Current through Register Vol. 47, No. 12, March 26, 2025
(a) Level I
perinatal care service means a comprehensive maternal and newborn service
provided by a hospital designated as such by the department for normal low-risk
newborns and 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.
(b)
Level II perinatal care means a comprehensive maternal and newborn service
provided by a hospital designated as such by the department which includes
services for moderately high-risk newborns and for women who have been assessed
as having the potential or likelihood for a moderately complicated or high-risk
delivery and/or bearing a fetus exhibiting the potential for unusual or
high-risk development. Such services may also provide services to women
requiring care normally provided at Level I perinatal care services.
(c) Level III perinatal care means a
comprehensive maternal and newborn service provided by a hospital designated as
such by the department and which includes services for women and newborns who
have been assessed as high-risk patients and/or are bearing high-risk fetuses,
who will require a high level of specialized care. Such programs may also
provide services to women and newborns requiring care normally provided at
Level I and II perinatal care services.
(d) Regional perinatal center (RPC) means a
hospital or hospitals housing a perinatal care service which meets the
standards for a Level III perinatal care service but which also, includes
highly specialized services that may not be available at all Level III
hospitals, and designated as such by the department. An RPC serves a geographic
area or a group of perinatal affiliates. It provides all aspects of
comprehensive maternal and neonatal care, and its functions and
responsibilities also include efforts to coordinate and improve quality of
perinatal care among its affiliates, attending level consultation regarding
patient transfer and clinical management, transport of high-risk patients,
outreach to affiliates to determine educational needs, education and training
of affiliate hospitals, data collection, evaluation and analysis within that
region. If two or more hospitals jointly sponsor an RPC, they must define in a
written agreement between or among the hospitals comprising the RPC how the
aforementioned functions and responsibilities will be carried out.
(e) Perinatal affiliation agreement shall
mean a written fully executed agreement between a Level I, II or III perinatal
care hospital, and that hospital's designated RPC. A perinatal affiliation
agreement shall include provisions for, at a minimum:
(1) criteria, policies and procedures for
transfer of patients, with appropriate consent, to the RPC and from the RPC
back to the sending hospital;
(2)
criteria and process for attending level subspecialty consultation on a 24-
hour basis, including types of consultation processes (i.e., via telephone,
telemedicine or in-house consults) acceptable for each subspecialty;
(3) participation in the statewide perinatal
data system (SPDS) including the provision of the confidentiality and
protection of all data obtained through the SPDS;
(4) cooperation in outreach, education,
training and data collection activities;
(5) authority for one geographically
accessible RPC representative or representatives to participate in the
affiliate hospital's quality assurance committee and other reviews of the
quality of perinatal care provided by the affiliate and to provide
recommendations for quality improvement of perinatal services. Each RPC and
each affiliate hospital shall take actions necessary, including but not limited
to, entering into a perinatal affiliation agreement, to authorize such
participation by the RPC's representatives in the affiliate hospital's quality
assurance committee and for purposes of such participation, the RPC
representative or representatives shall be deemed member(s) of the affiliate's
quality assurance committee, shall maintain the confidentiality of all
information obtained in such capacity and are subject to the confidentiality
restrictions of Public Health Law section 2805-m;
(6) RPC involvement in the development of
written agreements among perinatal affiliates including criteria regarding
transport of women and newborns;
(7) timely consultation on treatment plans
for women and neonates who develop or exhibit unanticipated conditions which
may require transfer to a higher level of care; and
(8) resolution of disputes or disagreements
between the RPC and the perinatal affiliate, including disagreements regarding
interpretation of affiliation agreement criteria for consultation and/or
transfer. In cases of disputes or disagreement between an affiliate and its
RPC, the affiliate and the RPC shall follow the dispute resolution process
outlined in their perinatal affiliation agreement. If the dispute is not
resolved within 60 days, the parties must request review by the department. The
department shall initiate compliance reviews at both sites, advise each
facility of its findings, and require corrective action, as indicated, to
resolve the dispute. This process shall not interfere with the timely and
proper transfer of mothers and newborns.
(f) Transfer agreement shall mean a written
agreement between a Level I or II perinatal service and a Level III hospital
for the transfer of patients requiring Level III care. Perinatal transfer
agreements shall address the provision and/or coordination of all high-risk
maternal and newborn transports. The agreements shall reflect the following:
(1) the maximum allowable surface travel time
to reach a Level III or RPC hospital shall be two hours under usual weather and
road conditions, and the receiving hospital shall be accessible and convenient
to the mother's place of residence whenever possible;
(2) mutually agreed criteria for determining
when consultation and/or transfer is required;
(3) procedures and responsibility for
arranging transport;
(4)
requirement for 24-hour availability of appropriately qualified RPC medical
staff to respond to calls from affiliates;
(5) policies for obtaining patient or
parent/guardian consent for patient transfer and to exchange medical
information;
(6) procedures for
making arrangements for transfer to another hospital if the receiving hospital
is unable to accept the transfer due to capacity/bed limitations;
(7) a provision that an emergency transport
shall depart within 30 minutes of the request for transfer;
(8) provisions for the back transfer of
newborns who no longer need Level III or RPC care but who need continuing care
in a hospital located near their home communities shall be part of the
perinatal affiliation and/or transfer agreements between two hospitals;
and
(9) higher level hospitals
shall inform referring hospitals of major changes in status of transferred
patients, with patient's consent or with parental or guardian consent in the
case of newborn transfers.
(g) Definitions contained in section
405.21(b) of this
Title shall apply to this Part.
