iso1189认可和cap认证的流程和体会.pptVIP

* CHM.10300 PT Evaluation Phase II There 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 review, 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 AND ? Records of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to the nature and magnitude of the problem Type of Analytes/Procedures CMS Regulated: BOLD TYPE Centers for Medicare Medicaid Services (医疗保险和医疗补助服务中心) CMS Non-regualated: * What happens when a lab has a PT failure for :  a regulated analyte? Suspension of testing, Cessation of testing Revocation of a lab’s accreditation by CMS Non-regulated analytes? Each accrediting agency has different PT oversight standards. Unsatisfictory unsuccessful PT Failure Scenarios A B C Performance interpretation requirement 1 √ √ Χ At risk Needs to pass the next two events 2 Χ √ √ successful Lab is no longer at risk 3 Χ √ Χ unsuccessful 4 √ Χ √ Still at risk Has not yet passed two PT events in a row 5 √ Χ Χ Unsuccessful , at risk Nex two events and accre in jeopardy * D-A0206-F-501 纠正预防措施报告记录表 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 * 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 * 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 * 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 Pathologist） 内部： 自身发展的需要、自重、自尊。 * 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） * 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 * 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