation of the patient's qualitative clinical signs. For every patient receiving general anesthesia with an endotracheal tube, the quantitative carbon dioxide content of expired gases shall be monitored through the use of endtidal carbon dioxide analysis or superior technology. In all cases where ventilation is controlled by a mechanical ventilator, there shall be in continous use an alarm that is capable of detecting disconnection of any components of the breathing system.

(f) The patient's circulatory functions shall be continuously monitored during all anesthetics. This monitoring shall include the continuous display of the patient's electrocardiogram, from the beginning of anesthesia until preparation to leave the anesthetizing location, and the evaluation of the patient's blood pressure and heart rate at least every five minutes.

(g) During every administration of anesthesia, there shall be immediately available a means to continuously measure the patient's temperature.

(iv) All equipment and services provided shall be age and size appropriate. (v) Intraoperative anesthesia records shall document all pertinent events that occur during the induction, maintenance, and emergence from anesthesia. These pertinent events shall include, but not be limited to, the following: intraoperative abnormalities or complications, blood pressure, pulse, dosage and duration of all anesthetic agents, dosage and duration of other drugs and intravenuous fluids, and the administration of blood and blood components. The record shall also document the general condition of the patient.

(vi) With respect to inpatients a post-anesthetic follow-up evaluation and report by the individual who administered the anesthesia or by an individual qualified to administer anesthesia shall be written not less than three or more than 48 hours after surgery and shall note the presence or absence of anesthesia related abnormalities or complications, and shall evaluate the patient for proper anesthesia recovery and shall document the general condition of the patient.

(vii) With respect to outpatients, a post-anesthesia evaluation for proper anesthesia recovery performed in accordance with policies and procedures approved by the medical staff shall be documented for each patient prior to hospital discharge.

(3) Safety precautions shall be clearly identified in written policies and procedures specific to the department and include, but not be limited to:

(i) safety regulations posted;

(ii) routine inspection and maintenance of equipment;

(iii) use and maintenance of shockproof equipment;

(iv) proper grounding; and

(v) infection control.
 

Effective Date: 
Wednesday, September 10, 2014
Doc Status: 
Complete

Section 405.14 - Respiratory care services

405.14 Respiratory care services. Respiratory care services shall be provided in a manner which assures the safe and effective operation and management of staff and services necessary to provide respiratory care to hospital patients at all times. The service shall have effective and current written policies and procedures regarding staff assignments, the administration of medication, diluents and oxygen, the maintenance of safety controls and the intregration of such services with other related services of the hospital.

(a) Organization and direction. The services shall be directed by a physician who shall be responsible for the clinical aspects of organization and delivery of all respiratory care services. The physician, or another individual qualified by training and experience shall direct administrative aspects of the services.

(1) Respiratory care services shall be provided by staff who possess the necessary qualifications specified by the medical staff, consistent with provisions of the New York State Education Law.

(i) Each individual who provides respiratory care services shall be competent to provide such services as evidenced by education, training and experience and where applicable demonstrated adherence to hospital policies and procedures.

(ii) A sufficient number of qualified competent professional and support personnel shall be available to meet the respiratory care needs of the patient.

(2) Written policies and procedures shall describe mechanisms for effective management of the service, including the nature and the amount of supervision required for personnel to carry out specific procedures, as well as mechanisms governing interdepartmental relationships and communications.

(3) Staff orientation and inservice training shall be required, provided and documented in accordance with written hospital policies and procedures.

(b) Operation and service delivery. Respiratory care services shall be provided in manner which assures the achievement and maintenance of generally accepted standards of professional medical practice and patient care.

(1) Respiratory care services shall only be provided in accordance with specific hospital protocols/policies or upon the orders of members of the medical staff. The order for respiratory care services shall specify the type, frequency and duration of treatment, and, as appropriate, the type and dose of medication, the type of diluent, and the oxygen concentration, consistent with generally accepted standards of care.

(2) All respiratory care services provided shall be documented in the patient's medical record, including the type of therapy, date and time of administration, effects of therapy, and any adverse reactions.

(3) If blood gases or other clinical laboratory tests are performed in the respiratory care unit, the unit shall meet the requirements for clinical laboratories with respect to management, adequacy of facilities, proficiency testing and quality control as set forth in section 405.16 of this Part.

(4) The service shall implement a planned and systematic process of the monitoring and evaluation of the quality and appropriateness of patient care and for the resolution of identified problems. The process shall involve the reporting of findings, conclusions and recommendations to the quality assurance committee in accordance with hospital policies and procedures. (5) All equipment and services provided shall be age and size appropriate.

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.15 - Radiologic and nuclear medicine services

405.15 Radiologic and nuclear medicine services.

(a) General provisions for diagnostic and therapeutic radiologic services. The hospital shall maintain or have available diagnostic radiologic services defined for purposes of this subdivision as imaging services utilizing diagnostic radiation equipment or devices which emit radiation by virtue of the application of high voltage. If therapeutic services are provided, they shall meet the requirements established in subdivision (b) of this section in addition to the requirements of this subdivision. In addition, the hospital shall meet the standards of Part 16 of the State Sanitary Code.

(1) The hospital shall maintain or have available radiologic services according to the needs of the patients as determined by the governing body in consultation with the medical staff and the administration.

(2) Radiologic services shall be provided in accordance with generally accepted standards of practice only on the order of physicians or, consistent with State law, of those other practitioners authorized by the medical staff and governing body to order such services.

(3) Safety for patients and personnel. Written policies and procedures affecting safety shall be implemented and available for review. The policies and procedures regarding imaging studies for newborns and pediatric patients shall include standards for clinical appropriateness, appropriate radiation dosage and beam collimation, image quality and patient shielding. A policy and a procedure shall be developed to ensure that the practitioner's order for an imaging study is specific as to the body part(s) that are to be imaged.
Quality improvement audits shall verify that these policies and procedures are being followed. Quality improvement activities shall include a review of the adequacy of diagnostic images and interpretations.

(i) Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards and radiation hazards. This includes adequate shielding for patients and personnel, as well as appropriate storage, use and disposal of radioactive materials.

(ii) Any existing or potential hazards identified through periodic inspection by local or State health authorities shall be corrected promptly.

(iii) Personnel shall be instructed in radiation safety principles and practices. The radiation safety principles shall be adequate to ensure compliance with all generally accepted standards of practice as well as pertinent laws, rules and regulations. Policies and procedures shall be developed to minimize the radiation exposure that is necessary to produce high quality imaging studies on patients of all ages.

(iv) Radiologic procedures requiring the use of contrast media or fluoroscopic interpretation and control shall be performed with the active participation of a qualified specialist in diagnostic radiology or a physician qualified in a medical speciality related to the radiographic procedure. Emergency equipment and staff trained in its use shall be available for anaphylactic shock reactions from contrast media.

(4) Personnel. The hospital shall provide qualified personnel adequate to supervise and conduct the services. For radiologic tests, the following personnel standards shall apply for the purposes of this subdivision:

(i) a full-time or part-time radiologist who is a board certified or board admissible in radiology shall direct the clinical aspects of the organization and delivery of radiologic services. That radiologist or another individual qualifed by education and experience shall direct the administrative aspects of the services;

(ii) radiologic tests shall be interpreted by a board certified or board admissible radiologist, except that radiologic tests may be interpreted by practitioners within their field of specialization who are granted privileges to interpret such test by the governing body and the medical staff in consultation with the director of radiologic services pursuant to the credentialing process in the hospital;

(iii) the services of qualified radiologists, qualified practitioners, and licensed radiologic technologists shall be sufficient and available to meet the needs of the patients. A licensed technologist shall be on duty or available at all times and function in accordance with Article 35 of the Public Health Law and Part 89 of this Title.

(iv) Use of the radiologic equipment and administration of radiologic procedures shall be limited to personnel who are currently licensed and designated as qualified by the hospital in accordance with any applicable licenses and regulations.

(v) The chief of radiology, in conjunction with the radiation safety officer, shall ensure that all practitioners who utilize ionizing radiation equipment within the hospital are properly trained in radiation safety procedures for patients of all ages.

(5) Records. Records of radiologic services including interpretations, consultations and therapy shall be filed with the patient's record, and duplicate copies shall be kept in the radiology department/service. All films, scans and other image records shall be referenced in the patient's medical record and retained in the patient's medical record, radiology department/service or in another central location accessible to appropriate staff. All electronic images shall have a duplicate storage either offsite or in another area of the hospital separate from the primary storage devices.

(i) Requests by the attending practitioner for x-ray examination shall contain a concise statement of reasons for the examination which shall be authenticated by the requestor.

(ii) The radiologist or other practitioner who performs radiology services shall authenticate reports of his or her interpretations.

(iii) The hospital shall retain films, scans and other image records which have not been incorporated in the medical record for at least six years or three years after a minor patient reaches the age of majority.

(b) Therapeutic radiology or radiation oncology. Therapeutic radiology or radiation oncology services shall be provided in accordance with the following:

(1) no hospital providing the service shall refuse treatment of a patient on the basis of the referring practitioner or practitioner's facility affiliation, if any;

(2) institutions shall provide services for patients who cannot attend treatment sessions during normal day shift working hours;

(3) therapeutic radiology or radiation oncology services shall utilize six or more megavoltage (MEV) units with a source-axis distance of 100 or more centimeters as the primary unit in a multi-unit radiation oncology service.

(4) a therapeutic radiology service shall be headed by a board admissible or board certified radiation oncologist or a general radiologist who devotes at least 80 percent of his/her time to the practice of therapeutic radiology and who treats not fewer than 175 patients per year;

(5) a therapeutic radiology service shall have on staff:

(i) a full time New York State licensed radiation therapist sufficient to meet the needs of the service; and

(ii) a full-time registered professional nurse with appropriate education and experience;

(6) a hospital with a therapeutic radiology service shall have on staff or through formal arrangements:

(i) a board admissible or board certified medical oncologist, hematologist or other specialist who devotes at least 80 percent of his/her practice to medical oncology and who treats not fewer than 175 oncology patients per year; and

(ii) A New York State licensed radiation therapy physicist who will be involved in treatment, planning and dosimetry as well as calibrating the equipment. The hospital shall provide for the services of a licensed radiation therapy physicist(s) in sufficient quantity to adequately meet the needs of its patients of all ages.

(iii) A physicist in training must be supervised by a licensed radiation therapy physicist.

(7) the therapeutic radiology service shall be part of a multidisciplinary approach to the management of cancer patients, involving a variety of specialists in a joint treatment program, either through formal arrangement or in the facility;

(8) each patient shall have a treatment plan in his/her medical records;

(9) each therepeutic radiology service shall have access, either through formal arrangements or in the facility, to a full range of diagnostic services, including hematology, pathology, and medical imaging procedures;

(10) each facility providing therapeutic radiology services shall have access to the full range of rehabilitation therapies, including but not limited to physical therapy, occupational therapy, vocational training, and psychological counseling services for its radiotherapeutic patients;

(11) a radiation therapy program operating a linear accelerator with photon or electron beam energies greater than 10 MEV's must be a part of a comprehensive program of cancer care which includes surgical oncology, medical oncology, pathology and diagnostic radiology. In addition such program shall meet the following standards:

(i) there shall be two full-time equivalent radiation oncologists on staff who are board-certified in radiation oncology or have equivalent training and experience and whose professional practices are limited to radiation oncology;

(ii) there shall be a full-time medical radiation physicist assigned to the radiation therapy program for the treatment planning of patients; and

(iii) a CT scanner shall be available within the radiation therapy program that is equipped for radiation oncology treatment planning or arrangements shall be made for access to a CT scanner on an as needed basis. Provisions shall be made for access to an MRI scanner for treatment planning purposes on an as needed basis.

(c) Nuclear medicine services. If the hospital provides nuclear medicine services, those services shall meet the needs of the patients in accordance with generally acceptable standards of practice. Nuclear medicine services shall be ordered only by a physician whose Federal or State licensure and staff privileges allow such referrals.

(1) Organization and staffing. The organization of the nuclear medicine service shall be appropriate to the scope and complexity of the services offered.

(i) The clinical aspect of the organization and delivery of nuclear medicine services shall be directed by a physician who is qualified in nuclear medicine and named in the facility's New York State Health Department or New York City Health Department radioactive materials license as authorized to use radiaoctive materials in humans. The administrative aspects of these services shall be directed by that physician or another individual qualifed for such duties by education and experience.

(ii) The qualifications, training, functions, and responsibilities of all nuclear medicine personnel shall be specified by the clinical service director in accordance with applicable regulations and approved by the medical staff and the hospital.

(2) Delivery of service. Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with generally acceptable standards of practice and pertinent laws, rules and regulations.

(i) In-house preparation of radiopharmaceuticals shall be by, or under the direct supervision of, an appropriately trained registered pharmacist or a physician whose use of radioactive materials is authorized in the facility's New York State Health Department or New York City Health Department radioactive materials license.

(ii) If clinical laboratory tests are performed in the nuclear medicine service, the service shall meet the requirement for clinical laboratories with respect to management, adequacy of facilities, proficiency testing and quality control in accordance with the requirements of section 405.16 of this Part.

(3) Facilities. The hospital shall provide equipment and supplies which are appropriate for the types of nuclear medicine services offered and shall maintain such for safe and effective performance. The equipment shall be:

(i) maintained in safe operating condition; and

(ii) inspected, tested, and calibrated at least annually by qualified personnel and at the intervals specified in the hospital's quality assurance program.

(4) Records. The hospital shall maintain authenticated and dated reports of nuclear medicine interpretations, consultations and procedures.

(i) The hospital shall maintain copies of nuclear medicine reports which have not been incorporated into the patient's medical record for at least six years or three years after the patient reaches the age of majority.

(ii) Interpretation of the results of nuclear medicine procedures shall be made by a physician authorized in the facility's New York State Health Department or New York City Health Department radioactive materials license, or a physician under his/her tutelage. Interpretations may be made in consultation with the referring practitioner or other practitioners. The authorized physician, or physicians in tutelage, shall authenticate and date the interpretations of these tests.
 

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.16 - Laboratory services

405.16 Laboratory services. The hospital shall provide laboratory services that meet the needs of the patients as determined by the medical staff and the hospital.

(a) The hospital shall ensure that all clinical laboratory services provided or arranged for by the hospital comply with article 5, title V of the New York State Public Health Law and with Subpart 58-1 (Clinical Laboratories) of this Title, or for facilities located in New York City, with article 13 of the New York City Health Code. Hospitals shall ensure that all blood banks and transfusion services comply with article 31 of the New York State Public Health Law and Subpart 58-2 (Blood Banks) of this Title.

(b) The hospital shall maintain an adequately organized and supervised clinical laboratory with the necessary staff, space, facilities and equipment to meet the needs of its patients.

(1) Emergency laboratory services shall be available 24 hours a day, seven days a week, including holidays.

(2) For emergency situations, the hospital shall have immediately available a minimum blood supply.

(3) A written description of all laboratory services provided shall be available to the medical staff.

(4) The laboratory shall make provision for the proper receipt and reporting of tissue specimens.

(c) Personnel. The hospital shall provide personnel qualified to direct and staff the laboratory.

(1) The hospital shall ensure that all laboratory services are conducted under the supervision of a director who holds a certificate of qualification issued by the New York State Department of Health or, where applicable, the New York City Department of Health.

(2) The laboratory director shall:

(i) provide technical supervision of all laboratory services, regardless of site;

(ii) assure that all tests, examinations and procedures are properly performed, recorded and reported;

(iii) Assure that all tests for hospital patients are ordered by a practitioner so authorized by the hospital;

(iv) assure that appropriate signatures are on all cytology and histopathology reports and that all reports are filed with the patient's medical record and duplicate copies kept in a manner which permits ready identification and accessibility;

(v) assure that the laboratory staff:

(a) have appropriate education, experience, and training to perform and report laboratory tests promptly and proficiently;

(b) are sufficient in number for the scope and complexity of the services provided; and

(c) receive inservice training appropriate to the type and complexity of the laboratory services offered; and

(vi) assure that there is a documented quality control program in effect for all laboratory services in accordance with the requirements outlined in Part 58 of this Title and in conjunction with the hospital-wide quality assurance program required by section 405.6 of this Part.

(d) Tissue examination. Tissue pathology services shall be provided by and under the direction of a pathologist possessing a certificate of qualification issued by the New York State Department of Health or, where appropriate, the New York City Department of Health. The medical staff and the pathologist shall identify which tissue specimens require a macroscopic examination only and which tissue specimens require both macroscopic and microscopic examinations. Policies and procedures pertaining to the receipt and holding of tissue specimens shall be developed and implemented and shall, at a minimum, include the following:

(1) a pathologist shall be responsible for verifying the receipt of tissues for examinations;

(2) a plan is established in the absence of a pathologist for sending all tissues requiring examination to a qualified patholgist outside the hospital; and

(3) provisions for maintaining a tissue file in the hospital.

(e) Blood, blood products and transfusion services. The hospital shall ensure that there are facilities provided or readily available for the acquisition, safekeeping, transfusion and distribution of blood and that storage and use of blood products is under the direction of a blood bank director possessing a certificate of qualification issued by the New York State Department of Health, or where applicable, the New York City Department of Health.

(1) The hospital shall maintain, as a minimum, proper blood storage facilities under control and supervision of the blood bank director.

(2) In the case of services provided by an outside blood bank, the hospital shall have an agreement governing the acquisition, transfer and availability of blood and blood products, including plasma derivatives, that is reviewed and approved by the blood bank director, transfusion committee and administration.

(3) There shall be provision for prompt blood grouping, antibody detection, and compatibility testing, and for laboratory investigation of tranfusion reactions. (4) Blood storage facilities in the hospital shall have a temperature alarm system that is regularly inspected.

(5) Records shall be kept on file indicating the receipt and disposition of all blood and blood products acquired by the hospital.

(6) Samples of each unit of transfused blood and blood products, including plasma derivatives, shall be retained for further testing the event of reactions. The hospital shall promptly dispose of all blood not retained for further testing that has exceeded its expiration date.

(7) The hospital, according to its established procedure, shall review all transfusions of blood or blood derivatives and promptly investigate and report all transfusion reactions. Procedures shall be established and implemented for ensuring that reports of all acute hemolytic transfusion reactions are made to the hospital-wide quality assurance program and to the department pursuant to section 405.8 of this Part and that, as appropriate, recommedations are made to the medical staff regarding improvements in transfusion procedures and practices.
 

Effective Date: 
Sunday, January 1, 1989
Doc Status: 
Complete

Section 405.17 - Pharmaceutical services

405.17 Pharmaceutical services. The hospital shall provide pharmaceutical services that are available at all times on the premises to meet the needs of the patients. The hospital shall have a pharmacy that is registered and operated in accordance with article 137 of the New York State Education Law and is directed by a registered pharmacist trained in the specialized functions of hospital pharmacy.

(a) Organization and direction. The pharmacy shall be responsible, in conjunction with the medical staff, for ensuring the health and safety of patients through the organization, management and operation of the service in accordance with generally accepted professional principles and the proper selection, storage, preparation, distribution, use, control, disposal and accountability of drugs and pharmaceuticals.

(1) The director shall be employed on a full-time or part-time basis based on the needs of the hospital.

(2) The director, in conjunction with designated members of the medical staff, shall ensure that:

(i) for patients of all ages weight shall be measured in metric units. Up-to-date drug information reference systemsrelating to drug interactions, drug therapies, side effects, toxicology, dosage, indications for use, and routes of administration are available to the professional staff. Pediatric dosing resources shall include age and size appropriate fluid and medication administration and dosing. Pediatric dosing must be weight based, should include the calculated dose, the dosing determination, such as the dose per weight (e.g., milligrams per kilogram) or body surface area, to facilitate an independent double-check of the calculation, and should not exceed adult maximum dosage, or in emergencies, length based,

(ii) a formulary is established and reviewed at least annually and updated as necessary to meet the needs of the patients for use in the hospital to assure quality pharmaceuticals at reasonable costs;

(iii) standards are established concerning the use and control of investigational drugs and research in the use of recognized drugs;

(iv) clinical data are evaluated concerning new drugs or preparations requested for use in the hospital; and

(v) the list of floor stock medication is reviewed and recommendations are made concerning drugs to be stocked on the nursing unit floors and by other services.

(3) The director shall be responsible for developing and implementing written policies and procedures for the intrahospital distribution of drugs.

(4) Effective October 1, 1990, each hospital shall have implemented a unit-dose distribution system.

(5) The pharmaceutical service shall have an adequate number of registered pharmacists and other qualified personnel to ensure the availability of quality services including emergency services, 24 hours per day, seven days per week.

(6) All drug storage, preparation and dispensing shall be under the supervision of the director and shall be monitored for adherence to hospital policies and procedures. Monitoring reports shall be documented and available for inspection.

(7) The director shall ensure that current and accurate records are kept of the transactions of the pharmacy, including but not limited to:

(i) a system of records and bookkeeping in accordance with the policies of the hospital for:

(a) maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies; and

(b) charging patients for drugs and pharmaceutical supplies;

(ii) a record of inventory and dispensing of all controlled substances maintained in accordance with article 33 of the Public Health Law and Part 80 of this Title; and

(iii) the labeling of all inpatient and outpatient medications in accordance with article 137 of the State Education Law and 8 NYCRR Section 29.7.

(8) The director shall ensure that drug monitoring services are provided appropriate to each inpatient's needs. This shall include, but not be limited to, the maintenance of a medication record or drug profile for each inpatient which is based on available drug history and current therapy.

(9) The director will ensure that there is a quality assurance program to monitor personnel qualifications, training, performance, equipment and facilities.

(i) The director shall require and document the participation of pharmacy personnel in relevant education programs, including orientation of new employees as well as inservice and outside continuing education programs.

(ii) The quality assurance program shall include policies, procedures and monitoring and improvement activities to identify, measure, prevent, minimize and/or mitigate adverse drug events, adverse drug reactions and medication errors in accordance with generally accepted standards and practices in the field of medication safety and quality improvement.

(iii) The director in conjunction with the medical staff shall ensure the monitoring and evaluation of the quality and appropriateness of patient services provided by the pharmaceutical service.

(10) The director shall participate in those aspects of the hospital's overall quality assurance program that relate to drug utilization and effectiveness.

(b) Operation and service delivery. All drugs and biologicals shall be controlled and distributed in accordance with written policies and procedures to maximize patient safety and quality of care.

(1) The compounding, preparation, labeling or dispensing of drugs shall be performed by a licensed pharmacist or pharmacy intern in accordance with applicable State and Federal laws, rules and regulations. (2) All packing and repacking of medications shall be performed in the pharmacy by or under the direct supervision of a pharmacist in accordance with article 137 of the State Education Law.

(i) Written policies and procedures shall indicate how such packages shall be labeled to identify the lot number or reference code and manufacturer's or distributor's name for proper identification and safety.

(ii) Repacking and inventory records shall be maintained by the pharmacy.

(iii) Written policies and procedures shall specify those medications which will not be obtained from manufacturers or distributors in single unit packages and those which will not be repackaged as single units in the facility.

(3) Policies and procedures for the unit-dose drug distribution system shall be developed and implemented and shall include, but not be limited to:

(i) each patient shall have his or her own receptacle, such as a tray, bin, box cassette, drawer or compartment, appropriately labeled as to patient, and containing his or her own medications. Each single unit package of medication shall be labeled in accordance with requirements set forth in article 137 of the State Education Law;

(ii) delivery and exchange of patient medications shall occur as scheduled and as specified in the service's written policies and procedures. Not more than a 72-hour supply of prescribed medications shall be delivered to or available in the patient care area at any time;

(iii) methods for procuring drugs on a routine basis, in emergencies and in the event of disaster shall be identified in the service's written policies and procedures; and

(iv) written policies and procedures shall be developed and implemented regarding emergency kits and emergency carts including provisions for ensuring that emergency kits are secure and accessible and are specific to service locations, but are not kept under lock and key;

(a) locations and contents shall be identified and approved by the pharmaceutical service and the medical staff;

(b) frequency of checking contents and expiration dates shall be specified in written policies and procedures.

(4) Outdated, mislabeled, discontinued, expired or otherwise unusable drugs and biologicals shall not be available for patient use.

(5) A procedure shall be developed to provide for the availability of drugs and biologicals during periods of time when a pharmacist may not be immediately available.

(6) Drugs and biologicals not specfically prescribed as to time or number of doses shall automatically be stopped after a time that is specified in the service's policies and procedures as determined by the medical staff.

(7) Policies and procedures shall be developed and implemented for documenting, reviewing and, as appropriate, reporting dispensing errors, adverse drug reactions and drug defects.

(c) Physical facilities. The hospital shall provide facilities for the storage, safeguarding, preparation, and dispensing of drugs.

(1) Floor stock medications shall be issued to floor units in accordance with the facility's written policies and procedures:

(i) all floor stocks must be properly controlled and shall be limited to those medications identified on an approved floor stock list;

(ii) floor stock will be checked at least monthly by or under the direct supervision of a pharmacist for outdated and unauthorized medications.

(2) All drugs and biologicals shall be stored in locked storage areas and all controlled substances shall be stored in accordance with the storage requirements set forth in article 33 of the Public Health Law and Part 80 of this Title.

(3) All abuses and losses of controlled substances shall be reported to the director, and to the medical staff, as appropriate, in accordance with applicable Federal and State laws.
 

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
Complete

Section 405.18 - Rehabilitation services

405.18 Rehabilitation services. The hospital shall make available rehabilitation services consistent with the needs of the patients, which shall be designed to provide individualized, goal-oriented, comprehensive and coordinated services to minimize the effects of physical, mental, social and vocational disadvantages and to effect a realization of the patient's potential for useful and productive activity while ensuring the health and safety of the patient. Such services shall include but are not limited to audiology, occupational therapy, physical therapy and speech language pathology and shall be delivered in accordance with a written plan for treatment. Hospitals providing general rehabilitation services but not providing comprehensive inpatient physical medicine and rehabilitation programs shall meet the provisions of subdivisions (a) and (b) of this section. Hospitals which do provide comprehensive inpatient physical medicine and rehabilitation programs shall meet the provisions of subdivisions (a) and (c) of this section. Hospitals which provide a spinal cord injury program shall meet the provisions of subdivisions (a), (c) and (d) of this section. Hospitals which provide a tramatic head injury program shall meet the provisions of subdivisions (a), (c) and (e) of this section.

(a) Organization and staffing. (1) There shall be a director of the service who shall have administrative responsibility for the delivery of patient care and for the supervision of the service. The director shall have the necessary knowledge, experience and capabilities to properly supervise and administer the service.

(2) Physical therapy, occupational therapy, speech-language pathology, or audiology services, if provided, shall be provided by staff who meet the qualifications specified by the governing body, and who are licensed and currently registered by the New York State Education Department.

(i) Each individual who provides rehabilitation services shall be competent to provide such services by reason of education, training, experience and demonstrated performance.

(ii) A sufficient number of qualified competent professional and support personnel shall be available to meet the needs of the patient population and the objectives of the service.

(iii) Sufficient space, equipment and facilities shall be available to support the clinical and administrative functions of the service.

(3) Written policies and procedures which describe the mechanism for the management of the rehabilitation service as well as interdepartmental relationships and communications shall be implemented.

(4) Staff orientation and inservice training shall be required, provided and documented in accordance with hospital policies and procedures.

(b) Delivery of services. (1) The hospital shall assure that patients who require rehabilitation services are identified and that appropriate services are provided in accordance with the orders of attending physicians or other practitioners as authorized by the governing body, consistent with the New York State Education Law, to order such services. Working relationships among medical staff, nursing staff and rehabilitation service staff shall be established to ensure the identification of patients and delivery of appropriate services.

(2) Rehabilitation services shall be ordered by the attending physician or authorized practitioners and provided in accordance with a written multidisciplinary treatment plan which is based upon a functional assessment and evaluation performed and documented by a professional who is qualified under the provisions of the New York State Education Law, and shall include the diagnosis or diagnoses, precautions and contraindications, and goals of the prescribed therapy.

(i) The multidisciplinary treatment plan shall identify patient needs, establish realistic and measureable goals and identify specific therapeutic interventions by type, amount and frequency needed to maintain, restore and/or promote the patient's functioning and health, within stated time frames for achievement.

(ii) The multidisciplinary treatment plan shall be prepared by rehabilitation service staff with the involvement of the practitioner who ordered the services, the nursing staff, as well as the patient and the family to the extent possible.

(iii) The patient's progress and response to treatment shall be assessed on a timely and regular basis, in accordance with hospital policies and procedures, and documented in the patient's medical record.

(iv) Multidisciplinary treatment plans and goals shall be revised as appropriate in accordance with the assessment of the patient's progress and the results of treatment.

(v) The rehabilitation service shall monitor and evaluate the quality and appropriateness of patient care and resolve identified problems through implementation of a planned and systematic process. The process shall involve reporting to the quality assurance committee in accordance with hospital policies and procedures.

(vi) In accordance with the provisions of section 405.9(h) of this Part, rehabilitation therapy staff shall work with the attending practitioner, the nursing staff, other health care providers and agencies as well as the patient and the family, to the extent possible, to assure that all appropriate discharge planning arrangements have been made prior to discharge to meet the patient's identified needs.

(c) Comprehensive inpatient physical medicine and rehabilitation programs, if provided, shall be approved by the department and shall be organized and operated in accordance with the following:

(1) the beds shall be in a designated area forming a distinct organizational unit, shall be staffed and equipped for the specific purpose of providing a comprehensive physical medicine and rehabilitation program, and shall be used exclusively for such purpose;

(2) patients exhibiting conditions, including but not limited to the following, shall be considered as candidates for admission to a comprehensive inpatient physical medicine and rehabilitation program: severe disabling impairments of recent onset or recent progression, those being readmitted for such conditions, or those with such conditions who previously have not received comprehensive rehabilitation services;

(3) the program shall be directed by a chief of physical medicine and rehabilitation who shall be full-time with the physical medicine and rehabilitation program. The chief of physical medicine and rehabilitation shall be a board certified physiatrist or a physician who by training and experience is knowledgeable in physical and rehabilitative medicine;

(4) the attending physician for a patient admitted to the program shall be a rehabilitation physician, a physician who is board certified in physical medicine and rehabilitation or a physician who by training and experience is knowledgeable in physical medicine and rehabilitation;

(5) nursing care shall be provided under the direction of a registered professional nurse who has appropriate training and experience in rehabilitation nursing as determined by the program and the hospital;

(6) the program shall provide a core of services which includes: rehabilitation nursing, physical therapy, occupational therapy, medical social work, psychology and speech-language pathology;

(7) dependent upon the needs of the patients served, the program shall provide or make formal arrangements for the following services: dental, vocational rehabilitation, education, orthotics, prosthetics, respiratory therapy, rehabilitation engineering, driver education, audiology and therapeutic recreation;

(8) physician consultation shall be available, including but not limited to: general surgery, internal medicine, neurology, neurosurgery, opthalmology, orthopedic surgery, otorhinolaryngology, pediatrics, physicial medicine and rehabilitation, plastic surgery, psychiatry, pulmonary medicine and urology;

(9) patient care services shall be provided through a coordinated interdisciplinary team approach. Participation of members of the core team in the direct care of each patient will vary dependent upon individual patient needs. Patients shall receive a comprehensive evaluation within seven days following admission followed by regular team conferences at intervals appropriate to the treatment goals established for the patient. These conferences shall result in documentation of decisions on rehabilitation goals that meet professional standards of care, identification of services needed for the patients to progress toward those goals, and evaluation of progress toward meeting established goals;

(10) each program shall develop and implement written policies and procedures for the following: patient admission and orientation, assessment and evaluation, program management, discharge planning and follow-up;

(11) the program shall establish formalized relationships with other area hospitals and providers of comprehensive rehabilitation services, regardless of setting, which shall include provisions for consultation, inservice eduation, and the evaluation of common treatment protocols;

(12) programs shall have written agreements in place for the transfer of patients who need medical or specialty care not available at the hospital of admission. Transfer agreements shall be mutually agreed upon by both the transferring and receiving facility and shall be reviewed on at least an annual basis;

(13) there shall be an organized outpatient physical medicine and rehabilitation program at the hospital which shall provide a range of services equal in scope to that of the inpatient program including spinal cord and head injury programs where they are provided; and

(14) there shall be an organized program for follow-up care to maintain or improve patient health status and functioning following discharge. (d) A spinal cord injury program, if provided, shall provide coordinated and integrated services for spinal cord injured persons, whether from trauma or disease, enabling those patients served to achieve optimal functioning;

(1) The spinal cord injury program shall be a designated unit for spinal cord injured people with a designated staff to serve the spinal cord injured patients.

