Event Notification Report for September 20, 2022

EN Revision Imported Date: 9/20/2022

EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE

The following is a synopsis of a report received from the State of Washington, Office of Radiation Protection via email.

On Monday, November 15, 2021 a patient undergoing cancer treatment at University of Washington Medical Center received an under dose of Y-90 TheraSpheres. The details of the intended dose to the liver (target organ) are yet to be provided. They will be forwarded when obtained.

* * * UPDATE ON 9/19/22 AT 1657 EDT FROM JAMES KILLINGBECK TO BRIAN LIN * * *

The following information was received from the state of Washington State Department of Health via email:

"The University of Washington Medical Center reported that a patient received less dose than prescribed during a yttrium-90 microsphere (Nordion/BWXT model TheraSphere) liver cancer treatment on 11/15/2021. In this event, the patient was administered two dosages of yttrium-90 microspheres to treat the patient's liver at two different liver treatment sites.

"One dosage was 51.5 millicuries, which was successfully delivered.

"The other dosage was 34.1 millicuries, but only 24.2 millicuries (about 69 percent) was successfully administered. The prescribed dose was 13,100 rem, but the dose actually administered was only 9,300 rem (about 29 percent less). It appears that the microspheres that were not successfully administered remained mainly in the catheter since the radiation reading of the catheter and syringe after administration of the yttrium-90 microspheres was about 1 mR/hour instead of the usual reading of 0 mR/hour after administration.

"This appears to be an event where the catheter was blocked or clogged because of clumping of microspheres in the catheter. Events like these are discussed in 'NRC Information Notice 2019-12: Recent Reported Medical Events involving the Administration of Yttrium-90 Microspheres for Therapeutic Medical Procedures.' A copy of this information notice was sent to University of Washington officials in hopes that it would help them to fully understand this incident and to help them prevent future incidents from happening."

WA report no.: WA-21-024

Notified R4DO (Deese) and NMSS via 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.

EN Revision Imported Date: 9/20/2022

EN Revision Text: AGREEMENT STATE REPORT - BROKEN WINDOW ON NUCLEAR GAUGE

The following information was provided by the State of South Carolina, Department of Health & Environmental Control (DHEC) via email:

"On August 18, 2022, at 0948 EDT, DHEC inspector Leland Cave received a call from Mitsubishi Polyester Films, LLC (S.C. Lic. No. 036) to report an incident that had occurred at the plant. The licensee stated that earlier that morning the thin window film was torn on one of their Thermo EGS Gauging, LLC beta gauges [1.25 Ci of Kr-85]. The result of the tear was that the production line was stopped until the film could be replaced. The representative from Thermo was already onsite and needed verbal permission to begin the repair on the unit. The permission was given, and the reciprocity notification was sent in.

"The DHEC inspector called in the incident [to the NRC] at 0936 EDT on August 19, 2022, and is preparing to go to the licensee to review the cause of the incident."

* * * RETRACTION ON 9/19/22 AT 1622 EDT FROM LELAND CAVE TO BRIAN LIN * * *

The following information was submitted by the State of South Carolina, Department of Health & Environmental Control (DHEC) via email:

"The inspector called in the incident at 0936 EDT on August 19, 2022 and left to go to the licensee to review the cause of the incident. Upon the inspector's arrival, the Radiation Safety Officer (RSO), the representative from ThermoFisher, and other members of management sat down with him in a conference room to discuss the events that led to the call. The representative discussed with everyone about the gauging device and how it has a source side and a detector side. He stated that the detector side foil is an approximately six-inch circular piece of aluminum foil. He brought a piece that had torn before as well as the one that had been damaged the day before. He also brought an example of what the source side foil looks like and what it would look like when it would be damaged. The representative stated that the foil on the detector side ripped, and it shut down the machine as designed. The source was safe with no damage to any part. It was determined that this was not a reportable incident. They reviewed the specific unit and the RSO and representative best assessed that when the product is cut, it can leave a sharp edge on it that can lead to a tear. It is also possible for the product to bunch after it has been cut. The licensee and representative will continue to observe if this happens and potentially how often."

Notified R1DO (Arner) and NMSS via email.

AGREEMENT STATE REPORT - UNABLE TO RETRACT SOURCE

The following information was received by email from the state of Louisiana Department of Environmental Quality:

"On September 10, 2022 at approximately 1445 [CDT], a source hang out incident occurred while an industrial radiography crew was working at Cembell Industries, Inc., a steel fabrication facility located in St. Charles Parish, Louisiana.

"The radiography crew was working on ground level in the main fabrication shop of the facility. After approximately five seven-minute exposures to a 48-inch outer diameter schedule 40 steel pipe, using a 4-HVL panoramic collimator, the crew was suddenly unable to crank in the source after repeated retraction attempts. The crew took apart the pistol grip on their crank out controls and observed a broken drive cable. The crank out controls were manufactured by Industrial Radiography Maintenance and Supply (IRMS), device serial number, 22JA15867. The crew then pulled the remaining free end of the drive cable continuous with the source assembly and succeeded in pulling the source completely into the shielded position within the crew's Model 880D exposure device. Approximately three feet of the drive cable on the near end had broken off.

