PO_NX NX EQ Safe Label Printers for QR Medication JA REDACTED.pdf

This is a Justification and Approval for Other Than Full and Open Competition document executed by the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Equipment Life Cycle Management (ELCM) Program.

The VA seeks to procure the Codonics® Safe Label System® (SLS) through a non-competitive Fixed Price (FFP) Delivery Orders contract with Codonics®, Inc. (UEI: DLVVVBZ7/KNK9). The SLS is a medication labeling system designed specifically for operating rooms (OR), anesthesia locations, and pharmacies to enhance patient safety through barcode-based drug verification, standardized label generation, real-time safety checks, and compliance with Joint Commission and FDA requirements. The system supports VHA's clinical requirements including barcode-driven drug verification before labeling (BCEFORE), Numerical Electromagnetics Code 2 (NEC2) technology for audible and visual confirmation, machine-readable labels enabling closed-loop safety via AIMS/EHR integration, beyond-use expiration tracking, and durability under OR environmental conditions including exposure to alcohol, blood, fluids, and handling stress. Over 85+ VHA facilities currently use Codonics® SLS, and replacement with alternative systems would impose significant capital costs, training requirements for approximately 1,000 employees, and operational disruptions that could compromise patient safety. The performance period includes one 12-month base period and four 12-month option periods. The estimated Government cost is redacted (inclusive of all options).

Market research via Veteran-Owned Small Businesses searches, SBA NAICS Code 339112 searches, and a Request for Information (RFI 36C10X26Q0035, closed April 6, 2026) identified no viable competitors capable of meeting VHA's combined patient safety, environmental durability, and workflow integration requirements. The RFI responses from Begini Howard Private Equity (BHPE) LLC, AI Advanced Solutions LLC, and BD indicated no equivalent alternative systems. No publication notice is planned based on the finding that only Codonics®, Inc. through authorized distributors (including BD) can meet the stated requirements, and future acquisition strategies will be evaluated case-by-case. The justification was approved by the Contracting Activity Competition Advocate pursuant to 41 U.S.C. 3304(a)(1) and FAR Subpart 6.103-1.