六西格玛理论用于两台生化检测系统的比较  

Comparison of Six Sigma theory applied to two biochemical detection systems

作　　者：宋玉印 徐华 陈佳 SONG Yuyin;XU Hua;CHEN Jia(Department of Laboratory,Panjin Liaoyou Gem Flower Hospital,Liaoning Province,Panjin 124010,China;De-partment of General Medicine,Panjin Liaoyou Gem Flower Hospital,Liaoning Province,Panjin 124010,China)

机构地区：[1]辽宁省盘锦辽油宝石花医院检验科,辽宁盘锦124010 [2]辽宁省盘锦辽油宝石花医院全科医学科,辽宁盘锦124010

出　　处：《中国当代医药》2024年第1期111-115,共5页China Modern Medicine

摘　　要：目的探讨六西格玛(6σ)理论用于两台生化检测系统的比较。方法收集2022年7月1日至12月31日盘锦辽油宝石花医院检验科生化分析仪上32个项目的室内质控检测结果,通过两台仪器的室内质控数据计算每个项目的西格玛(σ)值和偏倚(bias),用传统比对方法计算每个项目的bias,采用SPSS 26.0统计软件对室内质控数据计算的σ值和bias与传统方法的bias进行Pearson相关性分析。结果32个项目中有15个项目σ值≥6,无需进行改进,17个项目通过计算质量目标指数(QGI)的结果进行改进,其中15个项目需要改进精密度,2个项目需要改进精密度和正确度,将需要改进的17个项目的计算变异系数(CV)与实验室允许CV比较,结果显示均小于允许CV,2台仪器比对通过,对于传统方法,两台机器的bias也在标准范围之内,2个质控水平的σ值与传统方法的bias之间均没有显著相关性(P=0.754、0.779),而2个质控水平的bias与传统方法的bias之间呈正相关(P=0.041、0.029)。结论应用质控数据计算σ值及QGI进行不同检测系统间的比对是一种比较方便、可操作性强的方法,可以随时监测实验室内不同检测系统间的可比性,并对传统的比对方法进行补充。Objective To explore the application of Six Sigma(6 o)theory for comparison of two biochemical detection systems.Methods The indoor quality control test results of 32 items on the biochemical analyzer in the Department of Laboratory,Panjin Liaoyou Gem Flower Hospital from July 1 to December 31,2022 were collected.The Sigma(o)value and bias of each item were calculated from the internal quality control data of two instruments,and the bias of each item was calculated by the traditional comparison method.The Pearson correlation analysis between the o value and bias calculated from the internal quality control data and the bias of the traditional method was carried out by using SPSS 26.0 statistical software.Results Among the 32 items,15 items had a value≥6 and did not need to be improved.17 items were improved by calculating the results of quality goal index(QGI),among which,15 items needed to improve the precision,and 2 items needed to improve the precision and accuracy.The calculated coefficient of variation(CV)of 17 items needed to be improved was compared with the allowable CV in the laboratory.The results showed that both were less than the allowable CV.According to the comparison of the two instruments,for the traditional method,the bias of the two instruments was also within the standard range.There was no significant correlation between the values of the two quality control levels and the bias of the traditional method(P=0.754,0.779),but there was a positive correlation between the bias of the two quality control levels and the bias of the traditional method(P=0.041,0.029).Conclusion Application of quality control data to calculate value and QGI for comparison between different detection systems is a relatively convenient and operable method,which can monitor the comparability between different detection systems in the laboratory at any time,and complement the traditional comparison method.

关 键 词：六西格玛 允许总误差 变异系数 偏倚 质量指标 

分 类 号：R446.1[医药卫生—诊断学]