[1]闫玉珠,王冀邯,赵和平.六西格玛质量管理规则在罗氏电化学发光免疫分析仪检测项目质量控制中的应用[J].现代检验医学杂志,2020,35(02):149-152.[doi:10.3969/j.issn.1671-7414.2020.02.041]
 YAN Yu-zhu,WANG Ji-han,ZHAO He-ping.Six Sigma Quality Management for Choosing Appropriate Quality ControlRules in Roche Electrochemical Luminescence Immunoanalyzer[J].Journal of Modern Laboratory Medicine,2020,35(02):149-152.[doi:10.3969/j.issn.1671-7414.2020.02.041]
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六西格玛质量管理规则在罗氏电化学发光免疫分析仪检测项目质量控制中的应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年02期
页码:
149-152
栏目:
质量控制
出版日期:
2020-05-24

文章信息/Info

Title:
Six Sigma Quality Management for Choosing Appropriate Quality ControlRules in Roche Electrochemical Luminescence Immunoanalyzer
文章编号:
1671-7414(2020)02-153-04
作者:
闫玉珠王冀邯赵和平
(西安交通大学附属红会医院检验科,西安 710054)
Author(s):
YAN Yu-zhu WANG Ji-han ZHAO He-ping
(Department of Clinical Laboratory, Honghui Hospital Affiliated to Xi’an Jiaotong University, Xi’an 710054, China)
关键词:
六西格玛允许总误差质量目标指数质量控制规则
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.02.041
文献标志码:
A
摘要:
目的 应用六西格玛(6σ)质量管理规则评价罗氏电化学发光免疫分析仪各项目检测性能水平,从而指导质量改进。方法 以我国国家标准和生物学变异导出的“最佳”允许总误差(TEa)为质量规范,以2019 年在罗氏Cobase 601 上测定的14 个检测项目的累计在控室内质控数据计算不精密度(CV),以2019 年两次卫生部室间质评偏倚数据均值作为偏倚(Bias)来源,计算σ 值,应用标准化西格玛性能验证图选择合适的质量控制规则,并计算各项目的质量目标指数(QGI),分析导致其性能不佳的原因,提出优先改进方法。结果 按国家标准,有8 个(57%)项目的σ值> 6;按生物学变异标准,只有2 个(18%)项目的σ 值> 6;加权σ 值后,6 个(43%)项目的σ 值> 6,1 个(7%)项目的σ 值> 5,6 个(43%)项目的σ 值> 4,1 个(7%)项目的σ 值< 3。其中,AFP,CA153,CA199,T4,FT3,T3 和NT-ProBNP 需改进精密度,FT4 需改进精密度和正确度。不同项目采用不同质控规则。结论 临床实验室可综合应用合适的质量规范计算6σ 度量,全面而有效地评价项目的性能指标,优化质量控制规则,保证检测项目质量。

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备注/Memo

备注/Memo:
基金项目:西安市科技计划项目[ 项目编号:2019115013YX005SF038(10)]。作者简介:闫玉珠(1988-),女,硕士,检验医师,从事临床化学研究,Tel:029-62818654,E-mail:312858826@qq.com。通信作者:赵和平(1967-),男,本科,主任技师,从事临床免疫学研究,E-mail:redcrossjyk@163.com。收稿日期:2020-01-03修回日期:2020-01-14
更新日期/Last Update: 2020-04-30