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The Richard L. Roudebush VA Medical Center holds VHA Permit Number 13-00694-03 under the VA's Master Material License (NRC License Number 03-23853-01VA). For a patient treatment on December 30, 2009, involving Yttrium-90 microspheres, the medical center discovered (on same date) that the total activity delivered to the treatment site was less than 80% of the total activity documented in the written directive.

The medical event was discovered when a waste container, which contained used catheters, lines, gloves, tongs, tape, etc., from the treatment were assayed. The waste materials indicated a higher than expected residual activity equal to about 25 percent of the activity that was in the source vial prior to treatment. Examination of the waste materials revealed that nearly all of the residual activity was distributed somewhat uniformly along the length of the approximately 100 cm microcatheter tubing. The current estimate is that about 47.03 millicuries were delivered to the patient, and 15.67 millicuries were in the wastes. The prescribed activity was 63.2 millicuries. Therefore, the patient was under-dosed by about 25.6%. Because this deviation exceeds 20%, a medical event is considered to have occurred per 10 CFR 35.3045(a)(1). Although a lower-than-intended activity was administered, the permittee estimates that the absorbed dose to the target organ was around 109 gray and was within the therapeutic target range of 100 to 150 gray. Therefore, no adverse biological effects to the patient are expected. 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.test

This report is made under 10 CFR 20.2201(a)(1)(ii). A loss of permitted material by Edward Hines Jr. VA Hospital in Hines, Illinois, became known on February 10, 2009. Approximately 54.6 millicuries of hydrogen-3 were released in animal research wastes handled as non-radioactive over a period of 15 years (1994-2008). The maximum amount released in any one year was 12.8 millicuries. These wastes were processed by incineration at off-site facilities. The activities that generated the affected wastes ended in March 2008. Hospital staff will review disposal practices for compliance before allowing similar activities. A written report for this event will be submitted to NRC Region III within 30 days of making this telephone notification. We have discussed with event with our NRC Project Manager (Cassandra Frazier, NRC Region III). Additional information:

Department of Veterans Affairs holds NRC License No. 03-23853-01VA, a master materials license. Permits are issued under the license to Veterans Health Administration facilities. The permit number for the facility involved in these medical events is VHA Permit No. 12-01087-07. National Health Physics Program makes required notifications to NRC. 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

In response to medical events discovered at the VA Medical Center Philadelphia, which have been reported under Event Number 44219, reviews are ongoing of samples of patient charts from other VA facilities with permanent prostate iodine-125 seed implant brachytherapy programs. As the result of these ongoing reviews, medical events were discovered on October 7, 2008, for 6 patients treated at the VA Medical Center in Cincinnati, Ohio. These 6 medical events involved seed distributions in the patients that resulted in D90 doses less than 80% of the prescribed doses. These circumstances were interpreted to meet the definition of a medical event under 10 CFR 35.3045. A 15-day written report on these 6 medical events will be submitted to NRC Region III. We have notified our NRC Project Manager, Cassandra Frazier (NRC Region III), of these medical events.

• * * UPDATE AT 1520 EDT ON 07/23/09 FROM ED LEIDHOLDT TO S. SANDIN * * *

Following the notification of the NRC on October 7, 2008, of the six medical events described in Event Report No. 44548, the NHPP initiated a reactive inspection on October 16, 2008. As a result of this inspection and related clinical reviews, the NHPP is notifying NRC of one additional medical event at the Cincinnati VA Medical Center, for a total of 7 medical events at this facility. This event, also involving prostate brachytherapy with I-125 seeds, was discovered on July 22, 2009. Like the previous six medical events, this additional medical event involves a D90 dose less than 80% of the prescribed dose. We note that the D90 doses for all seven events were based upon CT scans performed one day after the implants, when the prostate is subject to edema from the procedure which often causes underestimation of the true D90. Furthermore, the prescribed doses were 160 gray, instead of the more common 145 gray. Thus, most if not all of these patients likely received clinically adequate dose distributions, despite the percent-wise slightly low D90s. Adverse biological effects to these patients are not expected. The facility has notified the patient. A written report on this additional medical event will be submitted to NRC Region III pursuant to 10 CFR 35.3045. We will notify the NRC Project Manager, Cassandra Frazier, of NRC Region III. Notified R3DO (Hills) and FSME EO (Villamar). 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.