Event Notification Report for September 28, 2023
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
09/27/2023 - 09/28/2023
Agreement State
Event Number: 56770
Rep Org: PA Bureau of Radiation Protection
Licensee: University of Pittsburgh
Region: 1
City: Pittsburgh State: PA
County:
License #: PA-0190
Agreement: Y
Docket:
NRC Notified By: John Chippo
HQ OPS Officer: Ernest West
Licensee: University of Pittsburgh
Region: 1
City: Pittsburgh State: PA
County:
License #: PA-0190
Agreement: Y
Docket:
NRC Notified By: John Chippo
HQ OPS Officer: Ernest West
Notification Date: 10/02/2023
Notification Time: 10:19 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [EDT]
Last Update Date: 10/02/2023
Notification Time: 10:19 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [EDT]
Last Update Date: 10/02/2023
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Young, Matt (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Young, Matt (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE - I-125 SEED INADVERTENTLY TRANSECTED
The following information was provided by the Pennsylvania Bureau of Radiation Protection via email:
"On September 28, 2023, staff from Magee Pathology department called the [University of Pittsburgh] radiation safety office to report that they had accidentally transected an I-125 seed used for radioactive seed localization (RSL) in breast tissue during the pathology processing in the laboratory. The seed was a Best Medical International Model 2301 containing 169 microcuries of I-125. Two staff members were involved, and they were told to sequester in the room until personnel from radiation safety could respond. Shortly after, radiation safety personnel performed surveys to determine the extent of the contamination. No personnel contamination was observed. All contamination was discovered in waste material and on the tissue samples. The transected seed was contained. The radiation safety office took possession of the damaged seed and all radioactive waste. At the time of reporting, it is estimated that approximately 50 percent of the activity was lost to open contamination, which is greater than 1 annual limit on intake (ALI) of I-125, and therefore reached the criteria for [10 CFR] 22.2202 reportability. Workers had bioassays performed for thyroid exposure and all returned negative."
PA event report ID: PA230028
The following information was provided by the Pennsylvania Bureau of Radiation Protection via email:
"On September 28, 2023, staff from Magee Pathology department called the [University of Pittsburgh] radiation safety office to report that they had accidentally transected an I-125 seed used for radioactive seed localization (RSL) in breast tissue during the pathology processing in the laboratory. The seed was a Best Medical International Model 2301 containing 169 microcuries of I-125. Two staff members were involved, and they were told to sequester in the room until personnel from radiation safety could respond. Shortly after, radiation safety personnel performed surveys to determine the extent of the contamination. No personnel contamination was observed. All contamination was discovered in waste material and on the tissue samples. The transected seed was contained. The radiation safety office took possession of the damaged seed and all radioactive waste. At the time of reporting, it is estimated that approximately 50 percent of the activity was lost to open contamination, which is greater than 1 annual limit on intake (ALI) of I-125, and therefore reached the criteria for [10 CFR] 22.2202 reportability. Workers had bioassays performed for thyroid exposure and all returned negative."
PA event report ID: PA230028
Non-Agreement State
Event Number: 56763
Rep Org: Marathon Pipe Line LLC
Licensee: Marathon Pipe Line LLC
Region: 3
City: Indianapolis State: IN
County:
License #: GL-714799-28
Agreement: N
Docket:
NRC Notified By: Matthew Grimes
HQ OPS Officer: Sam Colvard
Licensee: Marathon Pipe Line LLC
Region: 3
City: Indianapolis State: IN
County:
License #: GL-714799-28
Agreement: N
Docket:
NRC Notified By: Matthew Grimes
HQ OPS Officer: Sam Colvard
Notification Date: 09/28/2023
Notification Time: 13:35 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [EDT]
Last Update Date: 09/28/2023
Notification Time: 13:35 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [EDT]
Last Update Date: 09/28/2023
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):
Orlikowski, Robert (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Orlikowski, Robert (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
NON-AGREEMENT STATE REPORT - STUCK OPEN SHUTTER
The following information was provided by the licensee via phone:
On September 27, 2023, at 1500 EDT, Marathon Pipe Line, LLC evaluated that a fixed density gauge device shutter (Ohmart/VEGA, SR-2, SN 3767GG, Cs-137 250 mCi) was stuck in the open position. The device is located in a locked location with controlled access. There was no personnel exposure. The vendor has been contacted for repairs.
