Radium Ra223 (Xofigo) Therapy Dichloride

DESCRIPTION AWARD NOTICE Contract No. 36C25723P0468 Radium Ra 223 (Xofigo) Dichloride Please see attached fully executed award for Department of Veterans Affairs North Dallas VAMC 4500 S. Lancaster Rd. Dallas, TX 75216-7167 Title of Requirement Radium Ra 223 (Xofigo) Dichloride Date of Award 06/07/2022 Effective Date 06/07/2023 Contract Award Office NCO-17 POC Name/Phone Sussie DeMello 214-857-0132 Elizabeth.Garces@va.gov Contracting Officer/ Administrator Name/Phone Myrtis Clemons Myrtis.clemons@va.gov (210) 694-6317 Contractor Name / POC Cardinal Health 414, LLC 7000 Cardinal PL Dublin, OH 43017-1091 POC: Kayla Sutton Email: kayla.sutton@cardinalhealth.com Phone: 617-822-4255 Contract Type FFP Total Contract Value: $403,996.00 Base Period Value: $403,996.00 Scope of Work. Contractor must be licensed by the US Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. Contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals. Contractor/licensee must be able to provide Radium-223 (Xofigo) radiopharmaceuticals to the Nuclear Medicine Service at the Dallas VA Medical Center. Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System. Ra223 (Xofigo) doses will be ordered/scheduled with at least 72 hours advance notice to the vendor to ensure dose availability. Should the vendor s ability to supply product from the applicable pharmacy be limited for any reason the vendor shall notify the Customer of any limitations on the delivery times and dates that may affect its ability to supply Product when requested. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. It is preferred that the Contractor ensure bar code compatibility with the VANTHCS Nuclear Medicine Information System (NMIS). Contractor will support any necessary steps to ensure approval for use of new infrastructure (Example: Information Security) if required - upon award, and prior to start of contract. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VANTHCS upon request. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only: (a) By-product material or cyclotron produced materials manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State. (b) Reagent kit that has been manufactured, labeled, packed, and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Contractor will utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care or IRB approved research. Contractor/licensee will deliver radioisotope in an amount greater than or equal to the activity ordered with calibration for the specified appointment time so that patient administered quantity is within regulatory limits of the prescribed dose. All routine radiopharmaceutical dose deliveries must occur >30 minutes prior to the calibration time. In the event that Nuclear Medicine Service is unable to perform a patient procedure due to the dose/injection arriving in an unusable form (e.g. too low activity), the vendor will not invoice for the dose.