Justification FAR Part 13 (JandA) (JUNE 2025) CardioGen_FINAL_Redacted.pdf

This document is a FAR Part 13 Justification and Approval document for a sole-source procurement of medical imaging equipment and software. The requirement is for an annual follow-on purchase of a Positron Emission Tomography (PET) imaging system with rubidium Rb-82 generator, accessories, infusion system, and related cardiac position emission tomography imaging software. The system will be used for imaging the heart to evaluate regional myocardial perfusion in patients with suspected or existing coronary artery disease.

The procurement is for a one-year performance period covering fiscal years FY24-FY25. The procurement follows a Sources Sought Notice posted on SAM.gov, and market research was conducted by the technical representative and contracting officer representative. The document indicates that there is no opportunity for subcontracting, and the continued acquisition aligns with the departments' overall mission to provide comprehensive and advanced care to its beneficiaries. The procurement is being conducted under the simplified procedures for certain commercial items, with a determination that the anticipated cost will be fair and reasonable.