10A NCAC 42B .0102      NEWBORN SCREENING

(a)  The State Laboratory of Public Health will conduct screening for the core conditions listed on the Recommended Uniform Screening Panel developed by the Secretary of the United States Department of Health and Human Services and the Advisory Committee on Heritable Disorders of Newborns and Children (the "RUSP"), which is hereby incorporated by reference, including any subsequent editions and amendments, and available free of charge at https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html. Specimens shall be submitted to this laboratory for screening in accordance with the procedures set forth in 10A NCAC 43H .0314.

(b)  The process to develop and implement new screening for the conditions described in Paragraph (a) of this Rule shall begin after:

(1)           the screening fee set out in Rule .0108 of this Section is adjusted, as permitted by G.S. 130A-125(c);

(2)           funds exist to acquire instrumentation, equipment, Program supplies, and Program personnel; and

(3)           the Program performs assay validations, implements preventative follow-up interventions, secures necessary infrastructure, and meets all federal, State, and local requirements.

History Note:        Authority G.S. 130A‑88; 130A-125;

Eff. October 1, 1985;

Amended Eff. September 1, 1990;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. December 23, 2017;

Amended Eff. January 1, 2021.