特殊蛋白检测性能评价中的六西格玛理论应用分析  

Application analysis of six Sigma theory in performance evaluation of special protein detection

作　　者：李明[1] LI Ming(Department of Laboratory,Tianyou Hospital of Wuhan University of Science and Technology,Wuhan,Hubei 430064,China)

机构地区：[1]武汉科技大学附属天佑医院检验科,湖北武汉430064

出　　处：《国际检验医学杂志》2022年第S02期120-123,共4页International Journal of Laboratory Medicine

摘　　要：目的对特殊蛋白检测性能评价中的六西格玛理论应用进行分析,探讨六西格玛质量管理理论在临床实验室质量管理中所具有的价值。方法随机选取该院检验科近两年时间内室内质控和参加卫生部临床检验中心室中所产生的质评数据,对其中的累积变异系数和累积变异进行计算和处理,根据卫生部临床检验中心所规定的相关质评误差标准,在进行CV占TEa的百分数和Bias占TEa的百分数,从而算出其中的σ值,并且在比较标准化6σ方法性能决定图中进行检验的操作点标记。结果近两年时间中,所进行的特殊蛋白常见检测,其总体的质量水平具有参差不齐的特点,IgG能够准确达到6σ标准,C4和CRP则主要处于5σ的水平上,IgG、C3都没有能够进入到4σ的区间之内,IgA和IgM都只能够达到2σ的水平,这就和室内质控以及室间间质所得到的具体结果之间存在着一定的差别,这也就使得室内质控方案在进行特殊蛋白检测性能评价的时候,会存在着一些不足。结论使用标准化的6σ方法性能决定图对特殊蛋白进行必要的检测,能够更加直观的对能特殊蛋白项目的检测性能进行评价,使得其评价的质量能够有所改进。Objective To analyze the application of Six Sigma theory in the performance evaluation of spe-cial protein detection,and to explore the value of Six Sigma quality management theory in clinical laboratory quality management.Methods Randomly selected the quality assessment data generated by the laboratory de-partment of our hospital and participated in the clinical inspection center of the Ministry of Health in the past two years,and calculated and processed the cumulative coefficient of variation and cumulative variation.The relevant quality evaluation error standard stipulated by the inspection center is to calculate theσvalue in the percentage of CV in TEa and the percentage of Bias in TEa,and mark the operation point for inspection in the comparison standardization 6σmethod performance decision chart.Results In the past two years,the common detection of special proteins,the overall quality level is uneven,IgG can accurately meet the 6σstandard,C4 and CRP are mainly at the level of 5σ,IgG and C3 are both at the level of 5σ.Without being able to enter the 4σinterval,both IgA and IgM can only reach the 2σlevel,which is different from the specific results obtained by the indoor quality control and the interstitial interstitium.There are some deficiencies in the quality control program when evaluating the performance of special protein detection.Conclusion Using the standardized 6σmethod performance determination diagram to perform necessary detection of special proteins can more intui-tively evaluate the detection performance of special protein items,which can improve the quality of the evalua-tion.

关 键 词：特殊蛋白检测 性能评价 六西格玛理论 应用分析 

分 类 号：R446[医药卫生—诊断学]