应用六西格玛进行临床生化检验质量控制  

Application of six sigma for the quality control of clinical biochemistry

作　　者：史清梅[1] 代超[1] 岳晋巍[1] 张成磊[1] 王利新[1] SHI Qing - mei DAI Chao YUE Jin - wei ZHANG Cheng - lei WANG Li - xin(Department of Medical Laboratory, Cardiovascular Diseases Hospital, General Hospital of Ningxia Medical University, Yinchttan, Ningxia 750002, Chin)

机构地区：[1]宁夏医科大学总医院心脑血管病医院医学检验科,宁夏银川750002

出　　处：《中国卫生检验杂志》2016年第23期3420-3422,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的分析实验室检测项目的六西格玛(6σ)水平,探讨应用6σ评价方法评价和管理室内质控并改进生化检验质量。方法收集2013年-2015年本室9次常规化学室间质评数据,及各项目室内质控数据的累积变异系数(CV);以卫生行业标准WS/T 403—2012《临床生物化学常规检验项目分析质量指标》规定的允许总误差(TEa),计算本室已开展的室间质评项目的σ水平。结果共23个检测项目,2013年有10个项目的σ水平>6σ,14个项目的σ水平>3σ,<2σ的项目有3个。2014年室内质评结果 5个项目σ水平>6σ,17个项目的σ水平>3σ,其中σ水平<2σ的项目2个。2015年室内质评结果 9个项目σ水平>6σ,20个项目的σ水平>3σ,其中σ水平<2σ的项目1个。结论应用6σ标准分析室内质控、室间质评数据,能更全面有效地评价临床生化检验项目的性能指标,有助于实验室发现问题,采取措施,持续改进检验质量。Objective To value and manage internal quality control and improve the quality of biochemical tests by analyzing the six sigma（ 6σ） level. Methods We collected conventional chemical external quality assessment（ EQA） data in 9 times and the cumulative coefficient of variation（ CV） of internal quality control data during 2013-2015. The allowable total error（ TEa）was established by the health industry standard WS/T 403—2012 Analysis Quality Indicators of Clinical Biochemistry Routine Test Items. Results 23 test items were analyzed. In 2013,the σ level of 10 projects was greater than 6,that of 14 projects were 〉 3,in which 3 projects were less than 2. The indoor quality assessment results in 2014 showed 5（ σ 〉 6）,17（ σ 〉 3）and 2（ σ 〈 2）,among which 2 items were σ 〈 2. In 2015,the results were 9（ σ 〉 6）,20（ σ 〉 3） and 1（ σ 〈 2）. Conclusion Application of 6σ standard could help to evaluate the performance of clinical biochemistry project fully and effectively,finding problems and taking measures to improve the quality test continually.

关 键 词：常规化学 室间质量评价 结果分析 允许总误差 6σ标准 

分 类 号：R446.112[医药卫生—诊断学]