社區(qū)實(shí)驗(yàn)室檢查表分級(jí)認(rèn)證體系翻譯版

第1部分:簡(jiǎn)核查日期上次核查日期上次核查的情況核查員的名字和附屬關(guān)系名稱的數(shù)量的地址::傳真電子郵箱主管 工作附屬關(guān)概類全職數(shù)擁有中專以上學(xué)歷的醫(yī)學(xué)檢驗(yàn)專 擁有醫(yī)學(xué)檢驗(yàn)專業(yè)技術(shù)資格 文檔管 采 清潔 物 數(shù)據(jù)不其 操作并維持質(zhì)量管理體系？如果回答是否定的，需要在審核檢查表的最后總結(jié)部分做詳盡的說(shuō)明足夠的空是否儀器、設(shè)是否試劑、耗材是否是否基礎(chǔ)設(shè)是否其它情況請(qǐng)是否第2部分 核 是否可以提供準(zhǔn)確可靠的結(jié)果;2)確認(rèn) 實(shí)踐并3)識(shí)別 員運(yùn)用下面的方法評(píng) 操作的每個(gè)核查條款，并做詳細(xì)的記錄回顧的記錄，核實(shí)：質(zhì)量手冊(cè)，方針，，儀器設(shè)備維修記錄，核查，觀 的操作，確保檢驗(yàn)遵 的政策和分析前、分析中、分析后的程序程序是否適應(yīng)檢驗(yàn)的履行缺陷和不符合項(xiàng)的識(shí)別得到充分 ，并在確定的時(shí)間內(nèi)得到解 收集樣本登記、樣本準(zhǔn)備,樣本分離,分析,結(jié)果確認(rèn),報(bào)告，打印,分析后處理和 確認(rèn)能力驗(yàn)證（PT）結(jié)果、結(jié)果回顧和相應(yīng)的校正活動(dòng)是可以回顧評(píng)價(jià)支持工作的質(zhì)量和效能：比如采血，數(shù)據(jù)登記和接收，信息傳遞和投送，清潔，IT與臨床醫(yī)師的交流：在檢測(cè)性能上，學(xué)會(huì)從使用者的角度與臨床醫(yī)師交流。臨床審核評(píng)項(xiàng)目標(biāo)記為“是”接受相應(yīng)的值。一個(gè)問(wèn)題的所有元素必須是，才可以標(biāo)明“是”，對(duì)于給定的項(xiàng)目標(biāo)記“partial”獲得1分項(xiàng)目標(biāo)記“no”獲得0分當(dāng)標(biāo)記的“部分”或“不”，應(yīng)寫(xiě)在評(píng)論處解釋為什么沒(méi)有履行此項(xiàng)審核評(píng)分部第1部分:文檔記第2部分:管理評(píng)第3部分:組織和員第4部分:客戶管理和客戶服8第5部分:儀器設(shè)第6部分:評(píng)第7部分:供應(yīng)鏈和庫(kù)存管第8部分:過(guò)程控制和內(nèi)外部質(zhì)量評(píng)第9部分:信息管第10部分:糾正措第11部分:事件和突發(fā)狀況管理和流程改第12部分:設(shè)施和安總得YPN1.0文檔記1.1質(zhì)量手策和程序,并將手冊(cè)的內(nèi)容傳達(dá)給所ISO15189:4.2.3/4每點(diǎn)都做記YNISO15189,Section質(zhì)量方針，包括服務(wù)的范圍,服務(wù),描 其 ISO15189:4.2.3,1.2文件和信息控制系 YPN2ISO15189:4.3.1,4.3.2and1.3文檔和YPN2ISO15189:4.3.2 策略和標(biāo)準(zhǔn)操作程ISO15189YPN5政策和或標(biāo)準(zhǔn)操作規(guī)程每點(diǎn)都做記是否StandardISO15189:4.3.1,4.13.1-利StandardISO15189:通ISO15189:Standard:ISO15189:分包的檢Standard:ISO15189:采購(gòu)與庫(kù)存控定義過(guò)程（）需求，訂購(gòu)和接收的供應(yīng)，）批準(zhǔn)的供應(yīng)商的選擇，）接受Standard:ISO15189:咨詢服釋；和6）與用戶通信記錄的ISO15189:和反饋的Standard:ISO15189:Standard:ISO15189:糾正措Standard:ISO15189:預(yù)防措Standard:ISO15189:持續(xù)改Standard:ISO15189:質(zhì)量和技術(shù)記Standard:ISO15189:Standard:ISO15189:管理評(píng)Standard:ISO15189:Standard:ISO15189:培Standard:ISO15189:5.1.4,5.1.6,Standard:ISO15189:Standard:ISO15189:環(huán)境設(shè)施狀Standard:ISO15189:儀器設(shè)Standard:ISO15189:儀器設(shè)備的校ISO15189:ISO15189:5.4.2and樣本的和保ISO15189:檢驗(yàn)操作規(guī)ISO151895.5.3(a-q中ISO15189:2007儀器設(shè)備的驗(yàn)ISO15189:檢驗(yàn)的確認(rèn)/驗(yàn)ISO15189:質(zhì)量管IQCEQC的使用設(shè)置范ISO15189結(jié)果報(bào)定義報(bào)告的標(biāo)準(zhǔn)格式（ISO15189ISO15189:信息ISO15189:ISO15190標(biāo)準(zhǔn):標(biāo)準(zhǔn)操作規(guī)程（SOP）應(yīng)建立和維持 完成的所有任務(wù) 的，安全和廢物處理，文件控制，標(biāo)和處理，庫(kù)存控制，采購(gòu)，質(zhì)量保證。