Event Notification Report for April 19, 2023
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
04/18/2023 - 04/19/2023
Hospital
Event Number: 56477
Rep Org: United Hospital Center
Licensee: United Hospital Center
Region: 1
City: Bridgeport State: WV
County:
License #: 4701458-01
Agreement: N
Docket:
NRC Notified By: Kelly Stoneberg
HQ OPS Officer: Sam Colvard
Licensee: United Hospital Center
Region: 1
City: Bridgeport State: WV
County:
License #: 4701458-01
Agreement: N
Docket:
NRC Notified By: Kelly Stoneberg
HQ OPS Officer: Sam Colvard
Notification Date: 04/19/2023
Notification Time: 17:28 [ET]
Event Date: 04/19/2023
Event Time: 10:00 [EDT]
Last Update Date: 04/25/2023
Notification Time: 17:28 [ET]
Event Date: 04/19/2023
Event Time: 10:00 [EDT]
Last Update Date: 04/25/2023
Emergency Class: Non Emergency
10 CFR Section:
30.50(b)(2) - Safety Equipment Failure 35.3045(a)(1) - Dose <> Prescribed Dosage 20.2202(b)(1) - Pers Overexposure/Tede >= 5 Rem
10 CFR Section:
30.50(b)(2) - Safety Equipment Failure 35.3045(a)(1) - Dose <> Prescribed Dosage 20.2202(b)(1) - Pers Overexposure/Tede >= 5 Rem
Person (Organization):
Arner, Frank (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Rivera-Capella, Gretchen (NMSS DAY)
Arner, Frank (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Rivera-Capella, Gretchen (NMSS DAY)
STUCK SOURCE WITH POTENTIAL OVEREXPOSURE AND MEDICAL UNDERDOSE
The following information was provided by the licensee via email:
"At about 1000 EDT on 4/19/23 the licensee was performing an HDR treatment on a patient's cervix using a Nucletron B.V 136149A02 model Flexitron HDR remote after loader containing a 12 Ci Ir-192 source. The applicator has three sections: right and left partial rings on either side of the cervical os, and a tandem inserted into the cervix. The intended dose was 500 centi-Gray (cGy) to points called Right A and Left A, 2 cm up and 2 cm out from the cervical os.
"Computed clinical dose to the patient was 156 cGy to the A points which is 31 percent of what was prescribed. The total dose for the four treatments is 1,656 cGy which is 83 percent of prescribed.
"The HDR unit functioned properly in treating the first section, the right ring. It then treated the left ring properly, but at the end of treatment it gave an error message, and the radiation monitors in the room and above the door indicated that the source did not return to the safe position. As a result, the treatment was shutdown, and emergency procedures instituted. The tandem was not treated.
"After several unsuccessful attempts to bring the source to the safe position, the applicator was removed from the patient, the patient was removed from the room, and the room was closed and sealed.
"Preliminary dose estimates received by personnel are as follows:
"Authorized User - 10,000 mrem
Medical Physicist - 10,000 mrem
Nurse Anesthetist - 700 mrem
Radiation Technician - 4,000 mrem
Radiation Technician - 700 mrem
"Badge dosimetry was collected and sent for processing to confirm actual doses received.
"Staff were successful in returning source to a safe condition, and a manufacturer representative will be conducting an inspection of the device before further use.
"No adverse effects anticipated to the patient from this event, and the shortfall in dose will be made up at a future date."
* * * UPDATE ON 04/21/23 AT 0930 EDT FROM KELLY STONEBERG TO KERBY SCALES * * *
The following update is a summary of information received from the licensee via email:
Initial dose estimates for the individuals who were present in the room while the HDR source was outside the HDR unit due to malfunction of the unit were conservatively estimated to be greater than the 5 rem reportable limit. The dosimeters were immediately sent out for processing after the event and the actual readings were below the reportable limit. The individual's readings were as follows:
Radiation Technician 1 - 87 mrem
Radiation Technician 2 - 2 mrem
AMP - 47 mrem
Notified R1DO (Arner), NMSS (Rivera-Capella) and NMSS Events Notification via 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.
The following information was provided by the licensee via email:
"At about 1000 EDT on 4/19/23 the licensee was performing an HDR treatment on a patient's cervix using a Nucletron B.V 136149A02 model Flexitron HDR remote after loader containing a 12 Ci Ir-192 source. The applicator has three sections: right and left partial rings on either side of the cervical os, and a tandem inserted into the cervix. The intended dose was 500 centi-Gray (cGy) to points called Right A and Left A, 2 cm up and 2 cm out from the cervical os.
"Computed clinical dose to the patient was 156 cGy to the A points which is 31 percent of what was prescribed. The total dose for the four treatments is 1,656 cGy which is 83 percent of prescribed.
"The HDR unit functioned properly in treating the first section, the right ring. It then treated the left ring properly, but at the end of treatment it gave an error message, and the radiation monitors in the room and above the door indicated that the source did not return to the safe position. As a result, the treatment was shutdown, and emergency procedures instituted. The tandem was not treated.
"After several unsuccessful attempts to bring the source to the safe position, the applicator was removed from the patient, the patient was removed from the room, and the room was closed and sealed.
