Event Notification Report for May 02, 2012
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
05/01/2012 - 05/02/2012
EVENT NUMBERS
478924789347887478884788948058
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Power Reactor
Event Number: 47892
Facility: FORT CALHOUN
Region: 4 State: NE
Unit: [1] [] []
RX Type: (1) CE
NRC Notified By: NATHAN SEID
HQ OPS Officer: MARK ABRAMOVITZ
Region: 4 State: NE
Unit: [1] [] []
RX Type: (1) CE
NRC Notified By: NATHAN SEID
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 05/02/2012
Notification Time: 19:02 [ET]
Event Date: 05/02/2012
Event Time: 11:55 [CDT]
Last Update Date: 10/19/2012
Notification Time: 19:02 [ET]
Event Date: 05/02/2012
Event Time: 11:55 [CDT]
Last Update Date: 10/19/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(ii)(B) - UNANALYZED CONDITION
10 CFR Section:
50.72(b)(3)(ii)(B) - UNANALYZED CONDITION
Person (Organization):
GREG WERNER (R4DO)
GREG WERNER (R4DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | N | 0 | Refueling Shutdown | 0 | Refueling Shutdown |
POTENTIAL UNANALYZED CONDITION WITH CONTAINMENT PRESSURE INSTRUMENTS
"While investigating operating experience from another station it was determined that Fort Calhoun Station (FCS) is subject to similar conditions. The operating experience involved setpoint drift of safety related pressure switches beyond what had been accounted for in the station's safety analyses.
"Following investigation and evaluation, it was determined that pressure switches that provide safety related signals for high containment pressure to the reactor protection system (RPS) and engineered safeguards actuation circuitry may be similarly affected at FCS. The impact of the potential drift was evaluated, and it was determined that neither RPS nor the engineered safeguard circuitry may actuate at the required containment pressure of 5 psig. An evaluation determined that the actuation may not occur until slightly higher than the required pressure. Other systems are currently being evaluated to see if this same condition applies.
"The station is in MODE 5, refueling shutdown condition, and there is no immediate safety concern."
The pressure instruments are located in the penetration area which is subject to elevated temperatures.
The licensee notified the NRC Resident Inspector.
* * * RETRACTION AT 1616 EDT ON 10/19/2012 FROM LUKE JENSEN TO MARK ABRAMOVITZ * * *
"The condition was initially determined to be reportable under 10CFR50.72(b)(3)(ii)(B), plant in unanalyzed condition, based on a conservative assumption that the error introduced violated not only the Technical Specification limit (5.0 psig) but also the safety analysis limit of 5.4 psig, USAR Table 14.1-1. Subsequent evaluation of actual data concluded that the safety analysis limit was not exceeded and therefore not reportable under 10 CFR 50.72(b)(3)(ii)(B).
"LER 2012-004-1 reported this condition under 10CFR50.73(a)(2)(i)(B), 10CFR50.73(a)(2)(ix)(A), and 10CFR50.73(a)(2)(v)(A,B,C,D). Revision 2 of the LER will correct the reporting criteria."
The NRC Resident Inspector was notified by the licensee.
Notified the R4DO (Pick).
"While investigating operating experience from another station it was determined that Fort Calhoun Station (FCS) is subject to similar conditions. The operating experience involved setpoint drift of safety related pressure switches beyond what had been accounted for in the station's safety analyses.
"Following investigation and evaluation, it was determined that pressure switches that provide safety related signals for high containment pressure to the reactor protection system (RPS) and engineered safeguards actuation circuitry may be similarly affected at FCS. The impact of the potential drift was evaluated, and it was determined that neither RPS nor the engineered safeguard circuitry may actuate at the required containment pressure of 5 psig. An evaluation determined that the actuation may not occur until slightly higher than the required pressure. Other systems are currently being evaluated to see if this same condition applies.
"The station is in MODE 5, refueling shutdown condition, and there is no immediate safety concern."
The pressure instruments are located in the penetration area which is subject to elevated temperatures.
The licensee notified the NRC Resident Inspector.