SOP 人批準(zhǔn)1.5政策和程序的可YPN2ISO15189:5.5.3&4.3.2Part對(duì)他們的職責(zé)相關(guān)的YPN2ISO15189:1.6文件控制記YPN2ISO15189:4.3.1,4.3.2Part(e)and(f):過(guò)期的政策和程序性用文件中移除，是否按照和國(guó)家政策規(guī)定的時(shí)間期限保留、檔YPN2ISO15189:4.3.1,4.3.2Part(e)and1.8YPN2Standard:Copiesorfilesofresultsshouldbearchived.Thelengthoftimethatreporteddataareretainedmayvary;however,thereportedresultsshallberetrievableforasasmedicallyrelevantorasrequiredbynational,regionalorlocalISO15189:5.8.6,4.13.2,1.9存檔結(jié)果的可獲得YPN2Standard:ISO15189:5.8.6,第1部分：文檔、記錄小計(jì)對(duì)于每一條款，分別用“是”，“部分”或者“無(wú)”來(lái)評(píng)價(jià)；對(duì)于條款下面有多條評(píng)價(jià)準(zhǔn)則時(shí)，當(dāng)所有準(zhǔn)則均評(píng)價(jià)為“是”的時(shí)候，該條款才評(píng)價(jià)為“是”YPN2.0管理評(píng)2.1工作規(guī) YPN2Standard:ISO151894.1.5Part(a)and2.2質(zhì)量和技術(shù)記錄的回YPN5YN 環(huán) 比 結(jié)參考能力的評(píng)Standard:ISO15189:4.15.2(a)-(m).4.15.2.(a)-2.3質(zhì)量管理體系年度評(píng)管理層是否每年組織召開(kāi)質(zhì)管理體系回顧性會(huì)議YPN5Tickforeach管理和監(jiān)督的報(bào)儀器校準(zhǔn)和保養(yǎng)記PT的結(jié)果和其他形式的間比對(duì)活最近審核的結(jié)管理和監(jiān)督的報(bào)參考性能評(píng)Standard:ISO15189:2.4質(zhì)量管理系統(tǒng)改善措YPN3Standard:ISO15189:2.5操作的通信系YPN2Standard:ISO15189:管理評(píng)審小YPN內(nèi)得3.0組織機(jī)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組織架構(gòu)和內(nèi)/外部的YPN2Standard:ISO15189:5.1.1,4.1.5Part(e&3.4質(zhì)量管理系統(tǒng)YPN3Standard:ISO15189:4.1.5Part(3.5員 系員 信息是現(xiàn)用的嗎YPN3的工作描述，收到的文件安全手冊(cè)以及安全培訓(xùn)的文件審員工交流檢驗(yàn)質(zhì)量和的安全擔(dān)憂的程序?qū)I(yè)登Trainingrecord ingtrainingsreceived,vendortrainingreceivedon-site供應(yīng)商現(xiàn)場(chǎng)PeriodicPerformanceReviewincludingStandard:ISO15189:3.6YPN3Standard:ISO15189: 員工培YPN2Standard:ISO15189:4.12.5,5.1.6,會(huì)會(huì)議定期舉行YPN3TickforeachStandard:ISO15189:SECTION3:ORGANIZATION&NELForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN4.0顧客管理和顧來(lái)自合格員工的建議和培YPN2Standard:ISO15189:4.7;4.2為客戶提供的是否有針對(duì)用戶提供的證，操作，樣本收集，運(yùn)送和YPN2Standard:ISO15189:4.7,4.12.5,4.3延遲服務(wù)的告知政當(dāng)出現(xiàn)報(bào)告延遲或檢驗(yàn)中斷提供給顧客，或者發(fā)現(xiàn)必須要改變驗(yàn)程序YPN2Standard:ISO15189:4.4評(píng)估工具和跟饋信息是否有效地被用于提升服務(wù)YPN2Standard:ISO15189:4.8,4.15.2PartSECTION4:CLIENTMANAGEMENT&CUSTOMERSERVICE8Foreachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN5.0儀器設(shè)5.1堅(jiān)持正確的儀器設(shè)備YPN2standard:ISO15189:5.3.3“Eachitemofequipmentshallbeuniquelylabeled,marked,orotherwise5.2儀器設(shè)備和方法學(xué)確認(rèn)/確證和記錄YPN2ISO15189:5.3YPN2TickforeachStandard:ISO15189:5.4記相關(guān)設(shè)備服務(wù)信息便捷YPN2Tickforeach性能和記Standard:ISO15189:5.5陳舊設(shè)備程YPN2Standard:ISO15189:5.6遵守設(shè)備的校準(zhǔn)協(xié)YPN2Standard:ISO15189:4.2.5,5.7設(shè)備定期維YPN2Standard:ISO15189:4.2.5,5.8設(shè)備服 保養(yǎng)，并對(duì)這些信息做適當(dāng)?shù)挠涗沋PN2Standard:ISO15189:4.2.5,5.9設(shè)備維按照制造商的說(shuō)明執(zhí)行部分小維修YPN2ISO15189:5.10設(shè)備故障-應(yīng)答和記YPN2ISO15189:5.3.7,5.11設(shè)備維修和記YPN2Standard:ISO15189:5.12設(shè)備故障-應(yīng)急方是否有備選的程序在設(shè)備出現(xiàn)故障YPN2ISO15189:5.13制造商的操作手設(shè)備的制造商操作手冊(cè)隨時(shí)可提供檢測(cè)在可能的時(shí)候，用員工理解的語(yǔ)言YPN2ISO15189:5.14對(duì)質(zhì)量管理系統(tǒng)有效性的溝YPN2ISO15189:5.15檢測(cè)服YPN2SECTION5:EQUIPMENTForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsoftheitemmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN6.0內(nèi)6.1內(nèi)的實(shí)施在質(zhì)量手冊(cè)中設(