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

The purpose of this amendment is as follows: Answer questions from interested vendors. Extend the quote submission due date to December 1, 2025 at 12:00PM Eastern Standard Time. Establish that any questions or concerns regarding this solicitation should be forwarded to Jonathan Kilgore, Contracting Officer, •••••@•••••.•••Sign up to see this detail, no later than November 19, 2025 at 12:00PM Eastern Standard Time.
Below are the questions submitted by interested vendors and their corresponding answers:
Question: When going through the RFQ, we noticed the request for FDA approved PD-L1, 22C3. As you may be aware, 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 remanufactured state-of-the-art equipment) as offered for a period of at least one (1) year after the date of contract award. 3.1.3. The Contractor s equipment shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit and 10 and 32 degrees Celsius. 3.1.4. The Contractor s equipment shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent. 3.1.5. An operator s manual shall be furnished with all supplied equipment. 3.1.6. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the Statement of Work. 3.1.7. The equipment must maintain or preferably reduce the overall labor (technologist time) required to accomplish the required testing; this includes stainer maintenance. 3.1.8. The instrument must utilize a flexible open system, which includes use of reagents from third party vendors, able to create custom staining protocols and run multiple detection systems and chromogens in a single run, while retaining optimal staining results.
4.1. INSTRUMENTATION SPECIFICATIONS: 4.1.1. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. 4.1.2. All products to be shipped FOB Destination. All reagents supplied must have expiration dates of at least six months from date of receipt. 4.1.3. All pricing must be provided for all items which are required to produce a satisfactory test result. 4.1.3.1. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology/product shall be at the expense of the Contractor. 4.1.3.2. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, lab chiefs, and the VISN program office. These individuals shall be identified upon award of the contract. 4.1.3.3. All products, reagents that are found to be defective shall be warrantied until date of expiration and communicated as such to the Contractor at first occurrence. 4.1.4. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the SOW. 4.1.5. Industry Standards Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Immunohistochemistry (IHC) equipment, supplies and services. 4.1.6. Operational/Technical Features - The instrumentation offered shall provide the below capabilities: 4.1.6.1. Equipment shall be new, state of the art, and not used, recertified nor refurbished. Equipment shall be acquired for the Clinical Laboratory located Veteran Administration Western New Your Healthcare System at Buffalo New York. 4.1.6.2. Capacity for a minimum of 30 slides and minimum of 35 reagents on board, Accurate metering capability for monitoring reagent usages and reagent level detection. Reagent tracking must include product code, Lot number and expiration date. 4.1.6.3. Sufficient capacity and throughput at a minimum of 90 slides within 8 hours or less to enhance turnaround time and allow for maximum productivity and service demands as defined in the Test Menu. Contractor will supply completion times for all tests listed in Attachment A. 4.1.6.4. Fully automated FDA approved PD-L1 IHC 22C3, and HER2 neu must be included in test menu. 4.1.6.5. The IHC system must consistently deliver only the amount of reagent required with no cross-contamination between slides. Fresh reagents must be applied to each slide. 4.1.6.5. A reagent capacity of a minimum of 35 reagents. Positive identification of slides and reagents to minimize errors 4.1.6.6. The IHC instrument shall not be connected to the VA Lab Vista computer system. 4.1.6.7. Sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. 4.1.6.8. VA Safety regulations require strict control of chemical waste disposal. The system must separate hazardous waste from non-hazardous waste for GEMS and EPA compliance: 40 Code of Federal Regulations (CFR) Title 40: Protection of the Environment Part 261- Identification of Hazardous Waste. 4.1.6.9. Provided analyzers shall be able to accommodate a 20% increase in workload during the period of this agreement. 4.1.6.10. Minimal daily maintenance: Daily maintenance requires minimal time, less than 10 minutes of hands-on technologists time with the analyzer not required to be down for more than 20 minutes per day. Weekly maintenance performed by the end user must be minimal and not require more than 20 minutes of hands-on technologists time and monthly maintenance not more the 45 minutes of hands-on technologists time. There shall be easy access to the analyzer for the technical operator to perform maintenance. 4.1.6.11. Must have the ability and flexibility to add and remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. 4.1.6.12. Ease of use with reagent handling, i.e., barcoded reagents to prevent or reduce reagent mix up, ability to load reagents on as needed basis in an expeditious manner. Onboard reagent stability will be evaluated. Pre-packaged bulk solution reagent kits with no mixing and continuous access to bulks and waste for improved workflow. Techs must be able to access waste with minimal delay for slide processing. 4.1.6.13. FISH probes must include ALK/Ros/Ret. 4.1.6.14. The VAWNY Healthcare System at Buffalo estimates a test volume of 550 slides per month. Instrument must provide capability for both batch and stat patient-case processing, with the ability to add and process slides continuously. 4.1.6.15. The system must be an open system which allows use of reagents from third party vendors, and ability to create custom protocols. 4.1.6.16. The system must perform IHC, ISH and FISH, and have capability for fully automated overnight runs and fully automated FISH testing. Technician intervention is not required once slides and reagents have been loaded onto instrument. ALK FISH method must provide quality results as interpreted by VAWNY Healthcare System at Buffalo pathologists. 4.1.7.17. See attachment A for the list of specific Antibodies and Companion diagnostics which must be included in cost per slide. 4.1.7.18. The system must be fully automated and provide slide pretreatment, baking, deparaffinization, and cell conditioning. Optimal quality of slide staining as determined by VA WNY Healthcare System at Buffalo Staff pathologists. 4.1.7.19. Method of performance, comparison, and equipment validation shall be at the expense of the Contractor and shall include all lab supplies and reagents.