The following information was provided by the licensee via phone:
On September 27, 2023, at 1500 EDT, Marathon Pipe Line, LLC evaluated that a fixed density gauge device shutter (Ohmart/VEGA, SR-2, SN 3767GG, Cs-137 250 mCi) was stuck in the open position. The device is located in a locked location with controlled access. There was no personnel exposure. The vendor has been contacted for repairs.
Agreement State
Event Number: 56765
Rep Org: Kentucky Dept of Radiation Control
Licensee: University of Kentucky
Region: 1
City: Lexington State: KY
County:
License #: 202-049-22
Agreement: Y
Docket:
NRC Notified By: Russell Hestand
HQ OPS Officer: Lawrence Criscione
Licensee: University of Kentucky
Region: 1
City: Lexington State: KY
County:
License #: 202-049-22
Agreement: Y
Docket:
NRC Notified By: Russell Hestand
HQ OPS Officer: Lawrence Criscione
Notification Date: 09/29/2023
Notification Time: 10:55 [ET]
Event Date: 09/28/2023
Event Time: 09:30 [CDT]
Last Update Date: 10/02/2023
Notification Time: 10:55 [ET]
Event Date: 09/28/2023
Event Time: 09:30 [CDT]
Last Update Date: 10/02/2023
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Lally, Christopher (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Lally, Christopher (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - 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.
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.
Agreement State
Event Number: 56766
Rep Org: Illinois Emergency Mgmt. Agency
Licensee: Rush University Medical Center
Region: 3
City: Chicago State: IL
County:
License #: IL-01766-01
Agreement: Y
Docket:
NRC Notified By: Whitney Cox
HQ OPS Officer: Thomas Herrity
Licensee: Rush University Medical Center
Region: 3
City: Chicago State: IL
County:
License #: IL-01766-01
Agreement: Y
Docket:
NRC Notified By: Whitney Cox
HQ OPS Officer: Thomas Herrity
Notification Date: 09/29/2023
Notification Time: 14:55 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [CDT]
Last Update Date: 10/13/2023
Notification Time: 14:55 [ET]
Event Date: 09/28/2023
Event Time: 00:00 [CDT]
Last Update Date: 10/13/2023
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Orlikowski, Robert (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Orlikowski, Robert (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 10/16/2023
EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT
The following was received from the Illinois Emergency Management Agency (the Agency) via email:
"On September 29, 2023, the Agency was contacted by Rush University Medical Center of a potential medical event. The administration was determined to be clinically effective with no adverse patient impact reported.
"The medical event took place on September 28, 2023. The patient and the referring physician were notified within 24 hours. The Y-90 Therasphere dose was 23.5 percent less than the prescribed dose. Agency inspectors are scheduled to perform a reactionary inspection on October 3, 2023. Additional information is forthcoming from the licensee and updates will be sent as they are available."
Illinois Item Number: IL230027
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.
* * * UPDATE ON 10/13/23 AT 1638 EDT FROM GARY FORSEE TO KAREN COTTON * * *
The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
"On September 29, 2023, the Agency was contacted by Rush University Medical Center (IL-01766-01) to advise of a Y-90 Therasphere under dose that occurred the day before. The prescribed dose was 200 Gy and the prescribed activity was 45.92 mCi. The administered dose was 153.1 Gy with an administered activity of 35.15 mCi. This is a 23.5 percent deviation (under dose). The administration was determined to be clinically effective with no adverse patient impact reported. The patient and the referring physician were notified within 24 hours.
