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Event Notification Report for December 14, 2001

U.S. Nuclear Regulatory Commission
Operations Center

EVENT REPORTS FOR
12/13/2001 - 12/14/2001

EVENT NUMBERS
3857238573385623856338564385653856638567385683856938583

Hospital
Event Number: 38572
Rep Org: ST. JOSEPH'S HOSPITAL
Licensee: ST. JOSEPH'S HOSPITAL
Region: 3
City: KOKOMO   State: IN
County:
License #: 13-11385-01
Agreement: N
Docket:
NRC Notified By: TODD REYBURN
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 15:27 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POTENTIAL MEDICAL MISADMINISTRATION: UNDERDOSE OF SAMARIUM-153

The licensee was notified today by the RSO for Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet doses may be approximately 20-30% less than labeled due to an error in the attenuation calculation for the beta factor in the Sa-153 total activity calculation. This condition may have existed for greater than 1 year. The licensee found one patient who was treated with Sa-153 and that was on 10/05/00.

NRC Region 3 has been notified of this event.


Hospital
Event Number: 38573
Rep Org: MEMORIAL HOSPITAL
Licensee: MEMORIAL HOSPITAL
Region: 3
City: SOUTH BEND   State: IN
County:
License #: 13-18881-01
Agreement: N
Docket:
NRC Notified By: RICHARD SELLE
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 15:43 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POTENTIAL MEDICAL MISADMINISTRATIONS: UNDERDOSES OF SAMARIUM-153

The licensee was notified today by the RSO of Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet does may be approximately 20-30% less than labeled due to an error in the attenuation calculation for beta factor in the Sa-153 total activity. The licensee believes that he has treated two patients since 1998 with Sa-153.

NRC Region 3 has been notified of this event.


Power Reactor
Event Number: 38562
Facility: KEWAUNEE
Region: 3     State: WI
Unit: [1] [] []
RX Type: [1] W-2-LP
NRC Notified By: KEVIN HUJET
HQ OPS Officer: FANGIE JONES
Notification Date: 12/14/2001
Notification Time: 08:57 [ET]
Event Date: 12/14/2001
Event Time: 06:45 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
ANNE MARIE STONE (R3)
Power Reactor Unit Info
Unit SCRAM Code RX Crit Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 95 Power Operation 95 Power Operation
Event Text
PLANT COMPUTER AND SAFETY PARAMETERS DISPLAY SYSTEM INOPERABLE

The unit suffered a failure of the plant computer at 1452 CST on 12/13/01 and repairs are ongoing. The plant computer is expected to be down greater than 24 hours. The plant computer feeds the Safety Parameter Display System (SPDS), which is inoperable also. The licensee has made a decision to make this report under a major loss of emergency assessment capabilities per 10 CFR 50.72(b)(3)(xiii) as a conservative measure. The control board indicators are operable and are used by the operators normally in an emergency. The Shift Technical Advisor will perform a manual review of safety parameters in the case of an emergency, using the control board indications.

The licensee notified the NRC Resident Inspector.


Hospital
Event Number: 38563
Rep Org: ELKHART HOSPITAL
Licensee: ELKHART HOSPITAL
Region: 3
City: ELKHART   State: IN
County:
License #: 13-18879-01
Agreement: N
Docket:
NRC Notified By: GARETH WILLIAMS
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 12:17 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POSSIBLE MEDICAL MISADMINISTRATIONS: UNDERDOSES OF SAMARIUM-153

Elkhart Hospital was notified today by the RSO for Spectrum Pharmaceuticals that Sa-153 quadramet doses total activity shipped to them was incorrectly calibrated. Spectrum Pharmaceuticals informed the Hospital that they had made an error in the attenuation calculation for the beta factor in the samarium-153 total activity and that this error may have been made more than 6 months ago. Spectrum Pharmaceuticals believes that the Sa-153 total activity is actually less by 20 to 30%. At this time, Elkhart Hospital does not know how many patients have received an underdose of Sa-153.

NRC Region 3 has been notified of this event.


Hospital
Event Number: 38564
Rep Org: GOSHEN GENERAL HOSPITAL
Licensee: GOSHEN GENERAL HOSPITAL
Region: 3
City: GOSHEN   State: IN
County:
License #: 13-18845-01
Agreement: N
Docket:
NRC Notified By: Dr. SHEPERD
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 12:18 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POSSIBLE MEDICAL MISADMINISTRATIONS: UNDERDOSES OF SAMARIUM-153

Goshen General Hospital was notified today by the RSO for Spectrum Pharmaceuticals that Sa-153 quadramet, used for pain relief in bone cancer patients, beta attenuation were incorrectly calculated. This attenuation calculation error made by Spectrum Pharmaceuticals has resulted in patient's given Sa-153 at Goshen General Hospital being underdosed between 20 to 30%. The attenuation error may have existed for greater than 6 months. Three patients have been given a possible underdose of Sa-153.

NRC Region 3 personnel have been notified of this event by the licensee.


Hospital
Event Number: 38565
Rep Org: HOME HOSPITAL
Licensee: HOME HOSPITAL
Region: 3
City: LAFAYETTE   State: IN
County:
License #: 13-09788-01
Agreement: N
Docket:
NRC Notified By: DUNSEATH
HQ OPS Officer: BOB STRANSKY
Notification Date: 12/14/2001
Notification Time: 13:17 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POTENTIAL MEDICAL MISADMINISTRATION: UNDERDOSE OF SAMARIUM-153

The licensee was notified today by the RSO for Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet doses may be approximately 20-30% less than labeled due to an error in the attenuation calculation for the beta factor in the Sa-153 total activity calculation. This calculation error may have existed for greater than 6 months. The licensee is aware of one patient who was treated during this period and is reviewing treatment records to determine whether any others may be affected.