(2) The spinal cord injury program shall be directed by a physician with special interest and competence in the care of those with spinal cord injury.

(3) Nursing services for the spinal cord injury program shall be provided under the direction of a registered professional nurse who has appropriate training and experience in the provision of rehabilitation nursing for spinal cord injured patients as determined by the program and the hospital.

(4) The following shall be available seven days a week, 24 hours per day: registered professional nurses, trained personnel capable of provided intermittent catheterization, as required, and respiratory therapy services.

(5) There shall be a formally organized program for patient and family spinal cord injury education regarding bladder management, bowel management, pulmonary care, skin care, instruction in medications, nutrition, access to follow-up medical care, care of equipment, and sexual counseling.

(e) A traumatic head injury program, if provided, shall be designed specifically to serve medically stable, traumatically brain injured individuals. The program shall provide goal-oriented, comprehensive, interdisciplinary and coordinated services directed at restoring the individual to the optimal level of physical, emotional, cognitive and behavioral functioning.

(1) General requirements. The hospital shall ensure:

(i) the development and consistent application of written admission and continued stay criteria for this service which include but are not limited to the use of a generally recognized classification system for measuring each individual's physical, behavioral and cognitive level of functioning and the family's capabilities and functioning, and are consistent with the following requirements:

(a) a patient admitted for active rehabilitation shall be a person who has suffered a traumatic brain injury with structural nondegenerative brain damage, is medically stable, is not in a persistent vegetative state, demonstrates potential for physical, behavioral and cognitive rehabilitation and may evidence moderate to severe behavior abnormalities. The patient must be capable of exhibiting at least localized responses by reacting specifically but inconsistently to stimuli;

(b) a patient admitted for active coma stimulation shall be a person who has suffered a traumatic brain injury with structural nondegenerative brain damage and is in a coma. The patient may be completely unresponsive to any stimuli or may exhibit a generalized response by reacting inconsistently and nonpurposefully to stimuli in a nonspecific manner; and

(c) a patient who has diffuse brain damage caused by anoxia, toxic poisoning, cerebral vascular accident, or encephalitis may be considered appropriate for admission to this program either for active coma stimulation or active rehabilitation.

(ii) records shall be maintained for at least two years identifying persons who were determined by the facility to be ineligible for admission under the head injury program. The records shall indicate the reason for ineligibility and any referral action taken;

(iii) inservice and continuing education programs which address the medical, physical, cognitive, psychosocial and behavioral needs of head injured patients shall be conducted on a regular basis for all personnel caring for such patients;

(iv) educational programs shall be conducted for personnel not providing direct care but who come in contact on a regular basis with head injured patients. The programs should familiarize personnel with the specific needs of these patients; and

(v) education and counseling services shall be available and offered to the patient and families as needed.

(2) Program management and staffing. There shall be distinct staffing for the direct care services in the head injury program unit.

(i) The program shall be administered by a program director who has at least two years of clinical or administrative experience in head injury rehabilitation programs. The program director shall have specific responsibilities which include, but are not limited to:

(a) administrative direction and oversight of the program;

(b) ongoing review of the program and implementation of program changes as identified; and (c) development and implementation of educational programs on an ongoing basis for staff working with head injured patients.

(ii) A physician who has advanced training and experience in the care of the head injured shall be responsible for the medical direction and medical oversight of the head injury program and may serve as the program director.

(iii) A qualified specialist in physical medicine and rehabilitation or a physician who has training and experience in the care and rehabilitation of head injured patients shall be responsible for the care of each patient.

(iv) A primary interdisciplinary team of health care professionals with special interest, training, experience and expertise in head injury rehabilitation shall be responsible for the assessment, coordinated program and care planning, and direct services for each head injured patient. The interdisciplinary team members shall be specifically assigned to serve head injured patients and the team shall include as a minimum the following types of health care professionals:

(a) physician;

(b) registered professional nurse;

(c) physical therapist;

(d) occupational therapist;

(e) speech-language pathologist;

(f) social worker;

(g) dietitian;

(h) therapeutic recreation specialist; and

(i) clinical psychologist with training and experience in neuropsychology.

(v) Nursing services for the head injury unit shall be provided under the direction of a registered professional nurse who is certified or eligible for certification in rehabilitation nursing or who has demonstrated appropriate clinical competency, training and experience in the provision of rehabilitation nursing for head injured patients as determined by the program and the hospital.

(vi) There shall be at least one registered professional nurse with experience in rehabilitation nursing assigned to each shift on the head injury unit.

(vii) Depending upon types of patients being served and individual patient's need, the program shall provide or make formal arrangements for vocational rehabilitation services and special education services.

(3) Interdisciplinary care planning. (i) A member of the interdisciplinary team managing the patient shall be designated to:

(a) coordinate the overall plan of care and services and identify unmet needs for each patient including discharge and follow-up plans;

(b) serve as a liaison among patient, family and staff to ensure that patient and family concerns are addressed; and

(c) serve as a liaison with the educational, social and vocational resources in the community which are serving the patient.

(ii) A written, comprehensive care plan shall be developed and implemented which establishes rehabilitation goals for each patient. The plan shall be developed on admission by the interdisciplinary team and the attending physician in consultation with the patient, the patient's family and outside agencies, as necessary. The care plan shall be reviewed at least every 14 days and modified according to the patient's needs by the interdisciplinary team. The comprehensive care plan is based upon initial and ongoing integrated, interdisciplinary assessments which shall address as a minimum, medical, dental and neurological status, nutritional status, sensorimotor capacity, the developmental needs of children and adolescents, cognitive, perceptual and communicative capacity, affect and mood, activities of daily living skills, educational or vocational capacities, sexuality issues and concerns, family unity counseling and community reintegration needs and recreation and leisure time interests.

(iii) Findings from the comprehensive care plan reviews shall be integrated into the utilization review program of the facility.

(iv) A written discharge plan shall be developed for each patient as part of the overall care plan and shall include input from all professionals caring for the patient, the patient's family, the patient if capable and, as appropriate, any outside agency or resource that will be involved with the patient following discharge.

(v) The family and patient shall receive preparation for discharge through the facility's educational and counseling services.

(vi) There shall be effective provision for follow-up care and post discharge care which shall include as a minimum, formal linkages to other sources of care and services for head-or brain-injured patients including outpatient services, residential health care facility-based services, home care service agency services and vocational education and rehabilitation services.

(4) Utilization review monitoring. 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: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 405.19 - Emergency services

405.19 Emergency services.

(a) General.

(1) Emergency services shall be provided in accordance with this subdivision or subdivisions (b) through (e) of this section as appropriate.

(2) If emergency services are not provided as an organized service of the hospital, the governing body and the medical staff shall assure:

(i) prompt physician evaluation of patients presenting with emergencies;

(ii) initial treatment and stabilization or management; and

(iii) transfer, where indicated, of patients to an appropriate receiving hospital. The hospital shall have a written agreement with local emergency medical services (EMS) to accommodate the need for timely inter-hospital transfer on a 24 hours a day, 7 days a week, 365 days a year basis.

(b) Organization. (1) The medical staff shall develop and implement written policies and procedures approved by the governing body that shall specify:

(i) the responsibility of the emergency services to evaluate, initially manage and treat, or admit or recommend admission, or transfer patients to another facility that can provide definitive treatment. Such policies and procedures shall include a written agreement with one or more local emergency medical services (EMS) to accommodate the need for timely inter-facility transport on a 24 hours a day, 7 days a week, 365 days a year basis;

(ii) the organizational structure of the emergency service, including the specification of authority and accountability for services; and

(iii) explicit prohibition on transfer of patients based on their ability or inability to pay for services.

(2) At least one clinician on every shift must have the skills to assess and manage a critically ill or injured pediatric patient and be able to resuscitate an infant or a child. The emergency service shall be directed by a licensed and currently registered physician who is board-certified or board-admissible for a period not to exceed five years after the physician first attained board admissibility in emergency medicine, surgery, internal medicine, pediatrics or family practice, and who is currently certified in advanced trauma life support (ATLS), or has current training and experience equivalent to ATLS. Such physician shall also have successfully completed a current course in advanced cardiac life support (ACLS) and pediatric advanced life support (PALS) or have had current training and experience equivalent to ACLS and PALS. A licensed and currently registered physician who is board-certified or board-admissible in psychiatry for a period not to exceed five years after the physician first attained board-admissibility, in psychiatry may serve as psychiatrist director of a separately operated psychiatric emergency service. Directors of separately operated psychiatric emergency services need not be qualified to perform ATLS, ACLS and PALS or have current training and experience equivalent to ATLS, ACLS and PALS.

(3) An emergency service shall have laboratory and X-ray capability, including both fixed and mobile equipment, available 24 hours a day, seven days a week, to provide test results to the service within a time considered reasonable by accepted emergency medical standards.

(c) General policies and procedures. (1) The location and telephone number of the State Department of Health-designated poison control center, shall be maintained at the telephone switchboard and in the emergency service.

(2) All cases of suspected child abuse or neglect shall be treated and reported immediately to the New York State Central Register of Child Abuse and Maltreatment pursuant to procedures set forth in article 6, title 6 of the Social Services Law.

(3) Domestic violence. The emergency service shall develop and implement policies and procedures which provide for the management of cases of suspected or confirmed domestic violence victims in accordance with the requirements of section 405.9(e) of this Part.

(4) The emergency service shall establish and implement written policies and procedures for the maintenance of sexual offense evidence as part of the hospital-wide provisions required by this Part. An organized protocol for survivors of sexual offenses, including medical and psychological care shall be incorporated into such policies and procedures. These policies, procedures and protocols shall be consistent with the standards for patient care and evidence collection established in section 405.9(c) of this Part.

(5)  The emergency service shall provide for the identification, assessment and referral of individuals with documented substance use disorders or who appear to have or be at risk for substance use disorders, as that term is defined in section 1.03 of the Mental Hygiene Law, as described in subdivision (f) of section 405.9 of this Part.

(6)  The emergency service shall provide for the identification, assessment, and appropriate treatment or referral of individuals who are suspected to be human trafficking victims, as described in subdivision (g) of section 405.9 of this Part.

(7) The emergency service, in conjunction with the discharge planning program of the hospital, shall develop and implement written policies and procedures, including written patient criteria and guidelines, for transfer of those patients for whom the hospital does not have the capability to care. Such policies and procedures shall specify the circumstances, the actions to be taken, and the appropriate contact agencies and individuals to accomplish adequate discharge planning for persons in need of post emergency treatment or services, but not in need of inpatient hospital care.

(8) An admission and discharge register shall be current and shall include at least the following information for every individual seeking care:

(i) date, name, age, gender, ZIP code;

(ii) expected source of payment;

(iii) time and means of arrival, including name of ambulance service for patients arriving by ambulance;

(iv) complaint and disposition of the case; and

(v) time and means of departure, including name of ambulance service for patients transferred by ambulance.

(9) There shall be a medical record that meets the medical record requirements of this Part for every patient seen in the emergency service. Medical records shall be integrated or cross-referenced with the inpatient and outpatient medical records system to assure the timely availability of previous patient care information and shall contain the prehospital care report or equivalent report for patients who arrive by ambulance. On arrival to emergency services, a patient shall be asked for the name of his or her primary care provider, if known, which shall be documented in the patient's medical record.

(10) The hospital shall develop and implement written policies and procedures pertaining to the review and communication of laboratory and diagnostic test/service results ordered for a patient while admitted or receiving emergency services to the patient. If the patient lacks medical decision-making capacity, the communication shall be to the patient's medical decision-maker, if known. The results shall also be provided to the patient's primary care provider, if known. Such policies and procedures shall be reviewed and updated as necessary and at a minimum shall include:

(i) a requirement that all laboratory and other diagnostic tests/service results be reviewed upon completion by a physician, physician assistant or nurse practitioner familiar with the patient's presenting condition;

(ii) a requirement that all laboratory and other diagnostic test services results be forwarded to the patient's primary provider, if known, after review by a physician, physician assistant or nurse practitioner;

(iii) provisions to include in the discharge plan information regarding the patient's completed and pending laboratory and other diagnostic test/service results, medications, diagnoses, and follow-up care and to review such information with the patient or, if the patient is not legally capable of making decisions, the patient's parent, legal guardian or health care agent, or surrogate, as appropriate, subject to all applicable confidentiality laws and regulations;

(iv) a requirement that patients may not be discharged from the hospital or the emergency room until any tests that could reasonably be expected to yield "critical value" results – results that suggest a life-threatening or otherwise significant condition such that it requires immediate medical attention– are reviewed by a physician, physician assistant (PA) and/or nurse practitioner (NP) and are communicated to the patient, his or her parents or other decision makers, as appropriate.

(v) a requirement that all information be presented to the patient or if the patient is not legally capable of making decisions, the patient's parent, legal guardian or health care agent, or surrogate, as appropriate, subject to all applicable confidentiality laws and regulations, in a manner that reasonably assures that the patient, their parents or other medical decision makers understand the health information provided in order to make appropriate health decisions.

(11) Review of the hospital emergency service shall be conducted at least four times a year as part of the hospital's overall quality assurance program. Receiving hospitals shall report to sending hospitals and emergency medical systems, as appropriate, all patients that die unexpectedly within 24 hours upon arrival at the receiving hospitals. These patient mortalities shall be included in both hospitals' quality assurance review.

(d) Staffing. The following requirements are applicable to all organized emergency services:

(1) Emergency service physician services shall meet the following requirements:

(i) The emergency services attending physician shall meet the minimum qualifications set forth in either clauses (a) or (b) of this subparagraph.

(a) The emergency services attending physician shall be a licensed and currently registered physician who is board-certified in emergency medicine, surgery, internal medicine, pediatrics or family practice and who is currently certified in advanced trauma life support (ATLS) or has current training and experience equivalent to ATLS. Such physician shall also have successfully completed a course and be current in advanced cardiac life support (ACLS) and pediatric advanced life support (PALS) or have had current training and experience equivalent to ACLS and PALS. A licensed and currently registered physician who is board-certified in psychiatry may serve as psychiatrist attending in a separately operated psychiatric emergency service. A licensed and currently registered physician who is board-admissible in one of these specialty areas and is currently certified in ATLS or who has current training and experience equivalent to ATLS and has successfully completed a course and is current in ACLS and PALS or has had current training and experience equivalent to ACLS and PALS, may be designated as attending physician for a period not to exceed five years after the physician has first attained board-admissibility. The requirement to be qualified to perform ATLS, ACLS and PALS shall not be applicable to qualified psychiatrist attendings in a separately operated psychiatric emergency service. Physicians who are board-certified or admissible, for a period not to exceed five years after the physician first attained board-admissibility, in other specialty areas may be designated as attending physicians for patients requiring their expertise.

(b) The emergency services attending physician shall be a physician who:

(1) is licensed and currently registered;

(2) has successfully completed one year of post-graduate training;

(3) has, within the past five years, accumulated 7,000 documented patient contact hours or hours of teaching medical students, physicians-in-training, or physicians in emergency medicine. Up to 3,500 hours of documented experience in hospital-based settings or other settings in the specialties of internal medicine, family practice, surgery or pediatrics may be substituted for the required hours of emergency medicine experience on an hour-for-hour basis;

(4) has acquired in each of the last three years, an average of fifty hours or more per year of continuing medical education pertinent to emergency medicine or to the specialties of practice which contributed to meeting the 7,000 hours requirement specified in subclause (3) of this clause;

(5) is currently certified in ATLS or has current training and experience equivalent to ATLS; and

(6) has successfully completed a course and is current in advanced cardiac life support (ACLS) and pediatric advanced life support (PALS) or has had current training and experience equivalent to ACLS and PALS.

(ii) There shall be at least one emergency service attending physician on duty 24 hours a day, seven days a week. For hospitals that exceed 15,000 unscheduled visits annually, the attending physician shall be present and available to provide patient care and supervision in the emergency service. As necessitated by patient care needs, additional attending physicians shall be present and available to provide patient care and supervision. Appropriate subspecialty availability as demanded by the case mix shall be provided promptly in accordance with patient needs. For hospitals with less than 15,000 unscheduled emergency visits per year, the supervising or an attending physician need not be present but shall be available within 30 minutes of patient presentation, in person or by telemedicine, provided that at least one physician, nurse practitioner, or licensed physician assistant shall be on duty in the emergency service 24 hours a day, seven days a week. The hospital shall develop and implement protocols specifying when physicians must be present.

(iii) Other medical staff practitioner services provided in the emergency service shall be in accordance with the privileges granted the individual; and

(iv) Every medical-surgical specialty on the hospital's medical staff which is organized as a department or clinical service and where practitioner staffing is sufficient, shall have a schedule to provide coverage to the emergency service by attending physicians in a timely manner, 24 hours a day, seven days a week, in accordance with patient needs.

(2) Nursing services:

(i) There shall be at least one supervising emergency services registered professional nurse present and available to provide patient care services in the emergency service 24 hours a day, seven days a week;

(ii) Emergency services supervising nurses shall be licensed and currently registered and possess current, comprehensive knowledge and skills in emergency health care. They shall be able to demonstrate skills and knowledge necessary to perform basic life support measures, and be current in ACLS and PALS or have current training and experience equivalent to ACLS and PALS, and meet the competency requirements of Section 405.5(a)(7);

(iii) Registered professional nurses in the emergency service shall be licensed and currently registered professional nurses who possess current, comprehensive knowledge and skills in emergency health care. They shall have successfully completed an emergency nursing orientation program, be able to demonstrate skills and knowledge necessary to perform basic life support measures and meet the competency requirements of Section 405.5(a)(7). Within one year of assignment to the emergency service, each emergency service nurse shall be current in ACLS and PALS or have current training and experience equivalent to ACLS and PALS.

(iv) Additional registered professional nurses and nursing staff shall be assigned to the emergency service in accordance with patient needs. If, on average:

(a) the volume of patients per eight-hour shift is under 25, an additional registered professional nurse shall be available as needed to assist the supervising registered professional nurse with delivery of direct patient care; or

(b) the volume of patients per eight-hour shift is over 25, there shall be a minimum of two registered professional nurses per shift assigned to provide direct patient care. As patient volume and intensity increases, the total number of available registered professional nurses shall also be increased to meet patient care needs;

(3) Licensed physician assistants and nurse practitioners:

(i) patient care services provided by licensed physician assistants shall be in accordance with section 405.4 of this Part;

(ii) patient care services provided by certified nurse practitioners shall be in collaboration with a licensed physician whose professional privileges include approval to work in the emergency service and in accordance with written practice protocols for these services; and

(iii) the licensed physician assistants and the nurse practitioners shall meet the following standards:

(a) the licensed physician assistants and the nurse practitioners in the emergency service shall be current in ACLS and PALS or have had current training and experience equivalent to ACLS and PALS when determined necessary by the hospital to meet anticipated patient needs or when a physician assistant or nurse practitioner is serving as the sole practitioner on duty in a hospital with less than 15,000 unscheduled emergency visits per year;

(b) licensed physician assistants and nurse practitioners in the emergency service shall be current in ATLS or have had current training and experience equivalent to ATLS when determined necessary by the hospital to meet anticipated patient needs or when a physician assistant or nurse practitioner is serving as the sole practitioner on duty in a hospital with less than 15,000 unscheduled emergency visits per year.

(4) Support personnel. There shall be sufficient support personnel assigned to the emergency service to perform the following duties on a timely basis: patient registration, reception, messenger service, acquisition of supplies, equipment, delivery and labeling of laboratory specimens, responsible for the timely retrieval of laboratory reports, obtaining records, patient transport and other services as required.

(e) Patient care. (1) The hospital shall assure that all persons presenting for emergency services receive emergency health care that meets generally accepted standards of practice.

(2) Every person arriving at the emergency service for care shall be promptly examined, diagnosed and appropriately treated in accordance with triage and transfer policies and protocols adopted by the emergency service and approved by the hospital. Such protocols must include written agreements with local emergency medical services (EMS) in accordance with subparagraph (b) (1) (i) of this section. All patient care services shall be provided under the direction and control of the emergency services director or attending physician. In no event shall a patient be discharged or transferred to another facility, unless evaluated, initially managed, and treated as necessary by an appropriately privileged physician, physician assistant, or nurse practitioner. No later than eight hours after presenting in the emergency service, every person shall be admitted to the hospital, or assigned to observation services in accordance with section 405.32 of this part, or transferred to another hospital in accordance with paragraph (6) of this subdivision, or discharged to self-care or the care of a physician or other appropriate follow-up service.

(3) Hospitals that have limited capability for receiving and treating patients in need of specialized emergency care shall develop and implement standard descriptions of such patients, and have triage and treatment protocols including consultation and formal written transfer agreements with hospitals that are designated as being able to receive and provide definitive care for such patients. Patients in need of specialized emergency care shall include, but not be limited to:

(i) trauma patients and multiple injury patients;

(ii) burn patients with burns ranging from moderate uncomplicated to major burns as determined by use of generally acceptable methods for estimating total body surface area;

(iii) high risk maternity patients or neonates or pediatric patients in need of higher level care;

(iv) head-injured or spinal-cord injured patients;

(v) acute psychiatric patients;

(vi) replantation patients;

(vii) dialysis patients; and

(viii) acute myocardial infarction patients including but not limited to patients with ST elevation.

(4) Hospitals shall verbally request ambulance dispatcher services to divert patients with life threatening conditions to other hospitals only when the chief executive officer or designee appointed in writing, determines that acceptance of an additional critical patient would endanger the life of that patient or another patient. Request for diversion shall be documented in writing and, if warranted, renewed at the beginning of each shift.

(5) Reserved.

(6) Patients shall be transferred to another hospital only when:

(i) the patient's condition is stable or being managed;

(ii) the attending practitioner has authorized the transfer; and

(iii) administration of the receiving hospital is informed and can provide the necessary resources to care for the patient; or

(iv) when pursuant to paragraph (2) of this subdivision, the patient is in need of specialized emergency care at a hospital designated to receive and provide definitive care for such patients.

(7) Hospitals located within a city with a population of one million or more persons shall apply, and if accepted, participate to the full extent of their capability in the emergency medical service which is operated by such city or such city's health and hospitals corporation.

(f) Quality assurance.

(1) Quality assurance activities of the emergency service shall be integrated with the hospital-wide quality assurance program and shall include review of:

(i) arrangements for medical control and direction of pre-hospital emergency medical services;

(ii) provisions for triage of persons in need of specialized emergency care to hospitals designated as capable of treating those patients;

(iii) emergency care provided to hospital patients, to be conducted at least four times a year, and to include pre-hospital care providers, emergency services personnel and emergency service physicians; and

(iv) adequacy of staff training and continuing education to meet the needs of patients of all ages presenting for emergency services.

(2) hospitals as represented by emergency department practitioners and other clinical practitioners relevant to the care provided should also collaborate, as provided under Public Health Law Section 3006, in the quality improvement programs of their local EMS to review prehospital care issues including review of specific patient cases.

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 405.20 - Outpatient services

405.20 Outpatient services. Outpatient services, including ambulatory care services and extension clinics, shall be provided in a manner which safely and effectively meets the needs of the patients.

(a) General requirements. As a minimum when provided, outpatient services shall comply with the rules and regulations set forth in this Part as well as the outpatient care provisions of Part 751, sections 752.1 and 753.1 and Parts 756, 757 and 758 of Subchapter C of this Title.

(1) The provision of this section shall apply to hospital-sponsored ambulatory services, including part-time and off-site clinics, which accept primary responsibility for health supervision and medical care of patients.

(2) The hospital shall ensure that all care provided by its ambulatory services is in accordance with prevailing standards of professional practice.

(3) The hospital shall conduct periodic reviews of the care rendered by its ambulatory services as part of its overall quality assurance program.

(b) The hospital shall assign a physician to be responsible for the professional services of the outpatient department. Either this physician or an administrator qualified by training and experience shall be responsible for administration of the outpatient services.

(c) Patient care. The hospital shall effectively meet outpatient patient care needs by:

(1) the provision of patient care in a continuous manner by the same health care practitioner, whenever possible;

(2) the appropriate referral to other health care facilities or health care practitioners for services not available;

(3) the identification, assessment, reporting and referral of cases of suspected child abuse or neglect as required by section 405.9(d) of this Part;

(4) compliance with the domestic violence provisions of section 405.9(e) of this Part;

(5) identification, assessment, and referral of individuals with documented substance use disorders or who appear to have or be at risk for substance use disorders, as that term is defined in section 1.03 of the Mental Hygiene Law, as described in subdivision (f) of section 405.9 of this Part;

(6) compliance with the human trafficking provisions pertaining to the identification, assessment, and appropriate treatment or referral of individuals who are suspected to be human trafficking victims, as described in subdivision (g) of section 405.9 of this Part; and

(7) the development of a written plan of treatment. When treatment is provided it is revised, as necessary, in consultation with other health care professionals.

(d) Hospital-based ambulatory surgery service. In a hospital maintaining an on-site hospital-based ambulatory surgery service, the following requirements supplement existing applicable requirements of sections 405.12 (Surgical services) and 405.13 (Anesthesia services) of this Part. (Hospital-based ambulatory surgery services) shall mean a service organized to provide surgical procedures which shall be performed for reasons of safety in an operating room on anesthetized patients requiring a stay of less than 24 hours duration. These procedures do not include outpatient surgical procedures which can be performed safely in a private physician's office or in an outpatient treatment room.

(1) The hospital-based ambulatory surgery service shall be directed by a physician found qualified by the governing body to perform such duties.

(2) The governing body and the medical staff shall develop, maintain and periodically review a list of surgical procedures which may be performed in the service. The medical staff shall assure that procedures performed in the service conform with generally accepted standards of professional practice, in accordance with the competencies of the medical and professional staff that have privileges in the hospital-based ambulatory surgery service, and are appropriate in the facilities and consistent with the equipment necessary to meet the needs of all patients. The medical staff shall, based upon its review of individual medical staff qualifications, recommend to the governing body specific surgical procedures which each practitioner is qualified to perform in the hospital-based ambulatory surgery service.

(3) Hospital-based ambulatory surgery services may be located at the same site as the hospital (on-site) or apart from the hospital (off-site), pursuant to section 709.5 of this Title.

(i) Recovery rooms adequate for the needs of hospital-based ambulatory surgery patients, conveniently located to the operating room, shall be provided.

(ii) Waiting rooms adequate for the needs of patients and responsible persons accompanying patients shall be provided.

(4) Prior to surgery, each patient shall have a timely history and physical examination, appropriate to the patient's physical condition and the surgical procedure to be performed, which shall be recorded in the patient medical record.

(5) Each post surgery patient shall be observed for post-operative complications for an adequate time period as determined by the attending practitioner and the anesthesiologist. The service shall have written policies for hospital admission of patients whose post-operative status prevents discharge and necessitates inpatient admission to a hospital capable of providing the appropriate level of care.

(6) Detailed verbal instructions understandable to the patient, or the patient's parent, legal guardian, or health care agent, confirmed by written instructions, and approved by the medical staff of the hospital-based ambulatory surgery service shall be provided to each patient, or the patient's parent, legal guardian, or health care agent, at discharge, to include at least the following:

(i) information about complications that may arise;

(ii) telephone number(s) to be used by the patient should complications or questions arise;

(iii) directions for medications prescribed, if any;

(iv) date, time and location of followup visit or return visit; and

(v) designated place to go for treatment in the event of emergency.

(7) The hospital-based ambulatory surgery service staff shall develop written policies, approved by the medical staff, for documentation of the patient's postoperative course of treatment. The policies must be reviewed and adopted by the governing body of the hospital prior to implementation. The policies must provide a mechanism to assure that complications of surgery or anesthesia, which occur before and after discharge, are identified and documented in the patient's medical record.

(8) The hospital-based ambulatory surgery service shall have an organized system of quality assurance approved by the medical staff and the governing body which undertakes investigations into operative results of surgical procedures performed on the service and maintains statistics on operative failures and complications.

(9) Notwithstanding anything herein to the contrary, an off-site hospital-based ambulatory surgery service shall be operated in accordance with the provisions of Part 755 of this Title.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 405.21 - Perinatal services

405.21 Perinatal services.

(a) Applicability. This section shall apply to all general hospitals having maternity and newborn services and providing pregnancy-related care for women who are pregnant at any stage, parturient or within six weeks from delivery and for infants 28 days of age or less or, regardless of age, who are less than 2,500 grams (5 1/2 pounds).

(b) Definitions. For the purposes of this section:

(1) Perinatal services shall mean those services provided in a particular hospital where, as a regular practice, maternity patients and newborn infants receive care on a continuum ranging from preconception services to care during all stages of pregnancy, parturition, postpartum and neonatal care.

(2) Perinatal regionalization system shall mean the statewide organization of maternal and newborn health care services, designed as set forth in Part 721 of this Title, to ensure that mothers and newborns receive the care they need in a timely, safe and effective manner.

(3) Labor room shall mean a room for parturient patients in labor, distinct from patient bedrooms and from operating or delivery rooms.

(4) Delivery room shall mean a room distinct from patient bedrooms and set apart for the delivery of parturient patients.

(5) Single unit maternity or labor-delivery-recrovery-postpartum model shall mean a model for family-centered maternity and newborn care in which labor, delivery, nursery and postpartum care are all provided in a single room and movable equipment is introduced and withdrawn from the room as required to provide services and care to the mother and neonate.

(6) Rooming-in shall mean an arrangement which allows the mother and her newborn infant to be cared for together, so that the mother may have access to her infant during all or a substantial part of the day and night, not limited to feeding times.

(7) Newborns shall mean all infants 28 days of age or less.

(8) Premature infant shall mean an infant whose gestational age at birth calculated from the first day of the last menstrual period, or using another reliable method for patients with an unreliable history, is less than 37 completed weeks or 258 completed days.

(9) Low birth weight infant shall mean an infant weighing less than 2,500 grams (5 1/2 pounds) at birth.

(10) Normal newborn nursery shall mean a room for housing newborns who do not need intensive care and are not suspected of nor diagnosed as having any communicable condition.

(11) Neonatal intensive care unit ("NICU") shall mean a room at Level II, Level III and Regional Perinatal Center perinatal care services for housing newborns, including premature infants and low birth weight infants, who require specialized care and who are not suspected of nor diagnosed as having any communicable condition.

(12) Observation nursery shall mean a room, physically separate from the normal newborn nursery, where newborns exposed to potential sources of infection and newborns suspected of but not diagnosed as having any communicable condition may be observed, pending diagnosis.

(13) Isolation nursery shall mean a room, physically separate from other nurseries, for the isolation of newborns diagnosed as having any communicable condition.

(14) Family planning shall mean the planning and spacing of children by medically acceptable methods to achieve pregnancy, or prevent unintended pregnancy.

(15) Level I perinatal care service shall mean a comprehensive maternal and newborn service as defined by Section 721.2(a) of this Title.

(16) Level II perinatal care service shall mean a comprehensive maternal and newborn service as defined by Section 721.2(b) of this Title.

(17) Level III perinatal care service shall mean a comprehensive maternal and newborn service as defined by Section 721.2(c) of this Title.

(18) Regional perinatal center ("RPC") shall mean a hospital or hospitals housing a Level III perinatal care service as defined in Section 721.2(d) of this Title.

