405 - Hospitals--Minimum Standards
Chapter V, Subchapter A, Article 2, Part 405
AN:V-A-405
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Part 405 - Hospitals--Minimum Standards
Effective Date: May 1, 1996
Revised: March 2009 - 405.7 Patients' rights; Section b, Paragraph 2
PART 405
HOSPITALS--MINIMUM STANDARDS
(Statutory authority: Public Health Law,
õ 2803, 2805-k, 2805-l, 2805-m, 4351)
Sec.
405.1 Introduction
405.2 Governing body
405.3 Administration
405.4 Medical staff
405.5 Nursing services
405.6 Quality assurance program
405.7 Patients' rights
405.8 Incident reporting
405.9 Admission/discharge
405.10 Medical records
405.11 Infection control
405.12 Surgical services
405.13 Anesthesia services
405.14 Respiratory care services
405.15 Radiologic and nuclear medicine services
405.16 Laboratory services
405.17 Pharmaceutical services
405.18 Rehabilitation services
405.19 Emergency services
405.20 Outpatient services
405.21 Maternity and newborn services
405.22 Critical care and special care services
405.23 Food and dietetic services
405.24 Environmental health
405.25 Organ and tissue donation (anatomical gifts)
405.26 Utilization review
405.27 Information, policy and other reporting requirements
405.28 Social services
405.29 - 405.42 Reserved
405.43 Orders not to resuscitate
405.44 Separability
Statutory Authority: Public Health Law, Section 2803, 2805-k, 2805-l, 2805-m, 4
19960409
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) hospitals shall notify the commissioner in writing within seven
days after receipt of notice of the accreditation decision or
notification of a tentative non accreditation by the Joint
Commission on Accreditation of Healthcare Organizations or the
American Osteopathic Association.
(b) The provisions of Parts 700, except for paragraphs (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
and 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.
19900928
405.2 Governing body
Effective Date: March 25, 1992
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 registered physician's 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 a 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 within 20 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 purpose 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; and
(7) hospitals shall have available at all times personnel sufficient
to meet patient care needs;
(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.
19920306
405.3 Administration
Effective Date: October 12, 1994
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, students, and volunteers whose activities are such
that a health impairment would pose a potential risk to patients or
personnel. 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. The hospital shall
require the following of all personnel 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 or a laboratory
possessing a laboratory permit issued pursuant to Part 58 of this
Title, 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 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 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 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) ppd (Mantoux) skin test for tuberculosis 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 skin test. The medical staff shall develop and
implement policies regarding positive outcomes;
(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; and
(12) 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 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,
certified social worker, dental hygienist, dentist, nurse,
occupational therapist, ophthalmic dispenser, optometrist,
pharmacist, physical therapist, podiatrist, psychologist, 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.
19940926
405.4 Medical staff
Effective Date: November 10, 1993
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 practioners 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.
(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;
(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) 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 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; and
(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.
(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 on 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 accepted 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 post graduate 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 week 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 frequentl y
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 post graduate 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 Deaprtment; 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.
19941003
405.5 Nursing services
Effective Date: January 13, 1993
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.
(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.
(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 and in accordance with approved hospital policies and
procedures.
(1) All orders for drugs and biologicals shall be in writing and
signed by the practitioner or practitioners responsible for the care
of the patient as specified under section 405.2 of this Part.
Telephone or oral orders shall be used sparingly and shall be:
(i) accepted only by a registered professional nurse or
pharmacist, consistent with Federal and State law, and hospital
policies and procedures;
(ii) personally authenticated by the prescribing practitioner as
soon as possible but within 24 hours; and
(iii) monitored by the hospital and the medical staff.
(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.
(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
(vi) 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.
19921229
405.6 Quality assurance program
Effective Date: January 1, 1989
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;
(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 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 10 years the following information
concerning the physician, dentist or podiatrist:
(a) any pending professional misconduct proceedings or any
professional malpractice actions in New York or another
state;
(b) any judgment or settlement of a malpractice action and
any finding of professional misconduct in New York or
another state; and
(c) any information required to be reported by hospitals
pursuant to section 405.3(e) of this Part;
(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 ten 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 (ii) 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.
19900928
405.7 Patients' rights
Effective Date: April 17, 1996
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 manage a resource of skilled interpreters and
persons skilled in communicating with vision and hearing impaired
individuals and shall provide translations/transcriptions of
significant hospital forms, instructions and information in order to
provide effective visual, oral and written communication with all
persons receiving treatment in the hospital regardless of a
patient's language or impairment of hearing or vision. The capacity
of these resources shall be determined by the following criteria:
(i) interpreter services and translation/transcriptions of
significant hospital forms and instructions shall be regularly
available for non-English speaking groups comprising more than
one percent of the total hospital service area population, as
calculated by demographic information available from the United
States Bureau of the Census; and
(ii) 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
patients, 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 sign language interpreters for hearing impaired
patients for rural hospitals; which:
(a) 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
(b) have developed and implemented effective interim plans
addressing the communications needs of hearing impaired individuals
in the hospital service area.
(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, national origin, disability, sexual orientation, source of
payment, or age;
(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 heip, the hospital must provide assistance,
including an interpreter.
(2) Receive treatment without discrimination as to race, color,
religion, sex, national origin, disability, sexual orientation, 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) A no smoking room.
(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 "Do Not Resuscitate Orders - 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) 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.
19960402
405.8 Incident reporting
405.8 Incident reporting. (a) Any incident required to be reported pursuant
to subdivision (b) of this section shall be reported to the department's
Office of Health Systems Management on a telephone number maintained for
such purpose. Hospitals shall report such incidents within 24 hours of when
the incident occurred or when the hospital has reasonable cause to believe
that such an incident has occurred and shall take no more than seven
calendar days to determine whether an incident defined in paragraph (b) (1)
of this section is reportable and subject to the requirements of this
section. The hospital shall give written notification within seven calendar
days of the initial notification. This notification shall be submitted in a
format specified by the department and shall record the nature,
classification and location of the incident; medical record numbers of all
patients directly affected by the incident; the full name and title of
physicians and hospital staff involved in the incident as well as their
license, permit, certification or registration numbers; the effect of the
incident on the patient; follow-up treatments and evaluations planned; the
expected completion date for the hospital's investigation and identification
information required by the department.
(b) Incidents 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. 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
and that necessitate additional or more complicated treatment
regimens or that result in a significant change in patient status,
shall also be considered reportable under this subdivision;
(2) fires or internal disasters in the facility which disrupt the
provision of patient care services or cause harm to patients or
personnel;
(3) equipment malfunction or equipment user error during treatment or
diagnosis of a patient which did or could have adversely affected a
patient or personnel;
(4) poisoning occuring within the facility;
(5) reportable infection outbreaks as defined in section 405.11 of
this Part;
(6) patient elopments and kidnappings;
(7) strikes by personnel;
(8) diasters or other emergency situations external to the hospital
environment which affect facility operations; and
(9) unscheduled termination of any services vital to the continued
safe operation of the facility or to the health and safety of its
patients and personnel, 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.
(c) The hospital shall conduct an investigation of incidents described
in paragraphs (b)(1)-(6) of this section and those incidents in
paragraphs (7)-(9) deemed appropriate by the department.
(d) The hospital shall provide a copy of its investigative report to the
area administrator within 24 hours of its completion. This report shall
document all hospital efforts to identify and analyze the circumstances
surrounding the incident and to develop and implement appropriate
measures to improve the overall quality of patient care. This report
shall contain all information required by the department including:
(1) an explanation of the circumstances surrounding the incident;
(2) an updated assessment of the effect of the incident on the
patient(s);
(3) a summary of current patient status including follow-up care
provided and post-incident diagnosis;
(4) a chronology of steps taken to investigate the incident that
identifies the date(s) and person(s) or committee(s) involved in
each review activity;
(5) the identification of all findings and conclusions associated
with the review of the incident;
(6) summaries of any committee findings and recommendations
associated with the review of the incident; and
(7) a summary of all actions taken to correct identified problems,
to prevent recurrence of the incident and/or to improve overall
patient care and to comply with other requirements of this Part.
(e) This section does not replace other reporting required by this Part.
(f) Nothing in this section shall prohibit the department from
investigating any incident included in subdivision (b) of this section.
19921027
405.9 Admission/discharge
Effective Date: April 17, 1996
March 17, 1993
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 facility shall establish a separate
pediatric unit if the hospital regularly has 16 or more pediatric
patients or if pediatric patients cannot be adequately and safely
cared for in other than separately certified pediatric beds.
(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) Infants shall not be kept in the same nursery or room with
older children or with any adult patient unless their own
healthy mothers occupy the same room and the concurrence of the
other patients and their attending practitioners has been
obtained.
(v) 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.
(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 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 (f)(7) of this section.
(12) Every patient shall have a complete history and physical
examination performed by an appropriately credentialed practitioner
within seven 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.
(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 New York State 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.
(c) 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 which are consistent with
requirements of this section and which 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.
(1) The sexual offenses subject to the provisions of this
subdivision shall be sexual misconduct, rape, sodomy, sexual abuse
and aggravated sexual abuse.
(2) The sexual offense evidence shall include, as appropriate to the
injuries sustained in each case, slides, cotton swabs, clothing,
hair combings, fingernail scrapings, photographs, and other items as
may be specified by the local police agency and forensic laboratory.
(3) The hospital shall refrigerate items of sexual offense evidence
where necessary for preservation and ensure that clothes and 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.
(4) Privileged sexual offense evidence shall mean evidence which is
associated with the hospital's treatment of injuries sustained as a
result of a sexual offense.
(5) Sexual offense evidence that is not privileged shall mean that
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 or other injury 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, icepick or other sharp or
pointed instrument. Nothing in this paragraph shall prevent the
reporting of diseases or medical condition required by law to be
reported to health authorities.
(6) Upon admission of a patient who is an alleged sexual offense victim,
the hospital shall seek patient consent for collection and storage of
the sexual offense evidence and explain the specific rights of the
patient and obligations of the hospitals 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:
(i) the patient signs a statement directing the hospital not to
collect and keep privileged evidence;
(ii) such evidence is privileged and the patient signs a
statement directing the hospital to surrender the evidence to
the police before thirty days has expired;
(iii) the evidence is not privileged and the police request its
surrender before thirty days has expired;
(7) After thirty days from commencement of treatment, the refrigerated
evidence shall be discarded and the clothes shall be returned upon the
patient's request.
(8) 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) 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 Departmnt 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 (g) 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.
(g) 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 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 personal
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 1st 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 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 1st 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 Physician
Hospital Billing Office
(11) The provisions of this subdivision shall apply to hospital
inpatients admitted on and after January 1, 1988.
19960403
405.10 Medical records
Effective Date: January 1, 1989
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 and retained, and
accessible. The hospital shall use a system of author identification
and record maintenance that ensures the integrity of the authentication
and protects the security of all record entries.
(2) The hospital shall ensure that all medical records are completed
within 30 days following discharge.
(3) 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.
(4) 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.
(5) 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.
(6) 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) 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 completing
such action. Authentication may include signatures, written initials
or computer entry.
(3) All records shall document, as appropriate, at least the
following:
(i) evidence of a physical examination, including a health
history, performed no more than seven 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 case 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 patients
condition;
(vii) discharge summary with outcome of hospitalization,
disposition of case and provisions for follow-up care; and
(viii) final diagnosis.
