[1]何大海,孔丽蕊,张 艳,等.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[J].现代检验医学杂志,2025,40(02):202-207.[doi:10.3969/j.issn.1671-7414.2025.02.038]
　HE Dahai,KONG Lirui,ZHANG Yan,et al.Statistical Quality Control Strategy of Clinical Biochemistry Detection Project Based on Risk Model[J].Journal of Modern Laboratory Medicine,2025,40(02):202-207.[doi:10.3969/j.issn.1671-7414.2025.02.038]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第40卷
期数:
2025年02期
页码:
202-207
栏目:
质量控制·实验室管理
出版日期:
2025-03-15

文章信息/Info

Title:
Statistical Quality Control Strategy of Clinical Biochemistry Detection Project Based on Risk Model
文章编号:
1671-7414（2025）02-202-06
作者:
何大海; 孔丽蕊; 张 艳; 吴 风; 周朝琼; 黄 英; 余 林
（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）
Author(s):
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）
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
DOI:
10.3969/j.issn.1671-7414.2025.02.038
文献标志码:
A
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 ～ 1 000 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。
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.

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备注/Memo

备注/Memo:
基金项目：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）。
作者简介：何大海（1989-），男，本科，主管技师，研究方向：临床实验室质量控制，E-mail：524392472@qq.com。
通讯作者：余林（1975-），男，本科，主任技师，研究方向：免疫学和微生物学检验及实验室质量管理，E-mail：746852945@qq.com。
更新日期/Last Update: 2025-03-15