CAP实验室认可计划-检查流程总览(中英文对照)课件

1College of American PathologistsLaboratory Accreditation Program OverviewInspection ProcessCollege of American Pathologis2美国病理学家学院美国病理学家学院实验室认可计划实验室认可计划 检查流程检查流程总览总览美国病理学家学院实验室认可计划3College of American Pathologists(CAP)Overview of the Laboratory Accreditation Program (LAP)The Inspection ProcessQuestions&Answers College of American Pathologi4美国病理学家学院美国病理学家学院(CAP)实验室认可计划 (LAP)总览检查流程问题与回答 美国病理学家学院(CAP)实验室认可计划 (LAP)5LAP Philosophy Promote a Culture of QualityQuality controlPerformance improvementProficiency testingRegulatory roleAssess compliance with CAP requirements,including CLIA-88 regulationsLAP Philosophy Promote a Cult6LAP 哲学哲学 提升质量文化质量控制性能的提高能力验证法规的作用评价与CAP 的要求,包括 CLIA-88 的规定的一致性 LAP 哲学 提升质量文化7Why Accreditation?Participation in a Voluntary Laboratory Accreditation Program Improves the Quality ofServices for Patients.Why Accreditation?Participatio8为什么要认可为什么要认可?参与一个自愿的实验室认可计划可 提高对病人服务的质量.为什么要认可?参与一个自愿的实验室认可计划可9Laboratory Accreditation in the USState LicensureMinimum requirements set by a regulatory body.May require accreditation in addition.CertificationAssurance that a quality system is in place and is consistent with certain standards(e.g.ISO 9000).AccreditationDemonstration that an organization has met standards of quality as defined by the profession.Laboratory Accreditation in th10美国的实验室认可情况美国的实验室认可情况国家给予许可法规设置机构的最低要求可能需要另外的认可证明确保所使用的质量系统适合并和某些国际标准一致(e.g.ISO 9000)认可声明某一机构已经达到了由专业机构制定的质量标准美国的实验室认可情况国家给予许可11Laboratory Accreditation in the USGovernment Regulations(CLIA 88)Centers for Medicare and Medicaid Services(CMS)Ultimate regulatory authority,enforces the Clinical Laboratory Improvement Amendments of 1988(CLIA-88)In 1995,approved CAP as an accrediting organization under CLIA88In 2001,extended approval through 9/07Laboratory Accreditation in th12美国的实验室认可情况美国的实验室认可情况政府法规(CLIA 88)医疗保险和医疗救助服务中心(CMS)最终法规权威机构,加强1998年（CLIA-88）的临床实验室改进修正法案的实施1995年,批准CAP 作为在 CLIA88 下的认可组织2001年,通过 9/07延长批准美国的实验室认可情况政府法规(CLIA 88)13Laboratory Accreditation Organizations in the USCollege of American Pathologists(CAP)Joint Commission on Accreditation of Healthcare Organizations(JCAHO)COLAAmerican Association of Blood Banks(AABB)American Osteopathic Association(AOA)American Society of Histocompatibility and Immunogenetics(ASHI)Laboratory Accreditation Organ14美国的实验室认可机构美国的实验室认可机构美国病理学家学院(CAP)医疗卫生机构认可联合委员会(JCAHO)COLA美国血库协会(AABB)美国整骨疗法协会(AOA)美国组织配型和免疫遗传协会(ASHI)美国的实验室认可机构15CAP Laboratory Accreditation Program:HistoryIn Existence Since 1961Progressive GrowthRelationships with other OrganizationsCAP Laboratory Accreditation P16CAP 实验室认可计划实验室认可计划:历史历史从1961年开始成长过程和其他机构的关系CAP 实验室认可计划:历史从1961年开始17CAP Laboratory Accreditation Program:TodayOver 6,600 Participating LaboratoriesTen to Twelve Inspections per DayWorldwide Recognition 124 Civilian International labs70 US Military Labs Overseas38 CountriesCAP Laboratory Accreditation P18CAP 实验室认可计划实验室认可计划:今天今天有超过 6,600 个参与的实验室每天有10到12个检查国际公认 124 私人国际实验室70 美国海外军用实验室38 国家CAP 实验室认可计划:今天有超过 6,600 个参与的实19International ParticipationNorth America:Canada,United States,GreenlandCentral America&Caribbean:Bermuda,Cuba,MexicoSouth America:Argentina,Brazil,Columbia,PeruEurope:Belgium,Cyprus,France,Germany,Iceland,Irish Republic,Italy,Lithuania,Portugal,United Kingdom,Spain,Sweden,Switzerland,Turkey.International ParticipationNo20国际参与国际参与北美:Canada,United States,Greenland中美和加勒比:Bermuda,Cuba,Mexico南美:Argentina,Brazil,Columbia,Peru欧洲:Belgium,Cyprus,France,Germany,Iceland,Irish Republic,Italy,Lithuania,Portugal,United Kingdom,Spain,Sweden,Switzerland,Turkey.