ISO15189认可和CAP认证的流程和体会ppt课件.ppt

ISO15189认可和CAP认证的流程和体会 浙江大学医学院附属第二医院谭运年2013 11 08 1 一 为什么要做 二 认证认可差别三 体系建立和检查手段四 申请流程和体会 2 HELP FREE 3 一 为什么要做 为什么不想做 据说听说传说 文件工作多学习任务重硬件达不到要求软件达不到要求只按部分要求做 不评 4 推动的因素 外部 国内 优质医院 等级医院 卫生部重点专科评审 国外 JCI JointCommissiononAccreditationofHealthcareOrganizations JCAHO CAP CollegeofAmericanPathologist 内部 自身发展的需要 自重 自尊 5 归根到底 高品质医疗服务的需要 质的需要 深度 提供项目的质量量的需要 广度 覆盖面 提供多少项目 服务人群 对口支援单位 6 回归到正确的服务轨道上 过去 体系不完善 服务质量有待提高现在 提倡服务对象至上 服务契合对象需要 7 实验室如何证明自己的能力 第一方证明 自我声明第二方证明 客户的证明第三方证明 公正权威的证明 8 浙二医院检验科 ISO15189初次评审2012 4 23 25现场评审2012 9 29获得认可 编号121 CAP LaboratoryAccreditationProgram LAP 2013 7 10 12现场评审2013 9 10获得认证 中国大陆第6家公立医院 ISO15189监督扩项评审2013 10 11 13现场评审 9 10 背景简介 认可认证依据 11 11 二 认证认可差别Certification Accreditation 12 发个证先 你们符合结婚的条件 13 区分重点 谁组织检查 第三方还是权威机构 检查是体系要求符合性认定还是能力的认定 区别是建立在有一定内涵联系基础上CAP英文中称Accreditation 14 ISOI5189实验室文件体系 ISO15189 2007 医学实验室 质量和能力的要求 CNAS CL02 2008 医学实验室质量和能力认可准则 ISO15189 2012 医学实验室 质量和能力的要求 于2012年11月1日发布 国际实验室认可合作组织 ILAC 要求各国认可组织于2016年3月1日前完成标准转换工作 准则核查表2013 4 1实施的专业组核查表 15 三 体系建立和检查手段 CAP实验室文件体系 CLIA88美国临床实验室改进修正法规 88ClinicalLaboratoryImprovementAmendments CLIA of1988areUnitedStatesfederalregulatorystandardsthatapplytoallclinicallaboratorytestingperformedonhumansintheUnitedStates exceptclinicaltrialsandbasicresearch 2003CDCandCMSmodifiedCLSI美国临床和实验室标准协会ClinicalandLaboratoryStandardsInstituteisavolunteerdriven membershipsupported nonprofit standardsorganization CLSIpromotesthedevelopmentanduseofvoluntarylaboratoryconsensusstandardsandguidelineswithinthehealthcarecommunity CAP3000Checklist 16 评审依据的内容 17 ISO151894 1组织和管理 18 对比举例一 组织和管理 注 包括实验室负责人和普通员工要求 ISO中未见一般员工要求 CAPPERSONNELREQUIREMENTBYTESTNGCOMPLEXITY DIRECTORS MDorDO SECTIONDIRECTORS TECHNICALSUPERVISORS MDorDO SUPERVISORS GENERALSUPERVISORSALLPERSONNEL 19 CAP组织和管理 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 20 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 21 HEM 40000Personnel BenchTestingPhaseIIThepersoninchargeofbenchtestinginhematologyhaseducationequivalenttoanassociate sdegree orbeyond inachemical physicalorbiologicalscienceormedicaltechnologyandatleast4yearsexperience oneofwhichisinclinicalhematology underaqualifieddirector EvidenceofCompliance Recordsofqualificationsincludingdegreeortranscript certification registration currentlicense ifrequired andworkhistoryinrelatedfield CHM 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 andworkhistoryinrelatedfield 22 CAP普通员工资质要求很具体 所有员工的资质证明 23 对比举例二 人员能力评价 生化 应制定员工能力评审的内容和方法 每年评审员工的工作能力 对新进员工在最初2个月内应至少进行2次能力评审 间隔为30天 并记录 当职责变更时 或离岗6个月以上再上岗时 或政策 程序 技术有变更时 应对员工进行再培训和再评审 没有通过评审的人员需经再培训和再评审 合格后才可继续上岗 并记录 血液 应制定员工能力评审的内容和方法 每年评审员工的工作能力 对新进员工 尤其是从事血液学形态识别的人员 在最初2个月内应至少进行2次能力评审 间隔为30天 评审内容包括 培训内容和过程 现场考核 检验结果的分析与判断 检查工作单与各种记录 当职责变更时 或离岗6个月以上再上岗时 或政策 程序 技术有变更时 应对员工进行再培训和再评审 没有通过评审的人员应经再培训和再评审 合格后才可继续上岗 并记录 24 ISO15189人员能力评价 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 25 CAP人员能力评价 谁来评估 怎样评估 明确间隔时间 比ISO15189要求更细 ISO15189未对PT做出规定整合在准则核查表条款4 9不符合项的识别和控制4 10纠正措施4 11预防措施 CAP对PT有非常具体规定有非常多的Checkllist 举例三 PT数据的上报 分析 强制要求 26 27 28 CHM 10300PTEvaluationPhaseIIThereisongoingevaluationofPTandalternativeassessmentresults withpromptcorrectiveactiontakenforunacceptableresults PrimaryrecordsareretainedfortwoyearsTheseincludeallinstrumenttapes workcards computerprintouts evaluationreports evidenceofreview anddocumentationoffollow up correctiveaction EvidenceofCompliance Recordsofongoing timelyreviewofallPTreportsandalternativeassessmentresultsbythelaboratorydirectorordesigneeAND Recordsofinvestigationof unacceptable PTandalternativeassessmentresultsincludingrecordsofcorrectiveactionthatisappropriatetothenatureandmagnitudeoftheproblem TypeofAnalytes Procedures CMSRegulated BOLDTYPECentersforMedicare MedicaidServices 医疗保险和医疗补助服务中心 CMSNon regualated 29 30 WhathappenswhenalabhasaPTfailurefor aregulatedanalyte Suspensionoftesting CessationoftestingRevocationofalab saccreditationbyCMSNon regulatedanalytes EachaccreditingagencyhasdifferentPToversightstandards Unsatisfictoryunsuccessful 31 PTFailureScenarios 32 33 D A0206 F 501纠正预防措施报告记录表 CNAS申请 安排现场评审 资料审查 不符合项整改 发证 四 申请流程和体会 SubmitapplicationrequestComplete