特殊蛋白检测项目基于患者风险的室内质量控制程序的设计

Design of internal quality control program for specific protein testing based on patient risk

目的用具有批长度的Westgard西格玛规则为9项特殊蛋白项目设计基于患者风险的统计质量控制(SQC)程序。方法收集北京同仁医院检验科2018年12月至2019年5月免疫球蛋白(Ig)G、IgA、IgM、C3、C4、类风湿因子(RF)、抗链球菌溶血素O(ASO)、转铁蛋白(TRF)和前清蛋白(PA)室内质控的累积在控变异系数作为不精密度的估计值,将该实验室参加室间质量评价(EQA)计划中10个批号的百分差值绝对值的均值作为偏倚的估计值,采用国家卫生健康委临床检验中心EQA的评价标准作为允许总误差(TEa),计算各项目的西格玛度量值(σ),采用具有批长度的Westgard西格玛规则为各项目设计合适的SQC程序,包括质控规则、质控结果个数(N)及质控频率。结果IgG、IgA、IgM、C4和TRF的σ>6。采用13s规则,质控结果个数(N)=2,批数(R)=1,批长度为1000个患者样品的SQC程序,结合每日平均工作量,IgG、IgA、IgM、C4可每10天进行1次室内质控,TRF每50天进行1次室内质控;C3的σ=5.86,采用13s/22s/R4s规则(N=2,R=1),批长度为450的SQC程序,结合每日平均工作量,可每4.5天进行1次室内质控;RF、ASO、PA的σ在3~4,采用13s/22s/R4s/41s/6X规则(N=6,R=1),批长度为45的SQC程序以及更高频次的室内质控活动。结论使用具有批长度的Westgard西格玛规则帮助实验室设计个性化的基于风险的SQC程序简单直观,建议各临床实验室积极应用该工具。

Objective Patient risk-based statistical quality control(SQC)program was designed for 9 specific protein projects using Westgard sigma rules with run length.Methods The cumulative coefficient of variation of immunoglobulin(Ig)G,IgA,IgM,C3,C4,rheumatoid factor(RF),antistreptolysin O(ASO),transferrin(TRF)and prealbumin(PA)from the laboratory department of Beijing Tongren Hospital between December 2018 to May 2019 were used as the estimated value of imprecision.The mean of the absolute value of the percentage difference of 10 batches in the laboratory,which was derived from the results of participating the external quality assessment(EQA),was used as the estimated value of bias.The National Center for Clinical Laboratories EQA evaluation criteria was used as an allowable total error(TEa),and the sigma value of each project(σ)was calculated.Westgard Sigma rule with run length was used to design appropriate SQC program for each project,including quality control rules,number of control measurements(N)and frequency of quality control.Results The sigma value was larger than 6 for SQC procedure of IgG,IgA,IgM,C4 and TRF.SQC could be established with the use of 13s rule,number of control measurements(N)=2,number of runs(R)=1,and a run length of 1000 patient samples.Combined with the average daily workload,internal quality control could be conducted once every 10 days for IgG,IgA,IgM and C4,every 50 days for TRF.Theσwas 5.86 for C3,SQC program could be established with run length of 450 using 13S/22S/R4s rule(N=2,R=1),combined with average daily workload,internal quality control could be conducted every 4.5 days.σwas between 3 and 4 for RF,ASO and PA.With the use of 13S/22S/R4s/41s/6X rule(N=6,R=1),SQC program with a run length of 45 and higher frequency internal quality control activities.Conclusion It is feasible to use Westgard sigma rules with run length for the laboratories design of personalized risk-based SQC procedures,the method is very simple and intuitive.This tool is valued to be recommended to be actively applied by all clinical laboratories.