六西格玛质量管理在临床肿瘤标志物检验质量控制中的应用  

The Application of Six Sigma Quality Management in Quality Control of Clinical Tumor Marker Test

作　　者：马红叶 洪燕英[1] 郭宏林[1] 桂红[1] MA Hongye;HONG Yanying;GUO Honglin;GUI Hong(Department of Clinical Laboratory, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010)

机构地区：[1]首都医科大学附属北京中医医院检验科,北京100010

出　　处：《标记免疫分析与临床》2021年第12期2162-2165,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的应用六西格玛(6σ)质量管理理论分析评价本实验室肿瘤标志物检测的方法性能,提供合适的质量控制方案,进一步提高实验室的检测能力。方法统计首都医科大学附属北京中医医院检验科2020年10月至2021年6月甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异性抗原(TPSA)、糖类抗原125(CA125)、糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、铁蛋白(Ferritin)、总β-人绒毛膜促性腺激素(β-HCG)、糖类抗原72-4(CA72-4)、细胞角蛋白19片段(CYFRA21-1)、神经元特异性烯醇化酶(NSE)和鳞状细胞癌抗原(SCCA)12个检验项目的室内质量控制数据,结合国家卫生健康委员会临床检验中心(NCCL)室间质量评价结果,根据不精密度(CV)、偏倚(Bias)、允许总误差(TEa)计算σ值,对于未达到6σ水平的检验项目,计算其质量目标指数(QGI),查找原因,进行改进。结果12个肿瘤标志物检验项目的平均σ值为3.67,其中,CA72-4、CYFRA21-1、NSE、TPSA和Ferr项目4≤σ<5;SCC、AFP、CA15-3、CA125和β-HCG项目3≤σ<4;CEA和CA19-9项目σ<3。CYFRA21-1项目的QCI处于0.8~1.2,其余11个项目QCI<0.8。在未达6σ的12个检验项目中,91.67%的项目需要优先改进精密度,有8.33%的项目需要同时改进精密度和准确度。结论6σ质量管理理论可以有效提高临床实验室肿瘤标志物检验质量。Objective To evaluate the method performance of the tumor marker test in our laboratory by using six sigma quality management theory,and to provide a reasonable quality control management plan to further improve the detection capability of the laboratory.Methods The data of internal quality control and external quality assessment of 12 tumor markers(AFP,CEA,PSA,CA125,CA15-3,CA19-9,FERR,β-HCG,CA72-4,CYFRA21-1,NSE and SCCA)which took part in an external quality assessment of National Center for Clinical Laboratories(NCCL)in the laboratory of Beijing Hospital of Traditional Chinese Medicine from October 1st,2020 to June 30th,2021 were collected for the study.The metric of sigma was calculated according to the imprecision(CV),the bias value(Bias)and allowable total error(TEa),and the quality goal index(QGI)was also calculated to investigate the main reasons causing the poor performance(withσ<6).Results The average sigma metric of the 12 tumor markers tests was 3.67,while the sigma metric of the test of CA724,CYFRA21-1,NSE,TPSA and Ferr were 4-5,also the sigma metric of the test of SCC,AFP,CA15-3,CA125 andβ-HCG were 3-4,and the sigma metric of the test of CEA and CA19-9 were less 3.The QGI of CYFRA21-1 was 0.8-1.2,and the QGI of the other 11 tests was below 0.8.Conclusion The six sigma quality management theory can effectively improve the quality of the tumor marker test in clinical laboratory.

关 键 词：六西格玛 肿瘤标志物 质量控制 

分 类 号：R-331[医药卫生]