对于INR警报值的实验室风险管理
Oana Roxana Oprea1,2, Ana-Maria Fotache3, Corina-Maria Rus3
1Department of Laboratory Medicine, Faculty of Medicine, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142, Targu Mures, Romania. oana.oprea@umfst.ro.
Scientific reports
|August 28, 2025
概括
在临床实验室中,高国际标准化比率 (INR) 预警值 (> 4. 5) 构成不可接受的风险. 这项研究强调了频繁发生的情况和严重的后果,需要改善实验室控制措施以确保患者的安全.
科学领域:
- 临床实验室科学
- 医疗诊断
- 患者安全
背景情况:
- 国际标准化比率 (INR) 对于监测维生素K抗剂治疗至关重要.
- 实验室INR警报值的有效管理对于最佳的患者护理至关重要.
- 评估与INR警报值相关的风险水平对于改善临床实验室的质量至关重要.
研究的目的:
- 在第三级医院的实验室中评估国际标准化比率 (INR) 警报值的风险水平.
- 将观察到的INR警报值风险与已确定的基准值进行比较.
- 确定导致INR警报值的潜在原因和故障模式.
主要方法:
- 在12个月内 (2023年9月至2024年8月) 分析了42,799个血样本的INR值.
- 使用风险评估矩阵对INR值>4.5的风险水平进行评估.
- 计算每日发生INR警报值的概率.
- 评估临床实验室内的样品运输和记录实践.
主要成果:
- 在42,799个样本中,347个样本 (0. 81%) 显示了INR警报值 (> 4. 5).
- 由于高频率 (每天发生0. 95) 和危险后果,INR警报值> 4.5 被归类为不可接受的风险水平.
- 潜在的故障模式包括不完整的通信文档和显著的重新采样延迟 (> 30% 的病例为 6 小时).
结论:
- 在临床实验室环境中,INR 预警值> 4.5 代表重大且不可接受的风险.
- 该研究确定了特定的故障模式,如文档缺口和样本处理延迟,导致不可接受的INR值.
- 建议实验室实施严格的控制措施,以减轻与关键INR预警值相关的风险.
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