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Event Notification Report for July 9, 2008

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
07/08/2008 - 07/09/2008

** EVENT NUMBERS **


44219 44335 44339

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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: 07/08/2008
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).

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General Information or Other Event Number: 44335
Rep Org: TEXAS DEPARTMENT OF HEALTH
Licensee: BAYLOR MEDICAL CENTER
Region: 4
City: WACO State: TX
County:
License #: L01290
Agreement: Y
Docket:
NRC Notified By: RAY JISHA
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 07/03/2008
Notification Time: 14:11 [ET]
Event Date: 07/02/2008
Event Time: 12:04 [CDT]
Last Update Date: 07/03/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
RUSS BYWATER (R4)
ANDREW PERSINKO (FSME)

Event Text

AGREEMENT STATE REPORT - LESS THAN 10% OF PRESCRIBED DOSE DELIVERED

"A medical event occurred at 12:04 pm on July 2, 2008. The licensee is Baylor University Medical Center, License Number L01290.

"The unsealed source is Y-90 Therasphere microspheres for treatment of liver cancer. The prescribed dose is 100 Gray, and the prescribed dose range is from 95 Gray to 105 Gray.

"The activity of the Y-90 Therasphere microspheres was verified at 9:13 am - with 13.4 mCi in the vial - using the dose calibrator as per the manufacturer instructions. However when the dose was delivered the 3 way stop-cock was set erroneously and almost the entire dose was collected in the vent vial. Attempts to recover and deliver the misdirected dose was very limited. Post-administration, the residual activity in the original dose vial, the vent vial, and contaminated effects (catheter line, tubing, needles, towels, gauze pads, etc) totaled 12.046 mCi normalized to the 9:13 am verification time. Therefore, the estimated administered activity was approximately 1.3 mCi, administered on 2-July-2008 at 12:04 pm. This translates to approximately 8.7 Gray delivered to the treatment site (Liver Tumor).

"Essentially only 8.7% of the prescribed dose was delivered. The licensee is continuing the investigation."

Texas event report I-8522

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: 44339
Facility: MCGUIRE
Region: 2 State: NC
Unit: [1] [2] [ ]
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: MICHAEL RICHARDSON
HQ OPS Officer: JOHN KNOKE
Notification Date: 07/07/2008
Notification Time: 16:54 [ET]
Event Date: 07/07/2008
Event Time: 14:22 [EDT]
Last Update Date: 07/08/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
MARVIN SYKES (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
2 N Y 100 Power Operation 100 Power Operation

Event Text

FAILURE OF THE ALERT NOTIFICATION SYSTEM

Alert Notification sirens (60 of 67) failed to operate properly and therefore required licensee to report this per 10 CFR 50.72(b)(3)(xiii). All Emergency Planning Zone counties have been notified and placed on backup route alerting, which means notification will be performed by local authorities. Investigation of this matter is ongoing.

Licensee has notified NRC Resident Inspector.


* * * UPDATE FROM MICHAEL RICHARDSON TO JOHN KNOKE AT 1435 EDT ON 07/08/08 * * *

A bad radio in the test shop created interference with the Alert Notification sirens, thus preventing them from operating properly. At 1425 EDT all Emergency Planning Zone counties were notified and the backup route alerting was cancelled. The sirens were tested satisfactorily multiple times.

Licensee has notified NRC Resident Inspector. Notified R2DO (Guthrie)

Page Last Reviewed/Updated Thursday, March 29, 2012
Thursday, March 29, 2012