U.S. Nuclear Regulatory Commission
License Requirements Which Stipulate Specific Individuals
Title: License Requirements Which Stipulate Specific
See the memorandum from L. B. Higginbotham to A. B. Davis
dated February 7, 1979. The memo provides guidance for
handling noncompliance involving unauthorized users at
hospitals. Non-compliance cases involving a critical
service to the public require a decision based on reasoned
judgement. The memo is essentially presented in its
Your memorandum of January 17, 1979 distinguished the RSOs
from the users of radioactive materials named on
university, hospital and radiography licenses. While the
RSO function of health and safety is important, our primary
concern should be with the actual users of the material.
We have no problem with university and radiography
licensees ceasing operations until they recruit and are
authorized by NMSS to permit work with new users and RSOs.
However, it is not the fault of NMSS if licensees fail to
request amendments for new users and RSOs, and IE should
not request NMSS to expedite approvals because the licensee
did not submit a timely request. Any request for
expediting NMSS actions should come from the licensee, and
it is up to NMSS to decide whether it will expedite action
on the request. With respect to what IE should do in these
situations, an IAL is appropriate as an initial step.
In theory, hospitals should be handled the same way;
however, we all realize that an immediate action to shut
down a hospital could have an effect on patient treatment
by not allowing a physician the use of certain nuclear
medical tools. On the other hand, as you have indicated,
if we are aware that a licensee is operating in
noncompliance and something adverse happens to a patient or
a worker we could be held accountable for taking no action.
Consequently, in situations involving nuclear medicine
programs, the decision on a course of action must be
tempered with reasoned judgement. The following guidance
1. Cases involving unauthorized users in a nuclear
medicine program should be brought to the attention of
Headquarters. Each case will probably be different, so
they should be handled on a case-by-case basis.
2. During inspections we should be primarily concerned
with users of the material, and secondarily with the RSOs.
3. We should try to determine if the "unauthorized
user" appears to have the requisite qualifications to be
named as an authorized user; if not, it would be
appropriate to take action to require immediate shut down
of the operation - considering carefully the impact on
4. If the "unauthorized user" appears qualified and
the program otherwise appears to be operating within
regulatory requirements, the hospital should be told to
send in an application to NMSS with a request to expedite
5. If there are no patients undergoing treatment, an
immediate requirement should be imposed to cease the
6. If patients are in the middle of a series of
treatments, this should not be stopped (see some
alternative considerations below).
7. New patients should not be accepted for the
program; they should be referred to another hospital with
a similar program.
8. Again, the use of an IAL would be appropriate for
an initial action.
Further considerations should include transfer of patients
undergoing treatment to another hospital, provided that the
hospital is nearby, consultation between the two hospitals
can be accomplished, and the patient can be moved. Another
consideration should be to ascertain whether only
diagnostic procedures are performed (less hazardous than
therapeutic treatment) and to ascertain the probability of
improper diagnoses (by an inexperienced user) and the use
of improper drugs. These considerations and others that
may come to mind in handling a case are important, and some
of them should be discussed with the licensee.
In summary, we (1) emphasize that the cases involving a
critical service to the public will require a decision
based on reasoned judgement, and (2) request that these
sort of cases be promptly discussed with Headquarters.
Regulatory references: License Conditions
Subject codes: 1.3, 12.7
Applicability: Byproduct Material