BS EN 14136-2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures《体外诊断检验程序的性能评定中外部质量评定方案的使用》.pdf

1、BRITISH STANDARD BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures The European Standard EN 14136:2004 has the status of a British Standard ICS 11.100 BS EN 14136:2004 This British Standard was published und

2、er the authority of the Standards Policy and Strategy Committee on 26 May 2004 BSI 26 May 2004 ISBN 0 580 43819 8 National foreword This British Standard is the official English language version of EN 14136:2004. The UK participation in its preparation was entrusted to Technical Committee CH/212, IV

3、Ds, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under t

4、he section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applica

5、tion. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; moni

6、tor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was las

7、t issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14136 May2004 ICS11.100 Englishversion Useofexternalqualityassessmentschemesintheassessment oftheperformanceofinvitrodiagnosticexaminationprocedures Utilisationdesprogrammesdvaluation

8、externedela qualitdanslvaluationdelaperformancedesprocdures dediagnosticinvitro VerwendungexternerQualittssicherungsprogrammebei derBewertungderDurchfhrungvon UntersuchungsverfahreninderInvitroDiagnostik ThisEuropeanStandardwasapprovedbyCENon2March2004. CENmembersareboundtocomplywiththeCEN/CENELECIn

9、ternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeof

10、ficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Esto

11、nia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCe

12、ntre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14136:2004:EEN14136:2004(E) 2 Foreword Thisdocument(EN14136:2004)hasbeenpreparedbyTechnicalCommitteeCEN/TC140“Invitrodiagnostic medicaldevices”,thesecretariatofwh

13、ichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyNovember2004,andconflictingnationalstandardsshallbewithdrawnatthelatest byNovember2004. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommis

14、sionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeAnnexZA,whichisanintegralpartofthisdocument. ThisdocumentincludesaBibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofth

15、efollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Cyprus,CzechRepublic,Denmark, Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta, Netherlands,Norway,Poland,Portugal,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingd

16、om.EN14136:2004(E) 3 Introduction Externalqualityassessmentschemes(EQAS)areanessentialfeatureofmechanismsdesignedtomaintainand improvetheanalyticalqualityandmedicalappropriatenessofclinicallaboratorydata.EQASaremosthighly developedinfieldsinwhichmostlyquantitative,numericaldataaregenerated;notablyin

17、clinicalchemistry, haematology,immunology,etc.However,EQAScanalsobeextendedtoqualitativeormoresubjective investigationssuchasinmicrobiologyandparasitology,aswellasinhistoorcytopathology. ParticipationandacceptableperformanceinEQASserveavaluablefunctioninraisingstandardsinlaboratory medicineandineduc

18、atingprovidersandusersaboutthepotentialbenefitsandlimitationsoflaboratory examinations.ObjectivedataprovidedbyEQASareanessentialcomponentofeffortstorelatethecurrentstateof theartoflaboratoryperformancetomedicalneeds. EQASarealreadyessentialpartsoflaboratoryaccreditationsystems,whethermandatoryornot,

19、inmemberstates oftheEuropeanUnion.Goodclinicallaboratorypracticeincludesbothexternalqualityassessmentandinternal qualitycontrolascomplementarycomponentsofqualityassurance. InadditiontothemajorobjectivesofEQAS(seeISO/IEC Guide 431),datafromEQAScanalsoprovidea valuableresourceinenablingcomparisonstobe

20、madebetweenalternativeneworestablishedanalytical procedures(includinginvitrodiagnosticmedicaldeviceshereaftercalledIVD MDs),orindemonstratingthe transferabilityofproceduresbetweenlaboratories,orindisclosingdifficultiesordeficienciesintheiroperationthat canonlybecomeapparentduringlongtermandwidesprea

21、duse.AnEQASinwhichthesurveysampleshave referenceprocedurevaluescanprovideevidenceofthetruenessofresultsobtainedbyusingdifferentprocedures; anEQASinwhichthesamesurveysamplesarecirculatedrepeatedlyandfrequentlycandemonstrate reproducibilityand,e.g.,thepossibleeffectsofchangesinthepropertiesofanIVDMD.

