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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56854 | 8 November 2023 06:00:00 | Agreement State | Agreement State - Door Interlock Failure | The following information was provided by the Wisconsin Department of Health Services (the Department) email: On Wednesday, November 8, 2023, the licensee was treating an individual in their high dose rate (HDR) suite. During the treatment, while the Ir-192 source was exposed, it was noticed that the door to the suite was ajar. The treatment was immediately paused, and the physicist confirmed that the door was open and that the door interlock was not functioning as required. The staff closed the door, put up caution tape, and maintained constant visual surveillance to ensure no one entered. Treatment was reinitiated and completed according to the written directive. On Friday, November 10, 2023, the interlock had not yet been repaired, and the licensee performed another HDR treatment utilizing caution tape and constant surveillance. The licensee reported the event to the Department by phone on November 14, 2023. The licensee performed an event reconstruction and surveyed at the open door with the Ir-192 source exposed. The highest dose rate of 0.3 mR/hr indicates that no member of the public would have received a dose exceeding public dose limits from this event. The patients were unaffected. The Department will be performing a reactive inspection on November 20, 2023. WI Event Report ID Number: WI230022 | ||
| ENS 53168 | 5 January 2018 06:00:00 | Agreement State | Agreement State Report - Delivered Dosage Different from Prescribed | The following was received from the State of Wisconsin via email: An email the department received on January 5, 2018 was believed to be an update to the previous notification (EN #53148). Upon further review by the department, it was discovered that the email pertained to a second medical event identified by the licensee on January 5, 2018. This was a medical event as described in DHS 157.72(1)(a)1.a. The prescribed dose was 145 Gy; the dose delivered was 70 Gy. The licensee uses D90 (dose delivered to 90% of the clinical target volume) < 80% for determining medical events. Using the licensee's dose based criteria; the dose received by the prostate was 48% of the intended dose. The licensee has an additional criterion that the volume of the CTV to which 100% of the prescription dose delivered must be above 80%. The licensee determined only 62% of the volume received the required dose. The implant was initially performed on November 10, 2017. A post implant CT scan was performed on December 14, 2017. The physician completed the contour for the dosimetrist to run a Post Seed Plan on January 3, 2018. The dosimetrist notified the physicist of a possible medical event on January 5, 2018. DHS is investigating and will be performing a site visit in regards to this event. Wisconsin Event Report ID: WI180002 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 53148 | 4 January 2018 06:00:00 | Agreement State | Agreement State Report - Delivered Dosage Different from Prescribed | The following was received from the State of Wisconsin: On January 4, 2018, the Department (Wisconsin Radiation Protection Section) received a telephone call and email from the licensee's medical physicist that a medical event of a prostate brachytherapy procedure was identified on January 4, 2018. The total dose delivered differs from the prescribed dose by 20% or more. This is a medical event as described in DHS (Department of Health Services) 157.72(1)(a)1.a. The prescribed dose was 145 Gy; the dose delivered was 105 Gy. The licensee uses D90 (dose delivered to 90% of the clinical target volume) < 80% for determining medical events. Using the licensee's dose based criteria; the dose received by the prostate was 75% of the intended dose. The post-implant computed tomography scan occurred on December 6, 2017. The subsequent dosimetric analysis was on January 3, 2018. The department will perform a site investigation to determine the root cause of this medical event. DHS inspectors will investigate this medical event. Wisconsin Event: WI180001 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 53009 | 11 August 2017 05:00:00 | Agreement State | Agreement State Report - Medical Underdose | The following report was received via e-mail: On October 10, 2017, the Department (Wisconsin Department of Health Services) received a telephone call and email from the licensee's medical physicist that a medical event occurred on August 11, 2017, involving a permanent implant of I-125 seeds for a prostate manual brachytherapy procedure where the total dose delivered differs from the prescribed dose by 20 percent or more. This is a medical event as described in DHS 157.72(1)(a)1.a. The prescribed dose was 145 Gy; the dose delivered was 90 Gy. The licensee uses D90 (dose delivered to 90 percent of the clinical target volume) < 80 percent of prescribed, for determining medical events. Using the licensee's dose based criteria; the dose received by the prostate was 62 percent of the intended dose. The underdose was identified during the post-implant computerized tomography scan on September 11, 2017 and subsequent dosimetric analysis on October 10, 2017. DHS (Wisconsin Department of Health Services) inspectors will investigate this medical event. Wisconsin Event Report: WI170016
The following update was received from the Wisconsin Department of Health Services (DHS) by email: During the ongoing investigations of other medical events reported to the Wisconsin Department of Health Services in 2017, licensee reviewed historic permanent implants of I-125 seeds for prostate manual brachytherapy. The licensee recently identified two additional implants that resulted in a D90 dose to the prostate that was greater than 130 percent of the prescribed dose. The licensee noted that there were no adverse outcomes to the patients. The first implant occurred on August 28, 2015. The prescribed dose to 90 percent of the prostate (D90) was 145 Gy and the D90 delivered was 192 Gy. The second implant occurred on June 17, 2016. The prescribed dose to 90 percent of the prostate (D90) was 145 Gy and the D90 delivered was 189 Gy. DHS is reviewing the circumstances surrounding these two implants as part of the investigation into the previously reported medical events. Notified R3DO (Stone) and NMSS Events. 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 52629 | 9 December 2016 05:00:00 | Agreement State | Agreement State Report - Total Dose Less than 80 Percent of Prescribed Dose | The following report was received from the Wisconsin Department of Health Services via email: On March 22, 2017, the (Wisconsin Department of Health Services) received a telephone call and email from the licensee's medical physicist that a medical event occurred on December 9, 2016, involving a permanent implant of I-125 seeds for a prostate manual brachytherapy procedure where the total dose delivered differs from the prescribed dose by 20% or more. This is a medical event as described in DHS 157.72(1)(a)1.a. The prescribed dose was 145 Gy; the dose delivered was 114 Gy. The licensee uses D90 (dose delivered to 90% of the clinical target volume) less than 80% for determining medical events. Using the licensee's dose based criteria; the dose received by the prostate was 78% of the intended dose. The underdose was identified during the post-implant computed tomography scan on January 9, 2017 and subsequent dosimetric analysis on January 27, 2017. The licensee's radiation oncologist informed the physicist that supplemental radiation will not be administered and that it is a reportable event on March 22, 2017. Corrective actions are being reviewed by the licensee's staff. DHS (Department of Health Services) inspectors will investigate this medical event. Wisconsin Event ID No.: WI-170005 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 52035 | 17 June 2016 05:00:00 | Agreement State | Agreement State Report - Contamination of Brachytherapy Patient | The following was received from Wisconsin via email: On Friday, June 17, 2016, a licensee discovered contamination on a package that was used to ship I-125 prostate brachytherapy seeds. The post procedure survey of the packaging revealed elevated levels of radiation. After wipes were taken, the licensee determined that there was I-125 contamination on the inside of the packaging. There was no other contamination in the operating room. The licensee had the patient return to the facility to perform a urine bioassay. The bioassay revealed elevated levels of I-125 in the patient's urine. However further analysis will be required to determine activity concentrations. The licensee has also administered Lugols solution to the patient to block the thyroid. The department and the licensee are still collecting data to determine if this is a medical event. Site visits and updates will be performed as needed. Wisconsin Report ID # WI160004 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. |