ISO15189认可和CAP认证的流程和体会.ppt

ISO15189认可和CAP认证的流程和体会,2013.11.08,一、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,HELP!FREE,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,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。,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）,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,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,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,背景简介,认可认证依据,11,二、认证认可差别CertificationAccreditation,发个证先，你们符合结婚的条件,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,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,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,评审依据的内容,ISO151894.1组织和管理,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,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.,*REVISED*07/31/2012GEN.53400SectionDirector/TechnicalSupervisorQualifications/RequirementsPhaseIISectionDirectors/TechnicalSupervisorsmeetdefinedqualificationsandfulfilltheexpectedresponsibilities.NOTE:Thesectiondirector/technicalsupervisorineachhighcomplexitylaboratorysectioncanbealicensedMDorDOwithcertificationinanatomicand/orclinicalpathology,orqualificationsequivalenttothoserequiredforboardcertification.Thesectiondirector/technicalsupervisorresponsibleforanatomicpathologymustbeanMDorDOcertifiedinanatomicpathologyorpossessqualificationsequivalenttothoserequiredforcertification.Thesectiondirector/technicalsupervisorresponsibleforclinicalpathologymustbeanMDorDOcertifiedinclinicalpathologyorpossessqualificationsequivalenttothoserequiredforcertification;ormaybeanindividualwhomeetsthealternatequalificationsforthespecialtiessupervised.ForlaboratoriessubjecttoUSregulations,alternatequalificationsforthefollowingspecialtyareascanbefoundinFedRegister.1992(Feb28):7177-718042CFR493.1449:bacteriology,mycobacteriology,mycology,parasitology,virology,diagnosticimmunology,chemistry,hematology,cytology,ophthalmicpathology,dermatopathology,oralpathology,radiobioassay,immunohematology.Additionalrequirementsforthesectiondirectorsoftheclinicalcytogenetics,histocompatibilityandtransfusionmedicineservicesarefoundintheCytogenetics,HistocompatibilityandTransfusionMedicineChecklists,respectively.,HEM.40000Personnel-BenchTestingPhaseIIThepersoninchargeofbenchtestinginhematologyhaseducationequivalenttoanassociatesdegree(orbeyond)inachemical,physicalorbiologicalscienceormedicaltechnologyandatleast4yearsexperience(oneofwhichisinclinicalhematology)underaqualifieddirector.EvidenceofCompliance:Recordsofqualificationsincludingdegreeortranscript,certification/registration,currentlicense(ifrequired)andworkhistoryinrelatedfield,CHM.25800Personnel-BenchTestingPhaseIIThepersoninchargeofbenchtestinginchemistryhaseducationequivalenttoanassociatesdegree(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,CAP普通员工资质要求很具体,所有员工的资质证明,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。,ISO15189人员能力评价,GEN.55500CompetencyAssessmentPhaseIIThecompetencyofeachpersontoperformhis/herassigneddutiesisassessed.NOTE:duringthefirstyearofanindividualsduties,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。,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,CHM.10300PTEvaluationPhaseIIThereisongoingevaluationofPTandalternativeassessmentresults,withpromptcorrectiveactiontakenforunacceptableresults.PrimaryrecordsareretainedfortwoyearsTheseincludeallinstrumenttapes,workcards,computerprintouts,evaluationreports,evidenceofreview,anddocumentationoffollow-up/correctiveaction.EvidenceofCompliance:Recordsofongoing,timelyreviewofallPTreportsandalternativeassessmentresultsbythelaboratorydirectorordesigneeANDRecordsofinvestigationofunacceptablePTandalternativeassessmentresultsincludingrecordsofcorrectiveaction