ENS 46236
ENS Event | |
|---|---|
05:00 Sep 8, 2010 | |
| Title | Medical Dose Different than Prescribed Dose |
| Event Description | The following information was received by e-mail from a program manager with the U.S. Department of Veterans Affairs, Veterans Health Administration (VHA), National Health Physics Program (NHPP):
[The VHA is] notifying the NRC of 11 medical events at G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi. These medical events occurred for Iodine-125 permanent prostate seed implant brachytherapy. As historical information, 10 medical events were reported to NRC on earlier dates for prostate seed implants at this medical center under NRC Event Report No. 44522. Following up on those medical event reports, VHA initiated a comprehensive external review and reanalysis of post-treatment dose parameters for all prostate seed implants performed at the medical center. Upon evaluation of updated dose information generated by the external review, medical center staff, working with NHPP, discovered on September 8, 2010, that 11 additional medical events need to be reported. 10 of the 11 events were based on updated D90 values (considered to be final values) for the planned treatment site being 80% or less than the prescribed dose. This circumstance is interpreted as meeting the definition of a medical event per 10 CFR 35.3045(a)(1)(i). 1 of the 11 events was based on absorbed dose to a tissue other than the treatment site exceeding the expected dose by 50% or more. This circumstance is interpreted as meeting the definition of a medical event per 10 CFR 35.3045(a)(3). As additional information, medical center staff, working with NHPP, has determined that 4 of the 10 previously reported medical events under NRC Event Number 44522 could be retracted because updated D90 values (considered to be final values) from the external review are above 80% of the prescribed dose. If retraction of these 4 events is pursued, NHPP will discuss the dose information with NRC Region III prior to notifying the NRC Operations Center of the retractions. NHPP will ensure that the medical center follows NRC requirements for notification of the referring physician and patient for these medical events. The patients involved in the medical events have been tracked by the medical center and the clinical outcomes for the patients have been verified to be consistent with expected clinical outcomes for successful prostate seed implants. A 15-day written report of these medical events will be submitted to NRC Region III. [The VHA] will notify the NRC Project Manager, Cassandra Frazier (NRC Region III), of these medical events. In summary, [VHA is] confirming a total of 17 medical events for the medical center. 11 medical events are reported today (10 based on a low dose to treatment site; 1 based on elevated dose to other organs and tissues). 6 medical events were reported previously under NRC Event No. 44522. 4 of the 10 medical events previously reported under NRC Event No. 44522 no longer meet criteria as medical events and might later be retracted. Additional Information: Department of Veterans Affairs has a Master Materials License (MML) from the NRC: License No. 03-23853-01VA. Permits are issued under the MML to VA facilities. The VA submits reports to the NRC through the VHA's National Health Physics Program office located in North Little Rock, AR. Address of permittee involved in this event: G.V. (Sonny) Montgomery VA Medical Center, 1500 East Woodrow Wilson Drive, Jackson, Mississippi 39216. VHA permit number of permittee involved in event: Permit No. 23-08786-01. 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 | |
|---|---|
| Department Of Veteran Affairs Jackson, Mississippi (NRC Region 4) | |
| License number: | 03-23853-01VA |
| Organization: | Va Medical Center Jackson |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+33 h1.375 days <br />0.196 weeks <br />0.0452 months <br />) | |
| Opened: | Thomas E. Huston 14:00 Sep 9, 2010 |
| NRC Officer: | Vince Klco |
| Last Updated: | Sep 9, 2010 |
| 46236 - NRC Website | |
Department Of Veteran Affairs with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 551962021-04-16T05:00:00016 April 2021 05:00:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Underdosage ENS 462362010-09-08T05:00:0008 September 2010 05:00:00 10 CFR 35.3045(a)(1) Medical Dose Different than Prescribed Dose 2021-04-16T05:00:00 | |