基于患者风险的室内质量控制程序对急诊免疫检验项目室内质量控制成本的影响  

The Application of Patient Risk-based Indoor Quality Control Procedures inEmergency Immunization Tests and Its Impact onIndoor Quality Control Costs

作　　者：何成钦 肖光军[1] 刘艳婷[1] 余冬梅[2] HE Chengqin;XIAO Guangjun;LIU Yanting;YU Dongmei(Department of Clinical Laboratory and Basic Laboratory,Suining Central Hospital,Suining 629000,China;Department of Cardiology,Suining Central Hospital,Suining 629000,China)

机构地区：[1]遂宁市中心医院检验科,四川遂宁629000 [2]遂宁市中心医院心内科,四川遂宁629000

出　　处：《标记免疫分析与临床》2023年第11期1954-1958,共5页Labeled Immunoassays and Clinical Medicine

基　　金：四川省医学科研课题计划(编号:S22045)。

摘　　要：目的使用具有批长度的Westgard西格玛规则为7个急诊免疫检验项目设计基于患者风险的统计质量控制(SQC)程序,评估其对各项目室内质量控制成本的影响。方法以遂宁市中心医院急诊检验科2022年7月至2022年12月血清降钙素原(PCT)、肌红蛋白(MYO)、肌酸激酶同工酶(CK-MB)、高敏肌钙蛋白I(hs-cTnI)、B型脑钠肽(BNP)、孕酮(PROG)、人绒毛膜促性腺激素(β-HCG)室内质控的累积在控变异系数(CV)作为各检测项目不精密度的估计值,实验室参加国家卫生健康委临床检验中心室间质量评价(EQA)活动中10个批号的百分差值绝对值的均值作为各检测项目偏倚(Bias)的估计值,并以EQA活动的评价标准作为各检测项目的允许总误差(TEa),计算各项目的西格玛度量值(σ),并采用具有批长度的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)、批数(R)及批长度(M)。根据2022年各项目日平均工作量,分别计算各项目现用室内质控控制方案和应用SQC程序后质控品的使用量,以及用于质量控制的试剂使用量,评估SQC程序对室内质量控制成本的影响。结果MYO的σ=5.54,采用1_(3S)/22S/R_(4S)(N=2,R=1)规则,批长度为450个患者样本,结合每日平均工作量,可每21.6d进行1次质控;CK-MB、hs-cTnI、PCT、PROG和β-HCG的σ在4~5,采用1_(3S)/2_(2S)/R _(4S)/4_(1S)(N=4,R=1)规则,批长度为200个患者样本,结合每日平均工作量,各项目依次为每9.6、9.6、20.6、29.5d和23.2d进行1次质控;BNP的σ=3.83,采用1_(3S)/2_(2S)/R _(4S)/4_(1S)/6 X(N=6,R=1)规则,批长度为45个患者样本的SQC程序以及更高频次的室内质量控制活动,结合每日平均工作量,至少每7.3d应进行1次质控。与当前室内质量控制方案相比较,采用基于患者风险的SQC程序后,室内质控中质控品和试剂的年使用量可减少58.90%~95.34%。结论简单直观的“具有批长度的Westgard西格玛规则”可帮助实Objective Based on the statistical quality control(SQC)procedure for patient risk assessment,We used Westgard Sigma rule with a batch length to assess the impact of indoor quality control(IQC)costs in seven emergency immunization testing items.Methods The cumulative coefficient of variation(CV)of serum procalcitonin(PCT),myoglobin(MYO),creatine kinase creatine kinase isoenzyme(CK-MB),high-sensitive troponin I(hs-cTnI),B brain natriuretic peptide(BNP),progesterone(PROG),and human chorionic gonadotropin(β-HCG)were used as estimator in the Emergency Laboratory of Suining Central Hospital from July,2022 to December,2022.The mean value of the absolute value of the 10 percentage numbers in the laboratory quality Evaluation(EQA)activity of the NHC was used as the estimation of each test item bias(Bias),and the sigma measurement(σ)was calculated using the evaluation criteria of EQA activity as the allowable total error(TEa)of each test item.The appropriate SQC procedure was designed for each project,including the quality control rules,the number of quality control results(N),the number of batches(R)and the batch length(M).According to the average daily workload of each project in 2022,we calculated IQC results of each project.The impact of SQC procedure on the cost of IQC was evaluated by the use of QC product and QC reagent after application of SQC procedure.Resultsσfor MYO was 5.54 when using the 13S/22S/R 4S(N=2,R=1)rule,while batch length was used for 450 samples,combined with the average daily work load,and QC could be performed every 21.6 days.σof CK-MB,hs-cTnI,PCT,PROG,andβ-HCG were from 4 to 5 when using 13S/22S/R 4S/41S(N=4,R=1)rule,with batch length of 200 patient samples,and combined with the average daily workload,leading to successively performance of 9.6,9.6,20.6,29.5,and 23.2 days.σfor BNP was 3.83,according to13S/22S/R 4S/41S/6 X(N=6,R=1)rule,with SQC procedure of 45 patient samples,and higher frequency IQC,and combined with average daily workload,leading to at least every 7.3 days.Compared with the

关 键 词：急诊检验 质量控制 具有批长度的Westgard西格玛规则 成本管控 

分 类 号：R-331[医药卫生]