ISO15189认可和CAP认证的流程和体会.ppt
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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
2、of American Pathologist) 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 Accredi
3、tation Program, 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,11,二、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
4、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,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 stan
5、dards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. 2003 CDC and CMS modified CLSI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 organizati
6、on. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.,CAP 3000 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
7、) SECTION DIRECTORS/TECHNICAL SUPERVISORS ( MD or DO) SUPERVISORS/GENERAL SUPERVISORS ALL PERSONNEL,19,CAP 组织和管理,*REVISED* 07/31/2012 TLC.10100 Laboratory Director Qualifications Phase II The laboratory director satisfies the personnel requirements of the College of American Pathologists. The direct
8、or must: a. Be an MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to th
9、ose required for certification OR a. Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Have at least one year of laboratory training during residency, or at least two years of experience supervising high complexity testing OR a. Hold a
10、n earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and b. Be certified and continue to be certified by a board approved by HHS* (or, for non-US laboratories, by an equivalent board) OR, for non-US laboratories (not subject to
11、US regulations) only a. Laboratory Director shall be an MD, DO, PhD or shall have commensurate education and experience necessary to meet personnel requirements as determined by the CAP .,*REVISED* 07/31/2012 GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase II Sectio
12、n Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities. NOTE: 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 e
13、quivalent to those required for board certification. The section director/technical supervisor responsible for 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 re
14、sponsible for clinical pathology must be an MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification; or may be an individual who meets the alternate qualifications for the specialties supervised. For laboratories subject to US regulations, al
15、ternate qualifications for the following specialty areas can be found in Fed Register. 1992(Feb 28): 7177-7180 42CFR493.1449: bacteriology, mycobacteriology, mycology, parasitology, virology, diagnostic immunology, chemistry, hematology, cytology, ophthalmic pathology, dermatopathology, oral patholo
16、gy, radiobioassay, immunohematology. Additional requirements for the section directors of the clinical cytogenetics, histocompatibility and transfusion medicine services are found in the Cytogenetics, Histocompatibility and Transfusion Medicine Checklists, respectively.,HEM.40000 Personnel - Bench T
17、esting Phase II The person in charge of bench testing in hematology has education equivalent to an associates degree (or beyond) in a chemical, physical or biological science or medical technology and at least 4 years experience (one of which is in clinical hematology) under a qualified director. Ev
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- ISO15189 认可 CAP 认证 流程 体会
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