Notice of Intent to Sole Source – Illumina

The National Institutes of Health, through its Clinical Center’s Department of Transfusion Medicine, intends to award a firm fixed price purchase order to Illumina, Inc. for the Illumina MiSeq i100 System under a sole source acquisition. This action is justified under FAR Part 13 – Simplified Acquisition Procedures, specifically 13.106-1(b)(1), as the acquisition value is below the simplified acquisition threshold of $250,000 and the system is uniquely required for clinical sequencing applications with no commercially equivalent alternatives available. The MiSeq i100 System is essential for high-accuracy, low-to-moderate throughput genomic analysis in the development and validation of diagnostic assays for transfusion-transmitted pathogens, and only Illumina, Inc. can provide the equipment with full manufacturer support and service. The procurement is exempt from full and open competition requirements under FAR Part 6 due to its classification under simplified procedures. The system must be delivered, installed, and maintained by the vendor at the NIH facility in Bethesda, Maryland, with performance expected to begin June 1, 2026. Interested parties may submit capability statements to demonstrate their qualifications, but the government retains sole discretion over whether to proceed without competition. All submissions must include the Unique Entity Identifier, Taxpayer Identification Number, business size certification, delivery terms, F.O.B. point, unit pricing, and shipping details, and must be sent electronically in Word or PDF format to Gregory Noland, Contract Specialist, no later than May 14, 2026. The vendor must be active in SAM.gov, though no set-aside provisions apply, and no small business preferences are specified. The contract will follow federal acquisition regulations consistent with FAR Part 12 for commercial items and FAC 2026-01, effective March 13, 2026, with no formal inspection protocols or packaging standards outlined beyond compliance with the manufacturer’s specifications. Payment and administrative coordination will be handled by the contracting office in Bethesda, and while no formal contract clauses, line items, or warranty terms are published in this notice, the award is strictly contingent upon the vendor’s ability to meet the technical and operational requirements of the system in a clinical research setting.