22、ThemajorobjectivesofindividualEQASdiffer,rangingfromthosethataredirectedprincipallytowardsensuring compliancewithspecificproficiencytargets,tothosethatareaimedatageneralsurveyandimprovementof particularservices:e. g.,indevelopinganetworkofparticipation,orinestablishingcriteriaforevaluating performan

23、ceofmoresubjectiveinvestigations.Thus,detailsofschemessuchasorganisation(e.g.,byregulatory authorities,professionalsocietiesorindustrialconcerns),natureandfrequencyofsampledistribution,and assessmentofresults,differfromoneschemetoanother. BecauseofthedifferingfunctionsandobjectivesofEQAS,itisneither

24、possiblenordesirabletoimposeasingle patternoforganisationonallsuchschemes,andthisEuropeanStandarddoesnotintendtodoso.Thegeneral principlesforthedesignandtheoperationofEQASareoutlinedinISO/IECGuide431andinclude: useofappropriatesurveysamples; effectivedistributiontoparticipants(e.g.laboratoriesand/or

25、pointofcaretestingsites); rapidprocessingofsurveydata; returntoparticipantsofreportsthatareclearlyinterpretedwithrespecttostatedcriteria; mechanismsforfollowupofunsatisfactoryperformance(e.g.throughadviceservices). InordertoenableEQAStoprovidedatathatareusefulinmonitoringtheanalyticalperformanceofsp

26、ecific procedures(includingIVDMDs),additionalfeaturesareused.Forexample,EQASshouldunequivocally identifyindividualprocedures(devices)usedinstatisticallysignificantnumbers,andaboveall,they shouldbeabletodistinguishperformancecharacteristicsinherentinaparticularprocedure(device)from thoseattributablet

27、oitsusers. ThisEuropeanStandardspecifieswaysinwhichEQAScanmeettheseprocedure(device)relatedcriteria.Thus, EQASisabletocontributetothepostmarketingmonitoringofIVDMDsasmentionedinDirective98/79/EConin vitrodiagnosticmedicaldevicestothebenefitofboththeirmanufacturersandusers.EN14136:2004(E) 4 1Scope Th

28、isEuropeanStandardappliestoexternalqualityassessmentschemes,hereaftercalledEQAS,thatincludein theirfunctionstheassessmentandevaluationoftheperformanceofspecifiedinvitrodiagnosticprocedures (includinginvitrodiagnosticmedicaldevices,hereaftercalledIVDMDs).Itsetsouttherequirementsthatare necessarytoena

29、bleEQAStofulfilthisfunctionrelatingto: schemedesignandorganisation; identificationofprocedures(IVDMDs)usedbytheparticipant; classificationandevaluationofdata. NOTE Externalqualityassessmentdatageneratedaccordingtothesecriteriawillhelpmanufacturers,usersorcompetent authoritiestomonitorindependentlyth

30、epostmarketingperformanceofIVDMDs. ThisEuropeanStandarddoesnotspecifywaysinwhichEQASthemselvesareorganised,norhowtheindividualor collectiveperformanceofclinicallaboratoriesisevaluated. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromotherpublications.The

31、se normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.For datedreferences,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicat

32、ionreferredtoapplies(includingamendments). EN375:2001, Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforprofessionaluse. EN12286:1998, InvitrodiagnosticmedicaldevicesMeasurementofquantitiesinsamplesofbiologicalorigin Presentationofreferencemeasurementprocedures. EN45003:1995, Cali

33、brationandtestinglaboratoryaccreditationsystemGeneralrequirementsforoperationand recognition. ENISO15195 ,LaboratorymedicineRequirementsforreferencemeasurementlaboratories(ISO/FDIS 15195:2003). ENISO17511, InvitrodiagnosticmedicaldevicesMeasurementofquantitiesinbiologicalsamplesMetrological traceabi

