社区实验室检查表分级认证体系翻译版

第1部分:简核查日期上次核查日期上次核查的情况核查员的名字和附属关系名称的数量的地址::传真电子邮箱主管 工作附属关概类全职数拥有中专以上学历的医学检验专 拥有医学检验专业技术资格 文档管 采 清洁 物 数据不其 操作并维持质量管理体系？如果回答是否定的，需要在审核检查表的最后总结部分做详尽的说明足够的空是否仪器、设是否试剂、耗材是否是否基础设是否其它情况请是否第2部分 核 是否可以提供准确可靠的结果;2)确认 实践并3)识别 员运用下面的方法评 操作的每个核查条款，并做详细的记录回顾的记录，核实：质量手册，方针，，仪器设备维修记录，核查，观 的操作，确保检验遵 的政策和分析前、分析中、分析后的程序程序是否适应检验的履行缺陷和不符合项的识别得到充分 ，并在确定的时间内得到解 收集样本登记、样本准备,样本分离,分析,结果确认,报告，打印,分析后处理和 确认能力验证（PT）结果、结果回顾和相应的校正活动是可以回顾评价支持工作的质量和效能：比如采血，数据登记和接收，信息传递和投送，清洁，IT与临床医师的交流：在检测性能上，学会从使用者的角度与临床医师交流。临床审核评项目标记为“是”接受相应的值。一个问题的所有元素必须是，才可以标明“是”，对于给定的项目标记“partial”获得1分项目标记“no”获得0分当标记的“部分”或“不”，应写在评论处解释为什么没有履行此项审核评分部第1部分:文档记第2部分:管理评第3部分:组织和员第4部分:客户管理和客户服8第5部分:仪器设第6部分:评第7部分:供应链和库存管第8部分:过程控制和内外部质量评第9部分:信息管第10部分:纠正措第11部分:事件和突发状况管理和流程改第12部分:设施和安总得YPN1.0文档记1.1质量手策和程序,并将手册的内容传达给所ISO15189:4.2.3/4每点都做记YNISO15189,Section质量方针，包括服务的范围,服务,描 其 ISO15189:4.2.3,1.2文件和信息控制系 YPN2ISO15189:4.3.1,4.3.2and1.3文档和YPN2ISO15189:4.3.2 策略和标准操作程ISO15189YPN5政策和或标准操作规程每点都做记是否StandardISO15189:4.3.1,4.13.1-利StandardISO15189:通ISO15189:Standard:ISO15189:分包的检Standard:ISO15189:采购与库存控定义过程（）需求，订购和接收的供应，）批准的供应商的选择，）接受Standard:ISO15189:咨询服释；和6）与用户通信记录的ISO15189:和反馈的Standard:ISO15189:Standard:ISO15189:纠正措Standard:ISO15189:预防措Standard:ISO15189:持续改Standard:ISO15189:质量和技术记Standard:ISO15189:Standard:ISO15189:管理评Standard:ISO15189:Standard:ISO15189:培Standard:ISO15189:5.1.4,5.1.6,Standard:ISO15189:Standard:ISO15189:环境设施状Standard:ISO15189:仪器设Standard:ISO15189:仪器设备的校ISO15189:ISO15189:5.4.2and样本的和保ISO15189:检验操作规ISO151895.5.3(a-q中ISO15189:2007仪器设备的验ISO15189:检验的确认/验ISO15189:质量管IQCEQC的使用设置范ISO15189结果报定义报告的标准格式（ISO15189ISO15189:信息ISO15189:ISO15190标准:标准操作规程（SOP）应建立和维持 完成的所有任务 的，安全和废物处理，文件控制，标和处理，库存控制，采购，质量保证。SOP 人批准1.5政策和程序的可YPN2ISO15189:5.5.3&4.3.2Part对他们的职责相关的YPN2ISO15189:1.6文件控制记YPN2ISO15189:4.3.1,4.3.2Part(e)and(f):过期的政策和程序性用文件中移除，是否按照和国家政策规定的时间期限保留、档YPN2ISO15189:4.3.1,4.3.2Part(e)and1.8YPN2Standard:Copiesorfilesofresultsshouldbearchived.Thelengthoftimethatreporteddataareretainedmayvary;however,thereportedresultsshallberetrievableforasasmedicallyrelevantorasrequiredbynational,regionalorlocalISO15189:5.8.6,4.13.2,1.9存档结果的可获得YPN2Standard:ISO15189:5.8.6,第1部分：文档、记录小计对于每一条款，分别用“是”，“部分”或者“无”来评价；对于条款下面有多条评价准则时，当所有准则均评价为“是”的时候，该条款才评价为“是”YPN2.0管理评2.1工作规 YPN2Standard:ISO151894.1.5Part(a)and2.2质量和技术记录的回YPN5YN 环 比 结参考能力的评Standard:ISO15189:4.15.2(a)-(m).4.15.2.(a)-2.3质量管理体系年度评管理层是否每年组织召开质管理体系回顾性会议YPN5Tickforeach管理和监督的报仪器校准和保养记PT的结果和其他形式的间比对活最近审核的结管理和监督的报参考性能评Standard:ISO15189:2.4质量管理系统改善措YPN3Standard:ISO15189:2.5操作的通信系YPN2Standard:ISO15189:管理评审小YPN内得3.0组织机3.1工作量、工作安排和工作范YPN2Standard:ISO151893.2值班表和日常的履行特定的工作YPN2Standard:ISO3.3组织架构和内/外部的YPN2Standard:ISO15189:5.1.1,4.1.5Part(e&3.4质量管理系统YPN3Standard:ISO15189:4.1.5Part(3.5员 系员 信息是现用的吗YPN3的工作描述，收到的文件安全手册以及安全培训的文件审员工交流检验质量和的安全担忧的程序专业登Trainingrecord ingtrainingsreceived,vendortrainingreceivedon-site供应商现场PeriodicPerformanceReviewincludingStandard:ISO15189:3.6YPN3Standard:ISO15189: 