QC Corrective Action Log: What CLIA Requires
When QC fails, CLIA requires the lab to hold patient results and investigate. The lab must evaluate every patient result since the last acceptable run, correct the problem and document every action. Patient results can't be reported until controls are acceptable (42 CFR 493.1256(f), 493.1282). Keep QC and corrective action records for at least two years.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Key facts and official sources
Control results must meet acceptability criteria before patient results are reported. Source: 42 CFR 493.1256(f)
All control procedures must be documented. Source: §493.1256(g)
All corrective actions must be documented, and patient results from the failed run back to the last acceptable run must be evaluated. Source: 42 CFR 493.1282(b)(2)
QC and analytic system records must be kept for at least 2 years. Source: 42 CFR 493.1105(a)(3)
When does CLIA require documented corrective action?
Section 493.1282(b) requires documented corrective action for every corrective action taken, including when:
the test system doesn't meet its performance specifications
results fall outside the reportable range
reference intervals are inappropriate for your patient population
control or calibration results fail acceptability criteria
reagent or specimen storage criteria aren't met
Separate rules cover errors in reports that have already been released (§493.1291(k)).
What must a QC corrective action entry include?
Date/time, test, instrument, control level and lot: Glucose, Analyzer 2, Level 2, Lot 1234
Failure and rule: Level 2 at +3.4 SD (1-3s)
Patient impact window: Runs since the last acceptable QC at 07:10
Investigation: Reagent, calibration, maintenance, control handling
Root cause: Example: reagent pack past its open-vial stability
Fix: New reagent pack, recalibration
Verification: Both control levels in range after the fix
Patient look-back result: Number of results reviewed and number corrected, with the corrected reports issued
Who and when: Tech initials; TC/TS review and signature
The examples above are for illustration only.
How do you do a patient look-back?
List every patient result reported since the last acceptable QC run.
Retest a selection of those specimens, or all of them where stability allows, after the system is fixed.
Compare the results against your allowable difference.
Issue corrected reports and notify the ordering providers for any clinically significant changes.
Document the decision and the evidence, even when no patient results were affected.
What QC corrective action mistakes get cited?
Rerunning controls until they pass, with no investigation.
No patient look-back.
A blank "action taken" field, or "QC repeated, OK."
No TC or TS review.
The same failure recurring with no trend review.
Records discarded before two years.
Surveyors usually cite these under QC and corrective action standards, often alongside the TC or TS responsibility standards.
How do you keep the log survey-ready?
Use one log format across all test systems, review it during monthly QC review, and trend repeat failures by analyte and instrument. A digital QC system such as myLabCompliance.io can link each failure to its Levey-Jennings chart and corrective action.
Frequently asked questions
Do we have to retest patients every time QC fails?
You must evaluate the patient results since the last acceptable run. The extent of retesting depends on the failure and on specimen stability. Document your rationale.
How long do we keep QC corrective action records?
At least two years under §493.1105. Your accreditor or state may require longer.
Who should sign corrective action entries?
The person who did the work, and then the TC (moderate complexity) or TS (high complexity) as reviewer.
Is a 1-2s warning a corrective action event?
Under Westgard multirules, 1-2s is a warning. Document the run evaluation according to your QC policy.
Want your QC records reviewed?
Sound Lab Consultants audits QC and corrective action records and fixes QC deficiencies before your survey.