shè)定好， YPN5Tickforeach室活動(dòng)執(zhí)行執(zhí)行內(nèi)審的有經(jīng)過(guò)培訓(xùn)并且有是否就不合格和的不足之處進(jìn)給管理和相關(guān)進(jìn)行6.2審計(jì)建議、行動(dòng)計(jì)劃和跟根據(jù)審計(jì)結(jié)果制定的糾正/預(yù)防措施，一個(gè)行YPN5ISO15189:4.2.4,4.10.3,SECTION6:INTERNALAUDITForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsofthequestionmustbesatisfactorilypresentindicate“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN7采購(gòu)與庫(kù)7.1庫(kù)存與系有一個(gè)準(zhǔn)確的需要的用品和藥劑的制YPN2ISO15189:4.6.4，ISO15189:服務(wù)供應(yīng)商績(jī)效評(píng)供應(yīng)和試劑的規(guī)格進(jìn)行定期和批準(zhǔn)供YPN2ISO15189:7.3制造商和供應(yīng)商是否為目前批準(zhǔn)的制造商/供應(yīng)商的YPN2Standard:ISO15189:7.4計(jì)的是基于，測(cè)試，設(shè)施和設(shè)YPN2Standard:ISO15189:ManagementReviewofSupplyRequestsDoesmanagementreviewthefinalizedsupplyrequests?供應(yīng)管理評(píng)審的要求管理定稿供應(yīng)要求YPN27.6OrderTracking,Inspection,andAreallorderstrackeduntildeliveryandinspected,receipted,andlabeledwithdateofreceiptwhentheordersarecheckedin?訂單，檢查，和文YPN2Standard:All ingordersshouldbeinspectedforconditionandcompleteness,receiptedand edappropriayandthedatereceivedinthelaboratoryandtheexpirydatefortheproductshouldbeclearlyindicated.ISO15189:4.6.1and7.7InventoryControlIsaninventorycontrolsysteminplace?YPN2CriteriaandproceduresforTickforeachAcceptanceandrejectionofconsumables接Recordingoflotnumber,dateofreceipt,receivedbyanddateplacedintoservice記錄的批號(hào)，收Storageofconsumables耗Standard:Therelaboratoryshallhaveaninventorycontrolsystemforsthatmonitorsreceipt,storageanduseofISO15189:4.6.1, CAPGEN7.8LaboratoryInventoryAreinventoryrecordscompleteandaccurate,withminimumandumstocklevelsYPN2Standard:TheLaboratoryinventorysystemshallreliablyinformtheLaboratoryofhowmuchatminimummustbekeptinthelaboratorytoavoidinterruptionofserviceduetostockoutsandhowmuchatummustbekeptbythelabtopreventexpiryofreagentsISO15189:7.9UsageRateTrackingofConsumablesIstheconsumptionratemonitored?YPN2Standard:TheinventorycontrolsystemmustallowtheLaboratorytotrackrateofusageofISO15189:7.10InventoryControlSystemStockCountsArestockcountsroutinelyperformed?庫(kù)存控YPN2Standard:ThelaboratorymustroutinelyperformstockcountsaspartofitsinventorycontrolISO15189:7.11StorageArestorageareassetupandmonitoredappropriay?區(qū)在區(qū)建立適當(dāng)監(jiān)測(cè)YPN2TickforeachIsthestorageareawell-organizedandfreeAretheredesignatedplaceslabeledforallinventoryArehazardouschemicalsstoredappropria化學(xué)品適當(dāng)Isadequatecoldstorageavailable?的可用Arestorageareasmonitoredasperprescribedstorageconditions?在區(qū)按規(guī)定的條IstheambienttemperatureIsstorageindirectsunlightavoided?Isthestorageareaadequayventilated?sthestorageareacleanandfreeofdustandpests?是區(qū)域清潔、無(wú)灰塵和有Arestorageareasaccess-controlled?