Navigating the Fragmented Landscape of Radiation Oncology Incident Reporting: A Framework for Regulatory Compliance,...

Radiation oncology incident reporting requires consideration of several parallel authorities and systems: Federal authorities governed through NRC Code of Federal Regulations, Agreement State regulations, additional state laws and regulations, voluntary reporting through incident learning systems such as the Radiation Oncology Incident Learning System (RO-ILS), and hospital enterprise safety platforms. Each system serves a distinct purpose and addresses a different audience. A single serious incident can activate multiple platforms simultaneously. Forty states have assumed Agreement State status with the NRC, and their reporting thresholds, timelines, and procedural requirements can differ substantially from the federal baseline. Many states have their own additional laws, regulations, and licensing requirements. Most hospital safety reporting systems were designed to capture and describe general medical incidents rather than radiation therapy incidents. As such, RO-ILS is a specialty-specific online safety tool administered through the Clarity Patient Safety Organization (PSO), with accompanying confidentiality and privilege protections outlined in the federal Patient Safety Act. The current goals of PSOs and incident learning systems are to reduce errors, improve quality, and promote safety. We describe the institutional model developed at UCLA, centered around the Quality and Safety Oversight Committee (QSOC) and a Medical Event Determination Committee (MEDC), which serves as an authoritative triage body for incident reportability determinations. The MEDC convenes within 24 hours of incident discovery, makes reportability determinations, and works with the institutional radiation safety officer to produce the necessary documents for reporting. This framework is replicable and adaptable to programs of any size.