6505--VA Loma Linda FDG

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 18-FDG, F18 NaF, and Bulk F-18 FDG. The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required. STATEMENT OF WORK (SOW) Nuclear Medicine Radiopharmaceutical Supply for FDG dose supplies. General: The Department of Veterans Affairs Loma Linda Healthcare System Nuclear Medicine service intends to set up a single award Firm Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ) Contract to procure radiopharmaceutical Supplies. Period of Performance: Base: 12/15/2026 12/14/2027 Option Year 1 (OY1): 12/15/2027 12/14/2028 Option Year 2 (OY2): 12/15/2028 12/14/2029 Option Year 3 (OY3): 12/15/2029 12/14/2030 Option Year 4 (OY4): 12/15/2030 12/14/2031 Deliverables: Item Description Base Estimated Qty OY1 Estimated Qty OY2 Estimated Qty OY3 Estimated Qty OY4 Estimated Qty 18-FDG 12 mCi per dose 240 240 240 240 240 F18 NAF 10 mCi 240 240 240 240 240 Bulk F-18 FDG US (30mCi max) 4 4 4 4 4 STAT Fees (if applicable) As needed As needed As needed As needed As needed The quantities cited above chart are estimated quantities for base and all option periods; quantities are not a contractual statement of precise quantities that the Government will order. The quantities given are estimated only, and no guarantee of their accuracy is either given or implied. The Government will only pay for quantities that are actually ordered and for which the services are fulfilled. Order Limitation Minimum Order per delivery order $10,000.00 Maximum Order per delivery order $350,000.00 Radioactive agents may be Injection, USP. Able to assay the dose in a suitable dose calibrator prior to administration. Must be a sterile dose for intravenous injection. Routine Orders: Routine orders require delivery on the next business day, unless specified elsewhere in this contract. Emergency Orders: Emergency delivery requires delivery on the same day and with the time specified during the placement of order. 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 Delivery Location Nuclear Medicine Section, Imaging Service. Main hospital, 4th Floor, Room 4E15, Extension 2669 or 2672. Normal Work Hours 8:00am to 4:00pm, Monday through Friday Instruction 1) Delivery shall be next business day. Unit Dose Item: 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. Packaging and Marking: The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. Items must be adequately packaged to prevent damage during shipping, handling, and storage. 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. 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. The Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products. Quality Assurance: The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than + 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 must 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. Contractor to provide FDG bulk dose for MEDRAD system. Contractor able to provide up to 15mCi of 18-FDG for PET patients. 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. 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. 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. National Holidays Observed by the Government: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day 3rd Monday in June Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. Contractor Delivery Personnel: All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English. Parking and Speed Limit: Park only in areas designated by the Point of Contact (POC) or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the POC of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Security, the offenses will be handled in Federal Court as they are Federal offenses. Placement of Verbal Orders: Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders. The sheet of paper will go to the Point of Contact (POC) or alternative Point of Contact (POC). Invoice and Payment: No advanced payments will be authorized. The contractor shall submit invoices on a monthly basis. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly. Personnel Policy: The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor. Smoking Policy: Smoking is prohibited at our facility. Security Requirements: The C&A requirements do not apply, and that Security Accreditation Package is not required. If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses to this notice shall be submitted via email to [email protected]. Telephone responses will not be accepted. Responses must be received no later than Friday, November 20, 2026, by 10AM Pacific Local Time. All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.