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Event Notification Report for July 23, 2008

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
07/22/2008 - 07/23/2008

** EVENT NUMBERS **


44219 44353 44358 44359

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Hospital Event Number: 44219
Rep Org: VA NATIONAL HEALTH PHYSICS PROGRAM
Licensee: VA MEDICAL CENTER, PHILADELPHIA
Region: 1
City: PHILADELPHIA State: PA
County:
License #: 03-23853-01VA
Agreement: Y
Docket:
NRC Notified By: EDWIN LEIDHOLDT
HQ OPS Officer: JEFF ROTTON
Notification Date: 05/16/2008
Notification Time: 20:30 [ET]
Event Date: 05/05/2008
Event Time: 09:30 [EDT]
Last Update Date: 07/22/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
PAUL KROHN (R1)
HIRONORI PETERSON (R3)
REBECCA TADESSEE (FSME)

Event Text

POTENTIAL MEDICAL EVENT DUE TO USE OF I-125 SEEDS OF LOWER APPARENT ACTIVITY THAN INTENDED

"Notification of a possible medical event per 10 CFR 35.3045 - a brachytherapy procedure in which the administered dose may differ from the prescribed dose by more than 0.5 gray to an organ and the total dose delivered may differ from the prescribed dose by twenty percent or more.

"Permittee: VA Medical Center, Philadelphia, PA

"Event: The event occurred on May 5, 2008, and was discovered on May 15, 2008.

"Description: A permanent implant prostate brachytherapy procedure was performed on May 5, 2008, using I-125 seeds. Seeds of a lower apparent activity than intended were mistakenly ordered and implanted. A CT scan of the patient was performed on May 6, 2008, and a postplan was performed on May 15, 2008. The D90 dose, calculated from the postplan, was less than eighty percent of the prescribed dose. Postplans based on CT scans performed approximately one month after an implant, when swelling from the procedure has partially resolved, are believed to provide more accurate assessment of dose to the prostate. It is intended to obtain another CT scan and postplan at about this time to better assess the prostate dose. The permittee intends to make a determination at that time regarding whether a medical event did occur. The permittee will complete a causal analysis and implement procedural changes to prevent a recurrence before any additional brachytherapy procedures are performed.

"Effect on Patients: The VA is continuing to evaluate this event. At this time, adverse effects to the patient are not expected.

"Patient notification: The permittee is ensuring that the referring physicians and patients were notified.

"Licensee will notify the NRC Project Manager, Cassandra Frasier, of NRC Region III."

* * * UPDATE ON 6/06/08 AT 18:16 EDT FROM LEIDHOLDT TO HUFFMAN * * *

"This is an amendment to NRC Event Number 44219 and is a notification of possible medical events per 10 CFR 35.3045.

"The VHA National Health Physics Program notified the NRC Operations Center on May 16, 2008, of a possible medical event at the VA Medical Center, Philadelphia, Pennsylvania, involving transperineal permanent seed implant prostate brachytherapy.

The VHA National Health Physics Program initiated a reactive inspection on May 28, 2008. As part of this reactive inspection, the medical center was requested to review additional brachytherapy procedures.

Based on a review of other brachytherapy procedures performed between February 1, 2007, and May 31, 2008, the medical center identified an additional four brachytherapy procedures that may be medical events because the D90 doses, determined from post-implant CT scans, were more than 20 percent less than the prescribed doses. The procedures are still under evaluation and a final determination has not been made.

VHA is continuing to evaluate these possible medical events. At this time, adverse effects to the patients are not expected.

If these patient procedures are determined to be medical events, the medical center will ensure that the referring physicians and patients are notified.

VHA has notified NRC, Region III (NRC Project Manager, Cassandra Frasier).

R1DO (Henderson), R3D(Pelke), and FSME (Chang) notified.

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.


* * * UPDATE FROM E. LIEDHOLDT TO JOE O'HARA AT 2009 ON 6/12/08 * * *

"This is an amendment to NRC Event Number 44219 and is a notification per 10 CFR 35.3045 of additional possible medical events.

"VHA notified the NRC Operations Center on May 16, 2008, of a possible medical event at the VA Medical Center, Philadelphia, Pennsylvania, involving transperineal permanent seed implant prostate brachytherapy.

"VHA initiated a reactive inspection on May 28, 2008. As part of this reactive inspection, the medical center was requested to review additional brachytherapy procedures.

"VHA provided an initial update on June 6, 2008. This update reflects the most current information.

"The medical center has identified 45 brachytherapy procedures that could be medical events because the D90 doses, determined from post-implant CT scans, were more than 20 percent less than the prescribed doses. The procedures are still under evaluation and a final determination has not been made.

