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Event Notification Report for August 17, 2020

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
8/14/2020 - 8/17/2020

** EVENT NUMBERS **


54764 54819 54821 54822 54823

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!!!!! THIS EVENT HAS BEEN RETRACTED. THIS EVENT HAS BEEN RETRACTED !!!!!
Agreement State Event Number: 54764
Rep Org: IOWA DEPARTMENT OF PUBLIC HEALTH
Licensee: University of Iowa
Region: 3
City: Iowa City   State: IA
County:
License #: 0037-1-52-AAB
Agreement: Y
Docket:
NRC Notified By: Randal Dahlin
HQ OPS Officer: Jeffrey Whited
Notification Date: 07/06/2020
Notification Time: 13:26 [ET]
Event Date: 07/02/2020
Event Time: 00:00 [CDT]
Last Update Date: 08/14/2020
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
Person (Organization):
KARLA STOEDTER (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text



EN Revision Imported Date : 8/17/2020

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT

The following was received via email:

"On 6/30/20 microspheres were injected in the patient [intended target of Hepatic Segments 4 through 8] at the vessel branch point with the intention of targeting both the right hepatic artery (RHA) and the middle hepatic artery (MHA). However, post-therapy imaging demonstrates that radiotracer was preferentially deposited along the MHA distribution. This is attributed to unforeseeable clumping of microspheres at the origin of the RHA, such that a majority of the microspheres were preferentially injected into MHA. As such, microspheres were predominantly deposited in the extrahepatic lymph node as well as an unexpected pancreaticoduodenal lymph node. Deposition in this second node can be attributed to additional unintended reflux into a third branching vessel upstream from the RHA and MHA, and further supports the assertion flow into the RHA was hindered by the clumping of microsphere particles. Ultimately, SPECT-CT image analysis suggests no more than approximately 40 percent of the therapy dose was deposited within the liver (as detailed below).

"It is estimated the following activity distribution from post-treatment imaging: At most, approximately 40 percent of the administered activity appears to be within the liver, with the other 60 percent being in extrahepatic tissue (e.g. lymph nodes). This breakdown should be considered approximate, as these images are not scatter corrected.

"From pre-treatment macro aggregated albumin (MAA) imaging, it appears that 84 percent of the administered activity was expected to be delivered to the liver, and 16 percent was expected to shunted to the nodes. Overall, this indicates that approximately 53 percent less activity than what was intended reached the liver. There is uncertainty in this estimate.

"The dose to extrahepatic tissue (lymph nodes) differs from what was intended/expected by more than 50 Rem (0.5 Gy)."

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.

* * * RETRACTION ON 8/14/2020 AT 1131 EDT FROM RANDAL DAHLIN TO KERBY SCALES * * *

The following retraction was received from the state of Iowa via email:

"On July 6, 2020 Iowa reported a potential medical event at the University of Iowa (License number 0037-1-52-AAB) involving Yttrium-90 (Y-90) microspheres. This potential medical event occurred on June 30, 2020 and was discovered by the licensee on July 1, 2020 during analysis of post therapy SPECT/CT imaging. This event was reported to the state on July 2, 2020 after staff working hours. Iowa Department of Public Health (IDPH) Radioactive Materials Program (RAM) staff became aware of the potential medical event on July 6, 2020 after the holiday weekend.

"IDPH staff conducted a reactive inspection at the University of Iowa on July 8, 2020 to interview university staff involved in the procedure and the university radiation safety officer, review the written directive for the Y-90 procedure and review fluoroscopic images of placement of the catheter in the right hepatic artery. IDPH staff determined that the university used due diligence in following their policies and procedures for Y-90 administrations and manufacturer's instructions and no violations were noted.

"The university followed up with a written report on July 16, 2020 which determined that the unintended dose to the lymph nodes was due to shunting through a pathway or bypass due to patient vasculature. A review of the NRC licensing guidance for Y-90 microspheres dated March 20, 2020 Revision 10.1 revealed that unintended doses to tissue or organs during a Y-90 procedure due to shunting is not considered a reportable medical event.

"IDPH program staff had a meeting with NRC Region III staff on Wednesday, August 12, 2020 to discuss this potential medical event. Region III staff agreed with IDPH that this unintended dose was due to shunting and therefore not a reportable medical event.

"Therefore Iowa is retracting event number 54764."

Notified R3DO (Pelke) and NMSS Events (email).

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Agreement State Event Number: 54819
Rep Org: VT OFFICE OF RADIOLOGICAL HEALTH
Licensee: Goodenough Rubbish Removal
Region: 1
City: Brattleboro   State: VT
County:
License #: N/A
Agreement: Y
Docket:
NRC Notified By: Francis O'Neill
HQ OPS Officer: Rodney Clagg
Notification Date: 08/06/2020
Notification Time: 10:33 [ET]
Event Date: 03/27/2020
Event Time: 00:00 [EDT]
Last Update Date: 08/06/2020
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
Person (Organization):
FRANK ARNER (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - RADIOACTIVE MATERIAL REJECTED AT WASTE FACILITY

The following is a summary of information received via email:

On 3/27/20, the Vermont Department of Health (VDH) was notified that a waste transport truck was rejected at a waste facility in Concord, NH. The truck was rejected because radioactive material was detected in the waste. The truck was redirected to Goodenough Rubbish Removal in Brattleboro, VT, and instructed to isolate the waste.

On 3/30/20, VDH Radiation Control responded to the waste center. The radioactive waste was identified as clay cat litter containing I-131 with a maximum dose rate of 8.04 mrem/hr on contact and 0.54 mrem/hr at one meter while background measurements were 10 microR/hr. The waste hauler was instructed to isolate the container in a remote section of the recycling center with the contents covered for 80 days.

On 4/3/20, VDH issued Vermont Information Notice IN 20-001 (Release of humans and animals receiving I-131 therapy) to all Vermont radioactive materials licensees who are authorized to use I-131. This Information Notice recommends all affected licensees review their I-131 administration procedures, patient release criteria, and pet owner release instructions.

On 6/26/20, a VDH inspector returned to survey the material, and found that the radiation levels of the material were indistinguishable from background.

With the decay of the I-131 waste this incident has been closed out by VDH on 8/5/20.

Vermont Incident No.: VT-20-002

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Agreement State Event Number: 54821
Rep Org: KENTUCKY DEPT OF RADIATION CONTROL
Licensee: North American Stainless
Region: 1
City: Ghent   State: KY
County:
License #: 201-499-57
Agreement: Y
Docket:
NRC Notified By: Anjan Bhattacharyya
HQ OPS Officer: Andrew Waugh
Notification Date: 08/06/2020
Notification Time: 13:46 [ET]
Event Date: 08/06/2020
Event Time: 00:00 [CDT]
Last Update Date: 08/06/2020
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
Person (Organization):
FRANK ARNER (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - STUCK SHUTTER

The following is a summary of information received via email:

On 8/6/2020, the licensee notified the Kentucky Radiation Health Branch of an event which had occurred on the same day. The shutter control mechanism malfunctioned on a nuclear gauge and the shutter could not be completely closed. The gauge has been taken out of service and no overexposures were reported as a result of this incident. A service provider has been contacted to help repair or replace the damaged gauge.

The gauge is a Data Measurement Corporation Model AM-3E containing a 3 Ci Am-241 sealed source.

Kentucky Event Report ID No.: KY200003

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Non-Agreement State Event Number: 54822
Rep Org: Department of Veterans Affairs
Licensee: Department of Veterans Affairs
Region: 4
City: North Little Rock   State: AR
County:
License #: 03-23853-01VA
Agreement: Y
Docket:
NRC Notified By: Kim Wiebeck
HQ OPS Officer: Andrew Waugh
Notification Date: 08/06/2020
Notification Time: 16:32 [ET]
Event Date: 08/05/2020
Event Time: 13:00 [CDT]
Last Update Date: 08/06/2020
Emergency Class: Non Emergency
10 CFR Section:
35.3045(a)(3) - Dose To Other Site > Specified Limits
Person (Organization):
KENNETH RIEMER (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

MEDICAL EVENT

"A Y-90 microsphere therapy administration was performed on August 5, 2020, [at VA Boston Healthcare System in Boston, Massachusetts]. The prescribed dose was intended for the right lobe of the liver. Post implant imaging on that day indicated that the dosage of microspheres was unintentionally administered to a portion of the left lobe of the liver.

"The patient and the referring physician have been notified.

"The National Health Physics Program (NHPP) will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045.

"NHPP notified our NRC Region III Project Manager (Parker)."

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: 54823
Rep Org: TENNESSEE DIV OF RAD HEALTH
Licensee: World Testing, Inc.
Region: 1
City: Mount Juliet   State: TN
County:
License #: R-95009
Agreement: Y
Docket:
NRC Notified By: Andrew Holcomb
HQ OPS Officer: Ossy Font
Notification Date: 08/07/2020
Notification Time: 16:59 [ET]
Event Date: 08/06/2020
Event Time: 15:30 [EDT]
Last Update Date: 08/07/2020
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
Person (Organization):
FRANK ARNER (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)

Event Text

AGREEMENT STATE REPORT - RADIOGRAPHY CAMERA GUIDE TUBE DENTED

The following was received from the Tennessee Division of Radiological Health via email:

"On August 6, 2020, World Testing radiographers were radiographing at Matrix Drilling in Lewisburg, Tennessee. They were radiographing pipes and one of the pipes (weighing approximately 1000 pounds) rolled onto the guide tube, denting it. They could not crank the source back in. They called the RSO [(Radiation Safety Officer)]. The guide tube was curled and making it more difficult to get the source back into the camera. They pulled on the crank to straighten out the guide tube and with enough pressure they were able to get the source past the dent and back into the exposure device. They placed lead on the collimator for additional shielding while working with it. The camera was a Sentinel, Model 880D, Serial number D-1120. The [Ir-192] source serial number was 96522G, with an activity of 44Ci. The source was exposed for approximately 4 hours. All personnel involved were wearing dosimetry. There were no overexposures."

Tennessee Event Report ID No.: TN-20-114


Page Last Reviewed/Updated Monday, August 17, 2020
Monday, August 17, 2020