Event Notification Report for October 10, 2023

AGREEMENT STATE REPORT - POSSIBLE MISADMINISTRATION

The following information was provided by the Kentucky Department for Public Health and Safety, Radiation Health Branch (KY RHB) via email:

"KY RHB was notified on 9/29/2023, by a representative from the University of Kentucky that two patients were scheduled for treatment with Lu-177, one with commercially available Lu-177 dotatate (Lutathera) and one under a research protocol also using Lu-177 dotatate but distributed under an investigational new drug label. Both vials contained the same drug and differed only in their label for distribution / intended use. The nuclear medicine technologist prepared and administered Lu-177 dotatate from the vial labeled for research to the standard of care patient instead of the correct (commercial) vial. The patient received the correct amount of drug (prescribed activity), the correct chemical form (identical Lu-177 dotatate) by the correct route of administration as intended for their treatment. However, since the drug was dispensed from the vial distributed under the investigational new drug application intended for the research study patient, KY RHB considers this to meet the reporting requirements in Part 35 for a medical event.

"The physician was informed, the patient was informed, and no harm is anticipated as a result of this incident. Additional notifications have also been made as required considering the involvement of investigational drug product and the Institutional Review Board.

"The incident remains under evaluation and investigation for corrective actions."

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 - UNDERDOSE TO PATIENT

The following was received from the Illinois Emergency Management Agency (the Agency) via email:

"On September 29, 2023, the Agency was contacted by Rush University Medical Center of a potential medical event. The administration was determined to be clinically effective with no adverse patient impact reported.

"The medical event took place on September 28, 2023. The patient and the referring physician were notified within 24 hours. The Y-90 Therasphere dose was 23.5 percent less than the prescribed dose. Agency inspectors are scheduled to perform a reactionary inspection on October 3, 2023. Additional information is forthcoming from the licensee and updates will be sent as they are available."

Illinois Item Number: IL230027

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 - DAMAGED MOISTURE DENSITY GAUGE

The following report summary was received by email from Virginia Radioactive Materials Program (VRMP):

"On September 29, 2023, at approximately 0930 EDT, a Troxler moisture density gauge (model number: 3430, serial number: 32732, 8 mCi Cs-137, 40 mCi Am-241:Be) was struck by a bulldozer while the rod was extended out into the soil for measurements. The area was secured. The gauge was left in place so that the source would remain shielded by the soil and the radiation safety officer (RSO) was notified. The impact cracked the plastic housing and significantly bent the source rod handle above the gauge. The RSO verified that the source rod below the gauge was still intact. They were unable to get the source to retract. With the source inserted back into the soil, survey readings were obtained by the licensee as follows: 1 mR/hr on top of the gauge on contact; @ 5 ft away to the side 0.1 mR/hr.

"According to the RSO, no public exposure occurred. The licensee has fitted a lead pig [lead shielded container] around the source for transport to a licensed nuclear gauge service company."

Virginia Event Report ID Number: VA230002

AGREEMENT STATE REPORT - RADIOGRAPHY SOURCE STUCK UNSHIELDED AND RECOVERED

The following was received from the Louisiana Department of Environmental Quality (the Department) via email:

"On September 30, 2023, Acuren Inspection, Inc. notified the Department that an industrial radiography camera failed to retract the source after an exposure. The industrial radiography camera was a Century 330 QSA Cobalt camera. The serial number of the camera is P30078. The radiation source is a Cobalt-60 with an activity strength of 52.2 curie. The source serial number is 59740G. The source was cranked back out the end of the source guide tube with a collimator.

"The facility where this event occurred is in St. Martin, Louisiana. Only the two man radiography crew was present at the site during the event, which occurred between 0300 [CDT] and 0350. A source retrieval was performed, resulting with the source in a shielded condition in the radiography camera. The individual performing the source retrieval received only 1 millirem."