国际参与北美:Canada,United State21International ParticipationMiddle East:Bahrain,Egypt,Lebanon,Saudi Arabia,UAE Asia:China,India,Japan,Philippines,Singapore,South Korea,Taiwan,ThailandAfrica:South Africa,UgandaInternational ParticipationMi22国际参与国际参与中东:Bahrain,Egypt,Lebanon,Saudi Arabia,UAE 亚洲:China,India,Japan,Philippines,Singapore,South Korea,Taiwan,Thailand非洲:South Africa,Uganda国际参与中东:Bahrain,Egypt,Leban23Inspection PhilosophyVoluntary programLaboratory ImprovementPeer ReviewEducationInspection PhilosophyVoluntary24检查的哲学检查的哲学自愿的项目实验室改进同行互审教育检查的哲学自愿的项目25Voluntary ProgramMeets US CLIA-88 regulatory requirementsOften more stringent than CLIA-88 requirementsVoluntary ProgramMeets US CLIA26自愿计划自愿计划符合美国 CLIA-88 法规要求常常比 CLIA-88 的要求更加严格自愿计划符合美国 CLIA-88 法规要求27Laboratory ImprovementInspection is part of Labs QILaboratory ImprovementInspecti28实验室改进实验室改进检查是实验室质量改进的一个部分实验室改进检查是实验室质量改进的一个部分29Peer ReviewWhat Is a Peer?Equal standing(pathologist,technologist,etc.)Laboratory professionalFirst-hand knowledgeOffers constructive feedbackPeer ReviewWhat Is a Peer?30同行互审同行互审什么是同行?相等的身份(病理学家,技术专家等.)实验室专业人员直接的认识提供建设性的反馈同行互审什么是同行?31Peer ReviewInspectors with Specialty Expertise Scientific Resources New Technology Ongoing Monitoring Education and ImprovementPeer ReviewInspectors with Spe32同行互审同行互审具备专业知识的检查官科学资源 新技术 持续监控 教育和改进同行互审具备专业知识的检查官33Peer ReviewBenefits of Being an Inspector:Promotes the laboratory profession to the publicGains insight through interacting with peer professionalsContinuing educationPeer ReviewBenefits of Being a34同行互审同行互审成为一名检查官的好处:推动实验专业的公众化通过和 同行的互动获得洞察力继续教育同行互审成为一名检查官的好处:35EducationOn-Site InspectionsInterim Self-InspectionsPT MonitoringTechnical/Regional ResourcesDocuments/ManualsSeminarsWeb siteScientific Resource CommitteesEducationOn-Site InspectionsDo36教育教育现场检查中间的自查PT 监测技术/区域的资源文件/手册研讨会网页科学资源委员会教育现场检查文件/手册37CAP Patient Safety GoalsImprove:Patient and sample identificationVerification and communication of life-threatening or life-altering informationIdentification,communication,and correction of errorsIntegration and coordination of the laboratorys patient safety role within overall organization.CAP Patient Safety GoalsImprov38CAP 患者安全目标患者安全目标改进:病人和样本的唯一编码对威胁和改变生命的信息的确认和沟通错误的识别，沟通和更正在整个机构中，整合并协调实验室的患者安全任务CAP 患者安全目标改进:39Volunteer InspectorInspections carried out by thousands of trained,knowledgeable volunteer team leaders and members.Volunteer InspectorInspections40志愿者检查官志愿者检查官检查由上千的经培训的,资深的志愿者组长和组员完成.志愿者检查官检查由上千的经培训的,资深的志愿者组长和组员完41Focus on ConsistencyConsistent inspection process through:Inspector TrainingTeam leader/member selectionChecklist inspection toolFocus on ConsistencyConsistent42关注一致性关注一致性一致的检查过程通过:检查官培训团队组长/组员的选择检查条款为检查工具关注一致性一致的检查过程通过:43Inspector Training-Earn CME/CENationwide live seminars(8 hours)Team Leader Workshops(2 hours)AudioconferencesOn-line education(www.cap.org)Virtual library contains previously broadcast audioconferencesNEW eLearning Team Leader Inspector Self-study available June 1,2006NEW eLearning Team Member