License Condition, "... Used by or Under the Supervision of..."
See the Interpretive Guide from the IE Manual entitled as above and dated October 1, 1979. It provides guidance on the degree of supervision to be exercised by authorized users, including medical users. An authorized user need not be present at all times but must be readily available for consultation.
This guidance applies to all materials licensees except radiography; the requirements for supervision of radiographic operations are defined in 10 CFR 34. HPPOS-145 contains a related topic.
In developing the following interpretation with members of the NRC staff and OELD, it was concluded that it was impractical to try and define numerical times and distances with respect to supervision availability because of the wide variations in circumstances. Similarly, it was impractical to define the frequency of verbal orders or the performance of audits by supervision since these would depend in part on the degree of changes in operations, equipment, personnel, etc.
Therefore, considerable judgment by the inspector (s) in implementing the guidance will continue to be required.
An authorized user named on an NRC license is considered to be supervising the use of radioactive materials when he directs personnel in the conduct of operations involving the licensed material. This does not imply that the authorized user must be present at all times during the use of such materials. However, the authorized user / supervisor is responsible for assuring that personnel under his supervision have been properly trained and instructed.
The authorized user / supervisor is therefore responsible for the supervision of operations involving the use of radioactive materials whether he is present or absent. When absent, the authorized user should be available for consultation (by telephone) in a reasonable amount of time commensurate with the need for consultation, based on the adequacy of the training of those personnel under the user's supervision.
For medical programs, the supervising physician should be located sufficiently close to the hospital in the event he is needed to personally supervise a procedure or interpret the results of a procedure. "Sufficiently close" cannot be defined for the reasons stated above; but the supervisor should be in the same city as the activity or close to the city (if it is a small city or town) so that he can get to the facility in a reasonable period of time. (Many physicians use a paging system so they can be alerted to call a hospital if needed.) A supervisor that goes on vacation or cannot be reached is not considered to be supervising. Further, for physicians licensed to supervise, it is necessary that they be available to interpret the results of a medical procedure whether or not they actually perform the scans, give injections, etc.
Regulatory references: 10 CFR 30, 10 CFR 35, License Conditions
Subject codes: 1.3
Applicability: Byproduct Material