CPT clinical laboratory immunohistochemistry (IHC) and in-situ hybridization (ISH) analyzer with Reagents

Solicitation / RFP / RFQ

This solicitation is for "Cost Per Test Clinical Immunohistochemistry (IHC) and In-Situ Hybridization (ISH) Analyzer - Automated system" services. The Department of Veterans Affairs (VA) Southern Nevada Healthcare System requires a contractor to supply and train on reagents, standards, quality controls, supplies, and equipment for IHC/ISH testing. The goal is to ensure accurate staining, analysis, data review, and reporting of IHC/ISH test results.

• Supply all reagents, standards, quality controls, supplies, consumables, disposable items, parts, and accessories for the operation of the analyzer system.

• Provide training on the use of the instruments.

• Maintain the Contractor Ventana analyzers.

• Offer routine preventative maintenance (PM) twice per year.

• Provide 24/7 telephone troubleshooting support.

• Offer on-site filed service support during normal business hours, with a one-hour response time.

• All parts and upgrades must be provided at no cost to the government.

• Supplies will be shipped on an as-needed basis.

• Special handling for emergency orders of supplies is required if found defective or unsuitable.

• Contract Type: Not explicitly stated, but implies a service contract with options.

• Period of Performance: Base year (04/01/2026 - 03/31/2027) with four (4) one-year option periods.

• Estimated Value: Not stated.

• Proposals must be submitted via email to Leah.Smith@va.gov by the due date specified in Block 8 (02-18-2026, 11:00 AM PDT).

• Questions must be submitted via email no later than 48 hours prior to the closing date.

• Evaluation will be based on Price Only, with consideration for option prices.

• Offerors must complete and return the SF1449 form, the Price/Cost Schedule, and all tabs of the attached Price List.

• The acquisition is set aside for Small Business.

• NAICS Code: 325413

• Size Standard: 1,000 employees.

• This is a sole source solicitation to Roche Diagnostic.

• The solicitation includes FAR clauses and VAAR clauses, some with deviations.

• Offerors must be accredited by the College of American Pathologists (CAP) and certified by CLIA.

• Offerors must be registered with the CDC's International Reagent Resource (IRR).

• Invoices must be submitted electronically via Tungsten Network.

Form / Attachment / Pricing Sheet

This document is a pricing sheet, likely intended to be used by bidders to provide their pricing for various items. It contains detailed lists of products, estimated quantities, units of measure, and fields for unit price and total price. The data is organized into several sheets, each representing a different fiscal year or option period (Base, OY1, OY2, OY3, OY4), and a 'RefData' sheet providing reference information.

• Product Listings: Extensive lists of specific items, identified by ITEM NUMBER, DESCRIPTION, and PART #. Many items appear to be diagnostic reagents and related supplies, with "Roche Diagnostics Corporation" listed as the OEM NAME.
• Quantities and Units: Estimated quantities and units of measure (primarily 'KT' for kit, and 'YR' for year for service items) are provided for each item.
• Pricing Fields: Columns for UNIT PRICE and TOTAL PRICE are present, indicating where bidders should input their cost information. All listed prices are currently 0.0.
• Origin and OEM: Country of Origin (COO) is listed as 'USA' for all items, and the Original Equipment Manufacturer (OEM) is predominantly 'Roche Diagnostics Corporation'.
• Reference Data: The 'RefData' sheet includes discount types, options for pricing, FOB terms, and state codes/descriptions, which may be relevant for contract terms and conditions.

This pricing sheet is crucial for bidders to understand the specific items and quantities for which pricing is required. Bidders must use this document to formulate their price proposals, ensuring they accurately quote prices for each line item and consider the specified quantities and units. The presence of multiple option year sheets suggests a multi-year contract structure. The zeroed-out prices indicate that this may be a template for initial pricing submission or a request for quote where prices need to be filled in.

Solicitation / Sole Source Justification

This document is a justification for a sole source procurement of a clinical laboratory immunohistochemistry (IHC) and an in-situ hybridization (ISH) analyzer, which is a continuous, automated slide staining system. The procurement is for a Cost-Per-Test (CPT) requirement.

• Automated IHC/ISH slide staining system (Cost per test).

• The cost per test is all-inclusive of instrumentation, reagents, consumables, service, and training.

• Contract Type: Firm Fixed Price.

• Period of Performance: One (1) year base period plus four (4) one (1) year option periods.

  • Base: 4/1/2026 – 3/31/2027
  • Option 1: 4/1/2027 – 3/31/2028
  • Option 2: 4/1/2028 – 3/31/2029
  • Option 3: 4/1/2029 – 3/31/2030
  • Option 4: 4/1/2030 – 3/31/2031

• FAR 52.217-8 Option to Extend Services will be incorporated.

• Estimated total value for the base and all option periods is provided, with a separate estimate for the base year.

• This is a sole source justification under Simplified Procedures (FAR 12.201-1 and FAR 12.102(b)).

• The statutory authority for restricting competition is 41 U.S.C. § 1901.

• The requirement is restricted to Roche Diagnostics because their BenchMark ULTRA system is the only automated IHC/ISH slide staining system that fits the available lab footprint and utility configuration. Modifications to the lab would be required to install other equipment.

• The government intends to synopsize this requirement with a notice of intent to sole source to Roche Diagnostics.

• This is a sole source procurement from a large business Original Equipment Manufacturer (OEM).

• The rule of two has not been met, indicating no other responsible sources are capable of meeting the requirement.

• Market research was conducted, including a review of recent IHC requirements and sources sought, which identified only large business OEMs capable of providing the necessary equipment and supplies under a CPT agreement.

• Roche Diagnostics has previously provided satisfactory performance for similar services.

• If this analyzer is not procured, there would be increased costs associated with sending lab specimens outside the lab for testing, potentially degrading patient care due to increased wait times.