CAP实验室认可计划-检查流程总览(中英文对照)

1、123Overview of the Laboratory Accreditation Program (LAP)The Inspection ProcessQuestions & Answers 4实验室认可计划 (LAP) 总览检查流程问题与回答 5Promote a Culture of QualityQuality controlPerformance improvementProficiency testingRegulatory roleAssess compliance with CAP requirements, including CLIA-88 regulation

2、s6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 7 8 9State 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).AccreditationDemonstratio

3、n that an organization has met standards of quality as defined by the profession. 10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11Government Regulations (CLIA 88)Centers for Medicare and Medicaid Services (CMS)Ultimate regulatory authority, enforces the

4、 Clinical Laboratory Improvement Amendments of 1988 (CLIA-88)In 1995, approved CAP as an accrediting organization under CLIA88In 2001, extended approval through 9/0712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13College o

5、f 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)14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

6、国整骨疗法协会 (AOA)美国组织配型和免疫遗传协会 (ASHI)15In Existence Since 1961Progressive GrowthRelationships with other Organizations16从1961年开始成长过程和其他机构的关系17Over 6,600 Participating LaboratoriesTen to Twelve Inspections per DayWorldwide Recognition 124 Civilian International labs70 US Military Labs Overseas38 Countrie

7、sHospital 74%IRL12%POL & Clinics7%Other7%18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19North America:Canada, United States, GreenlandCentral America & Caribbean: Bermuda, Cuba, MexicoSouth America:Argentina, Brazil, Columbia, PeruEurope:Belgium, Cyprus, France, Germany, Ic

8、eland, Irish Republic, Italy, Lithuania, Portugal, United Kingdom, Spain, Sweden, Switzerland, Turkey.20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, Uni

9、ted Kingdom, Spain, Sweden, Switzerland, Turkey.21Middle East: Bahrain, Egypt, Lebanon,Saudi Arabia, UAE Asia: China, India, Japan, Philippines, Singapore, South Korea,Taiwan, ThailandAfrica:South Africa, Uganda22中东: Bahrain, Egypt, Lebanon,Saudi Arabia, UAE 亚洲: China, India, Japan, Philippines, Sin

10、gapore, South Korea,Taiwan, Thailand非洲: South Africa, Uganda23Voluntary programLaboratory ImprovementPeer ReviewEducation24自愿的项目实验室改进同行互审教育25Meets US CLIA-88 regulatory requirementsOften more stringent than CLIA-88 requirements26符合美国 CLIA-88 法规要求常常比 CLIA-88 的要求更加严格27Inspection is part of Labs QI28检查

11、是实验室质量改进的一个部分29What Is a Peer?Equal standing (pathologist, technologist, etc.)Laboratory professionalFirst-hand knowledgeOffers constructive feedback30什么是同行?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31Inspectors with Specialty Expertise Scientific Resources New Technology Ongoing Monitoring Education

12、and Improvement32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33Benefits of Being an Inspector:Promotes the laboratory profession to the publicGains insight through interacting with peer professionalsContinuing education34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35On-Site InspectionsInterim Self-InspectionsPT Monitor

13、ingTechnical/Regional ResourcesDocuments/ManualsSeminarsWeb siteScientific Resource Committees36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37Improve:Patient and sample identificationVerification and communication of life-threatening or life-altering informationIdentification, communication, and correcti

14、on of errorsIntegration and coordination of the laboratorys patient safety role within overall organization.38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39Inspections carried out by thousands of trained, knowledgeable volunteer team leaders and members. 40检查由上千的经培训的, 资深的志愿者组长和组员完

15、成 . 41Consistent inspection process through:Inspector TrainingTeam leader/member selectionChecklist inspection tool42一致的检查过程通过:检查官培训团队组长/组员的选择检查条款为检查工具43Nationwide live seminars (8 hours)Team Leader Workshops (2 hours)AudioconferencesOn-line education()Virtual library contains previously

16、broadcast audioconferencesNEW eLearning Team Leader Inspector Self-study available June 1, 2006NEW eLearning Team Member Inspector Self-study available July 1, 200644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()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”45

