Using failure mode and Effects Analysis to increase patient safety in cancer chemotherapy

Medication errors may occur during chemotherapy and can have fatal consequences. Healthcare Failure Mode and Effects Analysis (FMEA) is a method used to detect potential risks and prevent them.

Aim of this study was to evaluate the medication process of intravenous tumor therapy in order to guarantee a high standard of patient safety.

The main part of the study was performed at the University Hospital of Bonn, Germany. After assembling a multidisciplinary team, the individual steps of prescription, compounding, transport, and administration of chemotherapy were mapped in a flow diagram. The possible failures were identified and analyzed by calculating the risk priority numbers (RPNs). Finally, corrective actions were developed and after hypothetical implementation re-analyzed to measure their effects on the process. Subsequently, a shortened FMEA based on the catalogue failure modes developed in Bonn was carried out at the University Hospital of Cologne in order to evaluate its transferability to another hospital.

A total of 52 potential failure modes was identified in Bonn. Relating to the RPNs the most critically steps in the process were associated with the prescription, namely, incorrect information about individual parameters of the patient; non-standardized chemotherapy protocols; and problems related to supportive therapy. A significant risk reduction for most of the failure modes was assessed by implementing suitable corrective actions. The shortened FMEA in Cologne led to a different ranking of failure modes.

The implementation of this analysis has not only identified various safety gaps, but also shows how patient safety during chemotherapy can be enhanced. Moreover, it has sensitized the practitioners to failure modes potentially occurring in their work routine.