34、lityofvaluesassignedtocalibratorsandcontrolmaterials(ISO17511:2003). ENISO18153, InvitrodiagnosticmedicaldevicesMeasurementofquantitiesinbiologicalsamplesMetrological traceabilityofvaluesforcatalyticconcentrationofenzymesassignedtocalibratorsandcontrolmaterials(ISO 18153:2003). ISO35341:1993, Statis

35、ticsVocabularyandsymbolsPart1:Probabilityandgeneralstatisticalterms. InternationalVocabularyofBasicandGeneralTermsinMetrology(VIM),2ndedition,Geneva:ISO,1993 3 Termsanddefinitions ForthepurposesofthisEuropeanStandard,thetermsanddefinitionsgiveninEN375:2001,EN12286:1998, ENISO17511:2003,EN45003:1995,

36、ISO35341:1993,theInternationalVocabularyofBasicandGeneralTerms inMetrology(VIM)andthefollowingapply.EN14136:2004(E) 5 3.1 assignedvalue valueattributedtoaparticularquantityandaccepted,sometimesbyconvention,ashavinganuncertainty appropriateforagivenpurposeISO/IECGuide431:1997 3.2 externalqualityasses

37、sment EQA determinationofindividualandcollectivelaboratoryperformance,andperformancecharacteristicsofexamination proceduresbymeansofinterlaboratorycomparison NOTE TheprimaryobjectivesofEQAareeducational,andcanbesupportedbyadditionalelements. 3.3 nominalscale scalewithasetofpossiblevalues,foragivenki

38、ndofproperty,thatareeachdesignatedbyawordorsymbol withoutanyrelationtomagnitude EXAMPLE Bloodgroup(A,B,AB,0) NOTE Thevaluescanbelistedinanyarbitraryorderaccordingtopracticalconsiderationsandconvention. 3.4 ordinalscale scalewithanorderedsetofpossiblevalues,forpropertiesofagivenkindofproperty,thatare

39、eachdesignatedby awordorsymbolusedforrankingaccordingtomagnitude,butwheredifferencesorratiosbetweenvalueshaveno arithmeticmeaning EXAMPLES Wordingsuchas“notdetected“,“weaklypositive“,“positive“,“stronglypositive“orfiguressuchas0,1,2,3. 3.5 targetvalue acceptedreferencevalue NOTE Examplesoftargetvalu

40、esareassignedvalues,referenceprocedurevalues,andconsensusvalues. 3.6 referencemeasurementprocedure thoroughlyinvestigatedmeasurementprocedureshowntoyieldvalueshavinganuncertaintyofmeasurement commensuratewithitsintendeduse,especiallyinassessingthetruenessofothermeasurementproceduresforthe samequanti

41、tyandincharacterizingreferencematerialsEN12286:1998,3.7 3.7 referenceprocedurevalue valueobtainedbyareferencemeasurementprocedure 3.8 surveysample samplesenttoparticipantsforselectedexamination,wheretheresultisreturnedtotheEQASorganisationfor independentassessmentofperformance 4 Designrequirementsfo

42、rEQAS 4.1 TheEQASorganisationshallformulatetheobjectivesofitssurveysatitsstart. 4.2 TheEQASorganisationshallprovidesurveysamplescomposedinsuchawaythattheysimulateasclosely aspossibletherelevantpropertiesofthesamplesonwhichtheexaminationproceduresareintendedtobeused. NOTE1 Forassigningtargetvaluestos

43、urveysamplesseeENISO17511.EN14136:2004(E) 6 NOTE2 Forsomeevaluationsitcanbeappropriatetouseasetofsurveysampleswithdifferenttargetvalues. NOTE3 TheresponsibilityoftheEQASorganisationforprovidingsurveysampleswithappropriatepropertiesissetoutin ISO/IECGuide431. NOTE 4 EQASorganisationsshouldnotselectsurveysamplescontainingunphysiologicaladditiveswhichmay disadvantageanindividualIVDMD. 4.3 Thefrequencyofsurveysshallbeappropriatefortheinvestigation,andpreferablyatleast6timesperyear. InordertoallowevaluationofrecentIVDMDperformancethesurveydatashallbe