Event Notification Report for February 08, 2019
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
02/07/2019 - 02/08/2019
EVENT NUMBERS
53868
Agreement State
Event Number: 53868
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: EASTERN REGIONAL MEDICAL CENTER
Region: 1
City: PHILADELPHIA State: PA
County:
License #: PA-0980
Agreement: Y
Docket:
NRC Notified By: JOHN CHIPPO
HQ OPS Officer: JEFF HERRERA
Licensee: EASTERN REGIONAL MEDICAL CENTER
Region: 1
City: PHILADELPHIA State: PA
County:
License #: PA-0980
Agreement: Y
Docket:
NRC Notified By: JOHN CHIPPO
HQ OPS Officer: JEFF HERRERA
Notification Date: 02/11/2019
Notification Time: 14:15 [ET]
Event Date: 02/08/2019
Event Time: 00:00 [EST]
Last Update Date: 02/14/2019
Notification Time: 14:15 [ET]
Event Date: 02/08/2019
Event Time: 00:00 [EST]
Last Update Date: 02/14/2019
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
10 CFR Section:
AGREEMENT STATE
Person (Organization):
CHRISTOPHER CAHILL (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
CHRISTOPHER CAHILL (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - DELIVERED DOSE TO PATIENT LESS THAN PRESCRIBED DOSE
The following report was received from the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection via email:
"The licensee reported that on February 8, 2019, while reviewing a patient treatment plan, it was discovered that the patient had received a dose from a high dose rate remote afterloader containing iridium-192 that was less than the prescribed dose in the written directive. The original treatment plan was prescribed for 7.0 Gy per fraction, however at the beginning of the 3rd fraction it was noticed that the total dose delivered was 4.67 Gy instead of the prescribed 14 Gy they should have received for the same 2 fractions. The physician has informed the patient and will amend the written directive to add additional fractions at different doses to achieve the original prescribed dose to the treatment area. No more information is available at this time from the licensee. We will update this event as soon as more information is provided.
"Cause of the Event: Unknown / Human error.
"ACTIONS: The Department [Pennsylvania Department of Environmental Protection] will perform a reactive inspection. More information will be provided upon receipt."
* * * UPDATE AT 1227 EST ON 02/14/2019 FROM JOHN CHIPPO TO TOM KENDZIA * * *
The following update was received from the Pennsylvania Department of Environmental Protection via email:
"The patient received treatment on January 29, 2019, and February 5, 2019. The patient had not finished her initially scheduled 3rd fraction. The Medical Event was identified on Friday, February 8, 2019. The equipment manufacturer is Varian, model VariSource iX(t), Serial Number 00400. The source activity as of February 11, 2019 was 6.819 Ci. The licensee is still in the process of identifying root cause and corrective action."
Pennsylvania Report: PA190003
Notified the R1DO (Ferdas) and NMSS Events (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 report was received from the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection via email:
"The licensee reported that on February 8, 2019, while reviewing a patient treatment plan, it was discovered that the patient had received a dose from a high dose rate remote afterloader containing iridium-192 that was less than the prescribed dose in the written directive. The original treatment plan was prescribed for 7.0 Gy per fraction, however at the beginning of the 3rd fraction it was noticed that the total dose delivered was 4.67 Gy instead of the prescribed 14 Gy they should have received for the same 2 fractions. The physician has informed the patient and will amend the written directive to add additional fractions at different doses to achieve the original prescribed dose to the treatment area. No more information is available at this time from the licensee. We will update this event as soon as more information is provided.
"Cause of the Event: Unknown / Human error.
"ACTIONS: The Department [Pennsylvania Department of Environmental Protection] will perform a reactive inspection. More information will be provided upon receipt."
* * * UPDATE AT 1227 EST ON 02/14/2019 FROM JOHN CHIPPO TO TOM KENDZIA * * *
The following update was received from the Pennsylvania Department of Environmental Protection via email:
"The patient received treatment on January 29, 2019, and February 5, 2019. The patient had not finished her initially scheduled 3rd fraction. The Medical Event was identified on Friday, February 8, 2019. The equipment manufacturer is Varian, model VariSource iX(t), Serial Number 00400. The source activity as of February 11, 2019 was 6.819 Ci. The licensee is still in the process of identifying root cause and corrective action."
Pennsylvania Report: PA190003
Notified the R1DO (Ferdas) and NMSS Events (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.