* * * RETRACTION AT 1616 EDT ON 10/19/2012 FROM LUKE JENSEN TO MARK ABRAMOVITZ * * *
"The condition was initially determined to be reportable under 10CFR50.72(b)(3)(ii)(B), plant in unanalyzed condition, based on a conservative assumption that the error introduced violated not only the Technical Specification limit (5.0 psig) but also the safety analysis limit of 5.4 psig, USAR Table 14.1-1. Subsequent evaluation of actual data concluded that the safety analysis limit was not exceeded and therefore not reportable under 10 CFR 50.72(b)(3)(ii)(B).
"LER 2012-004-1 reported this condition under 10CFR50.73(a)(2)(i)(B), 10CFR50.73(a)(2)(ix)(A), and 10CFR50.73(a)(2)(v)(A,B,C,D). Revision 2 of the LER will correct the reporting criteria."
The NRC Resident Inspector was notified by the licensee.
Notified the R4DO (Pick).
Power Reactor
Event Number: 47893
Facility: BRUNSWICK
Region: 2 State: NC
Unit: [1] [] []
RX Type: [1] GE-4,[2] GE-4
NRC Notified By: LEE GOLDSTEIN
HQ OPS Officer: PETE SNYDER
Region: 2 State: NC
Unit: [1] [] []
RX Type: [1] GE-4,[2] GE-4
NRC Notified By: LEE GOLDSTEIN
HQ OPS Officer: PETE SNYDER
Notification Date: 05/02/2012
Notification Time: 22:12 [ET]
Event Date: 05/02/2012
Event Time: 17:58 [EDT]
Last Update Date: 05/02/2012
Notification Time: 22:12 [ET]
Event Date: 05/02/2012
Event Time: 17:58 [EDT]
Last Update Date: 05/02/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
10 CFR Section:
50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
Person (Organization):
DEBORAH SEYMOUR (R2DO)
DEBORAH SEYMOUR (R2DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | Y | 37 | Power Operation | 37 | Power Operation |
HIGH PRESSURE COOLANT INJECTION INOPERABLE DUE TO ERRATIC GOVERNOR OPERATION
"On 5/2/2012 at 1758 EDT, the Unit 1 High Pressure Coolant Injection (HPCI) System was declared inoperable in accordance with Technical Specification 3.5.1 due to the flow controllers inability to maintain stable system flow and discharge pressure. This failure was discovered during the high steam pressure operability run (i.e., within 48 hours of achieving adequate test pressure following a scheduled refueling/maintenance outage) required by Technical Specification Surveillance 3.5.1.7 following refueling outage B119R1.
"This report is being made in accordance with 10 CFR 50.72(b)(3)(v)(D), as a condition that at the time of discovery could have prevented the fulfillment of the safety function of systems that are needed to mitigate the consequences of an accident.
"The safety significance of this event is considered minimal. The Reactor Core Isolation Cooling (RCIC) system, Automatic Depressurization System (ADS) and Low Pressure Emergency Core Cooling Systems (ECCS) remain operable at this time. Actions have been taken to protect redundant safety systems.
"The NRC Resident Inspector has been notified."
"On 5/2/2012 at 1758 EDT, the Unit 1 High Pressure Coolant Injection (HPCI) System was declared inoperable in accordance with Technical Specification 3.5.1 due to the flow controllers inability to maintain stable system flow and discharge pressure. This failure was discovered during the high steam pressure operability run (i.e., within 48 hours of achieving adequate test pressure following a scheduled refueling/maintenance outage) required by Technical Specification Surveillance 3.5.1.7 following refueling outage B119R1.
"This report is being made in accordance with 10 CFR 50.72(b)(3)(v)(D), as a condition that at the time of discovery could have prevented the fulfillment of the safety function of systems that are needed to mitigate the consequences of an accident.
"The safety significance of this event is considered minimal. The Reactor Core Isolation Cooling (RCIC) system, Automatic Depressurization System (ADS) and Low Pressure Emergency Core Cooling Systems (ECCS) remain operable at this time. Actions have been taken to protect redundant safety systems.
"The NRC Resident Inspector has been notified."
