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 10.10.13.04 - Permit
Universal Citation: MD Code Reg 10.10.13.04
Current through Register Vol. 51, No. 19, September 20, 2024
A. Eligibility.
(1) Except as set forth in a Departmental
mutual aid agreement, the Department's public health laboratory is the sole
laboratory that may hold a State permit to perform and that may perform a
first-tier newborn screening test on a newborn infant.
(2) A medical laboratory other than the
State's public health laboratory may obtain a permit to perform:
(a) A supplemental test;
(b) A second-tier test; or
(c) Supplemental and second-tier
tests.
B. Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall:
(1) Obtain
and maintain a valid:
(a) Permit issued by
the Secretary to operate a medical laboratory; and
(b) CLIA Certificate from the U.S. Health and
Human Services' Centers for Medicare and Medicaid Services; and
(2) Meet applicable standards and
requirements for:
(a) A medical laboratory, as
set forth in COMAR 10.10.01-.08; and
(b) Testing for hereditary or congenital
disorders in a newborn infant as set forth in this chapter.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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