P03. JA FAR 12.102 Restricting Competition MPT-SAT - 36C263-26-AP-2606 - P_Redacted.pdf
PDF 195 KB Posted
- Solicitation number
- 36C26326Q0883
About this file
This is a Brand Name Only Justification for Restricting Competition under FAR 12.102(a) for a procurement by the Department of Veterans Affairs, Network Contracting Office 23, on behalf of the VA Iowa City Health Care System.
The contracting activity seeks to procure a MEDRAD Intego PET Infusion System, an automated F18 FDG infusion system with full installation, parts, materials, labor, travel, and training. The acquisition plan action ID is 36C263-26-AP-2606, with a 90-day period of performance. The estimated amount is redacted. The justification for brand name restriction centers on the MEDRAD Intego system being the only FDA-cleared device capable of automated delivery of both 18F-FDG and 18F-NaF radiopharmaceuticals, providing significant operator radiation exposure reduction from approximately 2 mSv to 0.4 mSv compared to manual processes. No competing manufacturer produces an equivalent PET infusion system with the required FDA-cleared indications and automated capabilities for dual radiopharmaceutical delivery.
Market research confirmed the Rule of Two is not met. Searches of the SBA Dynamic Small Business Search, GSA Advantage, GSA eLibrary, SAM.gov, and a Sources Sought notice identified only one interested Service-Disabled Veteran-Owned Small Business—1st American Medical Distributors, Inc., an authorized distributor for Bayer HealthCare LLC, the sole manufacturer. The product is not available through the Federal Supply Schedule and must be acquired on the Open Market. The applicable SBA Nonmanufacturer Rule Class Waiver for NAICS 334517 permits an authorized small business distributor to furnish the large business manufacturer's product. Contracting Officer Dennis Salmonsen certified the justification on June 29, 2026.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Buy American Certificate - 52.225-2 - Tailored - ALL SUPPLIES.docx | DOCX document | |
| S02 - PET Infusion System - IC - 36C26326Q0883.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
RFO FAR 12.102 Restricting Competition MPT up to SAT NCO 23 SST2 version: 02/20/2026 Page 1 of 2 Acquisition ID#
DEPARTMENT OF VETERANS AFFAIRS
Brand Name Only Justification for Restricting Competition IAW RFO FAR 12.102(a) For
Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold
Acquisition Plan Action ID: 36C263-26-AP-2606
1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office
23, 113 Comanche Rd., Fort Meade, SD 57741 for the VA Iowa City Health Care System, 601 Highway 6 West, Iowa City, IA 52246.
2237: 636-26-3-4154-0146
2. Brief Description of Supplies/ Services required and the intended use/Estimated
Amount:
Estimated Amount: $
Period of Performance: 90 DAY ARO
VA Iowa City Health Care System (VAICHCS) is requesting a Brand Name Only Medrad Intego PET Infusion System. The purpose of this requirement is to procure an automated F18 FDG infusion system. The procurement shall include all parts, materials, labor, travel, and training to complete the full installation of the F18 FDG infusion system at the location.
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
MEDRAD Intego PET Infusion System as it is the only device with cleared indications for use for delivery of FDG and NaF in the United States (see sole source letter in package from Bayer). The Intego PET Infusion System allows staff to move away from the radioactive source during injections, reducing total technologist exposure from ~2 mSv to ~0.4 mSv compared to manual processes. MEDRAD Intego is a fully automated PET infusion system that allows accurate dose-on-demand administration of 18F-FDG or 18F-NaF from a multi-dose vial while providing shielding and protection to the operator.
No other manufacture currently produces a PET infusion system with FDA-cleared indications for the automated delivery of both 18F-FDG and 18F-NaF. As a result, no equal product is known to exist that can satisfy the Government s minimum requirements for automated radiopharmaceutical administration, operator radiation
File details come from the government source that posted it. Updated .