The Application of Six Sigma to Assess the Analytical Performance of Plasma Proteins and Design a Risk-Based Statistical Quality Control Strategy: A Multicenter Study

IF 2.9 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis Pub Date : 2025-07-18 DOI:10.1002/jcla.70080

Ming Hu, Jiaping Wang, Huan Yang, Sugang Zang, Tingting Gao, Jian Zeng, Fumeng Yang

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Abstract

Background

This study applied the six sigma model to evaluate plasma protein testing performance in six laboratories, with customized quality control programs and targeted improvements introduced where necessary.

Methods

Internal quality control (IQC) and external quality assessment (EQA) data for plasma proteins were gathered from six laboratories. Sigma values for each analyte were determined based on the coefficient of variation (CV), bias, and total allowable error (TEa). Using six sigma performance verification charts, we calibrated analyte performance and, guided by Westgard sigma rules, batch length, and quality goal index (QGI), developed laboratory-specific quality control schemes and improvement plans.

Results

Despite standardized platforms and reagents, sigma values showed significant inter-laboratory variation, with some differences also observed within labs at varying analyte concentrations. For projects with sigma < 6, tailored quality control measures were implemented, leading to marked performance improvements.

Conclusion

The six sigma model provides an objective framework for evaluating plasma protein test performance and enhancing quality. It enables quantitative assessment of laboratory management and supports the development and implementation of customized, risk-based statistical quality control (SQC) strategies and improvement measures across multiple laboratory systems.

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应用六西格玛评估血浆蛋白分析性能及设计基于风险的统计质量控制策略：一项多中心研究。

背景：本研究应用六西格玛模型对六个实验室的血浆蛋白检测性能进行评估，并在必要时引入定制的质量控制程序和有针对性的改进。方法：收集6个实验室血浆蛋白的内部质量控制（IQC）和外部质量评价（EQA）数据。根据变异系数（CV）、偏差和总允许误差（TEa）确定每种分析物的Sigma值。使用六西格玛性能验证图，我们校准了分析物的性能，并在Westgard sigma规则、批次长度和质量目标指数（QGI）的指导下，制定了实验室特定的质量控制方案和改进计划。结果：尽管有标准化的平台和试剂，sigma值在实验室间显示出显著的差异，在不同分析物浓度的实验室内也观察到一些差异。结论：六西格玛模型为评价血浆蛋白检测性能和提高检测质量提供了客观的框架。它能够对实验室管理进行定量评估，并支持跨多个实验室系统开发和实施定制的、基于风险的统计质量控制（SQC）策略和改进措施。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Laboratory Analysis 医学-医学实验技术

CiteScore

5.60

自引率

7.40%

发文量

584

审稿时长

6-12 weeks

期刊介绍： Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.