Blood Chemistry Analyzer for In Vitro Diagnostic Testing

of Requirement: Defense Health Agency HCD-S has a requirement for two (2) Blood Chemistry Analyzers (lease). Justification for Sole Source Procurement: The nature of this acquisition is highly specialized. The combination of technical specifications, physical constraints, and interoperability

requirements creates a unique need that can only be met by one vendor, Werfen , with their NEO Iris system. No other known system can meet all of the Government's minimum

requirements as detailed below: Proprietary & Integrated Test Menu: The Government requires a comprehensive and specific panel of tests to be performed on a single platform, including highly specialized Antibody Screen, ABO/Rh, Antibody Titration, Antibody identification, Syphilis, Cytomegalovirus, HIV/HBV/HCV by Nucleic acid testing, WNV, Babesia, Hepatitis B Surface Antigen (HBsAg),Hepatitis B core Antibody (HBcAb), Hepatitis C Antibody (HCV Ab), Human Immunodeficiency virus types 1 and 2 antibody (HIV ½ ab), Human T Lymphotrophic virus types 1 and 2 antibody (HTLV ½ Ab), Chagas. The machine must also be able to test plasma and whole blood. Market research indicates that only the Werden NEO Iris system integrates this exact combination of assays, including the critical, FDA-approved NAT tests, onto a single automated platform. Other vendors offer these tests on separate platforms, which would require additional space, increased staffing, workflow inefficiencies, and present significant integration challenges with our Laboratory Information System (LIS). This single, integrated platform is essential to meet the high-throughput demands of the Basic Military Training mission. Unique Physical and Infrastructure

Requirements: The laboratory space at the 59th MDW has strict and unalterable infrastructure limitations. The required analyzer must operate without an onsite water source or a floor drainage system and must not exceed the physical dimensions of 86.6” W x 35.4” D x 73.2” H. The NEO Iris analyzer is specifically designed to operate with self-contained fluidics and waste management, eliminating the need for external plumbing. This design feature, combined with its specific physical footprint, makes it the only system capable of being installed and operated in the designated space without costly and mission-disrupting facility modifications. Advanced Sample Integrity and Handling: The SOW mandates a system with a unique combination of sample handling capabilities critical for the pediatric and low-volume samples common in a military trainee population. This includes clot, bubble, and short sample detection, automatic reflex dilution and repeat testing, and the ability to preserve pediatric samples upon aspiration error. The Werfen NEO Iris system utilizes a proprietary dual-arm pipettor with advanced liquid level sensing and clog detection that is uniquely capable of meeting all these

requirements simultaneously, ensuring sample integrity and minimizing the need for painful and time-consuming redraws from trainees. Interoperability with Existing Systems: The analyzer must establish a bi-directional interface with the hospital's Electronic Health Record (EHR) and Laboratory Information System (LIS). The NEO Iris system has a proven and validated interface that is currently operational at other DoD facilities, ensuring seamless integration without extensive and risky custom development. Response and Challenge: Interested parties who believe they can meet the

requirements are invited to submit a statement of capabilities and qualifications. This statement must be submitted in writing to the contact person identified in this notice and must be received no later than the noted time and date. The statement of capabilities must include: Company name, address,