六西格玛质量规则在特殊蛋白性能评价中的应用研究  

The application of six sigma metrics in the evaluation of special proteins

作　　者：谭太昌[1] 王甲甲[1] 麦涛[1] 王加强 袁红[1] TAN Tai-chang;WANG Jia-jia;MAI Tao;WANG Jia-qiang;YUAN Hong(Department of Medical Laboratory,Sichuan Academy of Medical Sciences ＆ Sichuan Provincial peopled Hospital,Chengdu,610012,China)

机构地区：[1]四川省医学科学院.四川省人民医院检验科,四川成都610072

出　　处：《实用医院临床杂志》2018年第5期158-160,共3页Practical Journal of Clinical Medicine

基　　金：四川省科技厅科研基金资助项目(编号:2016ZR0080);四川省卫生和计划生育委员会科研基金资助项目(编号:18PJ120)

摘　　要：目的应用六西格玛(6σ)质量规则评价特殊蛋白检测性能,指导实验室检验质量持续改进。方法分析本实验室特殊蛋白2017年第一次室间质评(EQA)及室内质控数据,分别计算各项目σ值和质量目标指数(quality goal index,QGI)。绘制标准化6σ性能评价图,评价检验性能,指导质控方案的设计;分析所有未达标项目性能不佳的主要原因,指导持续质量改进。结果根据2017年第一次EQA给出的偏倚,C3、ASO、CRPσ值为4~5,质量水平良好;Ig G、Ig A、Ig M、Ig Eσ值为3~4,检测质量一般;C4σ值为2~3,质量水平欠佳;RHFσ值为<2,检测质量为不可接受。QGI指数显示,Ig G、Ig A、Ig M、Ig E、C3、ASO、CRP的QGI指数均小于0.8,提示应该首先提高上述指标的精密度;C4、RHF的QGI值在0.8~1.2,需要同时提高检测的准确度和精密度。结论 6σ质量管理规则可以有效评价特殊蛋白检验项目的质量指标,设计合理的质控方案,从而达到控制检测质量的目的。Objective To evaluate the detection performance of special proteins by six sigma （ 6σ） metrics management in order to give the guide for laboratory quality improvement.Methods Data of external quality assessment （ EQA） and internal quality control （IQA） of 9 special proteins in 2017 were analyzed.The ct values and quality goal index （ QGI） of each item were calculated ac-cordingly.The standardized 6 ct performance evaluation chart for each item was drawn to evaluate the test performance and guide the de-sign of the quality-control rules.Meanwhile, the main causes of poor performance of non-qualified items were analyzed to give a continuous quality improvement.Results Based on the bias of the first EQA data in 2017 ,σ value of C3 , ASO and CRP were 4 - 5 , suggesting that the detection quality were good.The a values of IgG, IgA, IgM and IgE were 3 - 4, suggesting that the detection quality were com-mon.The σ values of C4 was 2 - 3, suggesting that the quality was poor.The σ value of RHF was less than 2 , suggesting that the detec-tion quality was unacceptable.The QGI of IgG, IgA, IgM, IgE, C3 , ASO and CRP were all less than0.8, suggesting that the detection precision should be improved firstly.The QGI of C4 and RHF were0.8 - 1.2,indicating that the accuracy and precision need be im-proved simultaneously.Conclusion The 6cr metrics is effective for evaluating the performance of special proteins, designing the optimal quality-control rules,and thus,controlling the detection quality.

关 键 词：六西格玛 实验室 质量控制 质量目标指数 

分 类 号：R446.11[医药卫生—诊断学]