(19) Perinatal affiliates shall mean Level I, Level II and Level III hospitals which have a current perinatal affiliation agreement as defined in Part 721 of this Title.

(20) Birth center shall mean a place, other than a traditional hospital childbirth unit or birthing room, where births are planned to occur away from the mother's usual residence following a normal uncomplicated pregnancy.

(21) Birthing room shall mean a hospital room designed as a homelike setting which serves as a combined labor/delivery/recovery room and where family members or other supporting persons may remain with a woman as much as possible throughout the childbirth process.

(22) Quality improvement shall mean improvement of the quality of care provided by the RPC or affiliate hospitals through initiatives and analyses designed to identify and then address potential problems in care in its own hospital or in affiliated hospitals, or in the region as a whole, through review of either sentinel cases or patterns of care.

(c) General requirements. (1) Hospitals providing perinatal services shall provide such services in accordance with current standards of professional practice. Written policies and procedures shall be developed and implemented which address the following:

(i) the professional qualifications of the hospital's obstetric and pediatric staff;

(ii) the requirements for consultation with a qualified specialist when required by specific medical conditions;

(iii) the establishment and implementation of rooming-in at the option of each patient unless the establishment or implementation of such program for that patient is medically contraindicated or unless the hospital does not have sufficient facilities to accommodate all such requests; (iv) protocols and resources available to stabilize and assess newborns for their need of neonatal intensive care; and

(v) the daily care of maternity patients and infants in the perinatal service.

(2) Medical record for each maternity patient. The medical record for each maternity patient admitted to the perinatal service shall be maintained in accordance with section 405.10 of this Part and also shall include the following:

(i) a copy or abstract of the prenatal record, if existing, including a maternal history and physical examination as well as results of maternal and fetal risk assessment, results of maternal HIV Hepatitis B and Group B strep testing if done, and ongoing assessments of fetal growth and development and maternal health;

(ii) the results of a current physical examination performed by staff granted privileges to perform such examination that meets the requirements of section 405.9(b)(11) of this Part; and

(iii) labor and birth information, including records of fetal monitoring and postpartum assessment.

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

(i) newborn physical assessment, including Apgar scores, presence or absence of three cord vessels, ability to feed, vital signs and accommodation to extrauterine life;

(ii) newborn care, including the administration of eye prophylaxis and vitamin K;

(iii) description of maternal-newborn interactions; and

(iv) orders for newborn screening tests, including arrangements for screening for hearing.

(4) The hospital shall ensure the transfer to the newborn's medical records of a mother's HIV test result, if one exists.

(5) The hospital shall maintain in a timely manner in the perinatal service area, a register of births, in which shall be recorded the name of each patient admitted, date of admission, date and time of birth, type of delivery, names of personnel present in the delivery room, sex, weight and gestational age of infant, location of delivery and outcome of delivery. Any delivery for which the institution is responsible for filing a birth certificate shall be listed in this register.

(6) Control of infection or other communicable condition. The provisions of section 405.11 of this Part shall apply to the perinatal service. In addition, the following requirements relating to the control of infection or other communicable conditions in the perinatal service shall be met:

(i) each patient admitted to the labor-delivery unit shall be screened for signs of, or exposure to, infection. Those with suspected or confirmed communicable conditions shall be reported to the responsible attending practioner and the infection control officer for observation or isolation as required;

(ii) isolation precautions shall be carried out for patients in labor with confirmed or suspected infection. There shall be at least one room readily available for the use of a maternity patient requiring isolation. The hospital shall implement safe and effective isolation precautions to prevent the spread of infection and assign professional and other staff in the perinatal service in a manner that will prevent the spread of infection. Written policies and procedures shall be developed and implemented reflecting such isolation precautions;

(iii) the hospital shall adopt and implement written policies and procedures governing the placement in observation or isolation nurseries of infants exposed to or showing signs of developing an infection or communicable condition. Such policies shall not unnecessarily restrict the mother's access to her infant; and

(iv) infection control measures shall be instituted to protect infants when the care and treatment of infants requires common surfaces.

(7) Preconception services. The hospital shall develop and implement written policies and procedures for preconception services either onsite or through referral arrangements. Services shall include but not be limited to family planning, nutritional assessment and counseling, genetic screening and counseling, and identification and treatment of medical conditions that could adversely affect a future pregnancy.

(8) Hospital prenatal care activities. (i) The hospital shall participate in and shall provide or arrange for effective prenatal care activities including conducting effective community outreach programs either directly or in collaboration with community-based providers and practitioners who provide prenatal care and services to women in the hospital service area. Activities and services of a prenatal care program shall include but not be limited to the following:

(a) active promotion of prenatal care for pregnant women during the first trimester of pregnancy and making services available to patients seeking initial care during each trimester;

(b) the initial prenatal care visit shall include a complete history, physical examination, pelvic examination, laboratory screening, initiation of patient education, screening for nutritional status, nutrition counseling and use of a standardized prenatal risk assessment tool;

(c) arrangements for repeat visits for follow-up prenatal care and education;

(d) nutrition counseling;

(e) psychosocial support services as needed;

(f) ongoing maternal and fetal risk assessment;

(g) prebooking for delivery; and

(h) providing HIV counseling and a clinical recommendation for testing to pregnant women. 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.

(ii) To perform the activities and provide the services in subparagraph (i) of this paragraph, the perinatal service shall accommodate and coordinate services with primary care providers as follows:

(a) the hospital shall develop a memorandum of understanding with each diagnostic and treatment center, prenatal care provider who is not a member of the medical staff, and prenatal care assistance program in the hospital service area. These memoranda shall establish protocols for the provision of prenatal care, testing, prebooking arrangements, timely transfer of records, and other necessary services; and

(b) the hospital shall require as a condition of continuing medical staff membership that medical staff members provide to maternity patients under their care prenatal care, prebooking arrangements, testing, timely transfer of records and other necessary services. Written policies and procedures implementing this requirement shall be developed.

(iii) Hospitals shall assure the availability of prenatal childbirth education classes for all prebooked women which address as a minimum the anatomy and physiology of pregnancy, labor and delivery, infant care and feeding, breastfeeding, 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.

(iv) The hospital shall assure that each prebooked woman receives the hospital's maternity information leaflet as described in PHL section 2803-j, which includes a written description of available options for labor, delivery and postpartum services. The attending practioner shall:

(a) advise the woman of options for treatment, care and technological support that are expected to be available at the time of labor and delivery, together with the advantages and disadvantages of each option;

(b) answer fully any questions the woman may have regarding the options available; and

(c) obtain from the woman her informed choice of mode of treatment, care and technological support that are expected to be necessary.

(9) Hospitals in consultation with the medical staff shall develop memoranda of understanding with free-standing birth centers in their service area, upon request from such centers, for the prompt admission of women and newborns and transfer of records of any birth center patients whose assessed condition necessitates admission to the level of perinatal service provided by such hospital.

(i) Such transfer shall be accomplished in accordance with the provisions of sections 754.2(e), 754.4, 795.2(e) and 795.4 of this Title.

(ii) Unless already performed at a free-standing birth center, newborns transferred to a hospital shall have newborn screening performed at the hospital in accordance with Part 69 of this Title.

(iii) The hospital, as part of its quality improvement activities, shall review all maternal and/or newborn transfers from birth centers to ensure adequacy of risk assessment and care, that each transfer has been appropriately arranged, and that reasons for the transfer have been documented clearly.

(10) Quality improvement activities. In addition to the quality assurance provisions of section 405.6 of this Part, the hospital shall, in conjunction with the medical staff and the nursing staff, monitor the quality and appropriateness of patient care and ensure that identified problems are reported to the quality assurance committee together with recommendations for corrective action. In accordance with section 721.9 of this Title, the hospital shall also perform quality improvement activities in accordance with its perinatal affiliation agreement.

(11) Functioning of perinatal services. (i) Inpatient perinatal services shall be operated as closed units with limited access to unnecessary hospital traffic.

(ii) The perinatal service shall have available: services for the identification of high-risk mothers and fetuses, continuous electronic fetal monitoring, Cesarean delivery capabilities within 30 minutes of determination of need for such procedure, anesthesia services available on a 24-hour basis, radiology and ultrasound examination, with at least one ultrasound machine immediately available for use by the labor and delivery service.

(12) Laboratory services. The perinatal service shall have immediate access to the hosiptal's laboratory services including a 24-hour capability to provide blood group, Rh type and cross-matching, and basic emergency laboratory evaluations. Either ABO Rh-specific or 0-Rh-negative blood and fresh frozen plasma shall be available at the facility at all times. Such other procedures as may be required by the perinatal service shall be performed on a timely basis.

(13) Admissions. (i) Women in need of medical care and services pertaining to pregnancy, delivery and the puerperal period shall be admitted to the maternity service. Such admission shall be consistent with section 405.9 of this Part.

(a) Each patient shall be attended by a licensed and currently registered obstetrician, family practitioner or licensed midwife who will be responsible for the patient's care.

(b) A patient may not be sent home without the prior knowledge and approval of her attending physician or licensed midwife.

(ii) Admission of non-obstetric patients.

(a) The hospital shall develop and implement written policies and procedures for the admission of non-obstetric female patients to the perinatal service area. The hospital shall ensure that obstetric patients take precedence over non-obstetric patients and that the safety and physical and psychological well-being of obstetric patients are not jeopardized.

(b) The following non-obstetric patients shall not be admitted to the maternity service:

(1) patients undergoing radiation therapy while they retain radioactive materials that have been administered for, or that result from, such treatment; and

(2) patients in an acute, infectious state or with signs and symptoms which may denote infection.

(c) If an acute or chronic infection or any other condition which would have contraindicated admission to the perinatal service is found during surgery or during any other period of hospitalization, the patient shall be removed from the perinatal service area.

(14) Voluntary acknowledgement of paternity for a child born out of wedlock.

(i) If a child is born to an unmarried woman and the putative father is readily identifiable to the responsible hospital staff and available, the hospital shall:

(a) provide to the child's mother and putative father documents and oral and written instructions and information necessary for such mother and father to complete an acknowledgement of paternity form in compliance with section 4135-b of the Public Health Law and section 111-k of the Social Services Law; and

(b) file the executed acknowledgement of paternity with the registrar at the same time at which the certificate of live birth is filed, if possible.

(ii) The hospital shall not be required to seek out or otherwise locate a putative father who is not readily identifiable or available.

(15) Hospitals with a perinatal care service shall participate in the perinatal regionalization system in accordance with their level of care designations under Part 721 of this Title.

(16) Each hospital providing Level I, II or III perinatal care services shall enter into a perinatal affiliation agreement with its designated RPC in accordance with Part 721 of this Title. Level I and II hospitals may also enter into transfer agreements in accordance with Part 721 with Level III hospitals.

(d) High-risk antepartum services at Level II, Level III and RPC perinatal services. (1) Level II, Level III and/or RPC perinatal services shall develop and implement written policies and procedures to indicate where pregnant patients with obstetric, medical, or surgical complications are to be assigned to provide for their continuous observation and care.

(2) Maternal intensive care services. (i) Hospitals providing Level I or II perinatal care services shall develop, enter into and implement written agreements with hospitals providing Level III and RPC perinatal care services for the transfer of obstetric patients whose physical conditions are evaluated as needing such higher level of care.

(ii) Hospitals which provide multiple levels of perinatal care services shall develop and implement written protocols and procedures for the in-house transfer of patients who are evaluated as requiring a level of care other than the level being provided in the area where the patient is currently located.

(iii) Evaluation of the patient's condition and need for intensive care services shall be conducted in accordance with standardized risk assessment criteria based on generally accepted standards of practice which shall be adopted in writing and implemented uniformly throughout the perinatal service.

(iv) Level II, Level III and RPC perinatal care services shall maintain a nursing staff that is appropriately trained and adequate in size to provide specialized care to distressed mothers and infants. The number of patient care staff on duty during any shift shall reflect the volume and nature of patient services being provided during that shift.

(v) An RPC shall:

(a) offer education and training to its perinatal affiliates and associated birth centers. Education and training shall be designed to update and enhance staff knowledge and familiarity with relevant procedures and technological advances;

(b) review, in conjunction with its perinatal affiliates, all cases of patients transferred to a higher level of care to determine whether such transfers were appropriate and accomplished according to established transfer agreements; and

(c) participate in case conferences with its perinatal affiliates and associated birth centers to determine whether any non-transferred high-risk cases were handled appropriately and whether the transfer guidelines were adequate to address such circumstances.

(d) For purposes of participation in such activities, the RPC representative or representatives shall be deemed member(s) of the perinatal 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.

(e) Intrapartum services. (1) The hospital shall develop and implement written policies and procedures that indicate the areas of responsibility of both medical and nursing personnel for normal, high-risk, and emergency deliveries. These policies and procedures shall be reviewed yearly and made available to all staff. There also shall be written policies for the care of pregnant patients when all antepartum and postpartum beds are occupied.

(2) Written polices and procedures shall be developed and implemented governing restrictions of entry to the closed labor and delivery unit, and the hospital shall ensure that, unless medically contraindicated, the patient may choose to be accompanied during labor and delivery by the father and/or other supportive person(s) who can provide emotional comfort and encouragement. Any such contraindications shall be noted in the medical record.

(3) Evaluation and preparation. (i) In conjunction with the required updated history and physical exam, the hospital shall provide for the following:

(a) laboratory data including serologic tests for blood group, Rh type, syphilis and rubella titer;

(1) if the woman's serology is positive, a cord blood serology shall be obtained. If the sample could not be taken prior to the pregnancy's end, the serology shall be taken at the time of termination of the pregnancy;

(2) the woman shall be evaluated for the risk of sensitization to Rho (D) antigen and if the use of Rh immune globulin is indicated, an appropriate dosage thereof shall be administered to her as soon as possible within 72 hours after delivery or termination of pregnancy;

(b) an assessment of the woman's HIV status and the provision of testing in accordance with Section 69-1.3(1) of this Title;

(c) an admitting physical examination which shall include the woman's blood pressure, pulse and temperature, the fetal heart rate, the frequency, duration and evaluation of the quality of the uterine contractions, and which shall be recorded in the patient's medical record. An evaluation of any complications should be made. If there is suspected leakage of amniotic fluid or any unusual bleeding, the attending physician or licensed midwife shall be notified immediately before a pelvic examination is performed. When there are no complications or contraindications, qualified nursing personnel may perform the initial pelvic examination to evaluate labor status and the imminence of delivery. The physician or licensed midwife responsible for the woman's care shall be informed of her status, so that a decision can be made regarding further management; and

(d) interval assessments including physical and psychological status of the woman and fetal status.

(ii) Pharmacological or surgical induction or augmentation of labor.

(a) 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 privileging and credentialing practitioners in management of labor and delivery in accordance with the hospital's policies and procedures.

(b) Pharmacological or surgical induction or augmentation of labor may be initiated only after a qualified practitioner has evaluated the woman, determined that induction or augmentation is medically necessary for the woman or fetus, recorded the indication, obtained informed consent for induction or augmentation of labor, and established a prospective plan of management acceptable to the woman. If the qualified practitioner initiating these procedures does not have privileges to perform cesarean deliveries, a physician who has such privileges shall be contacted directly prior to initiation of the induction or augmentation and a determination made that he or she shall be available within 30 minutes of determination of the need to perform a Cesarean delivery. If the patient has had a previous cesarean delivery, a physician with cesarean privileges must be immediately available during pharmacological induction or augmentation of labor.

(c) Pharmacological or surgical induction or augmentation shall be initiated by a qualified practitioner. A qualified practitioner shall initiate the induction or augmentation and shall remain with the woman for a period of time sufficient to ensure that the procedure or medication has been well-tolerated and has caused no adverse reaction. A physician capable of managing any reasonably foreseeable complications from the induction or augmentation of labor shall be available within a timeframe appropriate to the woman's needs.

(d) For pharmacological induction or augmentation of labor, the hospital shall develop and implement a written protocol for the preparation and administration of the oxytocic agent and/or other substances used to induce or augment labor.

(e) During the entire time of the labor induction or augmentation, the woman shall be monitored by staff who are trained and competent in both the monitoring of fetal heart rate and uterine contractions and interpretation of such monitoring. The monitoring shall be by either electronic fetal monitoring or auscultation. Where auscultation is used in lieu of electronic fetal monitoring it shall be performed no less frequently than every 15 minutes during the first stage of labor and every five minutes during the second stage of labor.

(iii) No attempt shall be made to delay birth of an infant by physical restraint or anesthesia.

(iv) Each maternity patient, when present in a labor, delivery, birthing room or birth center shall be under the care of a registered professional nurse available in accordance with the patient's needs.

(v) The medical record shall be updated to note whenever the woman's choice of position for labor, use of drugs or technological support devices or mode of treatment and care cannot be honored due to medical contraindications. Standing orders for drugs or technological support devices may only be implemented after the nature and consequences of the intervention have been explained to the woman, and the woman agrees to such implementation.

(4) Delivery. (i) Hospitals shall develop and implement policies and procedures for the delivery room that shall require at least the following:

(a) regular evaluation of maternal blood pressure and pulse both during and after delivery; and

(b) fetal heart evaluation.

(ii) Section 405.13 of this Part concerning anesthesia services shall apply to the clinical perinatal service. The anesthetist shall be informed in advance if complications with the delivery are anticipated.

(iii) The perinatal service and the medical staff shall designate in writing those situations which require consultation with and/or transfer of responsibility from a licensed midwife or a family practice physician to an obstetrician.

(iv) Alternative arrangements for the organization of the perinatal service, including but not limited to birthing rooms, birth centers or single unit maternity models, shall conform to pertinent requirements of this section and Parts 711 and 712 of this Title. Birth centers shall also conform to the patient care provisions of Part 754 of this Title.

(v) Immediate care of the newborn. The practitioner who delivers the baby shall be responsible for the immediate post delivery care of the newborn until another qualified person assumes this duty. At all times, the newborn shall be attended by a physician or licensed midwife and shall be under the care of a registered professional nurse.

(a) Resuscitation of a distressed newborn. The hospital shall develop and implement policies and procedures for the recognition and immediate resuscitation of a distressed newborn. Level I and II perinatal care services shall accomplish this in consultation with, and with assistance of, the RPC with which the hospital has a perinatal affiliation agreement. The policies and procedures shall include the following elements:

(1) the designation of a physician to assume primary responsibility for the establishment of standards of care, review of practices, maintenance of appropriate drugs and training of personnel;

(2) approval of these policies and procedures by the directors of maternity and newborn services, anesthesia, pediatrics, nursing and by the medical staff;

(3) requirement for immediate availability of needed resuscitative equipment and personnel;

(4) presence in the delivery room of a member of the professional staff specifically qualified in newborn resuscitation;

(5) capability to provide short-term respiratory support including bag and mask ventilation;

(6) procedures for the stabilization of the distressed newborn;

(7) capability to perform endotracheal intubation and umbilical vessel catheterization. For a Level I perinatal care service, the perinatal affiliation agreement with its designated RPC shall provide for staff training to develop current staff competence in these procedures; and

(8) procedures for the preparation and transfer of the distressed newborn to a Level III or RPC perinatal care service when medically indicated.

(b) The hospital shall administer eye prophylaxis and vitamin K in accordance with sections 12.2 and 12.3 of this Title, test for phenylketonuria and other diseases and provide or arrange for newborn hearing in accordance with Part 69 of this Title.

(c) The hospital shall conduct expedited HIV testing of a newborn whose mother's HIV status is unknown at delivery in accordance with Section 69-1.3(l) of the Title;

(d) A professional staff person in attendance at a delivery shall ensure the proper identification of a newborn before it leaves the room where the delivery has occurred.

(1) The hospital shall ensure continuous identification of the newborn infant during the entire period of hospitalization including verification of identity after each separation and reunion of mother and newborn. In addition to the development and implementation of written policies and procedures for continuous identification, further policies and procedures shall set forth steps to be taken when the means of identification which has been placed on the newborn becomes separated from the newborn.

(2) Newborns born of different mothers shall not be present at the same time in the room where delivery/recovery takes place, unless each has previously been identified by the methods prescribed in this clause.

(e) Circumcision, which shall be an elective procedure, shall not be performed during the newborn stabilization period after birth.

(f) Postpartum care of mother. Appropriate nursing care shall be available to the mother during the period of recovery after delivery. At all times after delivery, the mother shall have maximum access to her baby unless such access is medically contraindicated and recorded in the appropriate medical record.

(1) The mother shall be transferred to the postpartum area only after her vital signs have stabilized. The hospital shall adopt and implement policies and procedures for identifying any postpartum complications that arise and informing the responsible practitioner who shall manage complications.

(2) Postpartum monitoring shall include the following:

(i) vital signs shall be recorded on a regular basis;

(ii) fluid intake and output shall be recorded. The uterine fundus shall be frequently examined to determine if it is well contracted and whether there is excessive bleeding;

(iii) the patient's practitioner shall be notified of any unusual findings;

(iv) nursing personnel qualified to recognize postpartum emergencies and problems shall be immediately available to the patient;

(v) the father or other support person shall be allowed to remain with the mother during the recovery period unless medically contraindicated or unless the nursing staff determines that the continued presence of the individual would interfere with the continuing care of the mother or other patients;

(vi) a physical assessment of the mother shall be conducted in accordance with established protocols; and

(vii) unless medically contraindicated or unacceptable to the mother, the newborn shall remain with the mother who shall provide a preferred source of body warmth for the newborn. During this period the newborn shall be closely observed for any abnormal signs and breastfeeding shall be encouraged.

(3) Education and orientation of the mother who is planning to raise the baby.

(i) The hospital shall provide instruction and assistance to each maternity patient who has chosen to breastfeed and shall provide information on the advantages of breastfeeding and possible impacts of not breastfeeding to women who are undecided as to the feeding method for their infants. At a minimum:

(a) the hospital shall designate at least one person who is thoroughly trained in breastfeeding physiology and management to be responsible for ensuring the implementation of an effective breastfeeding program. At all times, there should be available at least one staff member qualified to assist and encourage mothers with breastfeeding;

(b) written policies and procedures shall be developed, updated, implemented and disseminated annually to staff providing maternity or newborn care to assist and encourage the mother to breastfeed which shall include, but not be limited to:

(1) prohibition of the application of standing orders for anti-lactation drugs;

(2) placement of the newborn skin-to-skin for breastfeeding immediately following delivery, unless contraindicated;

(3) restriction of the newborn's supplemental feedings to those indicated by the medical condition of the newborn or of the mother;

(4) provision for the newborn to be fed on demand; and

(5) pacifiers or artificial nipples may be supplied by the hospital to breastfeeding infants to decrease pain during procedures, for specific medical reasons, or upon the specific request of the mother.  Before providing a pacifier or artificial nipple that has been requested by the mother, the hospital shall educate the mother on the possible impacts to the success of breastfeeding and discuss alternative methods for soothing her infant, and document such education;

(6) prohibition of the distribution of marketing materials, samples or gift packs that include breast milk substitutes, bottles, nipples, pacifiers, or coupons for any such items to pregnant women, mothers or their families;

(7) prohibition of the use of educational materials that refer to proprietary product(s) or bear product logo(s), unless specific to the mother’s or infant’s needs or condition; and

(8) prohibition of the distribution of any materials that contain messages that promote or advertise infant food or drinks other than breast milk.

(c) the hospital shall provide an education program as soon after admission as possible which shall include but not be limited to:

(1) the importance of scheduling follow-up care with a pediatric care provider within the timeframe following discharge as directed by the discharging pediatric care provider.

(2) the nutritional and physiological aspects of human milk;

(3) the normal process for establishing lactation, including care of breasts, common problems associated with breastfeeding and frequency of feeding;

(4) the potential impact of early use of pacifiers on the establishment of breastfeeding;

(5) dietary requirements for breastfeeding;

(6) diseases and medication or other substances which may have an effect on breastfeeding;

(7) sanitary procedures to follow in collecting and storing human milk;

(8) sources for advice and information available to the mother following discharge; and

(d) for mothers who have chosen formula feeding or for whom breastfeeding is medically contraindicated, hospitals shall provide individual training in formula preparation and feeding techniques.

(ii) The hospital shall provide to the mother instructions in caring for herself and her baby. Topics to be covered shall include but not be limited to: to self-care, nutrition, breast examination, exercise, infant care including taking temperature, feeding, bathing, diapering, infant growth and development and parent-infant relationships.

(iii) The hospital shall determine that the maternity patient can perform basic self-care and infant care techniques prior to discharge or make arrangements for post discharge instruction.

(iv) Each maternity patient shall be offered a program of instruction and counseling in family planning and, if requested by the patient, the hospital shall provide the patient with a list, compiled by the department and made available to the hospital, of providers offering the services requested.

(4) Visiting. The hospital shall develop and implement written policies and procedures regarding visiting that:

(i) do not unreasonably restrict fathers or other primary support person(s) from visitation to the mother during the recovery period;

(ii) promote family bonding by allowing regular visitation for the newborn's siblings in a manner consistent with safety and infection control; and

(iii) permit visitations by other family members and friends in a manner consistent with efficient hospital operation and acceptable standards of care.

(5) Discharge planning. The discharge of mother and newborn shall be performed in accordance with section 405.9 of this Part. In addition, prior to discharge, the hospital shall determine that:

(i) sources of nutrition for the infant and mother will be available and sufficient and if this is not confirmed, the attending practitioner and an appropriate social services agency shall be notified;

(ii) follow-up medical arrangements, consistent with current perinatal guidelines and recommendations, have been made for mother and newborn;

(iii) the mother has been informed of community services, including the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and shall make referrals to such community services as appropriate.

(iv) the mother has been instructed regarding normal postpartum events, care of breasts and perineum, care of the urinary bladder, amounts of activity allowed, diet, exercise, emotional response, family planning, resumption of coitus and signs of common complications;

(v) the mother has been advised on what to do if any complication or emergency arises;

(vi) the newborn has had a documented and complete physical examination and verification of a passage of stool and urine;

(vii) the means of identification of mother and newborn are matched. If the newborn is discharged in the care of someone other than the mother, the hospital shall ensure that the person or persons are entitled to the custody of the newborn; and

(viii) the newborn is stable; sucking and swallowing abilities are normal. Routine medical evaluation of the neonate's status at two to three days of age shall have been conducted or arranged.  Newborn screening shall be conducted at time of discharge, provided discharge is greater than 24 hours after the birth, or between the third and fifth day of life, whichever occurs first, in accordance with Part 69 of this Title.

(g) High-risk neonatal care. (1) Each hospital providing Level I, II or III perinatal services shall enter into a perinatal affiliation agreement with its designed RPC in accordance with Part 721 of this Title. Level I and II hospitals may also enter into transfer agreements in accordance with Part 721 with Level III hospitals.

(i) The perinatal affiliation agreements and transfer agreements shall include provisions for standardized risk assessment based on generally accepted standards of practice, stabilization and resuscitation of newborns as necessary, newborn screening in accordance with Part 69 of this Title, consultation, patient transport, transfer of maternal and newborn records and any other features needed to ensure prompt and efficient transport of newborns, that minimize risks and provide the newborn with needed services.

(ii) Unless medically contraindicated, mothers shall be permitted to accompany distressed newborns to receiving perinatal care facilities.

(iii) The perinatal affiliation agreements and transfer agreements shall provide for the return of the distressed newborn to the sending hospital when the condition has been stabilized and return is medically appropriate.

(iv) If transfer necessitates separating the mother and newborn, mothers who have chosen to breastfeed should be encouraged to maintain lactation and breast milk should be available to newborn.

(2) Placement in nurseries. (i) Healthy newborns shall be placed in a normal newborn nursery. If a newborn in a normal newborn nursery is removed temporarily from the perinatal service for any reason, the newborn may be returned to the normal newborn nursery only if infection control measures established by the hospital have been followed.

(ii) Newborns requiring specialized care shall be placed in a NICU and hospitals shall develop and implement protocols for all phases of treatment of such newborns. Newborns who are delivered in perinatal care services that are not capable of providing all necessary care and services shall be transferred to perinatal care services at hospitals that can meet the newborns' needs.

(h) Neonatal intensive care services. (1) Neonatal intensive care services shall be provided by Level II, Level III and RPC perinatal care hospitals.

(2) Decisions regarding the appropriate level of care and the need for transport of a neonate to a higher level of care shall be made consistent with generally accepted standards of care and the hospital's perinatal affiliation agreement.

(3) Treatment of severely ill, injured, or handicapped infants with life-threatening conditions.

(i) Severely ill, injured or handicapped infants exhibiting life-threatening conditions shall be transferred to and/or treated at RPCs or other hospitals having Level III perinatal care services after consultation with that service has established that the infant might benefit from such transfer.

(ii) Level III perinatal care services and RPCs shall consult with the hospital's bioethical review committee which shall assist the service and provide guidance to staff and families in the resolution of issues affecting the care, support and treatment of severely ill, injured, or handicapped infants with life-threatening conditions. The committee:

(a) shall consist of such members of the medical staff, nursing staff, social work staff and administration as designated by the governing body and such other community-based individuals with experience in bioethical matters as may be chosen by the governing body;

(b) shall operate in accordance with written policies and procedures developed by the hospital. Such policies shall establish the protocols for organization and functioning of the committee and scope of responsibility for specified cases as well as development of general review policies governing bioethical matters. The hospital shall:

(1) ensure that the parents are fully advised regarding the infant's condition, prognosis, options for treatment, likely outcomes of such treatment and options, if any, for the discontinuance of heroic life-maintenance efforts; and

(2) ensure that any decision by competent parents to continue life-sustaining efforts is implemented by the hospital; and

(c) shall, in conjunction with the attending physician(s), child protective services, the medical staff and the governing body, recommend that the hospital obtain an appropriate court order to undertake a course of treatment, in all cases when in the judgment of the committee:

(1) the parents do not have the capacity to make a decision; or

(2) the parents' decision on a course of action is manifestly against the infant's best interest.

Effective Date: 
Wednesday, November 13, 2019
Doc Status: 
Complete

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.

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

(1) Definitions.

(1) 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.

(2) 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.

(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 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 reagrdless 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.

Effective Date: 
Wednesday, September 10, 2014
Doc Status: 
Complete

Section 405.23 - Food and dietetic services

405.23 Food and dietetic services. The hospital shall have an organized dietary department that is directed and staffed by an adequate number of qualified personnel. The hospital shall ensure that each patient's dietary needs are considered and correlated with physician's orders and with the patient's overall health status and that quality nutritional care is provided to patients.

(a) General. (1) The hospital food and dietetic services, including cafeterias and snack bars, shall be operated in conformance with the sanitary requirments of Part 14 (Service Food Establishments) of Chapter I (State Sanitary Code) of this Title.

(2) Nutritional needs of patients shall be met in accordance with recognized dietary practices and in accordance with orders of the practitioner or practitioners responsible for the care of the patients.

(b) Organization. The department shall be directed on a full-time basis by an individual who, by education and specialized training or experience, is knowledgeable about food service management.

(1) The director shall be responsible to the chief executive officer or his/her designee for the daily management of the dietary services, including quality food production, service and staff supervision and management.

(2) The director shall ensure that:

(i) overall coordination and integration of the therapeutic and administrative aspects of dietetic services are maintained; and

(ii) the quality, safety and appropriateness of the dietetic department/service functions are monitored, evaluated and that appropriate actions based upon findings are taken.

(3) The director shall ensure that relevant orientation and inservice education programs are conducted for dietetic personnel and, as appropriate, for other hospital personnel that shall include, at a minimum, personal hygiene, safety and infection control requirements and proper methods of waste disposal.

(4) The director shall be responsible for the development and implementation of policies and procedures concerning the scope and conduct of dietetic services which include:

(i) nutritional care policies and procedures which are developed by a qualififed dietitian;

(ii) personal hygiene and health of dietetic personnel; and

(iii) infection control measures to minimize the possibility of contamination and transfer of infection.