NRC Region 3 has been notified of this event.


Hospital
Event Number: 38566
Rep Org: ST. JOSEPH'S REGIONAL MEDICAL CENTR
Licensee: ST. JOSEPH'S REGIONAL MEDICAL CENTR.
Region: 3
City: SOUTH BEND   State: IN
County:
License #: 13-02650-02
Agreement: N
Docket:
NRC Notified By: Dr. JOHN SCHEU
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 14:13 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POTENTIAL MEDICAL MISADMINISTRATIONS: UNDERDOSES OF SAMARIUM-153

The licensee was notified today by the RSO for Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet doses may be approximately 20-30% less than labeled due to an error in the attenuation calculation for the beta factor in the Sa-153 total activity calculation. This calculation error may have existed greater than 6 months. The licensee is aware of two patients who were treated during this period.

NRC Region 3 has been notified of this event.


Power Reactor
Event Number: 38567
Facility: COOK
Region: 3     State: MI
Unit: [1] [2] []
RX Type: [1] W-4-LP,[2] W-4-LP
NRC Notified By: STEVE COSAR
HQ OPS Officer: BOB STRANSKY
Notification Date: 12/14/2001
Notification Time: 14:30 [ET]
Event Date: 12/14/2001
Event Time: 11:27 [EST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
26.73 - FITNESS FOR DUTY
Person (Organization):
ANNE MARIE STONE (R3)
Power Reactor Unit Info
Unit SCRAM Code RX Crit Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 100 Power Operation 100 Power Operation
2 N Y 100 Power Operation 100 Power Operation
Event Text
FITNESS-FOR-DUTY REPORT

A contract supervisor tested positive for illegal drug use during a random test. The individual did not have access to vital areas, and his site access has been terminated. The NRC resident inspector has been informed of this event by the licensee.


Hospital
Event Number: 38568
Rep Org: BORGESS MEDICAL CENTER
Licensee: BORGESS MEDICAL CENTER
Region: 3
City: KALAMAZOO   State: MI
County:
License #: 21-12275-02
Agreement: N
Docket:
NRC Notified By: ERIC RAMSAY
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 14:44 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [EST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POSSIBLE MEDICAL MISADMINISTRATION: UNDERDOSE OF SAMARIUM-153

The licensee was notified today by the RSO for Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet doses may be approximately 20-30% less than labeled due to an error in the attenuation calculation for the beta factor in the Sa-153 total activity calculation. This calculation error may have existed for greater than 6 months. The licensee does not know how many patients have been treated and is looking through records to determine number of patients treated with Sa-153.

NRC Region 3 has been notified of this event.


Hospital
Event Number: 38569
Rep Org: BRONSON METHODIST HOSPITAL
Licensee: BRONSON METHODIST HOSPITAL
Region: 3
City: KALAMAZOO   State: MI
County:
License #: 21-13125-01
Agreement: N
Docket:
NRC Notified By: MARK WATTS
HQ OPS Officer: JOHN MacKINNON
Notification Date: 12/14/2001
Notification Time: 14:48 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [EST]
Last Update Date: 12/14/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
35.33 - MED MISADMINISTRATION
Person (Organization):
ANNE MARIE STONE (R3)
FRED BROWN (NMSS)
Event Text
POSSIBLE MEDICAL MISADMINISTRATION: UNDERDOSE OF SAMARIUM-153

The licensee was notified today by the RSO for Spectrum Pharmaceuticals that the total activity of Sa-153 quadramet doses may be approximately 20-30% less than labeled due to an error in the attenuation calculation for the beta factor in the Sa-153 total activity calculation. This calculation error may have existed for greater than 6 months. The licensee is aware of one patient treated in the last year.

NRC Region 3 has been notified of this event.


General Information or Other
Event Number: 38583
Rep Org: CENTRAL SOYA COMPANY
Licensee: CENTRAL SOYA COMPANY
Region: 3
City: INDIANAPOLIS   State: IN
County:
License #:
Agreement: N
Docket:
NRC Notified By: TOM ANDORFER
HQ OPS Officer: STEVE SANDIN
Notification Date: 12/19/2001
Notification Time: 12:15 [ET]
Event Date: 12/14/2001
Event Time: 00:00 [CST]
Last Update Date: 12/19/2001
Emergency Class: NON EMERGENCY
10 CFR Section:
20.2201(a)(1)(i) - LOST/STOLEN LNM>1000X
Person (Organization):
MONTE PHILLIPS (R3)
JOHN HICKEY (NMSS)
Event Text
NUMEROUS GENERAL LICENSE TRITIUM EXIT SIGNS FOUND MISSING

During a review of tritium exit signs on hand, the licensee discovered that 28 of the 33 were missing. The 33 tritium signs shown in possession include 24 manufactured by Self Powered, Inc (Qty 8 - Model 700C with 4700 millicuries activity/each received on 2/15/89 and Qty 16 - Model 710 with 25,000 millicuries activity/each received on 5/15/88) and 9 manufactured by NRD LLC (Model T4001 with 8400 millicuries activity/each received on 5/15/93). The missing signs include 19 Self Powered units (specific models not identified at time of report) and all 9 NRD units. The facility in Indianapolis where these signs were installed experienced an explosion and fire in 1993 and was subsequently demolitioned in 1996. The licensee contacted NRC Region 3(Andrea Cook) and was advised to submit a written report.

* * * UPDATE 1459EST ON 12/19/01 FROM TOM ANDORFER TO S. SANDIN * * *

The licensee updated their notification to identify that the 5 exit signs in possession are the model 710. Notified R3DO(Phillips) and NMSS(Turner).