ENS 56816
ENS Event | |
|---|---|
05:00 Oct 23, 2023 | |
| Title | Possible Dose Misadministration |
| Event Description | The following information was provided by the Kentucky Department for Public Health and Safety, Radiation Health Branch (KY RHB) via email:
KY RHB was notified on 10/25/23 by the radiation safety officer (RSO) of University of Kentucky (UK) Broad Scope medical license, of an incident which occurred at the UK Chandler Medical Center on October 23, 2023. [The UK] RSO reports, 'During a high dose rate (HDR) treatment, the treatment was interrupted due to fluid in the transfer tubing. The authorized user (AU) directed that the transfer tubing be replaced and treatment completed. The tubing used to complete the cycle was not the correct length, resulting in approximately 10 seconds of source exposure at the wrong dwell position(s). The source was outside of the body during this exposure period, therefore, there is uncertainty in the dose estimates to patient skin. Likely exposure in the treatment position (legs apart) is likely below the reporting thresholds in 10 CFR 35, while conservative estimates (assuming patient's legs were closed) lead to doses above reporting thresholds. Since the exact positioning is indeterminant, the licensee did not report a dose from this incident at this time. Upper bound worse case estimates place the skin dose below the level where patient harm is expected by the treating oncologist and no changes in plan of care are anticipated from this event. This incident remains under investigation.' RHB is following up with the RSO for additional information not included in the initial report. The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance: The intended organ to be dosed was the cervix/uterus. Dose estimates were not available at the time the report was received from KY RHB.
On 10/25/2023 the University of Kentucky (UK) reported a possible dose misadministration that occurred at the UK Chandler Medical Center on 10/23/2023. During a high dose rate (HDR) cervix/uterus treatment, the treatment was interrupted due to fluid in the transfer tubing. The authorized user directed that the transfer tubing be replaced, and treatment completed. The tubing used to complete the cycle was not cut to the correct length. This resulted in the source being 12cm out of position for the 10 seconds remaining in the planned treatment. The source was outside of the patient's body during that exposure period, causing a potential radiation exposure to the skin of the thigh in excess of reporting requirements. The worst-case assessment assumes that the patient's thigh was in direct contact with the applicator for the full 10 seconds, resulting in a localized skin dose of 300 cGy. In the judgment of treating physician, the dose is below the level likely to cause injury. However, the dose is above the reporting threshold for a Medical Event. In the most likely scenario, the patient's thigh was at least 8 mm away, resulting in a significantly lower dose of less than 50 cGy. The patient and referring physician were informed in a timely manner. Corrective Actions: 1) A leak mitigation countermeasure is being trialed in an effort to prevent fluid from leaking down the catheter and potentially causing this issue in the future. 2) Current procedures are very specific about verification of transfer catheter length before starting a treatment. However, they have not until now directly addressed a process for interruption of a procedure to make adjustments to the patient set up. These procedures have been updated and training / education is being performed on the updated processes. Based on the investigation by the [Kentucky Department for Public Health and Safety] Radiation Health Branch in collaboration with the University of Kentucky, we find the corrective actions to be sufficient and consider this incident closed. NMED Item Number: 230461 Notified R1DO (Werkheiser), NMSS Division Director (Williams), 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 | |
|---|---|
| University Of Kentucky Lexington, Kentucky (NRC Region 1) | |
| License number: | 202-049-22 |
| Organization: | Kentucky Dept Of Radiation Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+59.27 h2.47 days <br />0.353 weeks <br />0.0812 months <br />) | |
| Opened: | Angela Wilbers 16:16 Oct 25, 2023 |
| NRC Officer: | Ernest West |
| Last Updated: | Dec 6, 2023 |
| 56816 - NRC Website | |
University Of Kentucky with Agreement State | |
WEEKMONTHYEARENS 578872025-08-22T05:00:00022 August 2025 05:00:00
[Table view]Agreement State Medical Event ENS 568162023-10-23T05:00:00023 October 2023 05:00:00 Agreement State Possible Dose Misadministration ENS 567652023-09-28T14:30:00028 September 2023 14:30:00 Agreement State Possible Misadministration ENS 457162010-02-23T15:45:00023 February 2010 15:45:00 Agreement State Agreement State Report - Gamma Knife Treatment to Wrong Location ENS 450112009-04-22T14:00:00022 April 2009 14:00:00 Agreement State Agreement State - Medical Misadministration ENS 411612004-10-22T19:00:00022 October 2004 19:00:00 Agreement State Agreement State Report ENS 400562003-06-23T20:30:00023 June 2003 20:30:00 Agreement State Agreement State Report 2025-08-22T05:00:00 | |