6505--VALL Iodine Isotope IDIQ

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT/RFI DESCRIPTION This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,300 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. The Department of Veterans Affairs (VA) is seeking sources capable of providing variety types of bread listed below. STATEMENT OF WORK 1. SCOPE The intent of this Request for Proposal is to enter a Firm Fixed-Priced Indefinite Quantity Indefinite Delivery (IDIQ) Contract to provide Radiopharmaceutical Supplies to the participating Veterans Affairs Healthcare System facilities specified herein. All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, and provisions of this solicitation for the base year period of October 1, 2026, through September 30, 2031, with the Government s option to extend the contract for four (4) additional one-year periods. PARTICIPATING VA HEALTHCARE SYSTEM: VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357 DELIVERABLES: CLIN Description Qty 0001 IODINE I-123 5 mCi per capsule 10 Capsules 1001 IODINE I-123 5 mCi per capsule 10 Capsules 2001 IODINE I-123 5 mCi per capsule 10 Capsules 3001 IODINE I-123 5 mCi per capsule 10 Capsules 4001 IODINE I-123 5 mCi per capsule 10 Capsules PERIOD OF PERFORMANCE: Base: 10/1/2026 9/30/2027 Option Year 1: 10/1/2027 9/30/2028 Option Year 2: 10/1/2028 9/30/2029 Option Year 3: 10/1/2029 9/30/2030 Option Year 4: 10/1/2030 9/30/2031 2. ROUTINE ORDERS Routine orders require delivery on the next business day, unless specified elsewhere in this contract. 3. EMERGENCY ORDERS Emergency delivery requires same day delivery and with the time specified during the placement of order. 4. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor s acceptance to commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by Government personnel. If the Contractor cannot make delivery and an outside source must be utilized, the Contractor will be responsible for paying the difference in cost. VA LOMA LINDA HEALTHCARE SYSTEM (VALLHCS): Delivery Location Nuclear Medicine Section, Imaging Service. Main hospital, 4th Floor, Room 4E15, Extension 2669. Normal Work Hours 8:00am to 4:00pm, Monday through Friday Instruction 1) Delivery shall be next business day. 5. UNIT DOSE ITEMS For unit-dose items, products shall be pre-drawn into a syringe, calibrated and delivered at time specified when ordered. The word Dose represents the maximum size potency per unit price; however, order may be less. 6. PACKAGING AND MARKING a) The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. b) Items must be adequately packaged to prevent damage during shipping, handling, and storage. c) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award. d) Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped. e) The Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products. 7. QUALITY ASSURANCE The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than + or 10% for therapeutic doses; = or 20% for imaging doses at the time of calibration, from the quantities specified. The Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to VALLHCS upon request. In the event that a quality control or material defect is suspected and/or detected by the Contracting Officer Representative (COR), the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise in calibration. Provide professional examination of product; submit results and recommendations to the Contracting Officer. Make expedient replacement of any product suspected of being deficient. The Contractor shall make quality control records available to VALLHCS upon written request from the Contracting Officer The Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc.; unless otherwise stipulated or prohibited by licensure or regulatory requirements. The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. Any recalled dose for any reason shall be credited to the Government for the full amount. Any individual doses shall be traceable to the original elution if requested by the Government as per VISN 22 pharmacy standards and regulations. Any dose deemed below standard by the facility shall be credited toward the account. This shall be determined by the Authorized User or COR. Substitutions or Generic Brands may only be used with the express permission of the facility. Items shall be bar-coded and be compatible with the existing NMIS System. The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive isotopes between facilities and shall strictly adhere to these requirements. Deliveries not properly handled according to regulations will not be accepted. The Contractor shall be responsible for all costs incurred for any radiopharmaceutical and nonradioactive items contracted must find alternate supplier for the contracted items. In the event of a manufacturer or pharmacy recall or quality assurance failure, the Contractor shall notify VALLHCS Nuclear Medicine Department immediately. A radio-pharmacist in the employ of the successful Contractor must be available to: Set-up the quality assurance program on the radiopharmaceutical preparations required by Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), and the Joint Commission. Act as a reference source concerning questions on the regulation of radiopharmaceuticals. Provide reference services for research drugs and radionuclides under research protocols. Provide instruction (continuing education) to the technologists on new changes in radiopharmaceutical products and availability. 8. RECALLED AND DEFECTIVE PRODUCTS The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products. 9. CERTIFICATION AND LICENSING REQUIREMENT Pharmacists employed by the Contractor shall be an authorized user on the Contractor s Radioactive Materials License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency. 10. SAFETY GUIDELINES AND REQUIREMENTS Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements. 11. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT New Year s Day January…