Event Notification Report for October 16, 2023

EN Revision Imported Date: 10/16/2023

EN Revision Text: 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.

* * * UPDATE ON 10/13/23 AT 1638 EDT FROM GARY FORSEE TO KAREN COTTON * * *

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

"On September 29, 2023, the Agency was contacted by Rush University Medical Center (IL-01766-01) to advise of a Y-90 Therasphere under dose that occurred the day before. The prescribed dose was 200 Gy and the prescribed activity was 45.92 mCi. The administered dose was 153.1 Gy with an administered activity of 35.15 mCi. This is a 23.5 percent deviation (under dose). The administration was determined to be clinically effective with no adverse patient impact reported. The patient and the referring physician were notified within 24 hours.

"Agency inspectors performed a reactionary inspection on October 3, 2023. The infusion of the Y-90 TheraSpheres went as intended with no identifiable irregularities. Post-admin calculations were performed which calculated that the dose delivered was 35.15 mCi. At this time the [accredited medical practitioner] (AMP) determined the dose delivered was 23.5 percent less than the written directive resulting in a potential medical event. The RSO interviewed all staff involved in the procedure and performed PET/CT imaging of the waste container (with dose vial, administration tubing kit, connector, extension tubing, microcatheter, forceps, etc.). This image was processed, and 3D volume renderings were utilized to identify where hot spots were located within the waste materials. Images of the waste container showed the highest activity was located in the dose vial. No additional apparent issues were discovered by the RSO. During an interview with the AMP, they stated that they tilted the dose vial back and forth to 90 degrees and tapped the vial on a hard surface. After the inspectors reviewed the procedures and through further questioning, they realized that the AMP was not tapping the vial sharply enough against a hard surface.

"Agency investigation findings identified the root cause of this event as inadequate agitation of the dose vial. Inspectors determined that the tapping process was not performed firmly enough against a hard surface to release the microspheres from the septum of the dose vial. This likely resulted in an increased number of microspheres remaining on the septum of the dose vial, and not released into the solution for administration to the patient. The RSO stated that they had begun the process of revising the checklist utilized during Y-90 TheraSphere procedures to better describe the dose vial preparation which includes the agitation process.

"Pending no further developments, this matter is considered closed."

Notified R3DO (Orth) and NMSS Events Notification (email).

OFFSITE NOTIFICATION

The following is a summary of information provided by the licensee via phone and email:

Two trespassers were observed by the central alarm station operator via site security cameras on the southeast end of the Maine Yankee property. Both trespassers observed to be carrying equipment to conduct manual digging for fish bait. Local law enforcement was called and responded to the Maine Yankee site. Law enforcement officers from Wiscasset Police and Lincoln County Sheriffs Department contacted both individuals and advised they had trespassed onto Maine Yankee property. Both trespassers apologized for their actions and were fully compliant with the officers. They were both advised and agreed to remain off Maine Yankee Property in the future. Their conduct was not deemed suspicious.

AGREEMENT STATE - GREATER THAN ANTICIPATED DOSE TO NON-TARGET ORGAN

The following information was provided by the New Hampshire Radiological Health Section (NHRHS) via email:

"Via telephone on October 9, 2023, the licensee's Radiation Safety Officer reported a medical event associated with use of their Varian BRAVOS high dose rate remote afterloader (HDR).

"During a treatment fraction administered on October 5, 2023, a patient received a dose of 435 centigray (cGy) (435 rad) versus a planned dose of 700 cGy (700 rad) to the target organ (the cervix) and an estimated 586 cGy (586 rad) versus an expected 300 cGy (300 rad) to the rectum (a non-targeted organ). The dose to the non-target organ exceeds 50 percent of the expected value had the procedure been given in accordance with the written directive.

"The preliminary findings indicate the wrong HDR channel had been selected. The patient and physician were notified. No health effects are anticipated as a consequence of this event. When the treatment fractions are completed, the target organ will have received a dose within 20 percent of the written directive.

"The patient and the patient's physician were advised. No negative health effects are anticipated. Treatment fractions will continue to ensure the desired dose to the target area will be provided. The investigation, with possible identification of further corrective actions, is ongoing. More information is anticipated within 15 days.

"Medical Event: Exposure to a non-target organ exceeding 50 percent of anticipated during a fractional treatment. Dose intended to target organ planned / actual: 700 cGy (700 rad) / 435 cGy (435 rad); 62 percent of planned. Dose to non-target organ anticipated / actual: 300 cGy (300 rad) / 586 cGy (586 rad); 95 percent greater than anticipated."

NMED Report Number: NH-23-0002

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 - MISSING SOURCE FOLLOWING VEHICLE ACCIDENT

The following information was provided by the North Dakota Department of Environmental Quality (DEQ), Radiation Control Program via phone and email:

The Radiation Safety Officer (RSO) for DMS Health Technologies Incorporated informed the North Dakota DEQ that a mobile nuclear medicine truck was involved in a vehicle accident around 1400 CDT, one to two miles east of Lakota, ND on Highway 2.

The RSO reported that a 10 mCi Co-57 sheet source was unaccounted for. One red ammo can containing a CS-137 and a Ba-133 source, as well as a 500 nanocurie rod source, were found undamaged at the scene.

North Dakota Highway Patrol is currently on the scene.

NMED Number: ND230002

National Response Center report number: 1381310.

* * * UPDATE ON 10/9/23 AT 1845 EDT FROM JANELL ANDERSON TO ADAM KOZIOL * * *

The licensee's RSO contacted North Dakota DEQ to report that the missing Co-57 source had been located at the scene of the vehicle accident.

Notified R4DO (Kellar), NMSS, ILTAB, and CNSC (email).

THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

PART 21 REPORT - EMERGENCY DIESEL GENERATOR DIGITAL REFERENCE UNIT PROBLEM

The following information was provided by the licensee via email:

"Donald C. Cook Nuclear Power Plant completed an internal Part 21 evaluation concerning an issue with an Emergency Diesel Generator (EDG) Digital Reference Unit (DRU) supplied by Engine Systems Incorporated (Appendix B Supplier for Woodward Governors). [On August 8, 2023,] a potential defect was identified [during a surveillance test] concerning a marginal solder joint on the DRU electronic circuit board that can result in a loss of continuity between the termination strip and the electronic board, causing a loss of setpoint output from the DRU to the Electronic Governor, and a subsequent loss of fuel to the EDG and inability to support any load. A formal failure analysis is ongoing at the time of this notification. A written notification will be provided within 30 days.

"Affected known plants include only Donald C. Cook Nuclear Power Plant Units 1 and 2 at the time of notification.

"The NRC Resident has been notified."

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

The EDG DRU was replaced after discovery of the potential defect and the EDG is currently operable.

MANUAL REACTOR TRIP

The following information was provided by the licensee via email:

"On 10/12/23 at 2127 EDT, with the Unit 1 in Mode 1 at 100% Power, operators identified degrading condenser vacuum and manually tripped the reactor. All control rods inserted as expected. The trip was not complex, and all systems responded normally post-trip. The cause of the degraded condenser vacuum was an unexpected closure of the condenser air ejector regulator. The cause of the air ejector regulator going closed is not fully understood and is being investigated.

"Following the SCRAM, Operators responded and stabilized the plant. Decay heat is being removed by the Main Steam System through the Atmospheric Relief Valves (ARVs) and Auxiliary Feed Water (AFW) systems. Due to the Reactor Protection System (RPS) 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) for a valid specified system actuation.

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