Notice of Intent to Sole Source-Roche Chemistry Analyzer-Supplies-Service-Taos Picuris Service Unit

NOTICE OF INTENT TO SOLE SOURCE Agency:

Indian Health Service (IHS), Albuquerque Area Office PSC:

DA10 NAICS:

334516 – Analytical Laboratory Instrument Manufacturing Notice Type:

Special Notice – Intent to Sole Source Authority: FAR 6.302 1 – Only One Responsible Source Set Aside: Not Applicable 1. Description of Requirement The Indian Health Service (IHS), Albuquerque Area Office, Taos Picuris Health Center intends to issue a sole source commercial item procurement under FAR Part 12 to Roche Diagnostics Corporation for brand name only Roche COBAS Pure chemistry analyzer equipment, proprietary reagents, calibrators, controls, consumables, manufacturer maintenance, replacement parts, and technical/software support required for uninterrupted clinical chemistry operations.

All Roche chemistry products and services are proprietary and must be acquired exclusively through Roche’s VA Federal Supply Schedule (FSS) Contract V797P 7347A, which is the only authorized federal contract vehicle for these items.

Vendor:

Roche Diagnostics Corporation UEI:

JDMDFEZBYH36 Address: 9115 Hague Rd, P.O. Box 50457, Indianapolis, IN 46250 0457 Required brand name Roche items include, but are not limited to:

• Roche COBAS Pure chemistry analyzer package • Clinical chemistry reagents, calibrators, QC materials, and assay cartridges • Required consumables and analyzer maintenance supplies • Refrigerated / frozen reagent shipping according to Roche specifications • Manufacturer preventive maintenance and field service support • 24 hour technical support and analyzer replacement if required • RPMS compatible connectivity, software integration, and firmware updates • All manufacturer approved QA, safety, and regulatory compliance items 2. Justification for Sole Source Market research confirms that Roche Diagnostics is the only responsible source authorized to provide Roche COBAS Pure analyzers, proprietary chemistry reagents, firmware, technical support, and maintenance.

Roche retains all intellectual property rights associated with: • COBAS Pure chemistry analyzer architecture • Reagent formulations • Analyzer firmware and calibration files • Software connectivity and interface modules • RPMS integration protocols • Maintenance parts and service procedures Roche further confirmed that only VA FSS Contract V797P 7347A is authorized for federal procurement of COBAS Pure chemistry systems and associated consumables.

No other vendor can legally manufacture, sell, service, or integrate Roche chemistry products, nor do any other vendors possess proprietary access or the ability to support existing workflows at Taos Picuris Health Center. Therefore, a sole source procurement is justified under FAR 6.302 1 – Only One Responsible Source. 3. This Notice Is Not a Request for Quotes This Special Notice solely announces the Government’s intent to negotiate on a sole source basis with Roche Diagnostics Corporation.

No competitive solicitation will be issued.

4. Capability Statement Instructions Interested parties may submit a capability statement ONLY if they can demonstrate: • Legal authority to sell Roche brand name chemistry equipment and proprietary reagents • Authorization under VA FSS Contract V797P 7347A specifically • Certification to provide manufacturer authorized maintenance and technical support • Proven compatibility with existing Roche configured RPMS chemistry workflows • Ability to comply with all Roche shipping, storage, safety, and regulatory requirements Capability statements proposing alternative analyzers, third party reagents, substitute chemistry systems, or non Roche platforms will NOT be considered. 5. Response Deadline Responses must be submitted by: August 14, 2026 – 4:00 PM Mountain Time Send responses to:

Raelynn Ray, Contract Specialist Indian Health Service – Albuquerque Area Office Email: raelynn.ray@ihs.gov Phone: 505 256 6757 6. Intended Award If no valid capability statements are received, the Government will award a sole source, firm fixed price, commercial item contract to Roche Diagnostics Corporation under FAR 6.302 1, using Roche’s VA FSS Contract V797P 7347A.

7. Period of Performance Base Year + Four (4) Option Years: • Base Year: 01/01/2027 – 12/31/2027 • Option Year 1: 01/01/2028 – 12/31/2028 • Option Year 2: 01/01/2029 – 12/31/2029 • Option Year 3: 01/01/2030 – 12/31/2030 • Option Year 4: 01/01/2031 – 12/31/2031 8. Contract Type Firm fixed price commercial item contract under FAR Part 12