Event Notification Report for June 30, 2025

EN Revision Imported Date: 6/30/2025

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT

The following report was received via phone and email from the South Carolina Department of Health and Environmental Control (the Department):

"The licensee informed the Department via telephone on June 6, 2025, that a medical event had occurred on June 5, 2025. The licensee reported that a Y-90 microsphere procedure resulted in 71 percent of the prescribed dose being administered to a patient (a difference of 29 percent), and that a spill also occurred during the administration. The licensee is reporting that the spill originated from the delivery system and likely caused the medical event.

"The licensee reported that the spill in the administration area was cleaned, and the area was released. The licensee is not reporting any overexposures or ongoing health or safety concerns. The referring physician was notified on June 6, 2025. This event is still under investigation by the Department."

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.

South Carolina Event Report ID Number: TBD

* * * UPDATE ON 06/27/2025 AT 0904 EDT FROM JACOB PRICE TO ROBERT THOMPSON * * *

The following is a summary of information provided by the South Carolina Department of Environmental Services (the Department) via email:

In the initial verbal notification, the licensee indicated that the patient received a dose of 29 percent less than prescribed. The written report submitted on June 6, 2025, indicates that the patient received a dose of 31.6 percent less than prescribed. This event is still under investigation.

South Carolina Event Number: SC250007

Notified R1DO (Arner), NMSS Events (email)

MEDICAL EVENT

The following information was provided by the licensee via phone and email:

"On 6/12/25 four patients received intradermal administrations of 3 mCi Tc-99m mebrofenin (in three 1-mCi injections at the site) instead of the prescribed 3 mCi Tc-99m sulfur colloid (in three 1-mCi injections at the site) for sentinel lymph node biopsy.

"A physician detected an abnormality on imaging. One patient was also administered the correct (prescribed) dose of 3 mCi Tc-99m sulfur colloid before going to surgery. The other three patients had already gone to surgery when the abnormality was detected. The surgeon detected lymph node counts for two of the patients and resected the nodes (assumed successfully). The surgical status of the third patient is unknown; nuclear medicine will review the pathology results for all four patients when available and follow up accordingly.

"Since 6/12/25, nuclear medicine has been investigating the circumstances that led to dispensing an administration of the wrong radiopharmaceutical and evaluating the dosimetry implications of mebrofenin. Because mebrofenin is typically administered intravenously for liver and gallbladder studies, there is little or no published information on skin dose from intradermal administration. The authorized medical physicist (AMP) does not believe the shallow-dose equivalent (SDE) from 3 mCi intradermal mebrofenin would exceed the documented SDE from 3 mCi intradermal sulfur colloid (105 rad) due to the biokinetics of mebrofenin. Imaging suggests that it quickly migrated away from the injection site. However, on 6/19/25, the radiation safety officer (RSO), in consultation with nuclear medicine and the AMP concluded that the event should be reported to NRC as a potential medical event, because we cannot be certain that the SDE does not exceed 50 rad.

"All patients and their referring physicians have been notified. The authorized user physician does not expect any adverse effects as a result of the dosing error.

"The RSO will contact REAC/TS to determine if an accurate SDE can be calculated or derived for this event."

The licensee notified the NRC Region 3 project manager.

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

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.

AGREEMENT STATE REPORT - DOSE TO MEMBER OF THE PUBLIC GREATER THAN LIMITS

The following information was provided by the South Carolina Department of Environmental Services (the Department) via phone and email:

"The licensee submitted a written report on May 30, 2025, indicating that the estimated total effective dose equivalent to an adult member of the public was determined to be 129 mrem/year for calendar year 2023 and 106 mrem/year for calendar year 2024. The licensee later submitted an updated calculation on June 17, 2025, indicating that the estimated total effective dose equivalent to an adult member of the public was determined to be 154 mrem/year for calendar year 2024.

"The member of the public was an employee of the licensee, who occupied office space adjacent to a portable gauge storage location. The licensee had an area dosimeter/monitor to monitor the dose in the occupied office space. The annual doses are based on results from the area dosimeter/monitor and calculations to account for distance from the area dosimeter/monitor and time spent in the office.

"The devices stored in the portable gauge storage location include four Troxler model 3400 series devices housing 8 millicuries of Cs-137 and 40 millicuries of Am-241/Be, and two Instrotek model 3500 series devices housing 10 millicuries of Cs-137 and 40 millicuries of Am-241/Be.

"The discovery of the event was the result of a routine inspection conducted by the Department between February 6, 2025, and March 19, 2025. The Department and the licensee corresponded several times between March 19, 2025, and May 30, 2025, regarding the details of the event. The licensee made a determination on reporting applicability and submitted a written report on May 30, 2025.

"The licensee's corrective actions included moving the member of the public to another office away from potential exposure, restricting access to the office space adjacent to a portable gauge storage location, and adding additional shielding to the portable gauge storage location for adjoining offices and hallway."

