ENS 55286
ENS Event | |
|---|---|
05:00 Apr 7, 2021 | |
| Title | Medical Event |
| Event Description | The following was received from the state of Iowa via e-mail:
The licensee reported a potential medical event involving a prostate seed implant therapy. The procedure was performed on April 7, 2021 and the post plan CT scan was conducted on May 27, 2021. The CT scan revealed that a number of seeds were implanted outside of the treatment site. The licensee called and emailed Iowa Department of Public Health (IDPH) Radioactive Materials (RAM) staff on Friday, May 28, 2021. RAM staff, who were out on extended memorial day holiday, did not receive the email or phone message until June 1, 2021 when returning to the office. RAM staff has reached out to the licensee for additional information. RAM staff is intending to conduct a reactive inspection of the licensee [the first week in June]. The licensee will be providing the 15 day written report as required by rule. This event will be updated once the additional information requested from the licensee is received. Item Number: IA210002
The following was received from the Iowa Department of Public Health (IDPH) via e-mail: IDPH conducted an onsite investigation on June 3, 2021. This event is being updated based on that investigation. It appears that the iodine-125 seeds were implanted correctly on the day of the procedure, but due to swelling of the prostate and the 50 days until the post plan CT when the prostate swelling had reduced, the plan showed 16 seeds outside of the target volume. IDPH staff found no procedural problems with the licensees implant procedure. This possible event will be updated once again when the written report is received from the licensee. Notified R3DO (Dickson), NMSS EO (Sida) and NMSS Event Notifications (email).
The following was received from the Iowa Department of Public Health (IDPH) via e-mail: On June 1, 2021 Iowa reported a potential medical event at Spencer Municipal Hospital (License number 0164-1-21-M1) involving Iodine-125 prostate implant seeds. This potential medical event occurred on April 7, 2021 and was discovered by the licensee on May 27, 2021 during their post procedure review. This event was reported to the State on May 28, 2021 and Iowa Department of Public Health (IDPH) Radioactive Materials Program (RAM) staff became aware of the event on June 1, 2021 after the long Memorial Day weekend. IDPH RAM staff conducted a reactive inspection at Spencer Municipal Hospital on June 3, 2021 to interview staff involved in the prostate treatment therapy procedure. IDPH staff determined that all seventy-one Iodine-125 seeds were implanted in the correct location of the prostate based on the treatment pre-plan and that when the post procedure CT scan was evaluated it was determined that sixteen seeds had migrated outside of the target volume. Therefore, this does not meet the definition of a reportable medical event per Iowa Administrative Code 641-38.2(136C). IDPH program staff had a meeting with NRC Region III staff (Darren Piccirillo and Geoff Warren) via Microsoft Teams on Monday, June 7, 2021 to discuss this potential medical event. Region III staff agreed with IDPH that this seed migration is not a reportable medical event. Therefore Iowa is retracting event number 55286 (IA210002). Notified R3DO (Kunowski) and NMSS Event Notifications (email). 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. |
| Where | |
|---|---|
| Spencer Municipal Hospital Spencer, Iowa (NRC Region 3) | |
| License number: | 0164121M1 |
| Organization: | Iowa Department Of Public Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+1329.67 h55.403 days <br />7.915 weeks <br />1.821 months <br />) | |
| Opened: | Randal S. Dahlin 14:40 Jun 1, 2021 |
| NRC Officer: | Joanna Bridge |
| Last Updated: | Jun 7, 2021 |
| 55286 - NRC Website | |
Spencer Municipal Hospital with Agreement State | |
WEEKMONTHYEARENS 552862021-04-07T05:00:0007 April 2021 05:00:00
[Table view]Agreement State Medical Event 2021-04-07T05:00:00 | |