6505--Lab - PET Radiopharmaceuticals

ent and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06. This solicitation is not set-aside and allows for Full and Open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 - Pharmaceutical Preparation Manufacturing, with a small business size standard of 1,300 employees. The FSC/PSC is 6505 - Drugs and Biologicals. The Department of Veterans Affairs, Network Contracting Office 2, 130 West Kingsbridge Road, Bronx, NY 10468, is seeking to purchase Positron Emission Tomography (PET) Radiopharmaceuticals for the Albany VA Medical Center (VAMC). All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 Base Year: Radiopharmaceuticals in accordance with the Statement of Work 1 Job 0002 Option 1: Radiopharmaceuticals in accordance with the Statement of Work 1 Job 0003 Option 2: Radiopharmaceuticals in accordance with the Statement of Work 1 Job 0004 Option 4: Radiopharmaceuticals in accordance with the Statement of Work 1 Job 0005 Option 5: Radiopharmaceuticals in accordance with the Statement of Work 1 Job Annual estimates for radiopharmaceuticals are found in the Statement of Work. The Government estimates the volumes listed in the Statement of Work but does not guarantee volumes as listed. The Guaranteed Minimum dollar amount to be executed between the date of contract award and 9/30/2026 is $50,000.00. Prices quoted shall be all inclusive to include all associated costs supplies, shipping, handling, packaging, storage, and licenses. Statement of Work Radiopharmaceuticals Scope The Department of Veterans Affairs Stratton VA Medical Center located at 113 Holland Avenue, Albany, NY 12208 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Stratton VA Medical Center at Albany intends to award a five-year, firm fixed price, Indefinite Delivery, Indefinite Quantity (IDIQ) Contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a contract period of performance of March 15, 2026, through March 14, 2031. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State, and Local Regulations. The Contractor shall be able to provide all items listed in the Schedule of Radiopharmaceuticals with deliveries as required. The respectively awarded contract is subject to funds availability. The total minimum amount for Ordering Period 1 will be obligated after award of the IDIQ through Purchase Orders. All invoices shall be submitted against the Purchase Orders. Schedule Of Radiopharmaceuticals: The Contractor shall provide the radiopharmaceuticals in accordance with the terms and conditions specified in the Statement of Work. The items to be procured per contract year (approximates) are as follows: 642 QTY of F18 FDG Fluorodeoxyglucose unit dose 5 QTY of F18 NaF Sodium Fluoride unit dose 140 QTY of Pylarify (piflufolastat F18) unit dose 60 QTY of Neuroceq (florbetaben F18) unit dose, and 35 QTY of Flyrcado (flurpiridaz F18) unit dose Statement Of Work The Contractor agrees to provide all radiopharmaceuticals as listed in the Schedule of Radiopharmaceuticals to the Stratton VA Medical Center at Albany on a daily and/or as needed basis in accordance with this Statement of Work and the respective awarded contract. The Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides New York and be regularly established in the business of providing radiopharmaceuticals. The Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their quote package. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal and or State standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This will include the FDA, USDOT, DOE, USNRC, and ICC regulations and standards. Documentation of USDOT package integrity testing shall also be provided. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled radioactive on the outside of the carton in which it is shipped. The Contractor shall label all products delivered as to the Stratton VA Medical Center at Albany with the radiopharmaceutical, activity, time of preparation, calibration time, expiration time, and date. The Contractor shall hold a current unrevoked NRC or an agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. The Contractor shall provide a copy of their radioactive material license with their quote. The Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify their radioactive materials license. The Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. The Contractor shall perform all quality control procedures as required by Federal and State Regulatory Agencies. The Contractor shall provide with their quote, the following information: The Contractor s regular work hours. The Contractor s telephone number for call-in orders during regular work hours. The Contractor s telephone number for expert advice concerning awarded products. The Contractor will furnish a statement that any radiopharmaceuticals delivered as ready-to-use (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and or with the United States Pharmacopeia. Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide those updated changes in writing to the CO and COR. Current package inserts of all radiopharmaceuticals supplied under the contract awarded will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR at the Stratton VA Medical Center at Albany Nuclear Medicine Service. The Contractor shall make quality control records available to the COR upon written request from the CO or COR. The Contractor shall test all products for quality control periodically as required by the USFDA. This testing shall be performed at no cost to the Government. The Contractor shall provide a detailed description of the test upon request. The Contractor shall replace any items delivered damaged o