1. A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory participates successfully in PT, when applicable, for each test or analyte in each of the following disciplines, subdisciplines, and specialties:

   1. (1) Microbiology, including the subdisciplines of:

      1. (a) Bacteriology;
      2. (b) Mycobacteriology;
      3. (c) Mycology;
      4. (d) Parasitology; and
      5. (e) Virology;

   2. (2) Immunology, including the subdisciplines of:

      1. (a) General immunology;
      2. (b) General serology; and
      3. (c) Syphilis serology;

   3. (3) Chemistry, including the subdisciplines of:

      1. (a) Blood gas analysis;
      2. (b) Endocrinology;
      3. (c) Routine chemistry; and
      4. (d) Toxicology;

   4. (4) Genetics, including the subdisciplines of:

      1. (a) Biochemical genetics;
      2. (b) Cytogenetics; and
      3. (c) Molecular genetics;

   5. (5) Hematology, including the subdisciplines of:

      1. (a) Coagulation testing; and
      2. (b) Routine hematology;
   6. (6) Pathology, including the subdiscipline of gynecologic cytology;

   7. (7) Immunohematology, including the specialties of:

      1. (a) ABO group and D(Rho) typing;
      2. (b) Unexpected antibody detection, that is, antibody screen;
      3. (c) Antibody identification; and
      4. (d) Compatibility testing; and
   8. (8) Forensic toxicology limited to job-related alcohol and controlled dangerous substances.

2. B. Discipline Standards.

   1. (1) General. A licensee operating under a permit shall ensure that the laboratory meets the applicable PT standards set forth in this chapter and in 42 CFR §§493.821493.865.
   2. (2) Gynecologic Cytology. A licensee operating under a permit to perform gynecologic cytology shall ensure that the laboratory enrolls and maintains successful participation in a cytology PT program approved by CMS.

   3. (3) Job-Related Testing.

      1. (a) A licensee operating under a permit to perform job-related testing for alcohol or controlled dangerous substances shall ensure that the laboratory enrolls and continues to participate satisfactorily, when applicable, in one or more of the programs listed in §B(3)(b)(e) of this regulation.

      2. (b) Screening Tests. A licensee operating under a permit to perform screening tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in:

         1. (i) The American Association of Bioanalysts (AAB) Urine Toxicology Screening survey;
         2. (ii) The American Association for Clinical Chemistry/College of American Pathologists (AACC/CAP) Forensic Urine Drug Testing Screening survey; or
         3. (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter.

      3. (c) Confirmation Tests. A licensee operating under a permit to perform confirmation tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in:

         1. (i) The AACC/CAP Forensic Urine Drug Testing Confirmatory survey;
         2. (ii) The federal Substance Abuse and Mental Health Services Administration's Federal Workplace Drug Testing Program; or
         3. (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter.

      4. (d) Blood Alcohol Tests. A licensee operating under a permit to perform tests for alcohol in blood shall ensure that the laboratory enrolls and participates satisfactorily in:

         1. (i) The AACC/CAP survey for whole blood alcohol or serum alcohol, or both; or
         2. (ii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter.

      5. (e) Hair Analysis. A licensee operating under a permit to perform tests for a controlled dangerous substance in hair shall ensure that the laboratory enrolls and participates satisfactorily in:

         1. (i) The State of Florida's P.T. program for drug testing in hair; or
         2. (ii) Another program that possesses standards set by the Secretary or that are equivalent to the State of Florida's PT program for drug testing in hair and is approved by the Secretary as set forth in Regulation .03 of this chapter.

Authority: Health-General Article, §§17-202 and 17-211, Annotated Code of Maryland

Effective date: October 5, 1998 (25:20 Md. R. 1529)

Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories — Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897)

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

Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

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

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

Regulation .04D amended effective November 29, 2010 (37:24 Md. R. 1658)

Regulation .05A, B amended effective March 1, 2026 (52:24 Md. R. 1198)

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

Regulation .05C amended effective November 29, 2010 (37:24 Md. R. 1658)