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Event Notification Report for June 9, 2004

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
06/08/2004 - 06/09/2004

** EVENT NUMBERS **


40789 40792 40797

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General Information or Other Event Number: 40789
Rep Org: ALABAMA RADIATION CONTROL
Licensee: ALABAMA DEPARTMENT OF TRANSPORTATION
Region: 1
City: GUNTERSVILLE State: AL
County:
License #:
Agreement: Y
Docket:
NRC Notified By: JAMES L. McNEES
HQ OPS Officer: ARLON COSTA
Notification Date: 06/03/2004
Notification Time: 08:37 [ET]
Event Date: 06/03/2004
Event Time: 06:30 [CDT]
Last Update Date: 06/04/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
KENNETH JENISON (R1)
THOMAS ESSIG (NMSS)
ROBERTA WARREN (TAS)

Event Text

ALABAMA AGREEMENT STATE REPORT ON STOLEN GAUGE

"At 4:07 p.m. Gary Brunson of the Alabama Department of Transportation called and reported that a Campbell Pacific gauge, Model MC3, Serial # M32076686 had been discovered stolen from their Guntersville, Alabama Project Office at approximately 6:30 this morning, Thursday, June 3, 2004. Brunson stated the device contained approximately 10 mCi of Cs-137 and 50 mCi of Am-241/Be.

"Brunson further stated he had delayed notifying the Agency until he had a copy of the police report from the Guntersville Police Department, who had investigated the theft. Someone had apparently climbed the fence, then broke into the testing lab building and took a nuclear density gauge and an air flow meter. A Troxler Model 4640 nuclear gauge was sitting beside the Campbell Pacific gauge but was not taken. Because both an air gauge and a density gauge were taken, Mr. Brunson believes the thief was taking something to sell and not taking something from which a radioactive source could be removed, or else they would have taken both nuclear gauges.

"Mr. Brunson agreed that if the device is not located by mid morning tomorrow, Friday, June 4, 2004, that he would work with the Agency to distribute an information notice on the missing device to area law enforcement agencies."

* * * UPDATE 1143 EDT ON 6/4/04 EMAIL FROM J. MCNEES TO W. GOTT * * *

The First Division Office located in Guntersville, AL reported the incident, but the project was in Huntsville, AL, which is part of the First Division.

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General Information or Other Event Number: 40792
Rep Org: SC DIV OF HEALTH & ENV CONTROL
Licensee: CANCER CENTER OF THE CAROLINAS
Region: 1
City: GREENVILLE State: SC
County:
License #: 676
Agreement: Y
Docket:
NRC Notified By: DAVID KING
HQ OPS Officer: CHAUNCEY GOULD
Notification Date: 06/04/2004
Notification Time: 15:15 [ET]
Event Date: 06/03/2004
Event Time: 14:00 [EDT]
Last Update Date: 06/04/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
KENNETH JENISON (R1)

Event Text

AGREEMENT STATE MEDICAL MISADMINISTRATION

The South Carolina Department of Health and Environmental Control was notified on Friday, June 04, 2004 of a possible medical rnisadministration notification which was reported by the Radiation Safety Officer for the Cancer Center of the Carolinas. A Cs-137 brachytherapy radiation dose was administered to a patient where the calculated administered dose differed from the prescribed dose by more than 20%. This apparently occurred when the radiation source was not fully extended to the end of the application catheter. The event is under investigation and updates will be made through the national NMED system as they become available.

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Hospital Event Number: 40797
Rep Org: WILLIAM BEAUMONT HOSPITAL
Licensee: WILLIAM BEAUMONT HOSPITAL
Region: 3
City: ROYAL OAK State: MI
County:
License #: 21-01333-01
Agreement: N
Docket:
NRC Notified By: CHERYL SCHULTZ
HQ OPS Officer: CHAUNCEY GOULD
Notification Date: 06/08/2004
Notification Time: 17:03 [ET]
Event Date: 06/08/2004
Event Time: 14:25 [EDT]
Last Update Date: 06/08/2004
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
MICHAEL PARKER (R3)
THOMAS ESSIG (NMSS)

Event Text

MEDICAL EVENT AT THE WILLIAM BEAUMONT HOSPITAL IN ROYAL OAK, MI

On Tuesday, June 8, 2004 at 2:25 p.m., a patient was scheduled for an I-131 thyroid uptake with an oral dose between 5 and 20 microcurie. Instead, the patient was administered 915 microcurie (34 MBq), which resulted in an absorbed dose of 2675 rad to the thyroid (assuming a 55% radioactive iodine uptake) and 81 rad effective dose equivalent.

