Rossi Elio G, Bellandi Tommaso, Picchi Marco, Baccetti Sonia, Monechi Maria Valeria, Vuono Catia, Sabatini Federica, Traversi Antonella, Di Stefano Mariella, Firenzuoli Fabio, Albolino Sara, Tartaglia Riccardo
Tuscan Regional Centre for Integrative Medicine, Region of Tuscany, 50100 Florence, Italy.
Regional Centre for Clinical Risk Management and Patient Safety, 50100 Florence, Italy;
Medicines (Basel). 2017 Dec 16;4(4):93. doi: 10.3390/medicines4040093.
To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.
通过使用重大事件审计（SEA）和失效模式与效应分析（FMEA），对托斯卡纳地区顺势疗法和针灸中心的活动进行分析，制定一种系统的方法来检测和预防补充医学（CM）中的临床风险，并提高患者安全性。SEA是用于研究不良事件（AE）和检测预防我们地区医疗服务（RHS）未来事件的最佳解决方案的选定工具。这需要所有参与者和外部专家的积极参与以验证分析结果。FMEA是一种前瞻性风险评估工具，包括选择临床过程、多学科专家小组的参与、过程描述、识别每个步骤的失效模式（FM）、估计FM的发生频率、严重程度和可检测性、计算风险优先数（RPN）以及为预防FM而确定优先改进措施。在顺势疗法中，最大的风险取决于从对抗疗法转向顺势疗法治疗的决定。在针灸中，主要问题可能主要源于治疗延迟和针刺方式。SEA和FMEA的结合可以揭示患者潜在风险，并为CM中更安全、更可靠的服务提供建议措施。