"Preliminary dose estimates received by personnel are as follows:
"Authorized User - 10,000 mrem
Medical Physicist - 10,000 mrem
Nurse Anesthetist - 700 mrem
Radiation Technician - 4,000 mrem
Radiation Technician - 700 mrem
"Badge dosimetry was collected and sent for processing to confirm actual doses received.
"Staff were successful in returning source to a safe condition, and a manufacturer representative will be conducting an inspection of the device before further use.
"No adverse effects anticipated to the patient from this event, and the shortfall in dose will be made up at a future date."
* * * UPDATE ON 04/21/23 AT 0930 EDT FROM KELLY STONEBERG TO KERBY SCALES * * *
The following update is a summary of information received from the licensee via email:
Initial dose estimates for the individuals who were present in the room while the HDR source was outside the HDR unit due to malfunction of the unit were conservatively estimated to be greater than the 5 rem reportable limit. The dosimeters were immediately sent out for processing after the event and the actual readings were below the reportable limit. The individual's readings were as follows:
Radiation Technician 1 - 87 mrem
Radiation Technician 2 - 2 mrem
AMP - 47 mrem
Notified R1DO (Arner), NMSS (Rivera-Capella) and NMSS Events Notification via 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
Event Number: 56479
Rep Org: SC Dept of Health & Env Control
Licensee: Mitsubishi Chemical America, Inc.
Region: 1
City: Greer State: SC
County:
License #: 036
Agreement: Y
Docket:
NRC Notified By: Korina Koci
HQ OPS Officer: Thomas Herrity
Licensee: Mitsubishi Chemical America, Inc.
Region: 1
City: Greer State: SC
County:
License #: 036
Agreement: Y
Docket:
NRC Notified By: Korina Koci
HQ OPS Officer: Thomas Herrity
Notification Date: 04/20/2023
Notification Time: 09:51 [ET]
Event Date: 04/19/2023
Event Time: 00:00 [EDT]
Last Update Date: 04/20/2023
Notification Time: 09:51 [ET]
Event Date: 04/19/2023
Event Time: 00:00 [EDT]
Last Update Date: 04/20/2023
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Arner, Frank (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Arner, Frank (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - DAMAGED GAUGE
The following information was received from the South Carolina Department of Health and Environmental Control (the Department) via email:
"The Department was notified via telephone at 1511 EDT on 04/19/23, that during a routine inspection of the licensee's fixed gauging devices, the source window of one device was discovered to have been damaged. The licensee is reporting that the fixed gauge is a Thermo Fisher Model ASC-185 gauging device, housing a Kr-85 Isotope Products Laboratories Inc. sealed source Model NER-588 with an activity of 46.25 giga-becquerel (1250 millicuries). The licensee is reporting that no immediate health and safety concerns have been identified. The licensee is reporting that the manufacturer of the gauging device has been contacted for repair, and this repair was initiated upon discovery on 04/19/23. A Department inspector will be dispatched to the facility. This event is still under investigation by the Department."
SC Event Report ID No.: EN 56479
The following information was received from the South Carolina Department of Health and Environmental Control (the Department) via email:
"The Department was notified via telephone at 1511 EDT on 04/19/23, that during a routine inspection of the licensee's fixed gauging devices, the source window of one device was discovered to have been damaged. The licensee is reporting that the fixed gauge is a Thermo Fisher Model ASC-185 gauging device, housing a Kr-85 Isotope Products Laboratories Inc. sealed source Model NER-588 with an activity of 46.25 giga-becquerel (1250 millicuries). The licensee is reporting that no immediate health and safety concerns have been identified. The licensee is reporting that the manufacturer of the gauging device has been contacted for repair, and this repair was initiated upon discovery on 04/19/23. A Department inspector will be dispatched to the facility. This event is still under investigation by the Department."
SC Event Report ID No.: EN 56479
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Hospital
Event Number: 56481
Rep Org: Southern Arizona VA Health Care
Licensee: Southern Arizona VA Health Care
Region: 3
City: Little Rock State: AR
County:
License #: 03-23853-01VA
Agreement: N
Docket:
NRC Notified By: Kim Wiebeck
HQ OPS Officer: Sam Colvard
Licensee: Southern Arizona VA Health Care
Region: 3
City: Little Rock State: AR
County:
License #: 03-23853-01VA
Agreement: N
Docket:
NRC Notified By: Kim Wiebeck
HQ OPS Officer: Sam Colvard
Notification Date: 04/20/2023
Notification Time: 17:20 [ET]
Event Date: 04/19/2023
Event Time: 12:30 [CDT]
Last Update Date: 05/02/2023
Notification Time: 17:20 [ET]
Event Date: 04/19/2023
Event Time: 12:30 [CDT]
Last Update Date: 05/02/2023
Emergency Class: Non Emergency
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
Person (Organization):
NMSS_EVENTS_NOTIFICATION (EMAIL)
Orth, Steve (R3DO)
Werner, Greg (EMAIL)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Orth, Steve (R3DO)
Werner, Greg (EMAIL)
EN Revision Imported Date: 5/3/2023
EN Revision Text: MEDICAL EVENT - PATIENT UNDERDOSE
The following information was provided by the licensee via phone and email:
"Per 10 CFR 35.3045(c), Veterans Health Administration (VHA) National Health Physics Program (NHPP) is reporting a possible medical event.
