N.Y. Comp. Codes R. & Regs. tit. 10 § 405.2

Current through Register Vol. 46, No. 50, December 11, 2024

Section 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 laws.

(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 for the delineation of their medical privileges. Such criteria shall include standards for individual character, competence, training, experience, judgment, 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 at 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 section 405.4(a) 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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.2

Amended New York State Register May 17, 2017/Volume XXXIX, Issue 20, eff. 5/17/2017

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019