AWARD
65 -- Y90 SIR Spheres
- Notice Date
- 2/23/2023 7:29:14 AM
- Notice Type
- Award Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25723P0195
- Archive Date
- 03/09/2023
- Point of Contact
- Contract Specialist, Phone: 512-228-1088
- E-Mail Address
-
robert.clark15@va.gov
(robert.clark15@va.gov)
- Award Number
- 36C25723P0195
- Award Date
- 02/22/2023
- Awardee
- SIRTEX MEDICAL INC MA 01801-3363 USA
- Award Amount
- 87750.00
- Description
- STATEMENT OF WORK: NUCLEAR MEDICINE SERVICE � Y90 RESIN MICROSPHERES VANTHCS requires the manufacturing and delivery of Y-90 resin microspheres which are tiny radioactive �beads� used in selective internal radiation therapy (SIRT), sometimes referred to as Y-90 radioembolization, and are used for the treatment of stage IV colon cancer that has spread to the liver and can�t be surgically removed. 1.� 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. The Radiopharmaceuticals must be shipped from the Licensee directly to VANTHCS.� Please note that the Offeror must provide copies of all relevant licenses, certifications, and/or partnering agreement(s), along with their proposal to the Contracting Officer. 2.� 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. 3. Contractor/licensee must be able to provide therapeutic Nuclear Medicine radiopharmaceuticals to VANTHCS: VA North Texas HCS (Dallas VA Medical Center)�� 4.� Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. Contractor must supply each VANTHCS facility with a bar code reader or comparable VA approved device that is compatible with the VANTHCS Nuclear Medicine Information System (NMIS) or provide approved infrastructure to meet this requirement. 5.� If the Contractor's/licensee�s system varies from the VANTHCS facility NMIS, the Contractor shall provide means for compatibility or an alternative system with any needed data migration, technical support, and training for staff on its use at no additional cost to the Government. Any additional tracking system(s) provided must comply with all VA and associated IT, as well as information security, requirements. 6. �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. 7.� All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. 8.� 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. 9.� 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. 10.� Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System with proof of contingency supply chain to prevent disruption of clinical care. 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. Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or surcharges. A tiered pricing structure with lower cost per increased quantity used is preferred. 11.� 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.� 12.� Radiopharmaceutical Returns for Credit:� VANTHCS facilities are each allowed a minimum 10% radioisotope returns for all contracted radiopharmaceuticals due to patient cancellation, no show, and/or rescheduling at no cost to the facility. In addition, the Contractor shall accept returns for full credit toward future orders under the following conditions:� a.� Product(s) ordered or shipped in error. b.� Product(s) damaged in shipment c.� Concealed shipping damages d.� Recalled product(s) e.� Outdated products in unopened, original container.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/977ad70f42c24084ac39061a3255f04c/view)
- Place of Performance
- Address: Dallas, TX 75216, USA
- Zip Code: 75216
- Country: USA
- Zip Code: 75216
- Record
- SN06599253-F 20230225/230224211920 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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