Current through Register Vol. 51, No. 19, September 20, 2024
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.
