Risk management. Regulation and validation expert, Haifa, Israel.
Sheba Medical Center, Ramat Gan, Israel.
Am J Med Qual. 2023;38(1):23-28. doi: 10.1097/JMQ.0000000000000095. Epub 2022 Nov 15.
Failure mode and effect analysis (FMEA) is a leading tool for risk management in health care. The term "blanket" approach FMEA describes a comprehensive simultaneous look at the variety of interrelated factors that may directly and indirectly affect patient safety. Applying FMEA with the "blanket" approach is not common, due to FMEA's limitations. Algorithmic prediction of failure modes in health care (APFMH) is leaner and enables the application of the "blanket" approach, but, like FMEA, it lacks formal validation. The authors set out to validate the APFMH method while applying a "blanket" approach. They analyzed the sterile supply handling at a 1900-bed academic medical center. The study's first step took place in the operating room (OR) aspect of the process. An APFMH analysis was performed using the "blanket" approach, to identify the hazards and define the common root causes for predicted hazards. The second step took place a year later at the sterile supply and equipment department (SSED) and aimed to validate these root causes, thus validating the reliability of APFMH. The "blanket" approach analysis with the APFMH method consisted of categorization into 3 risk-dimensions: patient safety, equipment damage, and time management. Root causes were defined for 8 high-ranking hazards. All the root causes for failures, identified by APFMH at the OR department, were revealed as actual hazards in the processes of the SSED. The independent findings at the SSED level validated the list of identified hazards that was formed at the target department (ie, the OR). APFMH methodology is a lean in time and human resources process that ensures comprehensive hazard analysis, which can include the "blanket" approach, and which was validated in this study. The authors suggest using the APFMH methodology for any organizational analysis method that requires the inclusion of "blanket" approaches.
失效模式与影响分析（FMEA）是医疗保健风险管理的主要工具。术语“全面”方法 FMEA 描述了对可能直接和间接影响患者安全的各种相互关联因素的全面综合分析。由于 FMEA 的局限性，采用“全面”方法进行 FMEA 并不常见。医疗保健失效模式的算法预测（APFMH）更精简，并能够应用“全面”方法，但与 FMEA 一样，它缺乏正式验证。作者着手验证 APFMH 方法，同时采用“全面”方法。他们分析了一家 1900 张床位的学术医疗中心的无菌供应处理。该研究的第一步发生在手术过程的手术室（OR）方面。使用“全面”方法进行了 APFMH 分析，以识别危害并定义预测危害的常见根本原因。第二步在无菌供应和设备部门（SSED）进行了一年后，旨在验证这些根本原因，从而验证 APFMH 的可靠性。使用 APFMH 方法进行的“全面”方法分析分为 3 个风险维度：患者安全、设备损坏和时间管理。为 8 个高排名危害定义了根本原因。在 OR 部门通过 APFMH 识别的所有故障根本原因都被揭示为 SSED 流程中的实际危害。在 SSED 层面上的独立发现验证了在目标部门（即 OR）形成的已识别危害清单。APFMH 方法学是一种精简的时间和人力资源过程，可确保全面的危害分析，包括“全面”方法，本研究对此进行了验证。作者建议在任何需要包含“全面”方法的组织分析方法中使用 APFMH 方法学。