(5) A dietitian, full-time, part-time or on a consultant basis shall supervise the nutritional aspects of patient care and assure that quality nutritional care is provided to patients.

(6) Dietetic services shall be provided by a sufficient number of administrative and technical personnel competent in their respective duties.

(c) Diets. There shall be a systematic record of diets and menus, consistent with the physician's orders which meet the needs of the patients.

(1) Therapeutic diets shall be prescribed by the practitioner or practitioners responsible for the care of the patients.

(2) A current therapeutic diet manual approved by the dietitian and medical staff shall be readily available to all medical, nursing and food services personnel.
 

Doc Status: 
Complete

Section 405.24 - Environmental health

405.24 Environmental health. The hospital shall be operated and maintained to ensure the safety of patients.

(a) Building and grounds. Facility grounds and physical plant shall be maintained in a manner to assure a safe and suitable environment for patients.

(1) Grounds and buildings shall be maintained in functional condition and to meet design intent, free of safety hazards, excessive noise, odors and environmental pollutants as may adversely affect the health or welfare of patients.

(2) There shall be facilities for emergency provision of adequate fuel and water supplies during any period in which the supply of fuel and/or water from usual sources temporarily becomes disrupted.

(b) Life safety from fire. (1) Buildings and equipment shall be so maintained as to prevent fire.

(2) The hospital shall have a written master fire plan that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and visitors; evacuation; and cooperation with firefighting authorities.

(3) Personnel shall be trained in procedures to be followed in emergencies, including but not limited to the use of firefighting equipment, evacuation of patients and personnel and all other duties in the master fire plan.

(4) Fire drills shall be conducted at irregular intervals at least 12 times per year covering all shifts.

(5) The hospital shall ensure the thorough investigation of all fires. A written report of the investigation shall be produced and shall remain on file for not less than six years.

(c) Engineering and maintenance. (1) Water supplies of medical facilities. All water used in operation shall be provided in conformance with Part 5 of the State Sanitary Code and section 702.1(a) of this Title.

(2) Preventive maintenance. A written preventive maintenance program shall be established and implemented to insure that all equipment and buildings are operative, safe, sanitary and maintained in good repair.

(i) Hospitals shall develop and adhere to schedules for testing, maintenance and calibration of all patient care and life safety equipment. Such maintenance schedules shall, at a minimum, be conducted in accordance with manufacturer's specifications.

(ii) Written reports documenting such tests, maintenance and calibration shall be retained on file for not less than three years after the date of such tests, maintenance or calibration.

(d) Waste. Hospitals shall develop and implement infectious waste management programs as required by the provisions of title XIII of article 13 of the Public Health Law.

(e) Housekeeping. (1) The entire facility, including but not limited to the floors, walls, windows, doors, ceilings, fixtures, equipment and furnishings, shall be kept clean and maintained in good repair.

(2) The facility shall be kept free of insects and rodents.

(3) All cleaning shall be done in a manner which will not spread dust or other particulate matter.

(4) Supplies and equipment for housekeeping functions shall be provided with cleaning compounds and hazardous substances properly labeled and stored.

(f) Linen and laundry. (1) Clean linen shall be provided to meet the requirements of patients.

(2) All linen shall be handled, stored, laundered and processed, and transported in a manner that will prevent infection and assure the maintenance of linen that is clean and in good repair. The hospital shall ensure that any use of inks or dyes contained aniline oil (aminobenzene) or oil of mirbane (nitrobenzene) or other benzene derivatives by such hospital, laundry or diaper service conforms to the requirements in section 12.10 of the State Sanitary Code.

(3) All linen, including blankets, shall be laundered between patient use.

(4) To prevent the spread of infection, all soiled linen shall be enclosed in containers within the patient care unit for transportation to the laundry.

(5) All linen from isolation rooms, infectious patients and the pathology service shall be enclosed in identifiable containers distinguishable from other laundry.

(g) Emergency and disaster preparedness. The hospital shall have a written plan, rehearsed and updated at least twice a year, with procedures to be followed for the proper care of patients and personnel, including but not limited to the reception and treatment of mass casualty victims, in the event of an internal or external emergency or disaster arising from the interruption of normal services resulting from earthquake, flood, bomb threat, chemical spills, strike, interruption of utility services, nuclear accidents and similar occurrences. Personnel responsible for the hospital's accommodation to extraordinary events shall be trained in all aspects of preparedness for any interruption of services and for any disaster.  This shall be in addition to the Surge and Flex Plan that is required pursuant to Part 360 of the Title.

(h) Animals. Animals, exclusive of those required for laboratory purposes shall only be allowed in a hospital in the following instances:

(1) service dogs or other service animals which have been individually trained to do work or perform tasks for the benefit of an individual with a disability when the presence of such animal will not pose a significant risk to the health or safety of others that cannot be eliminated by reasonable accommodation and is not medically contraindicated. However, if the safe operation of the hospital would be jeopardized, a service animal need not be allowed to enter. A finding by appropriate medical personnel at the hospital that the presence or use of a service animal would pose a significant health risk in certain designated areas of a hospital may serve as a basis for excluding service animals in those areas;

(2) when a hospital chooses to initiate and operate an organized animal visitation or animal-assisted therapy program that is jointly developed, approved and monitored by the hospital's quality assurance, risk management and infection control committees or designees. In each such approved program, the hospital must at a minimum ensure that:

(i) participating animals meet the qualifications set by the hospital including:

(a) certification of current vaccinations and being free of communicable diseases or infections;

(b) documentation of having training and temperament acceptable to the hospital;

(ii) each participating patient signs a patient consent form that includes an assessment of the risks and benefits of program participation;

(iii) hospital personnel and non-participating patients in proximity to the program are not negatively impacted by the presence of such animals;

(iv) the well-being of the participating animals is considered and maintained;

(v) patient and staff satisfaction is assessed, ensuring that participating patients and staff as well as a representative sample of non-participating patients and staff are routinely sampled for feedback; and

(vi) infection control protocols established for the program include a comparative assessment of infections for participating and non-participating patients.

(i) Central supply services. The hospital shall ensure the provision of central supply services for the preparation, storage, handling and distribution of sterile supplies and other patient care items. The hospital shall conform to current, acceptable standards of practice for central services.

(1) Central services shall be under the direction of an individual qualified by education, training and experience to supervise the personnel and functions of central services, and who shall be responsible to the chief executive officer either directly, or through a designated department head.

(2) Central services shall be evaluated as part of the hospital's ongoing quality assurance program.

(3) The functional design and workflow patterns in central services shall provide for the separation of soiled and contaminated supplies from those that are clean and sterile.

(4) There shall be written policies and procedures for the decontamination and sterilization activities performed in central services and elsewhere in the hospital, and for related requirements. These policies and procedures shall include, but not be limited to provisions for:

(i) the decontamination, cleaning, preparation and sterilization of patient care supplies and equipment;

(ii) the separation of soiled or contaminated supplies and equipment from clean and sterilized supplies and equipment;

(iii) the assembly, wrapping, storage, handling and distribution of sterile supplies and equipment in central services and all other areas of the hospital as applicable;

(iv) requirements for aeration of gas-sterilized items;

(v) maintaining and recording time and temperature for each sterilization cycle and aeration cycle, if any, with provisions for records to be kept at least one year;

(vi) the labeling of each sterilized item with the date sterilized, cycle and expiration date indicating the shelf life of the sterilized item if the hospital chooses to use time-related sterility criteria with established expiration dating of in-house reprocessed and sterilized supplies and equipment;

(vii) event-related sterility assurance if the hospital chooses to use such criteria for sterility assurance. Such sterility assurance shall:

(a) comply with generally accepted standards for sterility assurance such as those endorsed by the Association for the Advancement of Medical Instrumentation, the Joint Commission on the Accreditation of Healthcare Organizations or other such entities recognized as appropriate by the Commissioner;

(b) be based on the results of an evaluation of current hospital policies and procedures for handling sterile supplies;

(c) be reflected in the hospital's written policies which detail the process and responsibilities and which have been approved by the infection control officer and Infection Control Committee, if any;

(d) be addressed through inservice education of staff; and

(e) provide for quality assurance monitoring to evaluate effectiveness;

(viii) the use of chemical indicators with each cycle and weekly bacteriological spore monitoring for all sterilizers;

(ix) the rotation and reprocessing of sterile equipment and supplies; and

(x) the routine checking and removal of outdated or damaged sterile supplies and equipment or supplies or equipment which no longer meet the sterility standards of the event-related sterility assurance criteria and the recall of such supplies and equipment from all areas of the hospital.

(j) Injury control. The hospital shall:

(1) have a safety education program which shall include both orientation of new employees and continuing inservice training programs;

(2) develop and implement programs designed to eliminate safety hazards; and

(3) maintain, during any construction, alterations or repairs, a safe environment and safe access.

Effective Date: 
Thursday, August 6, 2020
Doc Status: 
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Section 405.25 - Organ and tissue donation (anatomical gifts)

405.25 Organ and tissue donation (anatomical gifts). (a) Definitions. For the purposes of this section, the following terms shall have the following meanings:

(1) designated requestor shall mean a person selected by the hospital to discharge the responsibilities of requesting the spouse, next of kin or guardian of the decedent to consent to an anatomical gift. The designated requestor shall be a trained hospital employee, or an employee of an organ procurement organization, eye bank or other tissue bank. Designated requestors, at a minimum, must complete a course, that meets the criteria set forth in subdivision (e), provided or approved by an organ procurement organization and designed in consultation with the eye bank or other tissue bank community, whichever is applicable, on how to approach potential donor families and request organ, eye or other tissue donation. The hospital administrator may select more than one designated requestor;

(2) suitability for organ, eye and other tissue donation shall mean that the organ procurement organization, eye bank or other tissue bank in consultation with the hospital, after appropriate medical screening (which may include serological testing if applicable) determines that the patient meets the medical criteria for donation.

(3) Organ procurement organization (OPO) shall mean an organization which is designated by the Secretary, U.S. Department of Health and Human Services, to perform or coordinate the performance of retrieving, preserving and transporting organs and to maintain a system of locating prospective recipients for available organs; and (4) tissue bank shall mean a tissue bank licensed under Part 52, which includes eye banks.

(b) The hospital shall assure that written policies and procedures are established, implemented and maintained for notifying an organ procurement organization and/or appropriate tissue banks, including eye banks, licensed pursuant to Part 52 when death of a patient has occurred or is imminent, designating the requestor(s) to approach the family, selecting eye bank(s) and other applicable tissue bank(s) for referrals, causing a timely request to be made by the designated requestor and monitoring the implementation of these functions. These policies and procedures shall be developed in consultation with organ procurement organizations and licensed eye banks and other tissue banks selected by the hospital. Written policies and procedures to be established shall include:

(1) protocol for notification of the organ procurement organization, eye bank or other tissue bank upon the death or imminent death of every patient, including provisions specifying that for ventilator patients declared brain dead, the organ procurement provider must be notified and able to determine suitability for donation prior to removal of such patients from the ventilator;

(2) procedures for seeking consent by the designated requestor so that requests are made only when the candidate meets the medical criteria for screening potential donors, and that no requests are made when conditions listed in subdivision (d)(1), (2) or (3) of this section are present;

(3) a procedure for documenting in the patient's medical record notification of the organ procurement organization, eye bank or other applicable tissue bank(s), and the results of such notification and requests for consent or absence of a request;

(4) an ongoing system for monitoring compliance with routine referral of potential donors including the outcomes of such referrals and any resulting requests. When a hospital contracts with an outside organization to review hospital policies, procedures, patient records and outcomes to assess compliance with this section, the contract shall be written and executed in accordance with section 400.4 of this Title and shall require the contractor to be held to the same standards of patient confidentiality as the hospital; and

(5) a method for hospitals to select at least one eye bank(s) and all applicable tissue bank(s) for the procurement of tissue and any policies and procedures the hospital has adopted concerning the rotation of referrals. (c)(1) Where a patient is a suitable candidate for organ, eye or other tissue donation and where the patient has not properly executed an organ donor card, or other authorization for organ, eye or other tissue donation, the designated requestor shall, in a timely manner at the time of death of a hospital patient, request the persons listed below, in the order of priority stated, to consent to the gift of all useful organs, tissues and/or other body parts of the decedent's body:

(i) the spouse;

(ii) a son or daughter eighteen years of age or older;

(iii) either parent;

(iv) a brother or sister eighteen years of age or older; or

(v) a guardian of the person of the decedent at the time of his/her death.

(2) Consent or refusal need only be obtained from any person in the highest priority class available when persons in prior classes have been sought with due diligence and are not available at the time of death. Any consent to an anatomical gift by a person designated in this subdivision shall be given by a document signed by him/her or given by his/her telegraphic, recorded telephonic or other recorded message. (3) A designated requestor may also request consent to an anatomical gift from any other person who is authorized or under the obligation to dispose of the body including, but not limited to, a person named in a decedent's will, a commissioner of a social services district, a coroner, a medical examiner, or a hospital administrator. (d) Anatomical donations shall not be requested when any one of the following conditions are present:

(1) actual notice of contrary intentions by the decedent; or

(2) actual notice of opposition by a member of the highest priority class available specified in paragraphs (c)(1), (i), (ii), (iii), (iv) and (v) above; or

(3) other reason to believe that an anatomical gift is contrary to the decedent's religious or moral beliefs. The medical record shall document the evidence that served as the basis for the "reason to believe".

(e) The designated requestor shall be selected by the hospital based on his/her ability to relate to families in a sensitive and caring manner and shall complete a course provided by a tissue bank and approved by the organ procurement organization, or provided by the organ procurement organization and designed in consultation with community eye bank or other tissue bank, whichever is applicable, to have demonstrated proficiency in the following areas:

(1) psychological and emotional considerations when dealing with bereaved families and particularly with individuals with diminished mental capacity;

(2) social, cultural, ethical and religious factors affecting attitudes toward organ donation;

(3) general medical concepts involved in organ and tissue transplantation and the use of organs and tissues in research and education;

(4) procedures for declaring death, and collecting and preserving organs, tissues and/or other body parts and how these procedures are most appropriately explained to the decedent's family;

(5) the cost implications to the family for organ and tissue donation, if any;

(6) the existing networks for the procurement of organs and the systems for allocating donated organs, tissues and other body parts to suitable recipients; and

(7) the routine referral law and the hospital's policies and procedures regarding requests for consent to anatomical gifts.
 

Effective Date: 
Wednesday, July 26, 2000
Doc Status: 
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Section 405.26 - Utilization review

405.26 Utilization review. (a) Hospitals shall comply with Federal regulations regarding utilization review. Such regulations shall include section 482.30 of the Code of Federal Regulations (42 CFR Part 482).

(b) All patients admitted to units having an operating certificate granted by the New York State Division of Alchoholism and Alcohol Abuse for the operation of an acute care alcoholism program or inpatient rehabilitation program shall be subject to the admission, continuation of stay, care plan, staffing, services and discharge requirements of applicable State regulations. Such regulations include requirements of 14 NYCRR Parts 374 and 381.
 

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Section 405.27 - Information, policy and other reporting requirements

405.27 Information, policy and other reporting requirements. (a) Hospitals shall comply with the requirements of section 400.18 of thisTitle regarding the provision to the commissioner of the following data and reports:

(1) uniform bill;

(2) uniform discharge abstract;

(3) data from hospital-based ambulatory surgery services;

(4) uniform financial report and uniform statistical reports; and (5) emergency service data.

(b) Access to and disclosure of data contained in the uniform bill, uniform discharge abstract, emergency service data and ambulatory surgery data abstract shall be governed by the provisions of section 400.18(e) of this Title.

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Section 405.28 - Social services

405.28 Social services. The hospital shall provide appropriate supportive services to meet the psychosocial needs of its patients. The services shall be oriented to assist patients and their families with personal and environmental difficulties which predispose to illness or interfere with obtaining maximum benefits from hospital care.

(a) Each patient shall be screened prior to or upon admission to determine the need for social services. All patients and families identified through such screening, and all patients and families subsequently identified as needing social services by medical, nursing or other clinical staff, shall be provided with the support they require.

(b) Social services shall be provided under the direction of 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), with the scope of practice defined in Article 154 of the Education Law.

(c) Personnel providing social services shall be qualified by training and experience to:

(1) recognize the psychosocial needs of patients and their families;

(2) evaluate crisis situations and disability resulting from emotional, social and economic stresses of illness;

(3) counsel patients and families to deal with the particular stresses affecting them;

(4) participate in hospital care planning and assist patients and families to understand, accept and follow medical and other professional recommendations to restore patients to optimum social and health adjustments; and

(5) arrange for specialized assistance from other sources within the hospital and from community resources for patients and families who need such assistance. Such arrangements shall include but not be limited to educational and tutorial services with the patient's school district in accordance with section 3202 (6) of the Education Law for inpatients between the ages of five and twenty-one who:

(i) are physically and mentally capable of benefitting from such services,

(ii) are expected to be hospitalized for a period of time sufficient to interrupt their normal educational program, and

(iii) if over age sixteen, are still enrolled in school.

(d) All hospitals except rural hospitals and hospitals outside an urban area shall have an organized social work department, which shall be directed by a qualified medical social worker. The department shall be integrated with other departments of the hospital, and shall participate in appropriate education, training and orientation programs for medical, nursing and other clinical staff, and for administrative personnel.

(e) The hospital shall implement, in conjunction with the quality assurance committee, a systematic process for the monitoring and evaluation of the quality and appropriateness of social services provided to patients and families and for the resolution of identified problems.

(f) The hospital shall develop and implement written policies and procedures relating to the long term care ombudsmen program as provided for in section 545 of the Executive Law and section 2803-c of the Public Health Law which provide the following:

(1) The hospital shall permit and not restrict or prohibit access to the hospital by duly designated ombudsmen who are performing their official duties on behalf of hospital inpatients who have been admitted from or who are awaiting readmission to, a residential health care facility licensed under Article 28 of the Public Health Law, or adult care facility licensed under section 461-b of the Social Services Law.

(2) The hospital and the hospital staff shall permit and not interfere with confidential visits and communications between such inpatients and such ombudsmen except in the case of in-person visits which are medically contraindicated. Such medical contraindication shall be documented for that patient by the attending practitioner in the patient's medical record.

(3) The hospital and the hospital staff shall not retaliate or take reprisals against any patient, employee or other person, who has filed a complaint with, or provided information to, such ombudsmen.
 

Effective Date: 
Tuesday, December 31, 2013
Doc Status: 
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Section 405.29 - Cardiac Services

405.29 Cardiac Services

(a) Definitions. For the purposes of this section, the following terms shall have the following meanings:

(1) Adult patient means a patient 18 years of age or older at the time of admission;

(2) Pediatric patient means a patient who has not reached their eighteenth birthday at the time of admission to the hospital;

(3) Cardiac Surgery Center means a general hospital that is approved through the certificate of need process to perform surgery on the heart and great vessels, and is approved for and provides cardiac diagnostic and interventional services including, but not limited to percutaneous coronary interventions (PCI) and diagnostic cardiac angiography procedures. Heart transplant procedures may only be performed at Cardiac Surgery Centers that are also approved as heart transplant centers in accordance with standards at Section 709.9 of this Title and approved for organ sharing by the United Network for Organ Sharing (UNOS). Cardiac Surgery Centers must operate in compliance with this Section, and must meet the construction provisions of Part 711 and Part 712 of this title. Cardiac Surgery Centers may be approved to serve adult patients (Adult Cardiac Surgery Centers) and or pediatric cardiac patients (Pediatric Cardiac Surgery Centers). However, separate certificate of need approvals are required for Adult and Pediatric Cardiac Surgery Centers in accordance with standards at Section 709.14 of this Title.

(4) Cardiac Catheterization Laboratory Center means a general hospital approved through the certificate of need process to perform catheter based procedures in specially equipped laboratories. Such laboratories are rooms with specialized radiological equipment and supplies used primarily to perform cardiac based angiographic or electrophysiological (EP) procedures on the heart or great vessels. Cardiac Catheterization Laboratory Centers may be approved to serve adult and or pediatric cardiac patients, but separate certificate of need approvals are required in accordance with standards at Section 709.14 of this Chapter for each service. Cardiac Catheterization Laboratory Centers must operate in compliance with standards set forth in this section. Cardiac Catheterization Laboratory Centers are further categorized by the procedures performed as defined below:

(i) A PCI capable cardiac catheterization laboratory center performs percutaneous coronary and other percutaneous procedures to diagnose and treat abnormalities of the heart or great vessels in adult patients. Such PCI capable cardiac catheterization laboratory centers may be approved with or without cardiac surgery at the same hospital site, however, those with no cardiac surgery on site must meet additional criteria at subparagraph (c)(8)(i) of this section;

(ii) A Diagnostic Cardiac Catheterization Service performs catheter based angiographic procedures on the heart or great vessels and is strictly limited to the diagnosis of abnormalities in adult patients. Such hospitals must maintain an affiliation with a Cardiac Surgery Center as specified in subparagraph 405.29(c)(8)(i) of this section, and are subject to annual review by DOH to determine the continuing operation of the center. Catheter based interventional procedures, such as percutaneous coronary intervention, are prohibited at Diagnostic Cardiac Catheterization Service hospitals;

(iii) A Cardiac EP Laboratory Program shall be located in a Cardiac Catheterization Laboratory Center and is approved through the certificate of need process to perform catheter based cardiac electrophysiology (EP) procedures. Such programs may be approved with or without cardiac surgery at the same hospital site, however, those with no cardiac surgery on site must meet additional criteria at paragraph 405.29(e)(5) of this section.

(iv) A Pediatric Cardiac Catheterization Laboratory Center shall be located at a Cardiac Surgery Center approved through the certificate of need process to provide cardiac surgery to pediatric patients and is approved to perform catheter based diagnostic and interventional procedures on pediatric patients; and

(5) Cardiac Reporting System is a New York State reporting system that gathers demographic, clinical, procedural and outcomes information from Cardiac Surgery Centers and Cardiac Catheterization Laboratory Centers on every patient who has undergone a surgical procedure or a percutaneous interventional procedure on the heart or great vessels. The Cardiac Reporting System includes separate reporting modules to capture procedure specific data elements for the procedure (cardiac surgery or percutaneous interventions) and age group (adult or pediatric) involved.

(b) State Cardiac Advisory Committee. There shall be a State Cardiac Advisory Committee consisting of physicians and other professionals with expertise in cardiac care appointed by the Commissioner of Health. The State Cardiac Advisory Committee shall, at the request of the Commissioner, consider any matter relating to Cardiac Services including, but not limited to review of existing and prospective services, and shall advise the Commissioner thereon.

(c) General Provisions.

(1) Cardiac Catheterization Laboratory Center services shall be limited to general hospitals.

(2) Hospitals shall not admit patients for cardiac surgery or cardiac catheterization laboratory procedures unless the hospital is approved to provide such services.

(3) Hospitals that provide cardiac surgery, Diagnostic Cardiac Catheterization Service, interventional cardiac laboratory services including percutaneous coronary intervention (PCI) and other percutaneous cardiac interventions, or cardiac electrophysiology (EP) must comply with subdivision 405.22 (a) of this Part.

(4) Review and Approval. Site visits to and or data and record reviews from existing and prospective new centers by the Department, members of the Cardiac Advisory Committee or other designees of the Commissioner shall be made as indicated, as an adjunct to initial approval and or for consideration of continued approval. Such site visits and reviews shall include, but not be limited to, evaluation of data, review of service specific quality of care, and compliance with minimum workload standards as set forth in this section.

(5) Closure.

(i) Failure to meet one or more statutory or regulatory requirements or inactivity in a program for a period of 6 months may result in actions to include: probationary status, withdrawal of approval as a Cardiac Surgery Center and or Cardiac Catheterization Laboratory Center.

(ii)Voluntary Closure. The hospital must give written notification, including a closure plan to the Department at least 60 days prior to planned discontinuance of Cardiac Surgery or Cardiac Catheterization Laboratory Center Services. No Cardiac Surgery Center and no Cardiac Catheterization Laboratory Center shall discontinue operation without first obtaining written approval from the Department.

(6) Notification of significant changes. A hospital must notify the Department of Health in writing within 7 days of any significant changes in its Cardiac Surgery Center or Cardiac Catheterization Laboratory Center services including, but not limited to, any temporary or permanent suspension of services; departure of or change in the physician program director; if the program is without a physician credentialed to perform one or more of the procedures or services of the Cardiac Surgery Center or Cardiac Catheterization Laboratory Center; or inability to meet workload requirements.

(7) Data collection and reporting. Data as deemed necessary by the Commissioner shall be maintained for cardiac patients treated by the hospital and submitted upon request to the Department of Health in a format specified by the Department. Such data shall include, but not be limited to data documenting appropriate case selection and or appropriate access to care and, Cardiac Reporting System data for Cardiac Surgery Centers and Cardiac Catheterization Laboratory Centers.

(8) Quality Assurance. There shall be an organized quality assurance program for cardiac surgery and cardiology that requires participation by all clinical members of the cardiac surgery team and or cardiac laboratory team and includes: monitoring of volume and outcomes; morbidity and all case mortality review; regular multidisciplinary conferences including all health professionals involved in the care of cardiac patients; medical/nursing audit; utilization review, pre hospital and post hospital care review, and a system that assesses pre-operative risk and evaluates outcome trends. Quality improvement efforts must recognize that patients move through multiple systems of care (EMS, Emergency Department, catheterization laboratory etc.) and optimum quality improvement efforts must include participation from as many systems as possible to address those issues at the juncture of systems of care.

(i) In addition, cardiac catheterization laboratory centers located in hospitals with no cardiac surgery on-site must enter into and comply with a fully executed written clinical sponsorship agreement with a New York State cardiac surgery center. The agreement will include provisions that address, at a minimum:

(a) cardiac surgery center representatives shall participate in the affiliated cardiac catheterization laboratory center hospital's quality assurance committee and other reviews of the quality of cardiac care provided by the affiliated cardiac catheterization laboratory center and in the provision of recommendations for quality improvement of cardiac services. Each cardiac surgery center and each affiliated cardiac catheterization laboratory center hospital shall take actions necessary, including but not limited to entering into a written agreement to authorize such participation by the cardiac surgery center representatives in the affiliated cardiac catheterization laboratory center hospital's quality assurance committee and for purposes of such participation, the cardiac surgery center representative or representatives shall be deemed members of the affiliated cardiac catheterization laboratory center hospital's quality assurance committee. Cardiac surgery center representatives may only access confidential patient information for 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 and other applicable confidentiality restrictions as provided by law. The cardiac surgery center representative(s) shall participate in the review of information and data for quality improvement purposes as described in the agreement which may include:

(1) statistical data and reports used in quality improvement activities;

(2) the affiliated cardiac catheterization laboratory center hospital's quality improvement program, policies, and procedures;

(3) care provided by medical, nursing, and other health care practitioners associated with the cardiac services;

(4) appropriateness and timeliness of patient referrals and of patients retained at the affiliated cardiac catheterization laboratory center hospital who met criteria for transfer to the cardiac surgery center hospital; and

(5) adverse events or occurrences including death and major complications for patients receiving cardiac care at the affiliated cardiac catheterization laboratory center hospital.

(b) joint cardiology/cardiac surgery conferences to be held at least quarterly, with a focus on continuous quality improvement to include review of: all cardiac laboratory related morbidity and mortality, review of a random selection of uncomplicated routine cases, patient selection, rates of normal outcomes for diagnostic studies performed, rates of studies needed to be repeated prior to intervention, quality of the studies conducted, rates of patients referred for and receiving interventional procedures subsequent to the diagnostic cardiac catheterization procedure, and the number and duration of cardiac catheterization laboratory system failures;

(c) a mechanism for a telemedicine link between the cardiac catheterization laboratory center and the cardiac surgery center that provides the capability for off-site review of digital studies, and a commitment on the part of each hospital to provide timely treatment consultation by appropriate physicians on an as needed basis;

(d) the cardiac surgery center's involvement in developing privileging criteria for physicians performing cardiac catheterization procedures at the hospital with no cardiac surgery on-site;

(e) development and ongoing review of patient selection criteria and review of implementation of those criteria. The process shall include a comprehensive review of the appropriateness of treatment for a random selection of cases;

(f) consultation on equipment, staffing, ancillary services, and policies and procedures for the provision of cardiac catheterization laboratory procedures;

(g) a pre-procedure risk stratification tool which ensures that high risk and or complex cases are treated at a cardiac surgery center;

(h) procedures to provide for appropriate patient transfers between facilities;

(i) an agreement to notify the department of any proposed changes to the initial agreement and to obtain department approval prior to the change;

(j) an agreement to jointly sponsor and conduct annual studies of the impact that the cardiac catheterization laboratory center service has on costs and access to cardiac services in the hospital's service area;

(k) a plan for how the proficiency of physicians, nurses and other staff at the affiliated cardiac catheterization laboratory center will be maintained through rotational or other training opportunities; and

(l) a plan for how the cardiac catheterization laboratory center will maintain the capacity to provide PCI services on a 24 hour a day, 365 days a year basis and be capable of assembling a dedicated team within 30 minutes of the activation call to provide coronary interventions 24 hours a day and 365 days each year.

(ii) The Department's Cardiac Surgery Center reviews, as specified at paragraph 405.29(c)(4), shall include review of the quality of the services the Cardiac Surgery Center has provided to each of the Cardiac Catheterization Laboratory Centers with which it has a written agreement as specified at subparagraph 405.29(c)(8)(i); and

(iii) Cardiac Surgery Centers with one or more affiliated Cardiac Catheterization Laboratory Centers shall provide professional education and training for physicians, nurses and other staff of the affiliated centers 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.

(9) The hospital must have written policies and procedures clearly delineating medical equipment vendor activities in the hospital including restrictions on vendor participation in clinical services.

(10) Cardiac Surgery Centers shall be approved to operate as PCI Capable Cardiac Catheterization Laboratory Centers without a separate certificate of need (CON) approval, but must operate in compliance with standards at 405.29 (e) (1) and 405.29 (e) (2) of this Title.

(11) Hospitals with approved cardiac catheterization laboratories approved prior to July 1, 2009 to perform PCI with no cardiac surgery on site shall be approved to operate as PCI Capable Cardiac Catheterization Laboratory Centers without a Certificate of Need approval but must operate in compliance with standards at 405.29(e)(1) and 405.29(e)(2) of this Title.

(12) Hospitals with approved cardiac catheterization laboratories approved prior to July 1, 2009 to perform cardiac electrophysiology procedures shall be approved to operate as Cardiac EP Laboratory Programs without a Certificate of Need approval but must operate in compliance with standards at 405.29(e)(1) and 405.29(e) (5) of this Title.

(d) Cardiac Surgery Center Criteria. The following criteria apply to Cardiac Surgery Centers approved to perform adult and or pediatric cardiac surgery. The cardiac surgery services must be provided in a manner which protects the health and safety of the patients in accordance with generally accepted standards of medical practice:

(1) Direction. The physician director is responsible for the overall quality of the cardiac surgical program and carries out this responsibility through the administrative structure of the institution, including but not limited to the governing body. The hospital must notify the Department of Health within 7 days of any change in the cardiac surgery program director, together with the name and curriculum vitae of the new director. The director shall be a qualified physician board certified in Thoracic Surgery or meet accepted equivalent training and experience.

(i) The Director shall:

(a) Continuously monitor the performance of all surgeons working in the cardiac surgical program, including each individual surgeon's annual case load and level of competence. The director shall advise the Chief of Service, Hospital Medical Director and Credentials Committee on requirements for credentialing and privileging within the cardiac surgery department and will provide assessments of compliance with standards of care, policies and guidelines as part of the credentialing and privileging process;

(b) In conjunction with the medical staff, monitor the quality and appropriateness of cardiac related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved; and

(c) Assure the timely and accurate reporting of the cardiac surgery component of Cardiac Reporting System data to the Department.