"The crew's exposure device automatic lock was observed to function properly upon shielding the source. Crew members read their direct-reading pocket dosimeters and noted cumulative daily exposures of 62 mR and 68 mR. After briefing their RSO on the successful source retraction, the crew utilized a backup set of crank out controls and completed the temporary job. In an abundance of caution, the RSO of the crew collected the crew's Landauer body badges and [sent] the badges to Landauer for rush processing.

"No rust, corrosion or birdcaging was observed by the manufacturer, IRMS, upon physical inspection of the crank out controls and drive cable pieces. The root cause investigation by the manufacturer is still ongoing to determine what caused extreme tension in the cable, which contributed to its breakage. The RSO stated he believed the distal end of the cable had become snared in a crimped copper fitting, which was attached to conduit on one end and to a swivel on the pistol grip at the other. The IRMS crank out controls were approximately 45 feet in length and all components were manufactured by IRMS. The crew's source guide tube was in good physical condition and was approximately six feet in length.

"Note: because the crew's pocket dosimeters did not go off scale and the crew members did not approach the high radiation area at any time during expedient retraction operations in which the source was re-shielded, the above incident is being treated as a source retraction rather than a source retrieval. The RSO stated the source was fixed during the incident approximately one to two inches in front of the exposure device outlet nipple, which provided non-negligible shielding throughout the incident.

"The radiography exposure device was a QSA Model 880 Delta, device serial number, D13936. The source, Model A-424-9, was a sealed source of Ir-192 with 97.2 Ci of activity. The source serial number was 53444M."

Louisiana Event Report ID Number: LA20220008

AGREEMENT STATE REPORT - UNDERDOSE OF Y-90 MICROSPHERES

The following was submitted by the California Department of Public Health by email:

"On Sept. 12, 2022, the RSO of Cedars Sinai Medical Center (CSMC) contacted Los Angeles County Public Health, Radiation Management (LA County) to report a medical event that ocurred at CSMC.

"During administraton of Y-90 Theraspheres to a patient, the Y-90 spheres were stuck in the microcatheter and the Authorized User (AU) was unable to administer the full dosage. The dosage drawn in the syringe was approximately 1.77 GBq (48 mCi) but only 1.05 GBq (28 mCi) was administered, a residual dosage of 40.7 percent [not administered]. Additionally, the prescribed dose to the target organ, liver, was 124 Gy (12,400 rad). The liver received a dose of approximately 71 Gy (7,100 rad), a difference of 5.3 Gy (5,300 rad).

"The RSO has initiated an investigation and the AU will be providing a detailed report."

California Reference Number: 091222

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.

SAFETY SYSTEM INOPERABILITY

The following information was provided by the licensee via email:

"At 0132 CDT on September 19, 2022, River Bend Station (RBS) was operating at 100% power when the high pressure core spray (HPCS) system was declared inoperable in accordance with technical specification 3.8.9, condition E (declare HPCS and standby service water system pump 2C inoperable immediately) due to a E22-S003, HPCS transformer feeder malfunction.

"The HPCS is a single train system at RBS, therefore this event is being reported in accordance with 10 CFR 50.72(b)(3)(v)(D) as an event or condition that could have prevented the fulfilment of a safety function. The reactor core isolation cooling system has been verified to be operable.

"The NRC Resident Inspector has been notified."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

RBS has entered a 14-day limiting condition for operation due to the loss of HPCS and they have upgraded their on-line plant risk model to "yellow".

FITNESS FOR DUTY (FFD) REPORT - NON-LICENSED SUPERVISOR VIOLATED FFD POLICY

The following information was provided by the licensee via email:

"On September 19, 2022, a non-licensed supervisor violated the station's FFD policy. The employee's unescorted access at South Texas has been terminated. This event was determined to be reportable under 10 CFR 26.719(b)(2)(ii).

"The NRC resident inspector has been notified."

OFFSITE NOTIFICATION DUE TO FATALITY

The following information was provided by the licensee via email:

"At approximately 1520 CDT on September 19, 2022, Grand Gulf Nuclear Station (GGNS) requested transport for treatment of a non-responsive individual, a contract employee, to an offsite medical facility. The offsite medical facility notified GGNS at approximately 1630 CDT that the individual had been declared deceased.

"The fatality was not work-related, and the individual was outside of the Radiological Control Area.

"This is a four-hour non-emergency notification in accordance with 10 CFR 50.72(b)(2)(xi) related to the notification of a government agency. The contractor's employee will be notifying the Occupational Safety and Health Administration.

"The NRC Senior Resident Inspector has been notified."