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Event Notification Report for July 3, 2008

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
07/02/2008 - 07/03/2008

** EVENT NUMBERS **


44219 44298 44321 44333 44334

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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: 07/02/2008
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).

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General Information or Other Event Number: 44298
Rep Org: SC DIV OF HEALTH & ENV CONTROL
Licensee: ASTEN JOHNSON, INC
Region: 1
City: CHARLESTON State: SC
County:
License #:
Agreement: Y
Docket:
NRC Notified By: JAMES PETERSON
HQ OPS Officer: BILL HUFFMAN
Notification Date: 06/13/2008
Notification Time: 15:13 [ET]
Event Date: 06/13/2008
Event Time: 13:28 [EDT]
Last Update Date: 07/02/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
ROBERT SUMMERS (R1)
ANDREW MAUER (FSME)
ILTAB VIA E-MAIL ()

This material event contains a "Less than Cat 3" level of radioactive material.

Event Text

AGREEMENT STATE REPORT - PORTABLE GAUGE MISSING IN TRANSIT

The following report was received from the State via facsimile:

"The South Carolina Department of Health and Environmental Control was notified at 1:28 p.m. on June 13, 2008 by the licensee that a package containing a radioactive source was lost by Fed-Ex. The sealed source contains 80 mCi of Am-241 and is used in an NDC Systems Model 104 portable gauge. The package was shipped from Macon, GA on June 5th. On June 11th, the licensee received the shipping label, with no package attached, at the licensee's office on Corporate Road in Charleston, SC. The licensee contacted Fed-Ex on the 11th where Fed-Ex then placed a trace on the package which they indicated could take 48 hours. The 48 hour time frame has expired and Fed-Ex has indicated that they cannot find the package but they are continuing their search through various warehouses. Fed-Ex still has the package listed as "in route to its destination". The licensee has also notified the Georgia radiation control program. This event is open pending the results of the licensee's and Department's investigation. Notifications and updates will be made through the NMED system."


* * UPDATE FROM JIM PETERSON TO JOHN KNOKE AT 1432 EDT ON 07/02/08 * *

FedEx has found the missing sealed source at their warehouse.

Notified R1DO (Bellamy), FSME EO (Zelac) and ILTAB via Email

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks.

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General Information or Other Event Number: 44321
Rep Org: CALIFORNIA RADIATION CONTROL PRGM
Licensee: UCLA
Region: 4
City: WESTWOOD State: CA
County:
License #: 1335-19
Agreement: Y
Docket:
NRC Notified By: BARBARA HAMRICK
HQ OPS Officer: PETE SNYDER
Notification Date: 06/27/2008
Notification Time: 11:33 [ET]
Event Date: 06/23/2008
Event Time: [PDT]
Last Update Date: 06/27/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
DAVID PROULX (R4)
CINDY FLANNERY (FSME)

Event Text

POTENTIAL UNDERDOSE TO PATIENT UNDERGOING WHOLE BODY RADIATION

The following report was received from the state via e-mail:

"On June 25, 2008 at approximately 3 pm, RHB received preliminary notification of a medical event, which occurred June 23, 2008, involving a 50% under-dose to a patient undergoing whole-body irradiation with a Co-60 teletherapy unit. The event was discovered at approximately 2 pm on June 25, 2008. RHB held the initial report to NRC until additional details could be provided by the licensee, who was still reviewing the situation with the radiation oncology department. The prescription was for total body irradiation at 17.12 minutes AP (anterior posterior), then 17.13 minutes AP, then 17.12 minutes PA (posterior anterior), then 17.13 minutes PA, for a total of 34.25 minutes AP and 34.25 minutes PA, and a total of 300 cGy. The therapist only treated 17.13 minutes AP and 17.13 minutes PA for a total dose of 150 cGy. The patient was seen by the attending physician on 6/25/08, with no known medical effects observed. There is currently no plan to re-treat the patient per the attending physician. The licensee is following up with a written report.

"5010 Number - 062508"

The attending physician and patient have been 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.

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Hospital Event Number: 44333
Rep Org: HELEN NEWBERRY JOY HOSPITAL
Licensee: HELEN NEWBERRY JOY HOSPITAL
Region: 3
City: NEWBERRY State: MI
County:
License #:
Agreement: N
Docket:
NRC Notified By: CHAD BRUNO
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 07/02/2008
Notification Time: 16:40 [ET]
Event Date: 07/02/2008
Event Time: 15:00 [EDT]
Last Update Date: 07/03/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
20.1906(d)(1) - SURFACE CONTAM LEVELS > LIMITS
Person (Organization):
RONALD BELLAMY (R1)
THOMAS KOZAK (R3)
ANDREW PERSINKO (FSME)

Event Text

MOLYBDENUM-99 PACKAGE WITH EXTERNAL CONTAMINATION

A nuclear medicine technologist from Helen Newberry Joy Hospital reported receiving a package containing a Molybdenum-99 generator (148 GBq) that had an external radiation of 30 mR/hr and 23,985 dpm (with a background of 11695 dpm). The external contamination was removable using a wipe test. The Molybdenum generator will not be used until next Tuesday and will be stored in a room requiring entry through three locked doors. The Nuclear Technologist will be informing the package carrier of the contamination. He was uncertain where the packaged originated or who the licensed shipper of the package was at the time of the report but would attempt to determine the information and contact the responsible party.

* * * UPDATE BY HUFFMAN AT 0930 EDT ON 7/3/08 * * *

Thi event was updated to make some minor editorial corrections and clarifications.

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Power Reactor Event Number: 44334
Facility: OYSTER CREEK
Region: 1 State: NJ
Unit: [1] [ ] [ ]
RX Type: [1] GE-2
NRC Notified By: CARL SUCHTING
HQ OPS Officer: STEVE SANDIN
Notification Date: 07/03/2008
Notification Time: 09:06 [ET]
Event Date: 07/03/2008
Event Time: 05:40 [EDT]
Last Update Date: 07/03/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
RONALD BELLAMY (R1)

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 COMMERCIAL TELEPHONE AND DEDICATED EP LANDLINES

"Reportable Event SAF 1.10

"Major loss of offsite communications capability was experienced at 0540 on 7/3/08. Conventional phones and the EP [Emergency Preparedness] notification lines were lost. Cell phones were available for offsite communications. Offsite communications capability via landlines was restored at 0550 on 7/3/08 with the exception of EP lines, however the ability to contact State and Local authorities using landlines was verified at 0621 on 7/3/08. At 0714 on 7/3/08 the auto ring down EP lines were restored and tested. Source of the problem appears to be failure of Verizon equipment offsite to automatically transfer to alternate when one path was interrupted by a car pole accident."

The licensee informed the NRC Resident Inspector.



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