Current through Register Vol. 46, No. 39, September 25, 2024
(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.
