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1、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,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(Joint Commission on Accreditation of Healthcare Organizations,JCAHO)，CAP（College of American Patho
2、logist）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（Laboratory Accreditation Program,LAP)2013.7
3、.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,11,二、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,ISO I5189 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
4、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,CLIA 88美国临床实验室改进修正法规88 Clinical Laboratory Improvement Amendments(CLIA)of 1988 are United States federal regulatory standards that apply to all clinical labora
5、tory testing performed on humans in the United States,except clinical trials and basic research.2003 CDC and CMS modifiedCLSI美国临床和实验室标准协会Clinical and Laboratory Standards Institute is a volunteer driven,membership supported,nonprofit,standards organization.CLSI promotes the development and use of vo
6、luntary laboratory consensus standards and guidelines within the health care community.,CAP3000 Checklist,16,评审依据的内容,17,ISO 15189 4.1 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）,CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITY,DIRECTORS（MD or DO）SECTION DIRECTORS/TECHNICAL SUPERVISORS（MD or D
7、O）SUPERVISORS/GENERAL SUPERVISORSALL PERSONNEL,19,CAP 组织和管理,*REVISED*07/31/2012TLC.10100 Laboratory Director Qualifications Phase IIThe laboratory director satisfies the personnel requirements of the College of American Pathologists.The director must:a.Be an MD or DO licensed to practice(if required
8、)in the jurisdiction where the laboratory is located,andb.Be certified in anatomic or clinical pathology,or both,by the American Board ofPathology or American Osteopathic Board of Pathology,or possess qualificationsequivalent to those required for certificationORa.Be an MD,DO or DPM licensed to prac
9、tice(if required)in the jurisdiction where thelaboratory is located,and b.Have at least one year of laboratory training during residency,or at least two years of experience supervising high complexity testingOR a.Hold an earned doctoral degree in a chemical,physical,biological,or clinical laboratory
10、science from an accredited institution,andb.Be certified and continue to be certified by a board approved by HHS*(or,for non-USlaboratories,by an equivalent board)OR,for non-US laboratories(not subject to US regulations)onlya.Laboratory Director shall be an MD,DO,PhD or shall have commensurate educa
11、tionand experience necessary to meet personnel requirements as determined by the CAP.,*REVISED*07/31/2012GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase IISection Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities.N
12、OTE:The section director/technical supervisor in each high complexity laboratory section can be a licensed MD or DO with certification in anatomic and/or clinical pathology,or qualifications equivalent to those required for board certification.The section director/technical supervisor responsible fo
13、r anatomic pathology must be an MD or DO certified in anatomic pathology or possess qualifications equivalent to those required for certification.The section director/technical supervisor responsible for clinical pathology must be an MD or DO certified in clinical pathology or possess qualifications
14、 equivalent to those required for certification;or may be an individual who meets thealternate qualifications for the specialties supervised.For laboratories subject to US regulations,alternate qualifications for the following specialty areas can be found in Fed Register.1992(Feb 28):7177-7180 42CFR
15、493.1449:bacteriology,mycobacteriology,mycology,parasitology,virology,diagnostic immunology,chemistry,hematology,cytology,ophthalmic pathology,dermatopathology,oral pathology,radiobioassay,immunohematology.Additional requirements for the section directors of the clinical cytogenetics,histocompatibil
16、ity and transfusion medicine services are found in the Cytogenetics,Histocompatibility and Transfusion Medicine Checklists,respectively.,HEM.40000 Personnel-Bench Testing Phase IIThe person in charge of bench testing in hematology has education equivalent to an associates degree(or beyond)in a chemi
17、cal,physical or biological science or medical technology and at least 4 years experience(one of which is in clinical hematology)under a qualified director.Evidence of Compliance:Records of qualifications including degree or transcript,certification/registration,current license(if required)and work h
