1. A. Eligibility.

   1. (1) An individual directing a POL or POCL who offers to perform or performs tests limited to one or more excepted tests may obtain a letter of exception instead of a permit to offer to perform or perform those tests.

   2. (2) An individual eligible for a letter of exception shall:

      1. (a) Be qualified as a laboratory director as set forth in 42 CFR §493.1405, including:

         1. (i) Being a doctor of medicine or doctor of osteopathy licensed in the State and having laboratory training or experience appropriate for the testing performed; or
         2. (ii) Holding an earned doctoral, master's, or bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution;

      2. (b) Provide evidence of training in the performance and interpretation of excepted tests and be licensed in the State as a:

         1. (i) Nurse midwife;
         2. (ii) Nurse practitioner;
         3. (iii) Physician assistant;
         4. (iv) Chiropractor;
         5. (v) Podiatrist;
         6. (vi) Dentist; or
         7. (vii) Pharmacist; or

      3. (c) Be clinical staff who:

         1. (i) Meets the qualifications set forth in COMAR 10.47.01.06D;
         2. (ii) Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and
         3. (iii) Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program.
   3. (3) A person operating a temporary medical laboratory to perform health awareness tests, regardless of testing site location, is not eligible for a letter of exception.
2. B. Excepted Tests. A POL or POCL operating under a letter of exception may perform one or more CLIA waived tests.

3. C. Reporting Requirements for Whole Blood Lead Testing on a CLIA Waived Analyzer.

   1. (1) The blood tests for lead shall:

      1. (a) Be reported under this regulation in the format approved by the Maryland Department of the Environment; and
      2. (b) Include the information required by this regulation.

   2. (2) The blood tests for lead to be reported shall include the following information:

      1. (a) Demographic information including:

         1. (i) Name, including first, last, middle initial;
         2. (ii) Date of birth, sex, and race;
         3. (iii) Complete home address at the time the blood specimen was drawn including house or apartment number, street, city, county or town, zip code, and state;
         4. (iv) Telephone number; and
         5. (v) Parent or guardian name;
         6. (vi) Residential status, for example, whether parent or guardian owns their home or rents;
      2. (b) Type of specimen, either venous or capillary, and date the specimen was drawn;
      3. (c) Clinic or practice name, address, and telephone number;
      4. (d) Draw site name and address, if different from clinic or practice;
      5. (e) Blood lead level in micrograms per deciliter; and
      6. (f) Any additional information as may be required by the Maryland Department of the Environment.

4. D. Regulatory Requirements. An individual required to obtain a license to operate a laboratory who chooses to operate under a letter of exception shall:

   1. (1) Obtain, complete, and file an application as prescribed in Regulation .04 of this chapter; and

   2. (2) Comply with good laboratory practices that include:

      1. (a) Following the manufacturer's instructions for instrument or test system operation and test performance;
      2. (b) Having a procedure manual describing the processes for performing tests and reporting patient test results;
      3. (c) Performing and documenting quality control procedures using applicable levels of control materials each day of testing;
      4. (d) Performing and documenting that remedial action has been taken when problems or errors are identified;
      5. (e) Documenting lot numbers of all quality control reagents used; and
      6. (f) Performing and documenting test system function for instruments with internal quality controls on each day of testing.

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)