ISO 15189全面质量管理体系下临床生化领域比对方案应用  

The Application of Clinical Biochemical Field Comparison Scheme Under ISO 15189 Total Quality Management System

作　　者：郭丽丽[1] 郭胜利 李守霞[1] 张彦青[1] 孙彩霞[1] 秦志梅[1] 李佳[1] 梁淳[1] GUO Lili;GUO Shengli;LI Shouxia;ZHANG Yanqing;SUN Caixia;QIN Zhimei;LI Jia;LIANG Chun(Handan City Center Hospital Laboratory,Handan 056001,China;Handan Steel Hospital Laboratory,Handan 056001,China)

机构地区：[1]邯郸市中心医院检验科,河北邯郸056001 [2]邯郸邯钢医院检验科,河北邯郸056001

出　　处：《标记免疫分析与临床》2024年第3期558-563,共6页Labeled Immunoassays and Clinical Medicine

基　　金：邯郸市“百人计划”创新项目(编号:邯卫党字[2019]34号)。

摘　　要：目的基于ISO 15189建立的全面质量管理体系,探讨临床生化实验室涉及的多种比对方案,为日常检验工作正确使用比对方案提供参考。方法参照医学实验室认可相关文件、国家相关卫生行业标准、CLSI系列相关文件、结合工作实践经验,对临床生化领域比对活动中多种质量评估方案的应用进行分析,梳理总结其中涉及的比对方案。结果本研究针对临床生化领域中涉及的11种比对实验进行了列举总结,比对结果分别满足不同情况的要求。结论通过对不同比对方案的梳理及案例分析,能够指导日常检验工作比对方案的正确选择,提高实验室检验质量和能力。Objective Basing on total quality management system of ISO 15189,to explore various comparison schemes involved in clinical biochemistry laboratory and to further provide references for the optimal use of comparison scheme in daily inspection work.Methods Referring medical laboratory accreditation documents,‘National Relevant Health Industry Standards’,CLSI series related documents and by combining with our own working experience,we analyzed the application of various quality assessment programs in clinical biochemical field comparison activities,and sorted out and summarized the comparison schemes involved.Results In this study,11 comparison experiments involved in the field of clinical biochemistry were listed and summarized.The comparison results met the requirements of different situations.Conclusion Through the sorting of different comparison schemes and case analysis,the results can direct the daily inspection work to compare the correct choice of scheme,and improve the quality and capability of laboratory tests.

关 键 词：ISO 15189 医学实验室认可 质量管理体系 比对方案 

分 类 号：R-331[医药卫生]