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Event Notification Report for November 25, 2013

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
11/22/2013 - 11/25/2013

** EVENT NUMBERS **


49537 49540 49542 49573 49574 49575 49576

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Agreement State Event Number: 49537
Rep Org: WA DIVISION OF RADIATION PROTECTION
Licensee: SWEDISH HOSPITAL AND MEDICAL CENTER
Region: 4
City: SEATTLE State: WA
County:
License #: WN-M008-1
Agreement: Y
Docket:
NRC Notified By: CURT DEMARIS
HQ OPS Officer: BILL HUFFMAN
Notification Date: 11/14/2013
Notification Time: 14:40 [ET]
Event Date: 11/08/2013
Event Time: [PST]
Last Update Date: 11/14/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
THOMAS FARNHOLTZ (R4DO)
FSME EVENT RESOURCE (E-MA)

Event Text

AGREEMENT STATE REPORT - Y-90 THERASHPERE DOSE LESS THAN PRESCRIBED

The following report was received from the Washington Department of Health [WA DOH] via e-mail:

"The licensee was performing an administration of Nordion TheraSpheres, a procedure performed without incident for over sixty administrations so far, when measurements indicated that an inordinate amount of the material remained in the waste/tubing. The licensee has confirmed the catheter used had an internal diameter [ID] of 0.68mm, which equals and exceeds the manufacturer's specifications of equal or greater than 0.5 mm ID.

"1. On Friday, November 8, 2013 at approximately 1040 [PST], the RSO received notification of a possible medical event involving the administration of Y-90 microspheres (TheraSpheres). The Radiation Safety Specialist contacted WA DOH at approximately 1100 on Friday, November 8, 2013 to report a medical event in accordance with requirements in WAC 246-240-651.

"2. The routine procedure for Y-90 microsphere administration requires the measurement of the materials used for the administration at a fixed geometry both before and after administration. The ratio of the exposure rate measured (minus background) indicates the percentage of the microspheres remaining in the tubing. This value subtracted from the originally prescribed activity determines the percentage of activity actually administered to the patient. The prescribed dose was 129 Gy to the left lobe, equivalent to an administered activity of 5.0 GBq. The measured activity (via Capintec CRC-15R) was 5.04 GBq which resulted in a pre-administration exposure rate of 5.3 mR/hr. Post-administration, the residual waste exposure rate measurement was 3.8 mR/hr (using the same geometry). The post-administration measurement was taken about 2 hours after the pre-administration measurement. Based on the post administration measurement, it is estimated that at least 73% of the prescribed dose was still present in the waste materials implying that only 27% of the prescribed dose was administered or 1.36 Gbq which would result in a target dose of 35 Gy.

"3. Investigation into the root cause indicated that the use of a Surefire Catheter may have been the underlying factor of this medical event. The interventional radiologist (RA) reported that this was the first time he had used the Surefire Catheter in conjunction with a TheraSphere case. This catheter was chosen due to medical need. The interventional radiologist wanted to minimize the amount of auxiliary embolization required for this case and this catheter satisfied that requirement. Prior to administration, contrast was administered to verify the integrity of the infusion system. No issues were noted during the contrast administration. During the administration of the microspheres, the interventional radiologist noted that the feel of the syringe was different from past administrations and that it was more difficult to push the plunger, however it did appear that the infusion was occurring. After completion of the infusion, the interventional radiologist noted that the syringe plunger pushed back. Final measurement of both the patient and the waste materials by medical physics and nuclear medicine indicated that the dose was not properly infused and consequently an underdose had occurred.

"4. During the investigation it was noted that this case was the first time the Surefire Catheter was utilized. There were no other changes in the set up. The vendor representative mentioned that he had previously observed issues with the use of this catheter, however there are no documents or other notices issued with regards to catheter usage combinations. Review of the infusion materials did not reveal any physical issues with the setup, though based on the physician's report regarding the feel of the plunger during the infusion, it is possible that there was a kink or other similar issue in either the catheter or infusion system that resulted in incomplete administration of the TheraSphere dose.

"5. The interventional radiologist communicated directly with the patient regarding this medical event. Both the interventional radiologist and the radiation oncologist (who is also the physician authorized user for this material) do not anticipate any additional medical issues that would be a result of this incomplete administration. This is based on the history of the patient who had previously received a TheraSphere administration to his right primary lobe vs. the current administration to the left secondary lobe.

"6. In order to minimize the possibility of future medical events, the Surefire Catheter will not be used for future procedures. Since there have been no cases during our experience with this procedure prior to this event that have resulted in an underdosing due to equipment malfunction and since the only significant change in equipment set up was the use of the Surefire catheter, it is expected that a return to our previous catheter will insure that underdosing will not occur.

"7. In accordance with WAC 246-240-651 a full report regarding this event has been transmitted to WA DOH. "

Washington Incident : WA-13-055

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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Agreement State Event Number: 49540
Rep Org: WA DIVISION OF RADIATION PROTECTION
Licensee: UNIVERSITY OF WASHINGTON
Region: 4
City: SEATTLE State: WA
County:
License #: WN-C001-1
Agreement: Y
Docket:
NRC Notified By: ANINE GRUMBLES
HQ OPS Officer: NESTOR MAKRIS
Notification Date: 11/14/2013
Notification Time: 17:49 [ET]
Event Date: 11/12/2013
Event Time: [PST]
Last Update Date: 11/14/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
THOMAS FARNHOLTZ (R4DO)
FSME EVENT RESOURCE (EMAI)

Event Text

AGREEMENT STATE REPORT - RADIOACTIVE MATERIAL UNACCOUNTED FOR

The following was received via email from the Washington Dept. of Health, Office of Radiation Protection:

"Tuesday, November 12, 2013, I [State of WA] received a call from the Radiation Safety Officer of the University of Washington. He informed me that his staff was unable to account for 3.3 mCi of C-14 and 7 mCi of H-3, the sum of several vials [unsealed sources used for research], when reconciling the inventory of an AUI [Authorized Investigator] after he died. The AUI had a radioactive materials authorization at the university for well over 20 years. A staff member investigated the problem and interviewed current and previous laboratory staff in an effort to find the documentation of disposition of the missing material. This is believed to be a paperwork/failure to document issue with no actual loss or release. It will be discussed at their next Radiation Safety Committee meeting which the state will attend on 26 November 2013. The licensee will provide us with a full report by then. It is the C-14 which exceeds the reporting activities."

State incident number WA-13-056

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. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

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Non-Agreement State Event Number: 49542
Rep Org: INDIANA UNIVERSITY MEDICAL CENTER
Licensee: INDIANA UNIVERSITY MEDICAL CENTER
Region: 3
City: INDIANAPOLIS State: IN
County:
License #: 13-02752-03
Agreement: N
Docket:
NRC Notified By: MACK RICHARDS
HQ OPS Officer: BILL HUFFMAN
Notification Date: 11/15/2013
Notification Time: 13:27 [ET]
Event Date: 11/14/2013
Event Time: 13:50 [EST]
Last Update Date: 11/15/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
JAMNES CAMERON (R3DO)
FSME EVENTS RESOURCE (E-MA)

Event Text

Y-90 MICROSHPERE DOSE LESS THAN PRESCRIBED

"On the afternoon of 11/14/2013, a patient was scheduled for a Y-90 microsphere radioembolization treatment at Indiana University Medical Center under NRC License 13-02752-03. The treatment consisted of two separate doses of Y-90 for which two separate written directives were prepared. Segment 4 of the patient's liver was prescribed a dosage of 27.0 mCi, and the right lobe of the liver was prescribed a dosage of 88.0 mCi. At 13:50 on 11/14/2013, following measurement of the remaining activity after injection of the Y-90 microspheres, it was determined that a dose of 19.5 mCi was delivered to segment 4 (72.2% of the intended dose). Shortly thereafter, at 14:06, a dose of 87.5 mCi of Y-90 was delivered to the right lobe (99.4% of the intended dose).

"Both procedures appeared to proceed in accordance with standard operating procedures, and no abnormalities were identified during the procedure by the Interventional Radiology Physician or the Health Physicist supporting the procedure. Following the procedure, personnel and area surveys were performed using an SE International GM meter and no contamination of personnel, the room or equipment was identified. The container holding residual activity from the segment 4 treatment has been set aside for decay and further analysis.

"As the activity delivered to segment 4 of the liver meets the criteria in 10 CFR 35.3045(a)(1) and 10 CFR 35.3045(a)(1)(i), a report to the NRC Operations Center shall be made in accordance with 10 CFR 35.3045(c). The attending physician and patient will be contacted in accordance with 10 CFR 35.3045(e)."

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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Power Reactor Event Number: 49573
Facility: INDIAN POINT
Region: 1 State: NY
Unit: [2] [3] [ ]
RX Type: [2] W-4-LP,[3] W-4-LP
NRC Notified By: MICHAEL MCCARTHY
HQ OPS Officer: JEFF ROTTON
Notification Date: 11/22/2013
Notification Time: 15:18 [ET]
Event Date: 11/21/2013
Event Time: 15:45 [EST]
Last Update Date: 11/22/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
26.719 - FITNESS FOR DUTY
Person (Organization):
FRED BOWER (R1DO)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
2 N Y 100 Power Operation 100 Power Operation
3 N Y 100 Power Operation 100 Power Operation

Event Text

FITNESS FOR DUTY - BLIND SAMPLE RECOGNITION FAILURE

"On November 21, 2013 during an Access Authorization Fitness for Duty (FFD) Baseline Inspection, an NRC Inspector identified laboratory testing of a Blind FFD sample failed to provide anticipated testing results. Laboratory testing results for sample (specimen number 422136066) should have reported the sample as 'Dilute' but the laboratory report results came back as 'Negative.' In addition, the specific gravity of the sample was also outside the expected range. It should have been reported at or near 1.0015 but was reported at 1.0224 instead. The sample was submitted on March 3, 2013.

"The results error was not identified when the results were received which caused a violation of 10CFR26.

"An investigation with the laboratory has been initiated through the Medical Review Officer for IPEC [Indian Point Energy Center].

"Additionally an investigation with the vendor supplier of the Blind sample will be initiated.

"The corrective action for this event is that an extent of condition is being performed to verify that no other Blind errors exist."

The licensee notified the NRC Resident Inspector and will be notifying New York State Public Service Commission.

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Power Reactor Event Number: 49574
Facility: LASALLE
Region: 3 State: IL
Unit: [1] [2] [ ]
RX Type: [1] GE-5,[2] GE-5
NRC Notified By: RUDY CAPUTO
HQ OPS Officer: DANIEL MILLS
Notification Date: 11/22/2013
Notification Time: 23:59 [ET]
Event Date: 11/22/2013
Event Time: 19:20 [CST]
Last Update Date: 11/23/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(D) - ACCIDENT MITIGATION
Person (Organization):
DAVID HILLS (R3DO)

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

Event Text

CONTROL ROOM HVAC INOPERABLE

"This report is being made pursuant to 10CFR50.72(b)(3)(v)(D), Event or Condition that could have prevented fulfillment of a Safety Function needed to Mitigate the Consequences of an Accident. While the 'A' Train of Control Room HVAC was inoperable and out of service for emergent repairs due to a Freon leak, the 'B' Train of Auxiliary Electric Room HVAC became inoperable due to a failure of the Cooler Condenser Fan. The Main Control Room Envelope consists of the Main Control Room and the Auxiliary Electric Equipment Room. Both the Control Room HVAC and the Auxiliary Electric Equipment Room HVAC Systems are required to be Operable in the current Mode.

"This is a loss of safety function for a system that is intended to mitigate the consequences of an accident and is discussed in Chapter 6 of the UFSAR and is Tech Spec required and is Safety Related. Also, the system, structure, or component (SSC) is inoperable in a required mode in the Tech Spec Applicability and there is no redundant equipment in the same system that is operable.

"The Required actions of Tech Spec 3.7.5 were entered on 11/22/2013 at 1920 CST when the 'B' train became inoperable. Online Risk remains Green. The station is currently pursuing repairs to both trains."

The NRC Resident Inspector has been notified by the licensee.

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Power Reactor Event Number: 49575
Facility: FERMI
Region: 3 State: MI
Unit: [2] [ ] [ ]
RX Type: [2] GE-4
NRC Notified By: MARK EGHIGIAN
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 11/24/2013
Notification Time: 02:54 [ET]
Event Date: 11/24/2013
Event Time: 00:01 [EST]
Last Update Date: 11/24/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(v)(C) - POT UNCNTRL RAD REL
Person (Organization):
DAVID HILLS (R3DO)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
2 N Y 100 Power Operation 100 Power Operation

Event Text

MOMENTARY LOSS OF REACTOR BUILDING VENTILATION

"On 11/24/2013 at 00:00:54 seconds [EST], Reactor Building ventilation tripped due to low outside air temperature. At 00:01:42 seconds, Secondary Containment Differential pressure went positive, with a maximum of +0.08 inches WC [water column]. This is a loss of Secondary Containment function. At 00:02:30 seconds, Standby Gas Treatment System was started and Secondary Containment pressure then decreased to <0 inches WC at 00:03:18 seconds. All the above data parameters were taken from the Division 2 Reactor Building Differential pressure recorder.

"Secondary Containment pressure is stable with differential pressure negative <-0.30 inches WC.

"The loss of Secondary Containment function is reportable under 10CFR 50.72(b)(3)(v)(c) as an event or condition that could have prevented the fulfillment of a safety function needed to control the release of radioactive material."

Technical Specification requirement are to maintain secondary containment pressure <-0.125 WC. No actual radiation release occurred during the event.

The licensee notified the NRC Resident Inspector.

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Part 21 Event Number: 49576
Rep Org: CB&I LAKE CHARLES
Licensee: CB&I LAKE CHARLES
Region: 4
City: LAKE CHARLES State: LA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: KEVIN WALSH
HQ OPS Officer: STEVE SANDIN
Notification Date: 11/24/2013
Notification Time: 18:23 [ET]
Event Date: 02/08/2013
Event Time: [CST]
Last Update Date: 11/24/2013
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(a)(2) - INTERIM EVAL OF DEVIATION
Person (Organization):
DAVID PROULX (R4DO)
FRANK EHRHARDT (R2DO)
PART 21 GROUP (EMAI)

Event Text

INTERIM PART 21 REPORT REGARDING DEVIATIONS OF SUPPLIED MATERIALS FOR MODULE ASSEMBLY

The following is a summary of a fax updating a report initially submitted to the Document Control Desk on February 8, 2013:

"CBI Lake Charles (CBI-LC) provided an interim report to the NRC regarding the ongoing 10 CFR Part 21 evaluation that could not be completed within 60-days from discovery of the deviation. This deviation is related to Mechanical Splices delivered to AP1000 Projects, Vogtle Unit 3 and V.C. Summer Unit 2.

"CBI-LC executed the test plan and submitted the results to the Design Authority for evaluation. The 'Use-As-Is' disposition by the design authority was contingent upon additional qualification testing performed by the manufacturer. During the review of the testing by the manufacturer, there were some minor administrative errors identified. Therefore, upon the Design Authority approval of these minor error corrections, the evaluation to determine if this deviation is reportable per Part 21.21, could not be completed with the 60-days. Hence, this updated interim report is being provided. CBI Lake Charles expects the Design Authority approval of the test results by January 31, 2014."

Page Last Reviewed/Updated Monday, November 25, 2013
Monday, November 25, 2013