Justification and Approval for Other Than Full and Open Competition

This is a Justification and Approval (J&A) document for a sole-source procurement by the U.S. Embassy in Skopje, North Macedonia. The contracting activity seeks to procure one Monitor/Defibrillator, ZOLL® X Series® ALS, manufactured by ZOLL Medical Corporation, without full and open competition under FAR 6.302-1 authority.

The Health Unit at the Embassy requires a manual defibrillator with Advanced Life Support (ALS) capability meeting specific mandatory technical specifications: ECG monitoring via 3-lead, 5-lead, or hands-free electrodes; external paddles with convertible adult/pediatric surfaces; greater than 4 hours of continuous ECG monitoring on battery power; integrated pacing capability eliminating separate leads; automated self-test functions covering defibrillation, pacing, and ECG modules; additional monitoring parameters including SpO2, EtCO2, and NIBP; and a minimum 5-year manufacturer's warranty. The estimated acquisition value is $34,728. The justification establishes that ZOLL Medical Corporation is the sole manufacturer capable of providing the required proprietary features, including the integrated pacing-without-separate-leads capability, convertible adult/pediatric paddle design, and specific combination of SpO2/EtCO2/NIBP modules. Additional supporting factors include patient safety considerations, continuity of care with the existing ZOLL device fleet, and prior training investments in ZOLL equipment. The document was certified on September 4, 2026.