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Event Notification Report for August 28, 2017

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
08/25/2017 - 08/28/2017

** EVENT NUMBERS **


52910 52914 52916 52917 52922 52926 52927

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Agreement State Event Number: 52910
Rep Org: SC DIV OF HEALTH & ENV CONTROL
Licensee: INTERNATIONAL PAPER
Region: 1
City: GEORGETOWN State: SC
County:
License #: 060
Agreement: Y
Docket:
NRC Notified By: LELAND CAVE
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 08/17/2017
Notification Time: 12:12 [ET]
Event Date: 08/16/2017
Event Time: 11:30 [EDT]
Last Update Date: 08/17/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
HAROLD GRAY (R1DO)
NMSS_EVENTS_NOTIFICA (EMAI)

Event Text

AGREEMENT STATE REPORT - FIXED GAUGE LOST SHUTTER

The following report was received via e-mail:

"The licensee called to notify the state that during their annual inventory review, they found that one of their Thermo Measure Tech 5192 fixed gauges had lost its shutter. Upon searching, the shutter was later found on the floor. The call to the state was made on August 17, 2017 at 1010 [EDT]. The Radiation Safety Officer stated that surveys were done and that the highest reading around the gauge was less than 0.5 mR/hr. He also stated that a consultant has been called to replace the shutter and to evaluate the damaged gauge and several other gauges throughout the plant. The licensee stated that a written report will be sent within 30 days of the event. Updates to this event will be made through the NMED system."

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Agreement State Event Number: 52914
Rep Org: MISSISSIPPI DIV OF RAD HEALTH
Licensee: UNIVERSITY OF MISSISSIPPI MEDICAL CENTER
Region: 4
City: JACKSON State: MS
County:
License #: MS-MBL-01
Agreement: Y
Docket:
NRC Notified By: JAYSON MOAK
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 08/18/2017
Notification Time: 17:43 [ET]
Event Date: 08/18/2017
Event Time: [CDT]
Last Update Date: 08/18/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
THOMAS FARNHOLTZ (R4DO)
NMSS_EVENTS_NOTIFICA (EMAI)
PART 21 MATERIALS (EMAI)

Event Text

AGREEMENT STATE REPORT - PATIENT UNDERDOSE

The following report was received via e-mail:

"The licensee's RSO reported a possible medical event for four separate patients, involving a Nucletron Model microSelectron-HDR 106.990 remote afterloading brachytherapy unit. This was noticed during review by the medical physicist. The licensee notified Elekta for confirmation of the software error. The RSO confirmed on 8/18/2017, that two (2) patients were under dosed by more than 20% and the other two (2) patients were being reviewed by the medical physicist.

"An Elekta Notification was sent out to all MS Radioactive Licensees on 8/17/2017, that possess a Nucletron Model microSelectron-HDR."

Source: 12 Ci, Ir-192, Elekta Model 105.002
Mississippi Report: MS-170002

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: 52916
Rep Org: NIST
Licensee: NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
Region: 1
City: GAITHERSBURG State: MD
County:
License #: SNM-362
Agreement: Y
Docket:
NRC Notified By: MANUEL MEJIAS
HQ OPS Officer: STEVEN VITTO
Notification Date: 08/19/2017
Notification Time: 12:07 [ET]
Event Date: 08/18/2017
Event Time: 14:00 [EDT]
Last Update Date: 08/19/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
30.50(b)(1) - UNPLANNED CONTAMINATION
Person (Organization):
HAROLD GRAY (R1DO)
NMSS_EVENTS_NOTIFICA (EMAI)
TYRONE NAQUIN (PM)

Event Text

UNPLANNED CONTAMINATION EVENT - BROKEN FLAME-SEALED GLASS AMPOULE

"The purpose of this communication is to provide additional details surrounding the circumstances that led to the identification of unplanned contamination in one of the laboratories designated as a restricted area under the US NRC license SNM-362. As indicated verbally during the initial report at 1207 EDT, and required by 10 CFR 30.50(b)(1), this event is described as having a broken flame-sealed glass ampoule that resulted in contamination of the lead-shielding storage area on top of the countertop and other surfaces within room C11 in building 245 of the NIST Gaithersburg, MD campus. This was discovered at approximately 1400 EDT on 8/18/2017.

"The ampoule contained a well-characterized solution of Am-241 with an activity of approximately 47 MBq (most restrictive ALI [Annual Limit on Intake] is 0.006 uCi) and is registered in our database as being in a solution of nitric acid.