"We note that the medical center prescribes a dose of 160 gray instead of the more common 145 gray and that the number of possible events would be substantially less if the definition of a medical event were based upon the delivered dose instead of a percent of prescribed dose.

"Furthermore, the medical center determines D90 doses from post-implant CT scans performed the day after the procedures. Prostate swelling may cause the doses assessed from these scans to underestimate the delivered D90 doses.

"The permanent implant brachytherapy program has been suspended by the medical center director and an external review will be performed.

"Effect on patients:

"VHA is continuing to evaluate these possible medical events. At this time, adverse effects to the patients are not expected.

"Patient notification:

"If these patient procedures are determined to be medical events, the medical center will ensure that the referring physicians and patients are notified.

"Other notification:

"VHA has notified NRC, Region III (NRC Project Manager, Cassandra Frasier)."

Notified R1DO(Summers), R3DO(Louden), and FSME(Mauer).

* * * UPDATE BY E. LEIDTHOLDT TO J. KOZAL ON 6/21/08 AT 1841 * * *

"This is an amendment to NRC Event Number 44219, reported on May 16, 2008, and is a notification per 10 CFR 35.3045 of additional possible medical events. VHA provided amendments on June 6 and 12, 2008. This amendment reflects the most current information.

"VHA notified the NRC Operations Center on May 16, 2008, of a possible medical event at the VA Medical Center, Philadelphia, Pennsylvania, involving a transperineal permanent seed implant prostate brachytherapy procedure of a patient. This patient procedure is now considered to be a medical event.

"VHA initiated a reactive inspection on May 28, 2008. As part of this reactive inspection, the medical center was requested to review additional prostate brachytherapy procedures.

"The medical center has identified 63 brachytherapy procedures that could be medical events because the D90 doses, determined from post-implant CT scans, were 80% or less than the prescribed doses. The procedures are still under evaluation and a final determination has not been made for 60 of these procedures. For three of these 63 procedures including the May 5, 2008, procedure, the D90 doses have been confirmed to be 80% or less than the prescribed doses.

"We note that the medical center routinely prescribes a dose of 160 gray instead of the more common 145 gray and that the number of possible events would be substantially less if the definition of a medical event were based upon the delivered dose instead of a percent of prescribed dose.

"Furthermore, the medical center determines D90 doses from post-implant CT scans performed the day after the procedures. Prostate swelling may cause the doses assessed from these scans to underestimate the delivered D90 doses.

"The permanent implant brachytherapy program is suspended and an external review is in progress.

"Effect on patients:

"VHA is continuing to evaluate these possible medical events. At this time, adverse effects to the patients are not expected. The external review will assess potential medical consequences.

"Patient notification:

"The three patients whose D90 doses were confirmed to be 80% or less than the prescribed doses and their referring physicians have been notified. If other patient procedures are determined to be medical events, the medical center will ensure that the referring physicians and patients are notified.

"Other notification:

"VHA will notify NRC, Region III (NRC Project Manager, Cassandra Frasier)."

Notified R1DO (Schmidt), R3DO (Kunowski), and FSME (Holonich)

* * * UPDATE PROVIDED BY THOMAS HUSTON TO JASON KOZAL AT 1758 ON 6/25/08 * * *

"This report is an update to Event Report #44219. As the result of an ongoing review, a medical event was discovered for a fourth patient on June 24, 2008. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of the event will be sent to NRC Region III."

Notified R1DO (Grey), R3DO (Burgess), and FSME EO (Camper).

* * * UPDATE PROVIDED BY THOMAS HUSTON TO JOHN KNOKE AT 1245 ON 07/02/08 * * *

"This report is an update to Event Report #44219. As the result of an ongoing review, medical events were discovered for an additional seven (7) patients on July 2, 2008. This brings the total number of medical events to eleven (11) under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these seven (7) additional medical events will be submitted to NRC Region III."

Notified R1DO (Bellamy), R3DO (Kozak), and FSME EO (Zelac).

* * * UPDATE FROM HUSTON TO CROUCH ON 07/08/08 AT 1319 EDT * * *

"As the result of an ongoing review, medical events were discovered for an additional seven (7) patients on July 7, 2008. This brings the total number of medical events to eighteen (18) under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these seven (7) additional medical events will be submitted to NRC Region III."

Notified R1DO (Burritt), R3DO (Duncan) and FSME EO (Burgess).


* * * UPDATE PROVIDED BY LYNN MCGUIRE TO JOHN KNOKE AT 1335 ON 07/09/08 * * *

A 15-day written report of one of the medical events was submitted to NRC Region III.


