Md. Code Regs. 10.10.12.02

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

Section 10.10.12.02 - Definitions

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.

Md. Code Regs. 10.10.12.02

Regulations .02 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 .02B amended effective April 1, 2013 (40:6 Md. R. 473)