Md. Code Regs. 10.10.12.01 – Scope.

Regulation	Sections
.01 Scope	17-202
.02 Definitions	17-202
.03 Incorporation by Reference	17-201, 17-202
.04 Public Health Testing License, for Rapid HIV Antibody Testing	17-202, 17-204, 17-205, 17-206, 17-207, 17-208, 17-209, 17-210
.05 Quality Assessment Plan and Quality Control Requirements	17-202, 17-206
.06 Personnel Training and Competency	17-202, 17-206
.07 Standard Operating Procedures Manual	17-202
.08 Public Health Testing Program Director	17-203, 17-206
.09 Manufacturer's Requirements	17-202
.10 Confirmatory Test	17-202

A. This chapter sets the standards and requirements for a person to obtain and maintain a public health testing license to operate a public health testing program to perform rapid HIV antibody testing and rapid hepatitis C virus testing.
B. This chapter applies to public health testing programs approved by the Secretary to conduct rapid HIV antibody testing and rapid hepatitis C virus testing.
C. This chapter does not apply to any other type of laboratory testing entity such as a:
1. (1) Point-of-care laboratory;
2. (2) Commercial reference laboratory;
3. (3) Hospital; or
4. (4) Physician office laboratory.

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)