36C25726Q0447.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Ognian D. Ivanov ognian.ivanov@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Notice of Intent to Sole Source The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 17, intends to award a firm-fixed-price contract on a sole source basis to:

ROCHE DIAGNOSTICS CORPORATION

UEI: JDMDFEZBYH36

9115 Hague Road Indianapolis, IN 46256

1. Proposed Action The Government intends to award a firm-fixed-price contract on a sole source basis to Ventana Medical Systems, Inc., doing business as Roche Tissue Diagnostics, a member of the Roche Group, for one VENTANA BenchMark ULTRA PLUS Immunohistochemistry / In Situ Hybridization (IHC/ISH) stainer system, including all required system software, uninterruptible power supply (UPS), monitor, scanner, printer, technical support, and customer training, as described in the attached Statement of Work. The contractor shall also provide installation, instrument validation guidance, preventive maintenance, on-site/off-site operator training, and technical support in accordance with manufacturer specifications.

2. Statutory Authority This acquisition is being conducted under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

3. Rationale / Justification The VA North Texas Histology section requires an additional IHC stainer to meet current and projected testing volumes and to maintain timely diagnostic services for Veteran patients. The required system must:

Be a fully automated, random-access IHC/ISH staining platform capable of individual slide processing without interrupting workflow.

Provide continuous loading of reagents, controls, calibrators, and samples without interruption.

Include error-proof reagent and commodity design with built-in safeguards to help prevent reagent mix-ups, probe crashes, and unnecessary downtime.

Offer modularity to add staining capacity as laboratory needs increase.

Allow flexibility to optimize protocols, reagents, and timing to support best practices and varying tissue fixation conditions.

Provide an IHC stain menu that includes, at a minimum, tissue staining options for a broad range of disease-related markers using the VENTANA assay portfolio.

Be compatible with VENTANA specialized staining products currently used by the Government under existing Roche agreement.

Fit within the existing laboratory footprint, with dimensions appropriate for installation in Histology Room 1B-328 at VANTHCS.

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics), as part of the Roche Diagnostics Division, designs and manufactures the VENTANA BenchMark ULTRA PLUS tissue staining platform and associated reagents. The BenchMark ULTRA PLUS system is an advanced evolution of the BenchMark series, providing fully automated IHC/ISH slide staining with optimized workflow, integrated touchscreen, and enhanced software and productivity features. It is specifically designed to work with the VENTANA family of tissue-based diagnostic assays, which are already in clinical use at VA and are supported under the existing Roche contract, thereby ensuring reagent compatibility and consistent, validated test performance.

Substituting a different IHC platform would require extensive revalidation and correlation studies, adjustments to test protocols, and potential changes in reportable results, resulting in increased cost, extended implementation timelines, and risk of disruption to patient care. Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) is therefore the only responsible source that can provide the VENTANA BenchMark ULTRA PLUS system with full compatibility to the existing VENTANA reagent menu, established workflows, and current Roche contractual framework while meeting all technical and space requirements defined in the SOW.

For these reasons, only this source is considered capable of providing the required BenchMark ULTRA PLUS IHC/ISH stainer system in a manner that satisfies the Government’s minimum needs without incurring unacceptable schedule, cost, and operational risk.

4. Period and Place of Performance The contractor shall deliver, install, and validate the system at:

Histology Section, Room 1B-328 Pathology & Laboratory Medicine Service VA North Texas Health Care System 4500 S. Lancaster Rd.

Dallas, TX 75216

The performance period will begin upon award and continue through completion of installation, validation, training, and the applicable equipment warranty and service obligations, in accordance with the Statement of Work.

5. Other Considerations The contractor shall provide:

Delivery, installation, and setup of the instrument and all associated components.

Test validation guidance and validation supplies.

Basic and advanced operator training, including initial on-site training and an additional annual on-site or off-site operator class.

Preventive maintenance at manufacturer-recommended intervals, including all required parts and materials, at no additional cost to the Government.

Technical support during business hours and escalation to on-site support within 48 hours when required.

Detailed service and maintenance reports after all preventive maintenance and repair visits.

The contractor will have only supervised access while on VA premises for installation, service, and maintenance. There will be no access to the VA laboratory information system (LIS), and no VA data of any type shall be transferred from the VA.

6. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES This notice of intent is not a request for quotations or proposals. However, interested parties who believe they can meet the requirements described in the Statement of Work and this notice may submit a capability statement detailing their ability to provide an IHC/ISH stainer system that fully meets all required technical specifications, stain menu, footprint, and compatibility requirements. The capability statement must be received by the date and time specified in the posting and shall be sufficient to establish that the interested party can fulfill the Government’s requirement without degradation of service or disruption of operations.

Capability statements must be received no later than 04/ 27/ 2026, at 2:00 PM Central Standard Time (CST). Responses shall be submitted via email to:

Ognian D. Ivanov Contract Specialist, NCO 17 Email: ognian.ivanov@va.gov

A determination by the Government not to compete this requirement based on responses to this notice is solely within the discretion of the Government.

Special Notice