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Corrective Action Form - api-pt.com

Instrument Were instrument problems noted the day the samples were tested? Yes No Has there been any recent maintenance on the analyzer?

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Text of Corrective Action Form - api-pt.com

Checklist for Corrective Action Year/Testing Event_____________ Analyte_____________ Sample number_________ Date Sample Tested________________ Person Performing Test_________________________ Specimen Handling Were specimens received in an acceptable condition? Yes No Were specimens stored according to the instructions on the result forms? Yes No Were the samples hemolyzed? Yes No Were samples tested within the time allowed for sample stability? Yes No If applicable, were the samples reconstituted correctly? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ __________________________________ Clerical Errors Were the results transcribed onto the forms correctly? Yes No Were the results recorded on the correct result form? Yes No Was the correct instrument/reagent/kit selected? Yes No Were the results recorded in the correct units? Yes No Were the results on your evaluation the same as the results you reported? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Quality Control Were controls in range on the date the proficiency samples were tested? Yes No Is there any indication of trending or shifting of the control results? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Calibration Were there any problems with the most recent calibration? Yes No When was the last calibration performed? _______________________ How often is a calibration performed? _______________________ When was the last calibration verification performed? _______________________ Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Instrument Were instrument problems noted the day the samples were tested? Yes No Has there been any recent maintenance on the analyzer? Yes No Have you contacted your analyzer manufacturer for assistance? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Reagents Were the reagents stored properly? Yes No Were the reagents expired or was the open vial stability exceeded? Yes No Have there been any changes in reagent manufacturer or formulation? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Culture Was the media stored according to manufacturer s instructions? Yes No Was the media expired? Yes No Was the appropriate QC performed on the media? Yes No Was the incubator temperature/gas/humidity within acceptable limits? Yes No If applicable, have you contacted your kit manufacturer for assistance? Yes No Notes:__________________________________ ________________________________________ ________________________________________ ___________________________________ Findings:_______________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ ___________________________________ Could patient results have been affected? If so, explain course of action:___________________ ________________________________________ _____________________________________ ________________________________________ _____________________________________ Corrective Action:_________________________________ ______________________________ ________________________________________ ________________________________________ ________________________________________ ____________________________________ ________________________________________ ______________________________________ ________________________________________ ______________________________________ Person Performing Investigation___________________________ __ Date__________________ Lab Director________________________________ _____________ Date__________________ Completed correction action forms do not need to be sent to American Proficiency Institute. Keep all documentation with your records. You will be required to show them to your inspector at your next onsite inspection. You may also need to send a copy to your state or accrediting agency. This form is designed to offer assistance to the laboratory in investigation and troubleshooting proficiency testing failures. It is the laboratory s responsibility to effectively troubleshoot and resolve all proficiency testing failures. Completion of this form does not guarantee future successful performances with proficiency testing. Call 800-333-0958 for assistance.

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