Louisiana Event Report ID No.: LA20230010

AGREEMENT STATE - I-125 SEED INADVERTENTLY TRANSECTED

The following information was provided by the Pennsylvania Bureau of Radiation Protection via email:

"On September 28, 2023, staff from Magee Pathology department called the [University of Pittsburgh] radiation safety office to report that they had accidentally transected an I-125 seed used for radioactive seed localization (RSL) in breast tissue during the pathology processing in the laboratory. The seed was a Best Medical International Model 2301 containing 169 microcuries of I-125. Two staff members were involved, and they were told to sequester in the room until personnel from radiation safety could respond. Shortly after, radiation safety personnel performed surveys to determine the extent of the contamination. No personnel contamination was observed. All contamination was discovered in waste material and on the tissue samples. The transected seed was contained. The radiation safety office took possession of the damaged seed and all radioactive waste. At the time of reporting, it is estimated that approximately 50 percent of the activity was lost to open contamination, which is greater than 1 annual limit on intake (ALI) of I-125, and therefore reached the criteria for [10 CFR] 22.2202 reportability. Workers had bioassays performed for thyroid exposure and all returned negative."

PA event report ID: PA230028

AGREEMENT STATE REPORT - STUCK SHUTTER

The following report was received from the Louisiana Department of Environmental Quality (the Department) via email:

"On October 2, 2023, Syngenta Crop Protection, LLC notified the Department that a nuclear level gauge shutter was broken. The shutter is stuck open at approximately 40 percent. The gauge manufacturer is Texas Nuclear, Model: 5182, serial number 149. The source is Cs-137 with 50 mCi activity, serial number: J34.

"BBP Sales has been contacted to come out to the facility to perform repairs on the nuclear gauge."

Louisiana Event Report ID No.: LA20230012

AGREEMENT STATE REPORT - STUCK SHUTTER

The following report was received from the Louisiana Department of Environmental Quality (LDEQ) via email:

"On August 30, 2023, at approximately 0900 [CDT], an Ohmart Model SH-F1-0 level/density gauge experienced a shutter malfunction during a routine semiannual shutter test. The gauge was installed on the Reactor 3, West Production vessel within the Poly Process Unit. The gauge possesses a nominal 500 millicurie sealed source of Cs-137. The above gauge was undergoing a routine semiannual shutter test when the malfunction was observed. The gauge sealed source serial number is: 1560CO. The device serial number has not been provided by the licensee. The gauge containing source number 1560CO, is mounted on the Reactor 3, West Production Chamber vessel in the polyethylene unit. On the above date, the Radiation Safety Officer (RSO) for Union Carbide Corporation contacted BBP Sales (BBP), radioactive material license LA-10799-L01. BBP arrived on site on that day to repair the stuck shutter. After several unsuccessful attempts to break the shutter free, the licensee and the BBP service engineer decided the best course of action would be to order a rotor replacement kit and the BBP service engineer should return on site to replace it. BBP is currently awaiting delivery of the new rotor kit.

"On October 2, 2023, at 0824, Union Carbide RSO notified the LDEQ concerning this equipment malfunction. According to RSO, the gauge rotor bracket broke due to corrosion, which prevented the gauge shutter from closing fully. The gauge is under the licensee's control. There were no exposures to members of the public approaching regulatory limits. Currently, the shutter on the gauge remains in the open position as the gauge source is needed to operate process control equipment. The gauge cannot be locked out in its current state. No entry to the vessel will be conducted until the gauge is repaired by BBP. The licensee will continue to monitor the gauge until repaired. The licensee stated they will keep the LDEQ updated on the progress of repairs."

Louisiana Event Report ID No.: LA230011

AGREEMENT STATE REPORT - DISCONNECTED RADIOGRAPHY SOURCE

The following information was provided by the New Mexico Radiation Control Bureau via phone:

On October 2, 2023, at 1430 MDT, a radiography camera source became disconnected from its cable while still inside the guide tube during operations at a fabrication facility in Loving, NM. The device was described as a QSA D880 Model A424-9 camera with a 79.7 Ci iridium-192 source, serial number: 76167M. The licensee reconnected the source and secured the source inside the device in the shielded position by 2100 MDT. There were no public or occupational overexposure related to the source being disconnected from its control cable.

