Event Notification Report for January 11, 2011
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
01/10/2011 - 01/11/2011
Agreement State
Event Number: 46754
Rep Org: VIRGINIA RAD MATERIALS PROGRAM
Licensee: VIRGINIA HOSPITAL CENTER
Region: 1
City: Arlington State: VA
County:
License #: 013-220-1
Agreement: Y
Docket:
NRC Notified By: CHARLES COLEMAN
HQ OPS Officer: JOHN SHOEMAKER
Licensee: VIRGINIA HOSPITAL CENTER
Region: 1
City: Arlington State: VA
County:
License #: 013-220-1
Agreement: Y
Docket:
NRC Notified By: CHARLES COLEMAN
HQ OPS Officer: JOHN SHOEMAKER
Notification Date: 04/14/2011
Notification Time: 13:59 [ET]
Event Date: 01/11/2011
Event Time: 00:00 [EDT]
Last Update Date: 04/14/2011
Notification Time: 13:59 [ET]
Event Date: 01/11/2011
Event Time: 00:00 [EDT]
Last Update Date: 04/14/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
PAMELA HENDERSON (R1DO)
ANGELA MCINTOSH (FSME)
PAMELA HENDERSON (R1DO)
ANGELA MCINTOSH (FSME)
AGREEMENT STATE- UNDER DOSE ADMINISTERED TO PATIENT
The following was received via facsimile.
"In January 2011 a patient was administered 1.58 millicuries of (Iodine) I-I31 for a whole body scan. The written directive specified a 2.0 millicurie dosage. The difference was discovered during a routine audit by the licensee's health physics consultant in March 2011. Calculations by the health physicist indicated the difference between the written directive and the administered dose differed by more than 20 percent, that the difference in the effective dose exceeded 5 rem and that the difference in the dose to the thyroid exceeded 50 rem. A report dated March 24, 2011 was received by (Virginia Department of Health) VDH on April 4, 2011. An on-site investigation by VDH was performed on April 8, 2011. The licensee indicated that the quality of the whole body scan was not compromised and that because the administered dose was less than the written directive, there is no radiological hazard to the patient."
Virginia Radioactive Materials Program Event Report ID.: VA-11-01
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.
The following was received via facsimile.
"In January 2011 a patient was administered 1.58 millicuries of (Iodine) I-I31 for a whole body scan. The written directive specified a 2.0 millicurie dosage. The difference was discovered during a routine audit by the licensee's health physics consultant in March 2011. Calculations by the health physicist indicated the difference between the written directive and the administered dose differed by more than 20 percent, that the difference in the effective dose exceeded 5 rem and that the difference in the dose to the thyroid exceeded 50 rem. A report dated March 24, 2011 was received by (Virginia Department of Health) VDH on April 4, 2011. An on-site investigation by VDH was performed on April 8, 2011. The licensee indicated that the quality of the whole body scan was not compromised and that because the administered dose was less than the written directive, there is no radiological hazard to the patient."
Virginia Radioactive Materials Program Event Report ID.: VA-11-01
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.
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Hospital
Event Number: 47384
Rep Org: JEPPESEN RADIATION ONCOLOGY
Licensee: BAY REGIONAL MEDICAL CENTER
Region: 3
City: BAY CITY State: MI
County:
License #: 21-18585-01
Agreement: N
Docket:
NRC Notified By: DENNIS KEHOE
HQ OPS Officer: JOE O'HARA
Licensee: BAY REGIONAL MEDICAL CENTER
Region: 3
City: BAY CITY State: MI
County:
License #: 21-18585-01
Agreement: N
Docket:
NRC Notified By: DENNIS KEHOE
HQ OPS Officer: JOE O'HARA
Notification Date: 10/28/2011
Notification Time: 15:26 [ET]
Event Date: 01/11/2011
Event Time: 07:00 [EDT]
Last Update Date: 12/01/2011
Notification Time: 15:26 [ET]
Event Date: 01/11/2011
Event Time: 07:00 [EDT]
Last Update Date: 12/01/2011
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
PATTY PELKE (R3DO)
LYDIA CHANG (FSME)
PATTY PELKE (R3DO)
LYDIA CHANG (FSME)
MEDICAL EVENT - MISADMINISTRATION OF PROSTATE CANCER SEEDS
During a recent inspection, an NRC inspector noted two cases which occurred on 8/23/11 and 1/11/11, respectively in which two separate patients were under dosed by greater than 20% during prostate cancer treatment using Iodine 125 seeds. The underdose was determined during post operative treatments. The same physician administered the procedure in both cases. The licensee has informed the prescribing physician, and is investigating the cause of the events. There is no long term permanent functional damage suspected to any organ in either case.
The licensee discussed the issue with NRC Region 3 (Gattone).
* * * UPDATE FROM DENNIS KEHOE TO VINCE KLCO ON 11/01/11 AT 1841 EDT * * *
After the licensee reviewed 3 years of medical reports, fourteen patents were found to have been under-dosed greater than 20% of the prescribed dose. Specific under-dose dates were: 4/10/08; 4/21/08; 4/25/08; 9/15/08; 10/17/08; 11/03/08; 2/17/09; 8/27/09; 1/05/10; 1/14/10; 5/25/10; 10/12/10; 5/03/11 and 5/19/11.
The licensee discussed the issue with NRC Region 3 (Gattone).
Notified the R3DO (Valos) and the FSME EO (Camper).
* * * RETRACTION FROM DENNIS KEHOE TO VINCE KLCO ON 12/1/2011 AT 1440 EDT * * *
The licensee is retracting this event due to the fact that the prostate seed implant for all the above 16 referenced events are planned intra-operatively within the operation. The licensee evaluates the seed implants at the end of the implant operation.
Notified the R3DO (Riemer) and FSME (McIntosh).
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.
During a recent inspection, an NRC inspector noted two cases which occurred on 8/23/11 and 1/11/11, respectively in which two separate patients were under dosed by greater than 20% during prostate cancer treatment using Iodine 125 seeds. The underdose was determined during post operative treatments. The same physician administered the procedure in both cases. The licensee has informed the prescribing physician, and is investigating the cause of the events. There is no long term permanent functional damage suspected to any organ in either case.
The licensee discussed the issue with NRC Region 3 (Gattone).
* * * UPDATE FROM DENNIS KEHOE TO VINCE KLCO ON 11/01/11 AT 1841 EDT * * *
After the licensee reviewed 3 years of medical reports, fourteen patents were found to have been under-dosed greater than 20% of the prescribed dose. Specific under-dose dates were: 4/10/08; 4/21/08; 4/25/08; 9/15/08; 10/17/08; 11/03/08; 2/17/09; 8/27/09; 1/05/10; 1/14/10; 5/25/10; 10/12/10; 5/03/11 and 5/19/11.
The licensee discussed the issue with NRC Region 3 (Gattone).
Notified the R3DO (Valos) and the FSME EO (Camper).
* * * RETRACTION FROM DENNIS KEHOE TO VINCE KLCO ON 12/1/2011 AT 1440 EDT * * *
The licensee is retracting this event due to the fact that the prostate seed implant for all the above 16 referenced events are planned intra-operatively within the operation. The licensee evaluates the seed implants at the end of the implant operation.
Notified the R3DO (Riemer) and FSME (McIntosh).
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.