A.02.- Justification and Approval Modified for FAR Part13.501 for Bio-Rad Final 4-24-25_Redacted.pdf

This document is a Justification and Approval (J&A) Modified for a sole source contract with Bio-Rad Laboratories for HIV screening and testing equipment and services for the Walter Reed Army Institute of Research (WRAIR) Diagnostic Countermeasures Branch (DCB). The contract is a firm fixed-price, indefinite delivery/indefinite quantity (IDIQ) agreement with a five-year period covering the procurement of eleven Bio-Rad EVOLIS Analyzers, six Genius confirmatory analyzers, and seventeen Interruptible Power Supply backup systems.

The primary mission is to provide HIV screening, supplemental confirmatory testing, and molecular testing services for U.S. Army and Military Entrance Processing Command (MECOM) accession candidates, military personnel, and beneficiaries. Bio-Rad was selected as the sole source vendor because they are the only manufacturer capable of meeting stringent regulatory requirements for high-fidelity HIV testing with specific FDA-approved assays. The contract includes provisions for equipment maintenance, relocation, installation, and calibration, with previous sole source contracts dating back to June 2015. Market research conducted from October 2024 to March 2025 confirmed Bio-Rad as the only vendor meeting the required regulatory standards for this critical medical testing equipment.