Which of the following methods prospectively identifies vulnerabilities in a radiotherapy process and then ranks them according to risk?
Quality and Safety
Safety and Incidents
Failure mode and effects analysis (FMEA) is a tool that is recommended for process improvement in radiation oncology. Detailed descriptions have been published in the literature (Hug et al. IJROBP 2008) and AAPM TG-100 describes FMEA's application to a generic IMRT process.
FMEA prospectively considers what might go wrong during a specific radiation oncology process. Each process step may have several failure modes, and each mode may have several potential causes and outcomes. For each potential cause of failure, three specific values are defined between 1-10: O, the probability that a cause will result in failure, S, the severity of the effects of failure, and D, the probability that the failure mode resulting from a specific cause will go undetected. These three numbers are multiplied together to calculate the risk priority index (RPN). The RPN allows prioritization of failure modes so that quality improvement efforts can be directed towards the most severe failure modes that are most likely to go undetected.
Incident learning refers to the process of reporting a patient safety near-miss or adverse event, analyzing it in detail, and developing process improvements to prevent the error from happening again. This is a retrospective process.
Root cause analysis refers to a structured method for analyzing serious adverse events. This is also a retrospective process.
Kaizen refers to a quality improvement approach originally developed for Japanese manufacturing industries. The approach seeks to identify and address wasteful, defective, or non-value adding steps from a workflow process, such as radiotherapy planning. This approach has been used to improve the head and neck radiotherapy consultation and planning process (Kapur et al. PRO 2017).