Event Notification Report for August 28, 2012
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/27/2012 - 08/28/2012
EVENT NUMBERS
482424823848245482464829848752
Agreement State
Event Number: 48242
Rep Org: ARKANSAS DEPARTMENT OF HEALTH
Licensee: ANDERSON ENGINEERING
Region: 4
City: Little Rock State: AR
County:
License #: ARK-0519-0312
Agreement: Y
Docket:
NRC Notified By: STEVE MACK
HQ OPS Officer: BILL HUFFMAN
Licensee: ANDERSON ENGINEERING
Region: 4
City: Little Rock State: AR
County:
License #: ARK-0519-0312
Agreement: Y
Docket:
NRC Notified By: STEVE MACK
HQ OPS Officer: BILL HUFFMAN
Notification Date: 08/28/2012
Notification Time: 17:27 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [CDT]
Last Update Date: 05/03/2013
Notification Time: 17:27 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [CDT]
Last Update Date: 05/03/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
DAVID PROULX (R4DO)
FSME EVENT RESOURCE (EMAI)
DAVID PROULX (R4DO)
FSME EVENT RESOURCE (EMAI)
AGREEMENT STATE REPORT - DAMAGED TROXLER GAUGE
The following report was obtained from the Arkansas Radioactive Materials Program via e-mail:
"On August 27, 2012, the Radiation Control Program of Arkansas received notification from the Arkansas Department of Emergency Management that a tractor trailer had run over a nuclear gauge at the 192 mile marker on Interstate 40 near Hazen, Arkansas.
"The driver of a Motorists Assist Truck familiar with moisture density gauges identified the gauge parts on the side of the highway. The gauge had been struck by a vehicle and broken up. The driver reported the presence of the gauge parts to his construction company Project Manager who in turn notified Highway Police. At 1914 the west bound lane of Interstate 40 was closed and remained closed until 2155. The Highway Police asked for assistance from the Radiation Safety Officer of the Arkansas Highway and Transportation Department (AHTD) who drove to the scene.
"The 44 millicurie, Americium-241:Beryllium source was still contained within the original threaded cavity with the Caution-Radioactive Material label covering it. The base of the gauge was broken to the point that only the threaded cavity and surrounding lead remained.
"The 9 millicurie, Cesium-137 source remained attached to the source rod and inside the original shielding. The shielding was sheared off just above the tungsten sliding block (shutter).
"The AHTD Radiation Safety Officer, upon arrival, secured the Americium-241:Beryllium source in a polyethylene box brought to the scene. The Cesium-137 source was removed from the gauge shielding by the AHTD RSO and this source was placed in a lead shield brought to the scene.
"Two Health Physicists from the Arkansas Radiation Control Program were also dispatched and upon arrival took wipes of both sources. These smears were field counted utilizing a Ludlum-2241 and Ludlum 44-9 pancake probe. No loose contamination was found.
"All potential serial numbers were recorded and the sources were transferred to the Radiation Control Program by the AHTD RSO. The Health Physicists transported the sources to a secure storage area at the State Health Department.
"On Tuesday morning, Troxler identified the owner of the gauge by the serial number. The gauge is a Model 3430, Serial Number 21024. The gauge is owned by Anderson Engineering of Little Rock, Arkansas. Arkansas Radioactive Material License Number ARK-0519-03121.
"It appears that an Anderson Engineering technician had been working at a construction job site in De Valls Bluff, Arkansas. On Monday evening, he left this job site and returned to the Anderson Engineering Little Rock Office. The gauge was left unsecured in the back of the pickup. On Interstate 40 West at mile marker 192, the gauge fell out of the pickup bed, where it was struck by at least one vehicle. Upon arrival at the Anderson Engineering offices, the technician removed the Troxler Gauge Storage Box from the pickup bed and noted that it was empty. The technician believed that he had left the gauge at the job site. On the morning of August 28, 2012, he returned to the jobsite to search for the gauge.
"On Tuesday, August 28, 2012, the Radiation Safety Officer was contacted and retrieved the two sources from the Arkansas Department of Health and secured these in the Anderson Engineering permanent storage area.
"The Arkansas Radiation Control Program has assigned Incident Number AR-2012-006 and is continuing to investigate."
* * * UPDATE FROM STEVE MACK TO CHARLES TEAL ON 5/3/13 AT 1012 EDT * * *
The following was received from the State of Arkansas via email:
"The sources were disposed of through the manufacturer on 2/22/2013. The Department [Arkansas Department of Health] considers this event to be closed."
Notified R4DO (Haire) and FSME Event Resource via email.
The following report was obtained from the Arkansas Radioactive Materials Program via e-mail:
"On August 27, 2012, the Radiation Control Program of Arkansas received notification from the Arkansas Department of Emergency Management that a tractor trailer had run over a nuclear gauge at the 192 mile marker on Interstate 40 near Hazen, Arkansas.
"The driver of a Motorists Assist Truck familiar with moisture density gauges identified the gauge parts on the side of the highway. The gauge had been struck by a vehicle and broken up. The driver reported the presence of the gauge parts to his construction company Project Manager who in turn notified Highway Police. At 1914 the west bound lane of Interstate 40 was closed and remained closed until 2155. The Highway Police asked for assistance from the Radiation Safety Officer of the Arkansas Highway and Transportation Department (AHTD) who drove to the scene.
"The 44 millicurie, Americium-241:Beryllium source was still contained within the original threaded cavity with the Caution-Radioactive Material label covering it. The base of the gauge was broken to the point that only the threaded cavity and surrounding lead remained.
"The 9 millicurie, Cesium-137 source remained attached to the source rod and inside the original shielding. The shielding was sheared off just above the tungsten sliding block (shutter).
"The AHTD Radiation Safety Officer, upon arrival, secured the Americium-241:Beryllium source in a polyethylene box brought to the scene. The Cesium-137 source was removed from the gauge shielding by the AHTD RSO and this source was placed in a lead shield brought to the scene.
"Two Health Physicists from the Arkansas Radiation Control Program were also dispatched and upon arrival took wipes of both sources. These smears were field counted utilizing a Ludlum-2241 and Ludlum 44-9 pancake probe. No loose contamination was found.
"All potential serial numbers were recorded and the sources were transferred to the Radiation Control Program by the AHTD RSO. The Health Physicists transported the sources to a secure storage area at the State Health Department.
"On Tuesday morning, Troxler identified the owner of the gauge by the serial number. The gauge is a Model 3430, Serial Number 21024. The gauge is owned by Anderson Engineering of Little Rock, Arkansas. Arkansas Radioactive Material License Number ARK-0519-03121.
"It appears that an Anderson Engineering technician had been working at a construction job site in De Valls Bluff, Arkansas. On Monday evening, he left this job site and returned to the Anderson Engineering Little Rock Office. The gauge was left unsecured in the back of the pickup. On Interstate 40 West at mile marker 192, the gauge fell out of the pickup bed, where it was struck by at least one vehicle. Upon arrival at the Anderson Engineering offices, the technician removed the Troxler Gauge Storage Box from the pickup bed and noted that it was empty. The technician believed that he had left the gauge at the job site. On the morning of August 28, 2012, he returned to the jobsite to search for the gauge.
"On Tuesday, August 28, 2012, the Radiation Safety Officer was contacted and retrieved the two sources from the Arkansas Department of Health and secured these in the Anderson Engineering permanent storage area.
"The Arkansas Radiation Control Program has assigned Incident Number AR-2012-006 and is continuing to investigate."
* * * UPDATE FROM STEVE MACK TO CHARLES TEAL ON 5/3/13 AT 1012 EDT * * *
The following was received from the State of Arkansas via email:
"The sources were disposed of through the manufacturer on 2/22/2013. The Department [Arkansas Department of Health] considers this event to be closed."
Notified R4DO (Haire) and FSME Event Resource via email.
Power Reactor
Event Number: 48238
Facility: WATTS BAR
Region: 2 State: TN
Unit: [1] [] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: MICHAEL BOTTORFF
HQ OPS Officer: PETE SNYDER
Region: 2 State: TN
Unit: [1] [] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: MICHAEL BOTTORFF
HQ OPS Officer: PETE SNYDER
Notification Date: 08/28/2012
Notification Time: 06:13 [ET]
Event Date: 08/28/2012
Event Time: 03:32 [EDT]
Last Update Date: 08/28/2012
Notification Time: 06:13 [ET]
Event Date: 08/28/2012
Event Time: 03:32 [EDT]
Last Update Date: 08/28/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(2)(iv)(B) - RPS ACTUATION - CRITICAL 50.72(b)(3)(iv)(A) - VALID SPECIF SYS ACTUATION
10 CFR Section:
50.72(b)(2)(iv)(B) - RPS ACTUATION - CRITICAL 50.72(b)(3)(iv)(A) - VALID SPECIF SYS ACTUATION
Person (Organization):
ROBERT HAAG (R2DO)
ROBERT HAAG (R2DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | A/R | Y | 100 | Power Operation | 0 | Hot Standby |
AUTOMATIC REACTOR TRIP FOLLOWING FAILURE OF A FEEDWATER REGULATING VALVE
"On August 28, 2012, Watts Bar Nuclear Plant Unit 1 reactor automatically tripped due to low level in steam generator (SG) #2. The low level resulted when the Main Feedwater Control Valve for SG#2 (1-FCV-3-48) failed closed. This is being reported under 10CFR 50.72 (b)(2) (iv) (B).
"Concurrent with the reactor trip the Auxiliary Feedwater system actuated as designed. This is being reported under 10CFR 50.72(b)(3) (iv)(A).
"All Control and Shutdown rods fully inserted.
"All safety systems responded as designed. The unit is currently stable in Mode 3.
"The NRC Senior Resident has been notified."
Decay heat is being removed to the main condenser via condenser steam dumps. The plant is in its normal shutdown electrical lineup. No steam safety or relief valves lifted during the event.
"On August 28, 2012, Watts Bar Nuclear Plant Unit 1 reactor automatically tripped due to low level in steam generator (SG) #2. The low level resulted when the Main Feedwater Control Valve for SG#2 (1-FCV-3-48) failed closed. This is being reported under 10CFR 50.72 (b)(2) (iv) (B).
"Concurrent with the reactor trip the Auxiliary Feedwater system actuated as designed. This is being reported under 10CFR 50.72(b)(3) (iv)(A).
"All Control and Shutdown rods fully inserted.
"All safety systems responded as designed. The unit is currently stable in Mode 3.
"The NRC Senior Resident has been notified."
Decay heat is being removed to the main condenser via condenser steam dumps. The plant is in its normal shutdown electrical lineup. No steam safety or relief valves lifted during the event.
Power Reactor
Event Number: 48245
Facility: CALLAWAY
Region: 4 State: MO
Unit: [1] [] []
RX Type: [1] W-4-LP
NRC Notified By: TIM HOLLAND
HQ OPS Officer: HOWIE CROUCH
Region: 4 State: MO
Unit: [1] [] []
RX Type: [1] W-4-LP
NRC Notified By: TIM HOLLAND
HQ OPS Officer: HOWIE CROUCH
Notification Date: 08/28/2012
Notification Time: 18:51 [ET]
Event Date: 08/28/2012
Event Time: 15:00 [CDT]
Last Update Date: 08/28/2012
Notification Time: 18:51 [ET]
Event Date: 08/28/2012
Event Time: 15:00 [CDT]
Last Update Date: 08/28/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
DAVID PROULX (R4DO)
DAVID PROULX (R4DO)
| Unit | SCRAM Code | RX Crit | Initial PWR | Initial RX Mode | Current PWR | Current RX Mode |
|---|---|---|---|---|---|---|
| 1 | N | Y | 100 | Power Operation | 100 | Power Operation |
TECHNICAL SUPPORT CENTER DETERMINED TO BE NON-FUNCTIONAL DUE TO LOW RECIRC FLOW
"At 1500 CDT on Tuesday, August 28, the Callaway Plant Technical Support Center (TSC) was declared non-functional due to ventilation recirculation flow rate outside of normal limits.
"Efforts are underway to restore TSC ventilation recirculation flow rate to normal.
"If TSC activation is necessary during the period of TSC non-functionality, the Emergency Coordinator will evaluate the suitability of the facility for the specific conditions of the event.
"This notification is being made in accordance with 10 CFR 50.72(b)(3)(xiii) due to the unavailability of an emergency response facility.
"The NRC Resident Inspector has been notified"
* * * UPDATE FROM MATT SELLERS TO DONALD NORWOOD AT 1517 EDT ON 12/29/2012 * * *
"The TSC was restored to functional status at 1228 (CDT) on August 29, 2012."
The licensee notified the NRC Resident Inspector. Notified R4DO (Proulx).
"At 1500 CDT on Tuesday, August 28, the Callaway Plant Technical Support Center (TSC) was declared non-functional due to ventilation recirculation flow rate outside of normal limits.
"Efforts are underway to restore TSC ventilation recirculation flow rate to normal.
"If TSC activation is necessary during the period of TSC non-functionality, the Emergency Coordinator will evaluate the suitability of the facility for the specific conditions of the event.
"This notification is being made in accordance with 10 CFR 50.72(b)(3)(xiii) due to the unavailability of an emergency response facility.
"The NRC Resident Inspector has been notified"
* * * UPDATE FROM MATT SELLERS TO DONALD NORWOOD AT 1517 EDT ON 12/29/2012 * * *
"The TSC was restored to functional status at 1228 (CDT) on August 29, 2012."
The licensee notified the NRC Resident Inspector. Notified R4DO (Proulx).
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Power Reactor
Event Number: 48246
Facility: DIABLO CANYON
Region: 4 State: CA
Unit: [1] [2] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: DAN STERMER
HQ OPS Officer: JOHN KNOKE
Region: 4 State: CA
Unit: [1] [2] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: DAN STERMER
HQ OPS Officer: JOHN KNOKE
Notification Date: 08/29/2012
Notification Time: 00:16 [ET]
Event Date: 08/28/2012
Event Time: 17:00 [PDT]
Last Update Date: 09/08/2012
Notification Time: 00:16 [ET]
Event Date: 08/28/2012
Event Time: 17:00 [PDT]
Last Update Date: 09/08/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(ii)(B) - UNANALYZED CONDITION 50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
10 CFR Section:
50.72(b)(3)(ii)(B) - UNANALYZED CONDITION 50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
Person (Organization):
DAVID PROULX (R4DO)
DAVID PROULX (R4DO)
| 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 |
MITIGATING ACTIONS IMPLEMENTED FOR INOPERABLE CONTROL ROOM ENVELOPE
"On August 28, 2012, 17:00 PDT, Pacific Gas and Electric Company (PG&E) identified additional release pathways that could affect the control room (CR) operator dose following a Large-Break Loss-of-Coolant Accident (LBLOCA). Consequently, PG&E declared the control room envelope (CRE) inoperable and is establishing mitigative actions in accordance with TS 3.7.10, Action B.1, 'Initiate action to implement mitigating actions' immediately, and Action B.2, 'Verify mitigating actions ensure CRE occupant exposures to radiological hazards will not exceed limits, and CRE occupants are protected from smoke and chemical hazards' within 24 hours.
"PG&E is establishing mitigative actions in accordance with TS 3.7.10 and RG 1.196. These mitigative actions are for operations control room personnel to administer potassium iodide and don self-contained breathing apparatus equipment in a timely fashion should a LBLOCA occur. They will be communicated and controlled by a standing order to the control room staff.
"PG&E previously established controls on other release pathways that offset the potential increases to the maximum predicted offsite dose due to the new release pathways. No increase in maximum predicted offsite dose is expected from the new release pathways.
"Diablo Canyon (DCPP) is making this 8-hour, non-emergency notification under 10 CFR 50.72(b)(3)(ii)(B) and 10 CFR 50.72(b)(3)(v)(D).
"Plant personnel notified the NRC Resident Inspector."
* * * UPDATE AT 1600 EDT ON 9/8/12 FROM GLEN GOELZER TO PETE SNYDER * * *
"PG&E is retracting EN 48246, based on the results from a new dose analysis coupled with compensatory measures implemented to ensure that the analysis input parameters and assumption will not be inadvertently exceeded. The analysis concluded that the CRE was operable and that CR doses remained below regulatory limits.
"Plant personnel notified the NRC resident inspector."
Notified R4DO (Gaddy).
"On August 28, 2012, 17:00 PDT, Pacific Gas and Electric Company (PG&E) identified additional release pathways that could affect the control room (CR) operator dose following a Large-Break Loss-of-Coolant Accident (LBLOCA). Consequently, PG&E declared the control room envelope (CRE) inoperable and is establishing mitigative actions in accordance with TS 3.7.10, Action B.1, 'Initiate action to implement mitigating actions' immediately, and Action B.2, 'Verify mitigating actions ensure CRE occupant exposures to radiological hazards will not exceed limits, and CRE occupants are protected from smoke and chemical hazards' within 24 hours.
"PG&E is establishing mitigative actions in accordance with TS 3.7.10 and RG 1.196. These mitigative actions are for operations control room personnel to administer potassium iodide and don self-contained breathing apparatus equipment in a timely fashion should a LBLOCA occur. They will be communicated and controlled by a standing order to the control room staff.
"PG&E previously established controls on other release pathways that offset the potential increases to the maximum predicted offsite dose due to the new release pathways. No increase in maximum predicted offsite dose is expected from the new release pathways.
"Diablo Canyon (DCPP) is making this 8-hour, non-emergency notification under 10 CFR 50.72(b)(3)(ii)(B) and 10 CFR 50.72(b)(3)(v)(D).
"Plant personnel notified the NRC Resident Inspector."
* * * UPDATE AT 1600 EDT ON 9/8/12 FROM GLEN GOELZER TO PETE SNYDER * * *
"PG&E is retracting EN 48246, based on the results from a new dose analysis coupled with compensatory measures implemented to ensure that the analysis input parameters and assumption will not be inadvertently exceeded. The analysis concluded that the CRE was operable and that CR doses remained below regulatory limits.
"Plant personnel notified the NRC resident inspector."
Notified R4DO (Gaddy).
Agreement State
Event Number: 48298
Rep Org: RI DEPT OF RADIOLOGICAL HEALTH
Licensee: ROGER WILLIAMS MEDICAL CENTER
Region: 1
City: PROVIDENCE State: RI
County:
License #: 7D-026-01
Agreement: Y
Docket:
NRC Notified By: CHARMA WARING
HQ OPS Officer: STEVE SANDIN
Licensee: ROGER WILLIAMS MEDICAL CENTER
Region: 1
City: PROVIDENCE State: RI
County:
License #: 7D-026-01
Agreement: Y
Docket:
NRC Notified By: CHARMA WARING
HQ OPS Officer: STEVE SANDIN
Notification Date: 09/11/2012
Notification Time: 13:07 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [EDT]
Last Update Date: 05/30/2014
Notification Time: 13:07 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [EDT]
Last Update Date: 05/30/2014
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
CHRISTOPHER NEWPORT (R1DO)
FSME EVENTS RESOURCE (EMAI)
CHRISTOPHER NEWPORT (R1DO)
FSME EVENTS RESOURCE (EMAI)
AGREEMENT STATE REPORT - PATIENT RECEIVED TWO UNDERDOSES OF Y-90 TO DIFFERENT TREATMENT SITES
The following information was received from the State of Rhode Island via fax:
"Event Type: Medical event involving the administration of Yttrium-90 microspheres.