Power Reactor
Event Number: 47887
Facility: OCONEE
Region: 2 State: SC
Unit: [1] [2] [3]
RX Type: [1] B&W-L-LP,[2] B&W-L-LP,[3] B&W-L-LP
NRC Notified By: STEPHEN NEWMAN
HQ OPS Officer: DONALD NORWOOD
Region: 2 State: SC
Unit: [1] [2] [3]
RX Type: [1] B&W-L-LP,[2] B&W-L-LP,[3] B&W-L-LP
NRC Notified By: STEPHEN NEWMAN
HQ OPS Officer: DONALD NORWOOD
Notification Date: 05/02/2012
Notification Time: 12:18 [ET]
Event Date: 05/02/2012
Event Time: 10:05 [EDT]
Last Update Date: 05/02/2012
Notification Time: 12:18 [ET]
Event Date: 05/02/2012
Event Time: 10:05 [EDT]
Last Update Date: 05/02/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xii) - OFFSITE MEDICAL
10 CFR Section:
50.72(b)(3)(xii) - OFFSITE MEDICAL
Person (Organization):
DEBORAH SEYMOUR (R2DO)
DEBORAH SEYMOUR (R2DO)
| 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 |
| 3 | N | N | 0 | Refueling Shutdown | 0 | Refueling Shutdown |
POTENTIALLY CONTAMINATED INDIVIDUAL TRANSPORTED OFFSITE
"On 5/2/2012 at approximately 0914 hours, a Duke Energy contract worker performing activities in the Unit 3 reactor basement (currently defueled in a planned refueling outage), experienced dizziness and subsequently experienced a loss of consciousness. Upon discovery, the plant emergency medical team was dispatched to aid the individual. The individual soon regained consciousness but was immediately transported, via ambulance, to a local hospital for treatment. Accompanying the individual were two (2) radiation protection and one (1) Duke energy Public Affairs individuals. The individual was transported out of the protected area at approximately 1005 hours. Because the potentially contaminated individual's back could not be surveyed prior to being transported offsite, the individual was considered potentially contaminated. As such, this event is being reported as an 8-hour prompt report pursuant to 10CFR50.72(b)(3)(xii).
"On 5-2-2012 at approximately 1100 hours, the radiation protection personnel that accompanied the individual to the medical facility reported that the individual was determined not to be contaminated. As a result, no follow-up status report is planned.
"The licensee notified the NRC Resident Inspector."
"On 5/2/2012 at approximately 0914 hours, a Duke Energy contract worker performing activities in the Unit 3 reactor basement (currently defueled in a planned refueling outage), experienced dizziness and subsequently experienced a loss of consciousness. Upon discovery, the plant emergency medical team was dispatched to aid the individual. The individual soon regained consciousness but was immediately transported, via ambulance, to a local hospital for treatment. Accompanying the individual were two (2) radiation protection and one (1) Duke energy Public Affairs individuals. The individual was transported out of the protected area at approximately 1005 hours. Because the potentially contaminated individual's back could not be surveyed prior to being transported offsite, the individual was considered potentially contaminated. As such, this event is being reported as an 8-hour prompt report pursuant to 10CFR50.72(b)(3)(xii).
"On 5-2-2012 at approximately 1100 hours, the radiation protection personnel that accompanied the individual to the medical facility reported that the individual was determined not to be contaminated. As a result, no follow-up status report is planned.
"The licensee notified the NRC Resident Inspector."
