临床生物化学检验项目基于风险模型设计统计质量控制策略  

Statistical Quality Control Strategy of Clinical Biochemistry Detection Project Based on Risk Model

作　　者：何大海 孔丽蕊 张艳[1] 吴风 周朝琼 黄英[1] 余林 HE Dahai;KONG Lirui;ZHANG Yan;WU Feng;ZHOU Chaoqiong;HUANG Ying;YU Lin(Department of Clinical Laboratory,Traditional Chinese Medicine Hospital of Chengdu Pidu District/the Third Affiliated Hospital of Chengdu University of Chinese Medicine,Chengdu 611730,China)

机构地区：[1]成都市郫都区中医医院/成都中医药大学附属第三医院医学检验科,成都611730

出　　处：《现代检验医学杂志》2025年第2期202-207,共6页Journal of Modern Laboratory Medicine

基　　金：成都市医学科研课题(2022376);成都中医药大学“杏林学者”医院专项课题(XJ2023013901)。

摘　　要：目的基于风险模型定义临床生物化学检验项目的运行规模,通过合理调整风险因素,设计统计质量控制(SQC)策略。方法根据室内质量控制(IQC)的不精密度(CV)、外部质量评价(EQA)的偏移(Bias)和CLIA 2019允许总误差(TEa)计算临床生物化学检验项目的σ(σ)值。通过评估和调整风险因素,设计代表高σ、中σ和低σ等级的多个检验项目的SQC策略。结果不同质控水平的临床生物化学检验项目显示不同的σ性能,无机磷(P)和钾(K)水平2的σ值高于水平1,其余项目σ值均非常相似。风险σ≥4.96的项目有18个,分别为肌酸激酶(CK)、乳酸脱氢酶(LDH)、γ-谷氨酰基转移酶(GGT)、淀粉酶(AMY)、天门冬氨酸氨基转移酶(AST)、镁(MG)、三酰甘油(TG)、总胆红素(TBIL)、铁(FE)、钠(NA)、尿酸(UA)、肌酐(CREA)、无机磷(P)、碱性磷酸酶(ALP)、钾(K)、丙氨酸氨基转移酶(ALT)、胆固醇(TC)和钙(CA),采用13s N=2的QC程序进行质量控制,运行规模为179~1000份样本。清蛋白(ALB)、葡萄糖(GLU)、氯(CL)、总蛋白(TP)和尿素(UREA)需要通过调整风险因素达到预期的运行规模。结论实验室可以结合项目检测性能和患者安全目标,通过合理调整风险因素设计临床生物化学检验项目的SQC策略,应用尽可能少的SQC程序进行尽可能多的测试,使实验室工作量和报告间隔与患者样本数量保持一致。Objective To define the operation scale of the biochemical test project based on the risk model,and design the statistical quality control(SQC)strategy by rationally adjusting the risk factors.Methods The σ(σ)values for the biochemistry test items were calculated based on the imprecision(CV)of internal quality control(IQC),external quality assessment(EQA)offset bias(Bias)and allowable total error(TEa)of CLIA 2019.By evaluating and adjusting the patient risk factors,designed the SQC for multiple test biochemical items representing highσ,mediumσand lowσcategories.Results Clinical biochemistry testing items with different QC levels showed differentσperformance,with values for P and K quality control levels 2 higher than level 1 and the remaining items all had very similar.18 projects for riskσ≥4.96:CK,LDH,GGT,AMY,AST,MG,TG,TBIL,FE,NA,UA,CREA,P,ALP,K,ALT and CA,respectively.Controlled with a QC program 13s N=2,run size was 179~1000 samples.ALB,GLU,CL,TP and UREA need to achieve the expected operational scale by adjusting for risk factors.Conclusion The laboratory can combine program testing performance and patient safety goals,design SQC strategies for clinical biochemistry testing programs by rationally adjusting risk factors,apply as few SQC procedures for as much testing as possible,and align the laboratory workload and reporting interval with the number of patient samples.

关 键 词：σ值 风险因素 运行规模 统计质量控制策略 

分 类 号：R446.112[医药卫生—诊断学]