Event Notification Report for July 18, 2024

EN Revision Imported Date: 9/24/2024

EN Revision Text: AGREEMENT STATE REPORT - Y-90 DOSE MISADMINISTRATION

The following is a summary of information that was provided by the New Mexico Radiation Control Program via phone and email:

At approximately 1830 MDT on September 10, 2024, the licensee's radiation safety officer discovered that on July 18, 2024, a dose of 0.2 Gbq of yttrium-90 was prescribed for delivery to a patient, but the patient received a reported dose of 0.25 Gbq. The cause for the discrepancy between the prescribed and delivered dose is unknown. The licensee has been instructed to provide a complete written report.

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 09/23/2024 AT 1005 EDT FROM VICTOR DIAZ TO ROBERT THOMPSON * * *

The following information was provided by the New Mexico Radiation Control Program via email:

"On July 18, 2024, two microsphere radioembolization (yttrium-90) administrations were performed on the same patient. For the first dosage, 5.4 mCi was prescribed, 7.6 mCi was drawn, and 90 percent of the drawn dosage was delivered (6.84 mCi). For the second dosage, the prescribed dosage was 5.4 mCi, 7.2 mCi was drawn, and 60 percent of the drawn dosage was delivered (4.32 mCi). The first treatment is reportable because the total dosage delivered differs from the prescribed dosage by more than 20 percent and was not discovered to be due to stasis or an emergent condition. The second dosage is not reportable because the error was due to stasis as certified by the authorized user (AU).

"The misadministration was discovered on September 10, 2024, by the radiation safety officer (RSO) during the quarterly review of records. Upon discovery, a thorough review of the associated records was completed along with an investigation involving the lead certified nuclear medicine technologist (CNMT), the SirTex representative who was assisting with the procedure, the AU, and radiology management. It was determined that this misadministration occurred because the prescribed dosage was so small that the CNMT had a difficult time drawing it up into the syringe. When the CNMT would push one drop out of the syringe, the dosage would be too low. When adding a drop back to the syringe, the dosage would be too high. Since dosages under 10 mCi typically have a 15 percent residual, the CNMT and SirTex representative decided it was acceptable to supply a dosage that was 140 percent of the prescribed dosage, even though the facility policy is that the final activity in the syringe must be within 10 percent of the prescribed dosage. In addition, the AU was not informed that the drawn activity was outside of the allowed 10 percent range. Once it was determined that the first treatment met the definition of a medical event, the event was immediately reported.

"No adverse effects are anticipated. Follow up medical appointments with the patient have not indicated any immediate effects. This patient will continue to be monitored in line with standard of care.

"Due to the minimal risk expected due to this excess dosage, the AU along with the patient's medical oncologist decided notifying the patient would not be advisable. Notifying the patient would cause more stress than benefit."

Notified R4DO (Young), NMSS Events Notification (email).

EN Revision Imported Date: 9/17/2024

EN Revision Text: AGREEMENT STATE REPORT - LOST SOURCE

The following information was provided by the New York State Department of Health (NYSDOH) via email:

"The NYSDOH received an email from the radiation safety officer (RSO) on July 22, 2024, to report a lost Fe-55 source. The make and model of the missing source was not disclosed; however, NYSDOH is requesting additional information and will provide this information once available. The source serial no. is 55-1.1-8 and was last assayed 10/1/2015. At the time of manufacture and distribution, this source was 10 mCi.

"The source in question was last seen during routine inventory on January 5, 2023. Following this inventory, this source was not accounted for on March 23, 2023. It was believed that this source may have been utilized by an authorized user between January 5, 2023, and March 23, 2023. However, after many discussions between the authorized user and Stony Brook University's radiation safety office, it was confirmed that the source in question was officially lost on 7/18/2024. Decay calculations suggest that the missing Fe-55 source is approximately 1.07 mCi to date. As this source was last inventoried on January 5, 2023, it is estimated that the Fe-55 source was approximately 1.58 mCi at the time it was last confirmed as present in the storage area. This activity is approximately 15.8 times the quantity for Fe-55 requiring labeling as stated in Appendix C to 10 CFR 20. The loss of this source meets the reportability criteria in 10 CFR 20.2201(a)(1)(ii).

"It is not believed that this source may cause any incidental doses which may exceed the limits in Subparts C or D of 10 CFR 20. Furthermore, the loss of this source would not be expected to have any negative implications on public health. NYSDOH is monitoring this incident and has assigned incident number 1493 to track this event. Additional information will be provided to NMED once available."

Event Report ID No. NY-24-06
NYSDOH Incident Number: 1493

* * * UPDATE ON 9/16/2024 AT 1155 EDT FROM NATE KISHBAUGH TO ROBERT THOMPSON * * *

The following information was provided by the New York State Department of Health (NYSDOH) via email:

"On July 31, 2024, NYSDOH performed a full inspection and performed an on-site evaluation of this event. The above information provided indicated that the authorized user in question had their permits administratively terminated and their membership on the university's Radiation Safety Committee revoked because of this event and other compliance issues with the university's Radiation Safety Office.

"To date, the Fe-55 source in question is still missing. The radiation safety office (RSO) for the licensee is maintaining vigilance when performing audits and permit reviews for other permit holders to see if this Fe-55 source may be located. Additionally, the RSO has implemented a new inventory management system at their facility to further improve accountability of similar sources to prevent recurrence. NYSDOH was monitoring this incident and assigned incident number 1493 to track this event. At this time, NYSDOH has closed incident number 1493 given the corrective actions from this event but will reopen this incident in the event additional information is obtained or the source is located. The licensee is aware of the reporting requirement in the event additional information on this source is discovered following closeout."

Notified R1DO (Werkheiser), NMSS (email), ILTAB (email), CNSC (Canada) (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

AUTOMATIC REACTOR TRIP

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

"At 1524 [EDT] on 07/18/2024, with Unit 2 in Mode 1 at 100 percent power, the reactor automatically tripped due to a turbine trip. The trip was not complex, with all systems responding normally post-trip.

"Operations responded and stabilized the plant. Decay heat is being removed by discharging steam to the main condenser using the turbine bypass valves.

"Unit 1 implemented AOP-7K (abnormal operating procedure), overcooling event, due to a grid transient. Operations responded and stabilized Unit 1 in Mode 1 at 100 percent power.

"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).

"There was no impact on the health and safety of the public or plant personnel.

"The NRC resident inspector has been notified."


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

All rods fully inserted. There were no other specified system actuations.