实验室认可和质量体系认证.pptVIP

实验室认可和质量体系认证 杨振华 2000年11月24曰 现场检查 质量控制(QC),室间质评(EQA) 质量保证(QA) (美国实验室认可，CLIA 88) 质量改进(QI,CQI) 质量体系(QS) (ISO 9OO2，17025，15189) 质量管理(QM，TQM) Quality Standards for Medical Laboratories Dr. Pharm. Jean-Claude Libeer IPH - Brussels 医院质量体系认证 1995: 1999 Certification/accreditation in Health Care Institutions 欧共体倾向使用ISO文件 一些国家使用自巳的标准,如美国 认可(证)的花费 实验室为认可进行内部质量工作的花费 请外部耒认可的花费 COSTS FOR ACCREDITATION Hospital facilities Hotel accommodation Nursing Department Laundry Kitchen ?.. 医学专业部门 Intensive Care Unit Medium Care Unit Surgery ?. Hospital inter-relations 临床实验室认可标准 1995: 1999: Accreditation procedure for reference laboratories ISO 17025(25)是校正或参考实验室认可的标准 临床或常规实验室的认可标准 ISO 17025 as normative accreditation standard + ISO 15189 as sector specific document and additional requirements ISO 15189 as normative accreditation standard 二个文件合并认可的优缺点 优点 Uniform approach for all types of laboratories Same quality commitment is emphasized Same accreditation standard One single assessment 缺点 two documents, no easy reference 按ISO 15189认可 优点 easy reference for medical laboratories all over the world 缺点 vertical standard No link with other test laboratories Rather a peer review ISO 15189 与其它 ISO 文件的关系 ISO/CD 15189附加项目 medical competence professional judgement selection of tests, patient preparation, specimen collection TAT, POCT reference ranges procedure for immediate notification ethical aspects safety of employees Chain model I 二种认可类型 自愿型( ISO ) 强制型( CLIA 88 ) II ISO 规则的种类和历史 III CLIA 88，临床实验室管理 办法 CLIA 67 Clinical Laboratory Improvement Act 67 CLIA 88 Clinical Laboratory Improvement Amendment 88 临床实验室管理办法(暂行) 一。总则 二。执业登记和执业证书 三。检验质量管理 四