荷兰的质量控制;今天的实践和指导和未来研究的出发点
Huub H van Rossum1, Marith van Schrojenstein Lantman2,3,4, Michel Severens5
1Department of Laboratory Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.
荷兰临床实验室的内部质量控制 (iQC) 实践在荷兰临床实验室之间存在很大差异. 本研究突出了iQC方法的异质性,并确定了需要进一步研究和更新指导的领域.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 质量管理质量管理.
背景情况:
- 分析质量对于可靠的实验室结果至关重要.
- 内部质量控制 (iQC) 是确保分析质量的主要方法.
- 当前的iQC实践多样化,需要了解应用方法.
研究的目的:
- 调查荷兰临床化学实验室当前的内部质量控制 (iQC) 实践.
- 确定对iQC程序的更新指导的需要.
- 为了解决荷兰关于分析质量控制的指导文件的修订.
主要方法:
- 一份问卷调查分发给荷兰所有临床化学实验室.
- 该调查包括20个关于iQC实践的多选择题.
- 结果被描述性地分析.
主要成果:
- 从27个实验室获得的响应率为43%.
- 在iQC方法中观察到显著的异质性,包括分析特征,6-Sigma,基于风险和替代方法.
- 使用虚拟分析仪模型 (89%) 和各种方法来确定标准偏差 (SD) 值是常见的.
结论:
- 在荷兰临床实验室之间,iQC实践存在很大差异.
- 未来研究和指导的关键领域包括SD值的确定,虚拟分析仪模型和分析仪等效性.
- 需要更新指南来规范和改进iQC程序.
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