South Carolina Event Number SC250004

AGREEMENT STATE REPORT - RECOVERED SOURCES

The following information was provided by the New Jersey Bureau of Environmental Radiation Radiological & Environmental Assessment Section (NJDEP) via phone and email:

"On June 12, 2025, NJDEP was notified that three containers of waste were rejected at Stericycle in Elizabeth after triggering their radiation alarm. Stericycle indicated that the waste originated from the licensee, SOFIE Co. A maximum reading of 10 kcpm [kilo counts per minute] was observed, with a background of 4 kcpm. The radiation safety officer (RSO) of SOFIE was contacted and confirmed that all sealed sources were still within their possession. They indicated the waste was likely short-lived F-18. With this understanding, the waste was allowed to decay for a few days. Upon resurveying, no decrease in radiation levels was observed. The RSO stated that it was then likely to be filters which collect activation waste during cyclotron production. Staff from NJDEP responded at this time, and collected exposure rate readings on contact with the containers, which ranged from 36.3 micro-R/h to 236 micro-R/h. A gamma spectrometry analysis made preliminary identifications of Co-56, Co-57, and Co-58, which are expected activation isotopes. SOFIE then retrieved the containers and returned them to their facility to conduct an investigation. It was noted that the waste log indicated that two containers were closed without proper documentation of an outgoing survey to confirm background levels. The other container was surveyed and indicated background levels, which was inaccurate. Full investigation details are still pending.

"The root cause is under investigation"

Incident or investigation number: 452369-INV250001

AGREEMENT STATE REPORT - DAMAGED GAUGE

The following information was provided by the Illinois Emergency Management Agency (the Agency) via phone and email:

"The Agency was contacted on 6/21/25 by a gauge user at Klingner and Associates to report that a Humboldt 5001EZ gauge was hit by a truck and damaged on a construction site in Williamsfield, IL. A truck struck the gauge, damaging the handle and the right side of the case. The source rod was not extended when the incident occurred, and the licensee reported that the source appeared to be properly shielded. The licensee followed their emergency procedures, called the radiation safety officer, and then called the Agency for further instructions. The licensee reported that they did not have a survey instrument. The transport case was reported as undamaged, and the gauge was able to be placed in its shielded transport container. The gauge was then transported back to secure storage with strict directions to not open or handle until a reactive inspection could be performed.

"Agency staff arrived at the licensee's authorized gauge storage site on 6/23/2025 to assess the gauge condition and determine reportability under 32 Ill. Adm. Code 340.1220(c)(2). Both sources appeared undamaged, however, the sliding shield at the bottom of the gauge was observed to be approximately 25 percent open and the handle could no longer be used to fully close the shutter, due to the gauge handle being sheared off at the time of impact. A survey of the bottom of the gauge indicated a maximum reading of 150 mrem/hr at contact using a Ludlum model 3-IS-1 ion chamber. Agency inspectors confirmed that the incident did not result in contamination, loss of radioactive material, or exposures in excess of regulatory limits. A leak test will be conducted prior to transport for repair/disposal. With the gauge in its transportation case, Agency inspectors measured a TI (transport index) of 2.0 which would require a radioactive yellow III label and placarding [for shipment]. Discussions are ongoing regarding adding additional shielding and reducing the TI to 1.0 or less, to facilitate shipment using a radioactive yellow II label.

"Agency inspectors confirmed that the event is reportable under 32 Ill. Adm. Cod 340.1220(c)(2). No items of non-compliance resulted from the reactive inspection. Agency inspectors verified that the gauge user maintained adequate visual surveillance of the gauge and followed the licensee's emergency procedures. The licensee was advised of the requirement to submit a written report within 30 days.

"Pending additional information, this matter may be considered closed."

Illinois Reference Number: IL250025

PART 21 REPORT - SOLENOID VALVE DEFECT

The following information was provided by the licensee via phone and email:

"Valcor supplied replacement V70900-45 solenoid valves with substitute EM163-80 EPDM O-ring material (due to the obsolescence of the original E0515-80 material) and certified to the original qualification test report based on Delta Qualification report QRSKC26022-1. These replacement solenoid valves were installed at Columbia Generating Station (CGS) in July 2024 as control rod drive scram discharge volume solenoid drain valves. On September 26, 2024, CGS identified this change in material and the issue was entered into the corrective action program. Columbia's review of the Delta Qualification report identified the justification of the thermal life of the new O-ring compound when used in normally energized valves such as those supplied to CGS was not adequate. This issue was communicated to the NRC with an interim Part 21 notification on November 21, 2024 (ML24326A362).

"Valcor's report of additional testing to attempt to justify the new O-ring material as equal to or better than the original material was submitted to CGS on February 24, 2025. Columbia concluded the justification was inadequate and submitted to a third party for evaluation."

The Senior Resident Inspector has been notified.

MANUAL REACTOR TRIP AND AUTOMATIC ACTUATION OF AUXILIARY FEEDWATER SYSTEM

The following information was provided by the licensee via phone and email:

"On June 27, 2025, at 2209 CDT, with Unit 2 in mode 1 at 100 percent power, the reactor was manually tripped due to degrading condenser vacuum. The cause of the low vacuum is under investigation. All safety related systems responded normally post trip. Decay heat is being removed by atmospheric relief valves. Farley Unit 1 is not affected.

"An automatic actuation of auxiliary feedwater system occurred, which is an expected response from the reactor trip. Due to the reactor protection system actuation while critical, this event is being reported as a four-hour non-emergency notification per 10 CFR 50.72(b)(2)(iv)(B) and an eight-hour non-emergency notification per 10 CFR 50.72(b)(3)(iv)(A) as an event that results in a valid actuation of the auxiliary feedwater system.

"There was no impact on the health and safety of the public or plant personnel. The NRC Resident Inspector has been informed."