Authorized Users' Supervision of Medical Programs
See the memorandum from L. B. Higginbotham to J. H. Joyner (and others) dated December 23, 1981, and the enclosed memorandum from V. L. Miller to L. B. Higginbotham dated November 18, 1981.
These memos help to clarify the distinction between conditions in medical licenses that state "Licensed material shall be used by..." and "Licensed material shall be used by, or under the supervision of...."
The discussions provided by NMSS are helpful, but do not solve overall problems in distinguishing between compliance and non-compliance situations on matters relating to authorized users and their supervision in medical programs.
A person named as an authorized user on an NRC license is responsible for ensuring that radioactive materials are handled and used safely and in accordance with NRC regulations and the terms and conditions of the NRC license. For activities involving "human use" of licensed material, the person must be a physician (10 CFR 35.3).
"LICENSED MATERIAL SHALL BE USED BY _____."
This condition is used on private practice licenses (i.e., those issued pursuant to 10 CFR 35.12). The authorized physician-user has all of the responsibilities of an authorized user on any NRC license. In addition, he/she has the responsibilities listed in the proposed 10 CFR 35.32 (b). He/she may delegate (or direct) certain activities of properly trained paramedical personnel.
"LICENSED MATERIAL SHALL BE USED BY, OR UNDER THE SUPERVISION OF _____."
This condition is used primarily on institutional licenses issued pursuant to 10 CFR 35.11, and provides a means whereby unauthorized physicians, under the supervision of an authorized physician-user, can obtain training to enable them to qualify as authorized users. The authorized physician-user has all the duties and responsibilities outlined above, plus, he may provide clinical training for unapproved physicians and delegate to them the activities listed in 10 CFR 35.32 (b). Physicians working "under the supervision of" an authorized physician-user should be physicians-in-training. For short periods of time, a physician may work "under the supervision of" an authorized user while the license is being amended to add his name as an authorized user.
An authorized physician-user has the same responsibilities as an authorized user on non-medical licenses (e.g., ensuring radioactive materials are handled and used safely and in accordance with NRC regulations and the terms of the NRC license, and ensuring that personnel such as technologists and physician-trainees have appropriate training and instruction).
The authorized physician-user is expected to manage the medical program authorized by the license, to set up the clinical parameters to be used by the personnel he supervises with regard to patient selection, dose selection, clinical interpretation and, at a minimum, to closely review the radiation safety procedures used by, and the diagnostic and/or therapeutic procedures performed by the supervised physician trainee.
One of the authorized physician-users should be present on the licensee's premises for ongoing and reasonable periods of time. If none of the authorized users are present, one of the users should be available by telephone and should be able to get to the licensee's facility within a short time to handle any emergency. If authorized physician-users are ill, or otherwise unable to fulfill the responsibilities described above and in 10 CFR 35.32 (b), they should not be considered as supervising or directing other personnel. A physician, not necessarily one of the authorized users, must be readily accessible when radioisotopes are administered (e.g., to treat anaphylactic shock) pursuant to 10 CFR 35.32 (b).
Regulatory references: 10 CFR 35, License Conditions
Subject codes: 1.3
Applicability: Byproduct Material