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U.S. NUCLEAR REGULATORY COMMISSION

Office of Public Affairs, Region III
2443 Warrenville Road, Lisle, IL 60532
www.nrc.gov


No. III-05-035   July 20, 2005
CONTACT: Jan Strasma (630) 829-9663
Viktoria Mitlyng (630) 829-9662
E-mail: OPA3.RegionIII@nrc.gov

NRC TO MEET JULY 27 WITH SOUTH BEND, IND., HOSPITAL TO DISCUSS
APPARENT VIOLATIONS ASSOCIATED WITH UNINTENDED RADIATION DOSES
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The Nuclear Regulatory Commission staff will meet Wednesday, July 27, in Lisle, Ill., with officials of St. Joseph Regional Medical Center of South Bend, Ind., to discuss apparent violations of NRC requirements associated with unintended radiation doses to five patients during treatments last year.

The hospital reported to the NRC in March 2005 that the patients had received unintended 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 meeting will be at 1 p.m. CDT in the NRC's Region III Office, 2443 Warrenville Rd., Suite 210, in Lisle. The meeting is open to public observation. At the conclusion of the business portion of the meeting, NRC officials will be available for questions and comments from members of the public attending the meeting.

Two special NRC inspections have reviewed the incidents and the hospital’s response. NRC inspectors identified four apparent violations of NRC requirements associated with the unintended radiation doses.

"This meeting will allow the hospital officials to provide their perspective on the incidents and describe the measures they have taken to correct the problems and prevent a recurrence," said James Caldwell, NRC Regional Administrator.

"Our inspectors have reviewed the hospital’s radiation therapy program and found that, with the exception of these five cases, it is complying with NRC requirements," he said. "The unintended radiation doses to these five patients occurred under very specific circumstances that have since been corrected," he said.

The four apparent violations, identified during the inspections, included the failure to prepare adequate procedures, failure to instruct hospital staff in the procedures and requirements, failure to report the five unintended radiation doses promptly after discovery, and failure to ensure that radiation safety activities are performed in accordance with procedures and regulatory requirements. A fifth violation, not associated with the unintended radiation doses, involved the failure to approve a medical physicist before the individual began work.

The meeting between the NRC staff and the hospital, called a predecisional enforcement conference, is an opportunity for the hospital to provide its perspective on the apparent violations and to offer any other information that they believe the NRC should take into consideration in making an enforcement decision. No decision on the apparent violations or any enforcement action will be made at the conference. Those decisions will be made later by NRC officials.

The inspection report describing the apparent violations is available from the Region III Office of Public Affairs or from the agency's online document library (known as ADAMS): http://www.nrc.gov/reading-rm/adams/web-based.html - use accession number ML051750196 in the search box to locate the report. For assistance in using ADAMS, you may contact the NRC Public Document Room staff at 800/397-4209.


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