1. A. Primary Standard. A laboratory shall report or release test results, except results of a health awareness test, only to an authorized person.

2. B. Standards.

   1. (1) For all test results except those from a health awareness test performed at a temporary laboratory or from a job-related alcohol or controlled dangerous substance test, a licensee shall ensure that the laboratory:

      1. (a) Reports medical test results only to the physician, dentist, or other authorized person who requested the test, or to another laboratory that requested the test;

      2. (b) Sends a copy of a test result, other than a result for a health awareness or job-related alcohol or controlled dangerous substances test, directly to the individual tested only after the laboratory:

         1. (i) Receives a written request from the individual; and
         2. (ii) Notifies the authorized person who requested the test that the results will be released to the individual tested;
      3. (c) Meets the applicable standards concerning test reports contained in 42 CFR §§493.1234 and 493.1291; and
      4. (d) Reports a test result on a form that identifies the name and address of the laboratory that performed the test.
   2. (2) For test results stemming from a health awareness test, set forth in COMAR 10.10.01.03B, and performed at a temporary laboratory, the laboratory may report those results directly to the individual tested.

   3. (3) If the results of the tests listed in Regulation .02B(7) of this chapter are not within the desired range, the pharmacist shall provide:

      1. (a) The test results to the patient’s primary care practitioner for evaluation and treatment; or
      2. (b) The patient with a referral to a licensed independent practitioner for evaluation and treatment.

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Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md.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