Statistical Quality Control Strategy of Clinical Biochemistry Detection Project Based on Risk Model
10.3969/j.issn.1671-7414.2025.02.038
- VernacularTitle: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
- Author:
Dahai HE
1
;
Lirui KONG
1
;
Yan ZHANG
1
;
Feng WU
1
;
Chaoqiong ZHOU
1
;
Ying HUANG
1
;
Lin YU
1
Author Information
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
- Publication Type:Journal Article
- Keywords:
sigma value;
risk factors;
operation scale;
statistical quality control strategy
- From:
Journal of Modern Laboratory Medicine
2025;40(2):202-207
- CountryChina
- Language:Chinese
-
Abstract:
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 high σ,medium σ and low σ categories.Results Clinical biochemistry testing items with different QC levels showed different σ performance,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 risk σ≥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 179～1 000 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.
