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Event Notification Report for August 07, 2011

U.S. Nuclear Regulatory Commission
Operations Center

EVENT REPORTS FOR
08/06/2011 - 08/07/2011

EVENT NUMBERS
4713547174

Agreement State
Event Number: 47135
Rep Org: WISCONSIN RADIATION PROTECTION
Licensee: UW-MADISON
Region: 3
City: MADISON   State: WI
County:
License #: 025-1323-01
Agreement: Y
Docket:
NRC Notified By: CHRIS TIMMERMAN
HQ OPS Officer: CHARLES TEAL
Notification Date: 08/09/2011
Notification Time: 12:26 [ET]
Event Date: 08/07/2011
Event Time: 00:00 [CDT]
Last Update Date: 08/09/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
Person (Organization):
BILLY DICKSON (R3DO)
ANGELA MCINTOSH (FSME)
Event Text
AGREEMENT STATE REPORT - THERASPHERE TREATMENT TO WRONG LOBE OF LIVER

The following was received via fax:

"The Wisconsin Department of Health Services (DHS) received a phone call from the Radiation Safety Officer (RSO) on August 8, 2011 that a patient received a dose of 1.05 GBq of Y-90 Theraspheres on July 7, 2011 to the wrong side of the liver as documented on the written directive. The patient was scheduled for treatment of 1.04 GBq Y-90 Theraspheres for multinodular hepatocellular cancer (HCC) to the left lobe of the liver. The dosimetry for Y-90 Theraspheres was based on volume (mass) of the lobe bearing the tumors (the patient has tumors on both lobes, right and left). A treatment plan was created for the left lobe (using the volume of the left lobe) but during the procedure the right lobe was treated with the prescribed dose for the left lobe.

"DHS will be conducting an investigation on August 12, 2011 and the licensee will be submitting a 15 day written report concerning the medical event."

WI Event Number: 110012

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.


Agreement State
Event Number: 47174
Rep Org: VIRGINIA RAD MATERIALS PROGRAM
Licensee: CARILLION CLINIC
Region: 1
City: ROANOKE   State: VA
County:
License #: 770-051-1
Agreement: Y
Docket:
NRC Notified By: MIKE WELLING
HQ OPS Officer: HOWIE CROUCH
Notification Date: 08/19/2011
Notification Time: 15:42 [ET]
Event Date: 08/07/2011
Event Time: 00:00 [EDT]
Last Update Date: 09/02/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
Person (Organization):
JAMES TRAPP (R1DO)
BRUCE WATSON (FSME)
Event Text
VIRGINIA AGREEMENT STATE REPORT - DOSE RECEIVED BY PATIENT GREATER THAN PRESCRIBED

The following information was obtained from the State of Virginia via fax:

"On August 7, 2011, the licensee's RSO received notification of an incident. A patient was treated for bronchial/trachea carcinoma using temporary brachytherapy employing a HDR delivery system. Subsequent to treatment, it was realized that dwell positions were misrepresented on the approved treatment plan. Reconstruction of the applicator position led to the conclusion that dose to organs or tissue other than the treatment site received more than 50 Rem and more than 50% of the expected dose. Licensee notified Virginia Department of Health on August 17, 2011. Referring physician was notified on August 17, 2011. Physician is meeting with patient on August 19, 2011. Licensee indicated organs at risk and health effects to patient are under development."

Virginia Report ID: VA-11-08

* * * UPDATE AT 1458 EDT ON 09/02/11 FROM MIKE WELLING TO S. SANDIN * * *

The following update was received from the State of Virginia via email:

"On August 31st the licensee report was received. The report indicated the cause was human error during data loading into the delivery system. An error was received and in order to clear the error the source position spacing was changed. The report detailed the licensee's dose calculations to the surrounding organs and tissue. The estimated maximum amount received by the larynx was 2.332 Gy which was 581% over the expected dose of 0.42 Gy.

"A subsequent licensee response on September 1st detailed the dose to the lungs. The dose to the lungs did not differ between expected and delivered.

"The patient has had two follow up visits and shows no adverse effects. A positive tumor effect was observed by the referring physician."

Notified R1DO (DiPaolo) and FSME (Hsueh).

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.