Rezaei Fatemeh, Yarmohammadian Mohmmad H, Haghshenas Abbas, Fallah Ali, Ferdosi Masoud
Department of Health in Disasters and Emergencies, Isfahan University of Medical Sciences, Isfahan, Iran.
Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Int J Prev Med. 2018 Jan 29;9:7. doi: 10.4103/2008-7802.224046. eCollection 2018.
Methodology of Failure Mode and Effects Analysis (FMEA) is known as an important risk assessment tool and accreditation requirement by many organizations. For prioritizing failures, the index of "risk priority number (RPN)" is used, especially for its ease and subjective evaluations of occurrence, the severity and the detectability of each failure. In this study, we have tried to apply FMEA model more compatible with health-care systems by redefining RPN index to be closer to reality.
We used a quantitative and qualitative approach in this research. In the qualitative domain, focused groups discussion was used to collect data. A quantitative approach was used to calculate RPN score.
We have studied patient's journey in surgery ward from holding area to the operating room. The highest priority failures determined based on (1) defining inclusion criteria as severity of incident (clinical effect, claim consequence, waste of time and financial loss), occurrence of incident (time - unit occurrence and degree of exposure to risk) and preventability (degree of preventability and defensive barriers) then, (2) risks priority criteria quantified by using RPN index (361 for the highest rate failure). The ability of improved RPN scores reassessed by root cause analysis showed some variations.
We concluded that standard criteria should be developed inconsistent with clinical linguistic and special scientific fields. Therefore, cooperation and partnership of technical and clinical groups are necessary to modify these models.
失效模式与效应分析（FMEA）方法是一种重要的风险评估工具，也是许多组织认可的要求。为了对故障进行优先级排序，使用了“风险优先数（RPN）”指标，特别是因为它便于对每个故障的发生、严重程度和可检测性进行主观评估。在本研究中，我们试图通过重新定义RPN指标使其更贴近实际，从而应用更适合医疗保健系统的FMEA模型。
本研究采用定量和定性方法。在定性领域，采用焦点小组讨论收集数据。采用定量方法计算RPN得分。
我们研究了患者在外科病房从等候区到手术室的就医过程。基于以下两点确定了最高优先级的故障：（1）将纳入标准定义为事件的严重程度（临床影响、索赔后果、时间浪费和财务损失）、事件的发生（时间单位发生率和风险暴露程度）以及可预防性（可预防程度和防御障碍）；（2）使用RPN指标量化风险优先级标准（最高发生率故障的RPN为361）。通过根本原因分析重新评估的改进后RPN得分的能力显示出一些差异。
我们得出结论，应制定与临床语言和特殊科学领域不一致的标准。因此，技术和临床团队的合作与伙伴关系对于修改这些模型是必要的。
