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 10.10.12.05 - Quality Assessment Plan and Quality Control Requirements

Universal Citation: MD Code Reg 10.10.12.05

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

A. Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program.

B. Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and activities that occur before, during, and after testing and include the following components:

(1) Verifying, before performing a test; that:
(a) The testing process works as set forth in the manufacturer's test specifications and instructions;

(b) Personnel are trained and competent to perform assigned tasks;

(c) Procedures and logistics are in place for:
(i) Performing a confirmatory test;

(ii) Collecting a specimen for referral to a laboratory to perform a confirmatory test; or

(iii) Referring an individual to a health care provider to have a confirmatory test performed; and

(d) Biohazardous waste handling procedures are in place;

(2) Troubleshooting procedures that:
(a) Detect and resolve a problem that occurs during the testing process;

(b) Require communication of a problem immediately to the director or appropriate supervisory personnel;

(c) State when to discontinue testing;

(d) Identify how to take corrective action in response to a problem; and

(e) State how to:
(i) Document a problem and the actions taken; and

(ii) Verify that a corrective action taken has addressed the problem;

(3) Procedures and mechanisms to maintain records that document:
(a) Personnel training and competency;

(b) Specimen referral and transfer;

(c) Daily temperatures of the areas that will affect testing results;

(d) Quality control test results that include the:
(i) Results of the quality control test;

(ii) Date and time the control testing was performed;

(iii) Lot number and expiration of the test kit;

(iv) Lot number and expiration date of the quality controls; and

(v) Corrective actions taken if control results are invalid; and

(e) Test result records for the individuals who are tested that include the:
(i) Test result;

(ii) Date and time testing was performed;

(iii) Unique laboratory code for the individual being tested;

(iv) Test kit lot number and expiration date;

(v) Results of internal validity checks;

(vi) Action taken if a result is invalid;

(vii) Documentation of required confirmatory testing;

(viii) Documentation when a specimen is sent for confirmation or the individual is referred for a confirmatory test;

(ix) Confirmatory test results, when available; and

(x) Identity of the individual who performed the test.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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