.04 Responsibilities of the Department.

A. Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.

B. Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory oversight that includes surveys and proficiency testing as set forth in:

(1) COMAR 10.10.02; and

(2) COMAR 10.10.05.

C. Notification. The Department shall notify the parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory may perform post screening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.