搜索
EP5-AVol.19No.2ReplacesEP5-T2February1999Vol.12No.4EvaluationofPrecisionPerformanceofClinicalChemistryDevices;ApprovedGuidelineThisdocumentprovidesguidancefordesigninganexperimenttoevaluatetheprecisionperformanceofclinicalchemistrydevices;recommendationsoncomparingtheresultingprecisionestimateswithmanufacturer'sprecisionperformanceclaimsanddeterminingwhensuchcomparisonsarevalid;aswellasmanufacturer'sguidelinesforestablishingclaims.ABCiNCCLS...ServingtheWorld'sMedicalScienceCommunityThroughVoluntaryConsensusNCCLSisaninternational,interdisciplinary,nonprofit,ProposedAnNCCLSconsensusdocumentundergoesthestandards-developingandeducationalorganizationthatfirststageofreviewbythehealthcarecommunityasapromotesthedevelopmentanduseofvoluntaryconsensusproposedstandardorguideline.Thedocumentshouldstandardsandguidelineswithinthehealthcarecommunity.receiveawideandthoroughtechnicalreview,includinganItisrecognizedwordwidefortheapplicationofitsuniqueoverallreviewofitsscope,approach,andutility,andaline-consensusprocessinthedevelopmentofstandardsandby-linereviewofitstechnicalandeditorialcontent.guidelinesforpatienttestingandrelatedhealthcareissues.NCCLSisbasedontheprinciplethatconsensusisanTentativeAtentativestandardorguidelineismadeeffectiveandcost-effectivewaytoimprovepatienttestingavailableforreviewandcommentonlywhenaandhealthcareservices.recommendedmethodhasawell-definedneedforafieldInadditiontodevelopingandpromotingtheuseofspecificdatabecollected.Itshouldbereviewedtoensurevoluntaryconsensusstandardsandguidelines,NCCLSitsutility.providesanopenandunbiasedforumtoaddresscriticalissuesaffectingthequalityofpatienttestingandhealthApprovedAnapprovedstandardorguidelinehasachievedcare.consensuswithinthehealthcarecommunity.ItshouldbePUBLICATIONSearlierversionshavebeensatisfactorilyaddressed),andtoAnNCCLSdocumentispublishedasastandard,guideline,orcommitteereport.NCCLSstandardsandguidelinesrepresentaconsensusStandardAdocumentdevelopedthroughtheconsensusagreementbymateriallyaffected,competent,andprocessthatclearlyidentifiesspecific,essentialinterestedpartiesobtainedbyfollowingNCCLS’srequirementsformaterials,methods,orpracticesforuseinestablishedconsensusprocedures.ProvisionsinNCCLSanunmodifiedform.Astandardmay,inaddition,containstandardsandguidelinesmaybemoreorlessstringentdiscretionaryelements,whichareclearlyidentified.thanapplicableregulations.Consequently,conformancetoGuidelineAdocumentdevelopedthroughtheconsensususerofresponsibilityforcompliancewithapplicableprocessdescribingcriteriaforageneraloperatingpractice,regulations.procedure,ormaterialforvoluntaryuse.Aguidelinemaybeusedaswrittenormodifiedbytheusertofitspecificneeds.COMMENTSReportAdocumentthathasnotbeensubjectedtocon-ThecommentsofusersareessentialtotheconsensussensusreviewandisreleasedbytheBoardofDirectors.process.Anyonemaysubmitacomment,andallCONSENSUSPROCESSdocument.Allcomments,includingthosethatresultinaTheNCCLSvoluntaryconsensusprocessisaprotocolconsensuslevelandthosethatdonotresultinachange,establishingformalcriteriafor:arerespondedtobythecommitteeinanappendixtothe!TheauthorizationofaprojectinanyformandatanytimeonanyNCCLSdocument.!ThedevelopmentandopenreviewofdocumentsWestValleyRoad,Suite1400,Wayne,PA19087,USA.!TherevisionofdocumentsinresponsetocommentsbyusersVOLUNTEERPARTICIPATION!TheacceptanceofadocumentasaconsensusHealthcareprofessionalsinallspecialitiesareurgedtostandardorguideline.volunteerforparticipationinNCCLSprojects.PleaseMostNCCLSdocumentsaresubjecttotwolevelsofinformationoncommitteeparticipation.consensus–proposedandapproved.Dependingontheneedforfieldevaluationordatacollection,documentsmayalsobemadeavailableforreviewatanintermediate(i.e.,tentative)consensuslevel.evaluationorwhenarecommendedprotocolrequiresthatreviewedtoassesstheutilityofthefinaldocument,toensureattainmentofconsensus(i.e.,thatcommentsonidentifytheneedforadditionalconsensusdocuments.opinionongoodpracticesandreflectthesubstantialthisvoluntaryconsensusdocumentdoesnotrelievethecommentsareaddressed,accordingtotheconsensusprocess,bytheNCCLScommitteethatwrotethechangetothedocumentwhenpublishedatthenextdocument.ReadersarestronglyencouragedtocommentAddresscommentstotheNCCLSExecutiveOffices,940contacttheNCCLSExecutiveOfficesforadditionalVol.19No.2EP5-AiTHENCCLSconsensusprocess,whichisthemechanismformovingadocumentthroughtwoormorelevelsofreviewbythehealthcarecommunity,isanongoingprocess.Usersshouldexpectrevisededitionsofanygivendocument.Becauserapidchangesintechnologymayaffecttheprocedures,methods,andprotocolsinastandardorguideline,usersshouldreplaceoutdatededitionswiththecurrenteditionsofNCCLSdocuments.CurrenteditionsarelistedintheNCCLSCatalog,whichisdistributedtomemberorganizations,andtononmembersonrequest.Ifyourorganizationisnotamemberandwouldliketobecomeone,andtorequestacopyoftheNCCLSCatalog,contacttheNCCLSExecutiveOffices.Telephone:610.688.0100;Fax:610.688.0700;E-Mail:exoffice@nccls.org.EvaluationofPrecisionPerformanceofClinicalChemistryDevices;ApprovedGuidelineAbstractEvaluationofPrecisionPerforma