Proficiency testing exception review
Example Regional Laboratory · Chemistry Event 2026-A · Demonstration only
Event summary
One fictional chloride result exceeded the program's example peer-comparison limit. Patient testing impact, reportability, regulatory response, and final disposition would require review by the organization's authorized laboratory leaders.
Result review
AnalyteTargetReportedReview
Sodium142 mmol/L141 mmol/LAcceptable
Potassium4.10 mmol/L4.08 mmol/LAcceptable
Chloride103 mmol/L111 mmol/LInvestigate
Glucose98 mg/dL99 mg/dLAcceptable
Documented investigation
Before testingNo problem was found in receipt, storage, preparation, or timing records.
During testingReview identified a manually entered result that did not match the instrument printout.
After testingA second-person check was documented but did not compare the original source with the submitted result.
Example root cause and corrective action
Root cause: The manual entry check did not require comparison with the original result. Immediate correction: Document the accurate source result and complete the program's required response steps. Corrective action: Revise the entry checklist, retrain authorized staff, and require an independent source-to-portal comparison before submission.
Follow-up plan
- Audit the next three proficiency-testing submissions for independent verification.
- Confirm that the prior two events had no similar discrepancy.
- Review training records and checklist use at the next quality meeting.
- Escalate any recurrence to the laboratory director for additional action.
Prepared byAssayIQ Global, sample
Technical reviewRequired
Laboratory director approvalRequired