Inspector Self-study available July 1,2006Inspector Training-Earn CME/44检查官培训检查官培训-获得获得 CME/CE国内的现场研讨会(8 小时)团队组长工作会(2小时)可视会议在线教育(www.cap.org)虚拟图书馆，包含先前可视会议广播自2006年6月1日起可获得“新的电子学习团队组长检查官自学课程”自2006年7月1日起可获得“新的电子学习团队组员检查官自学课程”检查官培训-获得 CME/CE国内的现场研讨会(8 45Inspection Team Inspectors should be peers of lab staffMany international inspectors affiliated with CAP-LAPInspectors need specific expertise for:Flow CytometryCytogeneticsMolecular PathologyHistocompatibilityInspection Team Inspectors sho46检查组检查组 检查官应该为实验室员工的 同行 许多国际的检查官隶属于 CAP-LAP检查官需有特定的专业知识，包括:流式细胞学细胞遗传学分子病理学组织配型学检查组 检查官应该为实验室员工的 同行 47Standards and ChecklistsPurposes:Standards are the broad principles the laboratory must meet in order to achieve accreditationChecklists provide detailed requirements that inspectors use to determine whether laboratories meet the StandardsStandards and ChecklistsPurpos48标准和检查条款标准和检查条款目的:标准是指实验室需满足的含盖面广的原则，目的是通过认可。检查条款提供具体要求，检查员用它来看实验室是否满足了标准标准和检查条款目的:49The Standards forLaboratory AccreditationStandard IDirectorStandard IIPhysical Facilities&SafetyStandard III Quality Control andPerformance ImprovementStandard IV Inspection RequirementsThe Standards forLaboratory A50实验室认可的标准实验室认可的标准标准 I主任标准II物理设施和安全标准III 质控和性能提高标准IV 检查要求实验室认可的标准标准 I主任51LAP ChecklistsTeam Leader ChecklistLaboratory GeneralHematology&Coag.Chemistry&ToxicologyUrinalysisMicrobiologyTransfusion MedicineDiagnostic ImmunologyAnatomic PathologyCytopathologyCytogeneticsHistocompatibilityFlow CytometryMolecular PathologyLimited ServicePoint of CareLAP ChecklistsAnatomic Patholo52LAP 检查条款检查条款团队组长检查条款通用实验室条款血液和凝血生化和毒理学尿液分析微生物学输血医学诊断免疫学解剖病理学细胞病理学细胞遗传学组织配型流式细胞学分子病理学限制服务床旁诊断LAP 检查条款解剖病理学53ChecklistsChecklists guide the inspection by assisting with the interpretation of LAP Standards.ChecklistsChecklists guide the54检查条款检查条款检查条款通过帮助对LAP 标准的解释来指导检查.检查条款检查条款通过帮助对LAP 55ChecklistsHelp paint a complete pictureDetailBroad vantage pointProvide guidelines for development of policies,procedures and processesHelp ensure accurate,reliable test resultsChecklistsHelp paint a complet56检查条款检查条款帮助描绘一张完整的宏图具体内容含盖全面的点提供对政策，程序和流程发展的指导有助于确保得到准确、可靠的测试结果检查条款帮助描绘一张完整的宏图57Checklist QuestionsPhase IDo not seriously affect patient care and safety/welfare of lab workersPhase IIMay have a serious affect on patient care or may seriously affect safety/welfare of lab workersChecklist QuestionsPhase I58检查条款的问题检查条款的问题阶段 I不会严重影响患者医疗和实验室工作人员的安全/福利阶段 II可能会严重影响患者医疗和实验室工作人员的安全/福利检查条款的问题阶段 I59Answering Checklist QuestionsPossible responses:Yes,No,or Not Applicable(N/A)Partial complianceLikely to affect patient care or worker safety?If yes,cite a DeficiencyInspector expected to use judgmentMinor noncompliance does not change Phase II to Phase IAnswering Checklist QuestionsP60回答检查条款的问题回答检查条款的问题可能的回答:是,否,或不适用(N/A)部分的符合会影响患者医疗或员工安全吗?如果是,记录为一个缺陷检查者须做出判断较小的不符合不会改变阶段 II 到阶段 I回答检查条款的问题可能的回答:是,否,或不适用(N/61Checklist RevisionsOver 3,200 Checklist QuestionsChecklists are revised to:Incorporate new technologyEliminate outdated technologyAllow for more appropriate technologyNow Customized to Laboratorys specific activity menuChecklist RevisionsOver 3,200 62检查条款的修订检查条款的修订超过3,200 个检查条款问题检查条款会被修订用来:整合新技术去除过时的技术允许更多适合的技术目前根据实验室的特殊活动菜单用户化检查条款的修订超过3,200 个检查条款问题63Checklist DevelopmentChecklistModifications ParticipantsParticipants