10 CRR-NY 69-1.5NY-CRR
OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 10. DEPARTMENT OF HEALTH
CHAPTER II. ADMINISTRATIVE RULES AND REGULATIONS
SUBCHAPTER H. FAMILY HEALTH
PART 69. TESTING FOR PHENYLKETONURIA AND OTHER DISEASES AND CONDITIONS/EARLY INTERVENTION PROGRAM/NEWBORN HEARING SCREENING/STANDARD INFANT AUTOPSY PROCEDURES
SUBPART 69-1. NEWBORN SCREENING FOR PHENYLKETONURIA AND OTHER DISEASES
10 CRR-NY 69-1.5
10 CRR-NY 69-1.5
69-1.5 Duties of the responsible provider.
The responsible provider shall obtain initial screening results within 14 days of birth and shall ensure compliance with the following procedures:
(a) When notified by the testing laboratory that a repeat specimen is required, the responsible provider shall notify the parent(s) within one business day that a repeat specimen is required from the newborn. The responsible provider, or his or her designee, shall collect the repeat specimen, pursuant to guidance issued by the testing laboratory, and submit it to the testing laboratory as soon as practicable.
(b) Specimen collection forms shall be properly stored in a cool and dry environment prior to use.
(c) 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. All specimens shall be forwarded to the testing laboratory within 24 hours of collection to ensure delivery of specimens to the testing laboratory no later than 48 hours after collection.
(d) If a satisfactory specimen or repeat specimen is not collected due to newborn mortality, the responsible provider shall submit a written and/or electronic notification to the testing laboratory within five days after death.
(e) The responsible provider 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. The responsible provider shall inform parents of the newborn screening result.
(f) Except when a newborn is under the care of a specialty care center, the responsible provider shall report diagnostic evaluation and test results, case management information, and follow-up reviews to the testing laboratory no later than 90 days following receipt of testing laboratory test results. The responsible provider shall arrange for a diagnostic evaluation and case management with an approved specialty care center as necessary.
(g) Before performing any tasks relating to collection of specimens, the responsible provider, and any staff under his or her supervision performing specimen collection, shall complete comprehensive specimen collection training, and shall complete such training annually thereafter. The responsible provider shall retain documentation of all such training.
(h) The responsible provider shall establish written policies and procedures, which shall be available for the department’s review, for:
(1) the collection, storage, and shipping of specimens; and
(2) the tracking and disposition of test results.
(i) The responsible provider shall comply with the following additional requirements for all newborns who test positive for HIV antibodies:
(1) the responsible provider shall arrange for follow-up care with a provider experienced in the treatment of HIV. The responsible provider shall also submit to the department any specimen 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;
(2) the responsible provider shall provide or arrange for post-test counseling for the birth mother or person authorized by law to give consent to health care for the newborn if the mother lacks capacity to consent;
(3) the responsible provider shall provide, or refer the newborn for, appropriate and/or specialized health care, case management and other social services as needed;
(4) the responsible provider shall provide the parent(s) with referrals for health and social services as needed and shall transfer a copy of the newborn's HIV test result to the mother's physician as permitted by article 27-F of the Public Health Law; and
(5) the responsible provider 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.
10 CRR-NY 69-1.5
Current through May 31, 2020
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