国际医药卫生导报2018，Vol.24Issue(4)：459-465,7.DOI:10.3760/cma.j.issn.1007-1245.2018.04.001
应用六西格玛理论评价强生vitros5.1干化学生化分析仪系统性能和设计室内质控方案
The application of 6 σ theory in assessment of the internal quality control scheme in the performance and design in Johnson Vitros 5.1 dry biochemical analyzer system
摘要
Abstract
Objective To quantify the items of Johnson Vitros 5.1 dry biochemistry analysis system using 6 σ theory,and design the internal quality control (IQC) of each item,and explore the value of 6 σ theory in clinical quality management.Methods We calculated the σ levels of 8 items of Potassium,Sodium,Chlorine,Glucose,Urea,Creatinine,Cholinesterase,and Lipase in a equation of σ=[the total error (TEa)-bias] / coefficient of variation (CV).TEa was based on the external quality assessment (EQA) of National Center for Clinical Laboratory (NCCL) in 2018,with an average bias of the EQA by NCCL,and with a CV of daily imprecision from February 2016 to February 2017.According to the Westgard σ rnle[1],a personalized IQC scheme was developed.For items whose performance was not up to 6 σ,the quality target index (QGI=Bias/1.5CV) was calculated and the modified scheme was established.Results The σ level of total performance of the 8 items was from 2.21 to 14.01.Among them,Cholinesterase and Lipase were above 6 σ,and Potassium,Sodium,Glucose and Creatinine were more than 3 σ and less than 6 σ,while Chlorine and Urea were less than 3 σ.For items in which the performance did not reach 6 σ,when the QGI of Sodium,Urea,and Creatinine were less than 0.8,it needed to be improved in precision.When the QGI of Potassium,Chlorine,and Glucose were 0.8-1.2,it needed to be improved in both precision and accuracy.When Chlorine and Urea did not reach to 3 σ,this suggested that there were serious quality defects,for which it needed to be improved in quality improvement measures.According to the value of σ,each item of the quality control was designed individually.Conclusions The 6 σ theory can directly evaluate the performance of Johnson Vitros 5.1 dry chemical biochemistry analysis system.To design personalized IQC scheme is to guide a continuous quality improvement.关键词
6西格玛/干化学生化分析仪/性能评价/质量方案/质量改进Key words
Six σ/Dry chemical biochemical analyzer/Performance evaluation/Quality scheme/Quality improvement引用本文复制引用
许振杰,黄文波,汪印强,李启伟,陈富,李松,李有强..应用六西格玛理论评价强生vitros5.1干化学生化分析仪系统性能和设计室内质控方案[J].国际医药卫生导报,2018,24(4):459-465,7.基金项目
国家自然科学基金-青年科学基金项目(81601736)National Natural Science Foundation-Youth Science Fund Project (81601736) （81601736）
