Event Notification Report for March 20, 2024

EN Revision Imported Date: 3/20/2024

EN Revision Text: AGREEMENT STATE REPORT - PATIENT RECEIVED 45 PERCENT UNDERDOSE

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

"The South Carolina Department of Health and Environmental Control was notified via telephone at approximately 0930 EST on 11/10/23 that a medical event had been discovered by the licensee on 11/09/23 at approximately 1700 EST. The Medical University of South Carolina (MUSC) reported an underdose to a patient's liver during a Y-90 microsphere procedure by 45 percent of the prescribed 500 Gray (Gy) dose. MUSC estimates that the patient received 276 Gy of the intended 500 Gy dose. The licensee reported that the total dose or activity delivered differs from the prescribed dose or activity, as documented in the written directive, by 20 percent or more.

"The licensee reports no immediate or ongoing concerns to public health and safety. Department inspectors will be dispatched to the facility to investigate this event. This event is still under investigation by the South Carolina Department of Health and Environmental Control."

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 3/19/24 AT 1508 EDT FROM KORINA KOCI TO OSSY FONT * * *

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

"The licensee provided their 15-day written report dated 11/17/23, which was received on 11/18/23. The written report indicated that at the time of the Y-90 radioembolization procedure no leaking was present, and after three flushes were performed the dose vial (originally containing the TheraSpheres) was measured again. Surveys of the vial and procedure room indicated radiation doses to be at background levels. Additionally, the licensee reported that measurements of the Nalgene container contents demonstrated high levels of residual activity and based on these readings the licensee ascertained that 55 percent of the prescribed dose was administered to the patient. Upon further investigation, the licensee stated that the microcatheter passing through the Y-fitting ruptured allowing the TheraSpheres to escape and collect in the fitting. The licensee's corrective actions included: communicating the details of this event with the manufacturer and inquire on whether this event has previously occurred, and requested from the manufacturer to provide refresher training to staff on the set-up of administration lines. Finally, the licensee reported that no adverse effects to the patient are expected to occur as a result of this event, since only 55 percent of the intended dose was delivered.

"Department inspectors were dispatched to the facility on 12/06/23. The details of the event were consistent with the licensee's 15-day written report. This event and investigation are considered closed."

Notified R1DO (Ford) and NMSS Events Notification via email.

NON-AGREEMENT STATE REPORT - LOST TRITIUM EXIT SIGN

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

During an inventory which began the week of March 4, 2024, the licensee discovered one lost tritium exit sign (Isolite SLX-60, 4.4 Ci). The sign was at a location undergoing renovation. All other tritium exit signs that were on site have been accounted for. An investigation ensued to attempt to determine the disposition of the missing sign. This sign was declared lost on March 12, 2024.

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

AGREEMENT STATE REPORT - MISSING SHUTTER

The following information was received by the Minnesota Department of Health (MDH) via email:

"On March 12, 2024, at 1539 CDT, the licensee contacted MDH to report a gauge with a missing shutter. During their routine semiannual inventory and shutter check, the licensee discovered a Texas Nuclear model 5190 fixed gauge that was missing its shutter. The gauge contained a 100 mCi Cs-137 source (decayed to 35 mCi). The gauge was equipped with a removable shutter, and the licensee assumes that it had become loose and detached from the device due to normal operating vibration. The event was discovered at approximately 1420 on March 12, 2024.

"The licensee stated that they had a spare shutter and were able to install it on the gauge. The gauge was installed and operating when the missing shutter was discovered. Therefore, no abnormal radiation field or exposure occurred due to the missing shutter. At the time of the call, the licensee had not yet located the missing shutter. This gauge is used for density measurements on their tailings clarifier underflow pump."

Minnesota State Event Report Number: MN240002

PART 21 - FAILURE TO COMPLY WITH TESTING REQUIREMENTS

The following is a summary of the information provided by Alpha -Omega Services (AOS) via email:

During shipment of an Alpha Omega Services (AOS)-100A-0003 cask, a metallic seal was used instead of an elastomeric seal. The failure to comply, discovered February 16, 2024, is that the testing requirements for the metallic seal were not properly followed. The shipment arrived without incident.
The storage location of the active unit is Merritt Island, FL. The failure to comply is an isolated incident affecting one AOS-100A package which is certified and is currently in service. The remaining units are not in service.
AOS has initiated a corrective action plan that will identify the issue, begin the internal investigation process to determine the cause, and identify any additional corrective actions. This investigation is currently in progress.

HIGH PRESSURE COOLANT INJECTION ISOLATION

The following information was provided by the licensee via fax or email:

"While performing a planned high pressure coolant injection (HPCI) system surveillance, an isolation signal was received based upon an exhaust rupture disc high pressure signal. This resulted in an unplanned inoperability of the HPCI system. All systems responded as expected, and the event is under investigation. No other systems were affected by this condition.

"This event is reportable as an 8-hour non-emergency notification under 10CFR50.72(b)(3)(v) as HPCI is a single train safety system. There was no impact to plant personnel or the public as a result of this condition. The NRC resident has been notified of this condition."