员工培YPN2Standard:ISO15189:4.12.5,5.1.6,会会议定期举行YPN3TickforeachStandard:ISO15189:SECTION3:ORGANIZATION&NELForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN4.0顾客管理和顾来自合格员工的建议和培YPN2Standard:ISO15189:4.7;4.2为客户提供的是否有针对用户提供的证，操作，样本收集，运送和YPN2Standard:ISO15189:4.7,4.12.5,4.3延迟服务的告知政当出现报告延迟或检验中断提供给顾客，或者发现必须要改变验程序YPN2Standard:ISO15189:4.4评估工具和跟馈信息是否有效地被用于提升服务YPN2Standard:ISO15189:4.8,4.15.2PartSECTION4:CLIENTMANAGEMENT&CUSTOMERSERVICE8Foreachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN5.0仪器设5.1坚持正确的仪器设备YPN2standard:ISO15189:5.3.3“Eachitemofequipmentshallbeuniquelylabeled,marked,orotherwise5.2仪器设备和方法学确认/确证和记录YPN2ISO15189:5.3YPN2TickforeachStandard:ISO15189:5.4记相关设备服务信息便捷YPN2Tickforeach性能和记Standard:ISO15189:5.5陈旧设备程YPN2Standard:ISO15189:5.6遵守设备的校准协YPN2Standard:ISO15189:4.2.5,5.7设备定期维YPN2Standard:ISO15189:4.2.5,5.8设备服 保养，并对这些信息做适当的记录YPN2Standard:ISO15189:4.2.5,5.9设备维按照制造商的说明执行部分小维修YPN2ISO15189:5.10设备故障-应答和记YPN2ISO15189:5.3.7,5.11设备维修和记YPN2Standard:ISO15189:5.12设备故障-应急方是否有备选的程序在设备出现故障YPN2ISO15189:5.13制造商的操作手设备的制造商操作手册随时可提供检测在可能的时候，用员工理解的语言YPN2ISO15189:5.14对质量管理系统有效性的沟YPN2ISO15189:5.15检测服YPN2SECTION5:EQUIPMENTForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsoftheitemmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN6.0内6.1内的实施在质量手册中设定好， YPN5Tickforeach室活动执行执行内审的有经过培训并且有是否就不合格和的不足之处进给管理和相关进行6.2审计建议、行动计划和跟根据审计结果制定的纠正/预防措施，一个行YPN5ISO15189:4.2.4,4.10.3,SECTION6:INTERNALAUDITForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN7采购与库7.1库存与系有一个准确的需要的用品和药剂的制YPN2ISO15189:4.6.4，ISO15189:服务供应商绩效评供应和试剂的规格进行定期和批准供YPN2ISO15189:7.3制造商和供应商是否为目前批准的制造商/供应商的YPN2Standard:ISO15189:7.4计的是基于，测试，设施和设YPN2Standard:ISO15189:ManagementReviewofSupplyRequestsDoesmanagementreviewthefinalizedsupplyrequests?供应管理评审的要求管理定稿供应要求YPN27.6OrderTracking,Inspection,andAreallorderstrackeduntildeliveryandinspected,receipted,andlabeledwithdateofreceiptwhentheordersarecheckedin?订单，检查，和文YPN2Standard:All ingordersshouldbeinspectedforconditionandcompleteness,receiptedand edappropriayandthedatereceivedinthelaboratoryandtheexpirydatefortheproductshouldbeclearlyindicated.ISO15189:4.6.1and7.7InventoryControlIsaninventorycontrolsysteminplace?YPN2CriteriaandproceduresforTickforeachAcceptanceandrejectionofconsumables接Recordingoflotnumber,dateofreceipt,receivedbyanddateplacedintoservice记录的批号，收Storageofconsumables耗Standard:Therelaboratoryshallhaveaninventorycontrolsystemforsthatmonitorsreceipt,storageanduseofISO15189:4.6.1, CAPGEN7.8LaboratoryInventoryAreinventoryrecordscompleteandaccurate,withminimumandumstocklevelsYPN2Standard:TheLaboratoryinventorysystemshallreliablyinformtheLaboratoryofhowmuchatminimummustbekeptinthelaboratorytoavoidinterruptionofserviceduetostockoutsandhowmuchatummustbekeptbythelabtopreventexpiryofreagentsISO15189:7.9UsageRateTrackingofConsumablesIstheconsumptionratemonitored?YPN2Standard:TheinventorycontrolsystemmustallowtheLaboratorytotrackrateofusageofISO15189:7.10InventoryControlSystemStockCountsArestockcountsroutinelyperformed?库存控YPN2Standard:ThelaboratorymustroutinelyperformstockcountsaspartofitsinventorycontrolISO15189:7.11StorageArestorageareassetupandmonitoredappropriay?