Warnick Ronald E, Lusk Amy R, Thaman John J, Levick Elizabeth H, Seitz Andrew D
Mayfield Clinic, Cincinnati, OH, USA.
Gamma Knife Center, Jewish Hospital-Mercy Health, Cincinnati, OH, USA.
J Radiosurg SBRT. 2020;7(2):115-125.
This risk analysis describes our Failure Mode and Effects Analysis (FMEA) for Gamma Knife stereotactic radiosurgery at our community hospital. During bi-monthly meetings over 5 months, our FMEA team mapped a detailed Gamma Knife process tree and identified potential failure modes, each were scored a Risk Priority Number (RPN) for severity, occurrence, detectability. In our process tree of 14 subprocesses and 177 steps, we identified 31 potential failure modes: 7 high scoring (RPN o150) and 3 modes (<150) selected by clinicians for mitigation strategies. Eighteen months later, rescoring of high-risk failure modes showed significant reduction in RPN scores, thus confirming the benefit of our FMEA mitigation strategies. Our study provides a roadmap to achieve high-quality Gamma Knife radiosurgery that can be utilized by new centers as a starting point for their quality management program. Five quality control documents were developed that can be customized by any Gamma Knife center.
本风险分析描述了我们社区医院伽玛刀立体定向放射外科手术的失效模式与效应分析（FMEA）。在5个月的双月会议期间，我们的FMEA团队绘制了详细的伽玛刀流程树，并识别出潜在失效模式，每个模式都根据严重程度、发生概率、可探测性进行了风险优先数（RPN）评分。在我们包含14个子流程和177个步骤的流程树中，我们识别出31种潜在失效模式：7个高评分（RPN≥150）以及临床医生选择用于缓解策略的3个模式（RPN<150）。18个月后，对高风险失效模式重新评分显示RPN分数显著降低，从而证实了我们FMEA缓解策略的益处。我们的研究提供了一条实现高质量伽玛刀放射外科手术的路线图，新中心可将其作为质量管理计划的起点。我们制定了5份质量控制文件，任何伽玛刀中心都可对其进行定制。
