Becoming an Authorized User of Radiopharmaceuticals
Janis P. O'Malley
In an article in the August issue of AJR, a team of radiologists from the UAB School of medicine outlined the requirements for becoming an authorized user of radiopharmaceuticals.
InBrief talked with team lead Janis P. O'Malley about the article.
Who can become an authorized user?
The Nuclear Regulatory Commission (NRC) has set up processes to ensure that scientists, physicians, physicists, dentists, and others who use unsealed and sealed sources of radiation (e.g., radiopharmaceuticals for human use) are properly trained, certified, and supervised.
What are the steps to becoming an authorized user?
There are two main pathways to becoming an authorized user.
The first is to document training and education, including details of the type, dates, and time spent on various didactic, laboratory, and supervised clinical experience necessary to meet NRC requirements. This experience is documented on forms provided by the state or by the NRC (313A AUT and 313A AUD). The forms are submitted, along with an attestation letter by the authorized user who has supervised that training, to the radiation safety officer (RSO) at the site.
Most physicians can now use the board certification pathway instead, by checking the appropriate boxes on the NRC forms indicating that they have met the requirements of a recognized board (e.g., the American Board of Nuclear Medicine, the American Board of Radiology, and the Nuclear Cardiology Board). The supervising authorized user attests to the board that the applicant has completed all of the appropriate training. The forms, along with a copy of the board certificate and any attestation letters required by the RSO, are submitted to the site’s radiation safety committee. If the committee votes to add the applicant to a radiation license, the applicant becomes an authorized user.
What questions should a new radiologist ask prospective employers about the quality and safety of their facilities?
Radiologists who will be handling unsealed sources of radiation should understand how radiation safety measures are implemented and monitored at the facility. They should ask how the facility ensures that only trained professionals handle radiopharmaceuticals throughout the facility, as negligence in any area could jeopardize the radiation licenses for all. They should observe hot lab facilities and areas for disposal and storage of radiopharmaceuticals, as well as shielded areas for therapy and processes for radiopharmaceutical receiving.
After working for some years, many radiologists decide to start their own nuclear medicine practices. How should they begin that process?
Many radiologists in a group practice work under the umbrella of one or two authorized users. Because states vary in their requirements to become an authorized user, it is important that radiologists who wish to start a practice determine whether they meet the criteria for supervising a facility.
They will need to establish or join a radiation safety committee and apply to the state for a license and permission to operate, and may wish to hire a certified nuclear medicine technologist to maintain the logs and processes required for a safe and compliant facility. They must also ensure that the department structure meets the demands of a radiation safety program in terms of shielding, appropriate fume hoods, and locked doors (to prevent accidental exposure to the public).
What are the elements of a radiation safety program?
A radiation safety program protects employees and the public from the hazards of radiation. In a nuclear medicine department, the radiation safety program includes protocols for the receipt, storage, administration, and disposal of radiopharmaceuticals, and for the licensing of authorized personnel. Routine procedures for monitoring—such as daily wipe and camera flood tests—are established, as are procedures for handling major and minor spills.
Supervising certified technologists often monitor program effectiveness and are available for inspections from the RSO and the state; however, the authorized user on the license is ultimately responsible for the activities of those who work in the facility and who are on the authorized user’s license. Details can be found at the NRC web site: www.nrc.gov/materials/miau/med-use-toolkit.html.
Where can a radiologist find information about becoming an authorized user?
Information about becoming an authorized user can be found on the NRC web page. Specific information about 10 CFR part 35 can be found at www.nrc.gov/reading-rm/doc-collections/cfr/part035/.