Author: Robert A. Rodgers 👨🔬
Affiliation: Vanderbilt University School of Medicine 🌍
Purpose: Preparing for radioactive material (RAM) program audits or inspections can be stressful. A five-step method to ensure program compliance is described. This method is adaptable to implementing new medical RAM programs.
Methods: Step 1. Access the Nuclear Regulatory Commission’s (NRC) Medical Uses License Toolkit.1 Step 2. Select the Inspection link; review the applicable inspection procedure(s). Step 3. Review the clinic’s RAM license application, current license or permit, and previous inspection and audit reports. Together Steps 2 and 3 allows one to identify principal compliance requirements. Step 4. Confirm the licensing body (i.e., NRC or Agreement State2). It is recommended to first review the federal requirements (e.g. applicable Parts of the Code of Federal Regulations; available via the Toolkit, Regulations link) as these are the minimum program compliance requirements. One can identify any remaining and more restrictive items via respective Agreement State requirements. Step 5 (optional for established programs) consider available Guidance documents via the Toolkit link. Select the appropriate volume for the license type, usually volumes 9 or 11. Chapter eight of each document provides a comprehensive overview and requirements for the respective RAM license application. Agreement States provide similar and often less detailed documents but highlight restrictive requirements pertinent to that State.
Results: The five-step method was utilized for established and new high-dose rate brachytherapy programs. Over two years, each program underwent eight quarterly radiation safety audits and one biennial State Inspection, maintaining a compliant status (aka, passed with no violations).
Conclusion: This method was designed from an inspector’s viewpoint on compliance. It utilizes a government website that is maintained with current resources. The step-by-step method streamlines effort to ensure compliance and is adaptable to various medical RAM programs, established or new. This method is taught in our graduate and residency programs.
References:
1. https://www.nrc.gov/materials/miau/med-use-toolkit.html
2. https://www.nrc.gov/agreement-states.html