5.1. HARDWARE/SOFTWARE FEATURES:
5.1.1. Instrumentation, reagents, consumables and all other provided equipment shall have a total footprint that, when installed/stored in the laboratory shall save space and shall not negatively impact the functionality/operations of that laboratory. This footprint shall not require significant and/or costly infrastructure changes. The physical system must have a true benchtop footprint in order to meet the confined space of the existing laboratory space. 5.1.2. Hardware should include a 2D compatible digital barcode reader to provide positive identification for all specimen IDs. The equipment must also support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Accuracy of bar code reading must have a 1% failure rate. 5.1.3. Equipment must accept, at a minimum, a 10-character, alphanumeric specimen identifier (letters and numbers). 5.1.4. Easy slide insertion with no extra pieces to position 5.1.5. Have independently functioning slide staining chambers, or equivalent solution, to preserve sample integrity. Equivalent solutions must not be labor intensive. 5.1.6. Have the ability to add short turnaround time (STAT) requests with no interruption to routine runs. 5.1.7. Have the ability and flexibility to add/remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. 5.1.8. Optimized protocols with flexible options including variable incubation times and temperatures. 5.1.9. An on-board, adjustable monitor/screen that is easily readable. 5.1.10. The system includes a printer that has the capability of printing clear, legible and easy to read staining reports. 5.1.11. An uninterruptible power supply with line conditioner for each instrument will be provided. 5.1.12. Equipment shall have accurate metering capability for monitoring reagent usage and reagent level detection. The Contractor may in the alternative provide another means of tracking reagent usage and reagent level detection if the metering capability is not practical. System will have an effective automatic detection and tracking of insufficient reagent quantities and alert for remaining tests. The instrument shall include buttons and barcodes that automatically register and locate staining kits and slides. Barcoded reagents in which the Instruments must have capability to ensure that one can't use reagents if they are expired or if the volume of the reagents is insufficient to complete the run. 5.1.13. Provide instrument Operation Manual" printed copy at each facility and electronic procedure manual in the instrument software. The procedure manual shall be formatted in accordance with current approved CLSI guidelines
6.1. TEST AND DATA MANAGEMENT: 6.1.1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, be approved by the Food and Drug Administration (FDA) to perform the services/requirements as described and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act and related documents, Joint Commission Standards, and federal regulations and via validation of the VA. Instrument must be FDA approved.
7.1. SUPPORT FEATURES:
7.1.1. Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award. The report shall be provided to the CO at least ninety (90) days before installation. The Contractor shall visit and propose the location of equipment and determine specific site prep requirements including but not limited to: 7.1.1.1. Space availability 7.1.1.2. Power availability 7.1.1.3. Availability of waste drainage systems 7.1.1.4. Increase heat load affecting air conditioning 7.1.1.5. Specialized ventilation if required 7.1.1.6. Special finishes required 7.1.1.7. Carts for non-floor standing instrumentation 7.1.7.8. Equipment shall be new, state of the art, and not be used, recertified or refurbished. 7.1.7.9. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies and required to establish instruments for operation for performance of acceptance testing. 7.1.2. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no additional cost to the Government. 7.1.3. The Contractor shall perform all of the statistical analysis as stated in 2.4 and report data in an organized, clearly comprehensible format. 7.1.4. The Contractor shall visit each Facility at minimum one (1) time per quarter to review the account, provide product information, answer questions, provide Customer Service, handle any defective merchandise, and take care of any other issues that have not been resolved. The schedule shall be created post-award directly with the point of contacts provided at the time of award. 7.1.5. Special Handling for Emergency Orders of Supplies: 7.1.5.1. In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within twenty-four (24) hours of receipt of a verbal order for emergency delivery. 7.1.5.2. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one (1) week (under normal Government test load volume). 7.1.5.3. If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.