"Notification(s): On August 30, 2012, the RI Department of Health Office of Facilities Regulation, Radiation Control Program received a phone call from the facility's Radiation Safety Officer, with a follow-up e-mail the same day.
"Event Description: On 08/28/2012, two incorrect doses were prepared for a Y-90 microsphere treatment. Both doses were for the same patient (i.e., two different treatment sites). One dose was drawn at 28.7% less than prescribed and the other dose was drawn at 22.9% less than prescribed. The final administered doses were less than 40.3% and 27.2% prescribed, respectively.
"Cause of the event: Under investigation and unknown at this time.
"Actions: Adverse effects to the patient are not expected; a follow-up reactive inspection is planned.
"[Rhode Island] Event Report ID: 2012-001"
* * * UPDATE FROM CHARMA WARING TO PETE SNYDER AT 1503 EDT ON 10/24/12 * * *
The State of Rhode Island provided the following information via fax:
"Cause of the event: For both doses, after withdrawing the microspheres from the shipping container, the licensee nuclear medicine technologist added sterile water to the syringe prior to transferring them into the v-vial. The policy is that the Y-90 is transferred into the v-vial prior to adding sterile water. The technologist then added additional sterile water to the v-vials in accordance with procedure.
"For both doses, after placing the v-vial into the dose calibrator, the technologist noticed that the dose was less than the 10% prescribed by the physician. The technologist was confused about the correction factor of 0.82 required for the v-vial when placed into the dose calibrator. The technologist did not understand why the original dose drawn from the shipping vial was within +/- 10%, but the v-vial dose was not. The technologist ultimately concluded that the shipping v-vial should have also been corrected by 0.82 and sent the dose to Interventional Radiology (IR) where it was administered.
"Although the dose withdrawn from the shipping container was originally within +/- 10%, some of the microspheres were most likely lost during transfer to the v-vial. The most likely cause was due to adding sterile water, prior to transfer. The doses drawn by the Nuclear Medicine Technologist were 9.84 mCi for the right lobe (Vial 1) and 10.41 mCi for segment VII, neither of which are within the +/- 10% established by policy.
"After administration of both doses, the v-vials were sent back to Nuclear Medicine per procedure and assayed in the dose calibrator for residual activity. The dose to the right lobe (Vial 1) and the dose to segment VII (Vial 2) had 1.6 mCi and 0.57 mCi remaining, respectively. Therefore, not all of the microspheres were administered. As a result, the final administered dose to the right lobe was 8.24 mCi and the dose to Segment VII was 9.84 mCi. This resulted in an under administered dose of 40.3% to the right lobe and an under administered dose of 27.2% to segment VII.
"Licensee Actions: As a result of this event, the RSO performed an in-service training [that] was held on 9/21/12. The licensee also does an additional 'timeout' when the dose is brought to the IR suite to verify prescribed versus drawn dose. The Nuclear Medicine staff alternate drawing the Y-90 doses to maintain familiarity with the procedure.
"RI RCP [Rhode Island Radiation Control Program] Actions: The corrective actions outlined by the licensee have been complete therefore, no further action is required at this time."
Notified R1DO (Caruso) and FSME Events Resource (email).
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 AT 1144 EDT ON 5/30/14 FROM CHARMA WARING TO MARK ABRAMOVITZ * * *
The following information was received via fax:
"Per the physician, this misadministration, which was lower than the planned dose based on body surface area, will not result in any harm to the patient. Repeat administration was already anticipated, if there was evidence for a response. The Bremsstrahlung scan shows increased activity in the tumor bed as well, consistent with an adequate delivery to the target. As a result of this event, the RSO will perform an in-service training on the Y-90 SirSphere Worksheet which will include practice runs so staff are comfortable with the math involved (specifically the correction factor of 0.82). The RSO has requested and the Director of Diagnostic Imaging has agreed that the Nuclear Medicine technologists shall rotate frequently on performing Y-90 microsphere dose preparations. Additionally, once the dose is brought to IR there will be an additional timeout to verify that the prepared dose by Nuclear Medicine matches that of the WD [written directive].
