Event Notification Report for August 02, 2022
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/01/2022 - 08/02/2022
Agreement State
Event Number: 56029
Rep Org: MA Radiation Control Program
Licensee: Massachusetts General Hospital
Region: 1
City: Boston State: MA
County:
License #: 60-0055
Agreement: Y
Docket:
NRC Notified By: Tony Carpenito
HQ OPS Officer: Donald Norwood
Licensee: Massachusetts General Hospital
Region: 1
City: Boston State: MA
County:
License #: 60-0055
Agreement: Y
Docket:
NRC Notified By: Tony Carpenito
HQ OPS Officer: Donald Norwood
Notification Date: 08/04/2022
Notification Time: 11:27 [ET]
Event Date: 08/02/2022
Event Time: 15:30 [EDT]
Last Update Date: 08/04/2022
Notification Time: 11:27 [ET]
Event Date: 08/02/2022
Event Time: 15:30 [EDT]
Last Update Date: 08/04/2022
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Henrion, Mark (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Henrion, Mark (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - UNDERDOSE OF Y-90 SIR-SPHERES
The following information was received from the Massachusetts Radiation Control Program (the Agency) via email:
"On 8/3/2022 at 1444 EDT, the licensee reported [to the agency (MA Department of Public Health Radiation Control Program)] a medical event for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-site Y-90 16.2 mCi microsphere therapy treatment delivered to the patient liver on 8/2/22 remained in the delivery system causing delivery of 12.7 mCi Y-90 of the prescribed 16.2 mCi. The error was discovered the next morning during final post-treatment calculations. The administered dose to the treatment area differed from the prescribed dose by 21.6 percent. The licensee stated that the cause, including possible equipment malfunction, has not yet been determined. The prescribing physician and referring physician have been notified. The physician is to notify the patient (not yet confirmed). The licensee stated no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment is expected due to this situation. The licensee stated that all Y-90 was accounted for. The licensee is to submit a written report within 15 days of discovery date. This is a next day reportable medical event per regulation.
"Investigation is ongoing. The agency considers this event docket to still be open."
MA Event Number: TBD
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 received from the Massachusetts Radiation Control Program (the Agency) via email:
"On 8/3/2022 at 1444 EDT, the licensee reported [to the agency (MA Department of Public Health Radiation Control Program)] a medical event for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-site Y-90 16.2 mCi microsphere therapy treatment delivered to the patient liver on 8/2/22 remained in the delivery system causing delivery of 12.7 mCi Y-90 of the prescribed 16.2 mCi. The error was discovered the next morning during final post-treatment calculations. The administered dose to the treatment area differed from the prescribed dose by 21.6 percent. The licensee stated that the cause, including possible equipment malfunction, has not yet been determined. The prescribing physician and referring physician have been notified. The physician is to notify the patient (not yet confirmed). The licensee stated no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment is expected due to this situation. The licensee stated that all Y-90 was accounted for. The licensee is to submit a written report within 15 days of discovery date. This is a next day reportable medical event per regulation.
"Investigation is ongoing. The agency considers this event docket to still be open."
MA Event Number: TBD
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: 56031
Rep Org: Texas Dept of State Health Services
Licensee: GI Encore Petroleum Engineering
Region: 4
City: Katy State: TX
County:
License #: L 07058
Agreement: Y
Docket:
NRC Notified By: Randall Redd
HQ OPS Officer: Mike Stafford
Licensee: GI Encore Petroleum Engineering
Region: 4
City: Katy State: TX
County:
License #: L 07058
Agreement: Y
Docket:
NRC Notified By: Randall Redd
HQ OPS Officer: Mike Stafford
Notification Date: 08/04/2022
Notification Time: 16:42 [ET]
Event Date: 08/02/2022
Event Time: 00:00 [CDT]
Last Update Date: 08/04/2022
Notification Time: 16:42 [ET]
Event Date: 08/02/2022
Event Time: 00:00 [CDT]
Last Update Date: 08/04/2022
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Roldan-Otero, Lizette (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB, (EMAIL)
Roldan-Otero, Lizette (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB, (EMAIL)
AGREEMENT STATE REPORT - ATTEMPT TO OBTAIN MATERIAL WITHOUT LICENSE
The following information was provided by the Texas Department of State Health Services (the Agency) via email:
"On August 4, 2022, this Agency received information that a former licensee was trying to obtain 500 microCi of Am-241 without a license. The material would reportedly be used for calibration. The issue was reported to the appropriate Agency in California because that is where the seller is located. An informal report was made to the NRC in Arlington, Texas. It was decided that this needed to be reported to the FBI which was accomplished on this same day. The seller has reported that they will not provide a quote to the former licensee and hence will not be supplying the material. It is not clear if this is a misunderstanding or an attempt to gain material while bypassing regulations. This Agency will not investigate this matter immediately but will give the FBI some time to investigate. No further information is expected in the near future, but information will be provided when obtained per SA-300."
Texas Incident Number: I-9944
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
The following information was provided by the Texas Department of State Health Services (the Agency) via email:
"On August 4, 2022, this Agency received information that a former licensee was trying to obtain 500 microCi of Am-241 without a license. The material would reportedly be used for calibration. The issue was reported to the appropriate Agency in California because that is where the seller is located. An informal report was made to the NRC in Arlington, Texas. It was decided that this needed to be reported to the FBI which was accomplished on this same day. The seller has reported that they will not provide a quote to the former licensee and hence will not be supplying the material. It is not clear if this is a misunderstanding or an attempt to gain material while bypassing regulations. This Agency will not investigate this matter immediately but will give the FBI some time to investigate. No further information is expected in the near future, but information will be provided when obtained per SA-300."
Texas Incident Number: I-9944
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf