ep15-a.准确度精密度评价.pdf

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1、EP15-AReplacesEP15-PVol.21No.25Vol.18No.22UserDemonstrationofPerformanceforPrecisionandAccuracy;ApprovedGuidelineThisdocumentdescribesthedemonstrationofmethodprecisionandaccuracyforlaboratoryanalytedeterminationsutilizingaprotocoldesignedtobecompletedwithinfiveworkingdaysorless.Aguidelinef

2、orglobalapplicationdevelopedthroughtheNCCLSconsensusprocess.NCCLS...ServingtheWorld’sMedicalScienceCommunityThroughVoluntaryConsensusNCCLSisaninternational,interdisciplinary,nonprofit,theneedforfieldevaluationordatacollection,documentsstandards-developing,andeducationalorganizationthatmaya

3、lsobemadeavailableforreviewatanintermediatepromotesthedevelopmentanduseofvoluntary(i.e.,“tentative”)consensuslevel.consensusstandardsandguidelineswithinthehealthcareProposedAnNCCLSconsensusdocumentundergoesthecommunity.Itisrecognizedworldwideforthefirststageofreviewbythehealthcarecommunity

4、asaapplicationofitsuniqueconsensusprocessintheproposedstandardorguideline.Thedocumentshoulddevelopmentofstandardsandguidelinesforpatientreceiveawideandthoroughtechnicalreview,includingantestingandrelatedhealthcareissues.NCCLSisbasedonoverallreviewofitsscope,approach,andutility,andaline-the

5、principlethatconsensusisaneffectiveandcost-by-linereviewofitstechnicalandeditorialcontent.effectivewaytoimprovepatienttestingandhealthcareservices.TentativeAtentativestandardorguidelineismadeavailableforreviewandcommentonlywhenaInadditiontodevelopingandpromotingtheuseofrecommendedmethodhas

6、awell-definedneedforafieldvoluntaryconsensusstandardsandguidelines,NCCLSevaluationorwhenarecommendedprotocolrequiresthatprovidesanopenandunbiasedforumtoaddresscriticalspecificdatabecollected.Itshouldbereviewedtoensureitsissuesaffectingthequalityofpatienttestingandhealthutility.care.Approve

7、dAnapprovedstandardorguidelinehasachievedPUBLICATIONSconsensuswithinthehealthcarecommunity.ItshouldbeAnNCCLSdocumentispublishedasastandard,reviewedtoassesstheutilityofthefinaldocument,toguideline,orcommitteereport.ensureattainmentofconsensus(i.e.,thatcommentso