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 10.10.12.02 - Definitions
Universal Citation: MD Code Reg 10.10.12.02
Current through Register Vol. 51, No. 19, September 20, 2024
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) "CDC" means the federal Centers for
Disease Control and Prevention.
(2)
"CLIA" means the federal Clinical Laboratory Improvement Amendments of
1988.
(3) "Department" means the
Department of Health and Mental Hygiene.
(4) "Primary standard" means a general
comprehensive standard or set of standards as defined in COMAR
10.10.01.03B.
(5) "Public health testing
program" means a medical laboratory as defined in COMAR
10.10.01.03BB
that is affiliated or collaborating with the Department for the purpose of
offering or performing rapid HIV antibody testing or rapid hepatitis C virus
testing approved by the Secretary.
(6) "Public health testing license" means a
license as defined in COMAR
10.10.01.03BB
issued by the Secretary authorizing the director of a public health HIV or
hepatitis C (HCV) testing program to offer or perform rapid HIV tests or rapid
hepatitis C virus tests.
(7)
Quality Assessment Plan.
(a) "Quality
assessment plan" means a planned system of step-by-step activities to ensure
that:
(i) Testing is being carried out
according to the manufacturer's instructions;
(ii) Results are accurate and reliable;
and
(iii) Problems and mistakes are
found and corrected to avoid adverse outcomes.
(b) "Quality assessment plan" includes the
ongoing activities that monitor, review, evaluate, and improve the overall
quality of the procedures and processes before, during, and after a test is
performed.
(8) Quality
Control.
(a) "Quality control" means the
policies and procedures defined in COMAR
10.10.01.03BB
that monitor and evaluate the analytical or test performance phase of the
testing process.
(b) "Quality
control" includes the operational techniques, tasks, or activities used to find
and correct problems that might occur in the test system.
(8-1) "Rapid hepatitis C virus test" means a public health hepatitis test that:
(a) Is a
single-use test device as defined in COMAR
10.10.01.03B;
(b) Uses whole blood as the specimen to
detect hepatitis C antibodies;
(c)
Is waived under the CLIA program; and
(d) Provides a test result while the
individual being tested is waiting.
(9) "Rapid HIV antibody test" means a public
health HIV test that:
(a) Is a single-use test
device as defined in COMAR
10.10.01.03B;
(b) Uses whole blood or oral fluid as the
specimen to detect HIV antibodies;
(c) Is waived under the CLIA program;
and
(d) Provides a test result
while the individual being tested is waiting.
(10) "Secretary" means the Secretary of
Health and Mental Hygiene.
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