NOI to Sole Source to Werfen USA LLC

The National Institutes of Health (NIH) intends to award a one‑year firm‑fixed‑price contract to Werfen USA LLC for the HemoHub software, a proprietary middleware that integrates exclusively with Werfen’s ACL TOP hemostasis analyzers. Because the software is uniquely licensed to Werfen and no other vendor can provide the required functionality, the procurement is being executed as a sole‑source award under FAR Part 13. The contract will supply, install, support, and maintain the HemoHub system to improve quality‑control, calibration, workflow, and regulatory compliance for the DLM Hematology‑Coagulation Laboratory at the NIH Clinical Center. • Sole‑source award to Werfen USA LLC (Bedford, MA) for HemoHub middleware. • Purpose: centralized data management, QC oversight, calibration monitoring, and advanced coagulation workflow for ACL TOP 750 analyzers. • Product Service Code 6640 – Laboratory Equipment and Supplies; NAICS 325413 – In‑Vitro Diagnostic Substance Manufacturing. • Place of performance: NIH Clinical Center, Bethesda, MD. • Contract type: firm‑fixed‑price, one‑year term. • Questions/comments due by 24 Sep 2026 (2 pm EST) to Huda Malik, Contract Specialist ([email protected]). • No competition required; other vendors lack access to Werfen’s proprietary architecture. • Expected deliverables: software license, installation, validation support, cybersecurity updates, and ongoing technical support.