區(qū)的訪CAPGEN62000&7.12InventoryOrganizationandWastageIs-Expiration--Out(FEFO)是先到期先出（FEFO）YPN2Standard:Tominimizewastagefromproductexpiry,inventoryshouldbeorganizedinlinewiththe-Expiry--Out(FEFO)principle.Placeproductsthatwillexpirefrontofproductswithalaterexpirydateandissuestockaccordinglytoensureproductsinusearenotpasttheirexpirydate.Rememberthattheorderinwhichproductsarereceivedisnotnecessarilytheorderinwhichtheywillexpire.7.13DisposalofExpiredAreexpiredproductslabeledandYPN2過(guò)期產(chǎn)品貼上，并妥善處理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過(guò)程控制和和外部質(zhì)量審Areguidelinesforpatientidentification,specimencollection(includingclientsafety),labeling,andtransportreadilyavailabletosresponsibleforprimarysample括客戶安全），，容易負(fù)責(zé)標(biāo)本YPN2Standard:“Specificinstructionsforthepropercollectionandhandlingofprimarysamplesshallbeedandimplementedbylaboratorymanagementandmadeavailabletothoseresponsibleforprimarysamplecollection.”ISO15189:8.2Areadequatesamplereceivingproceduresinplace?有YPN3TickforeachArespecimenslabeledwithpatientID,test,anddate,timeofcollection,dateofcollectionandauthorizedrequester?被試的ID標(biāo)記，Arealltestrequests paniedbyanacceptableandapprovedtestrequisitionform?所有的測(cè)試Ifnota24hourlab,istherea edmethodforhandlingofspecimensreceivedafterhours?F不是24小時(shí)的，有記錄的方法后收Areallsamplesthatareeitherreceivedorreferredtoahigherlevellaboratory paniedbyasampledeliverychecklistortransmittalsheet?Arereceivedspecimensevaluatedaccordingtoacceptance/rejectioncriteria?收到樣品進(jìn)行的接Arespecimensloggedappropriayuponreceiptinthelaboratory(includingdate,time,andnameofreceivingofficer)?是在收到標(biāo)本記錄當(dāng)（包括日期，時(shí)間，和接收Whensamplesaresplit,cantheportionsbetracedbacktotheprimarysample?當(dāng)Isatwo-identifiersysteminuseandiseachsampleassignedauniqueidentifyingnumber?一二標(biāo)識(shí)Areproceduresinplacetoprocessspecimensandverbalrequests?Arespecimensdeliveredtothecorrectworkstationsinatimelymanner?被試的及時(shí)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?試Standard:“Relevantstoragespaceandconditionsshallbeprovidedtoensurethecontinuingintegrityofsamples,slides,histologyblocks,retainedmicro-s,files,manuals,equipment,reagents,laboratorys,recordsandresults.”Specimensshouldbestoredundertheappropriateconditionstomaintainthestabilityofthespecimen.Specimensnolongerrequiredshouldbedisposedofinasafemanner,accordingtoBiosafetyregulations.ISO15189:5.2.9,Arespecimenspackagedappropriayaccordingtolocalandorinternationalregulationsandtransportedtoreferrallaboratorieswithinacceptabletimeframes?被試的包裝適當(dāng)?shù)馗鶕?jù)當(dāng)?shù)鼗驀?guó)際和運(yùn)送到在可接受的時(shí)間周期的轉(zhuǎn)介YPN2Standard:Allsamplesshallbetransportedtothelaboratoryinsuchamannerastopreventcontaminationofworkers,patients,ortheISOSafetyStandard15190:ClauseCAPGEN40511,Arereferredspecimenstrackedproperlyusingalogbookortrackingform?稱標(biāo)本正確使用日志或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?