摘要
目的基于ISO 15189建立的全面质量管理体系,探讨WS/T 403-2024《临床化学检验常用项目分析质量标准》在日常检验工作中的正确使用。方法依据国家卫生行业标准,结合医学实验室认可相关文件、国家卫生健康委临床检验中心推荐标准、京津冀鲁区域医疗机构临床检验结果互认实验室精密度及重现性要求等文件,并参考目前实验室可实现的分析质量水平以及工作实践经验,梳理并转化为实验室生免项目分析质量标准,总结其实际应用方法及案例分析。结果根据生物学变异结合本实验室实际质量水平,对临床生免领域中103个项目的分析质量要求(TEa、CV、Bias)进行了设定、梳理、分析、评估,最终转化为《检验科生化免疫定量项目分析质量要求一览表》,分别满足不同检验活动的要求。结论根据生物学变异设定的分析质量要求分3个等级(优、中、低),可共同用于方法性能评价;实验室分析质量要求可用于室内质量控制、性能验证、结果比对、不确定度评定等活动的管理;指导日常工作涉及的不同检验活动,提高实验室检验质量和能力。
Objective Basing on total quality management system of ISO 15189,this study aimed to explore the properly use of WS/T 403-2024“Analytical performance standard for routine analytes in clinical chemistry”in daily inspection work.Methods According to national health industry standards,Referring medical laboratory accreditation relevant documents,National Center for Clinical Laboratories recommended standards,Beijing-Tianjin-Hebei-Shandong integration“General laboratory precision requirements for clinical biochemical test results”and other related documents,we decided the level of analytical quality that could be achieved in the laboratory and associated working experience,then transferred it into the analysis quality standard of laboratory biochemical immunization project,in order to summarize the practical application method and case analysis.Results According to the biological variation combined with the actual quality level of the laboratory,the analysis quality requirements(total error allowable,imprecision allowable,bias allowable)of 103 items in the field of clinical biochemical and immunization were set up,sorted out,analyzed and evaluated,then further transferred into“The list of analysis quality requirements for the biochemical immunological quantitative items in the laboratory”,to meet the requirements of different inspection activities.Conclusion There are three levels established(excellent,medium,low)for analytical quality requirements based on biological variation.This system can be used in the evaluation of method performance.Laboratory analytical quality requirements can be used in the management of indoor quality control,performance verification,result comparison,uncertainty assessment and other related activities,to guide the different inspection activities involved in daily work,and to improve the quality and capability of laboratory inspection.
作者
郭胜利
郭丽丽
李守霞
孙彩霞
王志宏
田佩玉
刘付杰
杨建峰
薛会敏
张鹏
马思思
杨骁
王丽琼
GUO Shengli;GUO Lili;LI Shouxia;SUN Caixia;WANG Zhihong;TIAN Peiyu;LIU Fujie;YANG Jianfeng;XUE Guimin;ZHANG Peng;MA Sisi;YANG Xiao;WANG Liqiong(Handan Han Gang Steel Hospital Laboratory,Handan 056001,China;Handan City Center Hospital Laboratory,Handan 056001,China;Handan Maternal and Child Health Care Hospital,Handan 056000,China;Handan Children’s Hospital,Handan 056000,China;Handan the Third Hospital,Handan 056001,China;Hebei Yiling Hospital,Shijiazhuang 050000,China)
出处
《标记免疫分析与临床》
2025年第5期1048-1056,共9页
Labeled Immunoassays and Clinical Medicine
基金
河北省医学科学研究课题计划资助(编号:20251361)。
