1. 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.

2. B. Tests Other than Excepted Tests.

   1. (1) A test other than an excepted test is one not listed in Regulation .02B of this chapter.
   2. (2) A person holding a permit may perform both excepted tests and tests other than excepted tests.

3. C. Regulatory Requirements. A person operating a medical laboratory under a permit shall:

   1. (1) Obtain, complete, and submit permit applications as prescribed in this chapter and COMAR 10.10.04;
   2. (2) Comply with the survey requirements set forth in this subtitle;
   3. (3) Comply with the applicable quality assurance and quality control requirements required in COMAR 10.10.06;
   4. (4) Comply with the applicable proficiency testing requirements required in COMAR 10.10.05; and
   5. (5) Comply with the applicable personnel requirements required in COMAR 10.10.06.15B and 10.10.07.

Authority: Environment Article, §6-303; Health-General Article, §§2-104(b), 17-202, 17-205—17-210, 17-212, 17-502, 17-503, 17-505, and 17-510; Annotated Code of Maryland

Effective date: December 13, 1999 (26:25 Md. R. 1897)

Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); July 23, 2001 (28:14 Md. R. 1321)

Regulation .01A amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .01E adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .02 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787); April 13, 2015 (42:7 Md. R. 568)

Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 16, 2012 (39:7 Md. R. 492)

Regulation .02B amended as an emergency provision effective November 1, 2004 (31:25 Md. R. 1789); amended permanently effective January 6, 2005 (31:26 Md. R. 1863); March 1, 2026 (52:24 Md. R. 1198)

Regulation .02B amended effective August 29, 2005 (32:17 Md. R. 1438); February 22, 2010 (37:4 Md. R. 341); April 16, 2012 (39:7 Md. R. 492); November 12, 2012 (39:22 Md. R. 1428); April 1, 2013 (40:6 Md. R. 473); March 13, 2017 (44:5 Md. R. 292)

Regulation .02C amended effective November 12, 2012 (39:22 Md. R. 1428)

Regulation .03C amended effective June 1, 2009 (36:11 Md. R. 787); August 29, 2016 (43:17 Md. R. 953)

Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .04B, E amended effective August 29, 2016 (43:17 Md. R. 953)

Regulation .05 adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .06 adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .06A amended effective August 29, 2016 (43:17 Md. R. 953)