应用六西格玛质量管理方法评价实验室质量水平

Evaluation of quality level in clinical laboratory by six sigma quality management method

目的应用六西格玛(6σ)质量管理方法定量分析临床实验室不同组别检验项目的质量控制数据并进行比较,分析评价性能,改进实验室质量。方法收集2013年度生化组与血液组共35个检验项目的室内质量控制及室间质量评价的数据,计算检验项目的σ值,评价检验项目分析性能。结果生化组参与评价的23个临床检验项目中σ≥6的10项,5≤σ<6的6项,4≤σ<5的3项,3≤σ<4的3项,σ<3的1项,平均σ值为5.962。血液组参与评价的12个临床检验项目中σ≥6的8项,5≤σ<6的2项,4≤σ<5的2项,平均σ值为7.38。生化组分析性能未达到6σ的检验项目占总项目的37%,血液组分析性能未达6σ的检验项目占总项目的11%。生化组与血液组检测项目σ质量水平比较差异有统计学意义(P<0.05),非配套试剂与配套试剂检测项目σ质量水平比较差异有统计学意义(P<0.05)。结论 6σ理论可以用于临床检验项目质量的评价,并可广泛用于临床实验室的质量管理。

Objective To apply the six sigma（6σ） quality management method to quantitatively analyze the quality control data of the detection items from different groups and conduct the comparison for analyzing the evaluation performance and improving the laboratory quality .Methods The data of the internal quality control and the external quality assessment were collected from35 de‐tection items in the clinical chemistry laboratory group and the hematology laboratory group during 2013 ,the σ value of every item was calculated and the analytical performance of the detection item was analyzed .Results Among 23 clinical detection items in the biochemistry group ,there were 10 items of σ ≥ 6 ,6 items of 5 ≤ σ 〈 6 ,3 items of 4 ≤ σ 〈 5 ,3 items of 3 ≤ σ 〈 4 and 1 item of σ〈 3 , the average σ was 5 .962 .Among 12 clinical detection items in the hematology group ,there were 8 items of σ ≥ 6 ,2 items of 5 ≤ σ 〈6 ,2 items of 4 ≤ σ 〈5 ,the average σ value was 7 .38 .The detection items in which the analytic performance did not reach 6σ in the biochemistry group accounted for 37% of the total items ,which in the hematology group accounted for 11% ,the differences in theσ quality level of detection items between the biochemistry group and the hematology group had statistical significance（P〈0 .05） , the differences in the σ quality level of detection items between the matched reagent and the non‐matched reagent had statistical sig‐nificance （P〈0 .05） .Conclusion The 6σ quality management method can be used used in the quality evaluation of clinical detection items and can be widely used in the quality management of clinical laboratory .