Proactive evaluation of clinical risk: a FMECA analysis in pediatric chemotherapy.

Abstract

In 2010-2011, we used FMECA to prospectively assess risk-management in chemotherapy of children with cancer, in a third level Italian children's Hospital (Ospedale Pediatrico Bambino Gesù; OPBG). We designed a flow chart representing the entire process; we described potential failure points for each step of the process, as well as their potential underlying causes. We calculated the risk priority number (RPN) of each failure point based on the severity of the failure, the frequency of occurrence, and the likelihood of detecting the failure prior to completion of the process. All FMECA activities were supported by a web-based tool. The highest RPN values were observed for failure points of the paper-based chemotherapy medication orders sent from clinicians to Pharmacy, the transcription of the orders into the Pharmacy paper-based work-sheet for medication preparation, and the selection of medications to be used for chemotherapy preparation. Causes of these failures were mostly related to illegible or incomplete handwriting. As a consequence of these results, the implementation of an electronic ordering process for children's chemotherapy medications was proposed as risk-reducing action.