Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 3. |
Subtitle 10. LABORATORIES |
Chapter 10.10.12. Medical Laboratories—Public Health HIV Testing Programs |
Sec. 10.10.12.07. Standard Operating Procedures Manual
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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.
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) How to set up the testing site;
(2) Use of quality assessment plan components, policies, and procedures;
(3) The test manufacturer's product inserts and instructions;
(4) Standard precautions for bloodborne pathogens;
(5) Use of gloves and other personal protective equipment;
(6) Handling and disposal of biohazardous waste;
(7) How to provide testing information to an individual before the individual is tested;
(8) How to counsel an individual receiving screening test results; and
(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 and 10.18.09.07.