19920325
405.11 Infection control
405.11 Infection control. The hospital shall provide a sanitary environment
to avoid sources and transmission of infections including nosocomial
infections which may lead to morbidity or mortality in patients and of
communicable diseases. 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 by the chief executive officer, medical director, director of
nursing services and the infection control officer on at least a yearly
basis.
(a) Organization. The hospital shall designate an infection control
officer who is responsible for the development and implementation of a
hospital-wide infection control program.
(b) Control of infections and communicable diseases. (1) The infection
control officer shall develop and, upon approval of the hospital
implement written policies and procedures for identifying; reporting;
investigating; preventing and controlling infections, both community
acquired and nosocomial; and communicable diseases of patients and
hospital personnel. Such policies and procedures shall include at a
minimum:
(i) asepsis, isolation, sanitation and all other infection
control measures specific for each service of the hospital;
(ii) effective disease and infection surveillance measures that
focus on those aspects of occurrence and spread of infections
and disease that are within the hospital's ability to control.
As appropriate to such factors as the severity of illness and
degree of disability in the hospital's patient population, the
age groups being cared for, types of procedures being performed,
the endemic microbial flora, and the presence of transmissible
or communicable diseases, surveillance measures shall include
the following approaches:
(a) total facility surveillance; or
(b) periodic surveillance;
(c) prevalence surveillance;
(d) laboratory-based surveillance;
(e) high-risked patient focused surveillance; and
(f) site or device focused surveillance.
(iii) prevention and control procedures that relate to the
inanimate hospital environment, including sterilization and
disinfection practices, storage and handling of supplies;
housekeeping; linen and laundry; integrity of systems for water,
air and sewage handling; food sanitation; and infectious waste
management; and
(iv) provisions to ensure that the activities of the hospital
infection control program are integrated with the hospital-wide
quality assurance pgogram required by section 405.6 of this Part
and include the identification, assessment and correction of
problems related to infection and communicable disease control.
(2) The hospital and the infection control officer shall require
compliance with written requirements for orientation and continuing
education programs for all personnel that are relevant to the
hospital's infection control program. Such continuing education
programs shall address problems identified by the infection control
and quality assurance programs of the hospital and the corrective
actions taken to ensure effective resolution of all identified
problems.
(3) The hospital shall be responsible for the implementation of
acceptable corrective action plans in affected problem areas and the
infection control officer shall report to the chief executive office
progress in correcting identified problems.
(4) The infection control officer shall maintain a log of
occurrences of infections and communicable diseases based on
hospital-wide surveillance activities and shall report increased
incidence of infections including nosocomial infections as defined
in section 2.2 of this Title to the appropriate area office of the
Office of Health Systems Management in accordance with the incident
reporting requirements of section 405.8 of this Part and shall
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.
19900928
405.12 Surgical services
Effective Date: January 1, 1989
405.12 Surgical services. If surgery is provided, the service shall be
provided in a manner which protects the health and safety of the patients in
accordance with generally accepted standards of medical practice.
(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) Licensed practical nurses and surgical technologists may perform
scrub functions under the supervision of a registered professional
nurse; they may assist in circulatory duties under the supervision of
a registered professional nurse who is immediately available to
respond to emergencies 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.
(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 patient's 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 include but are not
limited to:
(i) safety regulations posted;
(ii) routine inspection and maintenance of equipment;
(iii) availability in the operating room suites of a call-in
system, cardiac monitor, resuscitator, defibrillator, aspirator,
thoracotomy set and tracheotomy set; 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.
(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
emerge ncies 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.
19900928
405.13 Anesthesia services
Effective Date: January 1, 1989
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, 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.
(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 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 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
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 adminstration of local anesthetics unless medically
indicated.
(a) An anesthetist shall be continuously present in the
operating room throughout the adminstration 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
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. 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
qualitative 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) 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.
(v) 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.
(vi) 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.
19900928
405.14 Respiratroy 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
member 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.
(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.
19900928
405.15 Radiologic and nuclear medicine services
Effective Date: January 1, 1989
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 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. The radiologic services shall
be free from hazards for patients and personnel. Written policies
and procedures affecting safety shall be implemented and available
for inspection.
(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 radiation monitoring practices shall be adequate
to ensure compliance with all regulatory requirements.
(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.
(5) Records. Records of radiologic services including
interpretations, consultations and therapy shall be filed with
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.
(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 facility 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 four or more megavoltage (MEV) or cobalt teletherapy units
with a source-axis distance of 80 or more centimeters and rotational
capabilities as the primary unit in a multi-unit radiotherapy
service or as the sole unit in a smaller radiotherapy unit;
(4) a therapeutic radiology service shall be headed by a board
admissible or board certified radiation therapist 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) one full-time New York State licensed radiation therapy
technologist for every MEV unit; and
(ii) a full-time registered professional nurse with appropriate
education and experience;
(6) a facility 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 radiological physicist who will be involved in treatment,
planning and dosimetry as well as calibrating the equipment, and who
holds a degree in physics and who is either certified or admissible
for certification by the American Board of Radiology or the American
Board of Health Physicists; or
(a) a person holding a degree in physics and having
full-time radiation therapy experience; or
(b) a physicist in training or a dosimetrist supervised by a
part-time radiological 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 ultra-sound, hematology, pathology,
CT scanners, nuclear medicine and diagnostic radiology;
(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 an MEV unit 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) there shall be a simulator available within the radiation
therapy program used for producing precise mock-ups of geometric
relationships of treatment equipment to a patient and yielding
high quality diagnostic radiographs of the treatment portals.
(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.
19900928
405.16 Laboratory services
Effective Date: January 1, 1989
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.
19900928
405.17 Pharmaceutical services
Effective Date: January 1, 1989
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 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) information relating to drug interactions, drug therapies,
side effects, toxicology, dosage, indications for use, and
routes of administration is available to the professional staff;
(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 and
procedures to minimize drug errors.
(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.
(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.
(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.
19900928
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.
(ii) 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(f) 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 profess:
(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.
19900928
405.19 Emergency services
Effective Date: April 17, 1996
June 30, 1993
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
emergencies;
(ii) initial treatment and stabilization or management; and
(iii) transfer, where indicated, of patients to an appropriate
receiving hospital.
(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;
(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) 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 training and experience
equivalent to ATLS. Such physician shall also have successfully
completed a course in advanced cardiac life support (ACLS) or have had
training and experience equivalent to ACLS. 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 ACLS and ATLS.
(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 victims of sexual offense, including medical and
psychological care shall be incorporated into such policies and
procedures.
(5) The emergency service, 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 emergency treatment or services but not in need of
inpatient hospital care;
(6) 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.
(7) 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.
(8) Review of the hospital emergency service shall be conducted at
least four times a year as a 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 clause (a) or clause (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 training and experience equivalent to ATLS.
Such physician shall also have successfully completed a course in
advanced cardiac life support (ACLS) or have had training and
experience equivalent to ACLS. 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 training and experience equivalent to
ATLS and has successfully completed a course in ACLS or has had
training and experience equivalent to ACLS may be designated as
attending physician for a period not to exceed five years after the
physician has first attained board-admissibility except that the
requirement to be qualified to perform ATLS and ACLS 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 meet the
following minimum standards. The physician:
(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 training and experience
equivalent to ATLS; and
(6) has successfully completed a course in advanced cardiac life
support (ACLS) or has had training and experience equivalent to
ACLS.
(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 twenty minutes;
(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 have
at least one year of clinical experience, be able to demonstrate
skills and knowledge necessary to perform basic life support
measures and have current certification in ACLS or the
equivalent;
(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 at least one year of
clinical experience, have successfully completed an emergency
nursing orientation program and be able to demonstrate skills
and knowledge necessary to perform basic life support measures.
Within one year of assignment to the emergency service, each
emergency service nurse shall have current ACLS certification or
the equivalent; and
(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) Registered physician's assistants and nurse practitioners:
(i) patient care services provided by registered physician's
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 registered physician's assistants and the nurse
practitioners shall have current ACLS certification or the equivalent
and shall have training and experience in trauma management equivalent
to ATLS.
(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 labelling 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
arriving at the emergency service for treatment receive emergency health
care that meets generally accepted standards of medical care.
(2) Every person arriving at the emergency service for care shall be
promptly examined, diagnosed and appropriately treated in accordance
with triage policies and protocols adopted by the emergency service and
approved by the hospital. 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 unless
evaluated and treated as necessary by an appropriately privileged
physician, physician's assistant, or nurse practitioner. Hospitals
which elect to use physician's assistants or nurse practitioners shall
developand implement written policies and treatment protocols subject to
approval by the governing body that specify patient conditions that may
be treated by a registered physician's assistant or nurse practitioner
without direct visual supervision of the emergency services attending
physician.
(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 protocols 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 intensive care;
(iv) head-injured or spinal-cord injured patients;
(v) acute psychiatric patients;
(vi) replantation patients; and
(vii) dialysis patients.
(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) Where observation beds are used, they shall be for observation
and stabilization and they shall not be used for longer than eight
hours duration. Patients in these beds shall be cared for by
sufficient staff assigned to meet the patients needs. At the end of
eight hours observation or treatment the patient must be admitted to
the inpatient service, be transferred in accordance with paragraph
(6) of this subdivision, or be discharged to self-care or the care
of a physician or other appropriate follow-up service.
(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. Quality assurance activities of the emergency
service shall be integrated with the hospital-wide quality assurance
program and shall include review of:
(1) arrangements for medical control and direction of prehospital
emergency medical services;
(2) provisions for triage of persons in need of specialized
emergency care to hospitals designated as capable of treating those
patients;
(3) emergency care provided to hospital patients, to be conducted at
least four times a year, and to include prehospital care providers,
emergency services personnel and emergency service physicians; and
(4) adequacy of staff training and continuing education.
19960402
405.20 Outpatient services
Effective Date: April 1, 1991
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 section 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; and
(5) 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
a 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 than24
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 who have privileges in the hospital-based ambulatory
surgery service, and are appropriate in the facilities and consistent
with the equipment available. 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 shall be located in
an area convenient to existing hospital services at the same site.
(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.
(6) Detailed verbal instructions understandable to the patient,
confirmed by written instructions, and approved by the medical staff
of the hospital-based ambulatory surgery service shall be provided
to each patient 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 board 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.
19910225
405.21 Maternity and newborn services
Effective Date: May 1, 1996
405.21 Maternity and newborn services. (a) Applicability. This section shall
apply to all general hospitals having maternity and newborn services or
premature infant services and caring 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, less than 2,500 grams (5 1/2 pounds).
(b) Definitions. For the purposes of this section:
(1) Maternity and newborn 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) Labor room shall mean a room for parturient patients in labor,
distinct from patient bedrooms and from operating or delivery rooms.
(3) Delivery room shall mean a room distinct from patient bedrooms
and set apart for the delivery of parturient patients.
(4) Single unit maternity model shall mean a model for
family-centered maternity and newborn care such as a cybele cluster,
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.
(5) 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, not limited to feeding times.
(6) Newborns shall mean all infants 28 days of age or less.
(7) 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.
(8) Low birth weight infant shall mean an infant weighing 2,500
grams (5 1/2 pounds) or less at birth.
(9) Well-infant nursery shall mean a room for housing newborns who
are not suspected of nor diagnosed as having any communicable
condition.
(10) Special care nursery shall mean a room at Level II and Level III
perinatal care programs for housing newborns, including premature
infants and low birth weight infants, who require extraordinary care and
who are not suspected of nor diagnosed as having any communicable
condition.
(11) Observation nursery shall mean a room, physically separate from
the well-infant 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.
