通过基于患者风险的综合PBRTQC系统,提高临床实验室质量控制的效率
Xincen Duan1, Tony Badrick2, Wenqi Shao1
1Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
Clinical chemistry and laboratory medicine
|April 3, 2025
概括
结合内部质量控制 (IQC) 和基于患者的实时质量控制 (PBRTQC) 的综合系统提高了实验室的效率. 这种方法减少了质量控制事件,为传统的仅使用IQC的方法提供了更有效的替代方案.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 质量控制系统 质量控制系统
背景情况:
- 基于患者的实时质量控制 (PBRTQC) 为传统的内部质量控制 (IQC) 提供了替代方案.
- 目前的法规要求IQC,需要单独的PBRTQC系统,这增加了劳动力需求并阻碍了采用.
- 为了有效的实验室实施,需要一个结合IQC和PBRTQC的综合系统.
研究的目的:
- 提出和评估一个综合质量控制 (QC) 系统,将IQC与PBRTQC结合起来.
- 引入一个关键指标,即具有不可接受分析错误的患者的最大平均数量 (MaxANPTE),用于对系统效率进行基准测试.
- 将集成系统的效率与仅使用IQC的系统进行比较.
主要方法:
- 开发了一个集成的质量控制系统,将IQC与PBRTQC合并.
- 使用修改的帕文患者风险模型和MaxANPTE指标进行效率基准测试.
- 将综合PBRTQC (简单和RARTQC模型) 与仅使用历史数据的IQC (血清Na,Cl,ALT,CREA) 进行比较,从2019年开始.
主要成果:
- 综合系统,特别是具有回归调整实时质量控制 (RARTQC) 的系统,总体上表现优于仅使用IQC的系统.
- 观察到QC事件的显著减少,高达ALT的45%.
- 基于这些发现,提出了设计综合系统的策略.
结论:
- 与仅使用IQC的系统相比,集成的PBRTQC系统显示了更高的效率.
- 这些发现有助于实验室做出关于采用PBRTQC的明智决策.
- 结果为IQC法规的潜在修订提供了证据.
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