Notified R1DO (Burritt), R3DO (Duncan) and FSME EO (Burgess).

* * * UPDATE FROM THOMAS HUSTON TO JOE O'HARA AT 0943 ON 7/10/09 * * *

"This report is an update to Event Report #44219. As the result of an ongoing review, medical events were discovered for an additional two (2) patients on July 9, 2008. This brings the total number of medical events to twenty (20) under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these two (2) additional medical events will be submitted to NRC Region III.

"We have notified our NRC Project Manager, Cassandra Frazier (NRC Region III), of these additional events."

Notified R1DO(Burritt), R3DO(Duncan), and FSME EO(Burgess)

* * * UPDATE ON 7/15/2008 AT 1213 FROM GARY WILLIAMS TO MARK ABRAMOVITZ * * *

"This report is an update to Event Report #44219. As the result of an ongoing review, medical events were discovered for an additional nine patients on July 15, 2008. This brings the total number of medical events to 29 under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these nine additional medical events will be submitted to NRC Region III. I will notify our NRC Project Manager, Cassandra Frazier (NRC Region III), of these additional events."

Notified R1DO (Dentel), R3DO (Lara), and FSME (Burgess).

* * * UPDATE ON 7/18/2008 AT 1313 FROM HUSTON TO HUFFMAN * * *
Bur
"This report is an update to Event Report #44219. As the result of an ongoing review, medical events were discovered for an additional three patients on July 18, 2008. This brings the total number of medical events to 32 under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these three additional medical events will be submitted to NRC Region III. We will notify our NRC Project Manager, Cassandra Frazier (NRC Region III), of these additional events. "

Notified R1DO (Dentel), R3DO (Lara), and FSME (White).

* * * UPDATE ON 7/22/2008 AT 1500 EDT FROM WILLIAMS TO HUFFMAN * * *

"This report is an update to Event Report #44219. As the result of an ongoing review, medical events were discovered for an additional five patients on July 22, 2008. This brings the total number of medical events to 37 under Event Report #44219. The circumstances involved are similar to those previously reported for this event number. A 15-day written report of these five additional medical events will be submitted to NRC Region III."

The licensee will notify NRC Project Manager, Cassandra Frazier (NRC Region III), of these additional events.

Notified R1DO (Dentel), R3DO (Riemer), and FSME (Burgess).

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General Information or Other Event Number: 44353
Rep Org: WISCONSIN RADIATION PROTECTION
Licensee: UNIVERSITY OF WISCONSIN - MADISON
Region: 3
City: MADISON State: WI
County:
License #: 025-1323-01
Agreement: Y
Docket:
NRC Notified By: CHERYL ROGERS
HQ OPS Officer: BILL HUFFMAN
Notification Date: 07/17/2008
Notification Time: 12:05 [ET]
Event Date: 07/14/2008
Event Time: [CDT]
Last Update Date: 07/17/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
JULIO LARA (R3)
DUNCAN WHITE (FSME)

Event Text

AGREEMENT STATE REPORT - MEDICAL EVENT DUE TO DOSE LESS THAN PRESCRIBED DOSE

The following report was received from the State of Wisconsin via facsimile:

"On 7/14/2008, a patient was simulated and treatment planning performed for High Dose Rate (Ir-192) partial breast irradiation to the right breast using a Contura (SenoRx) balloon. The authorized user prescribed a dose of 3.65 Gy per fraction x 9 fractions for a total dose of 32.85 Gy to the Planning Target Volume. After the planning was done, the length of each of the five catheters was measured by the Nucletron Source Position Simulator. The readings were found to be 1154 each. The treatment file in the High Dose Rate treatment console was modified from its default value of 1500 to 1154 and patient was treated. The patient was treated in the High Dose Rate machine located in Room 'A'.

"On 7/15/08, the patient was scheduled to be treated in the High Dose Rate machine located in Room 'B'. Since the sources are different in activity, total time check was performed, at which time, the medical physicists also compared the measured lengths with a second patient under treatment with the Contura balloon in Room 'B'. At this point they noted the difference in the measured lengths between the two cases. The medical physicist checked the Source Position Simulator and noticed that there was an obstruction at the 1154 reading. The review of the actual delivered dose during the first fraction revealed that the source did not enter the patient's body and thus the negative impact was mitigated. A small region of the skin surface received some radiation dose, but the clinical impact is insignificant. The incident was immediately reported to the primary Radiation Oncologist and the Authorized User. The licensee states that no long-term, permanent side effects are anticipated as a result of the medical event.