区在区建立适当监测YPN2TickforeachIsthestorageareawell-organizedandfreeAretheredesignatedplaceslabeledforallinventoryArehazardouschemicalsstoredappropria化学品适当Isadequatecoldstorageavailable?的可用Arestorageareasmonitoredasperprescribedstorageconditions?在区按规定的条IstheambienttemperatureIsstorageindirectsunlightavoided?Isthestorageareaadequayventilated?sthestorageareacleanandfreeofdustandpests?是区域清洁、无灰尘和有Arestorageareasaccess-controlled?区的访CAPGEN62000&7.12InventoryOrganizationandWastageIs-Expiration--Out(FEFO)是先到期先出（FEFO）YPN2Standard:Tominimizewastagefromproductexpiry,inventoryshouldbeorganizedinlinewiththe-Expiry--Out(FEFO)principle.Placeproductsthatwillexpirefrontofproductswithalaterexpirydateandissuestockaccordinglytoensureproductsinusearenotpasttheirexpirydate.Rememberthattheorderinwhichproductsarereceivedisnotnecessarilytheorderinwhichtheywillexpire.7.13DisposalofExpiredAreexpiredproductslabeledandYPN2过期产品贴上，并妥善处理Standard:Expiredproductsshouldbedisposedofproperly.Ifsafedisposalisnotavailableatthelaboratory,themanufacturer/rshouldtakebacktheexpiredstockatthetimeoftheirnextdelivery.7.14ProductAreallreagents/testkitsinuse(andinstock)currentlywithinthemanufacturer-assignedexpirationdatesorwithinYPN2Standard:Allreagentandtestkitsinuse,aswellasthoseinstock,shouldbewithinthemanufacturer-assignedexpirydates.Expiredstockshouldnotbeenteredintouseandshouldbeedbeforedisposal.7.15LaboratoryTestingServicesHasthelaboratoryuninterruptedtestingservices,withnodisruptionsduetostockoutsinthelastyearorsincelastaudit?YPN2Standard:Testingservicesshouldnotbesubjecttointerruptionduetostockouts.Laboratoriesshouldpursuealloptionsforborrowingstockfromanotherlaboratoryorreferringsamplestoanothertestingfacilitywhilethestockoutisbeingaddressed.SECTION7:PURCHASING&INVENTORYForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN8.0PROCESSCONTROLandINTERNAL&EXTERNALQUALITY过程控制和和外部质量审Areguidelinesforpatientidentification,specimencollection(includingclientsafety),labeling,andtransportreadilyavailabletosresponsibleforprimarysample括客户安全），，容易负责标本YPN2Standard:“Specificinstructionsforthepropercollectionandhandlingofprimarysamplesshallbeedandimplementedbylaboratorymanagementandmadeavailabletothoseresponsibleforprimarysamplecollection.”ISO15189:8.2Areadequatesamplereceivingproceduresinplace?有YPN3TickforeachArespecimenslabeledwithpatientID,test,anddate,timeofcollection,dateofcollectionandauthorizedrequester?被试的ID标记，Arealltestrequests paniedbyanacceptableandapprovedtestrequisitionform?所有的测试Ifnota24hourlab,istherea edmethodforhandlingofspecimensreceivedafterhours?F不是24小时的，有记录的方法后收Areallsamplesthatareeitherreceivedorreferredtoahigherlevellaboratory paniedbyasampledeliverychecklistortransmittalsheet?Arereceivedspecimensevaluatedaccordingtoacceptance/rejectioncriteria?收到样品进行的接Arespecimensloggedappropriayuponreceiptinthelaboratory(includingdate,time,andnameofreceivingofficer)?是在收到标本记录当（包括日期，时间，和接收Whensamplesaresplit,cantheportionsbetracedbacktotheprimarysample?当Isatwo-identifiersysteminuseandiseachsampleassignedauniqueidentifyingnumber?一二标识Areproceduresinplacetoprocessspecimensandverbalrequests?Arespecimensdeliveredtothecorrectworkstationsinatimelymanner?