18项内分泌项目风险管理的统计质量控制策略设计  

Design of Statistical Quality Control Strategies for Risk Management of 18 Endocrine Projects

作　　者：范德红 李公奇 FAN De-hong;LIGong-qi(Department of Clinical Laboratory,Linyi Mental Health Center,Shandong Linyi 276005)

机构地区：[1]临沂市精神卫生中心检验科,山东临沂276005 [2]临沂市中医医院医学检验科,山东临沂276003

出　　处：《医学检验与临床》2024年第7期16-19,共4页Medical Laboratory Science and Clinics

摘　　要：目的:选取实验室18项内分泌项目,通过批长度Westgard西格玛规则,对其质控策略进行优化,降低患者风险,节约检测成本。方法:采用国家卫生健康委临床检验中心室间质量评价(External Quality Assessment,EQA)标准作为质量规范,以参加国家卫健委临检中心EQA结果估算偏倚(Bias),以实验室室内质控数据估算不精密度(CV),计算西格玛(α)度量值,通过批长度Westgard西格玛规则,为18项内分泌项目分别选择合适的质控策略;并通过质量目标指数(qualitygoal index,QGI)评价检测系统的分析性能。结果:在18个内分泌项目中,≥6的项目有7个(38.9%),只采用1_(3S)质控规则,分析批长度为1000;3个项目(16.7%)5≤σ<6,采用多规则1_(3S)/2_(2S)/R_(4S),分析批长度为450;6个项目(33.3%)4≤σ<5,采用多规则1_(3S)/2_(2S)/R_(4S)/4_(1S),分析批长度为200;2个项目(11.1%)3≤σ<4,需提高检测系统分析性能。11个α值小于6的项目中,有10个项目(90.9%)QGI<0.8,提示精密度是首要改进目标;1个项目(9.1%)0.8<QGI<1.2,提示不仅要改进精密度,同时要改进正确度。结论:作为一种新的基于风险的统计质量控制(statistical quality control,SQC)策略工具,批长度Westgard西格玛规则能有效助力实验室选择客观科学合理的SQC策略,使患者风险最小化;结合QGI可进一步明确导致检测系统性能不良的问题来源,指导质量改进。Objective:To Optimize internal quality control strategy for 18 endocrine projects in the laboratory by using Westgard Sigma Rules with Run Size to reduce the risk of patients and save the cost of measurement.Methods:To adopt the standards of external quality ssessment in National Center For Clinical Laboratory as quality specification.To estimate bias based on the results of external quality assessmen in National Center For Clinical Laboratory.To estimate imprecision using the data of internal quality control,Sigma value was calculated To select appropriate quality control strategies for 18 endocrine projects by using Westgard Sigma Rules with Run Size,and to evaluate the performance of the measurement system through the Quality Goal Index.Results:Among the 18 selected items,the sigma value of 7 items(38.9%)was achieved 6,single rule 1_(3S) was selected according to the Westgard Sigma Rules with Run Size,the Run Size was 1000;The sigma value of 3 items(16.7%)was achieved 5,multi-rules 1_(3S)/2_(2S)/R_(4S) were selected,the Run Size was 450;The sigma value of6 items(33.3%)was achieved 4,multi-rules rules 1_(3S)/2_(2S)/R_(4S)/4_(1S) were selected,the Run Size was 200;The sigma value of2 items(11.1%)was achieved 3,which need to improve the performance of the measurement system.The QGI of 10 items(90.9%)had less than 0.8 among the 11 items which were not achieved 6o quality level,which required to improve the precision primarily,The QGI of1 items(9.1%)had more than O.8 but less than 12,which needed to improve the precision and accuracy at the same time.Conclusion:The Westgard Sigma Rules with Run Size as a new risk-based statistical quality control strategy tool can help laboratories to select objective and scientific and reasonable control strategies and reduce the risk of patients.To identify the sources of problems that lead to poor performance of the measurement system according to QGI and to guide the improvement of quality.

关 键 词：质控策略 患者风险 批长度Westgard西格玛规则 质量目标指数 

分 类 号：R446[医药卫生—诊断学] R58[医药卫生—临床医学]