質(zhì)量控制進(jìn)行記錄，并前，的結(jié)YPN3Standard:Thelaboratoryshalldesigninternalqualitycontrolsystemsthatverifytheattainmentoftheintendedqualityofresults.ItisimportantthatthecontrolsystemprovidestaffmemberswithclearandeasilyunderstoodinformationonwhichtobasetechnicalandmedicaldecisionsISO15189:4.2.2,AreQCresultsmonitoredandreviewed(biases,shifts,trends,andLevy-Jenningscharts)?Is ationofcorrectiveactionwhenqualitycontrolresultsexceedtheacceptablerangeinatimelymanner?QC結(jié)果和審查（偏差，移位，趨勢(shì)，和圖）？YPN3Standard:“Thelaboratoryshalldesigninternalqualitycontrolsystemsthatverifytheattainmentoftheintendedqualityofresults.”“AspartoftheLaboratoryinternalqualitycontrolsystemsL-Jchartsshallbeusedtomonitortativetestsonadailybasisandreviewedroutinely.ISO15189:8.11Areenvironmentalconditionscheckedandreviewedaccuray?YPN2條件準(zhǔn)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?做參與外部能力測(cè)3Arethefollowingcriteriamet?TickforeachAreblindedcharacterizedsamplesroutinelydistributedfortestingtodetermineaccuracy?采用DoPTsamplescomefromproviderswhoareaccreditedorapproved?做PT樣本來(lái)自供應(yīng)ArePTspecimenshandledandtestedthesamewayaspatientspecimens?PT樣品處理和測(cè)Is ysisperformedforunacceptableresults?PT結(jié)果進(jìn)行原因分Iscorrectiveaction edforunacceptablePTresults?糾正措施記錄不可接受的PTStandard:Thelaboratoryshouldhandle,yze,review,andreportresultsforproficiencytestinginmannersimilartoregularpatienttesting.Investigationandcorrectionofproblemsidentifiedbyunacceptableproficiencytestingshouldbeed.Acceptableresultsthatshowbiasortrendssuggestaproblemshouldalsobeinvestigated.ISO15189:4.2.2,5.6.4,5.6.5,5.6.7 Aretestrequestscheckedwithtestresults,therebyassuringtheaccuracyandcompletionofalltests?試驗(yàn)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結(jié)果報(bào)告Aretestresultslegible,technicallyverifiedbyan ,andconfirmedagainstpatientidentity?清晰，被人在技術(shù)上驗(yàn)證和確認(rèn)，對(duì)的YPN2Standard:Resultsmustbewritteninink,writtenclearlywithnomistakesintranscription.CancellationmustfollowGoodLabPractices.Thesperformingthetestmustindicateverificationoftheresults.Theremustbesignatureoridentificationofauthorizingthereleaseofthereport.ISO15189:9.2 nel測(cè)試Aretestingnelidentifiedontherequisitionandrecord?測(cè)試在YPN2Standard:ThewhoperformedtheproceduremustbeidentifiedonthereportforpurposesofauditISO15189:5.4.7“Allprimarysamplesreceivedshallberecordedinanaccessionbook,worksheet,computerorothercomparablesystem.Thedateandtimereceiptofsamples,aswellastheidentityofthereceivingofficer,shallbeTestResultYPN2Aretestresultsrecordedinalogbookorelectronicrecordinatimelymanner?Standard:Inlinewithmaintainingagreedturnaroundtimes,theLaboratoryshallperformandrecordtestresultsinatimelymannerandityofreportedandstoredresultreportsshallbemaintained.yticSystem/MethodYPN2Whenmorethanoneinstrumentisinuseforthesametest,aretestresultstraceabletotheequipmentusedfor同的測(cè)試，可追溯到用于Standard:Itisimportantthatthelaboratoryhastheabilitytotracespecimenresultstoaspecificyticalsystemormethod.Proficiencytestingspecimenswouldalsofallunderspecimenresults.ResultCross-checkSystem結(jié)果交叉檢查系YPN2Isthereasystemforreviewingfortranscriptionerrors?