Md. Code Regs. 10.10.12.05

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

Section 10.10.12.05 - Quality Assessment Plan and Quality Control Requirements

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.

Md. Code Regs. 10.10.12.05

Regulations .05 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)