U.S. Nuclear Regulatory Commission

License Requirements Which Stipulate Specific Individuals

HPPOS-182 PDR-9111210286

Title: License Requirements Which Stipulate Specific

Individuals

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

entirety.

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

is provided:

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

patient care.

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

approval.

5. If there are no patients undergoing treatment, an

immediate requirement should be imposed to cease the

operation.

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