CAP实验室认可计划-检查流程总览(中英文对照)概要.ppt

College of American Pathologists Laboratory Accreditation Program Overview Inspection Process 美国病理学家学院 实验室认可计划 检查流程 总览 College of American Pathologists(CAP) Overview of the Laboratory Accreditation Program (LAP) The Inspection Process Questions Answers 美国病理学家学院(CAP) 实验室认可计划 (LAP) 总览 检查流程 问题与回答 LAP Philosophy Promote a Culture of Quality Quality control Performance improvement Proficiency testing Regulatory role Assess compliance with CAP requirements, including CLIA-88 regulations LAP 哲学 提升质量文化 质量控制 性能的提高 能力验证 法规的作用 评价与CAP 的要求, 包括 CLIA-88 的规定的一致性 Why Accreditation? Participation in a Voluntary Laboratory Accreditation Program Improves the Quality of Services for Patients. 为什么要认可? 参与一个自愿的实验室认可计划可 提高对病人服务的质量. Laboratory Accreditation in the US State Licensure Minimum requirements set by a regulatory body. May require accreditation in addition. Certification Assurance that a quality system is in place and is consistent with certain standards (e.g.. ISO 9000). Accreditation Demonstration that an organization has met standards of quality as defined by the profession. 美国的实验室认可情况 国家给予许可 法规设置机构的最低要求 可能需要另外的认可 证明 确保所使用的质量系统适合并和某些国际标准一致 (e.g. ISO 9000) 认可 声明某一机构已经达到了由专业机构制定的质量标准 Laboratory Accreditation in the US Government Regulations (CLIA ’88) Centers for Medicare and Medicaid Services (CMS) Ultimate regulatory authority, enforces the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) In 1995, approved CAP as an accrediting organization under CLIA–88 In 2001, extended approval through 9/07 美国的实验室认可情况 政府法规 (CLIA ’88) 医疗保险和医疗救助服务中心(CMS) 最终法规权威机构, 加强1998年（CLIA-88）的临床实验室改进修正法案的实施 1995年, 批准CAP 作为在 CLIA–88 下的认可组织 2001年, 通过 9/07延长批准 Laboratory Accreditation Organizations in the US College of American Pathologists (CAP) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) COLA American Association of Blood Banks (AABB) American Osteopathic Association (AOA) American Society of Histocompatibility and Immunogenetics