"Southern Arizona VA Health Care System [the facility], Tucson, Arizona, which holds Permit Number 02-06186-01 under the VA master materials license, reported discovery of a 'possible' medical event to NHPP at approximately [1500] CDT, April 19, 2023.
"A yttrium-90 microsphere therapy administration for liver cancer was performed on April 19, 2023. The intended treatment site was hepatic segment 4 of the right lobe of the liver. During the administration, performed under fluoroscopy guidance, the Authorized User (AU) / administering Interventional Radiology physician noted a change in the catheter position and elected to stop the administration. Measurements and calculations indicated the patient received about 63 percent of the prescribed activity [15.06 mCi delivered vs. 21.6 mCi prescribed]. Post implant single-photon emission computerized tomography (SPECT) imaging verified that the dosage had been delivered to the correct location.
"The AU believes that the movement of the catheter qualifies as an emergent patient condition. The written directive was modified to include the reason for not administering the intended activity, the signature of an AU for yttrium-90 microspheres, and the date signed. NHPP in coordination with the facility and NRC will conduct further evaluation of this event to determine if the regulatory definition of emergent patient condition was met.
"The patient and the referring physician have been notified.
"At this time, short term harm to the patient is not expected.
"NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045.
"NHPP has notified the NRC Region III Project Manager."
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.
* * * RETRACTION FROM KIM WIEBECK TO BRIAN P. SMITH AT 1709 EDT ON 05/02/2023 * * *
The following information was provided by the licensee via email:
"Veterans Health Administration (VHA) National Health Physics Program (NHPP) placed a call to NRC Operations Center on May 2, 2023, to retract Event Number 56481 (NMED Item No. 230168).
"NHPP reported discovery of a "possible" medical event at Southern Arizona VA Health Care System, Tucson, Arizona, Permit Number 02-06186-01, on April 19, 2023.
"NHPP, in coordination with the facility and NRC, has conducted further evaluation and determined that the regulatory definition of emergent patient condition, in NRC's document, Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing Guidance, was met. Therefore, this event is no longer classified as a "possible" medical event and the 15-day written reporting requirement of 10 CFR 35.3045(d) will not be completed."
NHPP has notified the NRC Region III Project Manager.
Notified R3DO (Peterson), R4DO (Gaddy), and NMSS Events Notification.
EN Revision Text: MEDICAL EVENT - PATIENT UNDERDOSE
The following information was provided by the licensee via phone and email:
"Per 10 CFR 35.3045(c), Veterans Health Administration (VHA) National Health Physics Program (NHPP) is reporting a possible medical event.
"Southern Arizona VA Health Care System [the facility], Tucson, Arizona, which holds Permit Number 02-06186-01 under the VA master materials license, reported discovery of a 'possible' medical event to NHPP at approximately [1500] CDT, April 19, 2023.
"A yttrium-90 microsphere therapy administration for liver cancer was performed on April 19, 2023. The intended treatment site was hepatic segment 4 of the right lobe of the liver. During the administration, performed under fluoroscopy guidance, the Authorized User (AU) / administering Interventional Radiology physician noted a change in the catheter position and elected to stop the administration. Measurements and calculations indicated the patient received about 63 percent of the prescribed activity [15.06 mCi delivered vs. 21.6 mCi prescribed]. Post implant single-photon emission computerized tomography (SPECT) imaging verified that the dosage had been delivered to the correct location.
"The AU believes that the movement of the catheter qualifies as an emergent patient condition. The written directive was modified to include the reason for not administering the intended activity, the signature of an AU for yttrium-90 microspheres, and the date signed. NHPP in coordination with the facility and NRC will conduct further evaluation of this event to determine if the regulatory definition of emergent patient condition was met.
"The patient and the referring physician have been notified.
"At this time, short term harm to the patient is not expected.
"NHPP will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045.
"NHPP has notified the NRC Region III Project Manager."
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.
* * * RETRACTION FROM KIM WIEBECK TO BRIAN P. SMITH AT 1709 EDT ON 05/02/2023 * * *
The following information was provided by the licensee via email:
"Veterans Health Administration (VHA) National Health Physics Program (NHPP) placed a call to NRC Operations Center on May 2, 2023, to retract Event Number 56481 (NMED Item No. 230168).
"NHPP reported discovery of a "possible" medical event at Southern Arizona VA Health Care System, Tucson, Arizona, Permit Number 02-06186-01, on April 19, 2023.
"NHPP, in coordination with the facility and NRC, has conducted further evaluation and determined that the regulatory definition of emergent patient condition, in NRC's document, Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing Guidance, was met. Therefore, this event is no longer classified as a "possible" medical event and the 15-day written reporting requirement of 10 CFR 35.3045(d) will not be completed."
NHPP has notified the NRC Region III Project Manager.
Notified R3DO (Peterson), R4DO (Gaddy), and NMSS Events Notification.