(12) Isolation nursery shall mean a room, physically separate from
other nurseries, for the isolation of newborns diagnosed as having
any communicable condition.
(13) Family planning shall mean the planning and spacing of children
by medically acceptable methods to achieve pregnancy, or prevent
unintended pregnancy.
(14) Level I perinatal care program shall mean a comprehensive
maternal and newborn services program provided by a hospital
designated as such by the department for women who have been
assessed as having a normal, low-risk pregnancy and having a fetus
which has been assessed as developing normally and without apparent
complications. A woman at low risk means a woman with a normal,
medical surgical and obstetrical history and a normal uncomplicated
prenatal course as determined by adequate prenatal care, and
prospects for a normal uncomplicated birth.
(15) Level II perinatal care program shall mean a comprehensive
maternal and newborn services program provided by a hospital
designated as such by the department for women who have been
assessed as having the potential or likelihood for a complicated or
high-risk delivery and/or bearing a fetus exhibiting the potential
for unusual or high-risk development who may require an intermediate
or intensive level of specialized care services. Such programs may
also provide services to women requiring care normally provided at
Level I programs.
(16) Level III perinatal care program shall mean a comprehensive
maternal and newborn services program designated as such by the
department, provided by a tertiary care hospital for women who have been
assessed as high-risk patients and/or are bearing high-risk fetuses as
determined by a standardized risk assessment tool, who will require the
highest level of specialized care. Such programs may also provide
services to women requiring care normally provided at Level I and II
programs.
(17) Regional perinatal care center shall mean a facility housing a
Level III perinatal care program and designated as such by the
department, serving a given designated region which provides all
aspects of maternal and neonatal care and whose functions and
responsibilities also include education, evaluation and data
collection within that region.
(18) 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.
(19) 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.
(c) General requirements. (1) Hospitals providing maternity and newborn
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 hospital shall develop and implement written policies
and procedures for the maternity and newborn service which shall
include, but shall not be restricted to, the professional
qualifications of its obstetric and pediatric staff;
(ii) the hospital shall develop and implement written policies
and procedures designating the requirements for consultation
with a qualified specialist when required by specific medical
conditions;
(iii) the hospital shall develop and implement written policies
and procedures for 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; and
(iv) the hospital shall develop and implement written policies
and procedures for daily care of maternity patients and infants
which shall be implemented by the staff in the maternity and
newborn service.
(2) The medical record for each maternity patient admitted to the
maternity 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 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 and postpartum assessment.
(3) 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, description of
maternal-newborn interaction, ability to feed, eye prophylaxis,
vital signs and accommodation to extrauterine life;
(ii) orders for newborn screening tests; and
(iii) infant footprint and mother's fingerprint or other
comparable positive newborn patient identification.
(4) The hospital shall ensure the transfer to the newborn's medical
records of a mother's HIV test result, if one exists. The hospital must
ensure also that the mother is provided HIV counseling and that
voluntary HIV testing for her newborn is recommended by the responsible
physician or birth attendant after delivery and before discharge.
Counseling and/or voluntary testing shall be provided pursuant to Public
Health Law Article 27-F, and the infant's specimen shall be submitted to
the Wadsworth Center in conjunction with the newborn screening program
with disclosure of HIV results made to the responsible physician or
designated facility staff for disclosure to the mother, if consent is
given. If a mother chooses not to have the results of the HIV newborn
test disclosed to her, the hospital's medical record must document such
refusal by containing the mother's signature. If the mother has neither
consented nor refused consent, and the physician makes a determination
before discharge that an emergency exists, and the infant is in
immediate need of medical attention and an attempt to secure consent
would result in delay of treatment which would increase the risk to the
infant's life or health, then the physician may order the HIV newborn
test to determine whether the infant has been exposed to the HIV virus
such that testing would address the emergency and therefore would be
necessary to preserve the life or health of the infant, and would assist
in future treatment and follow-up care. Women and newborns with positive
HIV test results shall be referred for the necessary health and social
services within a clinically appropriate time.
(5) The hospital shall maintain in a timely manner in the maternity
and newborn 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 physicians,
nurse-midwives, assistants and anesthetists, sex, weight and
gestational age of infant, location of delivery and fetal 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
maternity and newborn service. In addition, the following
requirements relating to the control of infection or other
communicable conditions in the maternity and newborn 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
maternity and newborn 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 encompasses
common surfaces.
(7) The hospital shall develop and implement written policies and
procedures for the provision of preconception services either onsite
or through referral arrangements. Available services shall include
but not be limited to family planning, nutritional assessment and
counseling, and genetic screening and counseling.
(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 recommending voluntary testing to
pregnant women. Counseling and/or testing, if accepted, shall be
provided pursuant to Public Helath 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 maternity and newborn
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, 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 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
maternity services provided by such hospital.
(i) Such transfer shall be accomplished in accordance with the
provisions of sections 754.2(e) and 754.4 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 assurance 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) 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.
(11) Functioning of maternity and newborn services. (i) Inpatient
maternity and newborn services shall be operated as closed units
with limited access to unnecessary hospital traffic.
(ii) The maternity and newborn 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.
(12) Laboratory services. The maternity and newborn 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 maternity and newborn 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 and newborn 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
certified nurse-midwife.
(b) A patient may not be sent home without the prior
knowledge and approval of her attending physician or
certified nurse-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 maternity and
newborn 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 with any known malignancy;
(2) patients requiring radiotherapy; and
(3) 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 maternity
and newborn service is found during surgery or during any
other period of hospitalization, the patient shall be
removed from the maternity and newborn 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
written instructions necessary for such mother and father to
complete a notarized acknowledgement of paternity form in compliance
with section 4135-b of the Public Health Law;
(b) provide to the mother and putative father, prior to the
execution of the acknowledgement of paternity, written information
as required by section 111-k(1) of the Social Services Law
concerning the legal consequences of signing a voluntary
acknowledgement of paternity; and
(c) 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.
(d) High risk antepartum services at Level II and III perinatal care
programs.
(1) Level II and III perinatal care programs 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 special care services. (i) Hospitals providing Level I
or II perinatal care programs shall develop, enter into and
implement written agreements with hospitals providing Level III
perinatal care programs 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 maternal special
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 special
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 maternity service.
(iv) Perinatal care programs. Hospitals shall:
(a) 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;
and
(b) a regional perinatal care center shall:
(1) offer education and training to all hospitals and
birth centers in the region which provide maternity and
newborn services. Education and training shall be
designed to update and enhance staff knowledge and
familiarity with relevant procedures and technological
advances;
(2) review all cases of patients transferred to the
regional center to determine whether such transfers were
appropriate and accomplished according to established
transfer agreements; and
(3) participate in case conferences with hospitals and
birth centers in the region to determine whether any
non-transferred cases which resulted in a poor pregnancy
outcome were handled appropriately and whether the
transfer guidelines were adequate to address such
circumstances.
(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 and
emergency deliveries. These policies and procedures should 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 or other supportive person 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 has not been
taken and the pregnancy terminates as a result of an
emergency, 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 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 certified nurse-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 certified
nurse-midwife responsible for the woman's care shall be
informed of her status, so that a decision can be made
regarding further management; and
(c) an interval assessment including physical and
psychological status of the woman and fetal status.
(ii) Chemical induction or augmentation of labor may be initiated only
after a physician has evaluated the woman, determined that induction
or augmentation is medically necessary for the woman or fetus,
recorded the indication, and established a prospective plan of
management acceptable to the woman. If the physician initiating these
procedures does not have privileges to perform cesarean deliveries, a
physician who has such privileges shall be contacted directly prior to
infusion of the oxytoxic agent, or other substance used to induc e or
augment labor, and a determination made that he or she shall be
available within 30 minutes of determination of the need to perform a
cesarean delivery.
(a) The hospital shall develop and implement a written protocol for
the preparation and administration of an oxytoxic agent or other
substance used to induce or augment labor.
(b) The attending, or another physician who has assumed
responsibility for the patient's care, shall initiate the infusion
of the oxytoxic agent, or other substance used to induce or augment
labor, and remain with the woman for a period of time sufficient to
ensure that the drug is well tolerated and has caused no adverse
reactions.
(c) During the entire time of the infusion of the oxytoxic agent, or
other substance used to induce or augment labor, the attending, or
another physician who has assumed responsibility for the patient's
care, shall be available within 10 minutes to manage any
complications that may arise.
(d) During the entire time of the infusion of the oxytoxic agent, or
other substance used to induce or augment labor, 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.
(iii) No attempt shall be made to delay birth of 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 immediately available to attend to
her 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 durgs 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 maternity and newborn service. The
anesthetist shall be informed in advance if complications with
the delivery are anticipated.
(iii) The maternity and newborn service and the medical staff
shall designate in writing those situations which require
consulation with and/or transfer of responsibility from a
certified nurse-midwife or a family practice physician to an
obstetrician.
(iv) Alternative arrangements for the organization of the
maternity 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 licensed
physician or certified nurse-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 skillful resuscitation of a
distressed newborn. Level I and II perinatal care programs
shall accomplish this in consultation with, and with
assistance of, the Level III perinatal care program with
which the facility has a transfer 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 Level I perinatal
care programs, the transfer agreements with Level III
perinatal care programs shall provide for staff training
to ensure current staff competence in these procedures.
The agreements shall also specify those situations that
require immediate transfer rather than onsite performance
of these procedures; and
(8) procedures for the preparation and transfer of the
distressed newborn to a Level III perinatal care program
when medically indicated.
(b) The hospital shall administer eye prophylaxis in
accordance with section 12.2 of this Title and test for
phenylketonuria and other diseases in accordance with Part
69 of this Title.
(c) 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) The footprint of the newborn and fingerprint of the
mother shall be taken, by a person trained in such
procedures and such prints shall be maintained as part
of the respective medical records. In the case of a
multiple birth, a separate form shall be used for each
newborn, and the form shall indicate the order in which
the newborns were born.
(3) If there are medical contraindications to the taking
of the footprint of the newborn or the fingerprint of
the mother before either leaves the room where the
delivery has taken place, the print of the newborn or
the mother shall be taken as soon as possible
thereafter, but in any event prior to the discharge of
the newborn or mother.
(4) If a newborn is born before the mother is admitted
to the hospital, the required prints shall be taken upon
admission.
(5) 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.
(d) Circumcision, which shall be an elective procedure,
shall not be performed during the newborn stabilization
period after birth.
(f) Postpartum care of mother. Each maternity patient shall be under the
immediate care of a registered professional nurse 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.
(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 and disadvantages of
breastfeeding to women who are undecided as to the feeding
method for their infants. As 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;
(b) written policies and procedures shall be developed and
implemented to assist the mother to breastfeed which shall
include, but not be limited to:
(1) prohibition of the application of standing orders
for antilactation drugs;
(2) placement of the newborn 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) restriction on distribution of discharge packs of
infant formula to an individual order by the attending
practitioner or at the request of the mother;
(c) the hospital shall provide an education program as soon
after admission as possible which shall include but not be
limited to:
(1) the nutritional and physiological aspects of human
milk;
(2) the normal process for establishing lactation,
including care of breasts, common problems associated
with breastfeeding and frequency of feeding;
(3) dietary requirements for breastfeeding;
(4) diseases and medication or other substances which
may have an effect on breastfeeding;
(5) sanitary procedures to follow in collecting and
storing human milk; and
(6) 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 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, arrangements
for family planning services shall be made if desired by the
patient.
