Event Notification Report for August 22, 2006
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/21/2006 - 08/22/2006
EVENT NUMBERS
42811
General Information or Other
Event Number: 42811
Rep Org: ILLINOIS EMERGENCY MGMT. AGENCY
Licensee: RUSH COPELY MEDICAL CENTER
Region: 3
City: AURORA State: IL
County:
License #: IL-01207-01
Agreement: Y
Docket:
NRC Notified By: DAREN PERRERO
HQ OPS Officer: MIKE RIPLEY
Licensee: RUSH COPELY MEDICAL CENTER
Region: 3
City: AURORA State: IL
County:
License #: IL-01207-01
Agreement: Y
Docket:
NRC Notified By: DAREN PERRERO
HQ OPS Officer: MIKE RIPLEY
Notification Date: 08/29/2006
Notification Time: 10:35 [ET]
Event Date: 08/22/2006
Event Time: 00:00 [CDT]
Last Update Date: 08/29/2006
Notification Time: 10:35 [ET]
Event Date: 08/22/2006
Event Time: 00:00 [CDT]
Last Update Date: 08/29/2006
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
HIRONORI PETERSON (R3)
MICHELE BURGESS (NMSS)
HIRONORI PETERSON (R3)
MICHELE BURGESS (NMSS)
AGREEMENT STATE REPORT - MEDICAL EVENT
The State provided the following information via email:
"Yesterday [name deleted] the medical physicist for this Aurora, IL based licensee (IL-01207-01) called to report a medical event which had come to her attention. While preparing a 'Mammosite' treatment plan for an upcoming patient, she had found that two previously administered therapy treatments were not as intended (on 7/28/06 and 8/22/06). Both treatment plans called for a dose of 3400 cGy to be administered to each of the patients over 10 fractions at 340 cGy per fraction with two fractions delivered each of 5 days. However, due to confusion and misunderstanding of the data entry into the treatment planning software, an error occurred and the dose per fraction delivered was only 34 cGy for a total treatment dose of only 340 cGy. Thus, both patients received only 10% of the dose they should have received for their cancer treatments.
"The treatment planning software, named Eclipse, developed by Varian Medical Systems had a known issue with regards to 'fractionated doses'. A company technical bulletin, (CTB-BV-318) had been generated by the company in March of 2003 and provided to its customers alerting them to the appropriate method for data entry for fractionated doses. The technical bulletin for the treatment planning software contains a warning that 'incorrect use could possibly cause a misadministration.' However, Rush Copley did not acquire its high dose rate afterloading system and treatment planning software until August of 2005 and although the treatment planning software had been updated to a newer version, the same issue remained in the new version. According to the authorized user and the medical physicist, there was no training provided on this aspect of use of the treatment planning software when they had attended the manufacturer's training last year.
"The hospital has administered only these two fractionated doses since they acquired the unit. Both patients have been contacted by the authorized user and the patients are considering the available options for additional treatment if necessary. Considering the treatment regimen is designed for post surgical lumpectomies of the breast, the physician believes the effect of the under dose on the patients will be minimal. The licensee has been advised of the need to file the appropriate report in the next 15 days including its corrective action.
"Because the dose to the patient differs by more than 20% from that originally prescribed, the Agency must notify the U.S. NRC Operations Center with this event.