"The initial report requirements of 10 CFR 30.50(b)(1) (i) through (iii) are satisfied by the phone notification and supplemented by this communication and attachments. Additional information regarding corrective actions taken and planned, as well as evaluations and/or assessments, will be provided to our Project Manager and Region I in the near future and the required written report will be provided within the required 30 days.

"After reporting event #52916, at the direction of the Radiation Safety Officer and with the support of the NIST Senior Management, multiple efforts will continue to evaluate the extent of the condition and a Stop Work Order will be issued effective today for all other laboratories at NIST Gaithersburg that store similar ampoules until the extent of condition is evaluated and/or mitigated.

"Extensive surveys of the area and air monitoring have confirmed that the contamination is isolated to portions of room C11."

Access has been restricted to room C11.

The licensee notified NRC R1 (Ullrich) and NRC HQ PM (Naquin) regarding this event.

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Non-Agreement State Event Number: 52917
Rep Org: WASHINGTON UNIVERSITY
Licensee: WASHINGTON UNIVERSITY
Region: 3
City: St. Louis State: MO
County:
License #: 24-00167-11
Agreement: N
Docket:
NRC Notified By: SUSAN LANGHORST
HQ OPS Officer: DONALD NORWOOD
Notification Date: 08/19/2017
Notification Time: 16:14 [ET]
Event Date: 08/18/2017
Event Time: 14:00 [CDT]
Last Update Date: 08/19/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(3) - DOSE TO OTHER SITE > SPECIFIED LIMITS
Person (Organization):
AARON McCRAW (R3DO)
NMSS_EVENTS_NOTIFICA (EMAI)

Event Text

MEDICAL EVENT - Y-90 THERASPHERES ADMINISTERED TO THE WRONG LIVER LOBE

"A medical event occurred on 8/18/2017 when Y-90 TheraSpheres meant for treatment of the patient's left liver lobe were administered to the patient's right liver lobe. The patient treatment plan was for radioembolization of the left lobe of the liver on 8/18/17 and radioembolization of the right liver lobe approximately one month later. The interventional radiologist (IR) and radiation oncologist authorized user (AU) signed off on planning activity for the left lobe via the left hepatic artery on 8/2/17 and 8/3/17, respectively. The AU completed the 8/18/17 written directive to deliver 124 Gy to the left lobe via the left hepatic artery (LHA). The IR placed the catheter for treatment in the right hepatic artery which supplies the right liver lobe. The AU, medical physicist and radiation technologist came to the procedure room. A time out procedure was done asking all parties to confirm 124 Gy to the left lobe via the LHA. The IR gave a verbal affirmation of this plan. The IR discovered the error when reviewing patient notes following the procedure. He immediately notified the AU who then notified the Radiation Safety Officer (RSO). The AU estimated dose to the right lobe to be 63 Gy. The RSO continues investigating the event. The patient and the referring physician were notified of the medical event."

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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Part 21 Event Number: 52922
Rep Org: GEORGIA RADIOACTIVE MATERIAL PGM
Licensee: ELEKTA, INC
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: GREG REESE
HQ OPS Officer: BETHANY CECERE
Notification Date: 08/24/2017
Notification Time: 06:53 [ET]
Event Date: 08/08/2017
Event Time: [EDT]
Last Update Date: 08/24/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
Person (Organization):
SILAS KENNEDY (R1DO)
BILLY DICKSON (R3DO)
THOMAS FARNHOLTZ (R4DO)
NMSS_EVENTS_NOTIFICA (EMAI)
PART 21 MATERIALS (EMAI)

Event Text

PART 21 REPORT - ONCENTRA BRACHY SOFTWARE ERROR

The following is excerpted from a report received from the Georgia Department of Natural Resources:

On August 8th, a patient was undergoing a gynecological treatment using a ring applicator with the microSelectron HDR utilizing Oncentra Brachy Software version 4.5.2. On the 2nd of a 4 fraction treatment of ring and tandem, a mistreatment occurred due to inconsistent step size when treating the ring source path. A source step size of 2.5 mm was planned. What was reported in the case explorer was a 5 mm step size. This plan was sent to the TCS [Treatment Control System] and delivered at a 5 mm steps size.

It was intended to treat specific areas, but the delivered areas were 2.5 mm - 60 mm different than intended.

This was confirmed using gafchromic film on a QA plan after treatment was completed.

This event was reported by the State of Mississippi - see related EN 52914.

