1. A. Primary Standards. To obtain or maintain a permit to operate a laboratory, a person or licensee shall ensure that the laboratory:

   1. (1) Establishes and follows written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total, that is, preanalytic, analytic, and postanalytic phases of the testing process;

   2. (2) Maintains a quality assurance program that:

      1. (a) Continually evaluates the effectiveness of the laboratory's policies and procedures;
      2. (b) Routinely revises policies and procedures based on the results of on-going evaluation;
      3. (c) Identifies and corrects problems;
      4. (d) Assures accurate, reliable, and prompt reporting of test results;
      5. (e) Assures adequate and competent personnel; and
      6. (f) Documents all quality assurance activities; and
   3. (3) Establishes and maintains a laboratory safety program.

2. B. Standards. A licensee shall ensure that the laboratory:

   1. (1) Meets the applicable:

      1. (a) Quality assurance standards set forth in this chapter and in 42 CFR §§493.1230 — 493.1299; and
      2. (b) Quality testing standards for facility administration set forth in this chapter and in 42 CFR §§493.1100 — 493.1101;

   2. (2) Establishes, maintains, and enforces a laboratory safety program that:

      1. (a) Provides all personnel with access to a safety manual covering the following topics, when applicable:

         1. (i) General personnel safety;
         2. (ii) Fire prevention and control;
         3. (iii) Biological hazards;
         4. (iv) Chemical hazards;
         5. (v) Radiological hazards;
         6. (vi) Special medical waste disposal; and
         7. (vii) The reporting of incidents and accidents; and

      2. (b) Complies with the following applicable federal Occupational Safety and Health Administration standards:

         1. (i) “Occupational Exposure to Hazardous Chemicals in Laboratories”, contained in 29 CFR §1910.1450; and
         2. (ii) “Bloodborne Pathogens,” contained in 29 CFR §1910.1030; and

   3. (3) Maintains a collection station:

      1. (a) As part of and under the direction of the laboratory for which it collects specimens; and
      2. (b) With equipment and staff appropriate for the collection, preservation, storage, and maintenance of specimens in a manner suitable for later examination.

Authority: Health-General Article, §§17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland

Effective date: November 18, 1985 (12:23 Md. R. 2217)

Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859)

Regulations .01—.28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)

Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .09B amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .25 amended effective September 16, 1991 (18:18 Md. R. 2005)

Chapter, Physician Office and Other Point-of-Care Laboratories, repealed and new chapter, Medical Laboratories—Quality Assurance, adopted effective December 13, 1999 (26:25 Md. R. 1897)

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

Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)

Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)

Regulation .02C amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .03B amended effective July 24, 2000 (27:14 Md. R. 1340); January 13, 2011 (38:1 Md. R. 11)

Regulation .04B adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 492)

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

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

Regulation .06 repealed effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .08 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .08B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .09 repealed effective June 1, 2009 (36:11 Md. R. 787)

Regulation .10 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .10B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .12 amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)

Regulation .12B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)

Regulation .13B amended effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .14B amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .15 amended effective June 1, 2009 (36:11 Md. R. 787); April 1, 2013 (40:6 Md. R. 473)

Regulation .15B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .16 repealed effective April 1, 2013 (40:6 Md. R. 473)

Regulation .16A amended effective June 1, 2009 (36:11 Md. R. 787)