ISO認(rèn)可和CA認(rèn)證的流程和體會(huì)

ISO15189認(rèn)可和CAP認(rèn)證的流程和體會(huì)浙江大學(xué)醫(yī)學(xué)院附屬第二醫(yī)院譚運(yùn)年2013.11.081一、為什么要做？二、認(rèn)證認(rèn)可差別三、體系建立和檢查手段四、申請(qǐng)流程和體會(huì)HELP!!!FREE3一、為什么要做？為什么不想做？據(jù)說(shuō)聽(tīng)說(shuō)傳說(shuō)文件工作多學(xué)習(xí)任務(wù)重硬件達(dá)不到要求軟件達(dá)不到要求只按部分要求做，不評(píng)4推動(dòng)的因素外部：國(guó)內(nèi)：優(yōu)質(zhì)醫(yī)院、等級(jí)醫(yī)院、衛(wèi)生部重點(diǎn)專(zhuān)科評(píng)審。國(guó)外：JCI

(JointCommissiononAccreditationofHealthcareOrganizations,JCAHO)，CAP（

CollegeofAmericanPathologist）內(nèi)部：自身發(fā)展的需要、自重、自尊。5歸根到底：高品質(zhì)醫(yī)療服務(wù)的需要質(zhì)的需要：深度——提供項(xiàng)目的質(zhì)量量的需要：廣度——覆蓋面（提供多少項(xiàng)目、服務(wù)人群、對(duì)口支援單位）6回歸到正確的服務(wù)軌道上過(guò)去：體系不完善、服務(wù)質(zhì)量有待提高現(xiàn)在：提倡服務(wù)對(duì)象至上、服務(wù)契合對(duì)象需要7實(shí)驗(yàn)室如何證明自己的能力

第一方證明-自我聲明第二方證明-客戶(hù)的證明第三方證明-公正權(quán)威的證明

8浙二醫(yī)院檢驗(yàn)科ISO15189初次評(píng)審2012.4.23-25現(xiàn)場(chǎng)評(píng)審2012.9.29獲得認(rèn)可（編號(hào)121）

CAP（LaboratoryAccreditationProgram,LAP)2013.7.10-12現(xiàn)場(chǎng)評(píng)審2013.9.10獲得認(rèn)證（中國(guó)大陸第6家公立醫(yī)院）ISO15189監(jiān)督擴(kuò)項(xiàng)評(píng)審2013.10.11-13現(xiàn)場(chǎng)評(píng)審9醫(yī)學(xué)實(shí)驗(yàn)室ISO15189

CAP

（LAP)評(píng)審機(jī)關(guān)各國(guó)認(rèn)可機(jī)構(gòu)（官方

）中國(guó)CNAS美國(guó)病理學(xué)協(xié)會(huì)

（第三方）應(yīng)用法律本地法律弱化但地區(qū)法律法規(guī)適用

強(qiáng)調(diào)美國(guó)法律

所要求的技術(shù)水準(zhǔn)

國(guó)際性技術(shù)水平

美國(guó)技術(shù)水準(zhǔn)