"Agency inspectors performed a reactionary inspection on October 3, 2023. The infusion of the Y-90 TheraSpheres went as intended with no identifiable irregularities. Post-admin calculations were performed which calculated that the dose delivered was 35.15 mCi. At this time the [accredited medical practitioner] (AMP) determined the dose delivered was 23.5 percent less than the written directive resulting in a potential medical event. The RSO interviewed all staff involved in the procedure and performed PET/CT imaging of the waste container (with dose vial, administration tubing kit, connector, extension tubing, microcatheter, forceps, etc.). This image was processed, and 3D volume renderings were utilized to identify where hot spots were located within the waste materials. Images of the waste container showed the highest activity was located in the dose vial. No additional apparent issues were discovered by the RSO. During an interview with the AMP, they stated that they tilted the dose vial back and forth to 90 degrees and tapped the vial on a hard surface. After the inspectors reviewed the procedures and through further questioning, they realized that the AMP was not tapping the vial sharply enough against a hard surface.
"Agency investigation findings identified the root cause of this event as inadequate agitation of the dose vial. Inspectors determined that the tapping process was not performed firmly enough against a hard surface to release the microspheres from the septum of the dose vial. This likely resulted in an increased number of microspheres remaining on the septum of the dose vial, and not released into the solution for administration to the patient. The RSO stated that they had begun the process of revising the checklist utilized during Y-90 TheraSphere procedures to better describe the dose vial preparation which includes the agitation process.
"Pending no further developments, this matter is considered closed."
Notified R3DO (Orth) and NMSS Events Notification (email).
EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT
The following was received from the Illinois Emergency Management Agency (the Agency) via email:
"On September 29, 2023, the Agency was contacted by Rush University Medical Center of a potential medical event. The administration was determined to be clinically effective with no adverse patient impact reported.
"The medical event took place on September 28, 2023. The patient and the referring physician were notified within 24 hours. The Y-90 Therasphere dose was 23.5 percent less than the prescribed dose. Agency inspectors are scheduled to perform a reactionary inspection on October 3, 2023. Additional information is forthcoming from the licensee and updates will be sent as they are available."
Illinois Item Number: IL230027
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.
* * * UPDATE ON 10/13/23 AT 1638 EDT FROM GARY FORSEE TO KAREN COTTON * * *
The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
"On September 29, 2023, the Agency was contacted by Rush University Medical Center (IL-01766-01) to advise of a Y-90 Therasphere under dose that occurred the day before. The prescribed dose was 200 Gy and the prescribed activity was 45.92 mCi. The administered dose was 153.1 Gy with an administered activity of 35.15 mCi. This is a 23.5 percent deviation (under dose). The administration was determined to be clinically effective with no adverse patient impact reported. The patient and the referring physician were notified within 24 hours.
"Agency inspectors performed a reactionary inspection on October 3, 2023. The infusion of the Y-90 TheraSpheres went as intended with no identifiable irregularities. Post-admin calculations were performed which calculated that the dose delivered was 35.15 mCi. At this time the [accredited medical practitioner] (AMP) determined the dose delivered was 23.5 percent less than the written directive resulting in a potential medical event. The RSO interviewed all staff involved in the procedure and performed PET/CT imaging of the waste container (with dose vial, administration tubing kit, connector, extension tubing, microcatheter, forceps, etc.). This image was processed, and 3D volume renderings were utilized to identify where hot spots were located within the waste materials. Images of the waste container showed the highest activity was located in the dose vial. No additional apparent issues were discovered by the RSO. During an interview with the AMP, they stated that they tilted the dose vial back and forth to 90 degrees and tapped the vial on a hard surface. After the inspectors reviewed the procedures and through further questioning, they realized that the AMP was not tapping the vial sharply enough against a hard surface.
"Agency investigation findings identified the root cause of this event as inadequate agitation of the dose vial. Inspectors determined that the tapping process was not performed firmly enough against a hard surface to release the microspheres from the septum of the dose vial. This likely resulted in an increased number of microspheres remaining on the septum of the dose vial, and not released into the solution for administration to the patient. The RSO stated that they had begun the process of revising the checklist utilized during Y-90 TheraSphere procedures to better describe the dose vial preparation which includes the agitation process.
"Pending no further developments, this matter is considered closed."
Notified R3DO (Orth) and NMSS Events Notification (email).