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.