Redacted_Brand_Name_Justification_and_Approval.pdf

This is a Justification and Approval (J&A) document for a brand-name restriction procurement under Federal Acquisition Regulation (FAR) authority. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division-Northeast (HCD-NE) is procuring two (2) Olympus Endoscope Reprocessor (OER) Elite systems with associated software, accessories, and connectivity services for delivery within 60 days of contract award. The requirement includes equipment delivery, installation, system validation, and software configuration. This will be awarded as a Firm-Fixed-Price (FFP) contract to be funded through DHP (Defense Health Program). The systems are required at Blanchfield Army Community Hospital (BACH), Fort Campbell, Kentucky, to provide automated high-level disinfection of flexible endoscopes in accordance with manufacturer specifications and infection prevention standards.

The J&A justifies the brand-name restriction to Olympus based on technical and operational necessity. The OER-Elite utilizes proprietary hardware, software, and validated reprocessing cycles specifically engineered for Olympus flexible endoscopes currently in use at BACH. No alternative automated endoscope reprocessor brands are validated to safely reprocess BACH's existing endoscope inventory while maintaining manufacturer warranties, FDA-cleared processing instructions, and regulatory compliance for patient safety. To maximize competition, the solicitation will be conducted as a brand-name restriction among authorized Olympus resellers rather than a sole-source award. Market research confirmed that Olympus utilizes authorized federal resellers (such as First Nation Group), enabling competitive bidding among qualified distributors. The Contracting Officer has determined the anticipated cost to be fair and reasonable based on comparison with historical prices and an Independent Government Cost Estimate (IGCE). This is a new requirement documented for award at or below the Simplified Acquisition Threshold (SAT).