6550--Roche Ventana IHC/SS Mt Home VAMC Blanket Purchase Agreement Sole Source Notice IAW FAR 12. 102(b) Estimated Value

VHAPG Part 806.3 OFOC Page 1 of 4

Revision: 04 Effective Date: 12/15/25

Acquisition ID#: 36C249-26-AP-1835

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

IAW FAR Overhaul Part 12.102(b)

Acquisition Plan Action ID: 36C249-26-AP-1835

Contracting Activity:

Department of Veterans Affairs, Network Contracting Office 9 on behalf of VISN 9, James H. Quillen VA Medical Center

Purchase Request: 621-26-3-037-0534

Nature and/or Description of the Action Being Approved:

Sole source 24 month Blanket Purchase Agreement with Firm Fixed Unit Price Cost consumables with an estimated value of $880,000 and a period of performance from 6/1/2026 to 5/30/2028.

Description of Supplies/Services Required to Meet the Agency s Needs:

This acquisition is for the rental of two Roche-VENTANA BenchMark ULTRA PLUS (FS) Immunohistochemical Stainers (IHC Stainers) and one Benchmark Special Stainer for the Histology section of the Pathology and Laboratory Medicine Service (PLMS) at the James H. Quillen VA Medical Center (VAMC) at 809 Lamont Street, Mountain Home, TN 37684.

The acquisition includes all reagents, related stains, antibodies, consumables, technical support, associated services, and includes quarterly decontamination services. The required items and services are necessary to produce quality stained slides, which are evaluated by pathologists and assist in the diagnosis of patients.

Statutory Authority Permitting Other than Full and Open Competition in accordance with FAR Overhaul Part 12.102(b):

Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 U.S.C. 1901.

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

James H. Quillen VAMC uses the Roche Ventana Benchmark Ultra IHC Stainer and the Roche Ventana Ultra Benchmark Special Stainer. The Roche IHC and Special Stainer platforms offer the ability to add/remove slides without stopping workflow. These Stainers provide an exact footprint on restrictive available space. Roche reagents provide a unique capability to be added or removed from the Roche system without impacting workflow with the use of individual drawers. The system capability eliminates batch runs which provides operators continuous access to the system, thus preventing delays in patient tissue staining and subsequent diagnosis. The Special Stainer capability eliminates accidental use of expired reagents and mislabeling of reagents with manual entry. The Roche staining platform is the only staining system that meets the requirement in its entirety.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

This justification will be posted in accordance with FAR Part 5.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The procurement will and can be determined fair and reasonable based on historical contract pricing from a previous contract and other similar contract awards.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted from various sources indicated that this requirement has consistently been sole sourced across the VA, Department of Defense, and other government agencies. A review of SAM.gov Contract Opportunities identified five recent sole source justifications for same and similar requirements, all of which included documented market research, justifying and validating the sole source.

Any Other Facts Supporting the Use of Other than Full and Open Competition:

None.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

None.

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The Department of Veterans Affairs will continue to seek vendors capable of providing these supplies in future procurements. However, at the present time, based on available market research, there are no other sources that are fully capable of providing the required supplies other than Roche Diagnostics Corporation.

Requirements Certification:

I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

_____________________________ ________________________ Lisa White Date

Histology Supervisor

James H. Quillen VA Medical Center

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

_____________________________ ________________________ Robert Pitre Date

Contracting Officer

Network Contracting Office 9

One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

_____________________________ ________________________ Harry R. Grambo III Date

Clinical Support Branch Chief

Network Contracting Office 9 Awarded contract 36C24926A0041 to ROCHE DIAGNOSTICS CORPORATION for 880000.00000000 on 2026-05-26.