失效模式和效果分析如何改善ART中心的工作流程?
Sanja Vujisic1, Karolina Poljak Panic1, Tihana Grcic1
1BetaPlus Center for Reproductive Medicine, Ulica Charlesa Darwina 6H, 10 000 Zagreb, Croatia.
European journal of obstetrics, gynecology, and reproductive biology
|September 1, 2024
概括
在辅助生殖技术 (ART) 中心实施故障模式和效应分析 (FMEA) 显著降低了风险. 电子见证系统和员工教育改善了患者和样品的可追溯性,最大限度地减少了ART程序中的关键错误.
科学领域:
- 生殖医学与神经病理学
- 医疗保健中的质量管理系统
背景情况:
- 辅助生殖技术 (ART) 中心和试管婴儿实验室处理涉及患者及其性腺/胚胎的复杂日常操作.
- 将错误和不符合性最小化至接近零对于患者安全和ART的成功结果至关重要.
- 系统的风险管理方法对于识别和减轻这些高风险环境中的潜在故障至关重要.
研究的目的:
- 在ART中心和试管婴儿实验室内建立一个强大的风险管理系统.
- 定义明确的流程步骤,以预防和消除问题和不符合性.
- 评估实施的纠正措施在减少发现的风险方面的有效性.
主要方法:
- 应用了故障模式和效应分析 (FMEA) 来分类和评估ART中心 (临床程序,表格,识别,人员,患者,设施) 和试管婴儿实验室 (消耗品,媒体,设备,人员,工作空间,程序) 过程中的风险.
- 使用严重性 (S),发生率 (O) 和检测率 (D) 的指数 (尺度为1-5) 计算风险优先级数 (RPN),截止值为≥12.
- 在实施纠正措施之前和之后评估可追溯性和安全性,包括电子见证系统和人员教育.
主要成果:
- 在诸如胚胎移植,知情同意,空间条件,患者/生物样本识别和ART程序等关键领域确定了高RPN得分.
- 实施电子见证系统显著降低了患者和样本追踪的RPN得分 (例如,从20到10).
- 工作人员的教育和改进的程序也有助于大幅减少RPN,特别是在关键的ART步骤,如胚胎移植和冷保存.
结论:
- FMEA是识别ART中心和试管婴儿实验室中关键风险点的有效工具.
- 电子见证系统在提高患者可追溯性和降低相关风险方面取得了成功.
- 虽然FMEA具有价值,但其应用受组织特点,遵守指南以及风险评估的主观性质的影响.
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