CommissionersCommissioners Resource Resource CommitteesCommittees Technical StaffTechnical Staff Checklist DevelopmentChecklist64检查条款的发展检查条款的发展检查条款的修改 参与者参与者参与者参与者 委员委员委员委员 资源委员会资源委员会资源委员会资源委员会 技术人员技术人员技术人员技术人员 检查条款的发展检查条款 参与者 委员 65Checklist DevelopmentModificationsChecklistCommissionerCAP Resource CommitteesCommission on Laboratory AccreditationCMSLabs PrintingChecklist DevelopmentModificat66检查条款的发展检查条款的发展修改检查条款委员CAP 资源委员会实验室认可的委员会CMS实验室 打印检查条款的发展修改检查条款委员CAP 资源委员会实验室认可的67Team Leader ChecklistReleased October 2005Assesses Laboratory Directors qualifications and effectivenessMost questions not new but moved from Lab General ChecklistAdditional overarching questions about quality management,patient safety and director authorityTeam Leader ChecklistReleased 68检查组组长的检查条款检查组组长的检查条款2005年10月发布评估实验室主任的资质和有效性大多数问题不是新的，是从实验室通用检查条款中搬过来的另外的关于质量控制,患者安全和主任权限等方面的问题检查组组长的检查条款2005年10月发布69Team Leader ChecklistDetailed instructions on how to:Conduct inspection and interviewsAssess Directors involvement and commitment to qualityChecklist must be completed by Team LeaderTeam Leader ChecklistDetailed 70检查组组长的检查条款检查组组长的检查条款对以下的详细的说明:完成检查和审核评估主任的业绩和对质量的承诺检查条款必须由团队组长完成检查组组长的检查条款对以下的详细的说明:71Inspection ProcessAssignment and PreparationConducting the inspectionDocumenting inspection findingsReporting findings to the labPost-InspectionInspection ProcessAssignment a72检查过程检查过程分配任务和准备现场检查记录检查中的发现告之实验室检查结果检查后检查过程分配任务和准备73Team leader notified up to 12 months prior to anniversary dateLab is notified of team leader and team membersTeam Leader contacts lab to arrange inspection dateInspection may involveseveral laboratoriesFollow-up letter to lab DirectorInspector Assignment Team leader notified up to 12 74团队组长在检查年到期的12个月前通报实验室会接到团队组长和组员通知团队组长和实验室联系以确定检查日期检查可能包括几个实验室给主任的确认函检查官的委派检查官的委派 团队组长在检查年到期的12个月前通报检查官的委派 75Inspection PacketLaboratory demographicsDirector and Supervisor(s)Number of tests yearlyNumber of personnelActivity MenuTests and methods in each sectionProficiency testing requirementsInstrumentationChecklists used in each sectionInspection PacketLaboratory de76检查资料检查资料实验室信息主任和主管每年测试数员工数量活动菜单每个部分测试和检测方法能力验证的要求使用仪器每个部分适用的检查条款检查资料实验室信息77Inspection PacketStandards for Laboratory AccreditationLaboratory Accreditation ManualPrevious on-site inspection reportLaboratory organization&floor planCurriculum vitae of Lab DirectorVariant Proficiency Testing ReportInspection PacketStandards for78检查资料检查资料实验室认可标准实验室认可手册先前现场检查报告实验室组织和平面图实验室主任简历不同的PT 报告检查资料实验室认可标准79Inspector PreparationReview inspection materialsMeeting with team leaderInspector trainingMandatory for team leadersSoon mandatory for team membersOther CAP resourcesInspector questions-accredcap.org CAP web site-www.cap.orgInspector PreparationReview in80检查官的准备检查官的准备回顾检查材料与团队组长会面检查官培训组长的责任组员的责任其他CAP 资源检查官问题-accredcap.org CAP 网页-www.cap.org检查官的准备回顾检查材料81Inspector Conduct Fair,objective,open-mindedDoes the lab meet the intentintent of the checklist questions?Compliance with CAP StandardsNeed to cite appropriate deficienciesSuperficial inspection unfair to labDirector needs to know of problemsInspector Conduct Fair,objec82检查官的行为检查官的行为 公平,公正,思维开阔的实验室是否符合检查条款问题的意图意图?