Physical presence during gamma stereotactic radiosurgery

During an invited visit to the University of Pittsburgh Medical Center (UPMC) gamma knife facility, officials from the Nuclear Regulatory Commission (NRC) observed what they considered as an apparent violation of the physical presence requirements specified in 10 CFR 35.615(f)(3). This event initiated an inspection and two different but related investigations by the NRC Office of Investigations (OI). Based on the NRC inspection and investigations, the NRC identified three apparent violations that were under consideration for escalated enforcement. The University of Pittsburgh (licensee) requested an Alternative Dispute Resolution (ADR) session with the NRC to resolve issues related to whether a violation occurred, the appropriate enforcement action, and the appropriate corrective action. As a result of the ADR mediation session, the licensee and NRC agreed to final disposition of this matter by way of a single violation of the regulatory requirement in 10 CFR 35.24(b), whereby the licensee's Radiation Safety Officer failed to ensure that the physical presence requirements of 10 CFR 35.615(f)(3) were consistently met and failed to ensure that written directives were consistently signed by the Authorized User in accordance with 10 CFR 35.32. In addition to corrective actions the licensee had already taken to prevent recurrence, it also agreed to inform other licensees in the industry of this event, so that they may learn from this incident and take appropriate actions to assure that these types of violations do not occur at their institutions.