Power Reactor
Event Number: 47888
Facility: LIMERICK
Region: 1 State: PA
Unit: [1] [] []
RX Type: [1] GE-4,[2] GE-4
NRC Notified By: CHRIS GIAMBRONE
HQ OPS Officer: DONALD NORWOOD
Region: 1 State: PA
Unit: [1] [] []
RX Type: [1] GE-4,[2] GE-4
NRC Notified By: CHRIS GIAMBRONE
HQ OPS Officer: DONALD NORWOOD
Notification Date: 05/02/2012
Notification Time: 13:15 [ET]
Event Date: 05/02/2012
Event Time: 07:24 [EDT]
Last Update Date: 05/02/2012
Notification Time: 13:15 [ET]
Event Date: 05/02/2012
Event Time: 07:24 [EDT]
Last Update Date: 05/02/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(iv)(A) - VALID SPECIF SYS ACTUATION
10 CFR Section:
50.72(b)(3)(iv)(A) - VALID SPECIF SYS ACTUATION
Person (Organization):
RICHARD CONTE (R1DO)
RICHARD CONTE (R1DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | Y | 100 | Power Operation | 100 | Power Operation |
MANUAL INITIATION OF SECONDARY CONTAINMENT ISOLATION
"In response to a trip of Unit 1 reactor enclosure [secondary containment] HVAC and subsequent loss of reactor enclosure delta-p, a Unit 1 manual secondary containment isolation was initiated per station procedures. This manual initiation also resulted in an isolation signal to containment atmosphere control (CAC) system valves and primary containment instrument gas (PCIG) system valves. System responses were as expected.
"Unit 1 secondary containment delta-p was restored via standby gas treatment system (SGTS), and Unit 1 secondary containment integrity remains intact and operable.
"Investigation of the trip of Unit 1 reactor enclosure HVAC is ongoing.
"This is being reported under 50.72(b)(3)(iv) for containment isolation signal affecting containment isolation valves in more than one system."
The licensee notified the NRC Resident Inspector.
"In response to a trip of Unit 1 reactor enclosure [secondary containment] HVAC and subsequent loss of reactor enclosure delta-p, a Unit 1 manual secondary containment isolation was initiated per station procedures. This manual initiation also resulted in an isolation signal to containment atmosphere control (CAC) system valves and primary containment instrument gas (PCIG) system valves. System responses were as expected.
"Unit 1 secondary containment delta-p was restored via standby gas treatment system (SGTS), and Unit 1 secondary containment integrity remains intact and operable.
"Investigation of the trip of Unit 1 reactor enclosure HVAC is ongoing.
"This is being reported under 50.72(b)(3)(iv) for containment isolation signal affecting containment isolation valves in more than one system."
The licensee notified the NRC Resident Inspector.
Non-Agreement State
Event Number: 47889
Rep Org: ESCANABA PAPER COMPANY
Licensee: ESCANABA PAPER COMPANY
Region: 3
City: ESCANABA State: MI
County:
License #: 21-17630-01
Agreement: N
Docket:
NRC Notified By: DARREN HENDON
HQ OPS Officer: MARK ABRAMOVITZ
Licensee: ESCANABA PAPER COMPANY
Region: 3
City: ESCANABA State: MI
County:
License #: 21-17630-01
Agreement: N
Docket:
NRC Notified By: DARREN HENDON
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 05/02/2012
Notification Time: 14:16 [ET]
Event Date: 05/02/2012
Event Time: 00:00 [EDT]
Last Update Date: 05/02/2012
Notification Time: 14:16 [ET]
Event Date: 05/02/2012
Event Time: 00:00 [EDT]
Last Update Date: 05/02/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
30.50(b)(2) - SAFETY EQUIPMENT FAILURE
10 CFR Section:
30.50(b)(2) - SAFETY EQUIPMENT FAILURE
Person (Organization):
MARK RING (R3DO)
ANGELA MCINTOSH (FSME)
MARK RING (R3DO)
ANGELA MCINTOSH (FSME)
DENSITY GAUGE SHUTTER STUCK OPEN
The shutter on a Kay Ray model 7063PS, S/N S99F1501, was determined to be stuck open during its annual shutter check. The gauge shutter was last tested satisfactorily on 5/6/2011. The gauge measures density in a line kiln and the shutter is normally open. The area is not normally accessible to personnel i.e. the open shutter does not pose a risk to the operators. The source is a 50 mCi Cs-137 source.
The shutter on a Kay Ray model 7063PS, S/N S99F1501, was determined to be stuck open during its annual shutter check. The gauge shutter was last tested satisfactorily on 5/6/2011. The gauge measures density in a line kiln and the shutter is normally open. The area is not normally accessible to personnel i.e. the open shutter does not pose a risk to the operators. The source is a 50 mCi Cs-137 source.
