QUALITY ASSESSMENT (QA)WORKSHEET NAME__________________________
Quality Control is most effective when it takes into consideration all of the circumstances that are unique to each laboratory.
That is exactly what IQCP does, allowing the laboratory to develop a QC plan that is customized for how the test is performed on site while maintaining
compliance with the applicable regulations. https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP
https://www.cdc.gov/labquality/iqcp.html
An Individualized Quality Control Plan for a specific test system consists of three components:
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
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The Risk Assessment
The Quality Control Plan (QC Plan)
The Quality Assessment Review – as a component of your (QA) Plan
Use this form to complete your laboratory’s Quality Control Plan worksheet below. Use the questions
Laboratory Name____________________________ Test System Name___________________________
QA ACTIVITY TO MONITOR
What will you monitor?
Frequency
how often ?
ASSESSMENT OF QA ACTIVITY
How will you measure if there was variation from
established policy and procedures?
CORRECTIVE ACTION (WHEN INDICATED)
What action will be taken to correct?
Post- Analytical
Analytical
Pre- Analytical
Risk
Assessment
Specimen
Reagent
Test System
Environment
Testing Personnel
Risk:
H/ L