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Title: Section 721.2 - Definitions

Effective Date


Section 721.2 Definitions

(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; and

(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 sixty 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 thirty 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.


VOLUME E (Title 10)