服从 CAP 标准需要恰当地指出缺陷肤浅的检查对实验室来说是不公的主任需要知道存在的问题检查官的行为 公平,公正,思维开阔的83Inspection Schedule0800-0830Introductions,tour0830-1200Inspect larger section1200-1300Working lunch;review with team leader1300-1500Inspect smaller section1500-1600Presummation conf.1600-1700Summation conferenceInspection Schedule0800-083084检查时间表检查时间表0800-0830介绍,巡回检查0830-1200检查大的部分1200-1300工作午餐;和团队组长回顾 1300-1500检查小的部分1500-1600前总结会议1600-1700总结会议检查时间表0800-0830介绍,巡回检查85Conducting the InspectionConducting the InspectionReadObserveAskConducting the InspectionReadO86检查检查检查检查阅读阅读观察观察提问提问检查阅读观察提问87Conducting the InspectionFor each 3 hours in a section:1 hour reading2 hours observing and askingInspection approachesFollow the SpecimenDrill Down(in-depth analysis of select analytes)Teach Me(Pretend I am a new trainee!)Use open-ended questionsConducting the InspectionFor e88检查检查在一个部分中的每3小时:1 个小时阅读2 个小时观察和提问检查方法跟随样本深入研究(对选定样本深度分析)教我(假如我是一名新的工作人员!)使用开放式问题检查在一个部分中的每3小时:89Documentation vs.PracticeFor checklist requirements:Does the lab do it?Is it documented?All procedures must be documented;e.g.CHM.11000 Phase II “Is a complete procedure manual available”)Does practice match documentation?“actual practice must matchthe contents of the procedure manuals.”Documentation vs.PracticeFor 90文件文件 vs.操作操作检查条款的要求:实验室按文件操作了吗？有文件吗?所以程序必须文件化;例如：CHM.11000 Phase II “是一种完全的可获得的操作手册”)操作和文件吻合吗?“实际操作 必须 与操作程序手册吻合.”文件 vs.操作检查条款的要求:91Inspector Summation ReportPart AGeneral observations and conclusionsVerification of Directors qualificationsPart BDeficienciesRecommendationsCopy left with laboratoryInspector Summation ReportPart92检查官汇总报告检查官汇总报告A 部分总的观察和结论主任资质的确认B 部分缺陷建议副本留给实验室检查官汇总报告A 部分93Pre-Summation ConferenceTeam meeting at conclusion of inspectionSets the tone for the summation conferenceReview all deficienciesAnswer team members questionsAssure consistent interpretation Team members record Deficiencies&RecommendationsPre-Summation ConferenceTeam m94汇总报告前讨论会汇总报告前讨论会关于检查结论的小组会议为汇总会议设定基调回顾所有的缺陷回答组员的问题确定解释的一致组员记录的缺陷和建议汇总报告前讨论会关于检查结论的小组会议95The Summation Conference Scheduled for one hourTeam members present findingsDeficiencies and RecommendationsEducational value of inspectionCorrected deficiency reported to CAPRemains a deficiency on lab recordIf there are disagreements.Avoid argumentsCAP Commissioner is final arbiterThe Summation Conference Sche96汇总报告会汇总报告会 预期为一小时组员提出发现的问题缺陷与建议检查的教育价值向 CAP报告的矫正的缺陷在实验室记录中保留一项缺陷如果存在意见分歧.避免争论CAP 委员是最后的仲裁者汇总报告会 预期为一小时97Post-InspectionInspectors Summation ReportPart A-Team leaders commentsPart B-Deficiencies&RecommendationsReturned to CAP Central Office Post-Inspection EvaluationsExpense reimbursementPost-InspectionInspectors Sum98检查之后检查之后检查官的汇总报告A部分 团队组长注释B部分-缺陷和建议返回CAP 中心办公室 检查后的评估费用报销检查之后检查官的汇总报告99Post-Inspection ReviewLab documents corrected DeficienciesNew or revised policy/proceduresQC records with evidence of reviewInstrument printouts&Log sheetsPurchase orders and photographsReviewed by CAP Central Office and LAP CommissionerAccreditation decisionPost-Inspection ReviewLab docu100检查后的回顾检查后的回顾实验室记录了矫正的缺陷新的或修订的政策/程序有复核证据的 QC 记录仪器打印输出和记录单订购单和照片由 CAP 中心办公室和 LAP 委员回顾认可的决定检查后的回顾实验室记录了矫正的缺陷101SummaryFocus of CAP program:Laboratory improvementEducationRegulatory complianceProgram evolves with advances in laboratory medicineCAP continues to be a pioneer in laboratory inspection and accreditationSummaryFocus of CAP program:102小结小结CAP 计划的核心:实验室改进教育符合法规该计划会随实验医学的发展而改进CAP 继续成为实验室检查和认可领域的先锋小结CAP 计划的核心: