Event Notification Report for January 10, 2025
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
01/09/2025 - 01/10/2025
Agreement State
Event Number: 57490
Rep Org: Utah Division of Radiation Control
Licensee: Utah Cancer Specialists
Region: 4
City: Salt Lake City State: UT
County:
License #: UT 1800491
Agreement: Y
Docket:
NRC Notified By: Tim Butler
HQ OPS Officer: Natalie Starfish
Licensee: Utah Cancer Specialists
Region: 4
City: Salt Lake City State: UT
County:
License #: UT 1800491
Agreement: Y
Docket:
NRC Notified By: Tim Butler
HQ OPS Officer: Natalie Starfish
Notification Date: 01/10/2025
Notification Time: 14:02 [ET]
Event Date: 01/10/2025
Event Time: 10:00 [MST]
Last Update Date: 01/10/2025
Notification Time: 14:02 [ET]
Event Date: 01/10/2025
Event Time: 10:00 [MST]
Last Update Date: 01/10/2025
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Deese, Rick (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Einberg, Chris (MSEB)
Deese, Rick (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Einberg, Chris (MSEB)
EN Revision Imported Date: 1/22/2025
EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT
The following was provided by the Utah Division of Waste Management and Radiation Control (the Department) via email:
At 1000 MST, on 01/10/25, the Utah Cancer Specialists reported a medical event to the Department.
"A patient was undergoing a Lutathera treatment (contains Lu-177). During treatment, the patient was to receive an amino acid infusion prior to the radiopharmaceutical administration, as per standard protocol. Initially, saline was started; however, the saline line remained clamped, preventing the amino acid infusion from commencing. Fifteen minutes after administering the radiopharmaceutical, it was observed that the amino acids had not been infused. Consequently, the Lutathera treatment was paused, the amino acid infusion was initiated, and subsequently, the Lutathera administration was completed."
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The prescribed activity was 200 mCi of Lu-177 to the patient. The dose estimate, which is still being evaluated, falls under 10 CFR 35.3045 Subpart M.
Utah Event Report Number: UT250001
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.
EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT
The following was provided by the Utah Division of Waste Management and Radiation Control (the Department) via email:
At 1000 MST, on 01/10/25, the Utah Cancer Specialists reported a medical event to the Department.
"A patient was undergoing a Lutathera treatment (contains Lu-177). During treatment, the patient was to receive an amino acid infusion prior to the radiopharmaceutical administration, as per standard protocol. Initially, saline was started; however, the saline line remained clamped, preventing the amino acid infusion from commencing. Fifteen minutes after administering the radiopharmaceutical, it was observed that the amino acids had not been infused. Consequently, the Lutathera treatment was paused, the amino acid infusion was initiated, and subsequently, the Lutathera administration was completed."
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The prescribed activity was 200 mCi of Lu-177 to the patient. The dose estimate, which is still being evaluated, falls under 10 CFR 35.3045 Subpart M.
Utah Event Report Number: UT250001
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.
Non-Agreement State
Event Number: 57503
Rep Org: Goshen General Hospital
Licensee: Goshen General Hospital
Region: 3
City: Goshen State: IN
County:
License #: 13-18845-01
Agreement: N
Docket:
NRC Notified By: Samantha Korda
HQ OPS Officer: Josue Ramirez
Licensee: Goshen General Hospital
Region: 3
City: Goshen State: IN
County:
License #: 13-18845-01
Agreement: N
Docket:
NRC Notified By: Samantha Korda
HQ OPS Officer: Josue Ramirez
Notification Date: 01/22/2025
Notification Time: 14:03 [ET]
Event Date: 01/10/2025
Event Time: 00:00 [EST]
Last Update Date: 01/22/2025
Notification Time: 14:03 [ET]
Event Date: 01/10/2025
Event Time: 00:00 [EST]
Last Update Date: 01/22/2025
Emergency Class: Non Emergency
10 CFR Section:
30.50(b)(2) - Safety Equipment Failure
10 CFR Section:
30.50(b)(2) - Safety Equipment Failure
Person (Organization):
Betancourt-Roldan, Diana (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Betancourt-Roldan, Diana (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
DAMAGED I-125 SEED
The following is a summary of information provided by the licensee via phone and email:
On January 10, 2025, two seeds were removed from a patient and placed in a safe in pathology. On January 14, 2025, a nuclear medicine technologist, retrieved the seeds from the safe for check-in with nuclear medicine. When checking in the used seeds the technologist noticed one of the seeds was shorter in length than the other. A seed evaluation was performed and comparisons revealed that seeds were different in size and that the shorter seed appeared to be hollow.
