Instructions for Adding a Site for Medical Use - Radioactive Materials
Moving to a new location will require a request with varying information depending on whether the location is within the same building, ownership of the facility and the type of use planned.
Interior remodeling of an authorized diagnostic room without changing walls, access or ventilation scheme would not require an amendment to your license. Additionally, no discussion of survey locations and safety procedures is needed unless there is a change in those procedures of practices.
Only use locations that are fully described will be authorized by the license. Therefore, areas such as nuclear stress labs, storage areas, or operating rooms used for implants, etc., will need to be described even if radioactive material is only periodically used in the area.
It is suggested that designs of a proposed facility be submitted to the BRC for approval while in the planning stage. This will prevent expensive remodeling should any recommendations be made prior to approval of the design. Bureau of Radiation Control guidance can be found in Appendix E of Regulatory Guide 3.1 - Medical Use of Radioactive Material (PDF, 149KB).
Required Information to Add a New Site
The following criteria should be considered depending on the use authorized:
- If moving, identify the building's name, physical address, floor of occupancy, restricted areas and occupancy of adjacent nonrestricted rooms.
- If the space is rented or leased, an affidavit from the owner is needed acknowledging the presence and use of radioactive material at the physical address being use.
- Submit drawings of the facility with sufficient detail to evaluate traffic flow, engineered controls, equipment and surroundings. A minimum of two drawings is typical, one floor plan and one enlarged drawing of the proposed use/storage areas.
- The floor plan should outline the path of radioactive material transport to a temporary stress lab or permanent storage area. No drawing is needed when requesting temporary injection sites as various patient treatment areas.
- Identify within the enlarged drawing all fixed radiation detection equipment, work counters, fixed safety equipment, shielding, decontamination sinks, areas of use or storage and adjacent areas.
- Provide information that floors and counters are of a material design appropriate for non-contained radioactive material.
- Describe how restricted rooms are secured and how access is limited. Explain if restricted areas are dedicated to cyclotron material use.
- Describe the traffic flow and how the layout will minimize traffic into or through restricted areas.
- Describe the space and shielding used to deal with typical waste needs and/or higher energy radionuclides.
- Shielding. Typically, sufficient labeling on the drawing is adequate for most diagnostic areas. Additional discussion and evaluations must be submitted to warrant sealed source therapy storage and or use.