Event Notification Report for July 10, 2018
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
07/09/2018 - 07/10/2018
EVENT NUMBERS
53501
Agreement State
Event Number: 53501
Rep Org: TEXAS DEPT OF STATE HEALTH SERVICES
Licensee: CENTRAL TEXAS MEDICAL SPECIALISTS PLLC
Region: 4
City: AUSTIN State: TX
County:
License #: L 06618
Agreement: Y
Docket:
NRC Notified By: CHRIS MOORE
HQ OPS Officer: STEVEN VITTO
Licensee: CENTRAL TEXAS MEDICAL SPECIALISTS PLLC
Region: 4
City: AUSTIN State: TX
County:
License #: L 06618
Agreement: Y
Docket:
NRC Notified By: CHRIS MOORE
HQ OPS Officer: STEVEN VITTO
Notification Date: 07/11/2018
Notification Time: 15:58 [ET]
Event Date: 07/10/2018
Event Time: 00:00 [CDT]
Last Update Date: 07/13/2018
Notification Time: 15:58 [ET]
Event Date: 07/10/2018
Event Time: 00:00 [CDT]
Last Update Date: 07/13/2018
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
10 CFR Section:
AGREEMENT STATE
Person (Organization):
GREG PICK (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
GREG PICK (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - MEDICAL EVENT
The following was received from the State of Texas via E-mail:
"On July 11, 2018, a license notified the Agency [Texas Department of State Health Services] that a medical event had occurred. On July 10, 2018, a patient received the first fraction of a treatment plan delivered by a high dose rate afterloader (HDR) utilizing iridium-192. On July 11, 2018, the medical physicist noticed that the dose per fraction entered in the treatment plan of the 1st fraction was incorrect. Instead of a 350 cGy/fraction for 6 fractions, a value of 2100 cGy was entered for one fraction (which was the total dose for the brachytherapy course). The Radiation Oncologist (RO) was notified and he notified the referring physician and patient that day. RO will follow the patient closely and make all possible interventions to minimize potential adverse effects. The Agency is awaiting answers to multiple questions including identification of target area. More information will be provided as it is obtained and in accordance with SA-300.
"Texas Incident #: I-9594"
* * * UPDATE FROM CHRIS MOORE TO DONALD NORWOOD AT 1621 EDT ON 7/13/2018 * * *
The following was received from the State of Texas via E-mail:
"The patient was treated for vaginal cancer using HDR (High Dose Rate) brachytherapy using a 6 Curie Iridium-192 source. A written report was received from the licensee indicating several factors contributed to the medical event including a busy work day, mental fatigue, verbal description of the intended dose instead of written direction, and unavailability of another medical physicist (MP) to independently review the dose/fraction entered in the treatment planning system. The overall brachytherapy plan was modified and the volume treated in the first fraction was considered completed and [the patient] will not receive further treatment. The Radiation Oncologist will follow the patient closely and make all possible interventions to minimize potential adverse effects. Immediate changes implemented at the facility include: no HDR treatment will start without a written prescription in the patient electronic medical record and an independent check of the prescription entry and radiation dosimetry will be conducted by an Authorized User, other than the MP who generated the treatment plan. An Agency team will conduct an onsite investigation in early August 2018 when all parties involved are available. Additional information will be provided as it is obtained and in accordance with SA-300."
Notified R4DO (Pick) and NMSS Events Notification E-mail group.
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 was received from the State of Texas via E-mail:
"On July 11, 2018, a license notified the Agency [Texas Department of State Health Services] that a medical event had occurred. On July 10, 2018, a patient received the first fraction of a treatment plan delivered by a high dose rate afterloader (HDR) utilizing iridium-192. On July 11, 2018, the medical physicist noticed that the dose per fraction entered in the treatment plan of the 1st fraction was incorrect. Instead of a 350 cGy/fraction for 6 fractions, a value of 2100 cGy was entered for one fraction (which was the total dose for the brachytherapy course). The Radiation Oncologist (RO) was notified and he notified the referring physician and patient that day. RO will follow the patient closely and make all possible interventions to minimize potential adverse effects. The Agency is awaiting answers to multiple questions including identification of target area. More information will be provided as it is obtained and in accordance with SA-300.
"Texas Incident #: I-9594"
* * * UPDATE FROM CHRIS MOORE TO DONALD NORWOOD AT 1621 EDT ON 7/13/2018 * * *
The following was received from the State of Texas via E-mail:
"The patient was treated for vaginal cancer using HDR (High Dose Rate) brachytherapy using a 6 Curie Iridium-192 source. A written report was received from the licensee indicating several factors contributed to the medical event including a busy work day, mental fatigue, verbal description of the intended dose instead of written direction, and unavailability of another medical physicist (MP) to independently review the dose/fraction entered in the treatment planning system. The overall brachytherapy plan was modified and the volume treated in the first fraction was considered completed and [the patient] will not receive further treatment. The Radiation Oncologist will follow the patient closely and make all possible interventions to minimize potential adverse effects. Immediate changes implemented at the facility include: no HDR treatment will start without a written prescription in the patient electronic medical record and an independent check of the prescription entry and radiation dosimetry will be conducted by an Authorized User, other than the MP who generated the treatment plan. An Agency team will conduct an onsite investigation in early August 2018 when all parties involved are available. Additional information will be provided as it is obtained and in accordance with SA-300."
Notified R4DO (Pick) and NMSS Events Notification E-mail group.
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.