1. A. Requirement.

   1. (1) General. A person shall possess a license before:

      1. (a) Offering to perform or performing a medical laboratory test or examination in this State;
      2. (b) Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; or
      3. (c) Representing or servicing in this State a laboratory regardless of the laboratory's location.

   2. (2) Prohibited Tests. The Secretary may impose principal and alternative sanctions as set forth in COMAR 10.10.08.01A if a person offers to perform or performs a test or part of a test, including the use of a reagent, supply, procedure, technique, kit, or equipment, that:

      1. (a) Does not produce accurate or reliable results as evidenced by documented, independent scientific testing and evaluation; or
      2. (b) Lacks proof of efficacy substantiated by an independently conducted and documented scientifically based clinical trial.

   3. (3) Cholesterol Testing Plan for Health Departments.

      1. (a) A local or county health department intending to perform cholesterol testing outside a permanently located laboratory may submit to the Secretary a cholesterol testing plan instead of applying for a cholesterol testing permit.
      2. (b) If the submitted plan meets applicable standards under this chapter, the Secretary may waive the permit requirement for a cholesterol testing permit.
      3. (c) If the plan does not meet the applicable standards of this chapter, the local or county health department shall apply for a permit as set forth in this chapter.
2. B. Limitation. A person may not operate a laboratory in a discipline other than what is listed on the license.

3. C. Eligibility. A person meeting the requirements and standards of this chapter may apply for one or more of the following licenses:

   License:	Laboratory that may apply for the license:
   Letter of exception	POL POCL
   Permit (single-site)	POL POCL State, county, or municipal hospital commercial
   Permit (multi-site)	State, county, or municipal hospital private nonprofit mobile

4. D. Issuance.

   1. (1) Provisional Permit.

      1. (a) The Secretary may issue a provisional permit before or after conducting an initial survey and pending determination of compliance with the standards in this chapter.
      2. (b) A provisional permit is valid for not more than 180 days and may not be renewed.

   2. (2) Letter of Exception and Permit. The Secretary may issue a letter of exception or permit that:

      1. (a) Is valid for not more than 2 years from the date of issue; and
      2. (b) Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period.

   3. (3) Single-Site and Multi-Site Licenses.

      1. (a) Except as set forth in §D(3)(b) of this regulation, a person shall obtain a separate, single-site license for each location at which a laboratory performs a test.

      2. (b) The Secretary may issue a multi-site license to a person operating:

         1. (i) A mobile laboratory using the address of its home base or main administrative office in the State;
         2. (ii) A nonprofit laboratory or public health laboratory performing limited public health testing; and
         3. (iii) Hospital laboratories located at the same street address or within contiguous buildings and under common direction.
5. E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local laboratory requirements.

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)