Q522--Intent to Sole Source Pharmaceutical PetNet Dosages | New Base plus

Quick Summary

The Ralph H. Johnson VA Medical Center (RHJVAMC), under a Special Notice indicating an Intent to Sole Source, is procuring Amyvid™ and 18FDG (fluorodeoxyglucose) radiopharmaceuticals in a shielded delivery and administration system. These essential radioisotopes are used for Positron Emission Tomography (PET) imaging to diagnose Alzheimer's disease and various cancers, ensuring optimal patient care for veterans. Responses are due March 16, 2026.

Scope of Work

The contractor shall provide single-unit doses of FDG and Amyvid™ for routine PET/CT studies at the RHJVAMC in Charleston, SC. This includes:

• Product Supply: Provision of calibrated FDG (7 mCi or 12 mCi ± 10%) and Amyvid™ (10 mCi ± 10%) doses.
• Delivery: Monday through Friday, within 30 minutes before calibration time, to the PET/CT department Hot Lab (Room B212E). Deliveries must be in shielded dose administration containers within shielded shipping containers, meeting DOT regulations, USNRC ALARA, and government weight guidelines.
• Ordering: Orders placed by RSO certified Nuclear Medicine personnel during standard hours (Mon-Fri, 7 AM - 5 PM EST), typically the business day prior to delivery.
• Notification: Immediate notification (within two hours) if unable to provide doses.

Contract & Timeline

• Type: Special Notice (Intent to Sole Source)
• Set-Aside: None specified (implied sole source)
• Response Due: March 16, 2026, 4:00 PM ET
• Published: March 11, 2026
• Point of Contact: Holly Bowling, Contract Specialist (Holly.Bowling@va.gov)

Eligibility & Requirements

• Licensing: Offerors and their production facilities must be FDA approved and licensed by the USNRC or a relevant State Radioactive Materials Licensing Agency.
• Compliance: Adherence to 10 CFR Part 35 and 49 CFR Part 173 Subpart I.
• Pricing: No additional fees (e.g., delivery, service, prep, disposal) beyond the schedule/price list are permitted.

Additional Notes

• Credit & Returns: Contractor must offer credit for unused, cancelled, damaged, recalled, or incorrectly delivered doses under specified conditions. Incorrectly delivered doses are credited for the full amount, not to exceed one per month. Doses deemed below standard are credited, not to exceed one per quarter.
• Invoicing: Monthly, in arrears, submitted within 15 days after the billing month to the COR for review.
• Security: Strict adherence to VA information and IT security requirements (VA HANDBOOK 6500.6) is mandatory, including data protection, access controls, incident reporting, and potential liquidated damages for data breaches.
• Records Management: Compliance with Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33) and NARA policies is required for all Federal records created or handled under the contract, with flow-down requirements to subcontractors.