在高度自动化的实验室中完善质量控制策略:在整合多阶段统计设计和风险管理方面的经验
María Costa-Pallaruelo1,2, Álvaro García-Osuna1,2, Marina Canyelles1,2
1Biochemistry Department, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain.
Biochemia medica
|October 17, 2025
概括
实验室分析仪实施了新的基于风险的质量控制策略,简化了计划并确保了可靠的患者结果. 这种方法提高了自动化实验室的质量保证和资源配置.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 质量管理系统 质量管理系统
背景情况:
- ISO 15189:2022强调了质量控制规划中的分析方法稳定性和错误风险.
- 韦斯特加德和其他人. 基于运行大小的质量控制 (QC) 规则选择,以尽量减少不可靠的患者结果.
研究的目的:
- 实施标准化,基于风险的质量控制策略,用于缺乏集成的车载质量控制的分析仪.
- 确保在多个实验室平台上的实际质量保证.
主要方法:
- 在Alinity c和Cobas Pro系统上对35个生物化学参数使用sigma指标评估分析性能.
- 根据西格玛指标统计QC运行尺寸名ogram设计的多阶段括号质量控制计划 (QCP).
- 优先考虑更简单的质量控制规则,并通过优先考虑那些涵盖每个分析仪更多参数的QCP管理来简化QCP管理.
主要成果:
- 最初为35个参数建立了7个QCP,并对非自动化系统进行了实际调整.
- 简化了QCP,采用了两个一般计划和四个个性化计划,用于具有较低西格玛值的参数.
- 通过改进的质量控制战略,实现了高效的质量保证和资源配置.
结论:
- 在高度自动化的实验室中,对Sigma ≥ 4的参数进行精细的质量控制策略的可行性.
- 确保一致的质量保证和高风险测试的高效资源配置.
- 强调了基于风险的QC在实验室环境中的实际应用.
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