被试的及时交付到Standard:ISO15189:5.4.1,5.4.5,5.4.7,5.4.8,5.4.10,5.4.11,8.3Arespecimensstoredappropriaypriortotesting?YPN2Arespecimensdisposedofinasafemanner?试Standard:“Relevantstoragespaceandconditionsshallbeprovidedtoensurethecontinuingintegrityofsamples,slides,histologyblocks,retainedmicro-s,files,manuals,equipment,reagents,laboratorys,recordsandresults.”Specimensshouldbestoredundertheappropriateconditionstomaintainthestabilityofthespecimen.Specimensnolongerrequiredshouldbedisposedofinasafemanner,accordingtoBiosafetyregulations.ISO15189:5.2.9,Arespecimenspackagedappropriayaccordingtolocalandorinternationalregulationsandtransportedtoreferrallaboratorieswithinacceptabletimeframes?被试的包装适当地根据当地或国际和运送到在可接受的时间周期的转介YPN2Standard:Allsamplesshallbetransportedtothelaboratoryinsuchamannerastopreventcontaminationofworkers,patients,ortheISOSafetyStandard15190:ClauseCAPGEN40511,Arereferredspecimenstrackedproperlyusingalogbookortrackingform?称标本正确使用日志或YPN2Standard:“Thelaboratoryshallmaintainaregisterofallreferrallaboratoriesthatituses.Aregistershallbekeptofallsamplesthathavebeenreferredtolaboratory”ThereferrallogmustbereviewedroutinelyforoutstandingresultsandturnaroundISO15189:8.6Iscompleteproceduremanualavailableattheworkstationorintheworkarea?玩YPN3Standard:“Allproceduresshallbeedandbeavailableattheworkstationforrelevantstaff.edproceduresandnecessaryinstructionsshallbeavailableinalanguagecommonlyunderstoodbythestaffinthelaboratory.”ISO15189:IsthereareagentlogbookforlotnumberanddatesofopeningthatreflectsverificationofnewYPN2Standard:“Purchasedequipmentandconsumablesthataffectthequalityoftheserviceshallnotbeuseduntiltheyhavebeenverifiedascomplyingwithstandardspecificationsorrequirementsdefinedfortheproceduresconcerned.Thismaybe plishedbyexaminingqualitycontrolsamplesandverifyingthatresultsareacceptable.”ISO15189:4.6.2Iseachnewlotnumber,newshipmentofreagents,orconsumablesverifiedbeforeuse?YPN2Standard:“Purchasedequipmentandconsumablesthataffectthequalityoftheserviceshallnotbeuseduntiltheyhavebeenverifiedascomplyingwithstandardspecificationsorrequirementsdefinedfortheproceduresconcerned.Thismaybe plishedbyexaminingqualitycontrolsamplesandverifyingthatresultsareacceptable.”ISO15189:Isinternalqualitycontrolperformed,ed,andverifiedbeforereleasingpatientresults?质量控制进行记录，并前，的结YPN3Standard:Thelaboratoryshalldesigninternalqualitycontrolsystemsthatverifytheattainmentoftheintendedqualityofresults.ItisimportantthatthecontrolsystemprovidestaffmemberswithclearandeasilyunderstoodinformationonwhichtobasetechnicalandmedicaldecisionsISO15189:4.2.2,AreQCresultsmonitoredandreviewed(biases,shifts,trends,andLevy-Jenningscharts)?Is ationofcorrectiveactionwhenqualitycontrolresultsexceedtheacceptablerangeinatimelymanner?QC结果和审查（偏差，移位，趋势，和图）？YPN3Standard:“Thelaboratoryshalldesigninternalqualitycontrolsystemsthatverifytheattainmentoftheintendedqualityofresults.”