Most labs are vigilant about running daily quality control. But what about the big picture?
CLIA requires labs performing non-waived testing to conduct a formal, documented review of QC records at least twice a year. This is not optional and failing to do it is one of the most frequently cited deficiencies during inspections.
The reason? It’s easy to assume that “QC is being monitored” just because it’s done every day. But CLIA wants to see a higher-level review that looks for trends, patterns, and long-term issues.
In this post, we’ll break down what this requirement really means, how to structure the review, and what to include in your documentation to stay inspection-ready.
What CLIA and CAP Require
For each non-waived test system, labs must:
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Review quality control results at least every 6 months
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Look for shifts, trends, outliers, or systematic issues
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Document the review, findings, and any corrective actions taken
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Have the review signed and dated by the lab director or designee
This review is distinct from daily QC checks, instrument flags, or monthly control summary reports.
What Labs Get Cited For
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No QC Review Documentation Exists
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Even if someone does review QC, there’s no record of it happening.
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Reviews Aren’t Signed or Dated
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No evidence of oversight by qualified personnel.
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Only Pass/Fail Is Reviewed
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No actual analysis of control values or patterns over time.
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Findings Not Addressed
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Obvious trends or shifts are ignored with no action taken.
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Missed Timeframes
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Reviews done sporadically or only annually.
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How to Run a Proper Biannual QC Review
1. Set a Recurring Schedule
Block time every 6 months to review QC data by instrument or test system. Use a calendar reminder, task management tool, or compliance platform to remove any possibility of human error.
2. Pull and Plot Your QC Data
Use:
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Levey-Jennings charts to accurately map QC stability
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Standard deviation and mean shifts
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Westgard rules compliance
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Day-to-day and batch-to-batch variation analysis
Automated tools (like StaffReady’s QC module or middleware systems) can help generate visual trends quickly.
3. Document Your Review
Your QC review report should include:
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Date of review
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Period covered (e.g., Jan–June 2025)
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Summary of QC performance
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Identified trends or anomalies
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Any corrective or preventive actions
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Reviewer signature and credentials
Attach charts or control logs as appendices for full transparency.
4. Follow Up and Close the Loop
If you notice recurring control failures, shifts, or reagent issues:
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Investigate root cause
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Update SOPs or retrain staff
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Document what was done and when
This follow-up is what turns a QC review from a formality into a meaningful quality event.
Why It Matters
Biannual QC review:
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Uncovers slow drifts in performance that daily QC might miss
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Identifies instrument problems before they cause test failures
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Demonstrates oversight to inspectors
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Strengthens your lab’s overall quality culture
A biannual review is your chance to catch issues early and show leadership in your QA program.
Common Lab Questions
Q: If we monitor QC daily, do we still need a 6-month review?
Yes. This is a separate requirement focused on aggregate trends over time.
Q: Can the same person who runs QC review it?
Yes, but the review must still be objective, signed, and dated. This is ideally performed by supervisory or director-level staff.
Q: If no trends are found, is documentation still needed?
Yes. You still need to document that the review occurred and no issues were found.
