ENS 49734
ENS Event | |
|---|---|
00:00 Jan 16, 2014 | |
| Title | Agreement State Report - Prostate Seed Implant Misadministration |
| Event Description | The following was received from the State of Arkansas via email:
Central Arkansas Radiation Therapy Institute, Inc. (CARTI), ARK-0654-02200, reported a medical event involving a patient treated for prostate cancer. The treatment plan included implanting 128 I-125 brachytherapy seeds (6 seeds were not implanted), containing a total activity of 1.592 GBq (43.036 mCi), in the patient's prostate for a prescribed therapeutic radiation dose of 14,400 cGy. It appears that approximately 40 of the total number of seeds were implanted into the prostate gland. The seeds were implanted on December 31, 2013. On January 15, 2014, the patient returned to the facility for a post implant CT scan. The scan showed that the implanted seeds, although in an appropriate pattern, were placed outside the intended target. The State performed an on-site review on January 16, 2014, of the event and discussed the initial details of the event. The licensee is continuing to investigate the cause and is preparing a written report. The State is continuing to investigate and will update this report when the report is received from the licensee. This event is reportable under 10 CFR 35.3045 of the NRC Regulations and RH-8800 of the Arkansas State Board of Health Rules and Regulations for Control of Sources of Ionizing Radiation. State Event Report Number: AR-2014-001
Doses: The D90 for the prostate pre-plan was 167.86 Gy and the D90 for the prostate post-plan is 25.31 Gy. Estimated mean doses to other organs and tissues were, Seminal Vesicles 13.99 Gy, Rectum 45.80 Gy, Bladder 3.89 Gy, and the Penile Bulb 185.24 Gy. Root cause of the event: The licensee stated: 'the facts of the case lead us to believe that the complexity of the patient anatomy contributed to anatomical misidentification by the attending urologist, i.e. mistaking the penile bulb with the prostate gland.' Corrective Actions Multiple corrective actions were implemented including: (1) Centralizing prostate seed implant programs to fewer facilities under the Radioactive Material License, (2) At those facilities continuing to perform prostate seed implants, ensure consistent adherence to the seed implant procedural and policies at each facility, (3) Re-evaluation of the prostate seed implant procedures by the radiation oncologists, (4) Require quality assurance documents on the ultrasound equipment utilized for prostate seed implants, and (5) Require training and proficiency records for operating room staff assisting with prostate seed implants. Manufacturer and model number of the seeds: The seeds used during this misadministration were Oncura, OncoSeed, Model 6711, containing 0.336 mCi of I-125. Thirty-four (34) seeds of 128 were implanted into the prostate. The Department [Arkansas Department of Health] considers this event to be closed. Notified R4DO (Allen) and FSME Resources via 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 | |
|---|---|
| Central Arkansas Radiation Therapy Institute Inc Conway, Arkansas (NRC Region 4) | |
| License number: | ARK-0654-0220 |
| Organization: | Arkansas Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+35.68 h1.487 days <br />0.212 weeks <br />0.0489 months <br />) | |
| Opened: | Steve Mack 11:41 Jan 17, 2014 |
| NRC Officer: | Charles Teal |
| Last Updated: | Jun 23, 2014 |
| 49734 - NRC Website | |
Central Arkansas Radiation Therapy Institute Inc with Agreement State | |
WEEKMONTHYEARENS 497342014-01-16T00:00:00016 January 2014 00:00:00
[Table view]Agreement State Agreement State Report - Prostate Seed Implant Misadministration ENS 404092003-12-04T06:00:0004 December 2003 06:00:00 Agreement State Agreement State Event 2014-01-16T00:00:00 | |