六西格玛质量管理在临床生化项目质量评价中的应用

Application of six Sigma quality Management in quality Evaluation of Clinical biochemical Project

目的:应用六西格玛(6σ)质量管理模式评价临床生化项目分析性能,进一步改进检验质量。方法:收集本实验室22个常规生化项目2018年~2020年卫生部室间质评的偏倚(bias)和室内质控累计变异系数(CV),并采用卫生行业标准WS/T403-2012《临床生物化学常规检验项目分析质量指标》[1]规定的总允许误差(TEa),计算本实验室临床生化项目的σ水平。结果:本实验室22个项目的σ值来看,连续3年σ值>3的项目有ALT、AST、CREA、UA、FE占22.73%,配套系统的项目占80%。连续三年σ值<3的项目有AMY、MG占9.09%,均为非配套系统。2018年σ值>3的项目占22.73%,实施改进措施后,在2019年到2020σ值>3的项目分别为54.55%、90.91%,呈逐年上升的趋势。结论:6σ质量管理能科学的评价临床生化项目的性能指标,有助于实验室发现问题、采取相应的措施,进一步指导检验质量的改进。

Objective:To evaluate the analysis performance of clinical biochemical items by using six Sigma(6σ)quality management model,and to further improve the test quality.Methods:The bias(bias)and cumulative coefficient of variation of internal quality control(CV),of 22 routine biochemical items in our laboratory from 2018 to 2020 were collected,and theσlevel of clinical biochemical items in our laboratory was calculated by using the total allowable error(TEa),stipulated in the Health Industry StandardWS/T 403-2012"Analytical quality Indexes of Clinical biochemical items"[1].Results:Theσvalues of 22 projects in our laboratory showed that for 3 consecutive years,ALT,AST,CREA,UA and FE accounted for 22.73%,and supporting systems accounted for 80%.For three consecutive years,projects with a value of less than 3 have AMY and MG accounting for 9.09%,all of which are non-supporting systems.In 2018,the projects withσvalue>3 accounted for 22.73%.After the implementation of improvement measures,the projects withσvalue>3 from 2019 to 2020 were 54.55%and 90.91%respectively,showing an upward trend year by year.Conclusion:The 6σquality management can scientifically evaluate the performance index of clinical biochemical projects,help the laboratory to find problems,take corresponding measures,and further guide the improvement of inspection quality.