(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 for mother and infant have
been made;
(iii) 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;
(iv) the mother has been advised on what to do if any
complication or emergency arises;
(v) the newborn has been examined for:
(a) possible dislocation of hips;
(b) both femoral pulses;
(c) vision capability; and
(d) passage of stools and urine;
(vi) 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
(vii) the newborn is normal and stable; sucking and swallowing
abilities are normal. Routine medical evaluation of the
neonate's status at two-three days of age shall have been
conducted or arranged as well as newborn screeing between the
third and fifth day of life in accordance with Part 69 of this
Title.
(g) Neonatal care. (1) Hospitals providing Level I and II perinatal care
programs shall enter into memoranda of agreement with Level III perinatal
care programs for the transfer of distressed newborns requiring such
higher level of care.
(i) The memoranda of agreement 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, which minimize risks and provide the newborn
with needed services.
(ii) Unless medically contraindicated, mothers shall be
permitted to accompany distressed newborns to receiving Level
III perinatal care facilities.
(iii) The memoranda of agreement 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) 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 well-infant nursery. If a newborn in a well-infant nursery is
removed temporarily from the maternity and newborn service for any
reason, the newborn may be returned to the well-infant nursery only
if infection control measures established by the hospital have been
followed.
(ii) Newborns requiring extraordinary care shall be placed in a
special care nursery and hospitals shall develop and implement
protocols for all phases of treatment of such newborns. Newborns
requiring extraordinary care who are delivered in Level I
perinatal care programs shall be transferred to Level III
perinatal care programs.
(h) Neonatal special care services provided by Level II and III
perinatal care facilities. (1) Level III perinatal care facilities which
provide neonatal special care services and are designated as regional
perinatal care centers shall provide care and services in accord with
the patient care provisions of section 708.5(f)(3) of this Title.
(2) Level II and III perinatal care facilities providing intensive
and/or intermediate neonatal care but not designated as regional
perinatal care centers shall provide care and services in accord
with the patient care provisions of section 708.5(f)(4) and (5) of
this Title.
(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 hospitals having Level III perinatal care programs
after consultation with that program has established that the
infant might benefit from such transfer.
(ii) Level III perinatal care programs shall establish an infant
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.
19960409
405.22 Critical care and special care services
Effective Date: December 2, 1994
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) Organ Transplant Center.
(1) Definitions. For purposes of this subdivision, unless the context
indicates otherwise, the following terms shall have the following
meanings.
(i) Organ means a human kidney, heart, heart valve, liver, lung, or
pancreas.
(ii) Organ procurement organization (OPO) means a person, facility, or
institution engaged in procuring organs for transplantation or therapy
purposes, but does not include:
(a) facilities or institutions which permit procurement activities
to be conducted on their premises by employees or agents of an
approved organ procurement organization; or
(b) facilities or consortia of facilities which conduct
transplantation activities in accordance with article 28 of this
chapter when the organ is procured through an approved organ
procurement organization, licensed bank or storage facility, or a
living donor. A bank or storage facility shall not constitute an
organ procurement organization solely by virtue of procuring heart
valves.
(iii) Service area of an organ procurement organization means the
geographic area of service approved by the Secretary, U.S. Department
of Health and Human Services, or, in the absence of such approval, by
the department.
(2) General requirements.
(i) Organ transplantation shall be performed only in hospitals
approved by the commissioner pursuant to Part 710 of this Title.
(ii) The hospital shall be a member of the Organ Procurement and
Transplantation Network approved by the Secretary, U.S. Department of
Health and Human Services and shall abide by its rules and
requirements.
(iii) When fully operational, to ensure quality of care and cost
effectiveness, the hospital shall perform at least 20 liver
transplants per year if an approved liver transplant center, or at
least 14 human heart transplants if an approved heart transplant
center, or at least 20 kidney transplants a year if an approved kidney
transplant center.
(iv) The hospital shall participate in a patient registry program with
an organ procurement organization designated by the Secretary, U.S.
Department of Health and Human Services. Each facility performing
transplant services shall inform a patient awaiting transplantation of
the prohibition against being placed on multiple facility waiting
lists before arranging for the placement of the patient on the waiting
list.
(v) Every hospital performing organ transplants shall maintain written
criteria for the selection of patients for transplant services which
shall be consistent with professional standards of practice, applied
consistently, and made available to the public.
(vi) The hospital shall maintain a record of:
(a) all patients who are referred for transplantation and the date
of their referral;
(b) 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;
(c) the date a suitable candidate is selected for transplantation;
(d) the reasons for, and date of, any declination of a matching
organ offered to a potential donee;
(e) the date transplantation surgery occurred;
(f) the organs utilized; and
(g) the donor's United Network for Organ Sharing (UNOS)
identification number.
(vii) There shall be an organized system for follow-up of transplant
patients after discharge which maintains records on the long-term
survival of persons who have received a transplant.
(viii) The hospital shall ensure that written procedures are
maintained and implemented for the receipt, identification, and
verification of all organs for transplantation.
(ix) Written infection control policies and procedures specific to the
transplant services shall be developed and implemented as an integral
part of the hospital's infection control program.
(x) The infectious disease program shall have sufficient professional
and laboratory resources needed to address donor organ issues dealing
with transmissible infections and necessary resources to discover,
identify and manage complications from organisms associated with
transplants which are commonly or uncommonly encountered.
(3) Organization and staffing.
(i) The director of the transplant center, in addition to the
requirements in paragraph (1) of subdivision (a) of this section,
shall be a qualified specialist with previous experience and
demonstrated competence in the transplant service. The director shall
oversee the quality assurance program in the transplant center.
(ii) Each transplant center shall have on-site a qualified transplant
physician and a qualified transplant surgeon who may also fulfill the
requirement as director of the service. An infectious disease
physician shall be on-site or available to address donor organ issues
dealing with transmissible infections and issues described in
subparagraph (x) of paragraph (2) of this subdivision.
(iii) The hospital shall provide a clinical transplant coordinator and
sufficient staff to coordinate the activities of the transplant
program, including patient follow-up after discharge;
(iv) The hospital shall ensure that all staff providing care to
transplant patients are prepared for their responsibilities through
education, experience, demonstrated competence and completion of
inservice education programs as needed;
(v) From admission to discharge, patient care evaluation, planning and
management shall be performed by the professional health care team
involved with the care of the patient, and shall include plans for
follow-up of the patient into the community. The patient and patient's
family shall be involved and have input into the patient's care plan.
(vi) Psychiatric and social services shall be made available to the
transplant center to assist with psychosocial problems of the patients
and their families and to participate as members of the health care
team responsible for the patient's care.
(4) Quality assurance and improvement.
(i) As part of the hospital's quality assurance or quality improvement
program, the hospital shall implement and maintain a system for
continuously evaluating the quality and appropriateness of patient
care and patient outcomes including survival rates and any
complications.
(ii) Reports summarizing the experience of the transplantation service
shall be submitted to the department as requested by the commissioner.
(iii) The patient specific data reported to the Health Resources and
Services Administration contractor, as required by the Organ
Procurement and Transplantation Network, shall be reported to the
department periodically as requested by the commissioner. The hospital
may designate the Health Resources and Services Administration Organ
Procurement and Transplantation Network contractor as an agent of the
hospital for the purpose of complying with this requirement.
(5) Organ acceptance criteria.
(i) In conjunction with an organ procurement organization, the
hospital shall adopt and uniformly apply organ acceptance criteria and
establish written policies and procedures to ensure the medical
suitability of organs to be transplanted. The organ acceptance
criteria shall be consistent with professional standards of practice.
Specific medical conditions of the donor shall be confirmed by the
transplant surgeon through the donor's medical history, appropriate
clinical laboratory testing and other confirmation methods and
documented in the recipient's medical record.
(ii) Written organ acceptance criteria shall be specific for each type
of organ and shall describe those medical conditions which would make
the potential donor ineligible under any circumstance.
(iii) Written organ acceptance criteria shall describe those medical
conditions for which medical discretion may be exercised regarding
organ acceptance with specified limits on this discretion, when the
potential organ recipient is fully informed of the issues posed by the
particular donor and organ.
(c) 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.
(d) Cardiac surgical centers. The hospital shall not admit patients for
cardiac surgery unless the facility is an approved cardiac surgical
center nor shall the hospital admit patients for heart transplantation
unless the facility is a cardiac surgical center approved for heart
transplantation. Cardiac surgical centers shall provide both diagnostic
and surgical services and shall be approved only as such a combined
center.
(1) Direction. The center shall be under the director of a qualified
specialist in thoracic surgery with adequate training and
concentration of practice in cardiovascular surgery.
(2) Staff. All personnel shall be prepared for their
responsibilities through appropriate training and education
programs.
(i) Physicians shall all be qualified specialists in their
respective speciality, and the medical staff shall at a minimum
include:
(a) a pediatric cardiologist to care for patients in the
pediatric age group herein defined as less than age 21;
(b) a cardiologist to care for adults;
(c) in centers doing surgery for coronary artery disease, a
cardiac arteriographer with basic medical training in
internal medicine or in radiology. Supplemental
qualifications shall include at least two years of training
or experience, including but not limited to the areas of
cardiac radiology, clinical and laboratory cardiology, basic
and/or clinical cardiac physiology and catheter techniques;
(d) a thoracic surgeon or surgeons whose training emphasized
cardiovascular surgery;
(e) a radiologist with additional training the the
cardiovascular field;
(f) an anesthesiologist with experience with cardiovascular
surgical patients and open chest anesthesia;
(g) a pathologist familiar with cardiac abnormalities of all
types;
(h) residents, resident fellows, physician's assistants or
specialist's assistants on a full-time basis, capable of
dealing with all problems that arise before, during and
after surgery;
(i) consultants, readily available for consultation in
additional specialties, including hematology, neurology,
renal physiology and clinical pharmacology; and
(j) in centers performing transplants, the director of this
service and other surgeons performing heart transplants
shall be a qualified specialist in thoracic surgery and
shall demonstrate adequate training and experience in
performing human heart transplants.
(ii) Nursing personnel shall include:
(a) a registered professional nurse supervisor;
(b) a registered professional nurse in charge and on the
unit at all times; and
(c) such registered professional nurses, licensed practical
nurses, and nursing aides in such ratios that are
commensurate with the type and amount of nursing needs of
the patients.
(iii) Heart-lung machine (pump) operators shall 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. The
operator may be a specially trained physician, nurse, or
technician, at the discretion of the director of the center.
(3) Diagnostic and surgical services. All services shall be
integrated and available on an inpatient basis, but there shall also
be adequately and appropriately organized outpatient services to
preclude unnecessary hosptialization and ensure continuity of care.
Diagnostic and surgical services shall consist of the following:
(i) a full range of diagnostic services, including but not
limited to diagnostic radiology, clinical laboratory and
noninvasive cardiac diagnostic capability;
(ii) medical social workers shall be available to the medical
staff of the unit to assist with social problems of the patient
and the family as they arise, regardless of the economic status
of patient and family;
(iii) all essential therapeutic procedures, including but not
limited to open and closed heart surgery;
(iv) a blood bank, that meets the requirements of Subpart 58-2
of this Title under the direction of qualified specialists in
this field;
(v) intensive care, in specific units, available on a 24-hour
basis to provide the special and constant care required by
cardiac surgical patients. The unit shall be staffed by
personnel trained in the use of monitoring devices, respirators,
pacemakers, defibrillators and other necessary equipment for
cardiac resuscitation;
(vi) preoperative and postoperative care as indicated;
(vii) patient and family education, preoperative and
postoperative care; and
(viii) a system of adequate patient follow-up.