有一個(gè)轉(zhuǎn)Standard:Thelaboratorymusthaveasystemforcross-checkingofresultsbeforereleasetorequestersinordertoidentifyandcorrectISO15189:5.8.3“Resultsshallbelegible,withoutmistakesintranscriptionandreportedtosauthorizedtoreceiveandusemedical9.6ArchivedDataLabelingandStorage存檔的數(shù)據(jù)標(biāo)識(shí)和Arearchivedresults(paperordata-storagemedia)properlylabeledandstoredinasecurelocationaccessibleonlytoauthorizednel?存檔的結(jié)果（文件或數(shù)據(jù)介質(zhì)）適當(dāng)?shù)臉?biāo)記，并在一個(gè)安全的地方，只有的YPN2Standard:Allpatientdata,paper,tapes,disksshouldbeproperlylabeledandstoredsecurelyinplacesaccessibleonlytoISO15189:5.8.3AnnexB9.7InformationandDataBackupSystem信Arethere edprocedurestopreventthelossoftestresu ataintheeventofhardware/softwarefailure,fireortheft?文件化的程序來(lái)防止在硬件/發(fā)生障的數(shù)據(jù)損失，火災(zāi)或者YPN2Standard:Thelaboratoryshouldhaveaproceduretoprotectessentialdataintheeventofequipmentfailureand/oranunexpecteddestructiveevent.Theseprocedurescouldincludefloodandfiresafestorageofdata,periodicbackingupandstoringofinformation,andoff-sitestorageofbackupdata.ISO15189:5.8.3AnnexB9.8TestResultReport報(bào)Isthelaboratoryresultreport(s)inastandardformdeterminedtobeacceptablebyitsYNP2IndicateforeachitemTickforeachIsthelaboratoryissuingthereportclearly是發(fā)布的報(bào)告清楚地識(shí)Doesthereportcontainthepatient’snameaddress,andthehospital/destinationofthereport?這份報(bào)/Isthenameofthe requestingthetestindicatedonthereport?有人請(qǐng)求測(cè)試的名稱Isthetypeofsamplereceivedandthetestrequestedincludedinthereport?是Arethedateandtimeforspecimencollection,receiptofspecimen,andreleaseofreportDoesthereportindicatebiologicalreferencerangesforeachtest?IstheresultreportedinSIunitswhereSIIstherespaceforinterpretationofresults,whenapplicable,andforindicationofwhenspecimensreceivedandunsuitablefortheprocedurerequestedfortesting?有空間的結(jié)果時(shí)，適用解釋，并Doestheresultcontainthenameofauthorizingreleaseofthereportandthesignature acceptingresponsibilityforitscontent?9.9TestResult檢驗(yàn)結(jié)Aretestresultsvalidated,interpretedandreleasedbyappropriay-authorized 2的解釋和驗(yàn)證，通過(guò)適當(dāng)SECTION9:INFORMATIONMANAGEMENTForeachitem,pleasecircleeitherYes(Y),Partial(P),orNo(N).Allelementsoftheitemmustbesatisfactorilypresentto“yes”.Provideexplanationorfurthercommentsforeach“partial”or“no”YPN10.0CORRECTIVEACTIONArealllaboratory- edoccurrencereportsindicatingtherootcauseoftheproblem(s)andcorrective&preventiveactionstakentopreventrecurrence?所有的記錄發(fā)生的報(bào)告問(wèn)題的根源（S）和采YPNTheremustbeatleastadescriptionofwhathappenedandwhatwasdonetopreventitfromhappeningagain.