Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.03 - Medical Laboratories - Licenses
Section 10.10.03.03 - Permits
Universal Citation: MD Code Reg 10.10.03.03
Current through Register Vol. 51, No. 19, September 20, 2024
A. Requirement. A person operating a medical laboratory that performs one or more tests other than excepted tests shall obtain and renew a laboratory permit as required in this chapter.
B. Tests Other than Excepted Tests.
(1) A test other than an
excepted test is one not listed in Regulation .02B of this chapter.
(2) A person holding a permit may perform
both excepted tests and tests other than excepted tests.
C. Regulatory Requirements. A person operating a medical laboratory under a permit shall:
(1) Obtain, complete, and submit permit
applications as prescribed in this chapter and COMAR 10.10.04;
(2) Comply with the survey requirements set
forth in this subtitle;
(3) Comply
with the applicable quality assurance and quality control requirements required
in COMAR 10.10.06;
(4) Comply with
the applicable proficiency testing requirements required in COMAR 10.10.05;
and
(5) Comply with the applicable
personnel requirements required in COMAR
10.10.06.15BB and
10.10.07.
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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