S02 Salient Characteristics_Enclosure 3.docx

Salient Characteristics and Requirements

A. Ordering Requirements

1. The Contractor shall provide personnel for orders for Yttrium-90 resin microspheres to be placed during standard hours of care Monday through Friday from 0800 (8:00 AM AZT) until 1630 hours (4:30 PM AZT), not including Federal holidays. Upon the order being placed, the Contractor is to send confirmation to the ordering VAMC official via email.

2. The Contractor shall receive orders for Yttrium-90 resin microspheres from the Nuclear Medicine section of SAVAHCS Radiology Service. The Contractor shall ensure the Nuclear Medicine staff name and contact information that placed the order is included.

3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose per specific requirements provided by the Nuclear Medicine section based on Nuclear Regulatory Commission guidelines outlined in 10 CFR Part 35 Medical Uses of Byproduct Material.

4. The Contractor shall notify VAMC Nuclear Medicine section immediately should the inability arise to provide Radiopharmaceutical (Yttrium-90) doses by the required date and time.

5. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist.

B. Additional Requirements

1. The Contractor shall provide any training or education, required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) to qualified Nuclear Medicine staff, Interventional Radiology staff, and the Radiation Safety Officer at SAVAHCS.

2. The Contractor shall provide any documentation required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) resin microspheres.

3. The Contractor shall obtain, maintain, and provide evidence at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the Yttrium-90 resin microspheres.

C. Government Responsibilities

1. The Government shall ensure all routine orders for Yttrium-90 resin microsphere doses will be placed by the VAMC to the Contractor a minimum of three business days prior to treatment and before the clinic close of business via phone or internet. The order will include specified activities of doses and calibration times.

D. Salient Characteristics

The Following are the salient characteristics for the Sirtex SIR-Spheres Y-90 resin microspheres:

Please Answer yes or no, in regards to your microspheres, under each of the 6 characteristics.

1. FDA approved manufacturer and distributor of these Radiopharmaceuticals.

2. The Radiopharmaceuticals must be resin microspheres, not glass. The doses must be drawn and allows for last minute adjustments to be possible.

3. Must contain the specific feature to treat stage 4 colon cancer that has spread to the liver and can't be surgically removed.

4. Must consist of biocompatible microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter.

5. Allow for radioactivity of particles to be delivered, which allows us to use a larger or smaller volume, to cover larger or smaller areas of the liver, depending on the need.

6. Contain the capability a feature to allow split one dose between 2 blood vessels, if needed for better delivery into the tumor, vs having to order 2 separate vials one for each vessel.