(4) State Cardiac Advisory Committee. The State Cardiac Advisory
Committee shall, at the request of the commissioner, consider any
matter relating to cardiac surgical centers and shall advise the
commissioner thereon.
(5) Approval and review. Site visits to existing and prospective new
centers by members of the State Cardiac Advisory Committee, or other
designees of the commissioner, shall be made as indicated, as an
adjunct to initial approval and/or for maintaining approval. The
public need for cardiac transplantation services shall be evaluated
in accordance with section 709.9 of this Title. There shall be
sufficient utilization of a cardiac surgical center or heart
transplant service to insure both quality and economy of services,
as determined by the commissioner. An institution seeking to
maintain approval, or in applying for initial approval, shall
present evidence that the annual minimum workload standards can be
achieved and maintained. The following annual minimum workload
standards shall be achieved within two years following initiation of
the service to ensure both quality and economy of services:
(i) surgical centers performing only adult open heart surgery
shall maintain an annual minimum of 100 procedures;
(ii) surgical centers performing only pediatric open heart
surgery shall maintain an annual minimum of 50 procedures; and
(iii) surgical centers performing both adult and pediatric open
heart procedures shall maintain an annual minimum of 100 adult
and 50 pediatric open heart procedures.
(6) Waiver of minimum workload standards. The commissioner or his
designee may waive the workload requirements upon a satisfactory
showing by the operator and a determination by the commissioner that
the quality of the service is adequate and:
(i) there are extenuating circumstances temporarily precluding
compliance with the workload requirements; and/or
(ii) there is a documented unmet need in the center's
geographical service area.
(e) Cardiac diagnostic centers. Cardiac diagnostic centers shall provide
coronary arteriography and/or other cardiac invasive diagnostic
procedures.
(1) For purposes of this subdivision, the following terms shall have
the following meanings:
(i) Combined center shall mean an adult or pediatric cardiac
diagnostic center located in the same facility as a
corresponding adult or pediatric cardiac surgical center.
(ii) Free-standing center shall mean an adult cardiac diagnostic
center located in a separate facility from an adult cardiac
surgical center.
(iii) Center shall mean an approved cardiac diagnostic facility
under the direction of a qualified specialist in internal
medicine (cardiovascular disease) and/or pediatrics
(cardiology), depending on the age group(s) served. A center may
operate more than one adult or pediatric catheterization
laboratory. Each of the adult and each of the pediatric
catheterization laboratories must meet the cardiac diagnostic
requirements for specialized facilities, equipment, support
staffing and workload pursuant to this subdivision and section
712.11 of this Title.
(iv) Laboratory shall mean an independent unit consisiting of a
separate room or rooms in a facility with specialized cardiac
diagnostic equipment and facilities primarily for the
performance of invasive cardiovascular diagnostic procedures as
referenced in paragraph (12) of this subdivision. Such
laboratories shall function under the supervision of a qualified
medical specialist, operate in compliance with this subdivision,
and meet the construction provisions of section 712.11 of this
Title.
(2) Cardiac diagnostic services may be provided at hospitals
independent of cardiac surgical centers only when the following
conditions have been met:
(i) these services are limited to adult cardiac diagnostic
service; and
(ii) there is a written affiliation agreement, acceptable to the
commissioner, between the approved cardiac diagnostic center and
an approved cardiac surgical center, which provides for:
(a) the management of cardiac surgical emergencies; and
(b) regular conferences held at least once per month or more
frequently if required by caseload between representatives
of the cardiac surgical center and the cardiac diagnostic
center in which a significant percentage of preoperative and
postoperative cardiac cases of the free-standing cardiac
diagnostic center are reviewed. Some of the joint
conferences shall take place at the cardiac diagnostic
center.
(3) Periodic cardiology conferences shall be held at which the staff
reviews the appropriate diagnostic studies of a statistically
significant number of cases. Records of these conferences indicating
attendance, cases reviewed and decisions on patient management shall
be maintained.
(4) Records of the disposition of the adult cases studied shall be
maintained. The number of patients referred for surgery and the
center(s) to which they are referred shall be part of these records.
(5) Criteria adopted by the cardiac diagnostic center to be used as
indications for coronary arteriography and/or other cardiac invasive
diagnostic procedures shall be available for review during site
visits. The criteria may be developed by the center or the center
may use the criteria promulgated by recognized specialty
organizations, such as the American Heart Association, the
Inter-Society Commission on Heart Disease, a professional standards
review organization or the Society for Cardiac Angiographers.
(6) Statistics shall be kept on the number of normal invasive
cardiac diagnostic studies performed, and written criteria shall be
available for determining when a study is to be considered abnormal.
(7) Direction. Patient services shall be under the direction of a
qualified specialist in internal medicine (cardiovascular disease)
and/or pediatrics (cardiology), depending upon the age group(s)
served.
(8) Staff. The staff of such center shall consist of the following:
(i) an internist and/or pediatrician, depending upon the age
group(s) served, with special training and experience in
cardiovascular diseases;
(ii) a cardiac artiographer whose basic medical training may be in
internal medicine or in radiology. Supplemental qualification shall
include at least two years of training or experience, including but
not limited to the areas of cardiac radiology, clinical and laboratory
cardiology, basic and/or clinical cardiac physiology and catheter
techniques;
(iii) anesthesiologists experienced in the management of cardiac
patients shall be available to the center;
(iv) nurses or medical technicians with appropriate education
and training who shall be regularly assigned to the center; and
(v) a surgeon or surgeons trained and experienced in vascular surgery
shall be available to the center for consultation and management of
complications.
(9) Services. All 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. The following
services shall be provided as a minimum:
(i) a full range of diagnostic services, including but not
limited to diagnostic radiology, clinical laboratory and
noninvasive cardiac diagnostic capability;
(ii) patient and family education; and
(iii) a system of adequate follow-up.
(10) State Cardiac Advisory Committee. The State Cardiac Advisory
Committee shall, at the request of the commissioner, consider any
matter relating to cardiac diagnostic centers and shall advise the
commissioner thereon.
(11) Approval and review. Site visits to existing and prospective
new centers by members of the State Cardiac Advisory Committee, or
other designees of the commissioner, shall be made as indicated, as
an adjunct to initial approval, and/or for maintaining approval.
There shall be sufficient utilization of a center to ensure both
quality and economy of services, as determined by the commissioner.
Any institution seeking to maintain approval, or in applying for
initial approval, shall present evidence that the annual minimum
workload standards can be achieved and maintained. The following
minimum workload standards shall be achieved within two years
following initiation of the service to ensure both quality and
economy of services:
(i) diagnostic centers performing only adult invasive
cardiovascular procedures shall maintain an annual minimum of
200 adult procedures;
(ii) a pediatric diagnostic center located in a facility
approved for pediatric cardiac surgery shall maintain an annual
minimum workload of 100 invasive cardiovascular procedures; and
(iii) diagnostic centers performing both adult and pediatric
procedures shall maintain an annual minimum of 200 adult and 100
pediatric invasive cardiac diagnostic procedures.
(12) Waiver of minimum workload standards. The commissioner may
waive the workload requirements upon a satisfactory showing by the
cardiac diagnostic center that the quality of the service is
adequate and:
(i) there are extenuating circumstances temporarily precluding
compliance with the workload requirements; and/or
(ii) there is a documented unmet need in the center's
geographical service area.
(13) Annual workload reporting. For annual reporting purposes, an
invasive cardiovascular diagnostic procedure shall include left
and/or right heart catheterization with or without the use of
contrast visualization and with or without coronary arteriograms,
excluding:
(i) placement of permanent or temporary pacemaker;
(ii) any floating type catheter;
(iii) his bundle study;
(iv) balloon septostomy;
(v) radionuclide study; and
(vi) right heart catheterization without contrast visualization
in adults.
(f) 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.
(g) 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;
and
(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.
(h) 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.
(i) 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.
(j) 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 medical 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 prior review of
architectural and engineering matters.
(k) 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 prior review
limited to architectural and engineering matters.
19940830
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.
19900928
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 linens 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 requirments in section 12.10 of the State Sanitary Code.
(3) All linen, including blankets, shall be laundered beetween
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 disater.
(h) Animals. No birds, turtles, dogs, cats or other animals exlcusive of
those required for laboratory purposes shall be allowed in a hospital.
Guide dogs or service dogs may accompany the sightless, hearing impaired
or otherwise physically impaired person unless:
(1) the presence of such dog in a particular area is medically
contraindicated; or
(2) the presence of such dog would conflict with or imperil
infection control efforts.
(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) Cental 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 seperation 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;
(vii) the use of chemical indicators with each cycle and weekly
bacteriological spore monitoring for all sterilizers;
(viii) the rotation and reprocessing of sterile equipment and
supplies; and
(ix) the routine checking and removal of outdated or damaged
sterile supplies and equipment or the recall of 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 continuning 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.
19900928
405.25 Organ and tissue donation (anatomical gifts)
Effective Date: December 2, 1994
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 representative shall mean a person appointed by the
hospital administrator to discharge the responsibilities of requesting
the spouse, next of kin or guardian of the decedent to consent to an
anatomical gift. The designated representative may be a hospital
employee, an employee or other agent of an organ procurement
organization or tissue bank, or any other person who has been properly
trained in the procedures for requesting such consents. The hospital
administrator may appoint more than one designated representative;
(2) suitable candidate shall mean a hospital patient who meets the
medical criteria established by the hospital for identifying acceptable
donors of organs, tissues and/or other body parts; and
(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.
(b) The hospital administrator shall assure that written policies and
procedures are established, implemented and maintained for identifying
suitable candidates, notifying an organ procurement organization and/or
appropriate tissue banks licensed pursuant to Part 52 of suitable
candidates, requesting consent by the hospital administrator or a
designated representative and monitoring the implementation of these
functions. These policies and procedures shall be developed in
consultation with organ procurement organizations and licensed tissue
banks operating in the hospital service area. Written policies and
procedures to be established shall include:
(1) criteria for identifying suitable candidates, including medical
criteria for screening potential donors based upon currently accepted
medical standards;
(2) except for when request for consent is not required pursuant to
subdivision (d), or when consent for donation has been denied, a
protocol for notifying an organ procurement organization of each
suitable candidate, including the method and timing of the notification
and the manner of documentation in the patient's medical record;
(3) except for when request for consent is not required pursuant to
subdivision (d), or when consent for donation has been denied, a
protocol for notifying appropriate tissue banks licensed pursuant to
Part 52 of suitable candidates, including the method and timing of the
notification and the manner of documentation in the patient's medical
record;
(4) procedures for seeking consent by the hospital administrator or a
designated representative 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;
(5) a procedure for documenting requests for consent or absence of a
request in the patient's medical record; and
(6) an ongoing system for monitoring compliance with required requests
and the referral of potential donors including the outcomes of such
requests and referrals. 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.
(c)(1) The hospital administrator or designated representative shall, at
the time of death of a suitable candidate who has not executed an organ
donor card, 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.
.TX.
(3) A hospital 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), (2), (3), (4), and (5)
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 person making requests shall be selected based on his/her ability
to relate to families in a sensitive and caring manner and shall be
trained and 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 required request law and the hospital's policies and procedures
regarding required requests for consent to anatomical gifts.
19940829
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.
19900928
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 this Title 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 report.
(b) Access to and disclosure of data contained in the uniform bill,
uniform discharge abstract and ambulatory surgery data abstract shall be
governed by the provisions of section 400.18(e) of this Title.
19900928
405.28 Social services
Effective Date: June 20, 1990
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
medical social worker or other person with appropriate training and
experience.
