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1Radiation Safety Office, University of Pittsburgh, G-7 Parran Hall, 130 DeSoto Street, Pittsburgh, PA 15261, USA. msheetz@pitt.edu
Health Physics
|January 7, 2009
Summary
A University of Pittsburgh Medical Center gamma knife facility faced Nuclear Regulatory Commission (NRC) scrutiny over physical presence requirements. An Alternative Dispute Resolution (ADR) led to a regulatory violation agreement and industry-wide notification to prevent recurrence.
Area of Science:
- Medical Physics
- Nuclear Regulatory Affairs
- Radiation Safety
Background:
- An invited visit by Nuclear Regulatory Commission (NRC) officials to the University of Pittsburgh Medical Center (UPMC) gamma knife facility revealed potential non-compliance with physical presence requirements (10 CFR 35.615(f)(3)).
- This observation triggered an inspection and investigations by the NRC Office of Investigations (OI), identifying three apparent violations.
- The University of Pittsburgh requested an Alternative Dispute Resolution (ADR) session to address the alleged violations and enforcement actions.
Purpose of the Study:
- To resolve disputes regarding alleged violations of physical presence and written directive requirements in a gamma knife facility.
- To determine appropriate enforcement and corrective actions following an NRC inspection.
- To share lessons learned from a regulatory incident to improve industry-wide radiation safety practices.
Main Methods:
- An NRC inspection and subsequent investigations were conducted.
- An Alternative Dispute Resolution (ADR) mediation session was held between the University of Pittsburgh and the NRC.
- A final disposition was agreed upon, resulting in a single violation of 10 CFR 35.24(b).
Main Results:
- The licensee and NRC agreed to a resolution involving a single violation of 10 CFR 35.24(b).
- The Radiation Safety Officer was found to have failed in ensuring consistent adherence to physical presence requirements (10 CFR 35.615(f)(3)) and proper signing of written directives (10 CFR 35.32).
- The licensee committed to implementing corrective actions and informing other institutions about the incident to prevent future occurrences.
Conclusions:
- The ADR process facilitated a resolution for regulatory compliance issues at the UPMC gamma knife facility.
- The incident underscores the importance of strict adherence to physical presence and written directive protocols in radiation therapy.
- Sharing this event aims to enhance regulatory compliance and safety standards across the nuclear medicine industry.
