Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.01 - General
Section 10.10.01.02 - Scope
Universal Citation: MD Code Reg 10.10.01.02
Current through Register Vol. 51, No. 19, September 20, 2024
A. This subtitle contains the standards and requirements that a medical laboratory shall meet to:
(1) Obtain and retain a license to offer
to perform or perform tests on human specimens; and
(2) Certify chemists and analysts in crime
laboratories to perform approved testing procedures for controlled dangerous
substances.
B. This subtitle does not apply to:
(1) A research
facility that tests human specimens and does not:
(a) Report any patient-specific test results
for use in connection with the diagnosis and control of human disease or the
assessment of the health, nutritional, or medical condition or job-related
alcohol and controlled dangerous substances evaluation of individual patients
or clients, or
(b) Provide test
results to the patient, the patient's family, or a health care
provider;
(2) A medical
laboratory operated by the federal government, unless the laboratory or tissue
bank is directed by a federal agency to meet the requirements of this subtitle;
and
(3) A crime laboratory operated
by the federal government.
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