6505--Radiopharmaceuticals for Positron Emitting Tomography (PET) Imaging

Questions & Answers / Clarifications

This document provides answers to questions submitted by potential bidders regarding Solicitation 36C25926Q0316 for Radiopharmaceuticals for Positron Emitting Tomography (PET) Imaging.

• Requirement Type: This is a follow-on requirement to task order 36C25925N0326, previously awarded to Progenics Pharmaceuticals, Inc.
• Contract Period: While the intent is to continue the contract for the full 4 years, funds are obligated one fiscal year at a time. An annual review process ensures needs are met, but the VA's intent is to utilize the product for the full duration.
• Funding Availability: Funds are obligated each fiscal year to meet the contract's specified amount. Validation is required annually to confirm funds are provided, available, and tied to the budget.
• Set-Aside: The requirement is designated as a Small Business set-aside. The agency has reviewed market research and found adequate competition under this set-aside, therefore, full and open competition cannot be considered at this time.

All offers must be emailed to heather.chase2@va.gov and received no later than 5:00 PM Mountain Time on March 20, 2026.

Form / Attachment / Pricing Sheet

This document is the "Buy American Certificate" provision (FAR 52.225-2), which requires offerors to certify the origin of end products proposed for contract award. It is used in conjunction with the "Buy American-Supplies" clause (FAR 52.225-1).

• Domestic vs. Foreign End Products: Offerors must identify which end products are domestic and which are foreign.
• Critical Components: For domestic end products, offerors must indicate if they contain a critical component.
• Country of Origin: For foreign end products, the country of origin must be listed.
• Domestic Content Percentage: For foreign end products (that are not COTS items), offerors must indicate if they exceed 55% domestic content.

Bidders must carefully review and complete this certificate to ensure compliance with the Buy American Act. Failure to properly certify the origin and domestic content of proposed items can impact offer evaluation and award. The definitions of "domestic end product," "foreign end product," and "critical component" are provided in the "Buy American-Supplies" clause (FAR 52.225-1), which should also be reviewed.

Statement of Work (SOW) / Performance Work Statement (PWS)

The VA Salt Lake City Health Care System (VASLCHCS) requires a Contractor to provide unit dose radiopharmaceuticals, radioactive sources, and supplies for diagnostic imaging exams and quality assurance procedures.

• Provide routine weekday deliveries (Monday-Friday, excluding holidays) to the Nuclear Medicine Department, no later than 8:00 AM MST.

• Supply F-18 Piflufolastat (Pylarify), or equivalent, for PET imaging.

• Provide radioactive sources for quality assurance/quality control as needed.

• Ensure all radiopharmaceuticals are prepared according to manufacturer's package inserts by a certified nuclear medicine pharmacist.

• Provide radiation safety equipment, such as syringe shields and shielded carriers.

• Maintain an adequate supply chain with contingency plans to prevent disruption.

• Deliver radiopharmaceuticals within two (2) hours during normal working hours if needed urgently.

• Comply with U.S. Pharmacopeia (USP) 797 and 825 guidelines.

• Ensure deliveries comply with all federal and state regulations for shipping radioactive materials (DOT, DOE, NRC, ICC).

• Contractor must be licensed by the State of Utah and hold current NRC and/or FDA licenses for production and distribution.

• Accept returns for credit under specific conditions (contractor error, shipping damage, recalls, expired prior to receipt).

• Establish a fair return for credit policy for unused radiopharmaceuticals.

• Provide contact information for orders (regular, emergency), expert advice, and ordering methods within ten (10) days of award.

• Furnish quality control statements for "ready-to-use" doses.

• Provide current package inserts and material safety data sheets (SDS) digitally or in binders, updating as necessary.

• Perform all quality control procedures required by regulatory agencies and make records available upon request.

• Provide patient orientation education materials and appropriate safety signs/posters.

• Ensure dosage radioactivity is within specified limits (±10% deviation if not otherwise specified).

• Indicate expiration date and time on each product (target: two (2) hours for ready-to-use and Piflufolastat).

• Provide technical expertise, credit, or examination for suspected quality control or material defects.

• Submit monthly invoices detailing period, date, product, quantity, amount, and purchase order number.

• Deliver one (1) shipment per day to the Nuclear Medicine Service by 8:00 AM MST, with additional deliveries at contractor discretion and cost.

• Shipments must include a Packing Slip with product information, PO number, invoice number, and a scannable barcode for the Nuclear Medicine Information System (NMIS).

