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NEWS ANNOUNCEMENT: RIII-97-33 April 4, 1997 CONTACT: Jan Strasma Angela Dauginas
The Nuclear Regulatory Commission staff will meet April 10 with representatives of Midwest Imaging Diagnostic, Inc., Cincinnati, Ohio, for a predecisional enforcement conference on apparent radiation safety program violations.
The meeting will start at 1:00 p.m. in the Third Floor Conference Room of the NRC Region III Office, 801 Warrenville Road, Lisle, Illinois. It will be open to public observation.
An NRC inspection in February determined that the clinic treated four patients for hyperthyroidism using therapeutic quantities of sodium iodide iodine-131. While the clinic's medical director is authorized by the NRC on another license to perform this treatment, the clinic's NRC license only allows diagnostic procedures to be conducted.
Radioisotopes are used in diagnostic procedures to provide x-ray type images of tissues and organs or as tracers to assist the physician in the diagnosis of a disease. Therapeutic treatment involves different procedures in that the radioisotopes are administered to treat a diagnosed disease. The NRC inspector also noted that the clinic did not, as required, have a written quality management program which details policies and procedures for the use of iodine-131.
Since the inspection, the clinic has applied to the NRC for a license amendment to allow the use of iodine-131 for therapeutic purposes. In the meantime, it has stopped conducting therapeutic treatments.
The decision to hold an enforcement conference does not mean the NRC has determined that a violation has occurred or that enforcement action will be taken. Rather, the purpose is to discuss apparent violations, their causes and safety significance; to provide the licensee an opportunity to point out any errors that may have been made in the NRC inspection report; and to enable the company to outline its proposed corrective actions.
No decisions on apparent violations or any contemplated enforcement action, such as a fine, will be made at this conference. Those decisions will be made by senior NRC officials at a later date.
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