U. S. NUCLEAR REGULATORY COMMISSION
OFFICE OF PUBLIC AFFAIRS, REGION IV
Walnut Creek Field Office
1450 Maria Lane, Walnut Creek, CA, 94596
|CONTACT:||Mark Hammond (Phone: (510) 975-0254, E-mail: email@example.com)|
CONTACT: Mark Hammond
April 2, 1997
The Nuclear Regulatory Commission staff has proposed a $2,500 fine against Fairbanks Memorial Hospital in Fairbanks, Alaska, for an apparent violation of NRC requirements that resulted in a patient receiving a dose of iodine-131 that was significantly more than prescribed.
The NRC cited the hospital for a failure to have a written directive signed by an NRC-authorized hospital physician for the administration of iodine-131 to a patient on June 20. The directive should have specified the type of radiopharmaceutical and dosage to the patient.
The hospital's radiation safety officer (RSO) incorrectly filled out a written directive, and failed to have an authorized physician review and sign it to ensure its accuracy, as required. The RSO misadministered a dose of 6.6 millicuries of iodine-131 to the patient. The woman should have received a dose of 100 microcuries. (Six millicuries equals 6,000 microcuries; a curie is a measure of radiation).
An NRC medical consultant, after reviewing the misadministration, determined that its effect on the patient's health should be negligible, with no long-term disability. The smaller 100 microcurie dose was intended for a localized thyroid scan. The higher 6.6 millicurie dose would be used for a whole-body thyroid scan.
``The NRC has concluded that the RSO (radiation safety officer) deliberately proceeded with the administration of this dosage to the patient without the signature of the authorized user on the written directive, which serves as a check to verify that the dosage is correct,'' Ellis W. Merschoff, Regional Administrator of NRC Region IV in Arlington, Texas, said in a letter to the hospital.
``The RSO stated that he did this because he noted that the patient was apprehensive and he feared that the patient would not tolerate the time delay required to obtain the physician's signature,'' Mr. Merschoff said. ''However, the RSO's actions circumvented the very purpose of having an authorized user sign and complete the written directive, as well as the intent of the hospital's NRC-required quality management program.''
Mr. Merschoff credited the hospital for identifying the misadministration and promptly reporting it to the NRC, as well as taking corrective actions designed to prevent recurrences.
The NRC has categorized the violation as Severity Level III. The agency's enforcement system uses four Severity Levels, with Level I being the most serious. The hospital has 30 days to respond to the NRC's citation, during which time it may pay the penalty or protest it. If the protest is denied, the hospital may ask for a hearing.