(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 the 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 State 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 State 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.
19901129
405.43 Orders not to resuscitate
Effective Date: July 8, 1992
405.43 Orders not to resuscitate. (a) The hospital shall adopt and implement
written policies and procedures governing orders not to attempt
cardiopulmonary resuscitation of a patient where consent has been obtained
and which ensure the clarification of the rights and obligations of
patients, their families, and health care providers regarding
cardiopulmonary resuscitation and the issuance of orders not to resuscitate.
Such policies shall assure that:
(1) each patient who consents to an order not to resuscitate is
informed of the range of available resuscitation measures,
consistent with the hospital's equipment and facilities; and
(2) all staff involved in the care of any person for whom an order
not to resuscitate has been issued are promptly informed of the
order, including any limitations or other instructions.
(b) Definitions. The following words or phrases, as used in this
section, shall have the following meanings unless the context otherwise
requires:
(1) Adult means any person who is 18 years of age or older, or is
the parent of a child, or has married.
(2) Attending physician means the physician selected by or assigned to a
patient in a hospital or, for the purpose of provisions herein governing
nonhospital orders not to resuscitate, a patient not in a hospital, who
has primary responsibility for the treatment and care of the patient.
Where more than one physician shares such responsibility, any such
physician may act as the attending physician pursuant to this section.
(3) Capacity means the ability to understand and appreciate the
nature and consequences of an order not to resuscitate, including
the benefits and disadvantages of such an order, and to reach an
informed decision regarding the order.
(4) Cardiopulmonary resuscitation means measures to restore cardiac
function or to support ventilation in the event of a cardiac or
respiratory arrest, such as manual chest compression, mouth-to-mouth
rescue breathing, intubation, direct cardiac injection, intravenous
medications, electrical defibrillation and open-chest cardiac
massage. Cardiopulmonary resuscitation shall also include the
transfer of a patient to another facility if solely for the purpose
of providing cardiopulmonary resuscitation. Cardiopulmonary
resuscitation shall not include measures to improve ventilation and
cardiac function in the absence of an arrest.
(5) Close friend means any person, 18 years of age or older, who
presents an affidavit to an attending physician stating that he is a
close friend of the patient and that he has maintained such regular
contact with the patient as to be familiar with the patient's
activities, health, and religious or moral beliefs and stating the
facts and circumstances that demonstrate such familiarity.
(6) Developmental disability means a developmental disability as
defined in section 1.03(22) of the Mental Hygiene Law.
(7) Emergency medical services personnel means the personnel of a
service engaged in providing initial emergency medical assistance,
including but not limited to first responders, emergency medical
technicians and advanced emergency medical technicians.
(8) Health care agent means a health care agent of the patient
designated pursuant to Article 29-C of the Public Health Law.
(9) Hospital means a general hospital as defined in New York State
Public Health Law, 2801 (10), a nursing home as defined in Section
414.1(a)(3) of this Title, and a health related facility as defined in
Section 414.1(a)(1).
(10) Hospitalization means the period during which a person is a
patient in, or a resident of, a hospital.
(11) Hospital emergency service personnel means the personnel of the
emergency service of a general hospital, as defined in subdivision 10 of
section 2801 of the Public Health Law, including but not limited to
emergency services attending physicians, nurse practitioners, emergency
services registered professional nurses, and registered professional
nurses, nursing staff and registered physicians assistants assigned to
the general hospital's emergency service.
(12) Medically futile means that cardiopulmonary resuscitation will
be unsuccessful in restoring cardiac and respiratory function or
that the patient will experience repeated arrest in a short time
period before death occurs.
(13) Mental hygiene facility means a residential facility operated
or licensed by the Office of Mental Health or the Office of Mental
Retardation and Developmental Disabilities.
(14) Mental illness means a mental illness as defined in section
1.03(20) of the Mental Hygiene Law, provided, however, that mental
illness shall not include dementia, such as Alzheimer's disease or other
disorders related to dementia.
(15) Minor means any person who is not an adult.
(16) Nonhospital order not to resuscitate means an order, issued in
accordance with section 2977 of the Public Health Law, that directs
emergency medical services personnel and hospital emergency service
personnel not to attempt cardiopulmonary resuscitation in the event a
patient suffers cardiac or respiratory arrest.
(17) Order not to resuscitate means an order not to attempt
cardiopulmonary resuscitation in the event a patient suffers cardiac
or respiratory arrest. Such order may cover all cardiopulmonary
resuscitation measures or may be limited to specific procedures or
equipment, depending on the scope of the consent.
(18) Parent means a parent who has custody of a minor.
(19) Patient means a person admitted to a hospital.
(20) Reasonably available means that a person to be contacted can be
contacted with diligent efforts by an attending physician or another
person acting on behalf of the attending physician or the hospital.
(21) Surrogate means the person selected to make a decision regarding
resuscitation on behalf of another person.
(22) Surrogate list means the list set forth in subparagraph (f)(2)(i)
of this section.
(23) Terminal condition means an illness or injury from which there
is no recovery, and which reasonably can be expected to cause death
within one year.
(c) Presumption in favor of a patient's consent to resuscitation;
lawfulness of order; effectiveness of order; duty to provide
information; no duty to expand equipment.
(1) Every person admitted to a hospital shall be presumed to consent
to the administration of cardiopulmonary resuscitation in the event
of cardiac or respiratory arrest, unless there is consent to the
issuance of an order not to resuscitate as provided in this section.
(2) It shall be lawful for the attending physician to issue an order
not to resuscitate a patient, provided that the order has been
issued pursuant to the requirements of this section. The order shall
be included in writing in the patient's chart. An order not to
resuscitate shall be effective upon issuance.
(3) Before obtaining, pursuant to this section, the consent of the
patient, or of the surrogate of the patient, or parent or legal
guardian of the minor patient, to an order not to resuscitate, the
attending physician shall provide to the person giving consent
information about the patient's diagnosis and prognosis, the
reasonably foreseeable risks and benefits of cardiopulmonary
resuscitation for the patient, and the consequences of an order not
to resuscitate.
(4) Nothing in this section shall require a hospital to expand its
existing personnel, training, equipment and facilities to provide
cardiopulmonary resuscitation.
(5) With regard to the provisions of Article 29-C of the Public Health
Law governing health care proxies:
(i) the provisions of that Article shall take precedence over
conflicting provisions of this section; and
(ii) when a patient who has a health care agent lacks capacity, the
agent shall have the rights and authority that a patient with capacity
would have under this section, subject to the terms of the health care
proxy and that Article.
(d) Determination of capacity to make a decision regarding
cardiopulmonary resuscitation. (1) Every adult shall be presumed to have
the capacity to make a decision regarding cardiopulmonary resuscitation
unless determined otherwise pursuant to this section or pursuant to a
court order. A lack of capacity shall not be presumed from the fact that
a committee of the property or conservator has been appointed for the
adult pursuant to article 77 or 78 of the Mental Hygiene Law, or that a
guardian has been appointed pursuant to article 17-A of the Surrogate's
Court Procedure Act.
(2) A determination that an adult patient lacks capacity shall be
made by the attending physician to a reasonable degree of medical
certainty. The determination shall be made in writing and shall
contain such attending physician's opinion regarding the cause and
nature of the patient's incapacity as well as its extent and
probable duration. The determination shall be included in the
patient's medical chart.
(3) (i) At least one other physician, selected by a person
authorized by the hospital to make such selection, must concur in
the determination that an adult lacks capacity. The concurring
determination shall be made in writing after personal examination of
the patient and shall contain the physician's opinion regarding the
cause and nature of the patient's incapacity as well as its extent
and probable duration. Each concurring determination shall be
included in the patient's medical chart.
(ii) If the attending physician of a patient in a general
hospital determines that a patient lacks capacity because of
mental illness, the concurring determination required by
subparagraph (i) of this paragraph shall be provided by a
physician certified or eligible to be certified by the American
Board of Psychiatry and Neurology.
(iii) If the attending physician determines that a patient lacks
capacity because of a developmental disability, the concurring
determination required by subparagraph (i) of this paragraph
shall be provided by a physician or psychologist employed by a
school named in section 13.17 of the Mental Hygiene Law, or who
has been employed for a minimum of two years to render care and
service in a facility operated or licensed by the Office of
Mental Retardation and Developmental Disabilities, or who has
been approved by the Commissioner of Mental Retardation and
Developmental Disabilities, in accordance with regulations
promulgated by such commissioner.
(4) Notice of a determination that the patient lacks capacity shall
promptly be given:
(i) to the patient, where there is any indication of the
patient's ability to comprehend such notice, together with a
copy of a statement summarizing the rights, duties and
requirements of this section;
(ii) to the person on the surrogate list highest in order of
priority listed, when persons in prior clauses are not
reasonably available; and
(iii) if the patient is in or is transferred from a mental
hygiene facility, to the facility director. Nothing in this
paragraph shall preclude or require notice to more than one
person on a surrogate list.
(5) A determination that a patient lacks capacity to make a decision
regarding an order not to resuscitate pursuant to this section shall
not be construed as a finding that the patient lacks capacity for
any other purpose.
(e) Decisionmaking by an adult with capacity.
(1)(i) The consent of an adult with capacity must be obtained prior
to issuing an order not to resuscitate, except as provided in
paragraph (3) of this subdivision.
(ii) If the adult has capacity at the time the order is to be
issued, the consent must be obtained at or about such time,
notwithstanding any prior oral or written consent.
(2)(i) During hospitalization, an adult with capacity may express a
decision consenting to an order not to resuscitate orally in the
presence of at least two witnesses 18 years of age or older, one of
whom is a physician affiliated with the hospital in which the
patient is being treated. Any such decision shall be recorded in the
patient's medical chart.
(ii) Prior to or during hospitalization, an adult with capacity
may express a decision consenting to an order not to resuscitate
in writing, dated and signed in the presence of at least two
witnesses 18 years of age or older who shall sign the decision.
(iii) An attending physician who is provided with or informed of
a decision pursuant to this subdivision shall record or include
the decision in the patient's medical chart if the decision has
not been recorded or included, and either:
(a) promptly issue an order not to resuscitate the patient
or issue an order at such time as the conditions, if any,
specified in the decision are met, and inform the hospital
staff responsible for the patient's care of the order; or
(b) promptly make his or her objection to the issuance of
such an order and the reasons therefor known to the patient,
and either make all reasonable efforts to arrange for the
transfer of the patient to another physician, if necessary,
or promptly submit the matter to the dispute mediation
system.
(iv) Prior to issuing an order not to resuscitate a patient who
has expressed a decision consenting to an order not to
resuscitate under specified medical conditions, the attending
physician must make a determination, to a reasonable degree of
medical certainty, that such conditions exist, and include the
determination in the patient's medical chart.
(v) If a member of the hospital staff responsible for the care
of a patient for whom an order not to resuscitate has been
issued objects to providing care in accordance with the order,
the hospital shall take reasonable steps, such as adjustments in
staff assignments, consistent with the care needs of the
patient, to accommodate the staff member's objections.
