CAP实验室认可挑战应对.pptVIP

CAP实验室认可的挑战与应对 ;浙二医院检验科;;为什么不想做？;认可初期要做工作多，可以合理分配、提高员工认识度，合理分担。;浙二启动认可的缘由： 对外交流越来越广，越来越频繁 特殊的地位：建设一流大学附属医院的需要 医院历史：百年老院，辉煌过去，重塑历史的要求 三甲医院复审、JCI评鉴、卫生部重点专科 临床药物研究基地 实验室内部发展要求;为什么选择CAP? 与美国的合作交流最多 JCI 认可CAP实验室的能力 FDA认可CAP实验室提供的临床药物实验数据 医院卓越战略之一 CAP是第三方认可机构;2012.3月底正式院务会启动 2012.9月提交CAP 认可申请 2013.7.10-12 CAP 现场评审（3位美国专家，1位台湾同胞，2位国内专家 2013.9.10 获得CAP 认可;二、所有实验室项目性能符合要求 （Method Performance Specifications ）;一、组织架构要清晰、岗位职责要明确、人员资??要阳光 Organization Chart ＆Job Responsibility ＆ personnel requriement by testing Complexity ;岗位职责如何落实到每一个人？;;;DIRECTORS（MD or DO） Clinical Consultant/Technical Consultant(Waived and high complexity not applicable ) Section Directors/Technical Supervisors （ MD or DO） Supervisors/General Supervisors Testing Personnel;**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 experie