(2) Structure and Service Requirements. Hospitals providing cardiac surgery services shall be adequately staffed and equipped for cardiac diagnostic and therapeutic services including, but not limited to cardiac surgery, percutaneous coronary interventions (PCI) and diagnostic cardiac catheterization and, in addition, provide the following:

(i) For Adult Cardiac Surgery Centers:

(a) Cardiac Surgical intensive care, organized, staffed and available on a 24 hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required by adult cardiac surgery patients, and

(b) coronary care organized, staffed and available on a 24-hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required of complex cardiac conditions, and

(c) PCI Capable Cardiac Catheterization Laboratory Center services meeting standards at 405.29(e)(1) and 405.29(e)(2).

(ii) For Pediatric Cardiac Surgery Centers: age appropriate intensive care, organized, staffed and available on a 24-hour basis by clinical personnel trained and equipped to meet the needs of pediatric patients undergoing cardiac surgery, and Pediatric Cardiac Catheterization Laboratory Center services meeting standards at 405.29(e)(1) and 405.29(e)(4).

(iii) For all Cardiac Surgery Centers:

(a) Operating Rooms adequately staffed and equipped for the needs of the Cardiac surgery patient;

(b) Preoperative and post operative care areas to serve the needs of the surgery patient;

(c) A qualified cardiac surgeon must be immediately available for consultation. The surgeon must remain available (arrive on-site within 20 minutes of being called) after each cardiac surgery procedure. The surgeon must remain available until at least such time that the patient is evaluated on post operative day one and for a clinically appropriate period of time thereafter to handle cardiac surgery emergencies;

(d) The hospital must assure that a cardiac surgery team is immediately mobilized for handling cardiac surgery emergencies. In the event that a patient must return on an emergency basis to the operating room, appropriate resources shall be immediately available in order to have the patient in the operating room and the team ready within 20 minutes of an identified surgical emergency. There shall be written documentation of a triage protocol including identification of specific responsibilities;

(e) Non-invasive cardiac diagnostic equipment and capabilities;

(f) In addition, the hospital shall provide clinical support services in keeping with generally accepted standards. Such services shall be integrated and available on an inpatient basis, but there shall also be adequately and appropriately organized outpatient services to preclude unnecessary hospitalization and ensure continuity of care;

(g) Cardiac surgery conferences shall be held no less than 10 times per year at which the staff reviews the studies of a statistically significant number of cases. Records of these conferences indicating attendance, cases reviewed and decisions on patient management shall be maintained; and

(h) The hospital shall attempt to determine and document the status of the patient at 30 days post surgery for those who are no longer inpatient and throughout the hospital stay for those who are discharged from the cardiac surgery service to another service within the hospital. Status shall include living or deceased and other pertinent criteria as determined by the Commissioner.

(3) Staffing. All personnel shall be qualified for their responsibilities through appropriate training and educational programs.

(i) Physicians shall all be residency trained and board certified, or meet accepted equivalent training and experience for physicians in their respective specialty and shall be appropriately credentialed and privileged as part of the medical staff, and shall be available in sufficient numbers and on a 24 hour basis to meet the needs of the cardiac surgery patients. Such specialists shall, at a minimum include:

(a) Cardiothoracic surgeons in sufficient numbers to meet the ongoing needs of the patients, and each of whom performs a minimum of 50 cardiac surgeries per year. Review by the physician director shall be conducted and provided to the Chief of Service, Hospital Medical Director and Medical Staff

Credentials Committee for all physicians whose annual volume is below 50 cardiac surgeries to determine what actions are deemed necessary. In addition, for programs approved to perform pediatric cardiac surgery, cardiac surgeons with advanced training and or with significant experience in pediatric cardiac surgery to meet the needs of the pediatric patients;

(b) Anesthesiologist(s), who have acceptable minimum experience with cardiac surgical procedures;

(c) Specialists with expertise in critical care and the care of post cardiac surgery patients;

(d) Cardiologists to care for adults and, for programs approved to care for pediatric patients, pediatric cardiologists, with expertise in children's cardiovascular diseases, each of whom meet qualifications in accordance with generally accepted standards from recognized specialty organizations; and

(e) Complement of additional physicians shall be in keeping with generally accepted standards to meet the needs of cardiac surgery patients and shall include, but not be limited to practitioners, readily available for consultation in additional specialties, including hematology, pulmonology, neurology, nephrology and clinical pharmacology.

(ii) Nurses. Nursing personnel shall be certified in advanced cardiac life support (ACLS) or meet acceptable equivalent training and experience and shall include:

(a) A registered professional nurse, with 24-hour accountability, in charge of coordinating the care of post cardiac surgery patients and in charge of staffing levels for the unit;

(b) Registered professional nurses, licensed practical nurses and nursing assistants in such ratios that are commensurate with the type and amount of nursing needs of the patients.

(iii) Nurse Practitioners, Advanced Practice Nurses and or Registered Physician Assistants may be utilized when these specialists are appropriately credentialed and privileged on the medical staff.

(iv) The Cardiac Surgery Center shall have perfusionists who have special training and experience in an active program of open heart surgery, including a thorough background in sterile techniques, perfusion physiology, and the use of monitoring equipment and must demonstrate, through a formal review process, competencies in these areas. The operator may be a specially trained physician, nurse, or technician, at the discretion of the director of the center.

(v) The Cardiac Surgery Center shall have a data manager who has special training in the clinical criteria used in the cardiac surgery module of the Cardiac Reporting System as provided by the Department or its designee, is designated and authorized by the hospital and shall work in collaboration with the physician director to ensure accurate and timely reporting of Cardiac Reporting System data to the Department. In addition to the data manager, relevant medical and administrative staff must be trained in the use of the Cardiac Reporting System and the specific data element definitions involved.

(4) Patient Selection Criteria and Limitations. Criteria shall be adopted by the Cardiac Surgery Center to be used as indications of appropriate case selection. Such criteria shall be in keeping with generally accepted standards and, at a minimum, shall provide the following limitations:

(i) The hospital shall not perform heart transplantation unless the hospital is a Cardiac Surgery Center approved for heart transplantation and approved for organ sharing by UNOS;

(ii) The hospital shall not electively admit patients for implantable ventricular assist devices unless the hospital is a Cardiac Surgery Center approved for heart transplantation or has an agreement with at least one New York State heart transplantation center that provides for appropriate consultation and expertise for such cases;

(iii) The hospital shall not admit patients under the age of 18 for cardiac surgery unless the hospital is a Cardiac Surgery Center approved for pediatric cardiac surgery or unless the patient's diagnosis indicates a condition, such as acquired heart disease, that can be most appropriately treated in an adult program with pediatric trained personnel and pediatric consultative services. Such exceptions must be supported by written documentation of consultation with a pediatric cardiologist; and

(iv) Cardiac Surgery Centers approved to perform pediatric cardiac surgery that are not also approved as Adult Cardiac Surgery Centers shall not admit patients over the age of 18 for cardiac surgery unless the procedure will be performed to treat a congenital anomaly and the hospital can meet the additional clinical needs of the patient.

(5) Minimum workload standards. There shall be sufficient utilization of a Cardiac Surgery Center to insure both quality and economy of services, as determined by the Commissioner. An institution seeking to maintain approval shall present evidence that the annual minimum workload standards have been achieved and maintained. The following annual minimum workload standards must be achieved within two years following initiation of the service to ensure both quality and economy of services:

(i) Adult Cardiac Surgery Centers shall maintain an annual minimum of 100 procedures on adult patients; and

(ii) Pediatric Cardiac Surgery Centers shall maintain an annual minimum of 75 pediatric cardiac surgery procedures excluding the number of isolated Patent Ductus Arteriosus (PDA) repairs. The annual minimum volume shall be deemed to be met when two or more Pediatric Cardiac Surgery Centers, at least one of which must perform a minimum of 75 pediatric cardiac surgery procedures a year (excluding isolated PDA repairs), join in a coordinated program based on a fully executed written agreement, approved by the Commissioner, and the combined volume of the collaborating Pediatric Cardiac Surgery Centers (excluding the number of PDA repairs) is greater than 100 procedures a year. The agreement between the collaborating hospitals must include, at a minimum, information on: quality improvement, peer review and coordination of care of patients between the coordinated Pediatric Cardiac Surgery Centers. The agreement must specify that the Department will be provided 60 day prior written notice of any proposed change, termination or expiration of the agreement. Changes must be found acceptable to the Department prior to implementation and any proposed termination or expiration of the agreement will result in termination of the coordinated Pediatric Cardiac Surgery Center program.

(6) Waiver of minimum workload standards. The Commissioner may waive the workload requirements upon a satisfactory showing by a Cardiac Surgery Center as determined by the Commissioner upon seeking advice from Cardiac Advisory Committee representatives that the quality of care provided is adequate as supported, at a minimum, by a review of cases and outcome trends conducted by the Department, and:

(i) There are extenuating circumstances precluding compliance with the workload requirements; and or

(ii) There is documented evidence that need for cardiac surgery in the hospital's geographical service area would be substantially unmet if the program were closed.

(e) Cardiac Catheterization Laboratory Center Criteria

(1) The following criteria apply to all Cardiac Catheterization Laboratory Centers. Cardiac Catheterization Laboratory Center services must be provided in a manner which protects the health and safety of the patients in accordance with generally accepted standards of medical practice.

(i) Direction. The physician director is responsible for the overall quality of the Cardiac Catheterization Laboratory Center and must have the appropriate authority to carry out those responsibilities through the support of the Chief of Cardiology, the Medical Director of the hospital and the hospital administration. The hospital must notify the Department within 7 days of a change in the directorship of the Cardiac Catheterization Laboratory Center, together with the name and curriculum vitae of the new director;

(ii) Qualifications of the Director. The director must be Board certified in Internal Medicine and the subspecialty of Cardiac Disease or meet equivalent standards, be experienced in the performance of procedures specific to type of Cardiac Catheterization Laboratory Center services provided, have good management skills and must be appropriately credentialed and privileged as a member of the medical staff;

(iii) The Director shall:

(a) Continuously monitor the performance of all cardiologists working in the Cardiac Catheterization Laboratory Center, including but not limited to, each cardiologist's annual case load requirement and level of competence. The director shall advise the Chief of Service, the Hospital Medical Director and the Credentials Committee on requirements for credentialing and privileging in the Cardiac Catheterization Laboratory Center and shall provide assessments of compliance with standards of care, policies and guidelines as part of the credentialing and privileging process;

(b) In conjunction with the medical staff, monitor the quality and appropriateness of cardiac related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved; and

(c) For centers approved as PCI Capable Cardiac Catheterization Laboratory Centers, assurance of the timely and accurate reporting the Cardiac Catheterization Laboratory Center module of the Cardiac Reporting System data to the Department.

(iv) Structure and Service Requirements:

(a) All Cardiac Catheterization Laboratory Centers must provide diagnostic services, including but not limited to diagnostic radiology, clinical laboratory, and invasive and noninvasive cardiac diagnostic procedures. Such services shall be available on an inpatient and outpatient basis;

(b) All Cardiac Catheterization Laboratory Centers must have a process in place that allows for appropriate transfer of cases to a higher level of care to handle cardiac emergencies;

(c) Cardiac Catheterization Laboratory Centers approved to provide care to adult patients must provide Coronary Care organized, staffed and available on a 24-hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required of complex cardiac conditions;

(d) Cardiac Catheterization Laboratory Centers approved to perform pediatric procedures must provide age appropriate intensive care, organized, staffed and available on a 24-hour basis by clinical personnel trained and equipped to meet the needs of pediatric patients undergoing cardiac laboratory procedures;

(e) Cardiology conferences shall be held no less than 10 times per year at which the staff reviews the studies of a statistically significant number of cases. Records of these conferences indicating attendance, cases reviewed and decisions on patient management shall be maintained;

(f) Records of the disposition of the cases shall be maintained in compliance with standards set forth in section 405.10 of this Title;

(g) The number of patients referred annually for surgery and the center(s) to which they are referred shall be maintained and readily available upon request from the Department of Health;

(h) Statistics shall be kept on the number of normal invasive cardiac diagnostic studies performed, and written criteria shall be adopted and used for determining when a study is to be considered abnormal. Such criteria shall be in keeping with generally accepted standards of medical practice; and

(i) The hospital shall ensure high quality imaging and radiation protection for patients and personnel in accordance with Section 405.15 of this Title.

(j) In addition to standards at subparagraph (c)(8)(i) of this section, for cardiac catheterization laboratory centers approved under a clinical sponsorship agreement as set forth in section 709.14(d)(5) of this Title, the written and signed clinical sponsorship agreement between a cardiac surgery center and the cardiac catheterization laboratory center without cardiac surgery on site must be maintained and must specify that the department shall be provided 60 day prior written notification of any proposed change, termination or expiration of the agreement, any changes must be found acceptable to the department prior to implementation and any proposed termination or expiration shall require prior submission of a plan of closure to the department. The agreement shall provide for an integration of expertise and resources from the cardiac surgery center that would support a high quality program at the hospital without cardiac surgery on site, and shall delineate responsibilities of each institution. The agreement shall further provide that the parties agree that termination or expiration of the agreement shall result in closure of the co-operated cardiac catheterization laboratory center.

(v) Staffing. All personnel shall be qualified for their responsibilities through appropriate training and educational programs.

(a) Physicians shall all be board certified, or meet accepted equivalent training and experience for physicians in their respective specialty, and shall be appropriately credentialed and privileged as part of the medical staff. Such specialists shall, at a minimum, include a cardiologist and or pediatric cardiologist depending upon the age group(s) served; a cardiac angiographer whose basic medical training is in keeping with generally accepted standards;

(b) Nurses with appropriate education and training shall be regularly assigned to the center; and

(c) Additional healthcare personnel as needed, each of whom is qualified through appropriate training and education to serve the needs of Cardiac Catheterization Laboratory Center patients.

(vi) Patient Selection Criteria.

(a) The hospital shall not admit patients under the age of 18 for a cardiac laboratory procedure unless the hospital is an approved Pediatric Cardiac Catheterization Laboratory Center or unless the patient's diagnosis indicates a condition, such as acquired heart disease, that can be most appropriately treated in an adult program with pediatric trained personnel and pediatric consultative services, or except as provided in 405.29(e)(5)(iii)(c). Such exceptions must be supported by written documentation of consultation with a pediatric cardiologist;

(b) Pediatric Cardiac Catheterization Laboratory Centers that are not also approved as adult cardiac services programs shall not admit patients over the age of 18 for a cardiac laboratory procedure unless the procedure will be performed to diagnose or treat a congenital anomaly and the hospital can meet the additional needs of the patient;

(c) The hospital shall not admit adult patients for percutaneous coronary intervention or other percutaneous cardiac interventions unless it is an approved PCI Capable Cardiac Catheterization Laboratory Center; and

(d) The hospital shall not provide Cardiac EP Laboratory Program services unless it is an approved Cardiac Catheterization Laboratory Center with an approved Cardiac EP Laboratory Program.

(2) PCI Capable Cardiac Catheterization Laboratory Centers.

PCI Capable Cardiac Catheterization Laboratory Centers must meet the following standards:

(i) Structure and Service Requirements

a) PCI Capable Cardiac Catheterization Laboratory Centers must be appropriately staffed and equipped for diagnostic and therapeutic services including but not limited to diagnostic cardiac catheterization and percutaneous coronary and other percutaneous interventions;

b) PCI Capable Cardiac Catheterization Laboratory Centers must maintain capabilities to perform emergency percutaneous coronary interventions including, but not limited to percutaneous coronary intervention for the treatment of ST elevation Myocardial Infarction (STEMI) on a 24 hour a day, 365 days a year basis and must be capable of assembling a dedicated team within 30 minutes of the activation call to provide coronary interventions 24 hours a day and 365 days each year.

Exception to this standard shall be made only for temporary and extenuating circumstances and when:

(1) Local Emergency Medical Services have been notified and documentation is in place for triaging patients in need of emergency PCI , and

(2) The Department of Health has been provided with a specific description of the circumstances, documentation of the revised triage arrangements and a timeline for return to the 24 hour provision of services, and has approved the arrangement.

c) The hospital must insure that once an ambulance calls to indicate transport of an emergency cardiac patient, the PCI team is immediately mobilized;

d) The hospital must effectively and efficiently identify patients in need of an emergency percutaneous coronary intervention and must transfer those patients rapidly (within 30 minutes) from the Emergency Department to the cardiac laboratory; and

e) The hospital must have a system documented and in place to ensure effective and efficient identification and transfer of a patient from the cardiac laboratory to a cardiac surgical program either in the hospital or at another hospital.

(ii) Staffing.

(a) Physicians shall all be board certified, or meet accepted equivalent training and experience for physicians in their respective specialty and shall be appropriately credentialed and privileged as members of the medical staff and in sufficient numbers to meet the care needs of the patients;

(b) A minimum of three interventional cardiologists, at least one of whom dedicates the majority of his or her professional time at the facility, must be credentialed and privileged on the medical staff to perform percutaneous coronary interventions. Each interventional cardiologist shall maintain sufficient volume on-site to maintain familiarity with the laboratory and shall perform a minimum of 75 total percutaneous coronary intervention cases per year of which 11 are emergency percutaneous coronary intervention cases, and not all 75 minimum cases or 11 minimum emergency cases must be performed at one site. Review by the physician director shall be conducted and provided to the Chief of Service, Hospital Medical Director and Medical Staff Credentials Committee for all physicians whose volume falls below these minimum volumes to determine actions deemed necessary; and

(c) the PCI capable cardiac catheterization laboratory center shall have a data manager who has special training in the clinical criteria used in the PCI module of the cardiac reporting system as provided by the department or its designee, is designated and authorized by the hospital and shall work in collaboration with the physician director to ensure accurate and timely reporting of cardiac reporting system data to the department. In addition to the data manager, relevant medical and administrative staff must be trained in the use of the cardiac reporting system and the specific data element definitions involved. For PCI capable cardiac catheterization laboratory centers that have a co-operated parent cardiac surgery center, responsibilities related to the cardiac reporting system may be performed by the cardiac surgery center on behalf of the data manager of the PCI capable cardiac catheterization laboratory center as long as all data is delineated at the facility level.

(iii) patient selection criteria. PCI capable cardiac catheterization laboratory centers shall adopt criteria for appropriate coronary artery diagnostic and interventional procedures in accordance with generally accepted standards for cardiac patients. For centers with no cardiac surgery on site and not co-operated with a New York State cardiac surgery center, patient selection criteria shall be reviewed and approved annually by the affiliated sponsored cardiac surgery center in accordance with subparagraph (c)(8)(i) of this section.

(iv) minimum workload standards. Each PCI capable cardiac catheterization laboratory center must maintain a minimum volume of at least 36 emergency percutaneous coronary intervention cases per year.  For hospitals that are part of a co-operated article 28 network and multi-site facilities with more than one approved PCI capable cardiac catheterization laboratory center, and for PCI capable cardiac catheterization laboratory centers operating under a clinical sponsorship agreement pursuant to section 709.14(d)(5) of this Title, minimum volume standards for emergency PCI procedures are site specific and may not be combined for purposes of achieving minimum workload standards.

(a) PCI capable cardiac catheterization laboratory centers with an annual volume below 150 percutaneous coronary intervention cases a year for two consecutive calendar years, or a volume below 36 emergency percutaneous coronary intervention cases a year for two consecutive calendar years, must procure the services of an independent physician consultant, acceptable to the department, who shall conduct an annual review of the appropriateness and quality of the percutaneous coronary intervention cases performed at the facility and shall provide a copy of the findings directly to the department.  Findings will be used by the department to determine whether continued approval or withdrawal of approval best meets the needs of the patients in the planning area. 

(v) PCI Capable Cardiac Catheterization Laboratory Centers with no cardiac surgery on-site must enter into a formal relationship documented by a fully executed written agreement with a Cardiac Surgery Center meeting standards at 405.29 (c)(8)(i).

(3) Diagnostic cardiac catheterization services.  No additional diagnostic cardiac catheterization services shall be approved. Diagnostic cardiac catheterization services hospitals are not approved to perform percutaneous coronary intervention or cardiac surgery, are subject to annual reviews of volume, appropriateness of cases and other quality indicators for diagnostic cardiac catheterization, and must meet the following standards:

(i) Affiliation agreement. The hospital must enter into and maintain a fully executed written agreement with a Cardiac Surgery Center with demonstrated high volume and high quality interventional cardiac services (cardiac surgery and percutaneous coronary interventions). The agreement, must be approved by the Commissioner, and must provide, at a minimum, for the standards at 405.29(c)(8)(i).

(ii) Patient Selection Criteria. Written criteria shall be adopted by the Diagnostic Cardiac Catheterization Service hospital to be used as indications for coronary angiography and or other cardiac invasive diagnostic procedures and shall be available for review during site visits.

(iii) Minimum Workload Standards. There shall be sufficient utilization of a Diagnostic Cardiac Catheterization Service to ensure both quality and economy of services, as determined by the Commissioner. For hospitals that are part of an Article 28 network and for multi-site facilities with more than one approved Cardiac Catheterization Laboratory Center, minimum volume standards are site specific and may not be combined for purposes of achieving minimum workload standards. Any institution seeking to maintain approval shall present evidence that the annual minimum workload standards have been achieved and maintained. Diagnostic Cardiac Catheterization Services shall achieve and maintain an annual minimum volume of 200 angiographic diagnostic cardiac catheterization procedures within two years of initial approval. Such procedures include left and or right heart catheterization with or without the use of contrast visualization and with or without coronary arteriograms, and such procedures exclude:

(a) Placement of permanent or temporary pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD);

(b) Any floating type catheter;

(c) Bundle of His study;

(d) Balloon septostomy;

(e) Radionuclide study;

(f) Right heart catheterization without contrast visualization in adults;

(g) Placement of intra-aortic balloon pump, and

(h) Non-Coronary studies.

(iv) Waiver of Minimum Workload Standards. The Commissioner may temporarily waive the workload requirements upon a satisfactory showing by the hospital that the quality of care provided is adequate as supported, at a minimum, by a review conducted by the Department of cases, outcome trends and appropriateness of care, and that:

(a) there are extenuating circumstances temporarily precluding compliance with the workload requirements, and

(b) there is a documented unmet need in the center's geographical service area that cannot be met by existing PCI Capable Cardiac Catheterization Laboratory Center Laboratory Centers.

(4) Pediatric Cardiac Catheterization Laboratory Centers. In addition to the standards at paragraph 405.29(e)(1) of this subdivision, Pediatric Cardiac Catheterization Laboratory Centers must meet the following standards:

(i) Pediatric Cardiac Catheterization Laboratory Centers are limited to hospitals approved to perform pediatric cardiac surgery and that meet standards at 405.29(d) of this section; and

(ii) During any interventional pediatric cardiac catheterization procedure and for a clinically appropriate period of time following such a procedure, a qualified pediatric cardiac surgeon must be immediately available for consultation and available on-site within 30 minutes, when requested, to perform procedures as needed to meet the patient's needs.

(5) Cardiac EP Laboratory Programs. In addition to the standards at paragraph 405.29(e)(1) of this section, Cardiac EP Laboratory Programs must meet the following standards:

(i) Structure and Service Requirements.

(a) Cardiac electrophysiology laboratories must be adequately staffed and equipped for providing intracardiac electrophysiology procedures;

(b) An ultrasound (echocardiographic) machine must be readily available to the laboratory during all electrophysiology procedures;

(c) The Cardiac EP Laboratory Program must have written protocols utilized for addressing complications including tamponade; and

(d) Cardiac EP Laboratory Programs serving patients between the ages of 12 and 18 with adult cardiac surgery on site, but no pediatric cardiac surgery on site, must maintain pediatric trained personnel.

(ii) Staffing. Staffing for Cardiac EP Laboratory Programs shall include:

(a) Electrophysiologists, board certified or with separate equivalent training and experience each of whom shall maintain an average annual volume of 50 adult cardiac electrophysiology procedures based on review of two years of cases, or 20 pediatric cardiac electrophysiology procedures per year depending on the population served. Review by the physician director shall be conducted and provided to the Chief of Service, Hospital Medical Director and Medical Staff Credentials Committee for all physicians whose volume falls below these minimum workload standards to determine what actions are deemed necessary;

(b) Physicians, on staff and immediately available to the laboratory with the expertise to perform local exploration and diagnose and treat tamponade; and

(c) Registered Nurses specifically trained in electrophysiology.

(iii) Patient selection criteria.

(a) Written criteria shall be adopted to be used as indications and contraindications for cardiac electrophysiology procedures in accordance with generally accepted standards of medical care for cardiac patients.

(b) Not withstanding 405.29(e)(1)(vi)(a) of this section, a hospital with a Cardiac EP Laboratory Program and no cardiac surgery on-site shall not admit patients under the age of 18, patients in need of chronic lead extractions, patients being treated for ventricular tachycardia ablations, and patients being treated for atrial fibrillation ablations for Cardiac EP Laboratory Program services. Additional patient selection criteria for Cardiac EP Laboratory Programs with no cardiac surgery on-site shall be developed in collaboration with a Cardiac Surgery Center with an active Cardiac EP Laboratory Program and the agreed upon criteria shall be documented in writing.

(c) Notwithstanding 405.29(e)(1)(vi)(a) of this section, a hospital with a Cardiac EP Laboratory Program and with adult cardiac surgery on-site, but no Pediatric Cardiac Surgery on-site may perform cardiac electrophysiology procedures on patients between the age of 12 and 18 when the patient's diagnosis and condition can be most appropriately treated in an adult program and when pediatric trained personnel are available to meet the additional needs of the patient and when consultation with a pediatric cardiologist is documented in writing for each pediatric patient.

Effective Date: 
Wednesday, September 25, 2019
Doc Status: 
Complete

Section 405.30 - Organ and Vascularized Composite Allograft Transplant Services/Programs

405.30 Organ and Vascularized Composite Allograft Transplant Services/Programs.

(a)
Definitions.For purposes of this section the following shall have the following meanings:

(1)
Departmentshall meant the New York State Department of Health.

(2)
Living donoris an individual who donates an organ or a vascularized composite allograft while alive.

(3)
Organmeans a human kidney, heart, liver, lung, pancreas, uterus, stomach, intestine, and/or any other tissue requiring revascularization or immunosuppression in the recipient.

(4)
Organ procurement organization(OPO) means a facility or institution engaged in procuring organs and/or vascularized composite allografts for transplantation, or therapy purposes but does not include:

(i) facilities or institutions which permit procurement activities to be conducted on their premises by employees or agents of an approved organ procurement organization; or

(ii) facilities or consortia of facilities which conduct transplantation activities in accordance with article 28 of the public health law when the organ is procured through an approved organ procurement organization, or from a living donor.

(5)
Organ traffickingis the recruitment, transport, transfer, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation.

(6)
Patientmeans either the living donor or the recipient:

(i) Adult means a patient 18 years of age or older at the time of the transplant;

(ii) Pediatric patient means a patient who has not reached his or her eighteenth birthday at the time of the transplant.

(7)
Qualified mental health professionalshall mean a psychiatrist, psychologist, or qualified social worker assigned to evaluate the potential recipient and/ or living donor.

(8)
Qualified social workershall mean a person who is licensed and registered by the State Education Department to practice as a licensed master social worker (LMSW) or licensed clinical social worker (LCSW), within the scope of practice defined in Article 154 of the Education Law.

(9)
Recipientis an individual who receives transplanted organs, or a vascularized composite allograft.

(10)
Transplant centermeans a unit within a hospital that performs transplants, including but not limited to activities such as qualifying patients for transplant, registering patients on the national wait list, performing transplant surgery and providing care before and after transplant. A transplant center may include one or more transplant programs.

(11)
Transplant commercialismis a policy or practice in which an organ is treated as a commodity, including being bought, sold, or used for material gain.

(12)
Transplant programmeans the persons or entity that provides organ specific transplant services within a transplant center.

(13)
Transplant servicesmeans the provision of organ, living donor and or vascularized composite allograft transplants and other medical and surgical specialty services required for the care of transplant recipients and living donors.

(14)
Transplant tourismis travel for transplant that involves organ trafficking and/or transplant commercialism.

(15)
Travel for transplantis the movement of organs, vascularized composite allografts, donors, recipients, or transplant professionals who travel across national borders for transplant purposes.

(16)
Vascularized composite allograftmeans a contiguous segment of mixed allogeneic tissues whose relationships have been altered only at the segment boundaries and whose transplantation requires revascularization and/or immunosuppression in the recipient. Vascularized composite allografts include, but are not limited to, hand, face, and other such contiguous segments.

(b)
General requirements.Hospitals shall not admit patients for, or otherwise provide, transplantation services unless the hospital is specifically approved by the Department to provide transplant services. Transplant services for pediatric patients shall only be provided in a hospital approved by the Department to provide transplant services. Hospitals that provide pediatric transplant services must comply with subdivision (a) of Section 405.22 of this Part and must develop and adhere to written policies and procedures specific to pediatric patients.

In addition, the following standards apply to all transplant centers and programs:

(1) Transplant services, or any new Institutional Review Board (IRB) approved medical/surgical treatments which involve transplant medical/surgical care including but not limited to transplant immunology, shall be performed only in hospitals approved by the Department to perform such transplant services.

(2) The hospital shall be a member in good standing of the Organ and Procurement and Transplantation Network (OPTN) approved by the Secretary of the U.S. Department of Health and Human Services (HHS) and shall abide by its rules and requirements.

(3) When fully operational, to ensure quality of care, the hospital shall perform at least 10 liver transplants per year if it is to continue as an approved liver transplant program; or at least 10 human heart transplants per year if it is to continue as an approved heart transplant program; or at least 10 kidney transplants a year if it is to continue as an approved kidney transplant program; or at least 10 lung transplants per year if it is to continue as an approved lung transplant program. The Department will monitor outcomes for graft and patient survival.

(4) The hospital shall participate in a patient registry program with an organ procurement organization designated by the Secretary of the U. S. Department of Health and Human Services. Before arranging for the placement of the patient on the waiting list, each facility shall inform a patient awaiting transplantation of the prohibition against being placed on multiple facility waiting lists within New York State before arranging for the placement of the patient on the waiting list.

(5) Every hospital performing transplant services shall maintain written criteria for the selection of patients for such services which shall be consistent with professional standards of practice, applied consistently, and made available to the public.

(6) The hospital shall maintain a record of:

(i) all patients who are referred for transplantation and the date of their referral;

(ii) the results of the evaluation of all candidates for transplantation which documents the reasons a candidate is determined to be either suitable or unsuitable for transplantation;

(iii) the psychosocial evaluation;

(iv) the date a suitable candidate is selected for transplantation;

(v) the reasons for, and date of, any declination of a matching organ or vascularized composite allograft offered to a potential recipient;

(vi) the date the transplantation surgery occurred;

(vii) documentation of donor and recipient blood type;

(viii) the donor’s United Network for Organ Sharing (UNOS) identification number; and

(ix) the organs or vascularized composite allografts utilized;

(7) The hospital will ensure that appropriate informed consent is obtained from both the recipient and if applicable, the living donor. The process for obtaining such consent shall include the provision of information, at a minimum of the following:

(i) the evaluation process used to determine suitability for transplant;

(ii) the surgical procedure including the post-operative period;

(iii) the availability of alternative treatments;

(iv) organ donor risk factors that could affect the success of the graft or the health of the patient, including, but not limited to, the donor’s history, condition or age of the organs or vascularized composite allografts used, and the recipient’s potential risk of contracting the human immunodeficiency virus (HIV) and other infectious diseases if the disease cannot be detected in an infected donor;

(v) if applicable, providing adequate information to the recipient to ensure his or her understanding regarding the risks to the living donor;

(vi) potential medical and psychosocial risks;

(vii) the national and transplant center outcomes for recipients;

(viii) the patient’s right to refuse transplantation, or the donor’s right to refuse to be a donor; and

(ix) the effect that provision of transplant services provided in a facility not approved as a Medicare-approved transplant center could have on the recipient’s ability to have his or her immunosuppressive drugs paid for under Medicare Part B.

