The administration of oncological medications represents a high-risk medical procedure where clinical errors can result in fatal patient outcomes. Failure Mode, Effects and Criticality Analysis (FMECA) is a well-established methodology for identifying and preventing latent systemic risks, and its efficacy has been demonstrated across diverse sectors, including healthcare delivery. The objective of this investigation was to identify potential vulnerabilities in the prescription and administration phases of oncology treatments to facilitate the implementation of targeted preventive interventions. This investigation utilized a prospective FMECA methodology. A working group of public health resident physicians from the University of Padua analyzed the clinical chemotherapy workflow. This analysis was conducted in collaboration with an interdisciplinary panel from the Veneto Institute of Oncology (a designated comprehensive cancer center) alongside two regional provincial hospitals. A process map was constructed to delineate 9 distinct phases of the chemotherapy continuum, spanning from the initial formulation of the treatment plan to final drug administration, to identify all potential failure modes. Criticality scores were determined by evaluating severity, frequency, and detection probability using modified versions of validated, previously published assessment scales. Corresponding clinical safety strategies were subsequently formulated and synthesized. The analysis revealed 22 distinct failure modes distributed across the sequential stages of the oncological care process, with 7 specific failure modes categorized as high risk. Every phase within the chemotherapy delivery workflow was determined to be potentially vulnerable, and at least one corrective intervention was developed for each identified high-risk failure mode. To mitigate root causes or enhance the detection probability of these failures, a comprehensive set of 10 systemic recommendations was formulated. FMECA serves as an effective, proactive tool for uncovering latent vulnerabilities in high-risk clinical processes. Practical safety strategies were successfully established for every high-risk failure mode identified during the analysis.