評(píng)審原則自愿，專(zhuān)家評(píng)審自愿，專(zhuān)家評(píng)審費(fèi)用

相對(duì)便宜

略貴認(rèn)可周期3年2年國(guó)內(nèi)已經(jīng)獲得認(rèn)可或認(rèn)證的醫(yī)學(xué)實(shí)驗(yàn)室132家23（其中公立醫(yī)院6家，其它為跨國(guó)醫(yī)藥公司或第三方實(shí)驗(yàn)室）10背景簡(jiǎn)介認(rèn)可可認(rèn)認(rèn)證證依依據(jù)據(jù)ISO15189CAP(LAP)ISO17025:《檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求》。ISO15189:《醫(yī)學(xué)實(shí)驗(yàn)室—質(zhì)量和能力的專(zhuān)用要求》CLIA88（美國(guó)臨床實(shí)驗(yàn)室改進(jìn)修正法規(guī)’88）CLSI（美國(guó)臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)協(xié)會(huì)）11二、、認(rèn)認(rèn)證證認(rèn)認(rèn)可可差差別別Certification＆Accreditation認(rèn)證認(rèn)可中華人民共和國(guó)國(guó)務(wù)院令(第390號(hào))《中華人民共和國(guó)認(rèn)證認(rèn)可條例》２００３年１１月１日起施行?？偫頊丶覍毜谝徽驴倓t第二條本條例所稱(chēng)認(rèn)證，是指由認(rèn)證機(jī)構(gòu)證明產(chǎn)品、服務(wù)、管理體系符合相關(guān)技術(shù)規(guī)范、相關(guān)技術(shù)規(guī)范的強(qiáng)制性要求或者標(biāo)準(zhǔn)的合格評(píng)定活動(dòng)。本條例所稱(chēng)認(rèn)可，是指由認(rèn)可機(jī)構(gòu)對(duì)認(rèn)證機(jī)構(gòu)、檢查機(jī)構(gòu)、實(shí)驗(yàn)室以及從事評(píng)審、審核等認(rèn)證活動(dòng)人員的能力和執(zhí)業(yè)資格，予以承認(rèn)的合格評(píng)定活動(dòng)。ISO/IEC導(dǎo)則2一個(gè)第三方（認(rèn)證機(jī)構(gòu)）對(duì)（一個(gè)組織的）產(chǎn)品、過(guò)程或服務(wù)符合規(guī)定的要求給出書(shū)面保證的過(guò)程是權(quán)威機(jī)構(gòu)對(duì)某一組織或個(gè)人有能力完成特定任務(wù)做出正式承認(rèn)的程序12發(fā)個(gè)個(gè)證證先先，，你你們們符符合合結(jié)結(jié)婚婚的的條條件件13區(qū)分分重重點(diǎn)點(diǎn)誰(shuí)組組織織檢檢查查：：第第三三方方還還是是權(quán)權(quán)威威機(jī)機(jī)構(gòu)構(gòu)？？檢查查是是體體系系要要求求符符合合性性認(rèn)認(rèn)定定還還是是能能力力的的認(rèn)認(rèn)定定？？區(qū)別別是是建建立立在在有有一一定定內(nèi)內(nèi)涵涵聯(lián)聯(lián)系系基基礎(chǔ)礎(chǔ)上上CAP英文文中中稱(chēng)稱(chēng)Accreditation14ISOI5189實(shí)驗(yàn)驗(yàn)室室文文件件體體系系質(zhì)量手冊(cè)程序文件項(xiàng)目操作指南（SOP)

各種記錄ISO15189:2007《《醫(yī)學(xué)學(xué)實(shí)實(shí)驗(yàn)驗(yàn)室室-質(zhì)量量和和能能力力的的要要求求》CNAS-CL02：2008《《醫(yī)學(xué)學(xué)實(shí)實(shí)驗(yàn)驗(yàn)室室質(zhì)質(zhì)量量和和能能力力認(rèn)認(rèn)可可準(zhǔn)準(zhǔn)則則》ISO15189:2012《《醫(yī)學(xué)實(shí)驗(yàn)驗(yàn)室-質(zhì)量和能能力的要要求》于2012年11月1日發(fā)布。。國(guó)際實(shí)實(shí)驗(yàn)室認(rèn)認(rèn)可合作作組織（（ILAC）要求各各國(guó)認(rèn)可可組織于于2016年3月1日前完成成標(biāo)準(zhǔn)轉(zhuǎn)轉(zhuǎn)換工作作。準(zhǔn)則核查查表2013.4.1實(shí)施的專(zhuān)專(zhuān)業(yè)組核核查表15三、體系系建立和和檢查手手段CAP實(shí)驗(yàn)室文文件體系系