(8) For procedures involving a living donor, the hospital must obtain a written attestation from the living donor attesting that the donor has not received anything of value in exchange for the donation, aside from reimbursement for expenses associated with the donation to the extent allowed by New York State and federal law. The recipient must also attest in writing that he or she has not offered and is not aware of any offers of valuable consideration to the donor for their donation, except as allowed by New York State or federal law.

(9) The hospital must utilize an organized system for follow-up of patients after discharge, including maintenance of records on the long-term survival of persons who have received a transplant or who have made a living donation. Transplant centers must follow the health of each donor for at least two years post-donation.

(10) The hospital shall ensure that written procedures are maintained and implemented for the receipt, identification, and verification of all organs and vascularized composite allografts for transplantation.

(11) The hospital shall develop, maintain and implement written infection control policies and procedures specific to the transplant services, as an integral part of the hospital’s infection control program.

(12) The hospital shall ensure that the infection control program utilizes sufficient professional and laboratory resources to address transplant-related transmissible infections, including discovery, identification and management of complications from organisms associated with transplants whether commonly or uncommonly encountered.

(13) Each transplant center shall develop and implement a policy for a formalized process of communication with OPOs, the center’s clinical staff, the Department and as appropriate, local/city departments of health with regard to suspected and confirmed donor disease transmission. This policy shall include:

(i) identification of a patient safety contact, with coverage so that there is a person available on a 24 hour, 7 days a week, 365 days a year basis, to be the primary contact for possible disease transmission events;

(ii) a procedure to promptly contact the OPO that recovered the organ whenever a suspected disease transmission has occurred;

(iii) prompt communication and documentation when made aware of the suspected transmission;

(iv) identification of an infectious disease resource available to assist in the evaluation of a potential disease transmission; and

(v) the documentation of and notification to the transplant program director or his or her designee of the potential disease transmission, and the implementation of mechanisms to ensure that the information is acted upon in a timely manner.

(14) Every transplant center shall develop and implement a policy on travel for transplant including, transplant tourism, transplant commercialism and organ trafficking. Such policy may include:

(i) notice to all potential donors and recipients of the legal prohibitions against the sale of organs or vascularized composite allografts;

(ii) information about the medical risks of receiving an organ or vascularized composite allografts in a foreign country, in particular, the risk of infectious disease transmission to and from the recipient, the possible difficulties in obtaining recipient records related to the surgical procedure and post-operative treatment, and in cases of living donation the records regarding the donor’s social/ medical history.

(iii) notice that participation in transplant commercialism and or organ trafficking may violate the laws of the countries involved as well as international treaties or conventions;

(15) Transplant centers that provide liver transplant services must join and be a member in good standing of a recognized consortium organization providing quality assurance, peer review, data sharing, and best practices collaboration activities for liver transplant services. If such a consortium(s) exists for other transplant services, such as heart or kidney, transplant centers must join the appropriate organization relevant to the transplants it performs and be a member in good standing.

(16) Review. Facilities shall allow the Department, or its designee, to conduct site visits to and/or survey data and patient record reviews from existing and prospective new transplant centers.

(17) Closure.

(i) Failure to meet one or more statutory or regulatory requirements or inactivity in a program for a period of 12 months may result in actions up to and including withdrawal of approval as a transplant center.

(ii) Voluntary closure. The hospital must provide a closure plan and written notification of potential closure to the Department at least 60 days prior to planned discontinuance of transplant services. Such closure plan must address and provide a means of implementation with regard to, at minimum, the following: the means by which the program's patients (including those being evaluated for transplant, wait-listed patients, transplant recipients and living donors currently being treated by the program) will be provided with written notice of the planned closure and the means by which such persons may transfer to another transplant program; the means by which the Organ Procurement and Transplant Network, operated under contract with the U.S. Department of Health and Human Services by the United Network for Organ Sharing, the federal Centers for Medicare and Medicaid Services and the hospital’s transplant program's referral networks will be notified of the planned closure; and the means by which the program's patients (including those being evaluated for transplant, wait-listed patients, transplant recipients and living donors currently being treated by the program) will be assisted in transferring to another transplant program. No transplant service shall discontinue operation without prior written approval from the Department.

(18) Notification of significant changes. A hospital must notify the Department in writing within 7 days of any significant changes in its transplantation services including, but not limited to:

(a) any temporary or permanent suspension of services,

(b) departure of or change in the physician program director,

(c) unavailability of the transplant surgeon or physician of more than 15 days, if a program is without a physician credentialed to perform one or more of the procedures or services of the transplant service as a result of such unavailability, or

(d) inability to meet workload requirements.

(19) Data collection and reporting. Data and governmental and accrediting body reports shall be maintained for a period at least as long as that required for the retention of patient medical records under this Part, and made available to the Department upon request.

(c) Organization and staffing.

(1) The director of the transplant center, in addition to the requirements in paragraph (1) of subdivision (a) of section 405.22 of this Part, shall be a qualified specialist with previous experience and demonstrated competence in the transplant service. The director is responsible for planning, organizing, conducting, and directing the transplant center and must devote sufficient time to carry out these responsibilities including, but not limited to overseeing the transplant center's quality assurance and performance improvement (QAPI) program.

(2) Each transplant center shall have on-site a qualified transplant physician and another person who is a qualified transplant surgeon who may also fulfill the requirement as director of the service.

(3) The hospital shall provide a clinical transplant coordinator and sufficient staff to coordinate the activities of the transplant center, including patient follow-up after discharge. The clinical transplant coordinator shall be a physician, registered professional nurse, registered physician assistant, or nurse practitioner, licensed and currently registered or certified to practice in New York State.

(4) The hospital shall ensure that all staff members providing transplant services are prepared for their responsibilities through ongoing education, experience, demonstrated competence and completion of in-service education programs as needed.

(5) From admission to discharge, including post discharge follow-up, patient care evaluation, planning and management shall be performed by a multidisciplinary care team involved with the care of the patient; (which includes, at a minimum physicians, surgeons, nurses, qualified social workers, clinical transplant coordinators, nutritional services as needed and pharmacy as needed).

The patient and, as appropriate, the patient’s family shall be involved and have input into the patient’s care plan.

(6) The transplant center shall make available nutritional assessments and diet counseling services to all transplant recipients and donors.

(7) The transplant center shall make psychiatric and social services available, directly or via referrals, to patients to assist with psychosocial problems of the patients, as related to the donation. Such professionals shall be skilled in individual and family counseling, shall understand the entire donation and transplantation process, and be able to provide information on financial issues and community resources.

(d) Quality assessment and performance improvement (QAPI) programs.

(1) The transplant center must develop, implement and maintain a written, comprehensive, data driven QAPI program to monitor and evaluate performance of all transplantation services, including services provided under contract or arrangement;

(2) The transplant center’s QAPI program must use objective measures to evaluate the center’s performance with regard to transplantation activities and outcomes. Outcome measures may include, but are not limited to: patient and donor selection criteria, accuracy of the waiting list in accordance with the Organ Procurement Transplantation Network (OPTN) waiting list requirements, accuracy of donor and recipient matching, patient and donor management, techniques for organ and vascularized composite allograft recovery, consent practices, patient education, patient satisfaction, and patient rights;

(3) The transplant center must take actions that result in ongoing performance improvements and track performance to ensure that improvements are sustained;

(4) A transplant center must establish and implement written policies to identify, analyze, report, address and document adverse events that occur during any phase of an organ or vascularized composite allograft transplantation case, and utilize such efforts to prevent future adverse events.

(e) Organ and vascularized composite allograft acceptance criteria.

(1) In consultation with an organ procurement organization, the hospital shall develop and uniformly apply organ and vascularized composite allograft acceptance criteria and establish written policies and procedures to ensure the medical suitability of organs and vascularized composite allografts to be transplanted. Hospitals shall also develop and uniformly apply acceptance criteria for living donors. Such acceptance criteria shall be consistent with professional standards of practice, and shall ensure that the living donor is at least eighteen (18) years of age at the time of the initial living donor evaluation. Specific medical conditions of the donor shall be determined by the transplant surgeon through the donor’s medical history, appropriate clinical laboratory testing and other confirmation methods and must be documented in the recipient’s medical record. A parent may consent to a living donation to the parent's own child, regardless of the parent's age.

(2) Written organ and vascularized composite allograft acceptance criteria shall be:

(i) specific for each type of organ or vascularized composite allograft;

(ii) shall describe those medical conditions and circumstances which would make the potential donor ineligible; and

(iii) shall describe those medical conditions for which medical discretion may be exercised.

(3) The potential recipient will be fully informed of the risks and benefits of the particular solid organ or vascularized composite allograft.

Effective Date: 
Wednesday, September 10, 2014
Doc Status: 
Complete

Section 405.31 - Living donor transplantation services

405.31 Living donor transplantation services.

Hospitals performing living donor transplants shall comply with the requirements of this section, section 405.30 and with subdivision (a) of Section 405.22 of this Part. In addition, the following standards apply to all living donor transplant services:

(a) Definition.

(1) Donor advocateis a person or a team responsible for ensuring that the rights and interests of the living donor and the prospective living donor are protected.

(b) Donor advocate responsibilities.A donor advocate shall be established for any living donor transplantation program. The transplant program shall, as appropriate, consult with an ethicist, and a psychiatrist or other qualified mental health professional, as defined in Section 405.30 (a)(6) of this Part. The donor advocate’s primary responsibility is to support the donor, beginning with the donor evaluation process and continuing through donation, the postoperative period, and discharge, and to ensure that there are appropriate referrals for post discharge care. The advocate shall assist the donor in making informed decisions and balancing external/family pressures to donate. The advocate must evaluate the donor and make a recommendation concerning donor suitability and ensure that the needs of the donor are fulfilled promptly and in accordance with best medical practice. The advocate shall:

(1) Advocate for the interests and well-being of the donor;

(2) Explain the evaluation process, what to expect, what it means to be a donor;

(3) Verify that such living donor is at least 18 years of age at the time of such donor’s initial evaluation related to the transplant procedure or is a parent donating to his or her child;

(4) Ensure all decisions made by the donor are informed and not coerced by:

(i) evaluating whether there is monetary or property enrichment for the donor, and ensuring the donor signs an attestation as specified in Paragraph (4) of this subdivision;

(ii) evaluating whether there is overt coercion to donate by family or others;

(iii) assessing the donor’s intellectual and emotional capability of participating in a balanced discussion of potential risks and benefits;

(iv) providing information to the donor about the medical, psychosocial, and financial implications of the living donation for the potential donor and about the recipient’s options for deceased donation transplant, including risks and outcomes;

(v) ensuring the donor understands that he or she may decline to donate at any time prior to his or her surgery; and

(vi) if requested by the donor, assisting the donor in the preparation of a general, medically accurate statement of unsuitability for donation.

(5) consult with the surgical team regarding donor suitability before issuing a formal recommendation;

(6) transmit donor advocate findings in writing to the surgical team. The transmittal shall include the reasons for the donor advocate’s recommendation. The final determination of donor suitability rests with the attending surgeons of the surgical team;

(7) The potential donor will be advised of the donor advocate’s recommendation. At least one attending surgeon and the donor advocate shall make themselves available to the potential donor upon his or her request to discuss the donor advocate’s recommendation; and

(8) assure there is continuity of care during hospitalization and assure that there are appropriate referrals for post-discharge care.

(c) Donor Advocate requirements.

(1) Such donor advocate or, in the case of multiple members of a donor advocate team at least one member of such team, must not participate in the care of transplant recipients. The advocate’s interests shall be centered on the well-being of the living donor.

(2) The donor advocate shall not receive any direct or indirect benefit from recommending continuation of the donor’s participation.

(3) The status of the donor advocate at the transplant center may not be affected by recommending for or against donation.

(4) The donor advocate shall be medically sophisticated in transplantation and aware of relevant statistics such as center volume and outcome data, and be able to explain such information to the potential donor.

(5) The donor advocate shall have sufficient preparation in his or her role to recommend that a specific donor is or is not a candidate for living donation.

(6) The donor advocate shall have a comprehensive working knowledge of living donor transplantation.

(d) Education of the donor.

In order to ensure that the potential donor has the knowledge and capacity to exercise informed consent, the advocate shall do the following:

(1) consider the intellectual and emotional capacity of the potential donor to exercise legally and ethically adequate informed consent as described in subdivision (e) of this section;

(2) inform him or her orally and in writing about the risks and benefits of medical interventions;

(3) evaluate whether there is a thorough understanding of the elements of the decision;

(4) evaluate whether the potential donor’s decision is voluntary;

(5) inform the potential donor that the donor advocate may recommend against donation and that the advocate’s recommendation will be given significant consideration in the surgical team’s decision. The reasons for the advocate’s decision shall be explained to the donor; and

(6) advise the potential donor of the opportunity to discuss donation with others who have donated in the past and assist in making arrangements to do so, if requested by the donor.

(e)
Informed Consent.A person who gives consent to be a living donor shall be competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, fully informed of the risks, benefits and any alternative treatments available to the recipient, at least eighteen (18) years of age at the time of the donor’s initial evaluation related to the transplant procedure unless the person is a parent seeking to donate to their own child, and be likely to benefit in a way not involving the transfer of money or property in connection with the donation, other than reimbursement of donation-related expenses as allowed by law. The informed consent process must include:

(1) informed understanding:

(i) presentation of all information to the potential donor in a language or manner understandable to him or her, consistent with his or her education level;

(ii) The potential donor shall be given the opportunity and adequate time to assimilate the information provided, ask questions and have questions answered;

(iii) The donor shall identify the family and loved ones who shall be given the opportunity to discuss openly with the donor advocate and the surgical team their concerns in a safe and non-threatening environment; and

(iv) The potential donor shall be informed with regard to the need for postoperative, long-term follow-up and testing by the transplant center. The donor shall also be provided with information regarding the need and importance for long term follow-up and annual primary care.

(f)
Disclosure Requirements.

(1) The donation process shall be explained to the potential donor. This explanation shall address, at a minimum:

(i) donor evaluation procedure;

(ii) surgical procedure;

(iii) recuperative period:

(iv) short and long term follow-up care;

(v) alternative donation and transplant procedures;

(vi) potential psychological benefits and detriments to the donor;

(vii) transplant center and surgeon specific statistics of donor and recipient outcomes;

(viii) confidentiality of the donor’s information and decision;

(ix) donor’s ability to opt out at any point in the process up to the time of surgery; and

(x) information about how the transplant center will follow the health of the donor for at least 2 years post donation.

(2) The transplant team and the donor advocate shall disclose their institutional affiliations to the potential donor.

(g) Risks.Risks shall be fully explained to the potential donor. The explanation shall include:

(1) physical;

(i) potential for surgical complications including risk of donor death;

(ii) potential for organ failure and the need for transplantation,

(iii) potential for other medical complications including long-term complications;

(iv) scars;

(v) pain;

(vi) fatigue;

(vii) abdominal and/or bowel symptoms such as bloating and nausea;

(2) psychosocial

(i) potential for problems with body image;

(ii) possibility of recipient death;

(iii) possibility of recipient rejection and need for retransplantation;

(iv) possibility of recurrent disease in the recipient;

(v) possibility of adjustment disorder post-surgery;

(vi) possible impact on donor’s family;

(vii) possible impact on recipient’s family; and

(viii) potential impact of donation on the donor’s lifestyle.

(3) Financial.

(i) out of pocket expenses;

(ii) possible loss of employment;

(iii) potential impact on ability to obtain future employment;

(iv) potential for disability benefits and need for assistance completing relevant paperwork; and

(v) possible impact on ability to obtain health and life insurance.

(h)
Documentation.The entire disclosure and consent process, including the attestation required by paragraph (8) of subdivision (b) of section 405.30 of this title shall be documented in the donor’s medical record, which shall be maintained separate and distinct from the recipient’s medical record.

(i)
Primary Medical Evaluation.A medical evaluation of the potential donor shall be made by an appropriate medical physician. Appropriate laboratory and imaging studies shall be done. Additionally, the following shall also be assessed:

(1) compatibility of the potential donor to the recipient;

(2) general health of, and surgical risk for, the potential donor;

(3) co-morbidities and significant medical conditions that impact the potential donor’s suitability;

(4) the potential donor’s vulnerability to infection, blood loss, or delayed wound healing; and the potential donor’s personal and family medical history.

(j)
Psychosocial.

(1) A psychosocial evaluation of the potential donor shall be made by the qualified mental health professional, as defined in Section 405.30 (a) (6) of this Title. The evaluation shall include, but not be limited to: consideration of the donor’s current and past history of: any psychiatric illness, physical abuse, sexual abuse, alcohol abuse, and substance abuse.

(2) Social services shall be provided in accordance with Section 405.28 of this Part as well as any additional requirements established in this Part.

(k)
Recipient Criteria.The transplant center must establish written policies and procedures governing recipient eligibility for living donation. At a minimum, such policies and procedures shall:

(1) ensure the patient meets the center’s written eligibility criteria as specified in paragraph (5) of subdivision (b), and subdivision (e), of Section 405.30 of this Part;

(2) ensure the recipient has received information regarding specific risks and benefits, alternative treatments and expected outcome of the transplantation;

(3) establish conditions which require recipient exclusion; and

(4) ensure that the benefits to both the donor and the recipient outweigh the risks before any living transplant is performed.

(l)
Donor Management.

(1) The donor surgeon shall have the primary responsibility for the donor’s care and welfare throughout his or her hospital stay.

(i) The donor surgeon is responsible for making the final determination regarding a donor’s suitability after reviewing and considering the donor’s medical, psychological, and social history; the donor’s current medical, psychological and social status; the recommendation of the donor advocate, all consultative reports; and the standards set forth in this subdivision.

(ii) If the donor surgeon decides to proceed with a donation after receiving an adverse recommendation from the donor advocate, the surgeon shall document the reasons for doing so in the patient’s medical record.

(m)
Imaging Service Requirements.

Hospitals performing living donor transplantation shall have adequate imaging services and staff support appropriate to evaluate recipients and living donors. Radiologists with experience in interventional procedures (angiography) and ultrasound imaging studies in the living donor and recipient, must be available at all times including weekends and holidays. If there is an emergent complication requiring imaging services, these patients should be prioritized for access to such imaging services by the hospital.

(n)
Discharge Planning Requirements.

The hospital shall comply with the discharge planning requirements contained in Section 405.9 of this Part as well as the following:

(1) The donor advocate shall be available to the donor from pre-admission to post-discharge.

(2) A detailed, written discharge plan shall be developed, given to the donor and provided to all health care professionals involved in the donor’s care, including the donor’s primary care physician.

(3) This plan shall be reviewed with the donor by a health care professional such as a registered professional nurse, qualified social worker or transplant coordinator.

(4) The plan shall include, at a minimum, instructions on:

(i) activities;

(ii) diet;

(iii) medication for pain; and

(iv) wound care.

(5) The patient shall be provided with a 24-hour contact number that he/she can call with questions. The responder shall be available when needed and knowledgeable about living donation.

(6) Information shall include the name, address and telephone number of the surgeon and instructions for the follow-up visit.

(7) Instructions for family members or caregivers shall be provided.

(o)
Post-Discharge Requirements.

(1) Medical follow-up shall meet generally accepted standards for someone who has undergone a major transplant procedure. This follow-up shall include:

(i) postoperative visits with the donor’s surgeon(s);

(ii) follow-up coordinated with the donor’s primary care physician to assess wound healing and to monitor for signs/symptoms of infection;

(iii) laboratory studies as appropriate; and

(iv) a written summary of the donor’s condition, which shall be provided to the donor and his or her primary care physician upon the donor’s discharge from the hospital.

(2) The hospital shall provide or arrange for follow-up social/psychological supports directly related to the donation as needed, which may include measures such as:

(i) visits with a social worker familiar with organ transplantation issues;

(ii) visits with a psychologist or psychiatrist familiar with organ transplantation issues;

(iii) participation in a professionally run support group;

(iv) participation in a center sponsored computer donor listserve or bulletin board to share patient concerns; and

(v) invitation to a donor recognition event, such as an annual recognition ceremony or presentation of a donor medal.

(3) Donors shall be informed of the option to discuss financial/insurance concerns with the transplant center’s financial coordinator.

(4) Hospitals shall report to the department such information as the department shall require to assist the department in assessing the quality of care provided; determining routine or unusual complications or outcomes, and identifying potential improvements to donor education, screening, consent, preoperative, surgical and postoperative care and follow-up. Such information shall include, but not be limited to:

(i) donor demographics;

(ii) preoperative medical and psychosocial information;

(iii) surgical information and complications;

(iv) hospital staff training and experience;

(v) recipient outcome; and

(vi) immediate and long-term postoperative care, complications, and impact on quality of life.

(5) Hospitals shall track the donor and his or her condition for at least 2 years post donation in accordance with the provisions set forth in Section 405.30 (b) (9) of this Part.

(p)
Living Adult Donor to Adult Recipient Liver Transplantation Services.

(1) Surgical Team Requirements:

(i) At least two liver transplant attending surgeons with experience as established in subparagraph (v) of this paragraph shall participate in the surgery of the donor. These two surgeons shall be present for the critical parts of the surgery including the live parenchymal transection. They both shall be available and scrubbed if needed for complications, however, only one surgeon need be present for the remainder of the donor operation.

(ii) A third liver transplant attending surgeon shall be present in the recipient operating room. This surgeon must have experience in deceased liver transplantation.

(iii) All three surgeons shall be board certified or board admissible in general surgery or have foreign certification determined to be equivalent by the New York State Department of Health.

(iv) All three surgeons shall have demonstrated experience in liver transplant surgery.

(v) One of the two surgeons must demonstrate experience as the primary surgeon or first assistant in 20 major hepatic surgeries (to include living donor hepatectomies or major hepatic resections), 7 of which must have been live donor hepatectomies within the prior 5 year period. The other of the two surgeons must be either a liver transplant surgeon or hepatobiliary surgeon practicing at a transplant hospital and must have performed at least 20 major liver resections within the prior 5 year period. Both of the surgeons must be available during the donor hepatic resection.

(2) Anesthesia Requirements:

(i) There shall be two separate attending anesthesiologists; one each for the living adult liver transplantation donor and recipient operations. These anesthesiologists shall be present for the critical anesthetic and surgical portions of the procedures and immediately available at all other times. As one case is completed, either anesthesiologist may take responsibility for the ongoing case. The anesthesiologists shall have experience in liver transplant anesthesia and/or major hepatic resection surgery and/or cardiac surgery anesthesia;

(ii) There shall be two separate anesthesia teams in two operating rooms (one for the donor, one for the recipient); and

(iii) These teams shall each be directed by a separate attending anesthesiologist for the living donor and the recipient procedure. In addition to the attending anesthesiologist who shall be present as specified in subparagraph (i) of this paragraph, at least one member of the anesthesia team who is an anesthesiologist, chief resident, fellow (postgraduate year 3, 4, or 5), or qualified certified registered nurse anesthetist shall be present and responsible, under the direction of the attending anesthesiologist, for the evaluation and care of the patient through all phases of the procedure pertaining to the administration of, and recovery from, anesthesia. All team members shall have ongoing education and training in liver and/or cardiac surgery and have had anesthesia responsibility for major liver resections.

(3) Postoperative Care Requirements. Donors shall receive postoperative care consistent with the following:

(i) Day 0-1: Living adult liver donors shall receive intensive care (ICU or PACU) for at least 24 hours, at a minimum;

(ii) Day 2: If stable and cleared for transfer by the transplant team after the first 24 hour period, donors shall be cared for in a hospital unit that is dedicated to the care of transplant recipients or a hospital unit in which patients who undergo major hepatobiliary resectional surgery are cared for. Living liver donors may be cared for on another unit if a specific medical condition of the donor warrants such a transfer and the transfer is documented in the donor’s medical record;

(iii) The donor shall be evaluated at least daily by one of the qualified liver transplant attending physicians with documentation in the medical record;

(iv) The transplant team shall be responsible for the pain management of the donor. In institutions where a pain management team is available, the transplant team may delegate its responsibility to this team. However, there shall be a written protocol in place for assessment and management of donor pain;

(v) The patient care staff shall be familiar with the common complications associated with the donor and recipient operations and have appropriate monitoring in place to detect these problems should they arise; and

(vi) If there is an emergent complication requiring reoperation, these patients shall be prioritized by the hospital for access to the operating room by the institution.

(4) Minimum Medical Staffing Requirements.

(i) There shall be 24-hour, seven day-a-week continuous coverage of the transplant service by general surgery residents at the postgraduate year 2 level or higher, transplant fellows, nurse practitioners or physician assistants. Between the hours of 6 p.m. and 8 a.m. on weekdays and at all times on the weekends and holidays, the covering residents, fellows, nurse practitioners, or physician assistants should be dedicated to the transplant service and not covering other surgical or nonsurgical patients. An attending transplant surgeon shall be available immediately as a resource for the residents, fellows, nurse practitioners or physician assistants at all times.

(ii) Any patient with abnormal vital signs or unusual symptoms shall be evaluated immediately. Notification to the appropriate senior medical staff member (fellow, chief resident, attending) shall be made in accordance with written hospital policy and procedures and in no case no more than 30 minutes after abnormal vital signs or unusual symptoms were first observed.

(5) Nursing Minimum Staffing Requirements.

(i) Nursing staff shall have ongoing education and training in live donor liver transplantation nursing care (donor and recipient). This shall include education in the pain management issues particular to the donor. The registered professional nursing ratio shall be at least one registered professional nurse for every two patients (1:2) in the ICU/PACU level setting, increased as appropriate for the acuity level of the patients.

(ii) After the donor is transferred from the ICU/PACU, the registered professional nursing ratio shall be at least 1:4 on all shifts, increased as appropriate for the acuity level of the patients

(iii) The same registered professional nurse shall not take care of both the donor and the recipient.

(iv) The nursing service shall verify that the potential donor received appropriate pre-surgical information.

(v) The names and contact numbers of the transplant team shall be posted on all units receiving transplant donors.

Effective Date: 
Wednesday, September 10, 2014
Doc Status: 
Complete

Section 405.32 - Observation services

405.32 Observation services.

(a) General.

(1) Observation services are post-stabilization services appropriate for short-term treatments, assessment, and re-assessment of those patients for whom diagnosis and a determination concerning inpatient admission, discharge, or transfer can reasonably be expected within forty-eight hours.

(2) If observation services are provided, the services shall be provided in a manner which protects the health and safety of the patients in accordance with generally accepted standards of medical practice.

(3) Direct referral is defined as a patient referred to the hospital for observation services by a nursing home, hospital outpatient clinic, diagnostic and treatment center, private practice physician or appropriately licensed practitioner, without receiving emergency room or critical care services on the day observation care begins. The referring practitioner must be a licensed physician or appropriately licensed practitioner and must have conducted a physical assessment of the patient within the previous eight hours from the referral.

(4) Patients may be assigned to observation services only by order of a physician or appropriately licensed practitioner.

(5) Patients may be assigned to observation services only through the emergency department or by direct referral in accordance with hospital policies, procedures and bylaws, in conformance with applicable statutes and regulations.

(b) Organization and Notice.

(1) The medical staff shall develop and implement written policies and procedures, approved by the governing body, that are based on the clinical needs of the patient, that shall specify:

(i) the organizational structure for providing observation services, including the specification of authority and accountability of the services,

(ii) the proper clinical location for the care of a patient requiring observation services,

(iii) the appropriate medical and administrative oversight of observation services

(iv) clinical criteria for observation assignment and discharge,

(v) assignment of a physician, nurse practitioner, or physician assistant who will be responsible for the care of the patient and timely discharge from observation services, and

(vi) integration with related services and quality assurance activities of the hospital.

(2) The hospital, in conjunction with the discharge planning program of the hospital, shall establish and implement written criteria and guidelines specifying the circumstances, the actions to be taken, and the appropriate contact agencies and individuals to accomplish adequate discharge planning for persons in need of post observation treatment or services but not in need of inpatient hospital care.

(3) Patients in observation shall be cared for by staff appropriately trained and in sufficient numbers to meet the needs of the patients.

(4) Patients being assigned to the observation services, or the patient representative, shall be provided with an oral and written notice within twenty-four hours of such placement that the patient is not admitted to the hospital and is under observation status. The hospital shall make a good faith effort to obtain written acknowledgment of receipt of the notice by the patient or the patient representative, and if not obtained, document its good faith efforts to obtain such acknowledgment and the reason why the acknowledgment was not obtained. Such written notice shall include, but not be limited to the following information:

(i) a statement that observation status may affect the patient’s Medicare, Medicaid and/or private insurance coverage for the current hospital services, including medications and other pharmaceutical supplies, as well as coverage for any subsequent discharge to a skilled nursing facility or home and community based care; and

(ii) that the patient should contact his or her insurance plan to better understand the implications of being placed in observation status.

(c) Locations. Hospitals may provide observation services in the following locations:

(1) Inpatient beds;

(2) Distinct Observation Units; or

(3) In a hospital designated as a critical access hospital pursuant to Subpart F of Part 485 of Title 42 of the Code of Federal Regulations or a sole community hospital pursuant to section 412.92 of Title 42 of the Code of Federal Regulations, or any successor provisions, observation services may be provided in the emergency department.

(d) Distinct Observation Units.

(1) Physical Standards

(i) The observation unit shall comply with the applicable provisions of Parts 711 and 712-2 and section 712-2.4 of this Title for construction projects approved or completed after January 1, 2011, except that the unit need not be adjacent to the emergency department.

(ii) Observation unit beds shall not be counted within the state certified bed capacity of the hospital and shall be exempt from the public need provisions of Part 709 of this Title.

(iii) The observation unit shall be marked with a clear and conspicuous sign that states: “This is an observation unit for visits of up to 48 hours. Patients in this unit are not admitted for inpatient services.”

(2) Any hospital seeking to establish a distinct observation unit shall, not less than 90 days prior:

(i) if no construction, as defined in subdivision 5 of section 2801 of the Public Health Law, will be needed, no construction waivers are being requested, and no service will be eliminated, notify the Department in writing of the general location of the unit and the number of beds; and submit a certification from a licensed architect or engineer, in the form specified by the Department, that the space complies with the applicable provisions of Parts 711 and 712-2 and section 712-2.4 of this Title for construction projects approved or completed after January 1, 2011; or

(ii) if construction, as defined in subdivision 5 of section 2801 of the Public Health Law, will be needed, or construction waivers are being requested, or a service will be eliminated:

(a) submit a request for limited review under 710.1(c)(5) of this Title, provided that for purposes of Part 710, a construction project involving only the creation of an observation unit and the addition of observation unit beds shall not be subject to review under section 710.1(c)(2) or (3) of this Title, unless the total project cost exceeds $15 million or $6 million respectively; and

(b) comply with the applicable provisions of Parts 711 and 712-2 and section 712-2.4 of this Title for construction projects approved or completed after January 1, 2011.

(3) Any hospital operating an observation unit pursuant to a waiver granted by the Department shall be required to comply with the provisions of this subdivision within 12 months of its effective date.

Effective Date: 
Wednesday, November 4, 2015

Section 405.33 Screening mammography services

405.33 Screening mammography services

(a) Applicability. This section shall apply to any general hospital or extension clinic that is certified as a mammography facility pursuant to the Mammography Quality Standards Act (MQSA).

(b) Extended service hours.

Any general hospital or extension clinic certified as a mammography facility pursuant to the MQSA shall provide extended hours, i.e. in the early morning, evening, or weekend hours, for screening mammography services. Extended hours for screening mammography services shall be provided on at least two days each week, for at least two hours each day offered, for a total of at least four hours each week, including but not limited to the following times:

(1) Monday through Friday, between the hours of 7:00 a.m. and 9:00 a.m.;

(2) Monday through Friday, between the hours of 5:00 p.m. and 7:00 p.m.; or

(3) Saturday or Sunday, between the hours of 9:00 a.m. and 5:00 p.m.