7.1.6. Service and Maintenance Plan: 7.1.6.1. The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation (or equivalent solution or better), as applies, and any incremental support equipment, e.g. water system, offered according to the following terms: 7.1.6.2. The Contractor shall provide remote support for trouble shooting. A technical assistance center shall be available by telephone Monday through Friday during administrative hours with a maximum callback response time of four (4) hours. 7.1.6.3. Equipment repair service shall be provided Monday through Friday during administrative hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. 7.1.6.4. Equipment repair service response time shall be no more than twenty-four (24) hours. 7.1.6.5. A minimum of two (2) scheduled preventative maintenance calls per year at each facility, once every six (6) months unless otherwise stated within a deviation document. A deviation shall be granted if this deviation is in the best interest of VISN under CO discretion. 7.1.7. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: 7.1.7.1. Date and time notified 7.1.7.2. Date and time of arrival 7.1.7.3. Serial number, type and model number of equipment 7.1.7.4. Time spent for repair, and 7.1.7.5. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 7.1.8. Each notification for an emergency repair service call shall be treated as a separate and new service call. 7.1.9. The Contractor will immediately notify the CO and Contracting Officer s Representative (COR) of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs processing recalls, i.e. administrative and clinical services to replace recalled/defective products. 7.1.10. A copy of each service/maintenance record shall be provided to the corresponding VA facility COR within five (5) working days of service/maintenance completion. 7.1.11. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide on-site training for minimally one (1) operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant included in the Blended CPRR/CPT price. In addition, remote training shall be included.
7.1.12. The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the art technology. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system updates that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. Should the facility decide to upgrade their current equipment, e.g., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement. 7.1.13. Information Technology Considerations - Ancillary support equipment - The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. 7.1.14. The Contractor shall be responsible for providing all hardware required for the connection; implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system 7.1.15. The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. 7.1.16. Characterization of hazardous waste The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations (CFR) Title 40 Protection of the Environment Part 261 et al. In addition, the list shall also identify any hazardous materials defined as Hazardous under the latest version of Federal Standard No. 313 that may be provided as a part of this contract. Material Safety Data Sheets (MSDS) shall be submitted for all products. The Contractor will provide a complete chemical analysis of waste, to include mercury, sodium azides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Subsequent waste analysis studies for any new test or new test formation introductions shall be provided. Documentation of all analysis will be provided to the CO for review. The description shall address the following: Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables and equipment. The Contractor shall also provide their own reports of effluent studies associated with their instrument. The Contractor shall also provide documentation to the COR concerning any items in this acquisition that contain cyanide. 7.1.17. The Contractor will provide written instructions and training material to ensure all required VHA Laboratory Staffs are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and State requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. 7.1.18. The Contractor shall provide a description of all wastes their equipment may discharge so that the Laboratory can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State, and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the Laboratories to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with the Contractors proposal: 7.1.18.1. Barium (Total) 7.1.18.2. Cadmium (Total) 7.1.18.3. Chromium (Total) 7.1.18.4. Copper (Total) 7.1.18.5. Cyanide (Total) 7.1.18.6. Lead (Total) 7.1.18.7 Mercury (Total) 7.1.18.8. Nickel (Total) 7.1.18.9. Silver (Total) 7.1.18.10. Zinc (Total) 7.1.18.11. Arsenic (Total) 7.1.18.12. Selenium (Total) 7.1.18.13. Tin (Total) 7.1.18.14. PH 7.1.18.15. Flash point 7.1.18.6. BOD (biochemical oxygen demand) 7.1.19. The documentation the Contractor provides will be used to work with the VA Medical Centers to determine whether or not the waste from each device can legally be disposed of via the sewerage system. 7.1.20. The systems shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. The Contractor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal
8.1. NATIONAL HOLIDAYS:
8.1.1. The Laboratory is not open on National Holidays 8.1.2. All deliveries must arrive before 3pm
Federal Holidays consist of: New Year's Day Martin Luther King's Birthday President's Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day