Agreement State
Event Number: 48058
Rep Org: CALIFORNIA RADIATION CONTROL PRGM
Licensee: SAINT JOSEPH HOSPITAL
Region: 4
City: EUREKA State: CA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: KENT PRENDERGAST
HQ OPS Officer: JOE O'HARA
Licensee: SAINT JOSEPH HOSPITAL
Region: 4
City: EUREKA State: CA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: KENT PRENDERGAST
HQ OPS Officer: JOE O'HARA
Notification Date: 06/29/2012
Notification Time: 15:59 [ET]
Event Date: 05/02/2012
Event Time: 00:00 [PDT]
Last Update Date: 12/20/2012
Notification Time: 15:59 [ET]
Event Date: 05/02/2012
Event Time: 00:00 [PDT]
Last Update Date: 12/20/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
JEFF CLARK (R4DO)
FSME RESOURCE (EMAI)
JEFF CLARK (R4DO)
FSME RESOURCE (EMAI)
AGREEMENT STATE REPORT - POTENTIAL MEDICAL EVENT DUE TO LEAKING I-125 SEEDS
The following was received via e-mail:
"On 6/28/12 Saint Joseph Hospital personnel were surveying a packing materials used to ship I-125 seeds, for a procedure conducted earlier that day, when they noted elevated readings. Further surveys revealed that the elevated readings were not coming from the packing material associated with the 6/28/12 procedure but from packing material that was used to ship I-125 seeds for a previous procedure, which was in the area of the survey. Surveys of the packing material revealed no loose contamination on the exterior or interior of the box but elevated readings of 2500-350000 cpm and .2 mrem/hr. Receipt and post procedure surveys of the procedure associated with contaminated box did not reveal any abnormal readings. The Saint Joseph RSO assumes the material is I-125 but they do not have the capability to verify this. No loose seeds were found in any of the packing material. The I-125 seeds were accompanied by the manufacturers leak test report which indicated no contamination.
"The patient, whose procedure was associated with the contaminated packing material, will be evaluated on Monday 7/2/12 to determine if there was any uptake in his urine or thyroid of I-125 as a result of leaking seeds."
CA Report Number: 062912
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 ON 7/2/12 AT 1806 EDT FROM EUGENE FORRER TO DONG PARK VIA EMAIL * * *
"This is a follow up of an incident, as information only, on Friday, June 29, 2012. Radiologic Health Branch reference would be 5010 #062912. The notification was about contaminated packaging that had contained Best Medical I-125 seeds. A thyroid count was performed on the patient who had the seeds implanted in May. The thyroid count verified that there had been an uptake of iodine by the thyroid. Below is the write up and preliminary dose estimate from the licensee regarding.
"Based upon this morning's patient measurements, instrument-manufacturer supplied efficiency data, and reference data for dose conversion, we estimate the patient involved received a thyroid uptake of 0.1 mCi of I-125 and a dose to the thyroid of 300 cGy.
"1) Conversion of counts per minute (cpm) to activity
Two[Pi] counting efficiency for I-125 (per manufacturer) is 133.5%
fraction of 2[Pi] solid angle subtended by a 2 inch diameter detector at a distance of 30 cm from the thyroid is 10.13 squared cm / 5654.9 squared cm = 0.00179
overall efficiency = 1.335 x 0.00179 = 0.00239
(190493 - 30) net cpm / 0.00239 x 4.505x10-10 mCi/dpm = 0.0359 mCi present thyroid burden.
Back-correcting 60 days to time of implantation (conservatively assuming that all uptake occurred at that time) with 42-day effective half-life, initial uptake given by 0.0359 / 0.3715 = 0.0967 approximately 0.1 mCi
"2) Taking the value quoted by Chen et.al. (attached) from NUREG/CR-6345, we assume the dose to thyroid is 780 cGy per mCi of I-125 administered, and this value assumes 25% uptake into the thyroid. Our calculated estimated thyroid burden of 0.1 mCi then gives an estimated absorbed dose of 0.0967 mCi x 780 cGy/mCi / 0.25 (since we measured actual thyroid burden v. amount administered) = 302 cGy approximately 300 cGy (rad) to thyroid.
