ISO15189认可及CAP认证的流程及体会.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;;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;ISO I5189 实验室文件体系 ;CAP 实验室文件体系 ;评审依据的内容;4.1.5;CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITY;**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 director 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 those 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 an 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 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 Section 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 an