Practical aspects of the use of FMEA tool in clinical laboratory risk management

Abstract

Introduction: This paper presents the failure modes and effects analysis (FMEA) tool in a clinical laboratory through the introduction of new technology for blood gas and serum ionized calcium in multi-parameter analyzers such as Point of Care Testing (POCT). Objective: To present FMEA as a tool for risk managing and improvement with the introduction of new technologies in a public laboratory. Methods: The change of multiparameter gas analyzer type POCT was defined and described as a process. Subsequently, the criteria were presented to the risk assessment and its quantification. We studied the failure modes that might occur in this process. We established three action plans involving improvements to be made in the technological change. FMEA was applied in two stages: at the beginning of the project and after the implementation of the proposed measures. Results: The first plan involved administrative measures related to the bidding process; the second preventive action involved the possibility of which supplier would win the bid by studying the efficiency of the analyzer and its impact on productivity; the third set of actions was directed to improvements in the relationship with the clinical staff in order to minimize occasional complaints. The last actions referred to employing new employees to meet the growing demand. Conclusion: FMEA proved to be a reliable tool for performance improvement, which proactively identifies, prioritizes and mitigates patient risks.

Application of failure mode and effects analysis to minimize quality failures in clinical biochemistry laboratory

“…Reported quality failures assigned values from 1 to 5 based on severity (S), occurrence (O) and detection (D) as given in Table 1. 10 Risk priority number (RPN) was calculated from severity, occurrence and detection scores (RPN = SI x OI x DI). RPN is helpful in identification of high risk failures modes requiring priority measures.…”

Análisis de riesgos en la industria farmacéutica: Desarrollo de un procedimiento operativo estandarizado en una empresa farmacéutica de Costa Rica

“…Como complemento, se necesitaban incluir las definiciones de riesgo y FMEA. Esto último para tener una comprensión acerca de cuál era la problemática del riesgo, pues se trata de un suceso que produce un efecto negativo, sea directo o indirecto, que es capaz de poner en riesgo la seguridad y la salud de la persona, afectando la imagen de la empresa o generando costos adicionales a los que habitualmente forman parte del proceso o producto (Mendes et al, 2013). También se tenía que adicionar el papel que tendría el uso de la herramienta FMEA en su análisis como una técnica organizada para la identificación de modos de falla críticos, causas de dichas fallas y efectos en el producto o proceso de interés (Rastayesh et al, 2020).…”

Risk Management in Clinical Laboratory: from Theory to Practice

“…FMEA and FTA should be applied together to assess all the possible failure paths and also the modalities to reduce them. Laboratory tests ensure approximately 70% of the medical decisions, so that the time until the release of the results and its accuracy are critical for the diagnosis and the efficiency of the treatment [1]. Although laboratory errors rate is small in comparison with the performed examinations, its importance for the health and safety of the patients are relevant [14].…”

“…• phase 1 -the initial contact with FMEA, during this period the tool and its applications are only partially understood; • phase 2 -the learning stage of FMEA when we are aware of its importance; • phase 3 -the proper built up of FMEA with improvements in its preparation and without the application of the action plans; • phase 4 -managers realize that preventive actions identified by FMEA help to change the systems and processes, improving in this way their work and products; • phase 5 -the processes have been adopted and FMEA becomes subject of insecurity [1]. In the clinical laboratory all the errors must be quantified and controlled by the means of quality indicators.…”

“…RPN limit where actions like prevention, minimizing or excluding the risk are essential, must be established by the laboratory. (The laboratory should decide the assessing scale of frequency, the severity and errors detection, this being different for each test) [1,17].…”