(c) Waiver.

(1) A facility may submit an application for a waiver from the requirements of this section, in whole or in part, if it can demonstrate, to the Department’s satisfaction, that the facility:

(i) does not have sufficient staff to provide extended hours for screening mammography services in accordance with this section, and that it is making diligent efforts to obtain staffing such that it can provide extended hours;

(ii) is in the process of discontinuing screening mammography services, as part of a consolidation or similar change; or

(iii) is subject to such other hardships as the Department deems appropriate.

(2) The Department may deny, grant or extend a waiver for 90 days, or more if the Department determines appropriate, in its sole discretion.
 

Effective Date: 
Wednesday, May 18, 2016
Statutory Authority: 
Public Health Law, Sections 2800 and 2803

Section 405.34 Stroke services

Section 405.34 Stroke services.

(a) Definitions. The following terms when used in this section shall have the following meanings:

(1) “Stroke patient” means a patient exhibiting the signs and symptoms of a suspected stroke.

(2) “Certifying organization” means an accrediting organization approved by The Centers for Medicare and Medicaid Services (CMS), that has applied to the Department and has been approved by the Department to certify that a hospital meets the criteria to provide advanced stroke care.

(3) “Certified stroke center” means a general hospital that has successfully completed a stroke center certification with a certifying organization.

(4) “Designated stroke center” means a certified stroke center approved by the Department to operate as a designated stroke center under this section.

(b) General Provisions.

(1) General hospitals may choose to participate in the designated stroke center program under this section.

(2) Only a certified stroke center may apply for stroke center designation from the Department.

(3) No hospital shall hold itself out to the public as having a stroke center designation unless it has a stroke center designation under this section.

(c) Certifying Organization Application. Accrediting organizations may apply, in a format determined by the Department, to be approved as certifying organizations. Upon review of the application, the Department may approve certifying organizations to perform stroke center certification.  

(d) Stroke Center Designation. Hospitals seeking stroke center designation shall:

(1) Obtain and maintain continuous stroke center certification from a certifying organization. The Department may participate in any onsite visits conducted by the certifying organization during certification and recertification.

(2) Submit an application to the Department with a copy of the certifying organization’s certification and supporting documents. When determining whether to approve a certified stroke center as a designated stroke center, the Department may take other criteria into consideration, including but not limited to investigations by federal or state oversight agencies.

(e) Issuing Authority. The Department shall make the final determination on all applications for stroke center designation. The Department shall provide written notification to a hospital when an application for a stroke center designation is approved. If an application for stroke center designation is denied, the Department shall provide written notification and a rationale for the denial, and shall allow additional opportunities for the hospital to apply for a stroke center designation.

(f) Withdrawal of Stroke Center Designation.

(1) The Department may withdraw a hospital’s stroke center designation upon notice to a designated stroke center if:

(i) The designated stroke center does not comply with state or federal regulations relating to stroke centers.

(ii) The designated stroke center fails to comply with its certifying organization’s certification requirements and certification lapses.

(iii) The designated stroke center requests withdrawal of stroke center designation.

(2) Before withdrawing a stroke center designation pursuant to subdivision (f)(1)(i) or (ii) of this section, the Department shall provide the designated stroke center with a written notice containing a statement of deficiencies. If the designated stroke center fails to adopt a plan of correction acceptable to the Department within thirty (30) days, the Department may withdraw the hospital’s stroke center designation.

(3) If a hospital no longer maintains stroke center designation, the hospital shall immediately notify affected parties and provide the Department with a written plan describing specific measures it has taken to alter its arrangements and protocols under subdivision (i) of this section within thirty (30) days of a withdrawal of stroke center designation.

(g) Transition Period.

(1) Hospitals designated as stroke centers by the Department prior to the effective date of this section shall have two years from the effective date of this section to initiate the stroke center certification process with a certifying organization approved by the Department. The process is initiated when a hospital enters into a contractual agreement with a certifying organization. Once the hospital has entered into a contractual agreement with a certifying organization, the hospital shall have one year to complete the certification process.

(2) Any hospital that does not initiate the stroke center certification process with a certifying organization within two years of the effective date of this section shall no longer maintain a stroke center designation and may no longer hold themselves out as a designated stroke center.

(h) Coordination Agreement. Designated stroke centers shall communicate and coordinate with one another to ensure appropriate access to care for stroke patients, in accordance with a written coordination agreement. The Department may issue guidance to specify the provisions of coordination agreements. Designated stroke centers shall have policies and procedures in place for timely transfer and receipt of stroke patients to and from other hospitals consistent with section 405.19 of this Part. Transport of stroke patients to the appropriate receiving hospital shall be in accordance with State Emergency Medical Advisory Committee (SEMAC) approved EMS protocols developed and adopted pursuant to subdivision two of section 3002-a of the Public Health Law.

(i) Emergency Medical Services Providers; Assessment and Transportation of Stroke Patients to Designated Stroke Centers. Designated stroke centers shall work with Emergency Medical Services agencies to ensure that stroke center destination protocols are consistent with protocols adopted by the State Emergency Medical Advisory Committee, the State Emergency Medical Services Council (SEMSCO), the Regional Emergency Medical Advisory Committee (REMAC), and the Regional Emergency Medical Services Council (REMSCO).

(j) The Department shall maintain and post on its public web page a list of designated stroke centers. The Department shall notify the State EMS advisory bodies and EMS regions via established communication networks whenever there is a change to a hospital stroke center designation, including but not limited to a new designation or a withdrawal of designation.

(k) Reporting of Data and Quality of Care Initiatives.

(1) Each designated stroke center shall submit data, as requested by the Department, that shall be sufficient to determine the performance of the hospital and the system of care on at least an annual basis and in a format determined by the Department.

(2) The Department shall define the data elements to be reported.

(3) Each designated stroke center shall conduct stroke quality improvement activities including, but not limited to:

(i) evaluation of the quality and appropriateness of care provided;

(ii) participation in regional and statewide quality improvement activities, including but not limited to activities conducted by the Regional Emergency Medical Advisory Committee, consistent with section 3006 of the Public Health Law;

(iii) analysis of data to identify opportunities for improvement; and

(iv) integration of these activities with the hospital’s quality assurance program, as required by section 405.6 of this Part.

 

 

Effective Date: 
Wednesday, March 20, 2019
Statutory Authority: 
Public Health Law, Section 2803

Section 405.35 - 405.42 Reserved

Effective Date: 
Wednesday, March 20, 2019

Section 405.43 REPEALED

Effective Date: 
Wednesday, March 26, 2014

Section 405.44 - Validity

405.44 Validity. If any clause, sentence, paragraph or section of this Part shall be adjudged by any court or 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

Section 405.45 - Trauma Centers

405.45 Trauma Centers

(a) Definitions.   The following terms when used in this section shall have the following meanings:

(1) “Trauma patient” means a patient at high risk of death or disability from multiple and severe injuries.

(2) “Trauma care” means health care provided to a trauma patient.

(3) “Level I trauma center” means a facility verified by the American College of Surgeons Committee on Trauma (ACS-COT), or other entity determined by the Department, and designated by the Department as a facility that is capable of providing the full range of services required of trauma patients; conducts trauma research; and provides training to surgical residents that comports with the ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014). The standards set forth in the ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014) are hereby incorporated by reference with the same force and effect as if fully set forth herein.  A copy of Resources for Optimal Care of the Injured Patient (2014) is available for inspection and copying at the Regulatory Affairs Unit, New York State Department of Health, Corning Tower, Empire State Plaza, Albany, New York 12237.  Copies are also available from the American College of Surgeons Committee on Trauma, 633 North Saint Clair Street, Chicago, Illinois 60611.  A Level I trauma center shall have a transfer agreement with at least one pediatric trauma center for trauma patients whose needs exceed the clinical capabilities of the facility.

(4) “Level II trauma center” means a facility verified by the ACS-COT, or other entity determined by the Department, and designated by the Department as a facility that is capable of providing comprehensive trauma care. A Level II trauma center shall have a transfer agreement with at least one Level I trauma center and, unless otherwise designated, at least one pediatric trauma center for trauma patients whose needs exceed the clinical capabilities of the facility.

(5) “Level III trauma center” means a facility verified by the ACS-COT, or other entity determined by the Department, and designated by the Department to serve communities that do not have immediate access to a Level I or II trauma center that is capable of providing prompt assessment, resuscitation, emergency operations and stabilization of trauma patients. A Level III trauma center shall have a transfer agreement with at least one Level I or Level II trauma center, whichever is the most appropriate trauma center, and at least one pediatric trauma center for trauma patients whose needs exceed the clinical capabilities of the facility.

(6) “Level IV trauma center” means a facility located in a rural area verified by the ACS-COT, or other entity determined by the Department, and designated by the Department as a facility that is capable of providing initial evaluation and stabilization of trauma patients prior to transfer to a higher level trauma center. A Level IV trauma center shall have a transfer agreement with at least one Level I, Level II, or Level III trauma center, whichever is the most appropriate trauma center, and at least one pediatric trauma center for trauma patients whose needs exceed the clinical capabilities of the facility.

(7) “Pediatric trauma center” means a facility verified by the ACS-COT, or other entity determined by the Department, and designated by the Department as a Level I or Level II trauma center and as a facility that is capable of providing comprehensive pediatric trauma care to pediatric trauma patients. A pediatric trauma center shall have a transfer agreement with at least one Level I or Level II trauma center, whichever is the most appropriate trauma center.

(8) “Region” means a defined geographic area of the state where a regional trauma advisory committee has been established pursuant to PHL § 3065.

(9) “Regional Trauma Center” means a Level I or Level II trauma center selected by the Department to coordinate regional trauma performance improvement activities in its region.  The Regional Trauma Center will be selected from facilities in a region that have been successfully verified by ACS-COT, or other entity determined by the Department, and designated as a trauma center by the Department, with a history of leadership and commitment to the region.

(10) “Transfer agreement” means a written and fully executed agreement between a hospital that has limited capability to receive and treat trauma patients in need of specialized emergency care and a designated trauma center that is capable of providing such care, for the transfer of such patients, that is consistent with the criteria, policies and procedures set forth in the hospitals’ trauma affiliation agreement with the Regional Trauma Center.

(11) “Trauma affiliation agreement” means a written and fully executed agreement between the Regional Trauma Center and each of the Level I, Level II, Level III, and Level IV trauma centers and non-designated hospitals in the Regional Trauma Center’s region.  A trauma affiliation agreement shall include provisions for:

 (i) criteria, policies and procedures for the transfer of trauma patients to trauma centers and between levels of trauma center;

(ii) participation in the New York State Trauma Registry including the maintenance of confidentiality and protection of all data provided to the Registry;

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

(iv) authority for a representative or representatives of the Regional Trauma Center to participate in and receive information from the affiliate hospital’s quality assurance committee, participate in other reviews of the quality of trauma care provided by the affiliate, and provide recommendations for quality improvement of trauma care.  

(b) General Provisions.

(1) The Department may designate a hospital as a designated trauma center if the hospital demonstrates that it has met the requirements of section 3066 of the Public Health Law and this Part, to the Department’s satisfaction.

(2) Only those hospitals designated as trauma centers by the Department shall admit and provide trauma care to trauma patients; provided, however, that if the existing designated trauma centers have exceeded their capacity during a state-declared disaster or an emergency surge, an undesignated hospital, upon approval by the commissioner, may temporarily provide trauma care. 

(3) Any hospital not designated as a trauma center that receives a trauma patient shall transfer such patient to the most appropriate trauma center pursuant to a transfer agreement as required under section 405.19 of this Part. Trauma centers shall be consulted prior to transfer. Trauma patients requiring trauma care shall be transported to the most appropriate trauma centers in accordance with State Emergency Medical Advisory Committee (SEMAC) approved Emergency Medical Services (EMS) protocols developed and adopted pursuant to subdivision two of section 3002-a of the Public Health Law.

(4) No hospital shall state that it has trauma center status unless so designated by the Department. 

(c) Trauma Center Designation

(1) A hospital seeking designation as a trauma center must receive verification by the American College of Surgeons, Committee on Trauma (ACS-COT), or other entity determined by the Department. To receive verification, the hospital must undergo a consultation site visit and verification site visit by the ACS-COT, or other entity determined by the Department. During the verification site visit, the hospital must exhibit that it is capable of providing Level I, Level II, Level III, Level IV or pediatric trauma care in accordance with the trauma care standards set forth in ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014).

(i) Consultation site visits.

A hospital seeking designation as a trauma center shall request a consultation site visit by the ACS-COT, or other entity determined by the Department, for the purpose of providing recommendations and assistance in preparation for verification.

(a) The cost of the consultation site visit shall be at the facility’s own expense.  

(b) A hospital shall provide 30 days’ notice to the Department prior to any and all consultation site visits. 

(c) The Department may participate in any consultation site visits.

(ii) Verification site visit.

A hospital seeking designation as a trauma center shall request an official verification site visit by the ACS-COT, or other entity determined by the Department, no later than two years following a hospital’s receipt of its consultation site visit report.  The hospital must receive confirmation from the ACS-COT, or other entity determined by the Department, that the hospital meets the criteria for trauma center verification in accordance with the criteria outlined in the ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014). 

(a)  The cost of any verification site visit shall be at the hospital’s own expense.  

(b)  A hospital shall provide 30 days’ notice to the Department prior to any and all verification site visits.

(c) The Department may participate in any verification site visits.

(d) A hospital seeking Level I, Level II, or Level III trauma center designation shall require that any verification review team, as provided by ACS-COT, or other entity determined by the Department, include a nurse reviewer. The hospital shall submit to the Department documentation confirming that a nurse reviewer was a member of the verification review team.

(e) A hospital shall submit to the Department a copy of all verification site visit reports and verification certificates issued by the ACS-COT, or other entity determined by the Department, within ten business days of receipt.

(f) A hospital shall submit to the Department immediately upon receipt any statement of deficiencies found or interim reports of focused surveys issued by the ACS-COT, or other entity determined by the Department, during a verification review.

(g) A hospital shall notify the Department immediately upon receipt of notice of failure to be verified by the ACS-COT, or other entity determined by the Department.  Such notification must be made in writing to the Department by the hospital’s chief administrative official.

(2) A hospital seeking designation as a trauma center must provide to the Department any additional materials received by the hospital from the ACS-COT, or other entity determined by the Department, upon the Department’s request.

(3) A verified trauma center must be re-verified every three years by the ACS-COT, or other entity determined by the Department, and in accordance with subparagraph (ii) of paragraph (1) of subdivision (c) this section.

(d) Requirements for Operating a Trauma Center.

(1) Upon designation, a hospital operating a trauma center shall:

(i) remain subject to the provisions of this Part and all other applicable requirements of this Title and of the Public Health Law related to general hospitals;

(ii) comply with the trauma care standards set forth in ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014);                        

(iii) have age and size appropriate resuscitation equipment consistent with section 405.19(b) and this Part;

(iv) participate and submit information to the New York State Trauma Registry as set forth in subdivision (f) of this section;

(v) maintain transfer agreements with non-designated hospitals and the nearest designated Level I, Level II, Level III and pediatric trauma center, as appropriate for the region, to assure the timely transfer of trauma patients to the appropriate level of trauma care;

(vi) participate in the performance improvement process as set forth in subdivision (g) of this section; 

(vii) submit to the Department any notices of noncompliance issued by the ACS-COT, or other entity determined by the Department, within one business day of receipt;

(viii)  provide to the Department any additional materials received by the hospital from the ACS-COT, or other entity determine by the Department, upon the Department’s request; and

(ix) notify the Department immediately of any inability to meet the capabilities required by its current designation. Such notification must be made in writing to the Department by the hospital’s chief administrative official.

(e) Withdrawal of Designation

(1) The Department may withdraw designation from a hospital if:

(i) the hospital’s trauma center verification certificate lapses;

(ii) the hospital is not issued a certificate of trauma center verification after a reverification site visit; or

(iii) the hospital fails to comply with paragraph (1) of subdivision (d) of this section.

(2) Upon withdrawal of a trauma care designation, the hospital shall immediately take measures to notify affected parties and divert trauma patients to designated trauma centers, and within 30 days, provide to the Department a written plan describing the specific measures it has taken to notify affected parties and its process for diversion of trauma patients to designated trauma centers. In addition, the hospital shall ensure that it has a transfer agreement with at least one designated Level I, Level II or Level III trauma center, whichever is the most appropriate trauma center available, and at least one pediatric trauma center to assure the timely transfer of trauma patients in need of specialized emergency care, consistent with section 405.19 of this Part.

(f)  New York State Trauma Registry.

Each designated trauma center, and every hospital that treats trauma patients prior to transferring them to a designated trauma center, shall submit information to the New York State Trauma Registry.  The data elements that are required to be reported to the New York State Trauma Registry are set forth in the New York State Trauma Registry’s data dictionary.  Hospitals must submit data to the New York State Trauma Registry at least quarterly and at such other times as the Department may require.  The hospital shall have in place appropriate measures to ensure the confidentiality of all information provided to the Registry.

(g) Performance improvement.

(1) Each designated trauma center shall participate with the coordinating Regional Trauma Center and other hospitals and healthcare facilities, EMS agencies and governmental disaster preparedness programs in regional trauma performance improvement activities that shall include:

(i) evaluation of the quality and appropriateness of care provided, including providing referring hospitals with information on trauma patient outcome;

(ii) analysis of data from the New York State Trauma Registry, Patient Care Report database and other sources to identify opportunities for improvement.  The Regional Trauma Center shall have in place appropriate measures to ensure the confidentiality of all data utilized to conduct this analysis;

(iii) development of trauma protocols, procedures, guidelines and policies;

(iv) assessment of the regional trauma system;

(v) utilization of trauma and EMS data sources to guide public education and injury prevention efforts;

(vi) provision of trauma-related/injury prevention education to allied healthcare providers; and

(vii) participation in emergency and disaster planning including incorporation of resources and capabilities into plans to address mass casualty and other disaster events.

(2) The Regional Trauma Center in each region will coordinate with each hospital within its region to participate in regional trauma performance improvement activities.  

(i) Each Regional Trauma Center shall enter into and comply with a trauma affiliation agreement with each hospital in its region. A representative of the Regional Trauma Center may participate in and receive information from the affiliate hospital’s quality assurance committee, and may review other reviews of the quality of trauma care provided by the affiliate hospital, in order to make informed recommendations about improving trauma care and about the performance improvement process.  Each Regional Trauma Center and each affiliate hospital shall take actions necessary, including but not limited to, incorporating necessary provisions in the trauma affiliation agreement, to authorize such participation. For purposes of such participation, the Regional Trauma Center’s representative(s) shall be deemed a member(s) of the affiliate hospital’s quality assurance committee.  The Regional Trauma Center’s representative(s) shall only access confidential patient information for purposes of quality improvement of trauma care.  Members of an affiliate hospital’s quality assurance committee shall maintain the confidentiality of patient information and are subject to all applicable confidentiality laws and regulations, including subdivision three of section 3006 of the Public Health Law.

(ii) The Regional Trauma Center shall participate in the review of information and data for quality improvement purposes as described in the affiliation agreement, which shall include:

(a)  a quarterly review of all pediatric trauma deaths, delays of three hours or more in transferring trauma patients to a higher level of trauma care, and any transport and/or admission of trauma patients to a non-trauma center; 

(b) making quality improvement recommendations for trauma care for the hospitals in its region; and

(c) periodic review, at the Department’s request, of potential issues with trauma care in its region identified by the Department during routine analysis of regional data in the New York State Trauma Registry; and

(d) any other activities required by the Department for quality improvement purposes.

(iii) The Regional Trauma Center shall submit to the Department on a quarterly basis a report, in a format determined by the Department, describing its quality improvement reviews of all pediatric trauma deaths, delays of three hours or more in transferring trauma patients to a higher level of trauma care, any transport and/or admission of trauma patients to a non-trauma center and any additional information requested by the Department, and a report, in a format determined by the Department, describing any quality improvement recommendations made to the hospitals in its region.

(iv) The Regional Trauma Center shall cooperate with the Department in regular reviews by the Department of the Regional Trauma Center’s quality improvement activities, including providing medical records and other relevant documents and information on a timely basis when requested.

 

Effective Date: 
Wednesday, May 16, 2018
Statutory Authority: 
Public Health Law, Sections 2800, 2803, 3063, 3064, 3066, 3074 and 3075

Part 406 - Rural Hospital Swing Bed Demonstration

Effective Date: 
Wednesday, April 25, 1990
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 406.1 - Definition

Section 406.1 Definition.

For purposes of this section, a swing bed program operated by a rural hospital that has an approval from the Health Care Financing Administration (HCFA) to provide posthospital skilled nursing facility (SNF) care, shall mean beds used interchangeably as either general hospital or nursing home beds with reimbursement based on the specific type of care provided so that use of beds in this manner provides small hospitals with greater flexibility in meeting fluctuating demands for inpatient general hospital and nursing home care.
 

Effective Date: 
Wednesday, July 22, 1992
Doc Status: 
Complete

Section 406.2 - Applicability

406.2 Applicability. (a) With the prior approval of the commissioner pursuant to Part 710 of this Title and upon certification by the Health Care Financing Administration (HCFA), general hospitals located in a rural area including all areas not delineated as urbanized areas by the U.S. Census Bureau and licensed, exclusive of bassinets for newborns, distinct part psychiatric and rehabilitation unit beds and beds in intensive care inpatient units, for fewer than 100 inpatient beds or for 100 or more inpatient beds but consistently utilizing and staffing fewer than 100 beds shall be permitted to participate in the swing bed demonstration program. Participation in the program shall be for a period of three years and in accordance with the requirements of this Part. The program shall be conducted so as to show the extent and effect of the program on the availability and effective and economical provision of long-term care services in rural areas.

(b) The swing bed program shall utilize inpatient facilities and available beds in a manner which assures the provision of services to patients in accord with their assessed needs and shall be subject to the following:

(1) the swing bed program shall provide care throughout the period such patients require the nursing home level of care and in accord with the program's utilization review plan and policies governing length of stay; and

(2) patients may be admitted to the swing bed program for respite care in accord with nursing home medical eligibility criteria for admission so as to provide temporary relief to primary care givers; and

(3) reimbursement for patients whose length of stay exceeds 60 days shall be in accordance with alternate level of care payments (ALC) as set forth by Section 86-1.56 of this Title.
 

Effective Date: 
Wednesday, July 22, 1992
Doc Status: 
Complete

Section 406.3 - Admission, patient assessment, planning and services

406.3 Admission, patient assessment, planning and services. (a) The hospital administration shall develop and implement policies and procedures governing admission from the hospital's acute care unit(s), other hospital acute care unit(s), and the community, patient assessment, patient length of stay, patient care planning, and the provision of 24-hour nursing services and other services for the swing bed program which include as a minimum but are not limited to the following:

(1) the completion of the Hospital and Community Patient Review Instrument (H/C-PRI) and SCREEN prior to admission, and the PRI and SCREEN for admission review and continued stay review purposes for patients otherwise eligible for nursing home admission and whose expected length of stay does not exceed 60 days in coordination with procedures for discharge planning;

(2) patient's rights including admission, transfer, and discharge rights as set forth in Part 415 of this Title;

(3) patient care services and management in accord with the requirements governing patient behavior and facility practices as set forth in Part 415 of this Title; and

(4) patient care and services in accord with a multidisciplinary assessment of needs.

(b) A written, individualized, comprehensive care plan based upon the patient's assessed needs shall be developed and implemented which includes but is not limited to:

(1) 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;

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

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

(4) social services as the patient's medically related social and emotional needs indicate; and,

(5) an activities program involving community, interpersonal and self-care functions appropriate and sufficient in scope to the needs and interests of each patient to sustain physical and psychosocial functioning.
 

Effective Date: 
Wednesday, July 22, 1992
Doc Status: 
Complete

Section 406.4 - Transfer and affiliation agreements

406.4 Transfer and affiliation agreements. The hospital administration shall implement requirements governing transfer and affiliation agreements as set forth in section 400.9 of this Subchapter. In accordance with such agreements and for hospitals with more than 49 beds when a nursing home notifies such hospital of available bed(s), the hospital shall transfer the swing bed patient to the RHCF within 5 weekdays (excluding weekends and holidays) of the availability date unless the patient's physician certifies that a transfer is not medically appropriate.
 

Effective Date: 
Wednesday, July 22, 1992
Doc Status: 
Complete

Section 406.5 - Discharge planning

406.5 Discharge planning. The hospital administration shall implement procedures governing discharge planning as set forth in Part 405 of this Title and as also required for participation in the Medicaid program in coordination with the hospital's utilization review plan and policies governing length of stay applicable to the swing bed program in order to ensure that each patient has a planned program of continuing care that meets his or her post-discharge needs.
 

Effective Date: 
Wednesday, April 25, 1990
Doc Status: 
Complete

Section 406.6 - Evaluation

406.6 Evaluation. The hospital administration shall develop and implement procedures which provide for at least an annual written evaluation of the swing bed program to include, as a minimum, a profile of the characteristics of the patients admitted to the program, the services and degree of services drawn upon most, occupancy, length of stay and use rate, patient need and disposition upon discharge. The evaluation shall also include such items as may be identified and set forth on forms provided by the department.
 

Effective Date: 
Wednesday, April 25, 1990
Doc Status: 
Complete

Part 407 - Primary Care Hospitals - Minimum Standards

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 2803 and 2957

Section 407.1 - Definitions

Section 407.1 Definitions.

(a) "Primary care hospital (PCH)" shall mean a general hospital serving a rural area which:

(1) complies with the provisions of this Part and the provisions of Part 405 of this Title to the extent required by this Part;

(2) provides all services required by section 407.3 of this Part in a manner that safely and effectively meets patient needs;

(3) may provide one or more additional optional services authorized by section 407.14 of this Part in accordance with patient needs, the hospital's ability to meet these needs safely and effectively and the Commissioner's approval to provide such services;

(4) may participate in a rural health network as defined in subdivision (c) of this section;

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

(6) 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 less than two hundred fifty persons per square mile.

(b) Critical Access Hospital (CAH) shall mean a PCH serving a rural area which:

(1) is designated by the federal government as an RPCH pursuant to the requirements of 42 CFR section 485.606; and

(2) complies with provisions of this Part that relate to PCHs as well as those applying only to be CAHs. (c) Rural health network shall mean an affiliation of health care providers serving a rural area, pursuant to a contract, joint or cooperative agreement, or organized pursuant to the not-for-profit corporation law and approved pursuant to subdivision 14 of section 2801-a of the Public Health Law, which provides or arranges for the provision of health care services pursuant to a network plan to residents of a rural area or the provision of administrative or management services among such health care providers.
(d) Network plan shall mean a written plan prepared by a rural health network or rural providers planning to form a rural health network, with the involvement of consumers, describing the steps to be taken by such network and its participating providers to respond to the health care needs of the rural area, improve access to and the quality of care for residents of the community, promote the coordination of resources among providers and reduce duplication of services while achieving cost and other operational efficiencies.

(e) 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) (REMACs) responsible for the hospital's
(f) 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 specialists' assistants, registered professional nurses - nurse practitioners or clinical nurse specialists.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.2 - Designation of PCHs and CAHs

407.2 Designation of PCHs and CAHs.

(a) PCHs and CAHs shall be designated by the Commissioner of Health to operate as a primary care hospital pursuant to guidelines developed by the commissioner and the provisions of Part 710 of this Title. The decision to submit an application for designation as either a PCH or a CAH shall be at the discretion of the hospital seeking designation. The guidelines for designation may be obtained from the commissioner, and shall be published in the New York State Register.

(b) At the time of application to become either a PCH or a CAH, a facility shall be licensed as a general hospital, shall have a Medicare/Medicaid participation agreement in effect and shall be in substantial compliance with all other applicable state and federal requirements.

(c) Hospitals seeking designation as a CAH pursuant to this section, shall, in addition to complying with the provisions of this Part, comply with the following requirements of 42 CFR section 485.620.

(1) except as permitted for CAHs having Federal swing-bed agreements, the CAH maintains no more than 15 inpatient beds; and

(2) the CAH discharges or transfers each patient within 96 hours after admission, unless transfer to a hospital is precluded because of inclement weather or other emergency conditions.

(d) At the time of application PCHs may provide swing-bed services in accordance with Part 406 of this Title or seek approval to provide swing-bed services following designation as a PCH. CAHs shall comply with the following additional conditions pursuant to 42 CFR section 485.645 regarding swing-bed services:

(1) Federal swing-bed approval must not have been terminated within the two (2) years prior to the facility's application for CAH status; and

(2) a facility that, at the timie it applied for designation as a CAH, had in effect a swing-bed agreement for post-hospital skilled nursing facility care may continue to use its inpatient facilities for the provision of post-hosital SNF care, so long as the total number of beds that are used at any time for the furnishing of such services does not exceed 25 beds and the number of beds used at anytime for acute care inpatient services does not exceed 15 beds.
(e) Upon designation, PCHs and CAHs shall remain subject to the provisions of this Part and all other pertinent requirements of this Title and of the Public Health Law applicable to general hospitals, including those pertaining to operating certificates which shall also apply to the proposed revocation, suspension, limitation or annulment of a PCH or CAH designation.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.3 - Scope of service

407.3 Scope of service.

(a) PCHs and CAHs shall provide initial diagnostic services, a limited range of therapeutic services, resuscitation and stabilization services, and shall have the ability to arrange transport to other more appropriate facilities for patients in need of services not offered at the PCH/CAH.

(b) A PCH/CAH shall provide a minimum set of core services to meet patient needs, including:

(1) primary care: inpatient and ambulatory services;

(2) inpatient non-surgical clinical services;

(3) emergency services sufficient to handle a range of urgent and limited emergent care needs;

(4) laboratory services;

(5) imaging services; and

(6) pharmacy services.

(c) PCHs and CAHs may provide, subject to the approval of the Commissioner, one or more of the optional services listed in section 407.14.

(d) PCHs and CAHs shall: (1) participate in the development and implementation of an emergency medical services plan that is suitable to meet the needs of the rural area in which the hospital is located. If the PCH or CAH is a member of a rural health network. such plan shall be a component of the network plan. The emergency medical services plan shall be developed in conjunction with the existing local EMS system and service delivery providers. In the event that the PCH or CAH is a member of a rural health network, the plan shall reflect the agreement of all appropriate providers in the network;

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

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

(4) educate the community about the role of the hospital in meeting community health and health related needs including, but not limited to:

(i) the types of services provided at the hospital and, if applicable, within the network;

(ii) the hours of operation, which shall be posted publicly in the rural area served by the hospital and made available to the designated medical control facility for the area in which the hospital operates; and

(iii) changes in hours of operation, which shall be publicly posted and implemented only after a reasonable notification period to insure the rural area has had ample warning of the changes; and

(5) support and participate in any communication system that may be available for the area served by the PCH/CAH and the general hospital(s) with which it has a formal affiliation pursuant to section 407.1 of this Part. Such communication system may include but shall not be limited to electronic sharing of patient data, telemetry, and medical records as well as cellular and other radio transmission devices for providing immediate communication links with medical control, back-up services and transport systems; (6) CAH shall have the following additional agreements: (i) patient referral and transfer with its supporting hospital(s); (ii) the provision of emergency and non-emergency transportation between the CAH and its supporting hospital(s) pursuant to the provisions of section 407.12 of this Part; and (iii) credentialing and quality assurance activities with the CAH's support hospital(s) pursuant to the provisions of section 407.6 of this Part. (e) PCHs and CAHs shall comply with construction standards contained in Article 2 Subchapter C (Medical Facility Construction) of this Title.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.4 - Governing body

407.4 Governing body.

(a) The entity or person established as operator of the PCH/CAH shall be legally responsible for the quality of patient care services; for the conduct and obligations of the hospital as an institution and for ensuring compliance with all federal, state and local laws. The operator's governing body, which shall mean the governing authority as defined in subdivision (a) of section 600.9 of this Title, shall operate in accordance with the provisions of section 405.2 of this Title except as provided for below. In addition, the governing body shall:

(1) ensure that all officers, directors, trustees, partners, or sole proprietors participate in orientation and continuing education programs addressing the mission, role and responsibilities of the hospital, the local EMS system and if appropriate, the network of which the PCH/CAH is a member in meeting the health care needs of patients and the community;

(2) adopt by-laws which reflect the role, purpose and responsibilities (3) establish and maintain a coordinated program, in conjunction with an affiliated full service hospital and other area providers as appropriate, which integrates the operational review activities of all hospital services for the purpose of enhancing the quality of patient care and identifying and preventing potential malpractice issues;

(4) sets policies that assure that a doctor of medicine or osteopathy and/or a registered physician's assistant under the general supervision of a physician or a nurse practitioner collaborating with a physician, is on duty at all times during regularly scheduled hours of operation of emergency care services, and other services at times determined appropriate by the governing body of the hospital and specified by hospital policies and procedures; and

(5) sets policies that ensure that a doctor of medicine or osteopathy is on call at all times.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.5 - Administrative requirements

407.5 Administrative requirements.

(a) PCH and CAH administration. PCHs and CAHs shall comply with the requirements of section 405.3 of this Title regarding administration.

