Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.13 - Medical Laboratories - Testing for Hereditary and Congenital Disorders in Newborn Infants
Section 10.10.13.01 - Purpose
Universal Citation: MD Code Reg 10.10.13.01
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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