A risk assessment of automated treatment planning and recommendations for clinical deployment

Using FMEA, we assessed the risks in the clinical deployment of an automated treatment planning workflow and showed that a specialized QA program for the RPA, which included automatic QA techniques, improved the detectability of failures, reducing this risk. However, some residual risks persisted, which were similar to those found in manual treatment planning, and human error remained a major cause of potential failures. Through the risk analysis process, we identified three key aspects of safe deployment of automated planning: (a) user training on potential failure modes; (b) comprehensive manual plan review by physicians and physicists; and (c) automated QA of the treatment plan.