QMP

PolicyStandardOperationProcedure,SOP

RecordsCLIA88美國(guó)臨床床實(shí)驗(yàn)室室改進(jìn)修修正法規(guī)規(guī)’88ClinicalLaboratoryImprovementAmendments(CLIA)of1988areUnitedStatesfederalregulatorystandardsthatapplytoallclinicallaboratorytestingperformedonhumansintheUnitedStates,exceptclinicaltrialsandbasicresearch.2003CDCandCMSmodifiedCLSI美國(guó)臨床床和實(shí)驗(yàn)驗(yàn)室標(biāo)準(zhǔn)準(zhǔn)協(xié)會(huì)ClinicalandLaboratoryStandardsInstituteisavolunteerdriven,membershipsupported,nonprofit,standardsorganization.CLSIpromotesthedevelopmentanduseofvoluntarylaboratoryconsensusstandardsandguidelineswithinthehealthcarecommunity.CAP3000Checklist16評(píng)審依據(jù)據(jù)的內(nèi)容容ISO15189CAP(LAP)依據(jù)CNAS-CL02準(zhǔn)則《醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則》自查/核查表2013.4.1實(shí)施的專(zhuān)業(yè)組核查表（LIS…)3000條Checklist內(nèi)容4管理要求

4.1組織和管理

4.2質(zhì)量管理體系

4.3文件控制

4.4合同的評(píng)審

4.5委托實(shí)驗(yàn)室的檢驗(yàn)

4.6外部服務(wù)和供給

4.7咨詢(xún)服務(wù)

4.8投訴的處理

4.9不符合項(xiàng)的識(shí)別和控制

4.10糾正措施

4.11預(yù)防措施

4.12持續(xù)改進(jìn)

