Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56816 | 23 October 2023 05:00:00 | Agreement State | 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.
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. | ||
| ENS 56765 | 28 September 2023 14:30:00 | Agreement State | Possible 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 9/29/2023, by a representative from the University of Kentucky that two patients were scheduled for treatment with Lu-177, one with commercially available Lu-177 dotatate (Lutathera) and one under a research protocol also using Lu-177 dotatate but distributed under an investigational new drug label. Both vials contained the same drug and differed only in their label for distribution / intended use. The nuclear medicine technologist prepared and administered Lu-177 dotatate from the vial labeled for research to the standard of care patient instead of the correct (commercial) vial. The patient received the correct amount of drug (prescribed activity), the correct chemical form (identical Lu-177 dotatate) by the correct route of administration as intended for their treatment. However, since the drug was dispensed from the vial distributed under the investigational new drug application intended for the research study patient, KY RHB considers this to meet the reporting requirements in Part 35 for a medical event. The physician was informed, the patient was informed, and no harm is anticipated as a result of this incident. Additional notifications have also been made as required considering the involvement of investigational drug product and the Institutional Review Board. The incident remains under evaluation and investigation for corrective actions. 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. | ||
| ENS 45716 | 23 February 2010 15:45:00 | Agreement State | Agreement State Report - Gamma Knife Treatment to Wrong Location | A gamma knife treatment prescribed to be administered to the left side of a patient was instead administered to the patient's right side. The scheduled 30 minute, 90 Gray procedure was terminated after 1.4 minutes when the administering physician detected the error. It is estimated that 4% of the prescribed dose was administered to the wrong area. 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. | ||
| ENS 45011 | 22 April 2009 14:00:00 | Agreement State | Agreement State - Medical Misadministration | The following was received from the agreement state with a state control number of KY0901: At 1400 on 4/22/2009, the RSO of a medical licensee reported the misadministration of a radiopharmaceutical to a seven-month-old infant. The infant was scheduled for a renal scan and was ordered to receive a 2 mCi dose tagged with Tc-99m. The patient was inadvertently administered a 35 mCi dose of Sestamibi/Tc-99M. Event date: 4/22/2009. Discovery date: 4/22/2009. Report date: 4/22/2009. Licensee Reporting Party Information: University of Kentucky, Lexington KY 40506, License number: 202-049-22. Site of event: Lexington, KY. Event type: MD2 - Medical event. Event cause: Human error. The patient was informed on 4/22/2009. The intended diagnostic study was renal-glomerular filtration with dimercaptosuccinic acid (DMSA) radiopharmaceutical, with a 2 mCi (74 MBq) Tc-99m radionuclide. The given diagnostic study was cardiac perfusion with sestamibi/cardiolite radiopharmaceutical, with a 34.9 mCi (1291.3 MBq) Tc-99m radionuclide. The dose exceeded the prescribed dose by 1650%. It is estimated that the heart received a dose of 2.84 rem, and the whole body does was 6.84 rem. The effect on the patient is unknown at this time. 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. | ||
| ENS 41161 | 22 October 2004 19:00:00 | Agreement State | Agreement State Report | During the interlock check of a JL Shephard Model 1 Number 68-10 Irradiator, the source rod was lifted with the machine in the off position, indicating a failure of the interlock. Exposure determinations of the technicians present indicated an exposure less than reportable limits. An investigation is in progress. | ||
| ENS 40056 | 23 June 2003 20:30:00 | Agreement State | Agreement State Report | On June 23, 2003 at 3:30 PM the (University of Kentucky) radiation safety office received a call from an AU (Authorized User) in the Dept. of Biology, because a shipment of I-125, triiodothyronine, 100 microcuries, had not been received. Upon review of the records it was found that the package had arrived on June 18, 2003, and had measured 10 (millirem)/hr at the surface, 0.1 (millirem)/hr @ 1meter, and no external contamination. The Radiation Safety Office shipping paper record shows the I-125 package was included for delivery to room 109, Research Building 3, on June 19. The required signature of receipt for the package was not obtained. With the DOT shipping labels removed, the greatest likelihood is that the package was put into the ordinary trash. A thorough search of the Radiation Safety Office facilities and vehicles was conducted on June 23. On June 24, the authorized user's lab was searched, including use of a low energy NAI (Tl) detector, as well as all labs where deliveries were made on June 19. No trace of the package or contents has been found. It was concluded that the highest probability was that the package entered the normal waste stream and went to a landfill. Once in a landfill, the I-125 will be sequestered from any contact, and will be essentially non-radioactive in 1.65 years. Assuming worst case scenarios, the dose rate to the torso would be about 10 (millirem)/hr or less, and would have to be held against the body continuously by a single individual for 10 hours to produce a dose in excess of 100 (millirem). Additionally there is no indication or likelihood of intentional or accidental ingestion of the contents since this is not intended for human use. However, if the entire 100 microcuries were ingested by a single individual, as sodium iodide, the thyroid dose would be 78 rem, and the effective dose would be 2.4 rem. While no thyroid dose information has been found for the triiodothyronine form, the effective dose from ingestion of 100 microcuries would be 17 (millirem). Surveys are conducted on a continual basis, if the package did not go to a landfill it would likely be found during monthly use area surveys or quarterly supervisory surveys. No NOV was issued based on the corrective actions taken by licensee to correct deficiencies prior to report completion. |