U.S. Nuclear Regulatory Commission
Authorized Users' Supervision of Medical Programs
Title: 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