Sec. 10.10.13.01. Purpose

A. This chapter, together with COMAR 10.52.12, establishes a coordinated Statewide system for the screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development.

B. This chapter also protects the public health by ensuring that accurate and reliable newborn screening and diagnostic test results are provided to a newborn infant's health care providers by requiring a medical laboratory performing screening tests, diagnostic tests, or both, on newborn infants for hereditary disorders, congenital disorders, or both, to:

(1) Operate under reliable procedures and test methods;

(2) Employ qualified personnel;

(3) Establish and maintain reliable quality control and quality assurance programs; and

(4) Interact effectively with components of the Department's coordinated Statewide Newborn Screening Program to identify newborn infants who may be at risk for a hereditary or congenital disorder.