4.13質(zhì)量和技術(shù)記錄

4.14內(nèi)部審核

4.15管理評(píng)審5技術(shù)要求

5.1人員

5.2設(shè)施和環(huán)境條件

5.3實(shí)驗(yàn)室設(shè)備

5.4檢驗(yàn)前程序

5.5檢驗(yàn)程序

5.6檢驗(yàn)程序的質(zhì)量保證5.7檢驗(yàn)后程序

5.8結(jié)果報(bào)告174.1.5實(shí)驗(yàn)室管理層應(yīng)負(fù)責(zé)質(zhì)量管理體系的設(shè)計(jì)、實(shí)施、維持及改進(jìn)，包括：a)管理層為實(shí)驗(yàn)室所有人員提供履行其職責(zé)所需的適當(dāng)權(quán)力和資源；e)明確實(shí)驗(yàn)室的組織和管理結(jié)構(gòu)，以及實(shí)驗(yàn)室與其他相關(guān)機(jī)構(gòu)的關(guān)系；f)規(guī)定所有人員的職責(zé)、權(quán)力和相互關(guān)系；h)技術(shù)管理層全面負(fù)責(zé)技術(shù)運(yùn)作，并提供資源以確保滿(mǎn)足實(shí)驗(yàn)室程序規(guī)定的質(zhì)量要求；i)指定一名質(zhì)量主管（或其他稱(chēng)謂），賦予其職責(zé)和權(quán)力以監(jiān)督所有活動(dòng)遵守質(zhì)量管理體系的要求。質(zhì)量主管應(yīng)直接向?qū)?shí)驗(yàn)室政策和資源決策的實(shí)驗(yàn)室管理層報(bào)告；j)指定所有關(guān)鍵職能的代理人，但需認(rèn)識(shí)到，在小型實(shí)驗(yàn)室一人可能會(huì)同時(shí)承擔(dān)多項(xiàng)職責(zé)，對(duì)每項(xiàng)職責(zé)指定一位代理人不切實(shí)際。4.1.5生化h)應(yīng)至少有1名具有副高以上專(zhuān)業(yè)技術(shù)職務(wù)任職資格，從事臨床化學(xué)檢驗(yàn)工作至少5年以上的人員負(fù)責(zé)技術(shù)管理工作。4.1.5血液h)應(yīng)至少有1名具有副高以上專(zhuān)業(yè)技術(shù)職務(wù)任職資格，從事醫(yī)學(xué)檢驗(yàn)工作至少5年以上的人員負(fù)責(zé)技術(shù)管理工作。ISO151894.1組織和管管理18對(duì)比舉例例一、組組織和管管理注：包括括實(shí)驗(yàn)室室負(fù)責(zé)人人和普通通員工要要求（ISO中未見(jiàn)一般般員工要要求）CAPPERSONNELREQUIREMENTBYTESTNGCOMPLEXITYDIRECTORS（MDorDO）SECTIONDIRECTORS/TECHNICALSUPERVISORS（MDorDO）SUPERVISORS/GENERALSUPERVISORSALLPERSONNEL19CAP組織和管管理**REVISED**07/31/2012TLC.10100LaboratoryDirectorQualificationsPhaseIIThelaboratorydirectorsatisfiesthepersonnelrequirementsoftheCollegeofAmericanPathologists.…Thedirectormust:a.BeanMDorDOlicensedtopractice(ifrequired)inthejurisdictionwherethelaboratoryislocated,andb.Becertifiedinanatomicorclinicalpathology,orboth,bytheAmericanBoardofPathologyorAmericanOsteopathicBoardofPathology,orpossessqualificationsequivalenttothoserequiredforcertificationORa.BeanMD,DOorDPMlicensedtopractice(ifrequired)inthejurisdictionwherethelaboratoryislocated,andb.Haveatleastoneyearoflaboratorytrainingduringresidency,oratleasttwoyearsofexperiencesupervisinghighcomplexitytestingORa.Holdanearneddoctoraldegreeinachemical,physical,biological,orclinicallaboratorysciencefromanaccreditedinstitution,andb.BecertifiedandcontinuetobecertifiedbyaboardapprovedbyHHS**(or,fornon-USlaboratories,byanequivalentboard)OR,fornon-USlaboratories(notsubjecttoUSregulations)onlya.LaboratoryDirectorshallbeanMD,DO,PhDorshallhavecommensurateeducationandexperiencenecessarytomeetpersonnelrequirementsasdeterminedbytheCAP……….**REVISED**07/31/2012GEN.53400SectionDirector/TechnicalSupervisorQualifications/RequirementsPhaseIISectionDirectors/TechnicalSupervisorsmeetdefinedqualificationsandfulfilltheexpectedresponsibilities.NOTE:Thesectiondirector/technicalsupervisorineachhighcomplexitylaboratorysectioncanbealicensedMDorDOwithcertificationinanatomicand/orclinicalpathology,orqualificationsequivalenttothoserequiredforboardcertification.Thesectiondirector/technicalsupervisorresponsibleforanatomicpathologymustbeanMDorDOcertifiedinanatomicpathologyorpossessqualificationsequivalenttothoserequiredforcertification.Thesectiondirector/technicalsupervisorresponsibleforclinicalpathologymustbeanMDorDOcertifiedinclinicalpathologyorpossessqualificationsequivalenttothoserequiredforcertification;ormaybeanindividualwhomeetsthealternatequalificationsforthespecialtiessupervised.ForlaboratoriessubjecttoUSregulations,alternatequalificationsforthefollowingspecialtyareascanbefoundinFedRegister.1992(Feb28):7177-7180[42CFR493.1449]:bacteriology,mycobacteriology,mycology,parasitology,virology,diagnosticimmunology,chemistry,hematology,cytology,ophthalmicpathology,dermatopathology,oralpathology,radiobioassay,immunohematology.Additionalrequirementsforthesectiondirectorsoftheclinicalcytogenetics,histocompatibilityandtransfusionmedicineservicesarefoundintheCytogenetics,HistocompatibilityandTransfusionMedicineChecklists,respectively.HEM.40000Personnel-BenchTestingPhaseIIThepersoninchargeofbenchtestinginhematologyhaseducationequivalenttoanassociate'sdegree(orbeyond)inachemical,physicalorbiologicalscienceormedicaltechnologyandatleast4yearsexperience(oneofwhichisinclinicalhematology)underaqualifieddirector.EvidenceofCompliance:?Recordsofqualificationsincludingdegreeortranscript,certification/registration,currentlicense(ifrequired)andworkhistoryinrelatedfieldCHM.25800Personnel-BenchTestingPhaseIIThepersoninchargeofbenchtestinginchemistryhaseducationequivalenttoanassociate'sdegree(orbeyond)inchemical,physicalorbiologicalscienceormedicaltechnologyandatleast4yearsexperience(oneofwhichmustbeinclinicalchemistry)underaqualifieddirector.EvidenceofCompliance:?Recordsofqualificationsincludingdegreeortranscript,certification/registration,currentlicense(ifrequired)andworkhistoryinrelatedfieldintoxicology、bloodgastesting(orcertifiedorregisteredrespiratorytherapist）GEN.54750TestingPersonnelQualificationsPhaseIIAlltestingpersonnelmeetthefollowingrequirements.1.Personnelperforminghighcomplexitytestingmusthaveataminimumanearnedassociatedegreeinalaboratoryscienceormedicallaboratorytechnologyfromanaccreditedinstitution,orequivalentlaboratorytraining2.PersonnelperformingmoderatecomplexitytestingmusthaveataminimumanearnedhighschooldiplomaorequivalentanddocumentedtrainingEvidenceofCompliance:?Recordsofqualificationsincludingdegreeortranscript,certification/registration,currentlicense(ifrequired)andworkhistoryinrelatedfield22CAP普通員工資資質(zhì)要求很很具體所有員工的的資質(zhì)證明明23對(duì)比舉例二二、人員能能力評(píng)價(jià)5.1.11應(yīng)在培訓(xùn)后評(píng)審每個(gè)員工執(zhí)行指定工作的能力，之后定期評(píng)審。如需要，應(yīng)再次培訓(xùn)并重新評(píng)審。生化：應(yīng)制定員工工能力評(píng)審審的內(nèi)容和和方法，每每年評(píng)審員員工的工作作能力；對(duì)對(duì)新進(jìn)員工工在最初2個(gè)月內(nèi)應(yīng)至至少進(jìn)行2次能力評(píng)審審（間隔為為30天），并記記錄。當(dāng)職職責(zé)變更時(shí)時(shí)，或離崗崗6個(gè)月以上再再上崗時(shí)，，或政策、、程序、技技術(shù)有變更更時(shí)，應(yīng)對(duì)對(duì)員工進(jìn)行行再培訓(xùn)和和再評(píng)審。。沒(méi)有通過(guò)過(guò)評(píng)審的人人員需經(jīng)再再培訓(xùn)和再再評(píng)審，合合格后才可可繼續(xù)上崗崗，并記錄錄。血液：應(yīng)制定員工工能力評(píng)審審的內(nèi)容和和方法，每每年評(píng)審員員工的工作作能力；對(duì)對(duì)新進(jìn)員工工，尤其是是從事血液液學(xué)形態(tài)識(shí)識(shí)別的人員員，在最初初2個(gè)月內(nèi)應(yīng)至至少進(jìn)行2次能力評(píng)審審（間隔為為30天），評(píng)審審內(nèi)容包括括：培訓(xùn)內(nèi)容和和過(guò)程；現(xiàn)場(chǎng)考核；；檢驗(yàn)結(jié)果的的分析與判判斷；檢查工作單單與各種記記錄。當(dāng)職責(zé)變更更時(shí)，或離離崗6個(gè)月以上再再上崗時(shí)，，或政策、、程序、技技術(shù)有變更更時(shí)，應(yīng)對(duì)對(duì)員工進(jìn)行行再培訓(xùn)和和再評(píng)審。。沒(méi)有通過(guò)過(guò)評(píng)審的人人員應(yīng)經(jīng)再再培訓(xùn)和再再評(píng)審，合合格后才可可繼續(xù)上崗崗，并記錄錄。