Healthcare Safety Management: The Model of Fmea/Fmeca in Anatomic Pathology Service

Abstract

Safety is a universal concern in healthcare service management. In this context, patient safety can be defined as the absence of avoidable harm, because all health care activities bring inherent risk of adverse events (AE). Documenting and analyzing potential risks proactively is essential for improving patient safety. Accomplishing this goal requires an effective method to identify risks and an easily understood approach to manage them. Because of its complex nature, surgical pathology practice is inherently error prone: currently, pressure is done to reduce errors in several fields of healthcare, including pathology. This paper presents the failure mode and effects analysis (FMEA) tool applied to the whole set of activities in an Anatomic and Surgical Pathology Service of a University Hospital. After a wide search of scientific literature, a model was prepared to review main factors that contribute to error in this type of service. The use of a simulation method is also suggested, to increase results and obtain a more objective, comprehensive, and systematic panel to identify potential system risks. The model has been developed to conduct a FMEA as part of a wider strategy of risk reduction, based on a measure-analyze-implement-control methodology to improve the process of a surgical pathology laboratory and service. Failures were then analyzed for likelihood, severity, and discoverability of occurrence using the FMEA methodology and a high fidelity simulation was developed by creating scenarios based on actual sentinel events. Finally, attention has been paid to the preparatory steps of FMEA team assembly, given that FMEA successful completion is judged to be highly dependent on the team members' aptitude and on their commitment to hold regular, productive meetings. The developed model confirms to be a useful addition to the tool kit available to health professionals for assessing and improving the safety of health care processes. Abbreviations: FMEA: Failure Mode and Effect Analysis; FMECA: Failure Modes, Effects and Criticality Analysis; AE: Adverse Events