“AspartoftheLaboratoryinternalqualitycontrolsystemsL-Jchartsshallbeusedtomonitortativetestsonadailybasisandreviewedroutinely.ISO15189:8.11Areenvironmentalconditionscheckedandreviewedaccuray?YPN2条件准TickforeachArethefollowingenvironmentalconditionschecked查RoomtemperatureWaterBathStandard:“Thelaboratoryshallmonitor,controlandrecordenvironmentalconditions,asrequiredbyrelevantspecificationsorwheretheymayinfluencethequalityoftheISO15189:8.12Haveacceptablerangesbeendefinedforalltemperature-dependentequipmentwithproceduresand ationofactiontakeninresponsetooutofrangetemperatures?具有YPN2Standard:S,JohnsHopkinsUniversity,Baltimore,MD,Pro71-07,May20,2010.“Acceptablerangesorcriteriamustbedefined,withationofactiontakeninresponsetooutofrangetemperatures.” DoesthelaboratoryparticipateinexternalProficiencyTesting(PT)orexerciseanalternativeperformanceassessmentsystemwhenappropriate?做参与外部能力测3Arethefollowingcriteriamet?TickforeachAreblindedcharacterizedsamplesroutinelydistributedfortestingtodetermineaccuracy?采用DoPTsamplescomefromproviderswhoareaccreditedorapproved?做PT样本来自供应ArePTspecimenshandledandtestedthesamewayaspatientspecimens?PT样品处理和测Is ysisperformedforunacceptableresults?PT结果进行原因分Iscorrectiveaction edforunacceptablePTresults?纠正措施记录不可接受的PTStandard:Thelaboratoryshouldhandle,yze,review,andreportresultsforproficiencytestinginmannersimilartoregularpatienttesting.Investigationandcorrectionofproblemsidentifiedbyunacceptableproficiencytestingshouldbeed.Acceptableresultsthatshowbiasortrendssuggestaproblemshouldalsobeinvestigated.ISO15189:4.2.2,5.6.4,5.6.5,5.6.7 Aretestrequestscheckedwithtestresults,therebyassuringtheaccuracyandcompletionofalltests?试验YPN2Standard:“Authorized nelshallsystematicallyreviewheresultsofexaminations,evaluatetheminconformitywiththeclinicalinformationavailableregardingthepatientandauthorizedthereleasetheresults.”Astandardprocedureshouldbefollowedforcrosscheckingallresults.IninstanceswherethereisaLIS(laboratoryinformationsystem)dailyprintingofthependingreportslistshouldbedoneroutinelytocross-checkthecompletionofalltestswithinthedefinedturnaroundtimes.ISO15189:SECTION8:PROCESSCONTROLandINTERNAL&EXTERNALQUALITYAUDITForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN9.0INFORMATIONMANAGEMENT9.1TestResultReportingSystem结果报告Aretestresultslegible,technicallyverifiedbyan ,andconfirmedagainstpatientidentity?清晰，被人在技术上验证和确认，对的YPN2Standard:Resultsmustbewritteninink,writtenclearlywithnomistakesintranscription.CancellationmustfollowGoodLabPractices.Thesperformingthetestmustindicateverificationoftheresults.Theremustbesignatureoridentificationofauthorizingthereleaseofthereport.ISO15189:9.2 nel测试Aretestingnelidentifiedontherequisitionandrecord?测试在YPN2Standard:ThewhoperformedtheproceduremustbeidentifiedonthereportforpurposesofauditISO15189:5.4.7“Allprimarysamplesreceivedshallberecordedinanaccessionbook,worksheet,computerorothercomparablesystem.Thedateandtimereceiptofsamples,aswellastheidentityofthereceivingofficer,shallbeTestResultYPN2Aretestresultsrecordedinalogbookorelectronicrecordinatimelymanner?Standard:Inlinewithmaintainingagreedturnaroundtimes,theLaboratoryshallperformandrecordtestresultsinatimelymannerandityofreportedandstoredresultreportsshallbemaintained.yticSystem/MethodYPN2Whenmorethanoneinstrumentisinuseforthesametest,aretestresultstraceabletotheequipmentusedfor同的测试，可追溯到用于Standard:Itisimportantthatthelaboratoryhastheabilitytotracespecimenresultstoaspecificyticalsystemormethod.Proficiencytestingspecimenswouldalsofallunderspecimenresults.ResultCross-checkSystem结果交叉检查系YPN2Isthereasystemforreviewingfortranscriptionerrors?