西格玛度量值在肿瘤标志物检测质量持续改进中的应用

Application of Sigma measurement in continuous improvement for detection quality of tumor markers

目的应用西格玛(σ)度量值分析本科室常规开展的肿瘤标志物项目质量控制数据,评价其精密度分析性能,设计质量控制方法,指导质量持续改进。方法收集2018至2019年西安医学院第一附属医院检测的AFP、CEA、CA125、CA199、CA153、tPSA、fPSA、铁蛋白(FERR)、β-HCG和β2微球蛋白(β2-MG)共计10个参加国家卫健委临床检验中心室间质评的肿瘤标志物室内质控及室间质评数据,按照国家卫健委临床检验中心室间质评允许总误差(TEa)标准,采用6σ计算公式计算检验项目σ值,评价检测项目分析性能,设计质量控制方法,计算检测项目的质量目标指数(QGI),运用鱼骨图分析导致性能不佳的主要原因,提出优先改进方案。结果2018年数据结果显示,在10个肿瘤标志物项目中,平均σ值为4.25,其中σ≥6项目2个,5≤σ<6项目5个,4≤σ<5项目4个,3≤σ<4项目7个,2≤σ<3项目2个;根据QGI值,需要优先改进精密度的项目有7个,分别为:AFP、CA125、CA199、CA153、FERR、β-HCG和β2-MG;需要优先改进正确度的项目有3个,分别为CEA、t-PSA和f-PSA。通过持续改进,2019年σ值平均值为6.58,其中σ≥6项目16个,5≤σ<6项目3个,4≤σ<5项目1个。与2018年σ值相比,世界一流水平项目比例明显增多,差异具有统计学意义(P<0.05)。结论6σ质量管理是实验室开展质量控制的一项有效的管理工具,可以评价检测项目的性能,指导质量持续改进。

Objective To analyze the quality control data of tumor markers by using Sigma(σ)measurement items,evaluate its analytical performance,design the methods for quality control and guide continuous quality improvement.Methods The data of internal and external quality assessments of 10 tumor markers participating in the external quality assessment of Clinical Laboratory Center of National Health Commission were collected in The First Affiliated Hospital of Xi'an Medical College during the period of 2018 and 2019,including AFP,CEA,CA125,CA199,CA153,TPSA,fPSA,FERR(ferritin),β-hCG andβ2-MG(microglobulin).According to the total allowable error(TEa)standard of the Clinical Laboratory Center of National Health Commission,the 6σformula was used to calculate theσvalue of the test items,evaluate the analytical performance of the test items,design the quality control method,calculate the quality objective index(QGI)of the test items,analyze the main causes of poor performance by using fishbone diagram,and propose a the priority improvement scheme.Results The results of 2018 showed that,the average value ofσamong the 10 tumor markers was 4.25,includingσ≥6 in 2 items,5≤σ<6 in 5 items,4≤σ<5 in 4 items of,3≤σ<4 in 7 items,and 2≤σ<3 in 2 items.According to the QGI value,the precisions of 7 items were needed to improve,including AFP,CA125,CA199,CA153,FERR,β-HCG andβ2-MG.The accuracies of 3 items were needed to improve,namely CEA,t-PSA and f-PSA.By continuous improvement,the average value ofσin 2019 was 6.58,including 16 iterms withσ≥6,3 iterms with 5≤σ<6,and 1 item with 4≤σ<5.Compared with theσvalue of 2018,the proportion of iterms with world-class levels increased significantly(P<0.05).Conclusion Six Sigma quality management should be an effective management tool for laboratory quality control,which may evaluate the performance of test items and guide continuous quality improvement.