"[The physician] notified that patient via telephone on August 30, 2012."
Notified the R1DO (Rogge) and FSME Event Resources (via e-mail)..
The following information was received from the State of Rhode Island via fax:
"Event Type: Medical event involving the administration of Yttrium-90 microspheres.
"Notification(s): On August 30, 2012, the RI Department of Health Office of Facilities Regulation, Radiation Control Program received a phone call from the facility's Radiation Safety Officer, with a follow-up e-mail the same day.
"Event Description: On 08/28/2012, two incorrect doses were prepared for a Y-90 microsphere treatment. Both doses were for the same patient (i.e., two different treatment sites). One dose was drawn at 28.7% less than prescribed and the other dose was drawn at 22.9% less than prescribed. The final administered doses were less than 40.3% and 27.2% prescribed, respectively.
"Cause of the event: Under investigation and unknown at this time.
"Actions: Adverse effects to the patient are not expected; a follow-up reactive inspection is planned.
"[Rhode Island] Event Report ID: 2012-001"
* * * UPDATE FROM CHARMA WARING TO PETE SNYDER AT 1503 EDT ON 10/24/12 * * *
The State of Rhode Island provided the following information via fax:
"Cause of the event: For both doses, after withdrawing the microspheres from the shipping container, the licensee nuclear medicine technologist added sterile water to the syringe prior to transferring them into the v-vial. The policy is that the Y-90 is transferred into the v-vial prior to adding sterile water. The technologist then added additional sterile water to the v-vials in accordance with procedure.
"For both doses, after placing the v-vial into the dose calibrator, the technologist noticed that the dose was less than the 10% prescribed by the physician. The technologist was confused about the correction factor of 0.82 required for the v-vial when placed into the dose calibrator. The technologist did not understand why the original dose drawn from the shipping vial was within +/- 10%, but the v-vial dose was not. The technologist ultimately concluded that the shipping v-vial should have also been corrected by 0.82 and sent the dose to Interventional Radiology (IR) where it was administered.
"Although the dose withdrawn from the shipping container was originally within +/- 10%, some of the microspheres were most likely lost during transfer to the v-vial. The most likely cause was due to adding sterile water, prior to transfer. The doses drawn by the Nuclear Medicine Technologist were 9.84 mCi for the right lobe (Vial 1) and 10.41 mCi for segment VII, neither of which are within the +/- 10% established by policy.
"After administration of both doses, the v-vials were sent back to Nuclear Medicine per procedure and assayed in the dose calibrator for residual activity. The dose to the right lobe (Vial 1) and the dose to segment VII (Vial 2) had 1.6 mCi and 0.57 mCi remaining, respectively. Therefore, not all of the microspheres were administered. As a result, the final administered dose to the right lobe was 8.24 mCi and the dose to Segment VII was 9.84 mCi. This resulted in an under administered dose of 40.3% to the right lobe and an under administered dose of 27.2% to segment VII.
"Licensee Actions: As a result of this event, the RSO performed an in-service training [that] was held on 9/21/12. The licensee also does an additional 'timeout' when the dose is brought to the IR suite to verify prescribed versus drawn dose. The Nuclear Medicine staff alternate drawing the Y-90 doses to maintain familiarity with the procedure.
"RI RCP [Rhode Island Radiation Control Program] Actions: The corrective actions outlined by the licensee have been complete therefore, no further action is required at this time."
Notified R1DO (Caruso) and FSME Events Resource (email).
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 AT 1144 EDT ON 5/30/14 FROM CHARMA WARING TO MARK ABRAMOVITZ * * *
The following information was received via fax:
"Per the physician, this misadministration, which was lower than the planned dose based on body surface area, will not result in any harm to the patient. Repeat administration was already anticipated, if there was evidence for a response. The Bremsstrahlung scan shows increased activity in the tumor bed as well, consistent with an adequate delivery to the target. As a result of this event, the RSO will perform an in-service training on the Y-90 SirSphere Worksheet which will include practice runs so staff are comfortable with the math involved (specifically the correction factor of 0.82). The RSO has requested and the Director of Diagnostic Imaging has agreed that the Nuclear Medicine technologists shall rotate frequently on performing Y-90 microsphere dose preparations. Additionally, once the dose is brought to IR there will be an additional timeout to verify that the prepared dose by Nuclear Medicine matches that of the WD [written directive].