有一个转Standard:Thelaboratorymusthaveasystemforcross-checkingofresultsbeforereleasetorequestersinordertoidentifyandcorrectISO15189:5.8.3“Resultsshallbelegible,withoutmistakesintranscriptionandreportedtosauthorizedtoreceiveandusemedical9.6ArchivedDataLabelingandStorage存档的数据标识和Arearchivedresults(paperordata-storagemedia)properlylabeledandstoredinasecurelocationaccessibleonlytoauthorizednel?存档的结果（文件或数据介质）适当的标记，并在一个安全的地方，只有的YPN2Standard:Allpatientdata,paper,tapes,disksshouldbeproperlylabeledandstoredsecurelyinplacesaccessibleonlytoISO15189:5.8.3AnnexB9.7InformationandDataBackupSystem信Arethere edprocedurestopreventthelossoftestresu ataintheeventofhardware/softwarefailure,fireortheft?文件化的程序来防止在硬件/发生障的数据损失，火灾或者YPN2Standard:Thelaboratoryshouldhaveaproceduretoprotectessentialdataintheeventofequipmentfailureand/oranunexpecteddestructiveevent.Theseprocedurescouldincludefloodandfiresafestorageofdata,periodicbackingupandstoringofinformation,andoff-sitestorageofbackupdata.ISO15189:5.8.3AnnexB9.8TestResultReport报Isthelaboratoryresultreport(s)inastandardformdeterminedtobeacceptablebyitsYNP2IndicateforeachitemTickforeachIsthelaboratoryissuingthereportclearly是发布的报告清楚地识Doesthereportcontainthepatient’snameaddress,andthehospital/destinationofthereport?这份报/Isthenameofthe requestingthetestindicatedonthereport?有人请求测试的名称Isthetypeofsamplereceivedandthetestrequestedincludedinthereport?是Arethedateandtimeforspecimencollection,receiptofspecimen,andreleaseofreportDoesthereportindicatebiologicalreferencerangesforeachtest?IstheresultreportedinSIunitswhereSIIstherespaceforinterpretationofresults,whenapplicable,andforindicationofwhenspecimensreceivedandunsuitablefortheprocedurerequestedfortesting?有空间的结果时，适用解释，并Doestheresultcontainthenameofauthorizingreleaseofthereportandthesignature acceptingresponsibilityforitscontent?9.9TestResult检验结Aretestresultsvalidated,interpretedandreleasedbyappropriay-authorized 2的解释和验证，通过适当SECTION9:INFORMATIONMANAGEMENTForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsoftheitemmustbesatisfactorilypresentto“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN10.0CORRECTIVEACTIONArealllaboratory- edoccurrencereportsindicatingtherootcauseoftheproblem(s)andcorrective&preventiveactionstakentopreventrecurrence?所有的记录发生的报告问题的根源（S）和采YPNTheremustbeatleastadescriptionofwhathappenedandwhatwasdonetopreventitfromhappeningagain.必须至少有一个叙述所发生的5Standard:“Laboratoryshallhaveapolicyandproceduresfortheresolutionofcomplaintsorotherfeedbackreceivedfromclinicians,patientsorotherparties.Recordsofcomplaintsandofinvestigationsandcorrectiveactionstakenbythelaboratoryshallbemaintained.”ISO15189:Isnon-conformingworkreviewedandsubmittedfortroubleshootingandcauseysis?