Attachment 2_DF Part 12- Coagulation_Redacted.pdf

This is a Determination & Findings document for a sole source acquisition by the 88th Medical Group Clinical Laboratory (AFLCMC/PZIBA). The acquisition seeks two new fully automated Coagulation analyzers from Werfen, specifically the ACL TOP 350 or ACL TOP 370 models, to replace existing equipment and support approximately 2,300 annual PT/INR, D-dimer, Fibrinogen, and PTT tests. The analyzers feature state-of-the-art 671nm LED technology enabling pre-analytical checks on all samples while minimizing interference from hemolysis, lipemia, and hemoglobinopathy, and offer the fastest turn-around-time among competitors with ready-to-use reagents.

The justification for sole source acquisition is established under RFO 12.102(a) (Commercial Products and Services), citing that only Werfen is reasonably capable of meeting the Government's requirements. Key findings support exclusivity based on technological superiority, minimal hands-on maintenance requirements, seamless integration with the existing Laboratory Information System (LIS), staff continuity given current staffing challenges, and the fact that Werfen is the sole provider with authorized distribution in the United States. A Sources Sought notice was released on SAM.gov on August 19, 2026, with a closing date of August 25, 2026, and one capability statement was received and deemed technically unacceptable. The Contracting Officer approved the sole source determination on September 2, 2026.