六西格玛理论在临床生化检验质量评价中的应用

Application of Six Sigma Theory in Evaluating the Biochemical Test Quality

目的应用六西格玛(6σ)质量管理理论分析评价实验室常规化学检测项目的性能,改善质控规则,促进检验质量的持续改进。方法收集2016年度本实验室22个常规化学检测项目的室内质量控制(IQC)及同期卫生部临床检验中心室间质量评价(EQA)数据,将实验室常规化学检测项目的 IQC累积变异系数(CV%)作为不精密度值;取EQA常规化学检测项目15次数据的平均偏差(绝对值)评估偏倚(Bias%),反映实验方法的正确度;依据卫生行业标准WS/T403-2012的允许总误差(TEa%)作为质量规范,通过公式(TEa—Bias)/CV计算各检测项目的σ值、绘制西格玛性能验证图,评价实验室的22项常规生化检测项目的分析性能、计算检测项目的质量目标指数(QGI),分析导致性能不佳的主要原因。结果参与评价的22个检测项目中,有2个(9.09%)项目σ值≥6、有13个(59.09%)项目σ值为3≤σ<6、σ<3的项目有7项(31.82%),平均σ值为3.69。在20个σ<6的项目中需优先改进正确度的6个(30%)、需优先改进精密度的12个(60%)、正确度和精密度均需改进的2个(10%)。结论六西格玛质量管理理论是实验室质量管理的有效工具,有助于临床实验室检验质量水平的持续改进。

Objective To apply six sigma managing theory in the evaluation of routine chemical tests so as to improve the quality control and to promote the continous improvement of lab test quality. Methods The data of internal quality control（ IQC） of routine chemical test in our laboratory in 2016 and those of external quality assessment of the national clincal laboratory center were collected; the IQC cumulative coefficient of variation（ cv%） of routine chemical tests was taken as imprecision value; the average deviation（ absolute value） of the EQA routine chemical tests out from 15 times was used to assess the bias（ Bias%） so as to reflect the correctness of the test methods; the total allowable errors（ TEa%） according to the standard of health profession（ WS/T403-2012） were adopted as the quality specification,the σ value of each test item was calculated by the formula（ TEa-Bias）/CV and Sigma verification of performance was drawn with a professional software; the performance of 22 routine chemistry in the laboratory was evaluated,the quality goal index（ QGI） of the routine chmical tests was calculated while the main causes of poor performance were analyzed. Results Out of the 22 routine chemical testing items,2 items（ 9. 09%） were of σ ≥ 6,13（ 59. 09%） were of 3≤σ6,7（ 31. 82%） were of σ〈3,the average σ value was 3. 69; out of the 20 items ofσ6,6 items（ 30%） were in need of accuracy improvement,12 items（ 60%） were in need of precision improvement and 2 items（ 10%） were in need of both accuracy improvement and precision improvement.Conclusions Six sigma theory is an effective tool in quality control of lab tests and is helpful in the continous improvement of quality in clinical lab tests.