六西格玛理论用于两台生化检测系统的比较

Abstract
Figure/Table
References
Related Citation (6)

Download: PDF (520 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract Objective To explore the application of Six Sigma (6σ) 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 (σ) 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 σ 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 σ 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 σ 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 σ 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.

Key words： Six Sigma Allowable total error Coefficient of variation Bias Quality index

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	SONG Yuyin1 XU Hua1 CHEN Jia2

Cite this article:

SONG Yuyin1 XU Hua1 CHEN Jia2. Comparison of Six Sigma theory applied to two biochemical detection systems[J]. 中国当代医药, 2024, 31(1): 111-115.

URL:

https://www.dangdaiyiyao.com/EN/ OR https://www.dangdaiyiyao.com/EN/Y2024/V31/I1/111

[1]	中国合格评定国家认可委员会.CNAS-GL047医学实验室定量检验程序结果可比性验证指南[S]：北京CNAS，2021.
[2]	卫生部临床检验标准专业委员会.WS/T407-2012医疗机构内定量检验结果的可比性验证指南[S].北京：中国标准出版社，2012.
[3]	卫生部临床检验标准专业委员会.WS/T403-2012临床生物化学检验常规项目分析质量指标[S].北京：中国标准出版社，2012.
[4]	Clinical and Laboratory Standards Institute.EP9-A2 method comparison and bias estimation using patient samples；approved guideline-second edition[S].Wayne PA：CLSI，2010.
[5]	Taher J，Cosme J，Renley BA，et al.A novel Sigma metric encompasses global multisite performance of 18 assays on the Abbott Alinity system[J].Clin Biochem，2019，63：106-112.
[6]	李佳，高佳，崔婵娟，等.应用σ理论进行不同生化检测系统间比对的探讨[J].中华检验医学杂志，2022，45（5）：536-542.
[7]	马红叶，洪燕英，郭宏林，等.六西格玛质量管理在临床肿瘤标志物检验质量控制中的应用[J].标记免疫分析与临床，2021，28（12）：2162-2165.
[8]	刘玲丽，彭镜蓉.应用6σ质量管理方法评价c16000全自动生化分析系统检测质量水平[J].检验医学，2020，35（2）：164-167.
[9]	何芳，许汝槿，陈跃琴.六西格玛质量管理方法在临床免疫检测项目质量管理中的应用[J].中医药管理杂志，2021，29（13）：160-162.
[10]	贾建美，刘春霞.室间质评数据计算偏倚和σ值的三种方法比较分析[J].实验与检验医学，2021，39（1）：60-64.
[11]	吴雪，张再勤，何瑞堂，等.六西格玛质量管理在临床生化项目质量评价中的应用[J].医学检验与临床，2022，33（5）：30-33.
[12]	苏镜，刘振杰，来金欣，等.基于生物学变异的质量规范和六西格玛管理方法在临床生化质量控制中的应用研究[J].国际检验医学杂志，2020，41（5）：559-564.
[13]	杨伏猛，孙瑾，姚丽，等.六西格玛在选择临床化学项目质量目标上的应用研究[J].国际医药卫生导报，2020，26（5）：624-628.
[14]	刘佳丽，孙慧珍，郭拥军，等.特殊蛋白检测项目基于患者风险的室内质量控制程序的设计[J]中华检验医学杂志，2022，45（9）：963-967.
[15]	范笑笑，曾璇，扶春艳，等.六西格玛质量管理在临床生化检验中的应用[J].国际检验医学杂志，2020，41（19）：2402-2405，2432.
[16]	程秀丽，张玲，阚鹏程，等.六西格玛方法在临床常规化学检验质量管理中的应用[J].检验医学与临床，2018，（18）：2736-2739.
[17]	孙慧珍，王薇，赵海建，等.临床检验定量测定项目室内统计质量控制程序的研究进展[J].中华检验医学杂志，2019，42（10）：879-883.
[18]	黄云秀，李曼，欧阳能良，等.六西格玛理论应用于甲状腺功能检验项目质量水平的评价及指导室内质控[J].检验医学与临床，2021，18（15）：2226-2229.
[19]	王志勇，张超，李友建，等.利用六西格玛质量管理选择血常规项目室内质量控制个体化规则[J].检验医学与临床，2020，17（17）：2556-2558.
[20]	陈丽婉，罗东，余曼，等.六西格玛质量管理方法在临床血液学常规项目检测性能评价和质量控制中的应用[J].实验与检验医学，2021，39（1）：76-78.