U.S. Nuclear Regulatory Commission

Authorized Users' Supervision of Medical Programs

HPPOS-145 PDR-9111210386

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