18、istory in related field,CHM.25800 Personnel-Bench Testing Phase IIThe person in charge of bench testing in chemistry has education equivalent to an associates degree(or beyond)in chemical,physical or biological science or medical technology and at least 4 years experience(one of which must be in cli
19、nical chemistry)under a qualified director.Evidence of Compliance:Records of qualifications including degree or transcript,certification/registration,current license(if required)and work history in related fieldin toxicology、blood gas testing(or certified or registered respiratory therapist）,GEN.547
20、50 Testing Personnel Qualifications Phase IIAll testing personnel meet the following requirements.1.Personnel performing high complexity testing must have at a minimum an earned associate degree in a laboratory science or medical laboratory technology from an accredited institution,or equivalent lab
21、oratory training2.Personnel performing moderate complexity testing must have at a minimum an earned high school diploma or equivalent and documented trainingEvidence of Compliance:Records of qualifications including degree or transcript,certification/registration,current license(if required)and work
22、 history in related field,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
23、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,ISO 15189 人员能力评价,GEN.55500 Competency Assessment Phase IIThe competency of each person to perform his/her assigned duties is assessed.NOTE:during the first year of an individ
24、uals duties,competency must be assessed at least semiannually.After an individual has performed his/her duties for one year,competency must be assessed annually.Retraining and reassessment of employee competency must occur when problems are identified with employee performance.Elements of competency
25、 assessment include but are not limited to:1.Direct observations of routine patient test performance,including,as applicable,patientidentification and preparation;and specimen collection,handling,processing and testing2.Monitoring the recording and reporting of test results,including,as applicable,r
26、eportingcritical results3.Review of intermediate test results or worksheets,quality control records,proficiencytesting results,and preventive maintenance records4.Direct observation of performance of instrument maintenance and function checks5.Assessment of test performance through testing previousl
27、y analyzed specimens,internalblind testing samples or external proficiency testing samples;and6.Evaluation of problem-solving skills。,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,ISO 15189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,28,CHM
28、.10300 PT Evaluation Phase IIThere is ongoing evaluation of PT and alternative assessment results,with prompt corrective action taken for unacceptable results.Primary records are retained for two years These include all instrument tapes,work cards,computer pri ntouts,evaluation reports,evidence of r
29、eview,and documentation of follow-up/corrective action.Evidence of Compliance:Records of ongoing,timely review of all PT reports and alternative assessment results by the laboratory director or designee ANDRecords of investigation of unacceptable PT and alternative assessment results including recor
30、ds of corrective action that is appropriate to the nature and magnitude of the problem,Type of Analytes/Procedures,CMS Regulated:BOLD TYPECenters for Medicare&Medicaid Services(医疗保险和医疗补助服务中心)CMS Non-regualated:,30,What happens when a lab has a PT failure for:a regulated analyte?,Suspension of testin
31、g,Cessation of testingRevocation of a labs accreditation by CMSNon-regulated analytes?Each accrediting agency has different PT oversight standards.,Unsatisfictory unsuccessful,PT Failure Scenarios,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,Submit application requestComplete
32、 applicationReview customized checklists and prepare for inspectionInspection team assignedInspection concludedCorrect deficiencies and document improvementsAll requirements met;accredited for two yearsConduct self-inspection at one yearPerformance monitored continually,including PTContinue quality
33、improvement process,34,ISO 15189,CAP,35,附表1-1：申请认可的授权签字人一览表附表1-2：授权签字人申请表附表2：申请检验能力范围附表3：检测能力变更申请表/确认表附件1：医学实验室质量和能力认可自查/核查表附件2：仪器设备配置表/检验能力确认表附件3：能力验证计划/实验室间比对汇总表/确认表附件4：实验室人员一览表,二、申请书附表附件,一、医学实验室质量和能力认可申请书,申请提交的文件资料（ISO 15189),36,法律地位证明：包括法人证书、组织机构代码证、执业许可证及执业范围复印件；管理体系文件：包括实验室现行有效受控的质量手册和程序文件；概况图
34、：实验室平面图、组织机构图；检验服务文件、表单：全部检验项目清单；全部检测设备清单；全部作业指导书（SOP）清单；客户清单（适用于独立医学实验室）；委托实验室及委托项目清单；检验申请单；检验报告；样本采集手册；申请认可项目生物参考区间、危机值和报告时间一览表；申请认可项目量值溯源性一览表；检测系统/方法：室内质量控制SOP、分析性能验证报告(包括实验室内比对报告)；评审报告及相应记录：生物参考区间评审报告、危机值评审报告、合同评审报告、内部审核报告、管理评审报告等报告及相应记录；评估报告：不确定度评估报告、实验室风险评估报告、人员培训与能力评估报告；实验室简介；其他资料：无 有（如有请填写）：,37,申请提交的文件资料（CAP）（on-line),38,39,40,总 结,41,43,关键因素：人 科主任以及管理团队，合格的员工,谢谢!,44,
