Md. Code Regs. 10.10.12.04

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

Section 10.10.12.04 - Public Health Testing License for Rapid HTV Antibody Testing and HCV Testing

A. A person shall obtain a public health testing license before offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing.

B. A person may not:

(1) Offer or perform rapid HIV antibody testing or hepatitis C virus testing without obtaining a public health testing license issued under this chapter; or

(2) Transfer the public health testing license to another person.

C. The Secretary may issue a public health testing license under this chapter if the Secretary determines that the public health testing program meets the requirements of this chapter.

D. The Department shall issue a public health testing license that:

(1) Is valid for a period of not more than 2 years;

(2) States that the license is limited to the performance of rapid HIV antibody testing and rapid hepatitis C virus testing; and

(3) Lists the:

(a) Name of the director;

(b) Name of the public health testing program; and

(c) Address of the public health testing program.

E. To obtain, maintain, or renew a public health testing license, a person shall:

(1) Make records and reports available to the Department;

(2) Possess a valid CLIA Certificate of Waiver from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services;

(3) Submit to the Department:

(a) When seeking an initial license or license renewal, a quality assessment plan that describes the testing activities;

(b) The location of all testing sites; and

(c) The name and address of the laboratory that will perform confirmatory tests for the person operating the public health testing program; and

(4) Submit amendments or changes to the public health testing program's quality assessment plan to the Department and obtain the Department's approval prior to implementation.

F. The Department shall:

(1) Review each submitted quality assessment plan to determine compliance with the requirements of this chapter;

(2) Conduct on-site surveys of public health testing programs:

(a) To investigate a complaint; and

(b) Periodically to determine compliance with this chapter; and

(3) Approve the plan for implementation by the public health testing program if the plan is in compliance with the requirements of this chapter.

G. The Secretary may impose one or more sanctions as provided in COMAR 10.10.08.01B -.03 if the Secretary determines that the public health testing program does not meet the standards of this chapter.

Md. Code Regs. 10.10.12.04

Regulations .04 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 .04 amended effective April 1, 2013 (40:6 Md. R. 473); amended effective 43:17 Md. R. 953, eff. 8/29/2016