1. A. Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program.

2. B. Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and activities that occur before, during, and after testing and include the following components:

   1. (1) Verifying, before performing a test; that:

      1. (a) The testing process works as set forth in the manufacturer's test specifications and instructions;
      2. (b) Personnel are trained and competent to perform assigned tasks;

      3. (c) Procedures and logistics are in place for:

         1. (i) Performing a confirmatory test;
         2. (ii) Collecting a specimen for referral to a laboratory to perform a confirmatory test; or
         3. (iii) Referring an individual to a health care provider to have a confirmatory test performed; and
      4. (d) Biohazardous waste handling procedures are in place;

   2. (2) Troubleshooting procedures that:

      1. (a) Detect and resolve a problem that occurs during the testing process;
      2. (b) Require communication of a problem immediately to the director or appropriate supervisory personnel;
      3. (c) State when to discontinue testing;
      4. (d) Identify how to take corrective action in response to a problem; and

      5. (e) State how to:

         1. (i) Document a problem and the actions taken; and
         2. (ii) Verify that a corrective action taken has addressed the problem;

   3. (3) Procedures and mechanisms to maintain records that document:

      1. (a) Personnel training and competency;
      2. (b) Specimen referral and transfer;
      3. (c) Daily temperatures of the areas that will affect testing results;

      4. (d) Quality control test results that include the:

         1. (i) Results of the quality control test;
         2. (ii) Date and time the control testing was performed;
         3. (iii) Lot number and expiration of the test kit;
         4. (iv) Lot number and expiration date of the quality controls; and
         5. (v) Corrective actions taken if control results are invalid; and

      5. (e) Test result records for the individuals who are tested that include the:

         1. (i) Test result;
         2. (ii) Date and time testing was performed;
         3. (iii) Unique laboratory code for the individual being tested;
         4. (iv) Test kit lot number and expiration date;
         5. (v) Results of internal validity checks;
         6. (vi) Action taken if a result is invalid;
         7. (vii) Documentation of required confirmatory testing;
         8. (viii) Documentation when a specimen is sent for confirmation or the individual is referred for a confirmatory test;
         9. (ix) Confirmatory test results, when available; and
         10. (x) Identity of the individual who performed the test.

Authority: Health-General Article, Annotated Code of Maryland

Effective date:

Regulations .01—.10 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580)

Regulation .01A, B amended effective April 1, 2013 (40:6 Md. R. 473)

Regulation .02B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198)

Regulation .03 amended effective April 1, 2013 (40:6 Md. R. 473)

Regulation .04 amended effective April 1, 2013 (40:6 Md. R. 473)

Regulation .04D amended effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .04E amended effective August 29, 2016 (43:17 Md. R. 953)

Regulation .06D, E amended effective April 1, 2013 (40:6 Md. R. 473)

Regulation .07B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198)

Regulation .09 amended effective April 1, 2013 (40:6 Md. R. 473)

Regulation .10 amended effective April 1, 2013 (40:6 Md. R. 473)