Regulation .05 Quality Assessment Plan and Quality Control Requirements.
Regulation .05 Quality Assessment Plan and Quality Control Requirements.LinkCopy Citation
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.