Elekta identified that this issue occurs when using Applicator Models with a measured source path in combination with a specific afterloader configuration, as follows:

Oncentra Brachy - Version 4.5, 4.5.1, 4.5.2, Applicator Modeling with a measured source path, RDStore default step size 5.0 mm, 10.0 mm
Afterloader - microSelectron HDR/PDR V2, V3/Digital
Applicators - Ring Applicator Sets, Ring CT/MR Applicator sets, Interstitial CT/MR Rings, Vienna CT/MR Rings, Advanced Gynecological Applicator - Venezia with Lunar-shaped ovoids

In Elekta bulletin [IFSN 806-01-BTP-001] the Ring applicator will be used to represent all applicable applicators. Where ring is mentioned also lunar-shaped ovoids apply (Advanced Gynecological Applicator). Where 5.0 mm is used as a default step size this could also be 10.0 mm.

Oncentra Brachy incorrectly handles the placement of the ring applicator models with the measured source path in combination with the microSelectron treatment unit, for which the default step size differs from 2.5 mm.

Three other facilities previously reported this issue and the manufacturer had started working on a bug fix and field notification. All other cases found the issue during QA, so no patients were involved. Veenendaal has put a stop to the delivery of the Applicator Modeling until the Oncentra Brachy v 4.5.3 is released.

An Important Field Safety Notification was sent to all customers concerning the use of ring source paths with applicator modeling on 8/11/17 (IFSN 806-01-BTP-001 attached).

An Oncentra Brachy patch is in process to fix this safety issue.

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Part 21 Event Number: 52926
Rep Org: ELEKTA
Licensee: ELEKTA
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: DEBRA BENSEN
HQ OPS Officer: HOWIE CROUCH
Notification Date: 08/25/2017
Notification Time: 11:47 [ET]
Event Date: 07/13/2017
Event Time: [EDT]
Last Update Date: 08/25/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
Person (Organization):
SILAS KENNEDY (R1DO)
EUGENE GUTHRIE (R2DO)
BILLY DICKSON (R3DO)
THOMAS FARNHOLTZ (R4DO)
PART 21 MATERIALS (EMAI)

Event Text

PART 21 NOTIFICATION - ONCENTRA SOFTWARE PROBLEM MAY CAUSE UNINTENDED STEP SIZE DURING BRACHYTHERAPY TREATMENT

On July 13, 2017, a user in France notified Elekta that they discovered a software issue during their Quality Assurance audit of Elekta's Oncentra Brachy software. Elekta investigated and determined a software issue exists in Oncentra software versions 4.5, 4.5.1, and 4.5.2.

On August 11, 2017, Elekta issued an important field safety notice (IFSN) worldwide.

The software issue will be resolved in the next issued version of the Oncentra software.

See related NRC event numbers 52922 and 52914.

Elekta point of contact: Debra Bensen, RSO, debbie.bensen@elekta.com or (770) 670-2518.

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Power Reactor Event Number: 52927
Facility: THREE MILE ISLAND
Region: 1 State: PA
Unit: [1] [ ] [ ]
RX Type: [1] B&W-L-LP,[2] B&W-L-LP
NRC Notified By: TANYA BELLAY
HQ OPS Officer: DONG HWA PARK
Notification Date: 08/25/2017
Notification Time: 14:42 [ET]
Event Date: 08/25/2017
Event Time: 11:15 [EDT]
Last Update Date: 08/25/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(2)(xi) - OFFSITE NOTIFICATION
Person (Organization):
SILAS KENNEDY (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

Event Text

OFFSITE NOTIFICATION DUE TO EXCEEDING CHLORINE EFFLUENT LIMIT

"On August 24, 2017 a malfunction internal to the River Water Chemistry Control System resulted in measurable free available chlorine levels over a one-hour period at the station outfall to the Susquehanna River. The chlorine levels exceeded the station NPDES [National Pollutant Discharge Elimination System] permit effluent limitations. The River Water Chemistry Control System was shutdown until the condition is corrected.

"The concentrations released did not threaten the downstream users or the environment. Pennsylvania Department of Environmental Protection was notified of the NPDES non-compliance on August 25, 2017 at 1115 [EDT].

"Pursuant to 10 CFR 50.72(b)(2)(xi), this notification satisfies the requirement to notify the NRC of the occurrence of any event or situation related to the health and safety of the public or onsite personnel, or protection of the environment, for which notification to the other government agencies has been made.

"The NRC Resident Inspector has been notified."

Notified DOE, EPA, USDA, HHS, and FEMA.

Page Last Reviewed/Updated Monday, August 28, 2017
Monday, August 28, 2017