17、Inspectors should be peers of lab staffMany international inspectors affiliated with CAP-LAPInspectors need specific expertise for: Flow CytometryCytogeneticsMolecular PathologyHistocompatibility46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47Purposes:Standards are the br

18、oad principles the laboratory must meet in order to achieve accreditationChecklists provide detailed requirements that inspectors use to determine whether laboratories meet the Standards48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49Standard IDirectorStandard IIPhysical Facilities &am

19、p;SafetyStandard III Quality Control andPerformance ImprovementStandard IV Inspection Requirements50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51Team Leader ChecklistLaboratory GeneralHematology & Coag.Chemistry & ToxicologyUrinalysisMicrobiologyTransfusion MedicineDiagnostic ImmunologyAnatomic

20、PathologyCytopathologyCytogeneticsHistocompatibilityFlow CytometryMolecular PathologyLimited ServicePoint of Care52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53Checklists guide the inspection by assisting with the interpretation of LAP Standards.54检查条款通过帮助对LAP 标准

21、的解释来指导检查.55Help paint a complete pictureDetailBroad vantage pointProvide guidelines for development of policies, procedures and processesHelp ensure accurate, reliable test results56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57Phase IDo not seriously affect patient care and safety/welfare

22、 of lab workersPhase IIMay have a serious affect on patient care or may seriously affect safety/welfare of lab workers58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59Possible responses: Yes, No, or Not Applicable (N/A)Partial complianceLikely to affect patient care or worker safety?If

23、yes, cite a DeficiencyInspector expected to use judgmentMinor noncompliance does not change Phase II to Phase I60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 I61Over 3,200 Checklist QuestionsChecklists are revised to:Incorporate new technologyEliminate outdated t

24、echnologyAllow for more appropriate technologyNow Customized to Laboratorys specific activity menu62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63ChecklistModifications64检查条款的修改65ModificationsChecklistCommissionerCAP Resource CommitteesCommission on Laboratory AccreditationCMSLab

25、s Printing66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67Released 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 authority682005年10月发布评

26、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69Detailed instructions on how to:Conduct inspection and interviewsAssess Directors involvement and commitment to qualityChecklist must be completed by Team Leader70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71Assignment and Preparati

27、onConducting the inspectionDocumenting inspection findingsReporting findings to the labPost-Inspection72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 dateIns

28、pection may involveseveral laboratoriesFollow-up letter to lab Director74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75Laboratory demographicsDirector and Supervisor(s)Number of tests yearlyNumber of personnelActivity MenuTests and methods in each sectionProficiency testing r

29、equirementsInstrumentationChecklists used in each section76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77Standards for Laboratory AccreditationLaboratory Accreditation ManualPrevious on-site inspection reportLaboratory organization & floor planCurriculum vitae of Lab DirectorVariant

30、Proficiency Testing Report78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79Review inspection materialsMeeting with team leaderInspector trainingMandatory for team leadersSoon mandatory for team membersOther CAP resourcesInspector questions - CAP web site - 80回顾检查材料与团队组长会面检查

31、官培训组长的责任组员的责任其他CAP 资源检查官问题 - CAP 网页 - 81Fair, objective, open-mindedDoes the lab meet the of the checklist questions?Compliance with CAP StandardsNeed to cite appropriate deficienciesSuperficial inspection unfair to labDirector needs to know of problems82公平, 公正, 思维开阔的实验室是否符合

32、检查条款问题的?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830800 - 0830Introductions, tour0830 - 1200Inspect larger section1200 - 1300Working lunch; review with team leader1300 - 1500Inspect smaller section1500 - 1600Presummation conf.1600 - 1700Summation conference840800 - 0830介绍, 巡回检查0830 - 1200检查大的部分12

33、00 - 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85ReadObserveAsk86阅读阅读观察观察提问提问87For 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

34、!)Use open-ended questions88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89For 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 documen

35、tation?“actual practice must matchthe contents of the procedure manuals.”90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.”91Part AGeneral observations and conclusionsVerification of Directors qualificationsPart BDeficienciesRecommendationsCopy left with laboratory92A 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93Team meeting at conclusion of inspectionSets the tone for the summation conferenceReview all deficienciesAnswer team members questionsAssure consistent interpretation Team members record Deficiencies & Recommendations94关于检查结论的小组会议