6640--Immunohistochemical (IHC) Stainer Testing for the Buffalo VA Medical Center

Amendment / Modification

This amendment addresses vendor questions and extends the quote submission deadline.

• Quote Submission Due Date Extended: The deadline to submit quotes has been moved to December 1, 2025, at 12:00 PM Eastern Standard Time.

• Questions Deadline: Any questions or concerns regarding this solicitation must be submitted in writing via email to Jonathan Kilgore, Contracting Officer, no later than November 19, 2025, at 12:00 PM Eastern Standard Time.

• Clarification on PD-L1 and Her2 neu FDA Approval: The instrument must be capable of running PD-L1 22C3 and Her2 neu tests. If both cannot be FDA approved on a single platform, the instrument should be an open system to run them as lab-developed tests. A single platform is preferred.

• Clarification on Throughput vs. Benchtop Requirement: The throughput requirement will be evaluated; the instrument does not have to be a benchtop model.

• Clarification on Slide Volume for Pricing: The estimate of 5223 slides per year, as detailed in Attachment A, is the most accurate for pricing.

• Clarification on Vendor Responsibilities for Slide Preparation: Vendors are not required to supply cut slides; the VA will supply all slides for staining.

• Clarification on Statistical Analysis: The vendor's role is to assist with the initial validation of the instrument, not to perform the statistical analysis as dictated by CAP regulations.

• Response Date/Time/Zone

• Description section (for Q&A and deadline clarifications)

• Statement of Work (SOW) sections related to specific requirements (throughput, slide volume, validation assistance)

• The quote submission deadline has been extended to December 1, 2025.

• Vendors must submit questions by November 19, 2025.

Solicitation / RFP / RFQ

This is a combined presolicitation/solicitation (RFQ) for commercial products and services for Immunohistochemical (IHC) Stainer Testing for the Buffalo VA Medical Center. The Department of Veterans Affairs, Network Contracting Office 2, is seeking to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract.

• Provision of an automated Immunohistochemical (IHC) Auto-Stainer system.

• The system must be FDA approved, utilize a flexible open system, and be compatible with custom staining protocols.

• It must be capable of running multiple detection systems and chromogens in a single run.

• The system must include instrument, all reagents, all supplies, and delivery, priced on a Cost Per Reportable Result (CPRR) basis.

• Specific capabilities include: minimum 30 slides and 35 reagents on board, accurate reagent tracking, capacity for at least 90 slides within 8 hours, automated PD-L1 IHC 22C3 and HER2 neu testing, minimal daily/weekly/monthly maintenance, and compliance with VA safety and waste disposal regulations.

• Attachment A lists estimated annual quantities for various antibodies, reagents, and companion diagnostics.

• Contract Type: Indefinite Delivery Indefinite Quantity (IDIQ)

• Period of Performance: March 1, 2026 – February 28, 2031 (5 years total, including base and option years).

• Guaranteed Minimum: $20,000.00 between contract award and 9/30/2026.

• Submission Deadline: November 20, 2025, 3:00 PM Eastern Time.

• Submission Method: Electronic only, via email to jonathan.kilgore@va.gov.

• Evaluation Factors: Technical Capability, Veterans Involvement, and Price.

• Award Basis: Most advantageous to the Government, considering price and other factors using a comparative evaluation process.

• Offerors must state acceptance of terms and conditions or list exceptions.

• This solicitation is Unrestricted, allowing for Full and Open competition.

• NAICS Code: 334516 (Analytical Laboratory Instrument Manufacturing) with a small business size standard of 1,000 employees.

• FSC/PSC Code: 6640 (Laboratory Equipment and Supplies).

• The solicitation document and incorporated provisions and clauses are effective through Federal Acquisition Circular 2025-06.

• Vendors not the OEM must provide authorization verification.

• Questions must be submitted in writing via email.