(3)(i) In the event that the attending physician determines, in
writing, that to a reasonable degree of medical certainty, an adult
patient who has capacity would suffer immediate and severe injury
from a discussion of cardiopulmonary resuscitation, the attending
physician may issue an order not to resuscitate without obtaining
the patient's consent, but only after:
(a) consulting with and obtaining the written concurrence of
another physician selected by a person authorized by the
hospital to make such selection, given after personal
examination of the patient, concerning the assessment of
immediate and severe injury to the patient from a discussion
of cardiopulmonary resuscitation;
(b) ascertaining the wishes of the patient to the extent
possible without subjecting the patient to a risk of
immediate and severe injury;
(c) including the reasons for not consulting the patient in
the patient's chart; and
(d) obtaining the consent of a health care agent who is available
and would be authorized to make a decision regarding cardiopulmonary
resuscitation if the patient lacked capacity or, if there is no such
agent, a surrogate pursuant to subdivision (f) of this section;
provided, however, that the consent of an agent or surrogate shall
not be required if the patient has previously consented to an order
not to resuscitate pursuant to paragraph (2) of this subdivision.
(ii) Where the provisions of this paragraph have been invoked,
the attending physician shall reassess the patient's risk of
injury from a discussion of cardiopulmonary resuscitation on a
regular basis and shall consult the patient regarding
resuscitation as soon as the medical basis for not consulting
the patient no longer exists.
(4) If the patient is in or is transferred from a mental hygiene
facility, notice of the patient's consent to an order not to
resuscitate shall be given to the facility director prior to the
issuance pursuant to this subdivision of an order not to
resuscitate. Notification to the facility director shall not delay
issuance of an order not to resuscitate. If the facility director
concludes that the patient lacks capacity or that issuance of an
order not to resuscitate may be inconsistent with the patient's
wishes, the facility director shall submit the matter to the dispute
mediation system.
(f) Surrogate decisionmaking.
(1)(i) The consent of a surrogate of health care agent acting on behalf
of an adult patient who lacks capacity, or on behalf of an adult patient
for whom consent by a surrogate or health care agent is authorized by
paragraph (e)(3) of this section, must be obtained prior to issuing an
order not to resuscitate the patient, except as provided in subparagraph
(ii) of this paragraph or subdivision (g) of this section.
(ii) The consent of a surrogate or health care agent shall not be
required where the adult had, prior to losing capacity, consented to
an order not to resuscitate pursuant to paragraph (e)(2) of this
section.
(iii) A decision regarding cardiopulmonary resuscitation by a health
care agent on a principal's behalf is governed by Article 29-C of the
Public Health Law and shall have priority over decisions by any other
person except the patient or as otherwise provided in the health care
proxy.
(2)(i) One person from the following list, to be chosen in order of
priority listed, when persons in the prior clauses are not reasonably
available, willing to make a decision regarding issuance of an order not
to resuscitate, and competent to make a decision regarding issuance of
an order not to resuscitate, shall have the authority to act as
surrogate on behalf of the patient:
(a) a committee of the person or a guardian appointed
pursuant to article 17-A of the Surrogate's Court Procedure
Act, provided that this clause shall not be construed to
require the appointment of a committee of the person or
guardian for the purpose of making the resuscitation
decision;
(b) the spouse;
(c) a son or daughter 18 years of age or older;
(d) a parent;
(e) a brother or sister 18 years of age or older; or
(f) a close friend.
(ii) After the surrogate has been identified, the name of such
person shall be included in the patient's medical chart.
(iii) A determination that a surrogate is not competent to act
as surrogate shall be made in the same manner as a determination
that a patient lacks capacity pursuant to subdivision (d) of
this section, and may be the subject of an appeal to the dispute
mediation system by the surrogate.
(3)(i) The surrogate shall make a decision regarding cardiopulmonary
resuscitation on the basis of the adult patient's wishes, including a
consideration of the patient's religious and moral beliefs, or, if the
patient's wishes are unknown and cannot be ascertained, on the basis of
the patient's best interests.
(ii) Notwithstanding any law to the contrary, the surrogate
shall have the same right as the patient to receive medical
information and medical records.
(iii) A surrogate may consent to an order not to resuscitate on
behalf of an adult patient only if there has been a
determination by an attending physician, with the concurrence of
another physician selected by a person authorized by the
hospital to make such selection, given after personal
examination of the patient, that, to a reasonable degree of
medical certainty:
(a) the patient has a terminal condition; or
(b) the patient is permanently unconscious; or
(c) resuscitation would be medically futile; or
(d) resuscitation would impose an extraordinary burden on
the patient in light of the patient's medical condition and
the expected outcome of resuscitation for the patient.
Each determination shall be included in the patient's medical
chart.
(4)(i) A surrogate shall express a decision consenting to an order not
to resuscitate either:
(a) in writing, dated, and signed in the presence of one witness 18
years of age or older who shall sign the decision; or
(b) orally, to two persons 18 years of age or older, one of whom is
a physician affiliated with the hospital in which the patient is
being treated. Any such decision shall be recorded in the patient's
medical record.
(ii) The attending physician who is provided with the decision
of a surrogate shall include the decision in the patient's
medical chart and, if the surrogate has consented to the
issuance of an order not to resuscitate, shall either:
(a) promptly issue an order not to resuscitate the patient
and inform the hospital staff responsible for the patient's
care of the order; or
(b) promptly make the attending physician's objection to the
issuance of such an order known to the surrogate, and either
make all reasonable efforts to arrange for the transfer of
the patient to another physician, if necessary, or promptly
refer the matter to the dispute mediation system.
(iii) If the patient is in or is transferred from a mental
hygiene facility, notice of a surrogate's consent to an order
not to resuscitate shall be given to the facility director prior
to the issuance pursuant to this section of an order not to
resuscitate. Notification to the facility director shall not
delay issuance of an order not to resuscitate. If the facility
director concludes that the patient has capacity or that
issuance of an order not to resuscitate is otherwise
inconsistent with this section, the facility director shall
submit the matter to the dispute mediation system.
(iv) If the attending physician has actual notice of opposition
to a surrogate's consent to an order not to resuscitate by any
person on the surrogate list, or, if the patient is in or is
transferred from a mental hygiene facility, by the facility
director, the physician shall submit the matter to the dispute
mediation system and such order shall not be issued or shall be
revoked in accordance with the provisions of paragraph (m)(3) of
this section.
(v) If a member of the hospital staff responsible for the care
of a patient for whom an order not to resuscitate has been
issued objects to providing care in accordance with the order,
the hospital shall take reasonable steps, such as adjustments in
staff assignments, consistent with the care needs of the
patient, to accommodate the staff member's objections.
(5) If a surrogate has consented to an order not to resuscitate,
notice of the surrogate's decision shall be given to the patient
where there is any indication of the patient's ability to comprehend
such notice, except if determination has been made pursuant to
paragraph (e)(3) of this section. If the patient objects, an order
not to resuscitate shall not be issued.
(g) Decisionmaking on behalf of an adult patient without capacity for
whom no surrogate is available. (1) If no surrogate is reasonably
available, willing to make a decision regarding issuance of an order not
to resuscitate, and competent to make a decision regarding issuance of
an order not to resuscitate on behalf of an adult patient who lacks
capacity and who had not previously expressed a decision regarding
cardiopulmonary resuscitation, an attending physician:
(i) may issue an order not to resuscitate the patient, provided
that the attending physician determines, in writing, that, to a
reasonable degree of medical certainty, resuscitation would be
medically futile, and another physician selected by a person
authorized by the hospital to make such selection, after
personal examination of the patient, reviews and concurs in
writing with such determination; or
(ii) shall issue an order not to resuscitate the patient,
provided that a court has granted a judgment directing the
issuance of such an order.
(2) If the patient is in or is transferred from a mental hygiene
facility, prior to issuance of an order not to resuscitate pursuant
to paragraph (1) of this subdivision, notice of such order shall be
given to the facility director. Notification to the facility
director shall not delay issuance of an order not to resuscitate. If
the facility director concludes that the patient has capacity or
that issuance of an order not to resuscitate is otherwise
inconsistent with this section, the facility director shall submit
the matter to the dispute mediation system.
(3) Notwithstanding any other provision of this subdivision, where a
decision to consent to an order not to resuscitate has been made,
notice of the decision shall be given to the patient where there is
any indication of the patient's ability to comprehend such notice,
except where a determination has been made pursuant to paragraph
(e)(3) of this section. If the patient objects, an order not to
resuscitate shall not be issued.
(h) Decisionmaking on behalf of a minor patient. (1) An attending
physician, in consultation with a minor's parent or legal guardian,
shall determine whether a minor has the capacity to make a decision
regarding resuscitation.
(2)(i) The consent of a minor's parent or legal guardian and the
consent of the minor, if the minor has capacity, must be obtained
prior to issuing an order not to resuscitate the minor.
(ii) Where the attending physician has reason to believe that there is
another parent or a noncustodial parent who has not been informed of a
decision to issue an order not to resuscitate the minor, the attending
physician, or someone acting on behalf of the attending physician,
shall make reasonable efforts to determine if the uninformed parent or
non-custodial parent has maintained substantial and continuous contact
with the minor, and, if so, shall make diligent efforts to notify that
parent or noncustodial parent of the decision prior to issuing the
order.
(iii) If the minor is in or is transferred from a mental hygiene
facility, notice of a decision to issue an order not to
resuscitate the minor shall be given to the facility director
prior to issuance of an order not to resuscitate. Notification
to the facility director shall not delay issuance of an order
not to resuscitate. If the facility director concludes that
issuance of an order not to resuscitate is inconsistent with
this section, the facility director shall submit the matter to
the dispute mediation system.
(3) A parent or legal guardian may consent to an order not to
resuscitate on behalf of a minor only if there has been a written
determination by the attending physician, with the written
concurrence of another physician selected by a person authorized by
the hospital to make such selections, given after personal
examination of the patient, that, to a reasonable degree of medical
certainty, the minor suffers from one of the medical conditions set
forth in subparagraph (f)(3)(iii) of this section. Each
determination shall be included in the patient's medical record.
(4)(i) A parent or legal guardian of a minor, in making a decision
regarding cardiopulmonary resuscitation, shall consider the minor
patient's wishes, including a consideration of the minor patient's
religious and moral beliefs, and shall express a decision consenting
to issuance of an order not to resuscitate either:
(a) in writing, dated and signed in the presence of one witness 18
years of age or older who shall sign the decision, or
(b) orally, to two persons 18 years of age or older, one of whom is
a physician affiliated with the hospital in which the patient is
being treated. Any such decision shall be recorded in the patient's
medical record.
(ii) The attending physician who is provided with the decision
of a minor's parent or legal guardian, expressed pursuant to
this paragraph, and of the minor if the minor has capacity,
shall include such decision or decisions in the minor's medical
chart and shall comply with the provisions of subparagraph
(f)(4)(ii) of this section.
(iii) If the attending physician has actual notice of the
opposition of a parent or noncustodial parent to consent by
another parent to an order not to resuscitate a minor, the
physician shall submit the matter to the dispute mediation
system and such order shall not be issued or shall be revoked in
accordance with the provisions of paragraph (m)(3) of this
section.
(i) Effect of order not to resuscitate on other treatment. Consent to
the issuance of an order not to resuscitate shall not constitute consent
to withhold or withdraw medical treatment other than cardiopulmonary
resuscitation.
(j) Revocation of consent to order not to resuscitate. (1) A person may,
at any time, revoke his or her consent to an order not to resuscitate
himself or herself by making either a written or an oral declaration to
a physician or member of the nursing staff at the hospital where he or
she is being treated, or by any other act evidencing a specific intent
to revoke such consent.
(2) Any surrogate, parent or legal guardian may at any time revoke
his or her consent to an order not to resuscitate a patient by:
(i) notifying a physician or member of the nursing staff of the
revocation of consent in writing, dated and signed; or
(ii) orally notifying the attending physician in the presence
of a witness 18 years of age or older.
