Event Notification Report for April 18, 2007

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THIS IS NOT A NEW REPORT.

This event report was originally withheld from public release under the NRC's policy for protecting sensitive unclassified information. The NRC has reevaluated this policy and is now making this event report available to the public with suitable redactions.
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UNFAVORABLE GEOMETRY CONTAINER BELOW LIMIT IN URANIUM RECOVERY GENERAL PURPOSE AREA

"I. Event Description

"On Wednesday April 18, 2007, at approximately 1330, Uranium Processing and Research Reactors (UPRR) personnel notified Nuclear Criticality Safety that a procedural deviation had occurred during the transfer of solution from favorable geometry columns to an unfavorable waste container. The event occurred in the General Purpose Area of the Uranium Recovery Facility where used organic solution from the solvent extraction system is purified for re-use or disposal. The General Purpose Area is physically segregated from the Dissolution and Solvent Extraction Processing Areas of Uranium Recovery, is not part of the Container Controlled Area, and consequently carefully controlled use of unfavorable geometry containers is part of the approved process.

"Dual, independent sampling of the organic solution's uranium concentration is performed according to procedure to verify Nuclear Criticality Safety limits are met prior to bringing the solution into the General Purpose Area. The solution is then processed in favorable geometry columns to remove uranium in accordance with procedural requirements. After processing, the solution can be returned to the extraction process by performing dual sampling and subsequent transfer to a borosilicate glass Raschig ring filled (critically safe, neutron poisoned) container. If however, the material is to be disposed of, then an additional dual sampling by Nuclear Materials Control personnel is required prior to transfer to an unpoisoned, unfavorable geometry waste container through an inline monitor.

"In this event, approximately 60 liters of solution required processing. The operator performed the initial dual, independent sampling of the solution for entry to the process. The results of sampling [DELETED], well below the operating limit of [DELETED]. The operator then processed the solution according to procedure to remove the majority of the uranium. He then obtained two samples of the remaining low concentration solution and verified acceptability of the solution for transfer. These results were [DELETED], respectively. At this point the operator transferred the solution to an unfavorable geometry waste container without the required NMC samples or inline monitor.

"II. Evaluation of the Event

"10 CFR 70 Appendix A states that the NRC must be notified of an event within 24 hours followed by a 30-day written report if the following condition is met:

"(b) Twenty-four hour reports. Events to be reported to the NRC Operations Center within 24 hours of discovery, supplemented with the information in 10 CFR 70.50(c)(1) as it becomes available, followed by a written report within 30 days;

"(2) Loss or degradation of items relied on for safety that results in failure to meet the performance requirement of §70.61.

"An evaluation has determined that this event resulted in loss or degradation of items relied on for safety (IROFS's) resulting in failure to meet the performance requirement of §70.61 in that the risk of a credible high-consequence event (i.e., a criticality accident) was no longer limited such that its likelihood was highly unlikely. However, multiple other IROFS's as noted above (dual input sampling, uranium removal processing, and dual sampling prior to transfer) were in place and functioning to prevent a criticality accident.

"The documented ISA scenarios were reviewed. The evaluated scenario for this operation identified multiple IROFS to prevent transfer of an unsafe mass of uranium to an unfavorable geometry waste drum.

"1. First and foremost, the concentration limit of [DELETED] grams [DELETED]/liter verified by two independent samples ensures the mass of material in the process is limited.

"2. Second, dual independent sampling is performed by two different organizational groups to ensure an acceptable mass prior to transfer from the column system to unfavorable geometry.

"3. Third, the solution is transferred through an active in-line monitoring system that terminates the transfer (i.e., shuts off the flow) if an unacceptable concentration is detected.

"Of these controls, the first was executed properly in this event. Part, but not all, of the second control set was also executed. The third control was not used.

"Criticality safety calculations supporting the ISA demonstrate that even if the solution was at the upper limit for entry to the area, no Uranium was removed during processing, and the material was transferred to unfavorable geometry without verification, that a criticality could still not occur.

"III. Notification Requirements

"The event is reportable under 10 CFR 70 Appendix A (b) (2) Loss or degradation of items relied on for safety that results in failure to meet the performance requirement of §70.61.

"IV. Status of Corrective Actions:

"The solution has been returned to the favorable geometry columns using the approved procedures, and the concentration was confirmed by sampling to be less than [DELETED] grams [DELETED]/liter. Operations in the Uranium Recovery Facility General Purpose Area, where this process is performed, have been suspended. An investigation of the event is underway."

A facility representative notified the NRC Resident Inspector.

