EP17-A2Evaluation-of-Detection-Capability-for-Clin

EP17-A2Vol.32No.8ReplacesEP17-AVol.24No.34EvaluationofDetectionCapabilityforClinicalLaboratoryMeasurementProcedures;ApprovedGuideline—SecondEditionThisdocumentprovidesguidanceforevaluationanddocumentationofthedetectioncapabilityofclinicallaboratorymeasurementprocedures(ie,limitsofblank,detection,andquantitation),forverificationofmanufacturers’detectioncapabilityclaims,andfortheproperuseandinterpretationofdifferentdetectioncapabilityestimates.AguidelineforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsInstituteconsensusprocess.LicensedtoPattyWang.ANSIorderX_294860.Downloaded10/23/201211:09PM.Singleuserlicenseonly.Copyingandnetworkingprohibited.ClinicalandLaboratoryStandardsInstituteAdvancingQualityinHealthCareTestingClinicalandLaboratoryStandardsInstitute(CLSI)isaninternational,interdisciplinary,nonprofit,standardsdeveloping,andeducationalorganizationthatpromotesthedevelopmentanduseofvoluntaryconsensusstandardsandguidelineswithinthehealthcarecommunity.Wearerecognizedworldwidefortheapplicationofouruniqueconsensusprocessinthedevelopmentofstandardsandguidelinesforpatienttestingandrelatedhealthcareissues.Ourprocessisbasedontheprinciplethatconsensusisaneffectivewaytoimprovepatienttestingandhealthcareservices.Inadditiontodevelopingandpromotingtheuseofvoluntaryconsensusstandardsandguidelines,weprovideanopenandunbiasedforumtoaddresscriticalissuesaffectingthequalityofpatienttestingandhealthcare.PUBLICATIONSAdocumentispublishedasastandard,guideline,orreport.StandardAdocumentdevelopedthroughtheconsensusprocessthatclearlyidentifiesspecific,essentialrequirementsformaterials,methods,orpracticesforuseinanunmodifiedform.Astandardmay,inaddition,containdiscretionaryelements,whichareclearlyidentified.GuidelineAdocumentdevelopedthroughtheconsensusprocessdescribingcriteriaforageneraloperatingpractice,procedure,ormaterialforvoluntaryuse.Aguidelinemaybeusedaswrittenormodifiedbytheusertofitspecificneeds.ReportAdocumentthathasnotbeensubjectedtoconsensusreviewandisreleasedbytheappropriateconsensuscommittee.CONSENSUSPROCESSCLSI’svoluntaryconsensusprocessestablishesformalcriteriaforthefollowing:•Authorizationofaproject•Developmentandopenreviewofdocuments•Revisionofdocumentsinresponsetousers’comments•AcceptanceofadocumentasaconsensusstandardorguidelineInvitationforParticipationintheConsensusProcessCoretothedevelopmentofallCLSIdocumentsistheconsensusprocess.WithinthecontextandoperationofCLSI,voluntaryconsensusissubstantialagreementbymateriallyaffected,competent,andinterestedpartiesthatmaybeobtainedbyfollowingtheconsensusproceduresdefinedinCLSI’sAdministrativeProcedures.Itdoesnotalwaysconnoteunanimousagreement,butdoesmeanthattheparticipantsinthedevelopmentofaconsensusdocumenthaveconsideredandresolvedallrelevantobjectionsandarewillingtoaccepttheresultingagreement.CLSIdocumentsareexpectedtoundergoevaluationandmodificationinordertokeeppacewithadvancementsintechnologies,procedures,methods,andprotocolsaffectingthelaboratoryorhealthcare.CommentsonDraftDocumentsCLSI’svoluntaryconsensusprocessdependsonexpertswhoserveascontributingauthorsand/orasparticipantsinthereviewingandcommentingprocess.Attheendofeachcommentperiod,thecommitteethatdevelopedthedocumentisobligatedtoreviewallcomments,respondinwritingtoallsubstantivecomments,andrevisethedraftdocumentasappropriate.Allcommentsalongwiththecommittee’sresponsesareretainedonfileatCLSIandareavailableuponrequest.CommentsonPublishedDocumentsThecommentsofusersofpublishedCLSIdocumentsareessentialtotheconsensusprocess.Anyonemaysubmitacomment.Allcommentsareaddressedaccordingtotheconsensusprocessbyacommitteeofexperts.AsummaryofcommentsandcommitteeresponsesisretainedonfileatCLSIandisavailableuponrequest.Readersarestronglyencouragedtocommentatanytimeonanydocument.APPEALSPROCESSCLSIconsensusproceduresincludeanappealsprocessthatisdescribedindetailintheCLSIAdministrativeProcedures.VOLUNTEERPARTICIPATIONHealthcareprofessionalsinallspecialtiesareurgedtovolunteerforparticipationinCLSIprojects.Forfurtherinformationoncommitteeparticipationortosubmitcomments,contactCLSI.ClinicalandLaboratoryStandardsInstitute950WestValleyRoad,Suite2500Wayne,PA19087USA610.688.0100F:[e-mail]_294860.Downloaded10/23/201211:09PM.Singleuserlicenseonly.Copyingandnetworkingprohibited.EP17-A2ISBN1-56238-795-2(Print)ISBN1-56238-796-0(Electronic)ISSN1558-6502(Print)Volume32Number8ISSN2162-2914(Electronic)EvaluationofDetectionCapabilityforClinicalLaboratoryMeasurementProcedures;ApprovedGuideline—SecondEditionJamesF.Pierson-PerryJeffreyE.Vaks,PhDA.PaulDurham,MAChristianFischer,MDCorneliusGutenbrunner,PhDDavidHillyard,MDMarinaV.Kondratovich,PhDPaulaLadwigRobertA.Middleberg,PhD,DABFT,DABCCAbstractClinicalandLaboratoryStandardsInstitutedocumentEP17-A2—EvaluationofDetectionCapabilityforClinicalLaboratoryMeasurementProcedures;ApprovedGuideline—SecondEditionprovidesguidanceforevaluatingthedetectioncapabilityofclinicallaboratorymeasurementprocedures(ie,limitsofblank,detection,a