"[The physician] notified that patient via telephone on August 30, 2012."
Notified the R1DO (Rogge) and FSME Event Resources (via e-mail)..
Agreement State
Event Number: 48752
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: PENN STATE MILTON S. HERSHEY MEDICAL CENTER
Region: 1
City: HERSHEY State: PA
County:
License #: PA-0127
Agreement: Y
Docket:
NRC Notified By: JOE MELNIC
HQ OPS Officer: HOWIE CROUCH
Licensee: PENN STATE MILTON S. HERSHEY MEDICAL CENTER
Region: 1
City: HERSHEY State: PA
County:
License #: PA-0127
Agreement: Y
Docket:
NRC Notified By: JOE MELNIC
HQ OPS Officer: HOWIE CROUCH
Notification Date: 02/14/2013
Notification Time: 14:28 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [EST]
Last Update Date: 02/14/2013
Notification Time: 14:28 [ET]
Event Date: 08/28/2012
Event Time: 00:00 [EST]
Last Update Date: 02/14/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
ANTHONY DIMITRIADIS (R1DO)
FSME EVENTS RESOURCE (EMAI)
ANTHONY DIMITRIADIS (R1DO)
FSME EVENTS RESOURCE (EMAI)
AGREEMENT STATE REPORT - MEDICAL EVENT INVOLVING Y-90 SIR-SPHERES
The following information was obtained from the Commonwealth of Pennsylvania via email and facsimile:
"Notifications: On February 13, 2013 the licensee informed the Department's [Pennsylvania Department of Environmental Protection] South-central Regional Office of the medical event. The event is reportable within 24 hours per 10 CFR 35.3045(a)(1)(i). The referring physician was notified of this event but the patient passed away in November of 2012 as a result of metastatic pancreatic cancer.
"Event Description: During a routine audit of the Y-90 written directive program, an error was noted in a SIR-Sphere procedure that was performed on August 28, 2012. The patient was prescribed 17.6 mCi of Y-90 SIR-Spheres. The patient actually received only 12.8 mCi. This corresponds to a dose that is 27.3% lower than the prescribed dose.
"Cause of the Event: The physician recorded the wrong administered dose on the written directive form. Also a small liquid volume remained in the vial after the 'air-injection' final step.
"Actions: The licensee initiated and completed an audit of all SIR-Sphere procedures and no other issues were identified in any other patients since inception of the program. The South-central Regional Office has been in discussion with the licensee regarding corrective actions that will be implemented."
Pennsylvania Event Report ID No.: PA130006
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 information was obtained from the Commonwealth of Pennsylvania via email and facsimile:
"Notifications: On February 13, 2013 the licensee informed the Department's [Pennsylvania Department of Environmental Protection] South-central Regional Office of the medical event. The event is reportable within 24 hours per 10 CFR 35.3045(a)(1)(i). The referring physician was notified of this event but the patient passed away in November of 2012 as a result of metastatic pancreatic cancer.
"Event Description: During a routine audit of the Y-90 written directive program, an error was noted in a SIR-Sphere procedure that was performed on August 28, 2012. The patient was prescribed 17.6 mCi of Y-90 SIR-Spheres. The patient actually received only 12.8 mCi. This corresponds to a dose that is 27.3% lower than the prescribed dose.
"Cause of the Event: The physician recorded the wrong administered dose on the written directive form. Also a small liquid volume remained in the vial after the 'air-injection' final step.
"Actions: The licensee initiated and completed an audit of all SIR-Sphere procedures and no other issues were identified in any other patients since inception of the program. The South-central Regional Office has been in discussion with the licensee regarding corrective actions that will be implemented."
Pennsylvania Event Report ID No.: PA130006
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.