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为什么不想做？据说听说传说推动的因素归根到底：高品质医疗服务的需要回归到正确的服务轨道上实验室如何证明自己的能力浙二医院检验科医学实验室认可认证依据二、认证认可差别Certification＆Accreditation发个证先，你们符合结婚的条件区分重点ISOI5189实验室文件体系CAP实验室文件体系评审依据的内容4.1.5CAPPERSONNELREQUIREMENTBYTESTNGCOMPLEXITY**REVISED**07/31/2012
TLC.10100LaboratoryDirectorQualificationsPhaseII
ThelaboratorydirectorsatisfiesthepersonnelrequirementsoftheCollegeofAmericanPathologists.
…
Thedirectormust:
a.BeanMDorDOlicensedtopractice(ifrequired)inthejurisdictionwherethelaboratoryislocated,and
b.Becertifiedinanatomicorclinicalpathology,orboth,bytheAmericanBoardof
PathologyorAmericanOsteopathicBoardofPathology,orpossessqualifications
equivalenttothoserequiredforcertification
OR
a.BeanMD,DOorDPMlicensedtopractice(ifrequired)inthejurisdictionwherethe
laboratoryislocated,andb.Haveatleastoneyearoflaboratorytrainingduringresidency,oratleasttwoyearsofexperiencesupervisinghighcomplexitytesting
OR
a.Holdanearneddoctoraldegreeinachemical,physical,biological,orclinicallaboratory
sciencefromanaccreditedinstitution,and
b.BecertifiedandcontinuetobecertifiedbyaboardapprovedbyHHS**(or,fornon-US
laboratories,byanequivalentboard)
OR,fornon-USlaboratories(notsubjecttoUSregulations)only
a.LaboratoryDirectorshallbeanMD,DO,PhDorshallhavecommensurateeducation
andexperiencenecessarytomeetpersonnelrequirementsasdeterminedbytheCAP
……….**REVISED**07/31/2012
GEN.53400SectionDirector/TechnicalSupervisorQualifications/RequirementsPhaseII
SectionDirectors/TechnicalSupervisorsmeetdefinedqualificationsandfulfilltheexpectedresponsibilities.
NOTE:Thesectiondirector/technicalsupervisorineachhighcomplexitylaboratorysectioncanbealicensedMDorDOwithcertificationinanatomicand/orclinicalpathology,orqualificationsequivalenttothoserequiredforboardcertification.Thesectiondirector/technicalsupervisorresponsibleforanatomicpathologymustbeanMDorDOcertifiedinanatomicpathologyorpossessqualificationsequivalenttothoserequiredforcertification.Thesectiondirector/technical