P A M E T - N E V A D A
PHILIPPINE ASSOCIATION OF MEDICAL TECHNOLOGISTS - NEVADA, INC.
"To serve the community, the profession, and the person."
QUALITY CONTROL/QUALITY ASSURANCE
By Lydia Coleman, BSMT(ASCP)
What is quality assurance (QA)? It is a series of checks and balances to ensure quality services are provided by laboratory personnel. All analytical testing we do in the clinical laboratory affects patient care. It is a big responsibility because the analytical results we provide to physicians impact the diagnosis and treatment of patients. One way to ensure that laboratory personnel are reporting accurate results is through the analysis of Quality Control (QC) materials. QC results in the clinical laboratory follow Westgard Multi-Rule Technique and they are listed below:
13s rule is violated, this value should not be accepted even if the other control is within 2SD because this control is outside 3SD, that is what 13s rule means. This cannot be random error but a systematic one. We need to show corrective action such as re-analysis of the control using a new bottle of QC, or checking the calibration to see if it is close to the expiration and then performing a new calibration, or checking for instrumentation problems, or replacing the reagent with a new bottle of reagent, or checking that the parameters on the instrument match what is on the reagent package insert.
·
22s rule is violated, this rule means that both controls are outside 2SD within the run or two consecutive values of QC1 or QC3 across timepoints are outside 2SD. Therefore, this Westgard rule violation is not a random error but a systematic one requiring rejection of results. Instrumentation and/or method troubleshooting as in 13s rule should be applied as corrective action.
22s rule is violated, this rule means that both controls are outside 2SD within the run or two consecutive values of QC1 or QC3 across timepoints are outside 2SD. Therefore, this Westgard rule violation is not a random error but a systematic one requiring rejection of results. Instrumentation and/or method troubleshooting as in 13s rule should be applied as corrective action.·R4s rule is violated, techs are accepting the results without showing corrective action. This rule means that one control value is outside +2SD and the other control value is outside 2SD. This is considered random error but corrective action must be taken such as reanalysis of the QC.
R4s rule is violated, techs are accepting the results without showing corrective action. This rule means that one control value is outside +2SD and the other control value is outside 2SD. This is considered random error but corrective action must be taken such as reanalysis of the QC.·Three or more rules have been violated as in 13s, 22s, and 41s or 12s, R4s, and 10x, or 13s R4s 41s and 10x, techs should not accept results of the QC analysis. Corrective action taken must be documented and QC samples re-analyzed after the instrument is working properly again.
Three or more rules have been violated as in 13s, 22s, and 41s or 12s, R4s, and 10x, or 13s R4s 41s and 10x, techs should not accept results of the QC analysis. Corrective action taken must be documented and QC samples re-analyzed after the instrument is working properly again.·Please remember that 12S is a warning rule. However, you need to show and document that corrective action were taken to trouble-shoot such as re-analysis of the control, or re-calibration, or change of reagents, or use of fresh QC. When the repeat control value is within the mean +/- 2SD, the error is considered random and results are reported.
Please remember that 12S is a warning rule. However, you need to show and document that corrective action were taken to trouble-shoot such as re-analysis of the control, or re-calibration, or change of reagents, or use of fresh QC. When the repeat control value is within the mean +/- 2SD, the error is considered random and results are reported.
