#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCE>Pre-Analytic AssessmentsQA 6 RDoes the quality assessment review evaluate the laboratory’s processes for patient preparation; specimen collection,handling, labeling, transport, and specimen acceptability?The review should look at these criteria and determine if they are correct and appropriate for your lab, andverify that lab personnel are following them.QA 7 RAre quality assessment reviews performed to assess requisitions for completeness and relevance of content,including inconsistencies of age, gender, and, when available, diagnosis or pertinent clinical data, and relationshipwith the requests and/or results of other tests?Many laboratories utilize a chart audit or medical record review to easily assess the Patient TestManagement System. In the Pre-analytic phase this review should concentrate on the process for orderingtests, including assessment of the completeness and relevance of content of test requisitions, as well asretention of requisitions.QA 8 RAre all communication breakdowns between physicians (or other persons authorized to order tests) and laboratorypersonnel recorded and are corrective actions documented?This is generally not a problem in a small office lab. It can be a major problem if your laboratory accepts referralspecimens.Analytic AssessmentQA 9 RDoes the quality assessment review evaluate the corrective actions taken by laboratory personnel when qualitycontrol or calibration is out of range or instruments are out of calibration?The QA review should look at several months of QC, calibration and maintenance records to see if the laboratorystaff is identifying and taking corrective action when problems occur. Beyond this, the laboratoryshould look for patterns among the incidents requiring corrective action and the actual actions taken.Identification of a pattern of repetitive events is a trigger that something in the process is going awry.Identification of the root of this issue and formulation of process changes to prevent future occurrences isthe goal of the QA program.QA 10 RDoes the quality assessment review evaluate situations that indicate instruments or kits may no longer bemeeting stated performance specifications and the corrective actions taken in response to such situations?Performance specifications for:1) Unmodified FDA-cleared or approved test systems include accuracy, precision, reportable range of testresults, and verifying manufacturer’s reference ranges (normal values) are appropriate for the laboratory’spatient population.2) Modified FDA-cleared or approved test systems or a test system not subject to FDA clearance or approval(methods developed in house) requires accuracy, precision, sensitivity, specificity, reportable range of testresults, reference intervals (normal values), and any other performance characteristic required for test performance.As part of the QA process, you want to ensure that performance specifications have been completed and. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org57