This document is a Pre-Solicitation Notice from the National Institutes of Health (NIH) Clinical Center intending to award a fixed-price purchase order to Werfen USA, LLC for consumables and reagents for two ACLTOP® 750 hematology instruments. The sole-source procurement is for specialized laboratory testing supplies, including items such as HemosIL SynthASil, Rinse solution, Thrombin Time reagents, Protein C tests, Apixaban Calibrators, D-Dimer tests, and associated cuvettes and vials.
The NIH justifies the sole-source award based on Werfen USA being the only vendor capable of providing proprietary, validated reagents specific to the existing instruments, with any alternative potentially causing delays in patient care testing and requiring extensive validation. The estimated product list includes approximately 15 different reagent and supply items. Interested vendors may submit capability statements to kimala.winfield@nih.gov or dehnerm@cc.nih.gov, with the government reserving the right to evaluate potential competitive procurement. The acquisition will use Simplified Acquisition Procedures under NAICS code 324513, with a large business standard size of 1,250 employees.
