HPPOS-156 PDR-9111220130

Apparent Unauthorized Use of Byproduct Material, Resurrection Hospital, Chicago, Illinois

See the memorandum from L. B. Higginbotham to J. M. Allan dated August 14, 1975. If a licensee administers a radiopharmaceutical for an authorized procedure, it may conduct additional unauthorized procedures, provided that additional administrations are not given. HPPOS-313 contains a related topic.

An interpretation of what constitutes a venogram in nuclear medicine was sought. A venogram is defined as blood vein imaging that includes both blood pool imaging and blood flow studies. For all practical purposes, these two studies are inseparable; that is, blood pool images will also define the rate of blood flow depending on the presence of embolisms in the venous system being imaged. Such embolisms could include blood clots in the veins. Venous imaging is usually necessary to evaluate the outcome of lung scans and is commonly used in conjunction with lung scans.

If a licensee administers a radiopharmaceutical for a license-authorized procedure, it may conduct any number of additional procedures whether they are authorized or not provided that additional administrations are not performed for purposes of the unauthorized procedure (although additional administrations may be needed for the authorized procedure). The basis for the above is that once a dose is administered to a patient for a procedure that is authorized, no additional harm from radioactive materials can result to the patient during the conduct of other medical procedures. Of course, administering a dose solely for an unauthorized procedure is in noncompliance with NRC regulatory requirements.

The above interpretation has the concurrence of OELD and DBER.

Regulatory references: License Conditions

Subject codes: 3.8

Applicability: Byproduct Material