An Alternative to FMEA for Safety-Minded but Resource-Limited Radiation Oncology Departments
Abstract
Purpose
Quality and safety concepts have remained important to Radiation Oncology. Historically, adherence to strict and prescriptive quality assurance paradigms was prioritized, but attention has recently shifted towards prospective risk mitigation—including holistic review of processes and workflows; it is individualized to a center’s treatments, equipment, workforce, and community standards. The AAPM’s TG-100 Report is widely viewed as a standout model of how to introduce and apply these concepts in one’s own department. Many well-staffed and highly-resourced centers have successfully completed TG-100 style Failure Modes and Effect Analyses (FMEAs) to maximize the possibility of event-free success.
Methods
One relevant criticism is that departments without such ample resources are unlikely to be able to commit to such a time and personnel intensive review. As a group with significant FMEA experience, we explored other lesser-known safety paradigms as viable alternatives to FMEA, which therefore could be promoted to groups with a keen interest and awareness of safety principles, but lack the ability to complete a full FMEA.
Results
Emergent radiotherapy treatment is a high-stakes environment combined with a challenging scenario. Unsatisfied with vendor-provided solutions, we had sufficient in-house expertise to craft our own software solution, called the Sim-Free Wizard (SFW). We utilized the principles of Safe-By-Design (SbD) to vet its development, testing, and implementation. All phases of SFW were facilitated by a multidisciplinary team focused on developing practice-enhancing clinical software, primarily through incorporation of automations. Multiple built-in safety features were achieved. SFW requires the user to proceed through the workflow in a linear fashion, preventing individual steps from being bypassed or completed out of order. Audits of end user inputs were included to verify that performed steps are completed in accordance with expectations.
Conclusion
Using SbD principles, an in-house software was created to reduce the risk associated with emergent radiotherapy treatments.