Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs
Section 10.10.12.07 - Standard Operating Procedures Manual
Universal Citation: MD Code Reg 10.10.12.07
Current through Register Vol. 51, No. 19, September 20, 2024
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
10.18.08.10CC and
10.18.09.07C.
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