Event Notification Report for March 28, 2008

AGREEMENT STATE REPORT INVOLVING A PARTIAL EQUIPMENT FAILURE OF AN HDR UNIT DURING A SOURCE EXCHANGE

The following information was received from the State of Washington via email (quotations omitted for ease of reading):

STATUS: New

Licensee: Providence Everett Medical Center
City and State: Everett, WA
License Number: WN-M0135-1
Type of License: Medical
Date and time of Event: 28 March 2008
Location of Event: Everett, WA

ABSTRACT: (where, when, how, why; cause, contributing factors, corrective actions, consequences, Dept. of Health (DOH) on-site investigation; media attention):

A Varian Medical Systems (varian) representative was attempting a routine source exchange at the licensee's facility. There were no patients or Medical Center staff involved in the source exchange process. The varian rep noted some trouble with making the "old" source enter the exchange container. After several attempts the rep realized the transfer was not proceeding as expected. The rep telephoned staff at Varian Corporate headquarters for assistance. The decision was made to cut the source wire near the source and place the source assembly into the emergency shielded source container (emergency pig). After the wire was snipped and the cut piece placed into the emergency pig, the rep performed a survey and noticed that the radiation levels were less than expected. At this time the licensee and the Varian rep both notified the Office of Radiation Protection of the event by telephone.

The room was locked and barrier tape placed across the door. A Varian recovery team was called for and arrived at the Medical Center, with the source designer, on Saturday, 29 March 2008.

An Office of Radiation Protection investigator also joined the team on Saturday to direct the onsite investigation and recovery.

The investigation determined that both the dummy wire and the source wire had tried to exit the HDR unit simultaneously. The wires become stuck in the "home switch" part of the HDR. When a wire was cut it had been the dummy wire and not the source assembly wire. The cutoff dummy wire had been placed into the emergency pig which had given lower then the expected dose rate readings.

On Saturday, the recovery team successfully retracted the source into the HDR. Testing is underway to determine why the HDR source exchange process had allowed both wires to be sent out at once. A comprehensive written report is expected from the manufacturer within the next few days.

Notification Reporting Criteria: WAC 246-220-250 Equipment Failure.

Isotope and Activity involved: HDR Sealed Source: Ir-192, approximately 185 GBq (5 Curies).

Overexposures? (number of workers/members of the public; dose estimate; body part receiving dose; consequence): None

Lost, Stolen or Damaged? (mfg., model, serial number): Varian HDR source model VS2000 (not lost, not stolen, possibly damaged).

Disposition/recovery: Source recovered 29 March 2008 by Varian recovery team.

Leak test? No "official" leak test yet but several contamination wipe surveys were performed during the course of the recovery. All of these were negative.

Vehicle: N/A

Release of activity? None

Activity and pharmaceutical compound intended: N/A

Misadministered activity and/or compound received: N/A

Device (HDR, etc.) Mfg., Model; Varian VariSource Ix (Trademark) HDR

Exposure (intended/actual); consequences: None to patients and the public. The highest exposure received by a recovery team member was 87 mRem.

Was patient or responsible relative notified? N/A

Was written report provided to patient? N/A

Was referring physician notified? N/A

Consultant used? No

Event Report # WA-08-020.

* * * UPDATE VIA E-MAIL FROM ARDEN SCROGGS TO JASON KOZAL ON 04/18/08 AT 1836 * * *

"A written report was received [by the state] from the manufacturer.

"The Varian report concluded the cause of the incident was 'the service engineer mistakenly extending the active source wire while the dummy wire was already in the same pathway. This action jammed the dummy and source wires at the home switch and prevented the active wire from properly retracting to the tungsten safe when commanded.'

"[The manufacturer] also concluded the likelihood of a licensee / operator recreating this type of event was nil, since the conditions which allowed this to happen are only present when the factory service engineer is working on the unit.

"This was originally reported as an equipment failure but now appears to be an error by the manufacturer's representative."

