1. A. Primary Standard. A person seeking or holding a public health testing license shall develop and maintain a standard operating procedures manual (SOPM) that is available to and followed by the public health testing program personnel.

2. B. A person seeking or holding a public health testing license shall ensure that the SOPM includes the step-by-step instructions for the operations, tasks, and techniques occurring before, during, and after testing, including:

   1. (1) How to set up the testing site;
   2. (2) Use of quality assessment plan components, policies, and procedures;
   3. (3) The test manufacturer's product inserts and instructions;
   4. (4) Standard precautions for bloodborne pathogens;
   5. (5) Use of gloves and other personal protective equipment;
   6. (6) Handling and disposal of biohazardous waste;
   7. (7) How to provide testing information to an individual before the individual is tested;
   8. (8) How to counsel an individual receiving screening test results; and
   9. (9) How to refer an individual who has been tested for HIV antibodies or hepatitis C antibodies, or both, for services as prescribed in COMAR 10.18.08.10C.

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)