NOI to Sole Source to Werfen USA LLC

The purpose of this procurement is to obtain the HemoHub Software. HemoHub is a proprietary middleware and data management system developed, licensed, supported, and distributed exclusively by Werfen for use with its ACL TOP hemostasis analyzers. No other vendor is authorized to provide, modify, support, maintain, or integrate HemoHub with the ACL TOP platform.

The DLM Hematology-Coagulation Laboratory currently operates two ACL TOP 750 analyzers manufactured by Werfen. HemoHub was specifically designed to interface directly with ACL TOP analyzers and provides unique functionality that is not available through third-party middleware products. These capabilities include analyzer-specific QC management, calibration monitoring, clot curve analysis, peer-group QC comparison, advanced coagulation workflow management, and direct integration with ACL TOP instrument software and databases.

Product Service Code: 6640 Laboratory Equipment and Supplies NAICS Code: 325413 In-Vitro Diagnostic Substance Manufacturing Place of Performance: NIH Clinical Center, Bethesda, MD 20892 USA POTS: 26-007532 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. The National Institutes of Health (NIH) intends to award a one-year contract to Werfen USA LLC, located at 180 Hartwell Rd, Bedford, MA 01730, on a firm fixed price sole source award basis for the acquisition of the HemoHub Software.

The purchase of HemoHub will provide a centralized data management and middleware solution specifically designed for hemostasis laboratories. HemoHub will receive, process, display, store, and manage data generated by the ACL TOP analyzers while providing enhanced oversight of instrument performance, QC activities, and patient testing workflows. Because HemoHub is proprietary to Werfen, there are no equivalent commercial products that can provide the same level of native integration, functionality, performance monitoring, and technical support for the ACL TOP platform.

Third-party middleware vendors do not have access to Werfen's proprietary analyzer architecture, software algorithms, instrument communication protocols, or specialized coagulation data management features required to provide comparable functionality. In addition, ongoing software updates, validation support, maintenance, troubleshooting, cybersecurity updates, and technical support for HemoHub can only be provided by Werfen. Procurement from any other source is not possible because no other vendor is licensed or authorized to sell, implement, or support this software.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Huda Malik, Contract Specialist via email to [email on the source notice] by September 24, 2026 at 2 pm EST.