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

there are many different indications approved for PD-L1. We were curious if there were any specific indications you needed to be FDA approved on your IHC platform? Question: Additionally, we saw that the RFQ requested a stainer with both PD-L1 22C3 and Her2 neu FDA approved tests. My understanding is that there is no single platform that has both these tests FDA approved. Are you looking to sole source a single platform or a multi platform stainer? Answer: The instrument needs to have the ability to run the PD-L1 22C3, and Her2 neu. We understand that we may not be able to have them both as FDA approved and in that case the instrument will need to be an open system, and we will run them as lab developed tests. We would prefer a single platform. Question: SOW Section 5.1.1 - To our understanding of the market no benchtop model IHC instrument as capable of the required throughput capability specified in requirement 4.1.6.3. Can you please clarify whether the throughput or benchtop requirement will be evaluated or weigh more heavily in your assessment of proposals? Answer: The throughput requirement in 4.1.6.3 will be evaluated, the instrument does not have to be a benchtop. Question: SOW Section 4.1.6.14 - This requirement specifies 550 slides per month equating to 6600 slides per year. However, in the test menu section the total number of tests is 5223. Can you please clarify which slide volume VAMC Buffalo will use to base our pricing on? Answer: The information in Attachment A is the most accurate estimate of 5223. Question: SOE Section 7.1.2 - It is our interpretation of this question that this is more applicable to other lab disciplines. Specifically in order to meet this requirement a vendor, as it is currently worded, would be responsible for cutting tissue sections for validation. It is our belief that no vendor performs that work currently. Can you please clarify the scope of this requirement? Answer: The Vendor would not be required to supply any samples the VA would be responsible for supplying all cut slides for staining. Question: SOW Section - 7.1.3 - It is our interpretation of this requirement that a vendor would be unable to perform this requirement as CAP regulations dictate the statistical analysis is performed by the lab/VAMC. Can you please clarify this requirement? Answer: The requirement of the Vendor is to assist with the initial validation of the instrument. Description This is a combined presolicitation/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.201-1, Simplified procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06. This solicitation is Unrestricted allowing for Full and Open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1,000 employees. The FSC/PSC is 6640 Laboratory Equipment and Supplies. The Department of Veterans Affairs, Network Contracting Office 2, 130 West Kingsbridge Road, Bronx, NY 10468, is seeking to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the purchase Clinical Laboratory Immunohistochemistry Stainer Testing for the Buffalo VA Medical Center. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 Base Year: Immunohistochemistry (IHC) Stainer - Cost Per Reportable Result 1 Job 0002 Option 1: Immunohistochemistry (IHC) Stainer - Cost Per Reportable Result 1 Job 0003 Option 2: Immunohistochemistry (IHC) Stainer - Cost Per Reportable Result 1 Job 0004 Option 3: Immunohistochemistry (IHC) Stainer - Cost Per Reportable Result 1 Job 0005 Option 4: Immunohistochemistry (IHC) Stainer - Cost Per Reportable Result 1 Job Annual estimates for antibodies/reagents and required testing diagnostics are found in Attachment A of the Statement of Work. The Government estimates the volumes listed in the Statement of Work but does not guarantee volumes as listed. The Guaranteed Minimum dollar amount to be executed between the date of contract award and 9/30/2026 is $20,000.00. Pricing shall be in a Cost Per Reportable Result (CPRR) format that includes all associated costs, including instrument, all reagents, all supplies, and delivery. Statement of Work Immunohistochemical (IHC) Auto-Stainer Buffalo VA Medical Center 1.1. BACKGROUND: Immunohistochemical stains are necessary for accurate diagnosis and optimal treatment for patients with abnormal biopsy results. The turnaround time and clarity of staining is paramount for proper management of patient diagnosis. The automated IHC system must be FDA approved, utilize a flexible open system. It must be compatible to creating custom staining protocols, run multiple detection systems and chromogens in a single run while retaining optimal staining results. The Clinical Laboratory Immunohistochemistry (IHC) Analyzer requirement is an automated system for drying, dewaxing, cell conditioning, application of antibodies, detection, and counterstain chemistry. 2.1. GENERAL DEFINITIONS: 2.1.1 Cost Per Test (CPT) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per Test Clinical Laboratory Analyzers - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering equipment use, all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, Printer, toner and labels, and any other item required for the proper operation of the contractor s equipment and necessary for the generation and reporting of a test result, all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment. 2.1.2. Acceptable CPT Pricing Model Per test result fixed pricing approaches include but are not limited to the following two models. 2.1.2.1. Matrices of all net prices inclusive of subject fixed and variable costs as indicated in the above definitions. 2.1.2.2. Pricing of subject fixed and variable costs broken down individually and subject to an acceptable calculation that would be applied, resulting in the net fixed price consistent with the requirement of the solicitation. 3.1. GENERAL REQUIREMENTS: 3.1.1. The Contractor shall provide all upgrades to their equipment hardware and operating systems software. These enhancements to the Contractor s equipment shall be delivered to the Buffalo VA Laboratory and installed within thirty (30) days of their issuance or date of first commercial availability. One analyzer is required for the Buffalo Laboratory. 3.1.2. The Contractor s equipment shall be made available in the same condition of production (as newly manufactured and r