GLP体系下临床检测室的质量保证要素  

Elements of Quality Assurance for Clinical Laboratory under GLP System

作　　者：苗玉发[1] 潘东升[1] 刘芳[1] 汪巨峰[1] 李波[1] 

机构地区：[1]中国食品药品检定研究院,北京100176

出　　处：《中国药事》2012年第6期539-541,共3页Chinese Pharmaceutical Affairs

基　　金：国家"重大新药创制"科技重大专项(编号2008ZX09305-002)

摘　　要：目的介绍GLP体系下临床检测室的质量保证要素。方法通过研究美国病理学家学会(Collegeof American Pathologists,CAP)认可程序、美国临床实验室质量改进法案(CLIA-88)以及卫生行业标准WS/T 250-2005对实验室质量保证的要求,结合本实验室的具体情况,总结GLP体系下有关临床检测室的质量保证要素。结果质量保证涉及到实验室的所有工作,主要涵盖样品采集、标识、运输、接收、检验和报告、人员培训和考核、仪器管理、室内质量控制、室间质量评价、方法验证以及客户沟通和交流等等。结论质量保证各个要素的实施是临床检测室获得质量数据的决定性因素。Objective To summarize the critical elements of the quality assurance in clinical laboratory under GLP regulations. Methods The critical elements of the quality assurance in clinical laboratory under GLP regulations are summarized through reviewing the quality assurance requirements of CAP accreditation program, American CLIA-88 and health professional standards WS/T 250-2005. Results Quality assurance involves in all work in the laboratory, mainly including sample collection, identification, transportation, receipt, detection and report, staff training and assessment, instrumental management, internal quality control, external quality control, methods validation, and communication with customer. Conclusion Implementation of quality assurance elements is a key factor to achieve quality data in clinical laboratory.

关 键 词：质量保证 质量控制 室间质量评价 良好实验室管理规范 

分 类 号：R927.11[医药卫生—药学] R95