"Patient Information:
"Patient Number: 1; Patient Informed: Y; Date Informed: 08/28/2006
"Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR
"Organ: BREAST, RIGHT
"Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90
"Effect on Patient: OTHER
Administered By: PHYSICIAN
"Patient Number: 2; Patient Informed: Y; Date Informed: 08/28/2006
"Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR
"Organ: BREAST, RIGHT
"Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90
"Effect on Patient: OTHER
"Administered By: PHYSICIAN
"Source of Radiation:
"Form of Radioactive: SEALED SOURCE; Radionuclide or Voltage (kVp/MeV): IR-192
"Source Use: BRACHYTHERAPY; Activity: 10.2 Ci 377.4 GBq; Manufacturer: ALPH-OMEGA SERVICES
"Model Number: VS2000; Serial Number: 02-01-0699-001-062106-10250-03
"Device/Associated Equipment:
"Device Name: REMOTE AFTERLOADER HDR Model Number: VARISOURCE
"Manufacturer: VARIAN Serial Number: VS60037
"Reporting Requirements:
"Reporting Requirement: 32 IAC 335.1080 - Any administration of radioactive materials that results in a 'reportable event' (misadministration), licensee shall notify the agency by telephone NLT next day after licensee ascertains and confirms that a reportable event has occurred. Mode Reported: Telephone"
The State provided the following information via email:
"Yesterday [name deleted] the medical physicist for this Aurora, IL based licensee (IL-01207-01) called to report a medical event which had come to her attention. While preparing a 'Mammosite' treatment plan for an upcoming patient, she had found that two previously administered therapy treatments were not as intended (on 7/28/06 and 8/22/06). Both treatment plans called for a dose of 3400 cGy to be administered to each of the patients over 10 fractions at 340 cGy per fraction with two fractions delivered each of 5 days. However, due to confusion and misunderstanding of the data entry into the treatment planning software, an error occurred and the dose per fraction delivered was only 34 cGy for a total treatment dose of only 340 cGy. Thus, both patients received only 10% of the dose they should have received for their cancer treatments.
"The treatment planning software, named Eclipse, developed by Varian Medical Systems had a known issue with regards to 'fractionated doses'. A company technical bulletin, (CTB-BV-318) had been generated by the company in March of 2003 and provided to its customers alerting them to the appropriate method for data entry for fractionated doses. The technical bulletin for the treatment planning software contains a warning that 'incorrect use could possibly cause a misadministration.' However, Rush Copley did not acquire its high dose rate afterloading system and treatment planning software until August of 2005 and although the treatment planning software had been updated to a newer version, the same issue remained in the new version. According to the authorized user and the medical physicist, there was no training provided on this aspect of use of the treatment planning software when they had attended the manufacturer's training last year.
"The hospital has administered only these two fractionated doses since they acquired the unit. Both patients have been contacted by the authorized user and the patients are considering the available options for additional treatment if necessary. Considering the treatment regimen is designed for post surgical lumpectomies of the breast, the physician believes the effect of the under dose on the patients will be minimal. The licensee has been advised of the need to file the appropriate report in the next 15 days including its corrective action.
"Because the dose to the patient differs by more than 20% from that originally prescribed, the Agency must notify the U.S. NRC Operations Center with this event.
"Patient Information:
"Patient Number: 1; Patient Informed: Y; Date Informed: 08/28/2006
"Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR
"Organ: BREAST, RIGHT
"Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90
"Effect on Patient: OTHER
Administered By: PHYSICIAN
"Patient Number: 2; Patient Informed: Y; Date Informed: 08/28/2006
"Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR
"Organ: BREAST, RIGHT
"Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90
"Effect on Patient: OTHER
"Administered By: PHYSICIAN
"Source of Radiation:
"Form of Radioactive: SEALED SOURCE; Radionuclide or Voltage (kVp/MeV): IR-192
"Source Use: BRACHYTHERAPY; Activity: 10.2 Ci 377.4 GBq; Manufacturer: ALPH-OMEGA SERVICES
"Model Number: VS2000; Serial Number: 02-01-0699-001-062106-10250-03
"Device/Associated Equipment:
"Device Name: REMOTE AFTERLOADER HDR Model Number: VARISOURCE
"Manufacturer: VARIAN Serial Number: VS60037
"Reporting Requirements:
"Reporting Requirement: 32 IAC 335.1080 - Any administration of radioactive materials that results in a 'reportable event' (misadministration), licensee shall notify the agency by telephone NLT next day after licensee ascertains and confirms that a reportable event has occurred. Mode Reported: Telephone"