Attachment 2_ justification_and_approval_document_Redacted.pdf

This is a Department of the Air Force Justification for Other Than Full and Open Competition (CUI) document for a sole-source acquisition valued under $10M.

The contracting activity is AFLCMC/PZIBA, and the requirement is for Automated Blood Bank Instrumentation. The 88th Medical Group (88 MDG) requires the Ortho-Vision system to perform specialized, high-sensitivity blood screening and antibody identification integrated with a fully automated, walk-away solution. The system utilizes advanced Column Agglutination Technology (CAT) with ID-MTS Gel Cards to deliver required sensitivity and specificity for patient safety, optimizing lab productivity and standardizing clinical workflows to meet high-volume workload requirements. The statutory authority for sole-source procurement is 10 U.S.C. 3204(a)(1), citing that only one responsible source exists to satisfy agency requirements.

Quidelotrho Sales Company, LLC is identified as the only source capable of satisfying this mission-critical clinical requirement. The Ortho-Vision is the only platform on the market providing modular instrumentation delivering a single point of entry for the complete range of required tests, including ABO/RH Group, antibody screening and identification, antigen typing, cell panels, crossmatch (AHG), DAT (IgG and polyspecific), eluates, RH phenotype, and serial dilutions. The system is currently the only instrument approved and validated by the Armed Services Blood Program (ASBP) to perform Anti-A and Anti-B tier testing and Low Titer O Whole Blood protocols. Extensive market research was conducted, including a sources sought notice posted on SAM.gov from August 20-27, 2026, which yielded only one response that was ultimately deemed technically unacceptable. The justification recommends approval of the sole-source acquisition to prevent operational delays and ensure compliance with ASBP mandates and MHS GENESIS Laboratory Information System integration standards.