(b) Admission/discharge/transfer.

(1) General.

(i) The administrative and medical/professional staff shall develop for approval by the governing body written admission and discharge policies designed to protect the health and safety of patients, and shall not assign or delegate the functions of admission and discharge to any referral agency.

(ii) The priority use of inpatient beds in the hospital shall be for short stay acute cases that can be discharged or transferred within a limited period of time. A PCH or CAH certified to provide swing-bed services shall ensure the timely availability of acute care beds at all times.

(iii) Long term cases shall be assigned to the swing-bed capacity of the hospital.

(2) Admissions.

(i) Each patient shall be advised of his or her rights pursuant to section 407.7 of this Part and, as appropriate, the criteria for Medicaid eligibility.

(ii) No person shall be denied admission to the hospital because of race, creed, national origin, sex, disability (subject to the capacity of the hospital to provide necessary treatment), sexual orientation or source of payment.

(iii) Except in emergencies, patients shall be admitted only upon referral and under the care of a licensed and currently registered practitioner who has been granted admitting privileges by the governing body. The patient's condition and provisional diagnosis shall be established on admission by the patient's admitting practitioner and shall be noted in the patient's medical record.

(iv) Except in emergencies and under exceptional circumstances (i.e., weather, availability of transport, equipment or staff), a hospital shall admit as patients only those persons who require the type of medical services authorized by the hospital's operating certificate and specified in the hospital's written admission and discharge policies.

(a) Authorized admissions to CAHs shall involve only patients that, by the judgement of the admitting practitioner, are determined to have medical needs that can be managed and resolved within the 96 hour time period allowed for inpatient services pursuant to 42 CFR section 485.620 as expressly set forth in subdivision (c) of section 407.2 of this Part. Patients presenting with conditions that have the reasonable potential for requiring a greater amount of time to resolve shall be transferred to a more appropriate full service hospital.

(b) Authorized admissions criteria for PCHs shall be developed locally based on the service and resource capabilities of the PCH, its supporting full service hospital(s) and, if appropriate, any network in which it operates. Expected length of stay necessary to meet a patient's medical needs shall not be used as a criterion for admission to PCHs.

(v) PCHs and CAHs shall comply with the provisions of paragraphs (6) through (14) of subdivision (b) of section 405.9 of this Title.

(3) Sexual offense evidence. PCHs and CAHs shall comply with the provision of subdivision (c) of section 405.9 of this Title regarding the maintenance of sexual offense evidence.

(4) Child abuse and maltreatment. PCHs and CAHs shall comply with the provisions of subdivision (d) of section 405.9 of this Title with respect to identification, assessment, reporting and management of cases of suspected child abuse and maltreatment.

(5) Domestic violence. PCHs and CAHs shall comply with the provisions of section 405.9(e) of this Title with regard to the
identification, assessment, treatment and appropriate referral of cases of suspected or confirmed domestic violence.

(6) Discharge/transfer. Hospitals shall comply with the provisions of paragraph (1) of subdivision (i) of section 405.9 of this Title concerning discharge/transfer. In addition, PCHs and CAHs shall comply with the following:

(i) in carrying out discharge planning requirements, PCHs and CAHs that are members of a rural health network may include as the discharge planning coordinator a member of the network utilization review committee who has appropriate training and experience to perform such duties;

(ii) ensure that discharge planning staff have available current information regarding home care programs, institutional health care providers, and other support services, including their scope of services, admission and discharge policies and payment criteria;

(iii) each removal, transfer or discharge shall be carried out in accordance with written PCH/CAH policy, and if the facilitity is a member of a rural health network, network policy. Such policies shall specify referral arrangements and transfer protocols outlining the duties and responsibilities involved in determining the necessity of a transfer and for personnel involved in the transfer and shall be set forth in written agreements between the PCH/CAH and appropriate receiving hospital(s); and
(iv) each patient being removed or discharged shall be provided with information and/or assistance as required for linking the patient with a community based primary care provider.

(c) Incident reporting. PCHs/CAHs shall comply with the provisions of section 405.8 of this Title regarding incident reporting.

(d) Medical records. PCHs/CAHs shall comply with the provisions of section 405.10 of this Title regarding medical records.

(e) Request for consent to an anatomical gift. PCHs/CAHs shall comply with the provisions of section 405.25 of this Title regarding requests for consent to an anatomical gift.

(f) Utilization review. PCHs/CAHs shall comply with the provisions of section 405.26 of this Title regarding utilization review.

(g) Information policy and other reporting requirements. PCHs/CAHs shall comply with the provision of sections 86-1.2, 86-1.3 and 400.18 of this Title regarding information policy and other reporting requirements.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 407.6 - Quality assurance and utilization review

407.6 Quality assurance and utilization review.

(a) The governing body shall require the establishment and maintenance of a written coordinated quality assurance program which integrates the review activities of all PCH/CAH services to enhance the quality of patient care. This program shall be designed to identify and prevent potential malpractice issues, shall incorporate the minimum standards for a quality assurance program delineated in Section 405.6 of this Title and shall require at least quarterly quality assurance reports to be submitted to the governing body. For purposes of this Part, the quality assurance program may be developed and implemented for all services in accordance with the ongoing quality assurance program of the affiliated full service hospital.

(b) Where a PCH/CAH is a member of a rural health network and there is a network-wide quality assurance program and/or health information system, the PCH/CAH shall coordinate its assessment and improvement activities with such program or system.

(c) The PCH's/CAH's quality assurance program shall support a care delivery continuum and may utilize a performance measurement system for the analysis of care provided which includes, but need not be limited to:

(1) a permanent patient record; and

(2) an indicator measurement system for analysis of undesired outcomes related to:

(i) access to and availability of care;

(ii) variations from generally accepted standards of professional practice; and

(iii) if the PCH/CAH is a member of a rural health network, any departures within the network from established medical/professional standards delineated in paragraph (1) of subdivision (a) of section 405.4 of this Title, and generally accepted practice guidelines.

(d) In addition to implementing the activities required by the quality assurance provisions of this Part and subdivision (b) of section 405.6 of this Title, the PCH/CAH shall:

(1) review admissions made under exceptional circumstances;

(2) review cases involving an unanticipated transfer to a more service intensive facility;

(3) review cases involving a readmission within two days of discharge; and

(4) review cases that exceed a length of stay determined by the governing body to be in excess of what is appropriate for the PCH/CAH.

(e) A PCH's/CAH's utilization review program shall provide for prospective, concurrent and retrospective review processes.

(1) The prospective review process shall be locally developed by clinicians from the PCH/CAH and from the facility or facilities providing hospital support services to the network within which the PCH/CAH operates, and shall be based upon the service capabilities of those facilities.

(2) The concurrent review process shall provide for a review of patients admitted to the PCH/CAH 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 admission and may exceed the service capacity or capabilities of the PCH/CAH.

(3) The retrospective review process shall include case level assessments for patients as set forth in subdivision (b) of section 405.6 of this Title and subdivision (d) of this section and, in cases involving the transfer or referral of a patient to another facility, shall involve a facility level assessment.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.7 - Patients' rights

407.7 Patients' rights. PCHs/CAHs shall comply with the provisions of section 405.7 of this Title with regard to patients' rights. However, for PCHs/CAHs that participate in a rural health network, requirements for skilled interpreters and personnel skilled in communicating with vision and hearing impaired individuals may be met through effective communication within the network including telephone, radio or electronic communications.
 

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.8 - Medical/professional staff

407.8 Medical/professional staff.

(a) The Medical/Professional staff of the PCH/CAH shall consist of at least one doctor of medicine or osteopathy and may also include licensed dentists and other qualified personnel as defined in subsection (g) of section 407.1 of this Part and as determined to be appropriate by the governing body to provide approved services in accordance with their respective qualifications and patient needs.

(b) For purposes of this section, the term "medical staff", as used in section 405.4 of this Title, may refer to the medical/professional staff of a PCH/CAH.

(c) For the conduct of its medical/professional staff, PCHs/CAHs shall comply with the provisions of section 405.4 of this Title. In addition to such requirements, PCHs/CAHs shall:

(1) ensure that members of the emergency medical/professional staff have successfully completed the necessary course work and training for basic cardiac life support or advanced cardiac life support, have received their credentialing from the hospital and are available on-site at all times during posted hours of operation;

(2) ensure that a system is in place to provide for the ongoing oversight and direction by a physician of all professional staff in accordance with applicable practice acts and regulations;

(3) if the hospital is a member or a rural health network, develop a system in which network medical/professional staff participate and collaborate to provide consultation, assistance with medical emergencies, and patient referrals; and

(4) ensure that at least one doctor of medicine or osteopathy is available by radio or phone, and one is on standby as a backup for consultation and patient referral assistance, on a 24 hour a day basis except that CAHs shall ensure that physicians are present for sufficient periods of time to provide the necessary and appropriate medical direction, medical care services, consultation, and supervision of hospital health care staff in accordance with patient needs.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.9 - Nursing services

407.9 Nursing services. The PCH/CAH shall have an organized nursing service with a written plan of administrative authority which delineates responsibilities for patient care.

(a) Organization. The director of the nursing service shall be a licensed registered nurse with appropriate education and experience. He or she shall be responsible for the operation of the service, credentialling of nursing staff and the determination of the types, numbers, and mix of nursing personnel and support staff necessary to provide nursing care for all patients admitted to the hospital.

(b) Staffing and delivery of care. The nursing service shall have adequate numbers of licensed registered nurses, licensed practical nurses and other personnel to provide nursing care to all patients as needed. There shall be supervisory and staff personnel for each department or nursing unit to ensure the immediate availability within 20 minutes of a registered nurse for bedside care of any patient.

(1) The PCH shall be capable of providing 24-hour a day nursing care furnished or supervised by a registered nurse and shall have a licensed practical nurse or registered nurse on duty at all times, except for PCHs that have in effect a 24-hour a day nursing waiver granted by the federal government.

(2) CAHs shall not be required to provide nursing staff when there are no inpatients in the CAH.

(3) PCHs shall comply with the provisions of paragraph (3) of subdivision (a) through paragraph (2) of subdivision (e) of section 405.5 of this Title.
 

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.10 - Primary care related inpatient and outpatient services

407.10 Primary care related inpatient and outpatient services.

(a) Definition. Primary care related inpatient and outpatient services are those non-critical or special care services that are provided to patients on a short term inpatient or outpatient basis to protect and promote the health and well being of the patients. Such services shall be provided to inpatients who are in need of clinical preventive services and/or the continuous management of non-critical medical conditions and to members of the community on an outpatient basis.

(b) General provisions. Primary care related inpatient and outpatient services shall be organized to meet the needs of patients and provided to patients requiring such care on a short term basis. PCH/CAH primary care services shall be provided through medical and professional staff and support services appropriate to the scope of services offered and consistent with the primary health care needs of the patients.

(c) Organization and direction. Primary care related inpatient services shall be directed by a physician member of the medical/professional staff, who shall be responsible for the administrative and clinical aspects of all such inpatient care services. The director shall have received specialized training in and have demonstrated competence in the organization and delivery of, primary care services, and may also be responsible for the administrative and clinical aspects of all outpatient primary care services.

(1) The provision of all primary care related inpatient and outpatient services shall be in accordance with generally accepted standards of medical practice and other licensed health care practitioner standards of practice.

(2) The PCH shall ensure that written policies and procedures are developed for the provision of all inpatient and outpatient primary care services, and implemented by the medical and professional staff.

(3) Such policies shall set forth procedures for ensuring that all patients are provided with information necessary for their selection of or referral to community based primary care providers, and for the ongoing management of a patient's primary health care needs.

(d) If the PCH/CAH has an organized outpatient service, the service shall be operated in accordance with the provisions of subdivisions (a) through (c) of section 405.20 of this Title and organized in a manner that supports and augments other primary care services available in the rural area being served by the PCH/CAH.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.11 - Clinical and ancillary support services

407.11 Clinical and ancillary support services.

(a) Introduction. Required clinical and ancillary support services shall include diagnostic radiology, clinical laboratory, pharmaceutical, food and dietetic and social services. The PCH shall provide or have available such services as are necessary to meet the needs of the patients and the medical staff. Such services shall meet professionally approved standards for safety and personnel qualifications.

(b) Organization and direction.

(1) Diagnostic radiology services shall be directed by a radiologist who satisfies the requirements of subparagraph (i) of paragraph (4) of subdivision (a) of section 405.15 of this Title.

(2) Clinical laboratory services shall be supervised by an individual who satisfies the requirements of paragraph (1) of subdivision (c) of section 405.16 of this Title.

(3) Pharmacy services shall be directed by a registered pharmacist who satisfies the requirements of section 405.17 of this Title.

(4) Food, dietetic and social services shall be directed by individuals who are qualified by experience or training to manage and direct such services.

(c) Operation and service delivery.

(1) Diagnostic radiology. The hospital shall maintain or have available diagnostic radiologic services, defined for the purposes of this subdivision as imaging services utilizing diagnostic radiation equipment. In addition, the hospital shall meet the standards of Part 16 of the State Sanitary Code.

(i) Service delivery shall comply with the provisions of paragraphs (1) through (5) of subdivision (a) of section 405.15 of this Title.

(ii) Diagnostic imaging through the use of ultrasound devices, if provided, shall be under the supervision of the director of diagnostic radiologic services.

(2) Laboratory services shall be provided in accordance with the provisions of subdivisions (a) through (c) of section 405.16 of this Title.

(3) Pharmaceutical services.

(i) Pharmaceutical services shall be provided in accordance with the provision of section 405.17 of this Title.

(a) PCHs/CAHs shall provide or arrange for such services through a pharmacy that is registered and operated in accordance with Article 137 of the New York State Education Law and is directed by a registered pharmacist trained in the specialized functions of hospital pharmacy.

(b) For services provided off site, the PCH/CAH shall ensure the 24 hour a day availability of pharmaceuticals necessary to meet patient needs on a timely basis.

(ii) The service shall maintain, on site, a sufficient supply of drugs and biologicals, including electrolytes, fluid volume replacement solutions and other fluid supplements to meet patient needs.

(4) Food and dietetic services shall comply with the provisions of section 405.23 of this Title.

(5) Social services shall comply with the provisions of section 405.28 of this Title.
 

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.12 - Emergency services

407.12 Emergency services.

(a) General requirements for emergency services.

(1) Written protocols for the provision of emergency services by a PCH/CAH shall be developed for the area served by the PCH/CAH; they shall take into consideration the service capabilities of the PCH/CAH, the general hospital(s) with which it has a formal affiliation pursuant to section 407.1 of this Part, and other area providers, as appropriate.

(2) PCHs/CAHs shall participate in a system which assures the availability of emergency medical services on a 24-hour a day basis within a service area-wide emergency medical services system. A PCH/CAH shall maintain an instantaneous communications link with its affiliated general hospital(s) and other appropriate providers of emergency medical services, medical backup and consultation, and medical control.

(3) At a minimum, PCHs/CAHs 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, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and oral and IV electrolytes and replacement solutions (adult and pediatric); and

(ii) equipment and supplies commonly used in lifesaving and life support procedures including but not limited to 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.

(4) Emergency services shall be coordinated with appropriate area providers including ambulance providers serving the pre-hospital delivery system of the PCH's/CAH's service area.

(5) PCHs/CAHs shall establish comprehensive written procedures for screening and assessing patients to determine the most appropriate on-site treatment, for identifying cases beyond the facility's capability to treat which require safe transfer to a more appropriate facility, and for arranging such transfers.

(6) PCHs/CAHs shall maintain, or coordinate with the general hospital(s) with which it has a formal affiliation pursuant to section 407.1 of this Part, or, if a member of a rural health network, through the network, an emergency transportation system with advanced life support capability available on a 24-hour a day on call basis to provide timely inter-facility transport.

(7) PCHs/CAHs, in cooperation with other area emergency medical service providers, shall develop written procedures to allow appropriately trained PCH/CAH personnel to provide patient care on ambulances in potentially life-threatening situations where such assistance is required; and

(8) PCHs that do not provide 24-hour a day on-site emergency services shall:

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

(ii) ensure that EMS/ambulance personnel transporting patients are able, during operating and non-operating hours, to contact hospital personnel responsible for arranging for providing emergency care to facilitate appropriate and timely patient disposition.

(b) PCHs/CAHs shall comply with the provisions of subdivisions (b) through (e) of section 405.19 of this Title with regard to the provision of emergency services.

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.13 - Environmental health and infection control

407.13 Environmental health and infection control.
(a) PCHs/CAHs shall comply with the provisions of section 405.24 of this Title with regard to assuring a safe and suitable environment for patients.
(b) PCHs/CAHs shall comply with the provision of section 405.11 of this Title with regard to infection control requirements.
 

Effective Date: 
Wednesday, March 25, 1998
Doc Status: 
Complete

Section 407.14 - Optional services

407.14 Optional services. A Primary Care Hospital (PCH) may offer additional special services, for which it is able to provide appropriate technical and human resources, in order to respond to community need or to assure quality in the delivery of services. Optional services may include but are not limited to ambulatory surgery, inpatient surgery under anesthesia, full range laboratory services, full range imaging services, radiation oncology and nuclear medicine, full range pharmacy services, physical medicine and rehabilitation services, respiratory care services, perinatal services, mental health services, blood bank/transfusion services, or special care services. Such services may only be provided if approved by the Commissioner of Health pursuant to sections 407.2 (a) and 407.3 (c) of this Part and the applicable provisions of Part 710 of this Title.

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

Part 408 - Central services facility rural health networks (CSFRHN)

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

Section 408.1 - Definition

Section 408.1 Definition. (a) A "central services facility rural health network (CSFRHN)" shall be a not-for-profit corporation established pursuant to article 28 of the Public Health Law, and representative of health care providers within the network through board representation, membership and written agreements or any combination thereof, for the purpose of operating a rural health network. Such network board shall also include representatives of the general public residing in the area served by the central services facility rural health network.

(1) A CSFRHN may plan, and upon approval of its network operational plan by the Commissioner of Health, coordinate, provide or arrange for the provision of health care services to residents of the rural area served by the network, and may also perform administrative services for providers participating in the network pursuant to such network operational plan.

(i) At a minimum, the health care services provided or arranged for by a CSFRHN shall include acute care, comprehensive primary care, and emergency care.

(ii) A CSFRHN may provide or arrange for such other medical, public health or health related services for which it or any affiliated provider has received all requisite approvals.

(2) Administrative services performed on behalf of participating providers must be provided in accordance with all applicable requirements, including subdivision (f) of section 405.3, subdivision (d) of section 600.9 and section 400.4 of this Title, and may include, but need not be limited to, emergency medical services training, credentialing, payroll, purchasing and billing services, recruitment of qualified professionals, oversight and support of the network's communication, medical transportation, quality assurance, risk management, peer review, electronic data sharing, managed care systems oversight, performance of studies, planning, and solicitation and acceptance of grants. Such services shall be provided when necessary to effectuate the purposes of the CSFRHN and only pursuant to written agreement between the parties.

(b) Service Area. CSFRHNs shall serve a specified rural area as identified in its network operational plan. Rural areas are 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 less than two hundred fifty persons per square mile.

(i) The service area of a CSFRHN shall encompass only the towns for which the network can assure the availability of at least the minimum services defined in subparagraph (i) of paragraph (1) of subdivision (a) of this section.

(ii) Providers located outside of a CSFRHN service area may participate in a network if determined by a CSFRHN to be capable of serving the residents of such rural area comprising the CSFRHN's service area and agree in writing to comply with the provisions of the network's operational plan. Residents of a service area are not precluded from obtaining services from providers that are not affiliated with a network.
 

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

Section 408.2 - Network Operational Plans (NOP)

408.2 Network Operational Plans (NOP)

(a) "Network operational plan" shall mean a written plan, including periodic updates of such a plan, prepared by a CSFRHN, with the involvement of consumers unaffiliated with health care providers, describing the steps to be taken by such network and its participating providers to enhance access, by residents of the affected rural area, including special populations, to necessary health care services while promoting cost efficiencies in the provision of services.

(b) The commissioner shall not approve a network operational plan until he/she has considered the recommendations of the HSA(s) having jurisdiction in the region in which the network intends to operate and is satisfied that the plan complies with the provisions of section 2957 of the Public Health Law, and meets the following requirements:

(1) establishes an organizational structure that includes a decision making structure representative of participating providers and consumers, mission statement, goals, operating principles, and written agreements between the network and all affiliated providers, copies of which shall be submitted with a proposed plan;

(2) provides for the delivery of at least acute care, comprehensive primary care, and emergency medical care;

(3) ensures the provision of appropriate high quality health care services in accordance with prevailing standards of care and practice. At a minimum the plan shall demonstrate that:

(i) the roles and responsibilities of the network and its participating providers in quality assurance/improvement activities are identified. Quality assurance/improvement activities conducted by the network on behalf of one or more of its participating providers shall be specifically delineated;

(ii) a strategy for monitoring, coordinating and assuring that the quality assurance/improvement programs of network participants comply with existing criteria and standards applicable to participants. At a minimum this strategy shall assure that:

(a) both process and outcome based measures are included in network provider quality assessment programs;

(b) a network-wide communication and information system, or plans for such system, is available and contains the capacity to track patients throughout the system and provide network providers with the necessary information to enhance continuity of care; and

(c) procedures will be in place that delineate the duties and responsibilities of medical/professional and ancillary support staff necessary to ensure the provision of high quality services by network providers;

(4) ensures that all potential patients in the network service area have access to necessary services. At a minimum the plan shall provide assurances that:

(i) residents of the network service area shall be provided with information sufficient to make them aware of available services;

(ii) providers of the three required minimum services are located so as to ensure reasonable access to services by all residents of the area served by the network as determined by the commissioner; and

(iii) on-call systems are in place to provide 24-hour a day coverage within the network for at least the three required minimum services in settings appropriate to patient needs;

(5) provides for the efficient and effective coordination of affiliated network providers in planning and evaluating both the integration and provision of services. At a minimum this element of a network operational plan shall include:

(i) an organizational structure, or plans for such structure, for ensuring coordination among network members and other appropriate agencies involved in planning for health and health related services in the network's service area; and

(ii) a coordinated system for developing and using community service plans, county municipal health plans, and other appropriate existing or proposed health plans such as those of appropriate state and regional agencies including the HSAs;

(6) provides for the pooling and sharing of existing resources to facilitate greater system efficiencies; and

(7) establishes terms and conditions to ensure that no hospital, physician or other licensed or certified health care provider operating in good standing, serving the network service area, and willing to meet the terms and conditions of the network as defined in the network operational plan, shall be denied the ability to participate therein. Such terms and conditions may include, but need not be limited to, a prospective participant's ability to deliver services in accordance with prevailing standards of care and/or practice and a participant's willingness to participate in coordinated network quality assurance and improvement programs, peer review programs, credentialing systems, utilization review programs, medical record systems, consultation services, specialty services, communications systems and data collection systems. Such terms and conditions may also include provisions for the payment and reimbursement of services provided by network participants. (c) Periodic updates and revisions of network operational plans. The governing board of a central services facility rural health network shall annually review the network's operational plan, and amend it as necessary subject to the prior approval of the commissioner.

(1) When an operational plan is proposed to be amended, the network shall simultaneously notify the commissioner and the Health Systems Agency (HSA) having geographical jurisdiction in the region in which the network operates or intends to operate regarding all such proposed amendments. The network shall also provide reasonable prior notification to the public, by publication in a newspaper of general circulation in the service area, and through such other media as the network deems appropriate, of all significant amendments as described below.

(2) If, upon review, the commissioner finds that such amendment(s) are significant, he shall not issue a determination concerning such amendment(s) until he has received the recommendations of the health systems agency having jurisdiction. Significant amendments shall include but need not be limited to those materially affecting any of the criteria set forth in subdivision (3) of section 2957 of the Public Health Law, additions or deletions of network participants and changes in the geographic area being served by the network. In the event that a significant overlap in the service areas of two or more CSFRHNs is proposed, the commissioner may require one or more of the CSFRHNs to amend its defined service area.

(d) Upon request of a CSFRHN, through its proposed network operational plan, or a proposed amendment thereto, the commissioner may permit the network to make application for, or fulfill regulatory requirements on behalf of, network participating providers for purposes including, but not necessarily limited to, certificate of need, quality assurance, reimbursement, and professional credentialing and privileging.

(e) All amendments shall be described in an annual report which shall be submitted to the commissioner no later than March 31st of the following year. Such report shall describe in detail the manner and extent to which a network and its affiliated providers have achieved the efficiencies proposed in the network operational plan and have effected increased access to necessary health care services.

(f) No CSFRHN shall discontinue operation or implementation of a network operational plan unless it has first received the Commissioner's approval of a plan of closure pursuant to subdivisions (g) through (j) of Section 401.3 of this Title.
 

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

Section 408.3 - Administration

408.3 Administration.

(a) Upon establishment in accordance with the provisions of Part 680 of this Title, a central services facility rural health network shall establish a board of directors responsible for directing the operation of the network in accordance with all applicable regulations and guidelines for networks. The board shall:

(1) include equitable representation from the individual governing bodies and medical/professional or administrative staff of participating network providers;

(2) include consumer representation consisting of individuals unaffiliated with health care providers other than as purchasers of health care services; and

(3) maintain an appropriate balance of provider representatives and consumers residing in the rural area served by the network on the CSFRHN's board of directors.

(b) The CSFRHN board shall adopt written bylaws reflecting its responsibility, accountability and obligations to the community it was established to serve. The bylaws shall include:

(1) a description of the organization's service area and office locations;

(2) the purposes of the organization;

(3) a description of the duties, number and qualifications of directors, the appointment/election process, terms, or the processes for removing and filling vacancies and addressing conflicts of interest, and the compensation of directors;

(4) definitions of consumer and provider representatives on the board of directors;

(5) a list of officers and their responsibilities; and

(6) the mechanisms for adopting, reviewing and revising the bylaws.

(c) The CSFRHN board of directors shall ensure that reports and other documentation required for active supervision by the commissioner, as required in section 408.4 of this Part, shall be submitted in a timely fashion and that any additional requests for information deemed necessary to assess a network's degree of compliance with the intent and purposes of the network development program shall be provided upon request.

(d) CSFRHNs may, pursuant to the provisions of section 2952 of the Public Health Law and guidelines developed by the commissioner, directly receive grants and reimbursement for planning and coordination of services and may also directly receive global budgets, pooling arrangements and/or capitation payments on behalf of participating providers.

(e) A CSFRHN may submit applications for rate enhancements or regulatory waivers to promote the successful implementation and operation of the network pursuant to section 2952 of the Public Health Law, regulations promulgated pursuant thereto and guidelines established by the commissioner.

(f) Operation of hospitals.

(1) With the prior approval of the Public Health Council, pursuant to Parts 600 and 680 of this Title, central services facility rural health networks may directly operate a hospital.

(2) Central services facility rural health networks established to directly operate a hospital shall be subject to the provisions of all applicable Parts of this Title concerning facility operations and reimbursement.
 

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

Section 408.4 - Supervision by the commissioner

408.4 Supervision by the commissioner. The implementation of a NOP and operation of a CSFRHN shall be subject to the active supervision of the commissioner pursuant to the provisions of this Part and Parts 407, 680 and subpart 752-1 of this Title, and in accordance with the following provisions.

(a) Approval and implementation of network operational plans. A central services facility rural health network shall implement a network operational plan only after receiving the approval of the commissioner to do so.

(1) Networks seeking approval to implement an operational plan shall submit the plan simultaneously to the Department and to the HSA(s) having geographical jurisdiction in the region in which the network intends to operate.

(2) The commissioner shall consider the recommendations of the HSA(s) having jurisdiction in the region in which the network intends to operate in determining whether to approve or disapprove a NOP.

(3) The commissioner shall notify the applicant, the appropriate HSA(s), and the Public Health Council in writing of a determination to approve a NOP and of his findings concerning access and proposed efficiencies supporting such determination.

(4) Where the commissioner proposes to disapprove a network operational plan, he shall provide the applicant with a detailed written statement of the basis or bases for such disapproval.

(5) In the event that a CSFRHN fails to implement an approved network operational plan in accordance with its terms, is the subject of a resolution by the Public Health Council revoking its establishment approval or fails to provide information required or requested in the course of the commissioner's active supervision of the network, the commissioner, after a hearing, may revoke, limit or annul approval to implement a NOP. The commissioner shall notify the network, the Public Health Council and the HSA(s) having geographical jurisdiction in the region in which the network operates regarding any proposed revocation, limitation or annulment of approval to implement a NOP.

(b) Supervision of network operation. The commissioner shall actively supervise and monitor the operation of central services facility rural health networks and their participating providers to assure compliance with the intent and goals of the NOP, the requirements of Article 29-A of the Public Health Law, Parts 407, 680 and subpart 752-1 of this Title and this Part. To insure the active supervision of the commissioner, CSFRHNs and affiliated providers shall:

(1) be subject to scheduled and unscheduled surveillance visits;

(2) agree in writing to submit any documentation, reports or other information requested by the commissioner, including information necessary to complete an annual evaluation;

(3) cooperate in any review and assessment of written complaints or other documentation indicating that it is not in compliance with the intent and goals of the network development program pursuant to Sections 2950 and 2957 of the Public Health Law;

(4) certify in the annual network report that a process is in place to assure that all health care providers located in the network's service area interested in participating in the network and willing to meet the network's terms and conditions have been provided the opportunity to affiliate with the network, and that consumer input is available on a regular and on-going basis with respect to the development and operation of the CSFRHN; and

(5) submit, initially with a proposed NOP, or thereafter prior to implementing or amending, all agreements between a CSFRHN and affiliated providers, or between affiliated providers resulting from or in furtherance of the objectives of the network with which they are affiliated and which provide for arrangements involving prices, methods of payment, areas of operation or restrictions thereon or any other matter which is or may be construed to be inconsistent with the requirements of state or federal laws prohibiting monopolies, unreasonable restraints of trade and related activities. All such agreements shall contain express provisions acknowledging that:

(i) such agreements or any proposed amendments thereto, shall not be effective until approved by the commissioner;

(ii) that the commissioner may provide copies to and seek the advice of the Attorney General in making any determination to approve or disapprove such agreements; and

(iii) the parties agree to cease, suspend or amend any such agreement at any time upon receipt of written notification from the commissioner or the Attorney General to do so.

(6) The commissioner shall annually review and evaluate each agreement approved pursuant to subdivision 5 of this section as to its continuing effect on access to health services, efficiencies achieved in the provision of services and whether the advantages derived from any anticompetitive activity continue to outweigh any disadvantages, and shall issue a written report of his findings.

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