AGREEMENT STATE REPORT - MEDICAL UNDERDOSE

The following information was provided by the Oregon Department of Health Radiation Protection via email:

"At 1000 PDT on September 21, 2023, during an administration of a split-dose of Y-90 [yttrium] SirSpheres to the liver, the first dose was not completely delivered to the patient. The second dose, same lobe but a different site, was delivered completely. (First prescribed dose: 7.2mCi; First delivered dose: 5.614 mCi)

"The physician does not believe additional treatment will be needed but the case will be discussed by the licensee in a follow-up conference. The senior radiologist believes there was a `clump of spheres' remaining at the hub of the syringe for the first dose, resulting in under-dosing the patient by more than 20 percent.

"Corrective action is still to be determined."

Oregon Event Report Number: 23-0051

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: 10/6/2023

EN Revision Text: 60-DAY OPTIONAL TELEPHONIC NOTIFICATION FOR AN INVALID SPECIFIED SYSTEM ACTUATION

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

"At 1439 EDT on August 7, 2023, a spurious level spike on the unit 4 reactor coolant system (RCS) level instrument (4-RCS-LT160A, 'Hot Leg 1 Level') caused actuation of containment isolation, reactor trip, automatic depressurization system (ADS) stage 4, and in containment refueling water storage tank (IRWST) isolation signals. The spurious level changes caused an invalid signal based on the incidental response of the 4-RCS-LT160A instrumentation due to water spray that was being used for reactor vessel cleaning (being performed prior to initial fuel loading). The level fluctuations resulted in engineered safety features actuation signals (containment isolation, ADS stage 4, and IRWST isolation signals) and a reactor trip signal, with the reactor trip signal already present. Three containment isolation valves closed due to the containment isolation signal that was generated. These valves were: 4-CAS-V014, 'instrument air supply containment isolation, air-operated valve,' 4-SFS-V034, 'spent fuel pool cooling system suction header containment isolation, motor-operated valve,' and 4-SFS-V035, 'spent fuel pool cooling system suction header containment isolation, motor-operated valve.' The other automatic containment isolation valves were either already closed at the time of the event or properly removed from service. All affected equipment functioned properly. The other actuation signals that were observed during this event (ADS stage 4, IRWST isolation, and reactor trip) did not result in any equipment changing position or automatically operating (i.e., the actuation signals occurred while the systems were properly removed from service).

"Units 1, 2, and 3 were not affected. This event did not result in any adverse impact to the health and safety of the public."

The NRC Resident Inspector was notified.

60 DAY NOTIFICATION FOR AN INVALID SPECIFIED SYSTEM ACTUATION

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

"This 60-day telephone notification is being made in accordance with 10 CFR 50.73(a)(1) and 10 CFR 50.73(a)(2)(iv)(A)."

"On August 8, 2023, at 1107 hours pacific daylight time (PDT) with Unit 1 in Mode 1 at 100 percent power, an invalid actuation occurred when Unit 1 4-kV vital bus 'G' was automatically transferred from auxiliary power to startup power due to an invalid bus under voltage signal, which occurred during planned maintenance activities.

"As a result of the actuation signal, auxiliary salt water and containment fan cooling units transferred automatically and started as designed. Plant systems responded as expected. This event was entered into the Diablo Canyon Power Plant corrective action program for resolution.

"There was no plant or public safety impact.

"The NRC Senior Resident Inspector has been notified."

FITNESS-FOR-DUTY VIOLATION

The following information was provided by the licensee via email:

A non-licensed employee supervisor failed a test specified by the fitness for duty testing program. The individual's authorization for site access has been terminated.

The NRC Resident Inspector has been notified.