Each Month the Radiopharmacy prepares an oral solution of sodium iodide I-131 for uptake doses which are pipetted into individual patient dose vials. The sodium iodide I-131 uptake solution for June contained 12 microcurie per milliliter (ml) in a total volume of 300 ml. The Radiopharmacy technologist prepared the uptake dose by pipetting one ml of solution into the patient vial, which, should have yielded a dose of approximately 12 microcurie. The pipette that the Radiopharmacy technologist used to prepare this dose had been used earlier in the day to prepare therapeutic doses of I-131, and was labeled as the therapy pipette. The Radiopharmacy technologist did not realize that she had picked up the pipette labeled for therapy and assumed it was the pipette used for preparing the uptake doses. Usually the uptake pipette is stored in a shielded vial in the far right corner of the fume hood, but in this case, the therapy pipette was located in the far right corner. The Radiopharmacy technologist assayed the dose in the dose calibrator and noted that the reading was too high for an uptake dose. This caused the staff to question which pipette was used, and they confirmed that the therapy pipette was used. The Radiopharmacy staff discarded the dose in accordance with radioactive waste procedures, and proceeded to draw another uptake dose with the pipette labeled for uptakes. One milliliter was drawn and assayed in the dose calibrator and read 0.915 mCi/ml. The Radiopharmacy technologist accepted the dose thinking that it was really 9.15 microcurie instead of 0.915 millicurie. The computer program is set up to accept I-131 uptake doses on the basis of correct volume and since the volume was within the acceptable range of 1 ml, the computer printed a label for the dose and it was dispensed. The nuclear medicine technologist followed the procedure for confirming the dose prior to administration by checking the patient name, ID number, the I-131 uptake procedure and circling the dose. She looked at the dose printed on the label and thought that the dose was 9.15 uCi instead of the what was printed on the label (0.915 mCi), and administered the dose to the patient.

The Radiopharmacy technologist became concerned about using the wrong pipette and contacted the Radiopharmacist, who then discovered the error. The therapy pipette contained residual millicurie amounts of therapeutic I-131 solution which contaminated the I-131 uptake dose.

B. Why the Event Occurred

The root cause was determined to be the lack of an adequate double check of the I-131 uptake dose prior to administration. A pipette contaminated with 2 millicurie I-131 was inadvertently used to prepare the uptake dose. The Radiopharmacy computer was programmed to detect volume errors, but not activity errors, so it accepted the dose and printed the label. The Radiopharmacy technologist did not detect the error when she assayed the dose for this second redraw, because she assumed that the activity displayed 9.15 uCi, rather than the actual activity displayed, which was 0.915 mCi. The nuclear medicine technologist who double checked the dose mistook the 0.9 mCi for 9 uCi on the dose label and administered the dose. She had been working in an imaging room, but was needed to cover the thyroid uptake room near the end of the work shift. This may have contributed to the error made when confirming the dose.

C. The Effect on the Patient

The absorbed dose to the thyroid was 2675 rad (assuming a 55% radioactive iodine uptake) and the effective dose equivalent was 81 rad. The patient is expected to return to William Beaumont Hospital tomorrow (6/9/04) for treatment with I-131 for hyperthyroidism. The additional dose given for the uptake is a fraction of the dose that will be administered for therapy. The patient is not expected to have any adverse effects.

D. What improvements are Needed to Prevent Recurrence

A complete investigation was conducted to determine the root cause of the medical event. A new pipette will be used for each I-131 uptake patient dose, which will prevent the cross contamination. The computer will be re-programmed to accept uptake dose activity (ie., 5 - 20 microcurie) rather than volume. The computer will not print a label for the uptake dose unless the activity is within the predefined range. The radiopharmacy staff have been trained not to over-ride the failsafe mechanisms of the computer. The nuclear medicine technologist will be retrained in the dose verification process prior to a dose administration. Both the Radiopharmacy technologist and the nuclear medicine technologist will review the dose units (i.e., microcurie, millicurie, MBq) and pass a test.

E. Actions Taken to Prevent Recurrence

1. A new pipette will be used for each I-131 uptake patient dose, which will prevent the cross contamination.

2. The computer will be re-programmed to accept uptake dose activity (i.e., 5 - 20 microcurie) rather than volume. The computer will not print a label for the uptake dose unless the activity is within the predefined range.

3. The nuclear medicine technologist will be retrained in the dose verification process prior to a dose administration.

4. Both the Radiopharmacy technologist and the nuclear medicine technologist will review the dose units (i.e., microcurie, millicurie, MBq) and pass a test.

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Friday, March 30, 2012