P03 SSJ AP 4244_Redacted.pdf

This is a Justification for Single Source Award under FAR 13.106-1 for a procurement over the micro-purchase threshold but not exceeding the simplified acquisition threshold.

The Department of Veterans Affairs, Regional Procurement Office West, is procuring Brand Name Nihon Kohden NKV-330 non-invasive ventilators for VA Central California Healthcare System. These specialized medical devices provide mechanical non-invasive ventilation for patients who are physically unable to breathe independently or have insufficient breathing capacity. The contracting activity is the VA Central California Healthcare System (VISN 5, HSA 52, Network Contracting Office 21). The justification establishes that only one source—Nihon Kohden—can meet the Government's technical and regulatory requirements. The NKV-330 is proprietary and unique in its range of capabilities, including multiple high-flow oxygen modes, integrated CO₂ and SpO₂ monitoring, turbine-powered operation suitable for transport and bedside use, dual HEPA filtration, continuous ETCO₂ and SpO₂ monitoring, high-flow oxygen therapy, and continuous waveform data with minimum seventy-two-hour storage. Additionally, the ventilators must not be subject to active FDA recalls and must meet all clinical and safety requirements specific to Government use.

Market research was conducted through the Small Business Administration's database (NAICS code 339112), which yielded 931 Service-disabled Veteran-owned Small Businesses and 981 Veteran-owned Small Businesses, along with searches of NAC, GSA Advantage, and Adds Up databases. These searches confirmed no other vendors offer non-invasive ventilators with equivalent capabilities suitable for the required research capacity. The document is effective as of December 30, 2025 (Revision 02).