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I-98-56
May 15, 1998
The Nuclear Regulatory Commission has proposed a $2,750 fine against Altoona Hospital, in Altoona, Pa., for a violation of agency requirements involving the medical use of NRC-licensed radioactive materials.
NRC is taking the action based on the findings of an inspection conducted at the facility on March 9 and 10, as well as on information provided by hospital officials at a predecisional enforcement conference held on April 30 at the NRC Region I office in King of Prussia, Pa.
The NRC determined that the hospital administered iodine-131 in quantities greater than 30 microcuries without first preparing a written directive, or prescription, specifying how the radiopharmaceutical would be used and in what amount. All told, seven patients were administered 3 millicuries (one millicurie is equal to 1,000 microcuries) each of iodine-131 without a written directive during 1997.
Although these failures to complete a written directive did not, in any case, result in a medical misadministration, the occurrences represent a "substantial failure" to implement the facility's required Quality Management Plan, NRC Region I Administrator Hubert J. Miller wrote to the hospital in a letter regarding the enforcement decision.
"This failure was substantial given the number of occurrences and the repetitive nature of them, and the fact that the first recurrence happened in January 1997, so soon after you informed the NRC that the problem had been corrected," Mr. Miller stated.
In addition, the NRC is citing the hospital, but not issuing a fine, for another infraction. That violation involved a failure to provide adequate security for radioactive materials. An NRC inspector found that approximately 100 millicuries of technetium-99m were improperly stored in the hospital's "hot lab," an unrestricted area where there were insufficient controls in place to prevent unauthorized removal of the licensed radiopharmaceutical.
Altoona Hospital has 30 days to respond in writing to the Notice of Violation. The response must document any actions taken to prevent a recurrence of the violations. During this time, the hospital may pay the fine or file an appeal.
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