PEPFAR Quality Control and Method Validation Activity 11 Job Aid 3: Proficiency Testing Failure Checklist

Job Aid 3: PT Failure Checklist 1109 119 Proficiency Testing Failure Checklist Survey Name: Clinical Specialty: Specimens: Date: Problem Description: Assessment Review PT Report Reviewed for Clerical Errors: Evaluation results match your copy of submitted results Yes No N/A Wrong Data Entered Yes No N/A Wrong Units Reported Yes No N/A Incorrect instrument or methodology indicated Yes No N/A Sample Handling: Unexpected delays in receiving survey Yes No N/A Kit contents correct and in acceptable condition Yes No N/A Testing performed within suggested instructional time guidelines Yes No N/A Specimens stored at correct temperature between receipt and analysis Yes No N/A Specimen analyzed at correct temperature Yes No N/A Sample mixed properly before testing Yes No N/A Sample diluted properly Yes No N/A Special Handling instructions were followed Yes No N/A Testing Procedure: Testing Personnel competent to perform analysis Yes No N/A Manufacturer's package insert available and followed Yes No N/A Testing procedure properly followed Yes No N/A Kit components replaced from other kits Yes No N/A Sample mix-up Yes No N/A Samples demonstrate a matrix effect Yes No N/A Instrument recently calibrated or due for calibration Yes No N/A Instrument maintenance up-to-date Yes No N/A New lot number of reagents or calibrators used Yes No N/A Reagents within expiration date Yes No N/A Results reported within linearity Yes No N/A QC within established range Yes No N/A QC demonstrates an even distribution around the mean Yes No N/A QC results show a shift, trend, or bias Yes No N/A Manufacturer consulted Yes No N/A Sample Results: A single sample fails on several analytes Yes No N/A All samples failed for the analyte Yes No N/A Previous survey results for the analyte demonstrate a problem emerging Yes No N/A PT material reassayed Yes No N/A Date of Repeat Testing Specimen Analyte Reported Result Repeated Result Intended Results Number /Peer Group HILS1746 Effective Date: 12/6/2016 120 Proficiency Testing Failure Checklist (continued) Survey Name: Clinical Specialty: Specimens: Date: Investigation: Conclusion: Corrective Action Taken: Name Laboratory Director Review HILS1746 Effective Date: 12/6/2016