Event Notification Report for November 02, 2010
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
11/01/2010 - 11/02/2010
General Information
Event Number: 46386
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: WARREN GENERAL HOSPITAL
Region: 1
City: WARREN State: PA
County:
License #: PA-0083
Agreement: Y
Docket:
NRC Notified By: JOE MALNIC
HQ OPS Officer: STEVE SANDIN
Licensee: WARREN GENERAL HOSPITAL
Region: 1
City: WARREN State: PA
County:
License #: PA-0083
Agreement: Y
Docket:
NRC Notified By: JOE MALNIC
HQ OPS Officer: STEVE SANDIN
Notification Date: 11/03/2010
Notification Time: 09:43 [ET]
Event Date: 11/02/2010
Event Time: 00:00 [EDT]
Last Update Date: 12/28/2010
Notification Time: 09:43 [ET]
Event Date: 11/02/2010
Event Time: 00:00 [EDT]
Last Update Date: 12/28/2010
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
JOHN WHITE (R1DO)
MICHELE BURGESS (FSME)
JOHN WHITE (R1DO)
MICHELE BURGESS (FSME)
AGREEMENT STATE REPORT INVOLVING A MEDICAL EVENT DUE TO A DOSAGE DIFFERING FROM THE PRESCRIBED DOSE
The following information was received via fax from the Commonwealth of Pennsylvania:
"Notifications: On November 2, 2010 PaDEP [Pennsylvania Department of Environmental Protection] Central Office was notified by the licensee of a medical event involving a dosage that differs from the prescribed dose by 20% as required under 10 CFR 35.3045. This event also meets the criteria for Abnormal Occurrence reporting.
"Event Description: On November 2, 2010 a patient was undergoing brachytherapy treatment for prostate cancer. A partial seed implant of 85 Gy was prescribed, however, the full treatment of 144 Gy was implanted. This event was discovered upon completion of the procedure.
"Cause of the Event: Human Error
"Actions: The Department is awaiting more event details at this time and plans to send regional staff to conduct a follow-up inspection. Final event details will be communicated in an NMED and Abnormal Occurrence report."
PA Report ID No.: PA100025
* * * UPDATE FROM DAVID ALLARD TO JOE O'HARA VIA FAX AT 1741 ON 12/28/10 * * *
"NOTIFICATIONS: The licensee called the PaDEP Bureau of Radiation Protection on the afternoon of November 2, 2010 to provide a 24-hour verbal notice of a Medical Event. The event involved a patient dosage that differed from the intended [written directive] dose by greater than 20%, consequently requiring a 24-hour report per 10 CFR 35.3045(a)(1)(i). Subsequently, the licensee provided a written report to PaDEP on November 5th.
"EVENT DESCRIPTION: On November 2, 2010 a patient was undergoing brachytherapy Cesium-131 seed implant treatment for prostate cancer. A partial seed implant of 85 gray (Gy) was directed, with a 45 Gy follow-up external [IMRT] beam therapy. However, the full seed treatment of 114 Gy was implanted. The event was discovered upon completion of the implants.
"CAUSE OF THE EVENT: Human error was the cause of the event. Specifically, the incorrect prescribed prostate dose was entered into the licensee's VariSeed planning system (i.e.114 Gy vs. 85 Gy), and an incorrect seed order was placed with the vendor. The error persisted because the licensee's staff did not directly compare the written directive to the printed treatment plan. Such a comparison would have alerted the staff to the error.
"ACTIONS: The PaDEP performed a reactive inspection at the hospital on 11/4/2010. Warren General also initiated the following changes: Their current Operating Room (OR) "time-out" procedure will be altered to include the expected prescription dose. A copy of the original written directive will be utilized in the OR for reference before and during the implant. Forms will be amended to have the physician's written directive and the planned dose on the same form for easy review and comparison. Lastly, the weekly physics chart review that involves a check of the written directive has been altered such that a summary sheet that is normally used for external beam patients will now also be used for seed implant patients. This event will be also communicated to NRC via NMED. However, there was an initial miscommunication between the licensee and PaDEP. The full treatment of 114 Gy was used, not 144 Gy. Thus, there will not be an Abnormal Occurrence report from PaDEP to NRC."
Notified R1DO(Hansell) and FSME EO(Watson)
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 via fax from the Commonwealth of Pennsylvania:
"Notifications: On November 2, 2010 PaDEP [Pennsylvania Department of Environmental Protection] Central Office was notified by the licensee of a medical event involving a dosage that differs from the prescribed dose by 20% as required under 10 CFR 35.3045. This event also meets the criteria for Abnormal Occurrence reporting.
