Ortho Vision SSJ Updated Signed Redacted.pdf

Single Source Justification (Simplified Acquisition)

SAF/AQCP Template | 1 May 2014 Page 1 of 2

Section A: General Contract Information

Contracting Activity: AFLCMC/PZIBA Purchase Request/ Identification Number:

Project/Program Name: Ortho Vision Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

This requirement is for the new/sustained acquisition and leasing of Ortho Vision instrumentation and reagents/service in support of the 88 MDG, DTS/SGQC Transfusion Services to provide timely clinical diagnostic testing and patient care for DoD members and beneficiaries worldwide. Specifically, these reagents will be used for transfusion services and blood bank patient tests which will be analyzed by TS.

Currently, this requirement will be met through a 5 year BPA, with a ceiling price of and a Period of Performance from Dec 2019 - Dec 2024.

Estimated Total Value

Section C: Justification for Soliciting from a Single Source

Ortho Vision is the only platform that is capable of providing instrumentation in a modular fashion that provides a single point of entry (excluding sample automation lines that decap, aliquot and centrifuge specimens) for analysis of the following tests (while still remaining compatible with current methodology): ABO/RH Group, Antibody Screen, Antibody Identification, Antigen Typing, Cell Panels, Crossmatch (AHG), DAT (IgG and polyspecific), Eluates, RH Phenotype, Serial Dilutions for Titration Studies. This is the only system that uses column agglutination technology and has full automated serial dilutions. This is the only system that has full capability to interface with the current laboratory information system. Ortho Vision is currently the only instrument approved by the Armed Services Blood Program to perform Anti-A and Anti-B titer testing for Low Titer Group O Whole Blood. The Ortho Gel Card methodology is currently being used in the facility so additional resources are not needed since it has already been validated for use.

Section D: Efforts to Obtain Competition

The proposed sole source is the only known source able to satisfy the Government's requirements.

is known to be a close competitor, however, they cannot offer the full automation testing capabilities and HER integration that the MTF requires to improve patient safety. also utilizes a Solid Phase Capture Technology methodology, which is currently not in use by the WPMC Transfusion Service and would be a new methodology if implemented. This technology would require additional resources to include a different methodology testing and resources to validate the new methodology resulting in incurring an additional cost of $20K in reagents and consumables.

utilizes a different Gel IH Card methodology than is currently in use at the MTF. gel cards do not have gel bead technology within their cards which is necessary for the current methodology in use at the MTF. Using technology would require additional resources to include a different methodology testing and resources to validate the new methodology resulting in incurring an additional cost of $20k in reagents and consumables.

Section E: Steps to Preclude Future Single Source Awards

The Medical Treatment Facility will continue to monitor the field through market research to determine if another source can satisfy the Government's requirements.