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No: II-98-39 May 26, 1998
The Nuclear Regulatory Commission staff has proposed a $4,400 civil penalty against a physician at Manatí, Puerto Rico, for violations of NRC regulatory requirements related to the use of radioactive strontium-90 eye applicators for treatment of patients.
The NRC on May 22 notified Dr. José M. Colón Vaquer, a physician with offices at Manatí, that the penalty was being proposed because (a) between June 24, 1994 and March 5 of this year, a 91 millicurie strontium-90 eye applicator was used for administration of radiation doses to patients on approximately 131 occasions without preparation of required written directives; and (b) as of March 5, there was no dosimetry calculation and verification procedure to ensure that final treatment plans were in accordance with written directives. As a result, two misadministrations occurred on August 23 and September 27, 1994. Eight additional violations were identified for failure to implement various aspects of NRC licensed activities, but no additional civil penalty was proposed.
NRC officials said in the letter that the misadministrations were within normal treatment ranges but that the violations represented "a substantial programmatic failure" in the implementation of the physician's required quality management program.
The NRC also informed the physician that, since he had indicated intent to transfer or dispose of the licensed eye applicator, the agency will consider reduction of the proposed civil penalty to $2,200 if the device is properly disposed of or transferred in accordance with existing regulations within 90 days of the May 22 date of the letter.
Dr. Colón has 30 days in which to respond to the notice of the proposed civil penalty. He may either pay the penalty or protest all or part of its imposition.
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