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I-97-61 May 28, 1997
The Nuclear Regulatory Commission staff has cited Lower Bucks Hospital, in Bristol, Pa., for alleged violations of NRC requirements. The staff has proposed a fine of $2,750.
The NRC staff conducted inspections at Lower Bucks Hospital on January 9, at Nazareth Hospital in Philadelphia on December 12, and at waste disposal facilities in Morgantown and Allentown, Pa., to review the circumstances associated with the loss of control of a nuclear pacemaker (containing approximately 4.8 curies of plutonium-238). In addition, the NRC staff reviewed analysis of samples taken from the waste sites to determine whether the pacemaker had been damaged resulting in contamination at these locations. The sample results did not provide any evidence of contamination. Based on those inspections and information provided by Lower Bucks Hospital at a predecisional enforcement conference on May 13, the NRC staff has determined that three alleged violations of requirements occurred at the facility.
In 1978, a patient was given a nuclear pacemaker by staff at Lower Bucks Hospital as authorized by its NRC license. The pacemaker was removed at Nazareth Hospital on October 31, 1996, after the patient died. Although the hospital was notified in early November that the patient had died and the pacemaker had been removed, Lower Bucks Hospital did not notify the NRC within 24 hours as required, which constitutes one of the three violations.
On December 10, Nazareth Hospital notified Lower Bucks that the pacemaker could not be located and was assumed lost. Although Lower Bucks had contacted the supplier of the pacemaker to retrieve the pacemaker and properly dispose of it, the licensee did not ensure appropriate control and disposal. These failures resulted in two additional violations of NRC requirements.
During its inspection, the NRC learned of two additional instances (January 5, 1981 and September 18, 1983), in which pacemakers were buried with patients, and one additional instance in which the pacemaker was not returned to the supplier (August 1987). In addition, in 1987 two pacemakers were buried with patients.
In a letter to Lower Bucks Hospital, NRC Region I Administrator Hubert J. Miller said, "As the hospital that had initially implanted the pacemakers, as authorized by your NRC license..., you were responsible for taking appropriate and timely action to ensure proper retrieval and disposal of pacemakers. This did not occur. Given the significance of improper disposal of this material, the violations have been classified in the aggregate as a Severity Level III problem..."
Lower Bucks has 30 days either to pay the proposed fine or to request in writing that part or all of it be withdrawn.
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