Notified R4DO (Clark) and FSME (Von Till).

FILTERS NOT SCANNED PROPERLY FOR ACTIVITY PRIOR TO PACKAGING

"Some contaminated cartridge filters were placed/packaged in two (2) 55-gallon drums based on nominal values of U-235 content as opposed to measured values (i.e., some filters were not measured by the segmented scanning system).

"The control system is the scanning of the contaminated filters [individually]. The deficiency was the failure to scan the filters [individually] prior to placing the filters into drums. [Filters packaged in drums are required to be NDA scanned prior to packaging. This is an item relied on for safety (IROFS). Not scanning some filters was a degradation of an IROFS.]

"Written instructions were issued to operations personnel to package contaminated processing cartridge filters. The instructions indicated that the filters had been previously scanned and the U mass values were listed in an attachment to the instructions. However, some of the filters were not scanned, and instead were assigned nominal U-235 mass values. Nominal values are based on process history. Nuclear Criticality Safety required each filter to be scanned prior to being loaded/packaged into drums. Approval of the instructions was based on the implication that all of the cartridge filters had been scanned.

"The two (2) drums were scanned to confirm the total U-235 mass in each drum. The activity to package the filters has been suspended until additional corrective actions can be completed.

"The criticality safety significance is low due to the low U-235 mass values for each filter in addition to the low total U-235 mass for each drum [less than 350 grams U-235 process limit]. In addition, the nominal U-235 values are based on historical records and provide a good estimate of the U-235 content.

"Initial activities to inspect the filters and the use of nominal values prevented the drum limits from being exceeded.

"There were no actual or potential safety consequences to workers, the public, or the environment."

The licensee notified the NRC Resident Inspector.

* * *UPDATE ON 4/2/2008 AT 1615 FROM R. SHAKELFORD TO M. ABRAMOVITZ * * *

NFS is preparing a press release in anticipation of inquiries from the media. The licensee will notify the NRC Resident Inspector.

Notified R2DO (Evans), NMSS (Whaley) and Fuel Cycle OUO (via e-mail).

UNPLANNED DOSE TO FETUS

"A written directive was completed on 3/18/08 prescribing 18 mCi of I-131 (capsule) for the treatment of hyperthyroidism on 3/28/08. The [prescribing physician] indicated on the form that pregnancy test was negative and she was not breastfeeding. The pregnancy test result was attached to the directive.

"Upon arrival the patient completed an assessment form and consent form and she indicated in writing that she was not pregnant or breastfeeding. Staff and authorized user verified patient identity (name and birth date), dose, dose calibrator setting, and route of administration. The patient received the dose as prescribed.

"Nuclear Medicine was contacted by the lab shortly after the administration with a positive pregnancy result that was done on the day of the therapy. The patient's physician was notified. The patient was notified to increase fluids and void frequently and advised to make an appointment with her OBGYN physician. [A] Health Physicist Consultant was also notified and [the hospital] is awaiting the dose calculation to the embryo."

At the time of the report, the hospital had not calculated a dose to the unborn child. The hospital will provide the calculated dose when it is available but the Radiation Safety Officer believes that the result will be less than 50 milliSieverts (< 5 rem).

NEBRASKA AGREEMENT STATE REPORT - MISSING TRITIUM EXIT SIGN

"Fagen Inc. built the bioenergy facility in Fairmont, [NE]. Fagen Inc. purchased a number of tritium exit signs for the facility. After the facility was built, Fagan Inc. turned the facility over to Advance BioEnergy. Advance BioEngery did an inventory of the signs in the facility [on 03/28/08] and discovered a missing sign (SRB Technologies, Model BX020BK, Serial #C061355) [contains 17.5 curies of tritium].

"Advance BioEnergy contacted Fagen Inc. concerning the missing exit sign. Fagen contacted the supplier and, other sites that Fagen had done work at. They have not been able to locate the sign. Fagen has discontinued using tritium exit signs in facilities they construct.

Item Number: NE080008

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks.

This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source