不合格的工作，并提交故障YPN2Standard:“Proceduresforcorrectiveactionshallincludeaninvestigativeprocesstodeterminetheunderlyingcauseorcausesoftheproblem.Theseshall,whereappropriate,leadtopreventiveactions.Correctiveactionshallbeappropriatetothemagnitudeoftheproblemandcommensuratewithpossiblerisks.”“Thelaboratoryshall,recordand,asappropriate,expeditiouslyactuponresultsfromthesecomparisons.Problemsordeficienciesidentifiedshallbeacteduponandrecordsofactionsretained.”ISO15189:4.10.1;Iscorrectiveactionperformedonallnon-conformingaspectsofthequalitymanagement YPN3IndicateforeachitemTickforeachAreresultswithheld,ifindicatedbythelevelofcontrolviolated?结果保留，如果通过控制水ISO4.9.1partHavethesebeenrecalledandcorrected,ifresultshavebeenreleased?这些被纠正，如ISO4.9.1partIsthisapprovedbyanauthorized whentestingresumes?这是由批ISO4.9.1.partStandard:“Laboratorymanagementshallhaveapolicyandproceduretobeimplementedwhenitdetectsthatanyaspectofitsexaminationsdoesnotconformwithitsownproceduresortheagreeduponrequirementsofitsqualitymanagementsystemortherequestingclinicians.”ISO10.4Arediscordantresultstrackedandappropriatecorrectiveactiontaken?YPN2Standard:“ProceduresforcorrectiveactionshallincludeaninvestigativeprocesstodeterminetheunderlyingcauseorcausesoftheISO15189:SECTION10:CORRECTIVEACTIONForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN11.0OCCURRENCE/INCIDENTMANAGEMENT&PROCESS发生/11.1Aregraphicaltools(chartsandgraphs)usedtocommunicatequalityfindingsandidentifytrends?YPN2Standard:“Apartfromthereviewoftheoperationalprocedures,preventiveactionmightinvolveysisofdata,includingtrend-andrisk-ysesandqualityassurance.”Useofgraphicaldisplaysofqualitydommunicatesmoreeffectivelythantablesofnumbers.ExamplesofgraphicaltoolscommonlyusedforthispurposeincludeParetocharts,cause-and-effectdiagrams,frequencyhistograms,trendgraphs,andflowcharts.ISO15189:4.11.2,NoteArequalityindicators(TAT,rejectedspecimens,stockouts,etc.)selected,tracked,andreviewedregularlytomonitorlaboratoryperformanceandidentifypotentialqualityimprovement质量指标（TAT，标本，缺货，等选择，，并定期检讨，以监测YPN5Arethe esofinternalandexternalaudits,PT,customerfeedbackandallotherinformationderivedfromthetrackingofqualityindicatorsusedtoimprovelabperformance?有和外YPN3Isthe eoftheactiontakencheckedandmonitoredtodeterminetheeffectivenessofimprovedqualityoflabperformance?查和监测以确定改进的性能质量2Standard:“Laboratorymanagementshallimplementqualityindicatorsforsystematicallymonitoringandevaluatingthelaboratory’scontributingTheseindicatorsshouldbecomparedagainstabenarkfromanacknowledgedguideline.”“Laboratorymanagement,inconsultationwiththerequesters,shallestablishesturnaroundtimesforeachofitsexaminations.Aturnaroundtimeshallreflectclinicalneeds.”Keyindicatorsofqualitymustbemonitoredregularlyandevaluatedforopportunitiestoimprovetestingservices.Indicatorsshouldbedrawnfrompre-ytic,ytic,andpost-yticphasesandreflectactivitiescriticaltopatient es,thosethatcorrespondtoalargeproportionofthelaboratory’spatients,orareasthathavebeenproblematicinthepast.TheseindicatorsshouldbecomparedagainstabenarkfromanacknowledgedISO15189:4.12.4,SECTION11:OCCURRENCE/INCIDENTMGT,&PROCESSIMPROVEMENTForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN12.0FACILITIES&Isthesizeofthelaboratoryadequateandthelayoutofthelaboratory,asawhole,organizedsothatworkstationsarepositionedforoptimalworkflow?