6505--VASD PSMA

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. 1. SCOPE: The Department of Veterans Affairs (VA) is seeking sources capable of providing Gallium-68 Prostate-Specific membrane Antigen (PSMA) agent equivalent to Illuccix for diagnosis of patients with, or suspected of, having prostate cancer receiving services at VA San Diego Healthcare System. PERIOD OF PERFORMANCE (POP): Base: 7/1/2026 12/31/2026 Option Year 1 (OY1): 1/1/2027 12/31/2027 Option Year 2 (OY2): 1/1/2028 12/31/2028 Option Year 3 (OY3): 1/1/2029 12/31/2029 Option Year 4 (OY4): 1/1/2030 12/31/2030 PARTICIPATING VA HEALTHCARE SYSTEMS: VA San Diego Healthcare System 3350 La Jolla Village Drive Nuclear Medicine Service San Diego, CA 92161 2. ROUTINE ORDERS Routine orders require delivery on the next business day, unless specified elsewhere in this contract. 3. DELIVERABLES PoP CLIN Description Estimated Qty UOM Base 0001 Illuccix or equivalent GA-68 agent PSMA 160 EA OY1 1001 Illuccix or equivalent GA-68 agent PSMA 320 EA OY2 2001 Illuccix or equivalent GA-68 agent PSMA 325 EA OY3 3001 Illuccix or equivalent GA-68 agent PSMA 330 EA OY4 4001 Illuccix or equivalent GA-68 agent PSMA 335 EA 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. 4. SALIENT CHARACTERISTICS Equivalent PSMA must meet following salient characteristics: Must be FDA-approved. Must be suitable for use as a PSMA-targeted prostate PET imaging agent for prostate cancer detection. Must be labeled with Gallium-68 (GA-68). Substitution with any other radionuclide is not acceptable to continue the previously conducted clinical studies. Must help select candidates for PSMA-directed therapy. 5. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS: VA San Diego HEALTHCARE SYSTEM: Delivery Location Nuclear Medicine Service, Main Hospital, 4 West, 4th Floor Normal Work Hours 7:00am to 4:00pm, Monday through Friday 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 properly 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. 7. 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. 8. SAFETY GUIDELINES AND REQUIREMENTS The Contractor shall perform all functions of the contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The Contractor shall self-report any violations to the COR within twenty-four (24) hours. Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements. 9. 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 19 June 19 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. 10. 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. 11. PARKING AND SPEED LIMIT Park only in areas designated by the Contracting Officer Representative (COR) 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 COR 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. 12. INVOICE AND PAYMENT No advanced payments will be authorized. The contractor shall submit invoices monthly. 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. The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are 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