The pathology assistant ceased working and pulled excisions from the patient. Access to the workspace area was restricted. After surveying all tissue samples, only one tissue sample was determined to be radioactive. The radioactive tissue was then immediately placed in a locked box in pathology. The cutting workspace area was surveyed and determined not to be contaminated.
A medical health physicist consultant from Ohio Medical Physics Consulting (OMPC) was contacted for further direction.
A radiation safety officer (RSO) was called but was not in the office at the time. Therefore, a medical physicist took the call. The entire work area and the personnel in pathology were re-surveyed. After the second set of surveys was completed, all surfaces, floors, and previous instruments used in cutting the samples were all determined to be background. All trash and biohazard material in the pathology lab was surveyed. All surveyed material read background. The compactor and biohazard storage room were surveyed and resulted in background readings. Surgery and the cold room, where the samples were stored prior to coming to pathology, were also surveyed. The room and storage area measured background.
A radiologist was consulted regarding the imaging that was taken at the time of surgery. He stated specimen radiograph demonstrates the coil clip and the I-125 seed as well as the circular clip. The I-125 seed associated with the axillary clip was not imaged.
The imaging director and RSO were then notified of the events.
The RSO then requested to have the tissue and any items the tissue had come in contact within pathology surveyed. The specimen was determined to be radioactive along with blocks and slides the sample was placed on. A total of 9 blocks and 4 slides were determined to be contaminated. All items were placed in a lockbox. After which another area survey was completed including the pathologist's microscope, tissue processor, embedding center, microtome, and stainer. All equipment measured background. Wipe tests were also completed and measured background.
The seed and the contaminated blocks and slides will be stored in the nuclear medicine hot lab until it is deemed safe to dispose of properly.
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The I-125 seed contained an estimated activity of 269 microcuries.
The following is a summary of information provided by the licensee via phone and email:
On January 10, 2025, two seeds were removed from a patient and placed in a safe in pathology. On January 14, 2025, a nuclear medicine technologist, retrieved the seeds from the safe for check-in with nuclear medicine. When checking in the used seeds the technologist noticed one of the seeds was shorter in length than the other. A seed evaluation was performed and comparisons revealed that seeds were different in size and that the shorter seed appeared to be hollow.
The pathology assistant ceased working and pulled excisions from the patient. Access to the workspace area was restricted. After surveying all tissue samples, only one tissue sample was determined to be radioactive. The radioactive tissue was then immediately placed in a locked box in pathology. The cutting workspace area was surveyed and determined not to be contaminated.
A medical health physicist consultant from Ohio Medical Physics Consulting (OMPC) was contacted for further direction.
A radiation safety officer (RSO) was called but was not in the office at the time. Therefore, a medical physicist took the call. The entire work area and the personnel in pathology were re-surveyed. After the second set of surveys was completed, all surfaces, floors, and previous instruments used in cutting the samples were all determined to be background. All trash and biohazard material in the pathology lab was surveyed. All surveyed material read background. The compactor and biohazard storage room were surveyed and resulted in background readings. Surgery and the cold room, where the samples were stored prior to coming to pathology, were also surveyed. The room and storage area measured background.
A radiologist was consulted regarding the imaging that was taken at the time of surgery. He stated specimen radiograph demonstrates the coil clip and the I-125 seed as well as the circular clip. The I-125 seed associated with the axillary clip was not imaged.
The imaging director and RSO were then notified of the events.
The RSO then requested to have the tissue and any items the tissue had come in contact within pathology surveyed. The specimen was determined to be radioactive along with blocks and slides the sample was placed on. A total of 9 blocks and 4 slides were determined to be contaminated. All items were placed in a lockbox. After which another area survey was completed including the pathologist's microscope, tissue processor, embedding center, microtome, and stainer. All equipment measured background. Wipe tests were also completed and measured background.
The seed and the contaminated blocks and slides will be stored in the nuclear medicine hot lab until it is deemed safe to dispose of properly.
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The I-125 seed contained an estimated activity of 269 microcuries.