是充足和的布局的YPN2Standard:Thelaboratoryfloorplanshouldbeconfiguredtopromotehighqualitywork,nelsafety,andefficientoperations.ISO15189:5.2.2 CAPGEN6000012.2Arethepatientcareandtestingareasofthelaboratorydistinctlyseparatefromoneanother?YPN2Standard:“Thereshallbeeffectiveseparationbetweenadjacentlaboratorysectionsinwhichthereare patibleactivities.Measuresshallbetakentopreventcross-contamination.”Clientserviceareas(i.e.,waitingroom,phlebotomyroom)shouldbedistinctlyseparatefromthetestingareasofthelaboratory.Clientaccessshouldnotcompromise‘clean’areasofthelaboratory.ForBiosafetyreasons,microbiologyandTBtestingshouldbesegregatedinaseparateroom(s)fromterallaboratorytesting.ISO15189:12.3IseachindividualworkstationmaintainedfreeofclutterandsetupforefficientYPN2Arethefollowingcriteriamet:议TickforeachDoestheequipmentplacement/layoutfacilitateoptimumworkflow?这设备的位置/布局便于优AreallneededspresentandArethechairs/stoolsattheworkstationsappropriateforbenchheightandthetestingoperationsbeingperformed?是椅子凳子在适当的台阶高度ISO15190:Isreferencematerialreadilyavailable(criticalvaluesandrequiredaction,populationreferenceranges,frequentlycallednumbers?应俱全（Standard:Age-andsex-specificreferenceintervals(normalvalues)mustbeverifiedorestablishedbylaboratory.Ifaformalreferenceintervalsstudyisnotpossibleorpractical,thenthelaboratoryshouldcarefullyevaluatetheuseofpublisheddataforitsownreferenceranges,andretainationofthisevaluation.CAP:ChemistryandToxicologyChecklist,12.4Isthephysicalworkenvironmentappropriatefortesting?是物理工作YPN2Istheworkplace:TickforeachFreeof无ISO15190:AdequayISO15190:Freeofexcessmoisture?分ISO15190:Adequaylit?ISO15190:Climate-controlledforoptimumequipmentISO15190:Arefilterschecked,cleanedand/orreplacedatregularintervalswhereair-conditioningisinstalled?Arewiresandcablesproperlylocatedandprotectedfromtraffic?Isthereafunctioningback-uppowersupplyIscriticalequipmentsupportedbyuninterruptedpowersource(UPS)systems?Isequipmentplacedappropriayawayfromwaterhazards,outoftrafficareas)?是设备放置适当（远离水的危害，从交通区Isacontingencyplaninplaceforcontinuedtestingintheeventofprolongedelectricitydisruption?是一Areappropriateprovisionsmadeforadequatewatersupply,includingdeionizedwater(DI)ordistilledwater,ifneeded?话IsclericalworkcompletedoutsidethetestingIsmajorsafetysignagepostedandenforcedincludingNOEATING,SMOKING,DRINKING?是Standard:Thelaboratoryspaceshouldbesufficienttoensurethatthequalityofwork,thesafetyof nel,andtheabilityofstafftocarryoutqualitycontrolproceduresandation.Thelaboratoryshouldbecleanandwellorganized,freeofclutter,well-ventilated,adequaylit,andwithinacceptabletemperatureranges.Emergencypowershouldbeavailablesensitiveinstruments,temperaturecontrolledstorage,andotheressentialequipmenttopreventdamageanddisruptionduetounexpectedpowerfluctuationsandoutages.Sensitiveinstrumentsshouldbeequippedwithsurgecon