(3) Any physician who is informed of or provided with a revocation
of consent pursuant to this subdivision shall immediately include
the revocation in the patient's chart, cancel the order, and notify
the hospital staff responsible for the patient's care of the
revocation and cancellation. Any member of the nursing staff who is
informed of or provided with a revocation of consent pursuant to
this subdivision shall immediately notify a physician of such
revocation.
(k) Physician review of the order not to resuscitate. (1) For each
patient for whom an order not to resuscitate has been issued, the
attending physician shall review the patient's chart to determine if the
order is still appropriate in light of the patient's condition and shall
indicate on the patient's chart that the order has been reviewed:
(i) for a patient, excluding outpatients described in subparagraph
(ii) of this paragraph and alternate level of care patients, in a
hospital, other than a residential health care facility, at least
every seven days;
(ii) for an outpatient whose order not to resuscitate is effective
while the patient receives care in a hospital, each time the attending
physician examines the patient, whether in the hospital or elsewhere,
provided that the review need not occur more than once every seven
days; and
(iii) for a patient in a residential health care facility or an
alternate level of care patient in a hospital, each time the patient
is required to be seen by a physician, but at least every 60 days.
Failure to comply with this paragraph shall not render an order not to
resuscitate ineffective.
(2)(i) If the attending physician determines at any time that an order
not to resuscitate is no longer appropriate because the patient's
medical condition has improved, the physician shall immediately notify
the person who consented to the order. Except as provided in
subparagraph (ii) of this paragraph, if such person declines to revoke
consent to the order, the physician shall promptly (a) make reasonable
efforts to arrange for the transfer of the patient to another physician,
or (b) submit the matter to the dispute mediation system.
(ii) If the order not to resuscitate was entered upon the consent of a
surrogate, parent or legal guardian, and the attending physician who
issued the order, or, if unavailable, another attending physician, at
any time determines that the patient does not suffer from one of the
medical conditions set forth in subparagraph (f)(3)(iii) of this
section, the attending physician shall immediately include such
determination in the patient's medical record, cancel the order, and
notify the person who consented to the order and all hospital staff
responsible for the patient's care of cancellation.
(iii) If an order not to resuscitate was entered upon the
consent of a surrogate and the patient at any time gains or
regains capacity, the attending physician who issued the order,
or, if unavailable, another attending physician, shall
immediately cancel the order and notify the person who consented
to the order and all hospital staff directly responsible for the
patient's care of the cancellation.
(l) Interinstitutional transfer. (1) If a patient for whom an order not
to resuscitate has been issued is transferred from a hospital to a
different hospital:
(i) the transferring hospital shall notify the ambulance
personnel and the transferee hospital of the order; and
(ii) the order shall be binding upon ambulance personnel during the
transfer and shall remain effective for the transferee hospital unless
revoked pursuant to this section until the attending physician first
examines the transferred patient, whereupon the attending physician
must either:
(a) issue an order continuing the prior order not to resuscitate.
Such order may be issued without obtaining further consent from the
patient, surrogate or parent pursuant to this section; or
(b) cancel the order not to resuscitate, provided the attending
physician immediately notifies the person who consented to the order
and the hospital staff directly responsible for the patient's care
of the cancellation. Such cancellation does not preclude the entry
of a new order pursuant to this section.
(2) If the attending physician at the transferee hospital disagrees with
the person who consented to the order regarding the appropriateness of
issuing a new order, the attending physician shall promptly make his or
her objection to the issuance of an order known to the person who
consented and either make all reasonable efforts to arrange for the
transfer of the patient to another physician, if necessary, or promptly
submit the matter to the dispute mediation system.
(m) Dispute mediation system.
(1)(i) Each hospital shall establish a mediation system for the
purpose of mediating disputes regarding the issuance of orders not
to resuscitate.
(ii) The dispute mediation system shall be described in writing
and adopted by the hospital's governing authority. It may
utilize existing hospital resources, such as a patient
advocate's office or hospital chaplain's office, or it may
utilize a body created specifically for this purpose, which may
include the State Ombudsman representative, but, in the event a
dispute involves a patient deemed to lack capacity pursuant to:
(a) subparagraph (d)(3)(ii) of this section, the system must include
a physician eligible to provide a concurring determination, or a
family member or guardian of a person with a mental illness of the
same or similar nature; or
(b) subparagraph (d)(3)(iii) of this section, the system must
include a physician eligible to provide a concurring determination,
or a family member or guardian of a person with a developmental
disability of the same or similar nature.
(2) The dispute mediation system shall be authorized to mediate any
dispute including disputes regarding the determination of the patient's
capacity, arising under this section between the patient and an
attending physician or the hospital that is caring for the patient and,
if the patient is a minor, the patient's parent, or among an attending
physician, a parent, noncustodial parent, or legal guardian of a minor
patient, any person on the surrogate list, the hospital that is caring
for the patient, the Commissioner of Health and, where the dispute
involves a patient who is in or is transferred from a mental hygiene
facility, the facility director.
(3) After a dispute regarding the issuance of an order not to
resuscitate has been submitted to the dispute mediation system, an
order not to resuscitate shall not be issued, or shall be revoked
and may not be reissued, until (i) the dispute has been resolved or
the system has concluded its effort to resolve the dispute, or (ii)
72 hours have elapsed from the time of the submission of the
dispute, whichever shall occur first. Persons participating in the
dispute mediation system shall be informed of their right to
judicial review.
(4) If a dispute between a patient who expressed a decision
rejecting cardiopulmonary resuscitation and an attending physician
or the hospital that is caring for the patient is submitted to the
dispute mediation system, and either:
(i) the dispute mediation system has concluded its efforts to
resolve the dispute; or
(ii) 72 hours have elapsed from the time of submission without
resolution of the dispute, whichever shall occur first; the
attending physician shall either: promptly issue an order not to
resuscitate the patient or issue the order at such time as the
conditions, if any, specified in the decision are met, and
inform the hospital staff responsible for the patient's care of
the order; or promptly arrange for the transfer of the patient
to another physician or hospital.
(5) Persons appointed pursuant to this subdivision to participate in
the dispute mediation system shall not have authority to determine
whether a do not resuscitate order shall be issued.
(n) Judicial review. (1) The patient, an attending physician, a parent,
noncustodial parent, or legal guardian of a minor patient, any person on
the surrogate list, the hospital that is caring for the patient and, in
disputes involving a patient who is in or is transferred from a mental
hygiene facility, the facility director, may commence a special
proceeding pursuant to article 4 of the Civil Practice Law and Rules, in
a court of competent jurisdiction, with respect to any dispute arising
under this article, except that the decision of any patient not to
consent to issuance of an order not to resuscitate may not be subjected
to judicial review. In any proceeding brought pursuant to this paragraph
challenging a decision regarding issuance of an order not to resuscitate
on the ground that the decision is contrary to the patient's wishes or
best interests, the person or entity challenging the decision must show,
by clear and convincing evidence, that the decision is contrary to the
patient's wishes, including consideration of the patient's religious and
moral beliefs, or, in the absence of evidence of the patient's wishes,
the decision is contrary to the patient's best interests. In any other
proceeding brought pursuant to this paragraph, the court shall make its
determination based upon the applicable substantive standards and
procedures set forth in this section.
(2) In any proceeding brought pursuant to this subdivision, the
court may issue an order, pursuant to the standards applicable to
the issuance of a temporary restraining order according to section
6313 of the Civil Practice Law and Rules, which shall suspend the
order not to resuscitate to permit review of the matter by the
court.
(3) Where a person or entity may invoke the dispute mediation
system, no such proceeding shall be commenced until the dispute
mediation system has concluded its efforts to resolve the dispute or
72 hours have elapsed from the submission of the dispute to the
dispute mediation system, whichever shall occur first; provided,
however, that the patient may commence an action for relief with
respect to any dispute under this section at any time and provided
further that the Department of Health or any other duly authorized
State agency may commence an action or proceeding to enjoin a
violation of this section at any time.
(o) Immunity. (1) No physician, health-care professional, nurse's aide,
hospital or person employed by or under contract with the hospital shall
be subject to criminal prosecution, civil liability, or be deemed to
have engaged in unprofessional conduct for carrying out in good faith
pursuant to this section a decision regarding cardiopulmonary
resuscitation by or on behalf of a patient or for those actions taken in
compliance with the standards and procedures set forth in this section.
(2) No physician, health-care professional, nurse's aide, hospital,
or person employed by or under contract with the hospital shall be
subjected to criminal prosecution, civil liability, or be deemed to
have engaged in unprofessional conduct for providing cardiopulmonary
resuscitation to a patient for whom an order not to resuscitate has
been issued, provided such physician or person:
(i) reasonably and in good faith was unaware of the issuance of
an order not to resuscitate; or
(ii) reasonably and in good faith believed that consent to the
order not to resuscitate had been revoked or cancelled.
(3) No person shall be subjected to criminal prosecution or civil
liability for consenting or declining to consent in good faith, on
behalf of the patient, to the issuance of an order not to
resuscitate pursuant to this section.
(4) No person shall be subjected to criminal prosecution or civil
liability or be deemed to have engaged in unprofessional conduct for
acts performed in good faith as a mediator in the dispute mediation
system established by this section.
(p) Effect of order not to resuscitate on insurance and health-care
services. (1) No policy of life insurance shall be legally impaired,
modified or invalidated in any manner by the issuance of an order not to
resuscitate, notwithstanding any term of the policy to the contrary.
(2) A person may not prohibit or require the issuance of an order
not to resuscitate for an individual as a condition for such
individual's being insured or for receiving health-care services.
(q) Judicially approved order not to resuscitate. (1) If no surrogate is
reasonably available, willing to make a decision regarding issuance of
an order not to resuscitate, and competent to make a decision regarding
issuance of an order not to resuscitate on behalf of an adult patient
who lacks capacity and who had not previously expressed a decision
regarding cardiopulmonary resuscitation pursuant to this section, an
attending physician or hospital may commence a special proceeding
pursuant to article 4 of the Civil Practice Law and Rules, in a court of
competent jurisdiction, for a judgment directing the physician to issue
an order not to resuscitate where the patient has a terminal condition,
is permanently unconscious, resuscitation would impose an extraordinary
burden on the patient in light of the patient's medical condition and
the expected outcome of resuscitation for the patient, and issuance of
an order not to resuscitate is consistent with the patient's wishes
including a consideration of the patient's religious and moral beliefs
or, in the absence of evidence of the patient's wishes, the patient's
best interests.
(2) Nothing in this section shall be construed to preclude a court
of competent jurisdiction from approving the issuance of an order
not to resuscitate under circumstances other than those under which
such an order may be issued pursuant to this section.
(r) The hospital shall:
(1) ensure that each member of the hospital's staff involved in the
provision of care is trained in the requirements governing orders
not to resuscitate;
(2) ensure that all hospital emergency service personnel honor
nonhospital orders not to resuscitate in accordance with section 2977 of
the Public Health Law and that all hospital personnel otherwise comply
with the provisions of such section as they relate to in-hospital
activities affected by such nonhospital orders not to resuscitate.
(3) post in a public place in the hospital a summary of the rights,
duties and requirements of this section as prepared by the
commissioner; and
(4) furnish a copy of such summary to patients or to persons on the
surrogate list known to the hospital at the time of the first decision
made pursuant to subdivisions (e) through (h) of this section.
19920618
405.44 Separability
Effective Date: May 1, 1996
405.44 Separability. 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.
19960409
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New York State Department of Health Posted 08/07/96