F18 RADIOPHARMACEUTICALS

Solicitation / RFP / RFQ

This solicitation is for the supply of F18 Radiopharmaceuticals and related services to the Nuclear Medicine (NM) Service of the Atlanta Veterans Affairs Healthcare System (ATL VA HCS). The contract will be structured as a one-year base period with four (4) one-year option periods. The vendor will be responsible for providing all labor, supervision, and transportation necessary for daily delivery of specified radiopharmaceuticals.

• Products: F18-FDG (fluorodeoxyglucose), F18-NaF (sodium fluoride), F18-Pylarify (Piflufolastat), CAIX targeted PET radiopharmaceutical, choline PET radiopharmaceuticals, and F18-FET (Fluoro-Ethyl-Tyrosine).

• Delivery: Daily delivery to the ATL VAMC, Decatur, GA. Emergency studies require delivery within 4 hours of order placement during standard business hours. Extended hours or weekend doses require 3 months' advance notice.

• Vendor Qualifications: Must be an established commercial radio pharmacy with at least 10 years of continuous operation, financially sound, with a proven record of prompt and exemplary service. Must demonstrate ability and resources (technology, facilities, personnel) for excellent service and reliability.

• Operational Requirements: Must have a needleless system for ordering, shipment, delivery, and return of spent syringes, adhering to OSHA Biohazardous Waste Policy. Must outline contingency protocols for F18 shortages. Must comply with all relevant US and Georgia regulations for radioactive materials.

• Licensing & Documentation: Must be licensed by the US NRC and/or an Agreement State. Must provide documentation of FDA approval for cyclotrons used.

• Labeling: Each unit dose and multi-dose vial must be labeled with specific information including customer name, radiopharmaceutical name, calibration activity, manufacturer, volume, etc.

• Quality Control: Must perform all necessary quality control procedures per 10 CFR Part 35 and other applicable regulations. Results of quality control tests must be provided if requested.

• Packaging: Shipping containers must be free of radioactive contamination. Must provide means to upload dose information into the Nuclear Medicine Information System (NMIS).

• Credits: Vendor shall issue credit invoices for returned unused unit doses and/or multi-dose vials decayed to background, with specific limits on daily returns. Full credit is provided for product ordered/shipped in error, damaged product, recalled product, expired product in original container, or mutually agreed upon issues.

• Contract Type: Firm-Fixed-Price.

• Period of Performance: One base year (03/20/2026 - 03/19/2027) with four (4) one-year option periods.

• Estimated Value: Not explicitly stated in the provided sections, but the Price/Cost Schedule details estimated volumes for the base year and option years.

• Offer Submission: Offers must be signed and dated, submitted by the due date (04/30/2026, 10:00 am EDT), and include specific information as detailed in FAR 52.212-1 and 52.215-1.

• Evaluation Factors: Offers will be evaluated based on Technical, Past Performance, and Price. Technical and Past Performance are considered more significant than Price. There will be no discussions after evaluation.

• Key Deadlines: Offer Due Date: 04/30/2026, 10:00 am EDT.

• Set-Aside: This acquisition is a 100% Small Business Set-Aside.

• NAICS Code: 325412 (Pharmaceutical and Medicine Manufacturing).

• Size Standard: 1300 Employees.

• The solicitation includes numerous FAR and VAAR clauses related to contract terms, conditions, representations, and certifications.

• Attachments include a Table for Products, Doses and Estimated Volumes, and a Quality Assurance Surveillance Plan (QASP).

Solicitation / RFP / RFQ

This solicitation is for the supply of F18-Radiopharmaceuticals and related services to the Nuclear Medicine (NM) Service of the Atlanta Veterans Affairs Healthcare System (ATL VA HCS). The contract will be structured as a one-year base contract with four (4) one-year option periods. The vendor will be responsible for providing all labor, supervision, and transportation necessary for daily delivery of specified radiopharmaceuticals to the ATL VAMC in Decatur, GA.

• Products: F18-FDG, F18-NaF, F18-beta-amyloid imaging agents, F18-Axumin, F18-Tauvid, F18-Cerianna, F18-Posluma, F18-Pylarify, CAIX targeted PET radiopharmaceutical, choline PET radiopharmaceuticals, and F18-FET.

• Delivery: Daily delivery to the NM Service hot lab (Rm 1C335) during standard business hours (Monday-Friday, 07:00-17:00). Emergency deliveries may also be required.

• Ordering: Orders placed by authorized ATL VA HCS nuclear medicine technologists.

• Labeling: Each unit dose and multi-dose vial must be labeled with customer name, radiopharmaceutical name, calibration activity, calibration date/time, manufacturer, volume, mCi/ml, prescription number, and lot number. Syringes must also have specific caution labels.

• Quality Control: Vendor must perform all necessary quality control procedures and provide results upon request.

• Contingency: Vendor must outline contingency protocols for F18 shortages.

• Compliance: Full compliance with all relevant US and GA regulations regarding radioactive materials.

• Contract Type: Firm-Fixed-Price contract contemplated.

• Period of Performance: One-year base period (03/20/2026 - 03/19/2027) with four (4) one-year option periods.

• Estimated Value: Not explicitly stated, but detailed pricing is provided in the Price/Cost Schedule.

• Offer Submission: Offers must be submitted on SF 1449, letterhead stationery, or as otherwise specified, by the due date of 04/30/2026 at 10:00 am EST.

• Evaluation Criteria: Technical (proposal outline, small business status, SAM exclusions, financial stability, LOS document, licenses, FDA approval for cyclotrons) and Past Performance will be considered more significant than price.

• Key Deadlines: Offer Due Date: 04/30/2026.

• This acquisition is a Total Small Business Set-Aside.

• NAICS Code: 325412 (Pharmaceutical and Medicine Manufacturing)

• Size Standard: 1300 Employees

• Attachment 1 provides a table of Products, Doses, and Estimated Volumes.

• Attachment 2 is the Quality Assurance Surveillance Plan (QASP).

• Vendors must be licensed by the US NRC and/or an Agreement State. Cyclotrons used must be FDA approved.

• No access to VA sensitive information is required. Security Accreditation Package is not required.