• Deliveries must be made no later than 8:00 AM MST on weekdays, excluding holidays.

• Urgent requests must be fulfilled within two (2) hours during normal working hours.

• Compliance with USP 797 and 825 guidelines is mandatory.

• Radioactive material shipments must comply with all federal and state regulations.

• Quality control records must be available upon request.

• Deliveries to: Nuclear Medicine Department, VA Salt Lake City Health Care System, 500 Foothill Drive, Salt Lake City, UT 84148, room 1E27-1.

• Contract performance period is not specified in this document.

• Contractor personnel must be nuclear pharmacists or licensed technologists supervised by a nuclear pharmacist.

• Contractor must have a courier for hot lab delivery.

• Contractor must be local (within 60 minutes) for same-day stat orders.

• Contractor must have a cyclotron within 2 hours of the facility for add-on patient studies.

• Contractor must provide proof of a Dose Management System upon request.

• C&A requirements do not apply; a Security Accreditation Package is not required.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (RFQ #: 36C25926Q0316) for commercial items, seeking quotes for Radiopharmaceuticals for Positron Emitting Tomography (PET) Imaging for the George E. Wahlen VA Medical Center. The government intends to award a firm-fixed-price contract.

• Procurement of Radiopharmaceuticals for PET Imaging.

• Detailed requirements are specified in Attachment 1 – SOW.

• Offerors must provide new OEM medical supplies; remanufactured or gray market items are not acceptable.

• Offerors must be an OEM, authorized dealer, distributor, or reseller, verified by OEM authorization.

• Contract type: Firm-fixed-price.

• Period of performance: Not explicitly stated, but includes potential options for extension up to 6 months (52.217-8) and a total contract duration not exceeding 3 years (52.217-9).

• Response Date/Time: March 20, 2026, 5:00 PM Mountain Time, Denver, USA.

• Questions Deadline: March 16, 2026, 12:00 PM Mountain Time.

• Submission Method: Email quotes only to heather.chase2@va.gov (4MB email limit). No hand-carried or faxed quotes accepted.

• Evaluation Factors:

  1. Technical capability or quality.
  2. Price.
  3. Licenses (Utah Professional, NRC/FDA, Radioactive Material).
  4. RFO 52.225-2 Buy American Certificate.

• Award will be made on an All or Nothing Basis.

• The government reserves the right to make no award.

• This solicitation is a 100% set-aside for Small Business (SB).

• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1300 employees.

• Offerors must be SBA verified if applicable for SDVOSBs/VOSBs.

• See Attachment 1 – SOW for detailed requirements.

• See Attachment 2 – Price Schedule for pricing details.

• See Attachment 3 – RFO 52.225-2 Buy American Certificate to be completed.

• Offerors must provide specific licenses (Utah Professional, NRC/FDA, Radioactive Material) as part of their submission.

• Gray market items are prohibited.

Form / Attachment / Pricing Sheet

This document is a Price Schedule for the opportunity, detailing the CLINs (Contract Line Item Numbers), descriptions of services, quantities, units of issue, and placeholders for unit prices and total amounts. Bidders are expected to use this schedule to provide their pricing for the goods and services required.

• CLIN 0001 & 1001 & 2001 & 3001: Piflufolastat F18 (or equivalent)
  • Quantities: 150 Each (EA) for Base Year, Option Year 1, Option Year 2, and Option Year 3.
  • Period of Performance (POP): Varies by contract year (Base: April 1, 2026 – March 31, 2027; Option 1: April 1, 2027 – March 31, 2028; Option 2: April 1, 2028 – March 31, 2029; Option 3: April 1, 2029 – March 31, 2030).
• CLIN 0002 & 1002 & 2002 & 3002: Piflufolastat F18 (or equivalent) Cancellation Fee
  • Quantities: 20 Each (EA) for Base Year, Option Year 1, Option Year 2, and Option Year 3.
  • Period of Performance (POP): Varies by contract year, matching the primary CLIN.
• Totals: Placeholders for Base Year Total, Option Year 1 Total, Option Year 2 Total, Option Year 3 Total, and Grand Total (Base Plus 3 Option Years).

This price schedule is critical for bidders to understand the quantities and types of items being procured over a multi-year period (base year plus three option years). Bidders must complete the "UNIT PRICE" and "TOTAL AMOUNT" columns for each CLIN to submit a compliant and competitive proposal. The structure indicates a need for pricing for both the primary product and a potential cancellation fee.