EQAS Program User Guide - QCNet

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Chapter 1: Introduction and OverviewProgram AccreditationProgram AccreditationThe Bio-Rad EQAS Programs are accredited to help meet the regulatory needs of today's clinical laboratories.Accreditation is a process by which an organization gains recognition that its activities and processes have aguaranteed high quality. It involves an external audit by an independent and recognized body to anappropriate standard (regulation). By declaring a defined standard of practice and having it independentlyconfirmed, accredited programs, such as Bio-Rad EQAS, are able to attain a hallmark of performance andoffer reassurance to their participants of their competence as a provider, and in the high quality of productsand services offered.The American Association for Laboratory Accreditation (A2LA)Bio-Rad EQAS Programs are fully accredited by the American Association for Laboratory Accreditation (A2LA),a non-profit, non governmental public service, membership society. A2LA is governed by a Board of Directorsand obtains technical guidance from a number of technical committees. A2LA inspectors are trainedassessors who are technical experts in their fields. Accreditation decisions are made by the AccreditationCouncil.The Bio-Rad EQAS Program is accredited to the recognized International Standard ISO/IEC 17043:2010Conformity assessment-General requirements for proficiency testing. Additional information on the accreditingbody, A2LA, can be found on their website at www.a2la.org.EQAS Program User Guide 11
Chapter 1: Introduction and OverviewMonitoring of LaboratoriesNational Quality Assurance Advisory Panel (UK Labs)The National Quality Assurance Advisory Panel (NQAAP) retains responsibility for monitoring performance ofUK participants in the public and private sectors that perform medical testing for the detection, diagnosis ormanagement of disease in humans.The Bio-Rad EQAS policy for implementing the NQAAP guidance is to follow a series of steps designed toassist laboratories in effectively addressing performance issues. A consultation procedure is initiated whennecessary.Laboratory performance is assessed by:a) the consistent and timely return of results. Data must be submitted for a minimum of 75% of sampleswithin a cycle (9 of 12). Laboratories are expected to submit results by the Sample Due Date. Exceptionsmay be made where assays are carried out for clinical trials and regular reporting is not applicable.b) satisfactory analysis, as judged from the data. Results that fall consistently outside ± 2 Z-score from thecomparator mean usually indicates an analysis problem. The consultation procedure will be initiated forany laboratory submitting three results outside ± 2 Z-score in any four consecutive samples. Discretion isused in assessing results where the mean of comparison contains results from more than one method.Non analytical errors or “blunders” (for example, transcription errors), amended results, and inconsistentresults (such as several different analytes outside ± 2 Z-score at each sample) are also monitored. Theconsultation procedure is used where the frequency or clinical consequences of such results gives reason forconcern.If, after all avenues of consultation have been exhausted and there is no apparent improvement ofperformance, such performance issues are referred to the Bio-Rad EQAS Steering Committee and then, as alast resort to the NQAAP. Information concerning the actions and procedures of the NQAAP in relation tolaboratories referred, is available from the NQAAP.Additional details are available from Bio-Rad on request.Monitoring of non-UK laboratoriesBio-Rad EQAS can provide special reports to laboratory oversight and accrediting bodies to aid in theirauditing of laboratory services. In countries where participation and performance in this scheme can be usedfor laboratory accreditation purposes, Bio-Rad will provide all relevant information to participating laboratoriesand divulge laboratory results to the accrediting body. Contact Bio-Rad for more information.12 EQAS Program User Guide
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