* * * UPDATE AT 1107 ON 4/20/07 FROM L. MORELL TO P. SNYDER * * *

"BWXT's investigation of this issue is ongoing. Based on our investigation and associated time lines, BWXT believes that notification may also have been required under 10CFR70, Appendix A:(a)(5). This determination was made at approximately 10:30 am on April 20, 2007.

"This reporting criteria states:
"Loss of controls such that only one item relied on for safety, as documented in the ISA Summary, remains available and reliable to prevent a nuclear criticality accident, and has been in this state for greater than 8 hours.

"Therefore, BWXT is providing this update to the notification report and a corrected page 1 of the original Event Notification that includes identification of 10CFR70, Appendix A: (a)(5). The facts of the issue as described in the initial report remain as stated."

The coversheet of the original event notification has been revised to include the additional notification requirement as a result of this report.

The facility will notify the NRC Resident Inspector. Notified R2DO (Munday), FSME EO (Morell) and Fuels OUO Group (via e-mail).

* * * UPDATE 05/11/08 BY P. SNYDER * * *

THIS IS NOT A NEW REPORT.

This event report was originally withheld from public release under the NRC's policy for protecting sensitive unclassified information. The NRC has reevaluated this policy and is now making this event report available to the public with suitable redactions.

MEDICAL EVENT - PATIENT RECEIVED DOSE LESS THAN PRESCRIBED

The following information is taken from a facsimile sent by Community Hospital Indianapolis:

A patient undergoing Yttrium-90 theraSphere treatment of the liver received an under dose. The original estimated intended dose was 301 Gray (Gy). The authorized user confirmed the setup during performance of the pre-administrative checklist. The under dose occurred due a mis-positioned stopcock that resulted in part of the intended source material being directed to a waste vial rather than the patient catheter. When the mis-directed (source) liquid was noted in the waste vial tubing, the authorized user re-checked the delivery system and corrected the stopcock orientation. Based on a delivered source activity of 3.28 GigaBecquerel (GBq), the estimated dose received by the patient is 130 Gy.

The patient has been notified of the under dose.

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.

* * * UPDATE AT 1200 EDT ON 05/15/07 FROM ANDREA BROWNE TO OPS CENTER VIA COMMERCIAL MAIL * * *

The following information was received as an update to this report via letter dated April 30, 2007 addressed to the Operations Center:

"After an investigation by the region III office, Community Hospitals, Indianapolis, Materials License Number 13-06009-01 is expanding the written follow-up to the verbal report of a medical event made 4/18/07, given Notification Number 43308 and the written report filed 4/18/07.

"Per 35.3045

"(i) Licensee's Name: Community Hospitals of Indiana, Inc. (#13-06009-01)

"(ii) Name of Prescribing physician: [DELETED] (Authorized User)

"(iii) Brief Description of Event: Partial dose routed to waste vial because of incorrect stopcock orientation. The prescribed treatment site was the right liver lobe; the prescribed treatment site dose was 120 Gy. Because of the partial routing of the dose to the waste vial the dose delivered to the right liver lobe was 54.4 Gy.

"(iv) Why event occurred: Authorized user confirmed setup was correct when queried during the pre-administration checklist. However, stopcock was turned so that dose was directed to waste vial rather than into the patient delivery catheter. The interventional radiologist noted liquid in the waste vial tubing and directed the authorized user to stop; The authorized user re-checked the delivery system and corrected the stopcock orientation. The remainder of the dose was delivered to the patient.

"(v) Effect, if any, on the individual who received the administration: It is believed by the radiation oncologist and the interventional radiologist that there will be no effect on the patient. This treatment is one of several planned for this patient. Justification for this conclusion is that the original estimated tumor dose was 301 Gy based on the written directive of 120 Gy to the right lobe of the liver. Based on a delivered activity of 3.28 GBq, considering the tumor hypervascularity and volume, the estimated tumor dose is 130 Gy as a result of the 54.4 Gy delivered to the right liver lobe. This is within the dose range that the FDA has accepted for tumor dose in cases of liver metastases.

"(vi) Actions planned to prevent recurrence: A second individual (the interventional radiologist, radiologic technologist, nurse, or similarly trained individual) will be required to check the delivery setup portion in addition to the individual actually delivering the dose. This second check will be built in to the checklist.

"(vii) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not: The interventional radiologist has notified the patient of the event. The referring physician was also notified of the event.

"This revised report will also be sent to the Operations Center."

Notified R3DO (Bruce Burgess) and FSME (Greg Morell).