"Event Description: On November 2, 2010 a patient was undergoing brachytherapy treatment for prostate cancer. A partial seed implant of 85 Gy was prescribed, however, the full treatment of 144 Gy was implanted. This event was discovered upon completion of the procedure.
"Cause of the Event: Human Error
"Actions: The Department is awaiting more event details at this time and plans to send regional staff to conduct a follow-up inspection. Final event details will be communicated in an NMED and Abnormal Occurrence report."
PA Report ID No.: PA100025
* * * UPDATE FROM DAVID ALLARD TO JOE O'HARA VIA FAX AT 1741 ON 12/28/10 * * *
"NOTIFICATIONS: The licensee called the PaDEP Bureau of Radiation Protection on the afternoon of November 2, 2010 to provide a 24-hour verbal notice of a Medical Event. The event involved a patient dosage that differed from the intended [written directive] dose by greater than 20%, consequently requiring a 24-hour report per 10 CFR 35.3045(a)(1)(i). Subsequently, the licensee provided a written report to PaDEP on November 5th.
"EVENT DESCRIPTION: On November 2, 2010 a patient was undergoing brachytherapy Cesium-131 seed implant treatment for prostate cancer. A partial seed implant of 85 gray (Gy) was directed, with a 45 Gy follow-up external [IMRT] beam therapy. However, the full seed treatment of 114 Gy was implanted. The event was discovered upon completion of the implants.
"CAUSE OF THE EVENT: Human error was the cause of the event. Specifically, the incorrect prescribed prostate dose was entered into the licensee's VariSeed planning system (i.e.114 Gy vs. 85 Gy), and an incorrect seed order was placed with the vendor. The error persisted because the licensee's staff did not directly compare the written directive to the printed treatment plan. Such a comparison would have alerted the staff to the error.
"ACTIONS: The PaDEP performed a reactive inspection at the hospital on 11/4/2010. Warren General also initiated the following changes: Their current Operating Room (OR) "time-out" procedure will be altered to include the expected prescription dose. A copy of the original written directive will be utilized in the OR for reference before and during the implant. Forms will be amended to have the physician's written directive and the planned dose on the same form for easy review and comparison. Lastly, the weekly physics chart review that involves a check of the written directive has been altered such that a summary sheet that is normally used for external beam patients will now also be used for seed implant patients. This event will be also communicated to NRC via NMED. However, there was an initial miscommunication between the licensee and PaDEP. The full treatment of 114 Gy was used, not 144 Gy. Thus, there will not be an Abnormal Occurrence report from PaDEP to NRC."
Notified R1DO(Hansell) and FSME EO(Watson)
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.
Other Nuclear Material
Event Number: 46402
Rep Org: INPO
Licensee: VARIOUS
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: GEORGE MORTENSEN
HQ OPS Officer: JOHN KNOKE
Licensee: VARIOUS
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: GEORGE MORTENSEN
HQ OPS Officer: JOHN KNOKE
Notification Date: 11/08/2010
Notification Time: 15:53 [ET]
Event Date: 11/02/2010
Event Time: 00:00 [EST]
Last Update Date: 11/08/2010
Notification Time: 15:53 [ET]
Event Date: 11/02/2010
Event Time: 00:00 [EST]
Last Update Date: 11/08/2010
Emergency Class: NON EMERGENCY
10 CFR Section:
26.719 - FITNESS FOR DUTY
10 CFR Section:
26.719 - FITNESS FOR DUTY
Person (Organization):
KATHLEEN O'DONOHUE (R2DO)
KATHLEEN O'DONOHUE (R2DO)
FITNESS FOR DUTY - SUPERVISOR AT INSTITUTE OF NUCLEAR POWER OPERATIONS TESTED POSITIVE FOR ALCOHOL
A supervisor at the Institute of Nuclear Power Operations (INPO) had a confirmed positive for alcohol during a random fitness-for-duty test. The individual functioned as a supervisor at the Institute of Nuclear Power Operations. The employee's unescorted access has been suspended. Contact the Headquarters Operations Officer for further details.
A supervisor at the Institute of Nuclear Power Operations (INPO) had a confirmed positive for alcohol during a random fitness-for-duty test. The individual functioned as a supervisor at the Institute of Nuclear Power Operations. The employee's unescorted access has been suspended. Contact the Headquarters Operations Officer for further details.