Regulation .19 Proficiency and Competency Testing for Newborn Screening Tests.
Regulation .19 Proficiency and Competency Testing for Newborn Screening Tests.LinkCopy Citation
A permittee shall:
A.
Meet all requirements set forth in COMAR 10.10.05;
B.
Successfully participate in one or more approved proficiency testing programs that cover all first-tier, second-tier, and supplementary tests offered or performed;
C.
Evaluate and document performance, semiannually during the first year of testing and annually thereafter, of all individuals responsible for testing; and
D.
In addition to the proficiency testing requirement in §A of this regulation, participate in the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program.