"3) Whole body committed effective dose equivalent (CEDE) from a 300 rad dose to the thyroid (using a thyroid weighting factor of 0.04) would be 12 rem."
Notified R4DO (Allen) and FSME (Einberg).
* * * UPDATE FROM GENE FORRER TO CHARLES TEAL ON 12/19/12 AT 1650 EST * * *
"EVENT SUMMARY: While surveying an empty brachytherapy seeds package for return to Best Medical hospital personnel discovered contamination on the interior of the package. Follow up thyroid scans of the patient who was implanted with the seeds associated with the package verified an uptake of I-125 by the patient's thyroid. The initial report to RHB was intended, by the licensee, to be a notification of a Medical Event.
"REPORTING: This event was reported to the NRC, by phone, on 4/13/12, at 8:50 am via email.
"HEALTH AND SAFETY: Based on surveys of the packing material all contamination was contained within the package and did not pose a threat to hospital personnel. The estimated dose to the patient's thyroid was calculated to be approximately 330 rad with a CEDE of 12 rem.
"ADDITIONAL DETAILS: The RSO conducted an investigation of the incident and could not find any indication that there were any irregularities with the implantation procedures. Hospital personnel associated with the procedure indicated to the RHB inspector that there were no irregularities with the procedure. In addition receipt surveys of the package did not reveal any contamination of any of the packaging material. The RSO concluded that the cause of the contamination was due to a manufacturing error.
"The RSO of Best Medical conducted an investigation of the production of the seeds implanted in the patient. All records at Best Medical indicate that all QC tests of the seeds were done satisfactorily. The RSO concluded that the seeds had been damaged in transit or that Saint Joseph personnel must have damaged the seeds either during the initial surveys or during the implantation. The Best Medical RSO was unable to explain how the seeds could have been damaged and still be implantable. The Virginia Department of Health inspected the Best Medical facility and concluded that all QC testing on the seeds had been completed satisfactorily with no abnormalities noted.
"After interviewing Saint Joseph and Best Medical personnel RHB personnel concluded that the most logical explanation for the leaking seeds was a manufacturing error, however, without samples from the same lot of seeds implanted available for analysis this can not be proven conclusively.
"The hospital has changed suppliers for the brachytherapy seeds. In addition they have initiated a procedure where the needles containing the seeds are wiped after they have been removed from the shipping container.
"ENFORCEMENT ACTIONS: The hospital was not cited for this incident.
"INVESTIGATION STATUS: This investigation is closed."
Notified R4DO (Spitzberg) and FSME Event Resource via email.
The following was received via e-mail:
"On 6/28/12 Saint Joseph Hospital personnel were surveying a packing materials used to ship I-125 seeds, for a procedure conducted earlier that day, when they noted elevated readings. Further surveys revealed that the elevated readings were not coming from the packing material associated with the 6/28/12 procedure but from packing material that was used to ship I-125 seeds for a previous procedure, which was in the area of the survey. Surveys of the packing material revealed no loose contamination on the exterior or interior of the box but elevated readings of 2500-350000 cpm and .2 mrem/hr. Receipt and post procedure surveys of the procedure associated with contaminated box did not reveal any abnormal readings. The Saint Joseph RSO assumes the material is I-125 but they do not have the capability to verify this. No loose seeds were found in any of the packing material. The I-125 seeds were accompanied by the manufacturers leak test report which indicated no contamination.
"The patient, whose procedure was associated with the contaminated packing material, will be evaluated on Monday 7/2/12 to determine if there was any uptake in his urine or thyroid of I-125 as a result of leaking seeds."
CA Report Number: 062912
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 ON 7/2/12 AT 1806 EDT FROM EUGENE FORRER TO DONG PARK VIA EMAIL * * *
"This is a follow up of an incident, as information only, on Friday, June 29, 2012. Radiologic Health Branch reference would be 5010 #062912. The notification was about contaminated packaging that had contained Best Medical I-125 seeds. A thyroid count was performed on the patient who had the seeds implanted in May. The thyroid count verified that there had been an uptake of iodine by the thyroid. Below is the write up and preliminary dose estimate from the licensee regarding.
