ENS 56481
ENS Event | |
|---|---|
17:30 Apr 19, 2023 | |
| Title | Medical Event - Patient Underdose |
| Event Description | The following information was provided by the licensee via phone and email:
Per 10 CFR 35.3045(c), Veterans Health Administration (VHA) National Health Physics Program (NHPP) is reporting a possible medical event. Southern Arizona VA Health Care System [the facility], Tucson, Arizona, which holds Permit Number 02-06186-01 under the VA master materials license, reported discovery of a 'possible' medical event to NHPP at approximately [1500] CDT, April 19, 2023. A yttrium-90 microsphere therapy administration for liver cancer was performed on April 19, 2023. The intended treatment site was hepatic segment 4 of the right lobe of the liver. During the administration, performed under fluoroscopy guidance, the Authorized User (AU) / administering Interventional Radiology physician noted a change in the catheter position and elected to stop the administration. Measurements and calculations indicated the patient received about 63 percent of the prescribed activity [15.06 mCi delivered vs. 21.6 mCi prescribed]. Post implant single-photon emission computerized tomography (SPECT) imaging verified that the dosage had been delivered to the correct location. The AU believes that the movement of the catheter qualifies as an emergent patient condition. The written directive was modified to include the reason for not administering the intended activity, the signature of an AU for yttrium-90 microspheres, and the date signed. NHPP in coordination with the facility and NRC will conduct further evaluation of this event to determine if the regulatory definition of emergent patient condition was met. The patient and the referring physician have been notified. At this time, short term harm to the patient is not expected. NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP has notified the NRC Region III Project Manager. 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.
The following information was provided by the licensee via email: Veterans Health Administration (VHA) National Health Physics Program (NHPP) placed a call to NRC Operations Center on May 2, 2023, to retract Event Number 56481 (NMED Item No. 230168). NHPP reported discovery of a "possible" medical event at Southern Arizona VA Health Care System, Tucson, Arizona, Permit Number 02-06186-01, on April 19, 2023. NHPP, in coordination with the facility and NRC, has conducted further evaluation and determined that the regulatory definition of emergent patient condition, in NRC's document, Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing Guidance, was met. Therefore, this event is no longer classified as a "possible" medical event and the 15-day written reporting requirement of 10 CFR 35.3045(d) will not be completed. NHPP has notified the NRC Region III Project Manager. Notified R3DO (Peterson), R4DO (Gaddy), and NMSS Events Notification. |
| Where | |
|---|---|
| Southern Arizona Va Health Care Little Rock, Arkansas (NRC Region 3) | |
| License number: | 03-23853-01VA |
| Organization: | Southern Arizona Va Health Care |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+23.83 h0.993 days <br />0.142 weeks <br />0.0326 months <br />) | |
| Opened: | Kim Wiebeck 17:20 Apr 20, 2023 |
| NRC Officer: | Sam Colvard |
| Last Updated: | May 2, 2023 |
| 56481 - NRC Website | |
Southern Arizona Va Health Care with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 564812023-04-19T17:30:00019 April 2023 17:30:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Patient Underdose 2023-04-19T17:30:00 | |