必須至少有一個(gè)敘述所發(fā)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?結(jié)果保留，如果通過(guò)控制水ISO4.9.1partHavethesebeenrecalledandcorrected,ifresultshavebeenreleased?這些被糾正，如ISO4.9.1partIsthisapprovedbyanauthorized whentestingresumes?這是由批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發(fā)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質(zhì)量指標(biāo)（TAT，標(biāo)本，缺貨，等選擇，，并定期檢討，以監(jiān)測(cè)YPN5Arethe esofinternalandexternalaudits,PT,customerfeedbackandallotherinformationderivedfromthetrackingofqualityindicatorsusedtoimprovelabperformance?有和外YPN3Isthe eoftheactiontakencheckedandmonitoredtodeterminetheeffectivenessofimprovedqualityoflabperformance?查和監(jiān)測(cè)以確定改進(jìn)的性能質(zhì)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:議TickforeachDoestheequipmentplacement/layoutfacilitateoptimumworkflow?這設(shè)備的位置/布局便于優(yōu)AreallneededspresentandArethechairs/stoolsattheworkstationsappropriateforbenchheightandthetestingoperationsbeingperformed?是椅子凳子在適當(dāng)?shù)呐_(tái)階高度ISO15190:Isreferencematerialreadilyavailable(criticalvaluesandrequiredaction,populationreferenceranges,frequentlycallednumbers?應(yīng)俱全（Standard:Age-andsex-specificreferenceintervals(normalvalues)mustbeverifiedorestablishedbylaboratory.Ifaformalreferenceintervalsstudyisnotpossibleorpractical,thenthelaboratoryshouldcarefullyevaluatetheuseofpublisheddataforitsownreferenceranges,andretainationofthisevaluation.CAP:ChemistryandToxicologyChecklist,12.4Isthephysicalworkenvironmentappropriatefortesting?是物理工作YPN2Istheworkplace:TickforeachFreeof無(wú)ISO15190:AdequayISO15190:Freeofexcessmoisture?分ISO15190:Adequaylit?ISO15190:Climate-controlledforoptimumequipmentISO15190:Arefilterschecked,cleanedand/orreplacedatregularintervalswhereair-conditioningisinstalled?Arewiresandcablesproperlylocatedandprotectedfromtraffic?Isthereafunctioningback-uppowersupplyIscriticalequipmentsupportedbyuninterruptedpowersource(UPS)systems?Isequipmentplacedappropriayawayfromwaterhazards,outoftrafficareas)?是設(shè)備放置適當(dāng)（遠(yuǎn)離水的危害，從交通區(qū)Isacontingencyplaninplaceforcontinuedtestingintheeventofprolongedelectricitydisruption?是一Areappropriateprovisionsmadeforadequatewatersupply,includingdeionizedwater(DI)ordistilledwater,ifneeded?話IsclericalworkcompletedoutsidethetestingIsmajorsafetysignagepostedandenforcedincludingNOEATING,SMOKING,DRINKING?是Standard:Thelaboratoryspaceshouldbesufficienttoensurethatthequalityofwork,thesafetyof nel,andtheabilityofstafftocarryoutqualitycontrolproceduresandation.Thelaboratoryshouldbecleanandwellorganized,freeofclutter,well-ventilated,adequaylit,andwithinacceptabletemperatureranges.Emergencypowershouldbeavailablesensitiveinstruments,temperaturecontrolledstorage,andotheressentialequipmenttopreventdamageanddisruptionduetounexpectedpowerfluctuationsandoutages.Sensitiveinstrumentsshouldbeequippedwithsurgecon