关于重新设计内部质量控制流程的实际考虑,以验证临床结果的可追溯性,用于决策
Weizhi Cheng1, Zhiwei Zhou1, Shengkai Yan2
1Qualab Biotech. Co., Ltd., Shanghai, P.R. China.
Journal of medical biochemistry
|August 14, 2024
概括
医疗实验室的计量可追溯性对于标准化结果至关重要. 本研究探讨了根据ISO 15189:2022的可追溯内部质量控制 (IQC) 材料用于真实性验证的使用挑战.
科学领域:
- 临床实验室科学 临床实验室科学
- 计量学 计量学 计量学
- 质量管理系统 质量管理系统
背景情况:
- 计量可追溯性对于协调和标准化实验室结果至关重要,确保不同测量系统的可比性.
- 国际标准化组织 (ISO) 15189认证要求推动医疗实验室进入计量可追溯的时代.
- 虽然校准仪对于可追溯性至关重要,但内部质量控制 (IQC) 材料的用于真实性验证的使用仍然是争论的主题.
研究的目的:
- 探索应用可追溯性概念在医疗实验室中用于真实性验证的IQC材料的实施挑战和操作障碍.
- 为满足2022年版ISO 15189标准关于IQC和计量可追溯性的要求.
- 确定制造商和实验室在采用这些可追溯性实践时面临的实际考虑和局限性.
主要方法:
- 审查有关医疗实验室计量可追溯性的当前实践和文献.
- 分析2022年ISO 15189标准对IQC和可追溯性的要求.
- 讨论获取和使用IQC材料用于真实性验证的实际挑战.
主要成果:
- 将可追溯性应用于用于真实性验证的IQC材料提出了重大实施挑战.
- 在从制造商那里购买和使用IQC材料时,存在实际考虑和限制.
- 2022年ISO 15189标准强调可追溯性,但其适用于IQC需要仔细导航现有约束.
结论:
- 将计量可追溯性应用于IQC材料的真实性验证是复杂的,并面临实际障碍.
- 承认制造商和实验室的局限性对于成功将这些概念纳入常规实践至关重要.
- 需要进一步的研究和合作来克服所确定的挑战,并充分实施医疗实验室IQC的可追溯性.
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