1. (a) The hospital shall inform the parent(s) of each newborn born in the hospital, or admitted to the hospital within the first 28 days of life, of the purpose and need for newborn screening, and shall provide newborn screening educational materials made available by the department.
2. (b) Specimen collection forms shall be properly stored in a cool and dry environment prior to use.

3. (c) The hospital shall collect a satisfactory specimen from every newborn between 24 and 36 hours after birth, except under the following circumstances:

   1. (1) If a newborn is less than 24 hours of age at the time of discharge from the birth hospital, the birth hospital shall collect an initial satisfactory specimen prior to discharge. The birth hospital shall schedule and collect a repeat specimen from the newborn between 48 and 72 hours after birth.
   2. (2) If a newborn is transferred to another hospital, the birth hospital shall collect an initial satisfactory specimen from the newborn prior to transfer, submit the satisfactory specimen to the testing laboratory, and provide written and/or electronic notification to the receiving hospital that a specimen was collected. The receiving hospital shall collect any repeat specimens from the newborn following transfer that are required by the testing laboratory. If the newborn is less than 24 hours of age when the birth hospital collects the satisfactory specimen, the receiving hospital shall collect a repeat specimen from the newborn between 48 and 72 hours after birth.
   3. (3) If a newborn requires admission to an intensive medical care unit prior to the collection of a satisfactory specimen, the hospital shall collect an initial satisfactory specimen upon admission to the unit and shall submit the satisfactory specimen to the testing laboratory. The hospital shall collect a repeat specimen between 48 and 72 hours after birth and shall submit the repeat specimen to the testing laboratory. The hospital shall collect a third satisfactory specimen upon discharge or at 28 days after birth, whichever comes first, designate it a repeat specimen, and submit the repeat specimen to the testing laboratory.
   4. (4) If a newborn requires transfusion or total parenteral nutrition (TPN), the hospital shall collect an initial satisfactory specimen prior to any transfusion or administration of TPN and shall submit the satisfactory specimen to the testing laboratory. If a specimen is not collected prior to transfusion and/or TPN, the hospital shall wait to collect an initial satisfactory specimen until 72 hours after administration of a transfusion and/or TPN and submit the specimen to the testing laboratory. The hospital shall schedule and collect a repeat specimen no later than 120 days after the date of final transfusion and/or TPN, and submit the repeat specimen to the testing laboratory.
   5. (5) If a newborn is admitted to the hospital within the first 28 days of life and no specimen has been previously collected, the hospital shall collect a satisfactory specimen upon admission and submit it to the testing laboratory.
4. (d) All specimens shall be air dried thoroughly on a flat nonabsorbent surface for a minimum of three hours prior to forwarding to the testing laboratory.

5. (e) All specimens, including repeat specimens, shall be submitted to the testing laboratory within 24 hours of collection to ensure the specimens are received by the testing laboratory no later than 48 hours after collection using the testing laboratory's delivery service or an equivalent arrangement.

   1. (1) When notified by the testing laboratory that a repeat specimen is required, the hospital shall notify the parent(s) and responsible provider within one business day that a repeat specimen is required from the newborn. The hospital shall collect the repeat specimen, pursuant to guidance issued by the testing laboratory, and submit it to the testing laboratory as soon as practicable.
   2. (2) If the responsible provider documented on the initial specimen collection form is no longer responsible for the newborn’s care, the hospital shall identify a new provider, notify the new provider of the need for a repeat specimen, and submit the contact information for the new provider to the testing laboratory.
   3. (3) If the hospital is unable to obtain a repeat specimen, the hospital shall submit written and/or electronic documentation to the testing laboratory describing the steps taken by the hospital to notify the parent(s) and responsible provider that a repeat specimen(s) was required. The hospital shall submit this documentation to the testing laboratory no later than 90 days after receiving notification from the testing laboratory that a repeat specimen was required.

   (f)

6. (g) If a satisfactory specimen or a repeat specimen is not collected due to newborn mortality, the hospital shall submit a written and/or electronic notification to the testing laboratory within five days after death.

7. (h) The hospital shall submit all information required by the testing laboratory using an electronic format determined by the department, provided that:

   1. (1) specimen collection forms shall be submitted as directed by the testing laboratory; and
   2. (2) a hospital may request an exemption from electronic submission by demonstrating, to the department’s satisfaction, that the requirement imposes an undue burden.
8. (i) The hospital shall document on the newborn’s health record the LAB I.D., as it appears on the specimen collection form, the date and time of specimen collection, and all screening results.
9. (j) The hospital shall document the LAB I.D., as it appears on the specimen collection form, on any discharge summary, and shall transmit a copy of the screening results or a copy of the discharge summary to the responsible provider.
10. (k) Before performing any tasks relating to collection of specimens, an employee shall complete comprehensive specimen collection training. The employee shall complete such training annually thereafter. The hospital shall retain documentation of completion of all such training.
11. (l) The hospital shall provide the testing laboratory with the names and contact information for its hospital administrative designee(s) and medical designee(s), annually; within 90 days of any request from the testing laboratory; and within 30 days of a change of designee. Such information shall be provided on a form prescribed by the department.

12. (m) The hospital shall establish written policies and procedures, which shall be available for the department’s review, for:

    1. (1) the collection, storage, tracking and shipping of specimens; and
    2. (2) the tracking and disposition of test results.

13. (n) The hospital shall comply with the following additional requirements for HIV testing:

    1. (1) the hospital shall obtain written documentation of any HIV testing and treatment during the current pregnancy and include such documentation in the mother’s health record. The hospital shall counsel the mother consistent with such testing;
    2. (2) if no HIV test result is documented in the health record of a mother and the mother’s HIV status during the current pregnancy is unknown, the hospital shall immediately arrange an expedited HIV test of the mother with her consent, or if the mother declines testing for herself, arrange for expedited HIV antibody screen for the newborn with results available as soon as practicable, but no later than 12 hours after the mother provides consent for testing or, if she does not consent, 12 hours after the time of the newborn's birth;
    3. (3) the hospital shall maintain in the newborn’s health record the newborn’s HIV test result in accordance with article 27-F of the Public Health Law;
    4. (4) the hospital shall determine the need for, and ensure provision of, HIV prophylaxis and/or treatment per standard of care to prevent transmission to the infant, and shall record such in both the mother’s and newborn’s health records;
    5. (5) the hospital shall transmit a copy of the newborn's HIV test result to the responsible provider. For any newborn with a result indicating exposure to HIV, the hospital shall coordinate with the responsible provider to arrange appointments for follow up care with a provider experienced in the treatment of HIV;
    6. (6) the hospital shall submit to the department any specimen(s) necessary to confirm the HIV infection status of the newborn; or submit documentation of confirmatory test results from a laboratory permitted pursuant to section 574 of the Public Health Law;
    7. (7) the hospital shall collect and provide authorized department staff with such data as the department may require for program evaluation and, in the case of HIV exposed newborns, patient follow-up;
    8. (8) the hospital shall submit to the department information related to HIV testing and treatment history of mothers and newborns for the purposes of medical audits. Such information shall be kept confidential as required by section 206(1)(j) of the Public Health Law; and

    9. (9) the hospital shall provide the department with the names and contact information for an HIV administrative designee(s) and a hospital appointed HIV medical designee(s):

       1. (i) annually;
       2. (ii) within 90 days of any request from the testing laboratory; and
       3. (iii) within 30 days of a change of designee.

The CEO shall ensure that the hospital complies with the following procedures: