Sec. 10.10.03.03. Permits

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 10.10.06.15B and 10.10.07.