24ISO15189人員能力評(píng)評(píng)價(jià)GEN.55500CompetencyAssessmentPhaseIIThecompetencyofeachpersontoperformhis/herassigneddutiesisassessed.NOTE:duringthefirstyearofanindividual'sduties,competencymustbeassessedatleastsemiannually.Afteranindividualhasperformedhis/herdutiesforoneyear,competencymustbeassessedannually.Retrainingandreassessmentofemployeecompetencymustoccurwhenproblemsareidentifiedwithemployeeperformance.Elementsofcompetencyassessmentincludebutarenotlimitedto:1.Directobservationsofroutinepatienttestperformance,including,asapplicable,patientidentificationandpreparation;andspecimencollection,handling,processingandtesting2.Monitoringtherecordingandreportingoftestresults,including,asapplicable,reportingcriticalresults3.Reviewofintermediatetestresultsorworksheets,qualitycontrolrecords,proficiencytestingresults,andpreventivemaintenancerecords4.Directobservationofperformanceofinstrumentmaintenanceandfunctionchecks5.Assessmentoftestperformancethroughtestingpreviouslyanalyzedspecimens,internalblindtestingsamplesorexternalproficiencytestingsamples;and6.Evaluationofproblem-solvingskills。。。。。。。。。。25CAP人員員能能力力評(píng)評(píng)價(jià)價(jià)(誰(shuí)來(lái)來(lái)評(píng)評(píng)估估？？怎怎樣樣評(píng)評(píng)估估？？明明確確間間隔隔時(shí)時(shí)間間？？））比比ISO15189要求求更更細(xì)細(xì)ISO15189未對(duì)對(duì)PT做出出規(guī)規(guī)定定整合合在在準(zhǔn)準(zhǔn)則則核核查查表表?xiàng)l條款款4.9不符符合合項(xiàng)項(xiàng)的的識(shí)識(shí)別別和和控控制制4.10糾正正措措施施4.11預(yù)防防措措施施CAP對(duì)PT有非非常常具具體體規(guī)規(guī)定定有非非常常多多的的Checkllist舉例例三三、、PT數(shù)據(jù)據(jù)的的上上報(bào)報(bào)、、分分析析、、強(qiáng)強(qiáng)制制要要求求28CHM.10300PTEvaluationPhaseIIThereisongoingevaluationofPTandalternativeassessmentresults,withpromptcorrectiveactiontakenforunacceptableresults.PrimaryrecordsareretainedfortwoyearsTheseincludeallinstrumenttapes,workcards,computerprintouts,evaluationreports,evidenceofreview,anddocumentationoffollow-up/correctiveaction.EvidenceofCompliance:?Recordsofongoing,timelyreviewofallPTreportsandalternativeassessmentresultsbythelaboratorydirectorordesigneeAND?Recordsofinvestigationof"unacceptable"PTandalternativeassessmentresultsincludingrecordsofcorrectiveactionthatisappropriatetothenatureandmagnitudeoftheproblemTypeofAnalytes/ProceduresCMSRegulated:BOLDTYPECentersforMedicare&MedicaidServices(醫(yī)療療保保險(xiǎn)險(xiǎn)和和醫(yī)醫(yī)療療補(bǔ)補(bǔ)助助服服務(wù)務(wù)中中心心)CMSNon-regualated:30WhathappenswhenalabhasaPTfailurefor:aregulatedanalyte?Suspensionoftesting,CessationoftestingRevocationofalab’’saccreditationbyCMSNon-regulatedanalytes?EachaccreditingagencyhasdifferentPToversightstandards.UnsatisfictoryunsuccessfulPTFailureScenariosABCPerformanceinterpretationrequirement1√√ΧAtriskNeedstopassthenexttwoevents2Χ√√successfulLabisnolongeratrisk3Χ√Χunsuccessful4√Χ√StillatriskHasnotyetpassedtwoPTeventsinarow5√ΧΧUnsuccessful,atriskNextwoeventsandaccreinjeopardy33D-A0206-F-501糾正正預(yù)預(yù)防防措措施施報(bào)報(bào)告告記記錄錄表表CNAS申請(qǐng)請(qǐng)安排排現(xiàn)現(xiàn)場(chǎng)場(chǎng)評(píng)評(píng)審審資料料審審查查不符符合合項(xiàng)項(xiàng)整整改改發(fā)證證四、、申申請(qǐng)請(qǐng)流流程程和和體體會(huì)會(huì)SubmitapplicationrequestCompleteapplicationReviewcustomizedchecklistsandprepareforinspectionInspectionteamassignedInspectionconcludedCorrectdeficienciesanddocumentimprovementsAllrequirementsmet;accreditedfortwoyearsConductself-inspectionatoneyearPerformancemonitoredcontinually,includingPTContinuequalityimprovementprocess34ISO15189CAP35附表表1-1：申申請(qǐng)請(qǐng)認(rèn)認(rèn)可可的的授授權(quán)權(quán)簽簽字字人人一一覽覽表表附表表1-2：授授權(quán)權(quán)簽簽字字人人申申請(qǐng)請(qǐng)表表附表表2：申申請(qǐng)請(qǐng)檢檢驗(yàn)驗(yàn)?zāi)苣芰αΨ斗秶鷩奖肀?：