#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCE>Post-Analytic AssessmentQA 15 RDoes the quality assessment review assess test reports for completeness and relevance of the content, distributionof results to the appropriate parties, and maintenance of original or exact duplicate reports for therequired time periods?Many laboratories utilize a chart audit or medical record review to easily assess the post-analytic portion ofthe Patient Test Management System. In the Post-analytic phase, this review should concentrate on theprocesses for reporting, distributing, and maintaining test reports.In this phase, you will also want to evaluate compliance with policy for handling and reporting panic valuesas well as handling errors. When assessing errors focus on how the error was identified, what permitted theerroneous report to be released, and whether corrected reports were issued, affected parties promptly notified,and records kept of the original and corrected report.QA 16 RAre test turnaround times (such as STATs) evaluated to ensure results are obtained in a clinically useful period?General AssessmentsQA 17 RIn order to ensure the validity and effectiveness of the process provided by the Laboratory Information System(LIS) monitor all elements related to pre-analytic, analytic, and post-analytic processes. The LIS is an electronicbased laboratory data system.Does the quality assessment review of the Laboratory Information System include:QA 17.1Accuracy and precision of the data entry process, whether manual or automated?A review of the accuracy and precision of the data entry process, (manual or automated) may be conductedby comparing test records (tapes or screen values) to the data contained in the computer and printed on thereport. The patient information, entered through barcode or requisition information, should also be validatedfor accuracy.QA 17.2Correctness of computer calculations performed on patient data?QA 17.3Evaluation of data storage and recovery?Data storage and recovery systems should be assessed regularly to assure data is not lost, but can be appropriatelystored and can be retrieved in a timely manner.QA 18 RWhen there are complaints about the laboratory, is the complaint evaluated and, if necessary, is correctiveaction taken?The laboratory should have a protocol for dealing with complaints. Every complaint should be taken seriouslyand should be investigated by the laboratory director or supervisor. If the complaint is justified, correctiveactions should be taken to remedy the problem. The QA review should look at these complaints to determineif there is a generalized problem in the lab, to be sure that the protocol is followed, and that appropriateaction has been taken.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org59