Justification for Sole Source_Redacted.pdf

This is a Justification for Sole Source document for a simplified acquisition procedure (Micro-Purchase Threshold to Small Purchase Amount) for the U.S. Navy Ship Comfort (USNS Comfort). The purchase request number is 1301348452 and is restricted to QuidelOrtho Corporation under CAGE Code 9GPX1.

The requirement is for an annual maintenance service contract for two chemistry, immunoassay, and integrated systems instruments (VITROS 7600 systems with serial numbers 76001807 and 76002249) onboard the USNS Comfort. These are mission-critical diagnostic systems that support both routine clinical chemistry and immunoassay testing from a single patient sample. The estimated annual cost for the base year is redacted, with three 12-month option years resulting in a total estimated cost of approximately $650,000. The base performance period is September 20, 2026 through December 7, 2026, followed by option periods beginning December 8, 2026 through December 7, 2027 and continuing through December 7, 2030.

The sole source justification identifies QuidelOrtho Corporation as the original equipment manufacturer (OEM) with exclusive proprietary rights to the VITROS 7600 systems. As the OEM, QuidelOrtho is the only authorized provider of manufacturer-certified service, parts, training, technical support, field service, and software support. The document emphasizes that using non-OEM providers would create risks of diagnostic inaccuracies, equipment downtime, warranty voidance, and mission readiness impacts. QuidelOrtho holds proprietary rights and does not authorize third-party vendors to perform certified maintenance or access proprietary software updates.