"Due to the licensee's investigation of the Source Position Simulator revealing that a welded junction in the cable of this measuring device was kinked, it was immediately replaced with a new one. The licensee has also developed a new Quality Assurance form which will be exclusively used for Contura balloons and which incorporates the expected length for the five catheters. Department of Health Services (DHS) staff have been dispatched to investigate this incident."

Wisconsin Report Number: WI080017

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.

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Power Reactor Event Number: 44358
Facility: FARLEY
Region: 2 State: AL
Unit: [1] [ ] [ ]
RX Type: [1] W-3-LP,[2] W-3-LP
NRC Notified By: JIM HUNTER
HQ OPS Officer: HOWIE CROUCH
Notification Date: 07/22/2008
Notification Time: 04:10 [ET]
Event Date: 07/21/2008
Event Time: 20:58 [CDT]
Last Update Date: 07/22/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
50.72(b)(2)(i) - PLANT S/D REQD BY TS
Person (Organization):
ALAN BLAMEY (R2)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 100 Power Operation 100 Power Operation

Event Text

LOSS OF ACCIDENT MITIGATION CAPABILITIES DUE TO TWO EMERGENCY DIESEL GENERATORS OUT OF SERVICE

"On 7/20/08 at 1757, the 1B Emergency Diesel generator was voluntarily removed from service for a planned exhaust header replacement. The 1B Emergency Diesel remains out of service and is anticipated to be returned to service on 7/26/08.

"On 7/21/08 at 2058, the 1-2A Emergency Diesel generator was declared inoperable due to excessive amounts of water present in the diesel lube oil system.

"The combination of these two diesels being out of service results in two emergency diesels, one in each train, being inoperable for Farley Unit One. This represents a Unit One loss of safety function for mitigating the consequences of an accident in the event of a loss of off-site power.

"Farley Unit Two is affected only by the 1-2A Emergency Diesel and is maintaining a B-Train Emergency Diesel operable.

"The 1-2A Emergency Diesel is suspected of having a lube oil heat exchanger tube leak. Confirmation of the tube leak and repairs are anticipated to take three to four days."

The loss of two EDGs places Unit One in an 8-hr plant shutdown action statement which will require the unit to initiate shutdown by 0458 CDT on July 22, 2008 and be in hot standby by 1058 CDT. Unit Two is in a 10-day non-shutdown action statement as a result of the loss of the 1-2A Emergency Diesel Generator.

The licensee has notified the NRC Resident Inspector.


* * * UPDATE FROM HOBSON TO KNOKE AT 1009 ON 07/22/08 * * *

"On 7/20/08 at 1757, the 1 B Emergency Diesel Generator was voluntarily removed from service for a planned exhaust header replacement.

"On 7/21/08 at 2058, the 1-2A emergency Diesel Generator was declared inoperable per Technical Specification 3.8.1 due to excessive amounts of water present in the diesel lube oil system.

"The combination of both diesels out of service required entry into Technical Specification 3.8.1 Condition E. With both an 'A' train and a 'B' train Emergency Diesel Generators inoperable, a loss of safety function exists. A technical specification required shutdown from Mode 1 to Mode 3 was commenced at 0541 CST in accordance with Technical Specification 3.8.1 Condition F. Unit 1 is required to be in Mode 3 prior to 1058 CST.

"Unit 2 is affected by the 1-2A Emergency Diesel Generator being removed from service. However, there is no loss of safety function on Unit 2 because the B train Emergency Diesel Generator is operable. Unit 2 remains in Mode 1, 100% power."

Licensee will notify the NRC Resident Inspector. Notified R2DO (Blamey)

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Power Reactor Event Number: 44359
Facility: INDIAN POINT
Region: 1 State: NY
Unit: [2] [ ] [ ]
RX Type: [2] W-4-LP,[3] W-4-LP
NRC Notified By: TIM BUCHAL
HQ OPS Officer: JASON KOZAL
Notification Date: 07/22/2008
Notification Time: 20:30 [ET]
Event Date: 07/22/2008
Event Time: 18:45 [EDT]
Last Update Date: 07/22/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
INFORMATION ONLY
Person (Organization):
GLENN DENTEL (R1)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
2 N Y 100 Power Operation 100 Power Operation

Event Text

OIL RELEASE TO THE ENVIRONMENT

"At 1845 an oil sheen was noticed at the discharge canal of Unit #2. A slight oil sheen has reached the Hudson River. Estimated discharge is less than 1 gallon. The source is run-off from a parking lot and other paved areas due to recent heavy rain. Oil content is lessening in the runoff.

"The licensee notified the following organizations: USCG National Response Center (Report #878141), NY Department of Environmental Conservation, and the Westchester County Department of Health.

"Cleanup is being coordinated with Miller Environmental as required."

The licensee notified the NRC Resident Inspector.

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