"Based upon this morning's patient measurements, instrument-manufacturer supplied efficiency data, and reference data for dose conversion, we estimate the patient involved received a thyroid uptake of 0.1 mCi of I-125 and a dose to the thyroid of 300 cGy.
"1) Conversion of counts per minute (cpm) to activity
Two[Pi] counting efficiency for I-125 (per manufacturer) is 133.5%
fraction of 2[Pi] solid angle subtended by a 2 inch diameter detector at a distance of 30 cm from the thyroid is 10.13 squared cm / 5654.9 squared cm = 0.00179
overall efficiency = 1.335 x 0.00179 = 0.00239
(190493 - 30) net cpm / 0.00239 x 4.505x10-10 mCi/dpm = 0.0359 mCi present thyroid burden.
Back-correcting 60 days to time of implantation (conservatively assuming that all uptake occurred at that time) with 42-day effective half-life, initial uptake given by 0.0359 / 0.3715 = 0.0967 approximately 0.1 mCi
"2) Taking the value quoted by Chen et.al. (attached) from NUREG/CR-6345, we assume the dose to thyroid is 780 cGy per mCi of I-125 administered, and this value assumes 25% uptake into the thyroid. Our calculated estimated thyroid burden of 0.1 mCi then gives an estimated absorbed dose of 0.0967 mCi x 780 cGy/mCi / 0.25 (since we measured actual thyroid burden v. amount administered) = 302 cGy approximately 300 cGy (rad) to thyroid.
"3) Whole body committed effective dose equivalent (CEDE) from a 300 rad dose to the thyroid (using a thyroid weighting factor of 0.04) would be 12 rem."
Notified R4DO (Allen) and FSME (Einberg).
* * * UPDATE FROM GENE FORRER TO CHARLES TEAL ON 12/19/12 AT 1650 EST * * *
"EVENT SUMMARY: While surveying an empty brachytherapy seeds package for return to Best Medical hospital personnel discovered contamination on the interior of the package. Follow up thyroid scans of the patient who was implanted with the seeds associated with the package verified an uptake of I-125 by the patient's thyroid. The initial report to RHB was intended, by the licensee, to be a notification of a Medical Event.
"REPORTING: This event was reported to the NRC, by phone, on 4/13/12, at 8:50 am via email.
"HEALTH AND SAFETY: Based on surveys of the packing material all contamination was contained within the package and did not pose a threat to hospital personnel. The estimated dose to the patient's thyroid was calculated to be approximately 330 rad with a CEDE of 12 rem.
"ADDITIONAL DETAILS: The RSO conducted an investigation of the incident and could not find any indication that there were any irregularities with the implantation procedures. Hospital personnel associated with the procedure indicated to the RHB inspector that there were no irregularities with the procedure. In addition receipt surveys of the package did not reveal any contamination of any of the packaging material. The RSO concluded that the cause of the contamination was due to a manufacturing error.
"The RSO of Best Medical conducted an investigation of the production of the seeds implanted in the patient. All records at Best Medical indicate that all QC tests of the seeds were done satisfactorily. The RSO concluded that the seeds had been damaged in transit or that Saint Joseph personnel must have damaged the seeds either during the initial surveys or during the implantation. The Best Medical RSO was unable to explain how the seeds could have been damaged and still be implantable. The Virginia Department of Health inspected the Best Medical facility and concluded that all QC testing on the seeds had been completed satisfactorily with no abnormalities noted.
"After interviewing Saint Joseph and Best Medical personnel RHB personnel concluded that the most logical explanation for the leaking seeds was a manufacturing error, however, without samples from the same lot of seeds implanted available for analysis this can not be proven conclusively.
"The hospital has changed suppliers for the brachytherapy seeds. In addition they have initiated a procedure where the needles containing the seeds are wiped after they have been removed from the shipping container.
"ENFORCEMENT ACTIONS: The hospital was not cited for this incident.
"INVESTIGATION STATUS: This investigation is closed."
Notified R4DO (Spitzberg) and FSME Event Resource via email.