Serafini A, Troiano G, Franceschini E, Calzoni P, Nante N, Scapellato C
MD, Post Graduate School of Public Health, University of Siena, Italy.
Laboratory Technician, Clinical Pathology Unit, "Le Scotte" Teaching Hospital, Siena, Italy.
Ann Ig. 2016 Jul-Aug;28(4):288-95. doi: 10.7416/ai.2016.2108.
Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process.
We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority.
The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100.
This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.
风险管理是一套识别或鉴定风险、错误及其后果，并采取措施应对的行动。我们研究的目的是将失效模式、影响及危害性分析（FMECA）应用于活化蛋白C抵抗（APCR）检测，以便在这一过程中发现并避免错误。
我们组建了一个团队，将该过程分为多个阶段和子阶段。对于每个阶段，我们计算了错误发生概率（O）、可检测性得分（D）和严重性（S）。这三个指标的乘积得出风险优先数（RPN）。RPN较高的阶段需要采取优先级更高的纠正措施。
RPN的计算表明，超过20项活动的得分高于150，需要采取重要的预防措施；8项活动的得分在100至150之间。只有23项行动获得了低于100的可接受分数。
这是将FMECA分析应用于实验室流程的首批经验之一，也是将该技术应用于鉴定凝血因子V莱顿突变的首次经验，我们的结果证实FMECA可能是风险管理中一种简单、强大且有用的工具，有助于快速识别实验室流程中的关键因素。
