A centralized hybrid model for regulatory inspection readiness in a multi-site radiation oncology system.

Abstract

BackgroundState regulatory inspections of radiation-producing treatment equipment combine a review of quality assurance and regulatory records with direct verification of facility and safety systems. When these activities are performed entirely on-site across multiple facilities, real-time document retrieval can prolong visits and divert clinical staff.PurposeTo develop and evaluate a centralized hybrid framework that separates advance document review from focused on-site verification during state-mandated annual inspections of photon linear accelerators.MethodsThe framework was implemented across five photon treatment sites comprising 10 linear accelerators using an institutionally deployed cloud-based quality assurance platform (TotalQA, Image Owl Inc., Greenwich, NY). Site physicists uploaded machine- and site-specific records directly. A dedicated guest account allowed the inspector to review documents approximately 14 days before each visit. Document-verifiable items and photographs of required postings were reviewed remotely; audio/video monitoring systems, linac-on warning lights, staff access to applicable state regulatory requirements and personnel dosimetry records, written operating and emergency procedures, direct questions, and unresolved items remained on-site. A system-wide clinical deviation logbook containing protected health information was reviewed once in person at a central location. Operational outcomes included on-site duration, daily throughput, physicist support, schedule adherence, treatment impact, and inspection findings.ResultsHistorical inspections required approximately 120 min of on-site time per facility, based on calendar records, prior schedules, and staff recollection. During the hybrid implementation, on-site inspection time was approximately 30 minutes per facility based on records documented at the time of each inspection, representing an estimated 75% reduction. Daily throughput increased from approximately three sites per day to four sites per day. The inspector estimated that advance review required 1 to 2 h per site, generally closer to 2 h during the first cycle. All visits remained within scheduled blocks, no inspection-related treatment delays or interruptions occurred, and no documentation-related citations were identified.ConclusionsA centralized hybrid model was feasible for state-mandated annual inspections of linear accelerators in a multi-site radiation oncology system. Advance review reduced on-site document-navigation demands while preserving direct verification of physical and safety-related elements. Because remote-review time was estimated retrospectively, the findings support reduced on-site duration rather than reduced total inspector effort.