Event Notification Report for December 07, 2023

EN Revision Imported Date: 12/7/2023

EN Revision Text: AGREEMENT STATE REPORT - POSSIBLE DOSE MISADMINISTRATION

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.

* * * UPDATE ON 12/6/2023 AT 1904 EST FROM RUSSELL HESTAND TO ERNEST WEST * * *

"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.

AGREEMENT STATE REPORT - PARTIALLY STUCK OPEN SHUTTER

The following information was provided by the Iowa Department of Health and Human Services (HHS) via email:

"Arconic Davenport possesses an [Isotope Measuring Systems] IMS model 5221-02, profile thickness gauge for measuring thickness of aluminum on the production line. The C-frame gauge contains 5 independent source housings, with each housing containing a 5 curie, Americium-241 sealed source. The C-frame gauge is constructed from steel and is suspended from a monorail which allows the device to be moved off-line to a restricted access calibration area. The shutter is opened and closed by a pneumatic cylinder that is controlled from a remote location. In the afternoon of November 28, 2023, it was determined that shutter number 1 of the C-frame gauge had failed to fully close. This was determined when an automated attempt to close all 5 shutters on the gauge [failed], and the computer indicated that shutter number 1 was not fully closed. Per the licensee's procedures, the C-frame gauge was removed from the line using the monorail to the secured calibration house.

"Radiation surveys of the outside wall adjacent to the shutter 1 position were above background with a maximum dose rate of approximately 0.1 mR/hr. The licensee has contacted their service provider to perform repair work (identify and fix the equipment problem) which is tentatively scheduled for November 29, 2023. No reported overexposures and no release or contamination of radioactive material occurred because of this incident (most recent negative leak test was November 2, 2023). Iowa HHS will update this report once additional information is provided (cause, corrective actions, etc.)."

Iowa Item Number: IA230004

AGREEMENT STATE REPORT - Y-90 UNDERDOSE

The following information was received from the Arizona Department of Health Services (the Department) via email:

"On November 29, 2023, the Department received notification from the licensee about a medical event involving Y-90 TheraSpheres that occurred on 11/28/2023. A patient was prescribed a dose of 1.766 GBq, but was delivered 1.019 GBq. The dose delivered was 57.7 percent of the prescribed dose. The Department has requested additional information and continues to investigate the event."


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.