患者数据指数加权移动平均法在血清离子项目室内质量控制中的应用  

Application of patient-based real-time quality control using exponentially weighted moving average method on internal quality control procedures for serum ion items

作　　者：杨帆[1] 董丹凤[1] 陆怡德[1] YANG Fan;DONG Danfeng;LU Yide(Department of Clinical Laboratory,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]上海交通大学医学院附属瑞金医院检验科,上海200025

出　　处：《检验医学》2021年第9期962-968,共7页Laboratory Medicine

摘　　要：目的探讨患者数据实时质量控制(PBRTQC)的指数加权移动平均法(EWMA)在血清离子项目室内质量控制(IQC)中的应用价值。方法收集2019年10月—2021年5月上海交通大学医学院附属瑞金医院门诊及住院患者血清离子项目检测结果,基于PBRTQC专业智能软件系统进行检验数据正态分布检验、参数设置、程序建立、实时运行及性能验证。统计纳入分析的患者群体的每个检测结果的EWMA估计值,统计12个月的累积变异系数(CV),并比较累积CV与精密度质量标准和IQC的CV;统计EWMA质控程序在血清离子检测中的预警情况,并分析预警原因。结果患者血清离子总体截断浓度范围为:钾3.40~5.00 mmol/L、钠135~145 mmol/L、氯99~110 mmol/L、钙2.10~2.36 mmol/L、镁0.74~0.98 mmol/L、磷0.90~1.31 mmol/L。钾、钠、氯最适加权系数为0.02,钙、镁、磷最适加权系数为0.05;12个月内6个项目EWMA实际累积精密度(CV)均小于精密度质量目标。EWMA质控程序失控报警13次,钾、钠、氯、钙、镁、磷报警数分别为3、1、2、2、3、2次;其中血清钾、镁和磷各有1次假报警。结论基于PBRTQC专业智能软件工具建立的患者数据EWMA程序可作为日常质控品质量控制的补充,能较早提示离子项目分析性能的微小变化,并早期预警,避免潜在质量风险的发生。Objective To investigate the application of patient-based real-time quality control(PBRTQC)using exponentially weighted moving average(EWMA)method on internal quality control(IQC)procedures for serum ion items.Methods The serum ion item determination results of outpatients and inpatients in Ruijin Hospital of Shanghai Jiao Tong University School of Medicine from October 2019 to May 2021 were collected.Based on PBRTQC professional intelligent software system,the normal distribution test of test data,parameter setting,procedure establishment,real-time operation and performance verification were carried out.The estimated value of EWMA for each result was included in the analysis.The cumulative coefficient of variation(CV)was calculated and was compared with the criteria of precision quality standard and the analytical IQC CV.The early-warning cases by the EWMA quality control program were recorded and analyzed for the potential reasons of analytical performace changes.Results The truncated concentration range of K(3.40-5.00 mmol/L),Na(135-145 mmol/L),Cl(99-110 mmol/L),Ca(2.10-2.36 mmol/L),Mg(0.74-0.98 mmol/L)and P(0.90-1.31 mmol/L)were shown distributed normally.The optimal weighted coefficients of K,Na and Cl were 0.02,and the optimal weighted coefficients of Ca,Mg and P were 0.05.The actual cumulative precisions(CV)of the 6 items were all smaller than the precision quality target.A total of 13 warning cases were recorded.The number of alarm cases in K,Na,Cl,Ca,Mg and P were 3,1,2,2,3 and 2,respectively.Among them,serum K,Mg and P each had 1 false positive case.Conclusions PBRTQC quality control using EWMA,as a supplementary IQC procedure,has the advantage of monitoring micro-changes in order to avoid the potential quality risks.

关 键 词：患者数据实时质量控制法 血清离子项目 指数加权移动平均法 

分 类 号：R446.1[医药卫生—诊断学]