Md. Code Regs. 10.10.12.07

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.12.07 - Standard Operating Procedures Manual

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.

Md. Code Regs. 10.10.12.07

Regulations .07 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 .07B amended effective April 1, 2013 (40:6 Md. R. 473)