NRC PROPOSES $19,200 FINE AGAINST A SOUTH BEND, IND., HOSPITAL
FOR UNINTENDED RADIATION DOSES TO FIVE PATIENTS
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The patients received the radiation exposures to their legs during treatment for cervical cancer. The unintended exposures occurred when a small sealed capsule containing a radiation source shifted during treatment, resulting in the unintended radiation doses to the skin of each patient’s leg. The capsule with a radiation source shifted because it was not the appropriate size for the treatment device.

The radiation doses resulted in injury to a small area of three patients’ skin requiring followup treatment. Radiation doses received by two other patients did not cause visible injuries and did not require special treatment.

The NRC conducted two special inspections that reviewed the causes and the circumstances around these incidents and the hospital’s response. The NRC also retained an independent medical consultant to evaluate the radiation doses to the patients.

NRC inspectors identified violations of NRC requirements that included the unintended radiation doses; failure to develop proper procedures and to train hospital staff in the procedures and requirements; failure to report the unintended radiation doses promptly after discovery; and failure to ensure that radiation safety activities were performed in accordance with procedures and regulatory requirements.

"The NRC’s regulations are designed to protect public health and safety. We expect our license holders to adhere to these regulations to avoid situations such as this one," said James Caldwell, NRC Regional Administrator.

The hospital implemented immediate and extensive improvements to address the causes of the treatment problem and to enhance their radiation therapy program.

"The unintended radiation doses to the five patients occurred under very specific circumstances that have since been corrected," said Caldwell. "Our inspectors have reviewed the hospital’s enhanced radiation therapy program and found it to be in compliance with NRC requirements," he added.

The hospital has until Oct. 24 to either pay the fine or to protest it. If the fine is protested and subsequently imposed by the NRC staff, the hospital may request a hearing.

The letter notifying St. Joseph Regional Medical Center of the proposed fine has been posted to the NRC web site at: http://www.nrc.gov/about-nrc/regulatory/enforcement/current.html#materials.

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Thursday, December 11, 2008