(a) Perinatal services will be designated by the commissioner based on the following:

1. (1) each hospital designated as a Level I, Level II or Level III hospital shall enter a written perinatal affiliation agreement with an RPC;
2. (2) the level of care currently provided by the hospital shall meet the definition, standards and criterion set forth in this Part for a Level I, Level II, Level III perinatal service or RPC;

3. (3) for Level II, Level III and RPCs, the number of births and intensity of neonatal care at the hospital during the previous full calendar year must meet the following minimum volume standards:

   1. (i) a Level II perinatal care hospital shall provide no fewer than 1,200 high-risk newborn patient days annually, and no fewer than 150 high-risk maternal patient days annually;
   2. (ii) a Level III perinatal care hospital shall provide no fewer than 2,000 high-risk newborn patient days annually, and no fewer than 250 high-risk maternal patient days annually;
   3. (iii) RPCs shall provide no fewer than 4,000 high-risk newborn patient days annually, and no fewer than 400 high-risk maternal patient days annually. An RPC shall provide quality improvement services to a group of perinatal affiliates with a minimum total of 8,000 births each year;
4. (4) the availability of appropriate medical, nursing, and other staffing as described in this Part supportive of the perinatal service at the hospital;
5. (5) surface travel time for transfers. The surface travel time to reach a Level II hospital, a Level III hospital, or an RPC within the geographic area or affiliative perinatal network, under usual travel conditions shall be no more than two hours. Transfer decisions must be based on the appropriate level of perinatal care required, and care shall be provided at a hospital offering the appropriate level of care which is accessible and convenient to the mother's place of residence whenever feasible;
6. (6) the geographic distribution of designated hospitals throughout the state to ensure access to appropriate levels of care throughout the state; and

7. (7) such other additional information as the commissioner may require to make the designation.

   (b) Designation process.

8. (1) Each hospital certified to provide perinatal services shall complete a designation survey by the department and verify specific data about its maternal and newborn discharges. The department shall assess the results of the survey and data in order to assign a designation. The department may require an on-site review of services at a hospital before making a designation, in which case the hospital shall participate and cooperate in the review and provide any additional information requested. A hospital shall receive its designation only after this process is complete and the department has obtained and considered all relevant information to its satisfaction.
9. (2) The perinatal designation of a hospital shall appear on the hospital's operating certificate.

10. (3) Perinatal designation on the maternity information leaflet. The hospital's perinatal designation and a brief definition of the Level shall be included in the maternity information leaflet distributed to each prospective maternity patient, pursuant to Public Health Law section 2803-j(1).

    (c) Redesignations.

11. (1) A hospital may apply to change its designation no sooner than one year following its most recent designation.
12. (2) The department may initiate a review and monitor compliance with the definitions, standards and criteria set forth in this Part by perinatal services and RPCs at any time.
13. (3) The department may change a designation if it finds that a hospital perinatal service or RPC no longer meets the definition, standards and criterion for its current designation.
14. (4) Maintenance of minimum volume standards. To ensure that service capability and staff competence are maintained for Level II, Level III, or an RPC, a hospital which fails to meet minimum volume standards and is seeking to maintain its designation, or applying for another designation, shall present evidence that the annual minimum volume standards will be achieved within one year following the decision to allow the hospital to remain at the present level of designation or the initiation of the new designation. Minimum volume standards may be waived by the department if the department determines that a waiver will improve access while maintaining high quality care.