Section 12Sec./Art. 12

Establishment and Accreditation of Newborn Screening Centers. - The DOH shall ensure that Newborn Screening Centers are strategically located in order to be accessible to the relevant public and provide services that comply with the standards approved by the Committee upon the recommendation of the NIH. No Newborn Screening Center shall be allowed to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee.

At a minimum, every Newborn Screening Center shall: (i) have a certified laboratory performing all tests included in the newborn screening program, (ii) have a recall/follow up programs for infants found positive for any and all of the heritable conditions; (iii) be supervised and staffed by trained personnel who have been duly qualified by the NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.