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Event Notification Report for June 26, 2008

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
06/25/2008 - 06/26/2008

** EVENT NUMBERS **


44219 44281

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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: 06/25/2008
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).

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Other Nuclear Material Event Number: 44281
Rep Org: NATIONAL INST OF STANDARDS & TECH
Licensee: NATIONAL INST OF STANDARDS & TECH
Region: 4
City: BOULDER State: CO
County: BOULDER
License #: 0500316605
Agreement: Y
Docket:
NRC Notified By: LARRY GRIMM
HQ OPS Officer: HOWIE CROUCH
Notification Date: 06/10/2008
Notification Time: 15:11 [ET]
Event Date: 06/09/2008
Event Time: [MDT]
Last Update Date: 06/26/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
30.50(b)(1) - UNPLANNED CONTAMINATION
Person (Organization):
GEOFFREY MILLER (R4)
MICHELE BURGESS (FSME)

Event Text

UNPLANNED CONTAMINATION

On June 9, 2008, the Radiation Safety Officer (RSO) was notified that a vial containing standard reference material was discovered broken in one of the research laboratories. The reference material contained numerous isotopes of plutonium. It has not been determined how or when the breakage occurred.

National Institute of Standards and Technology (NIST) Health Physics personnel responded to the area and determined that low levels of contamination were spread outside of the laboratory into the adjoining hallway. At this time, the hallway has be decontaminated. The lab is isolated and will be undergoing decontamination.

The two researchers who discovered the broken vial were contaminated on their hands and were properly decontaminated. They will be undergoing bioassay and urinalysis to determine if an uptake occurred. Air samples were taken in the lab and are in the process of being counted to determine if an airborne problem existed.

The NIST RSO contacted NRC Region IV (Cain and Campbell).

* * * UPDATE AT 0038 ON 6/26/2008 FROM LARRY GRIMM TO MARK ABRAMOVITZ * * *

Received from the National Institute of Standards and Technology via e-mail.

"Since the initial incident report, NIST has done the following to mitigate the incident.

"1. NIST Boulder requested assistance from NIST Gaithersburg. Management sent expert Health Physics and Occupational Health and Safety personnel, as well as radiation detection equipment to Boulder.
"2. Hallways and areas potentially affected by the spill were again thoroughly surveyed to assure that no contamination existed outside the affected, sealed laboratory. This survey found two minor contamination spots in a stairwell, which easily cleaned up with soap and water. One office, which had contamination known from the earliest survey (Tuesday morning 6/10/08) was sealed pending future decontamination.
"3. Air monitoring equipment was installed in the adjacent hallway as a precaution in the unlikely event of air leakage from the contaminated laboratory. To date, airborne contamination has not been detected by this equipment nor has any airborne contamination been detected by other subsequently installed air monitoring equipment outside of the contaminated laboratory.
"4. Bioassay tests were initiated on personnel either known to have trace external contamination or determined to be potentially contaminated. Small sample bioassay tests have shown no internal contamination of individuals; however NIST is awaiting the results of more sophisticated bioassay tests.
"5. Using personal protective equipment, NIST Health Physicists made entries to the contaminated laboratory on 6/14/08 and 6/15/08 to investigate the cause and extent of the spill. They found contamination in the laboratory sink and subsequently learned that a researcher who worked directly with the plutonium sample had used that sink to wash his hands during the incident. This prompted NIST to alert city wastewater officials of a potential discharge of plutonium from the sink to the sanitary sewer system.
"6. For help in determining what might have been released to the sanitary sewer NIST requested help from the National Nuclear Security Administration's Radiological Assistance Program (RAP) on 6/16/08. RAP and its associated Department of Energy TRIAGE team have the ability to determine radioactive material activity quantities by taking radiation measurements with sophisticated equipment and computer programs.
"7. Further bioassays samples were collected from individuals and sent out for analysis. NIST is awaiting the results of these tests. Some individuals have also received additional medical tests on the advice of physicians specializing in exposure to plutonium.
"8. Planning with RAP personnel for entry to the laboratory ensued and the RAP team arrived 6/20/08. Entry occurred the same day and the RAP team collected the necessary data. The subsequent report of the RAP/TRIAGE analysis as well as NIST radiation measurements and calculations on dose rate data indicates that at least 76% - 87% of the spilled material can be accounted for. As many smaller areas of contamination have not been analyzed, NIST expects that more of the material will be accounted for during future entries and testing.
"9. Prior to entering the contaminated laboratory, air sampling had not shown airborne contamination. In the course of repeated entries to the contaminated lab room, air sampling equipment placed by the RAP team detected airborne contamination, likely as a result of the team's activities. The team ceased operations and subsequent air sampling showed that radiation readings had returned to normal background levels in the spill room laboratory. Since responding to the incident, NIST Health Physicists have monitored and found no evidence of any releases of contaminated air to the atmosphere."

Notified the R4DO (Proulx) and FSME (Camper).

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