SSJ under RFO FAR Part 8 GSAR538.7104-3-FINAL_signed_Redacted.pdf

This is a Justification and Approval (J&A) document for a sole-source acquisition under FAR Part 8.4 (Other than Full and Open Competition).

The Defense Health Agency's Healthcare Contracting Division-South (HCD-S) is awarding a sole-source task order to Roche Diagnostics Corporation for BenchMark ULTRA PLUS immunohistochemistry staining systems and reagents. The contract vehicle is a Federal Supply Schedule (FSS) order under GSA Advantage (contract GS-07F-0446V). The place of performance is Eglin Air Force Base's 96th Medical Group, with a Firm Fixed Price (FFP) contract structure. The period of performance runs from July 1, 2026 through June 30, 2031. The estimated total contract value is redacted in the document.

The 96th Medical Group requires a fully automated immunohistochemistry (IHC) stainer for tissue section staining to support patient diagnosis in the pathology department. The system must be fully automated with minimal manual intervention, process a minimum of thirty (30) slides simultaneously, support continuous loading and multiple protocols, and require minimal daily maintenance. Market research conducted between March 18 and April 2, 2026 confirmed that Roche Diagnostics is the sole source capable of meeting all mandatory technical requirements, as the BenchMark Ultra Plus system is proprietary and no compatible alternatives exist. The J&A justifies sole-source authority under 41 U.S.C. 3304(a)(1) based on the supplies being unique and highly specialized. A notice of intent (NOI) will be posted on SAM.gov to encourage small business participation, with continued market research planned to support future full and open competition if requirements change.