1. A. Primary Standard. A person seeking or holding a public health testing license shall ensure that the personnel of the public health testing program are trained in how to perform assigned tasks and responsibilities.

2. B. Personnel Training Components. A person seeking or holding a public health testing license shall ensure that personnel training includes the following components:

   1. (1) How to perform the test, including procedures performed before, during, and after testing;
   2. (2) How the testing is integrated into the overall counseling and testing program;
   3. (3) The components of the public health testing program's quality assessment plan; and
   4. (4) The use of bloodborne pathogen precautions and biohazard safety.

3. C. Training Method. A person seeking or holding a public health testing license shall ensure that the public health testing program personnel training includes the following activities:

   1. (1) Reading the manufacturer's instructions for performing the test;
   2. (2) Observing a trained individual performing the test or viewing a video of a trained individual performing the test;
   3. (3) Practicing the performance of the test with positive and negative controls;
   4. (4) Practicing the specimen collection procedure; and
   5. (5) Reviewing the procedures and forms on how to document the testing.

4. D. Personnel Competency. A supervisor or qualified trainer shall assess and document the competency of the public health testing program personnel for each task for which the individual is responsible:

   1. (1) Before the individual is permitted to perform testing without assistance for the first time;
   2. (2) Annually; and
   3. (3) When procedures or test systems are changed.
5. E. A person seeking or holding a public health testing license shall have available and ensure that personnel follow the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988” (2007).

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)