一个用于管理同一分析物测量的临床化学仪器网络质量控制的模型
Jean-Marc Giannoli1, Mathieu Bernard2, Julien L'Hirondel3
1Biogroup, Technical Direction, Lyon, France.
Clinical chemistry and laboratory medicine
|November 24, 2023
概括
对多种实验室仪器实施质量控制模型可确保可比结果并降低患者风险. 这种方法有效地检测出医学上重要的错误,改善了实验室的整体质量控制.
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:
- 在测量相同分析物的多个仪器中监测质量控制 (QC) 存在重大挑战.
- 在多仪器实验室网络中确保可比结果和最大限度地降低患者风险至关重要.
- 对于这些常见场景,有限的文献讨论了有效的质量控制管理.
研究的目的:
- 以后期评估一种新的质量控制模型,用于检测具有医学意义的失控错误条件.
- 确保测量相同分析物的多个仪器的结果一致和可比.
- 为了减少与实验室测试错误相关的患者风险.
主要方法:
- 使用单个Levey-Jennings控制图表,对五种临床化学分析物的同行目标组平均值和控制极限.
- 采用13s/22s/R4s QC规则,使用同行组数据为目标平均值和极限.
- 结合统计和临床评估来评估质量控制失败,并持续监测仪器偏差.
主要成果:
- 仪器偏差在统计或临床上与六个月的同行组平均值没有差异.
- 质量控制模型的错误率与应用规则的统计预期保持一致.
- 没有出现外部质量保证故障,没有发现的错误超过了允许的总错误 (TEa),最大限度地减少了不必要的重新校准和结果修改.
结论:
- 成功实施了QC模型,用于监测测量相同分析物的仪器网络.
- 该模型持续评估与外部QC目标相比的个别仪器偏差和不精确性.
- 该方法有效地检测出医学上显著的失控错误条件,确保网络范围的临床质量目标得到满足.
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