9.1. DESIGNATION OF CONTRACT OFFICER REPRESENTATIVE:
9.1.1. COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.
10.1. SCHEDULE OF TERMS:
10.1.1. The period of performance of the awarded contract shall run from 3/1/2026, through 2/28/2031. The awarded contract period of performance shall not exceed five years. 10.1.2. The implementation of the requirements described in this Statement of Work shall be completed no later than ninety days after the Contract award date. This ninety-day timeframe is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated ninety-day timeframe. The Contractor shall not be penalized for implementation timeframes that extend beyond the ninety day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 10.1.3. Upon award of the Contract, the transition period for the awarded Contract to have all equipment and peripherals installed and operational shall be from the date of award through ninety days. During this ninety-day time period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Training will include two operators per instrument at the Contractor s location. Further, training shall include provisions for additional training at the Contractor s location or at the Buffalo Laboratory as agreed upon by the Contractor and the Buffalo Laboratory. During this ninety-day time period all initial validations shall be completed to the satisfaction of the Buffalo Laboratory Manager. 10.1.4. The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor s submitted plan shall not exceed ninety days for the transition of all requirements under the awarded Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded Contract for cause under the Termination for Cause clause of the awarded Contract. 10.1.5. At the end of ninety days from the award of the Contract, the awarded Contractor shall have full and sole responsibility for all requirements identified in this Statement of Work against the awarded Contract. 10.1.6. Total period of performance shall not exceed five years. Each option year, if exercised, shall be funded by a separate delivery/task order.

ATTACHMENT A TEST MENU
ANTIBODIES/REAGENTS REQUIRED TESTING DIAGNOSTICS BCL-1 (Cyclin D1): 22 QTY per year ALK FISH: 95 tests per year BCL-2: 42 QTY per year ROS-1 FISH: 1 test per year BCL-6: 36 QTY per year RET FISH: 1 test per year BER EP4: 18 QTY per year ALK - IHC test: 1 test per year Calretinin: 34 QTY per year Hercep Test: 1 test per year CD 3: 73 QTY per year PDL-1 CLONE 22C3: 1 test per year CD 5: 43 QTY per year Her2 IQ FISH: 23 tests per year CD 10: 48 QTY per year CD 15 (Leu-M-1): 2 QTY per year CD 20: 101 QTY per year CD 21: 24 QTY per year CD 23: 32 QTY per year CD 30 (Ki-1): 24 per year CD 31: 64 QTY per year CD 34: 87 QTY per year CD43: 2 QTY per year CD 45: 18 QTY per year CD 56: 47 QTY per year CD79a: 38 QTY per year CD117: 55 QTY per year CD138: 44 QTY per year CD163: 74 QTY per year CDX2: 44 QTY per year CEA: 21 QTY per year CHROMOGRANIN A: 62 QTY per year CK 5/6: 104 QTY per year CK 7: 77 QTY per year CK 20: 101 QTY per year Desmin: 65 QTY per year EMA: 41 QTY per year ER (Estrogen Receptor): 23 QTY per year HepPar -1 (Hepatocyte): 18 QTY per year Her2 Neu: 79 QTY per year HMW-CK: 29 QTY per year H. pylori: 522 QTY per year KAPPA: 6 QTY per year KI-67: 72 QTY per year LAMBDA: 4 QTY per year Mart 1 (Melan A): 46 QTY per year MLH-1: 78 QTY per year MPO: 20 QTY per year MSH-2: 74 QTY per year MSH-6: 74 QTY per year Napsin A: 94 QTY per year P53: 9 QTY per year P63: 205 QTY per year Pancytokeratin+: 331 QTY per year PD-L1: 134 QTY per year PIN4: 463 QTY per year PMS-2: 75 QTY per year PR: 20 QTY per year PRAME: 279 QTY per year S-100: 103 QTY per year SOX10: 531 QTY per year Synaptophysin: 76 QTY per year UNC-Mouse Controls: 78 QTY per year UNC-Rabbit Controls: 78 QTY per year TTF-1: 136 QTY per year
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.
(End of Statement of Work)
The Indefinite Delivery/Indefinite Quantity (IDIQ) contract period of performance shall be for five (5) years, to include a twelve (12) month base period and four (4) twelve (12) month Option years.
Base Period: March 1, 2026 February 28, 2027 Option Year 1: March 1, 2027 February 28, 2028 Option Year 2: March 1, 2028 February 28, 2029 Option Year 3: March 1, 2029 February 28, 2030 Option Year 4: March 1, 2030 February 28, 2031
Delivery shall be FOB Destination. Place of Performance/Place of Delivery Buffalo VA Medical Center 3495 Bailey Avenue Buffalo, NY 14215
The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52.
The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services The following provision is incorporated into 52.212-1 as an addendum to this solicitation:
52.212-1 Instructions to Offerors Commercial Products and Commercial Services (NOV 2025)
(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include
(1) The solicitation number;
(2) The name, address, telephone number of the Offeror;
(3) The Offeror s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator;
(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;
(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and
(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.
(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.
(c) Late submissions, modifications, revisions, and withdrawals of offers.
(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.
(2) Any offer, modification, or revision received after the time specified for receipt of offers is late and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.
(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.
(4) Offerors may withdraw their offers by written notice to the Government received at any time before award.
(d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror s initial offer should contain the Offeror s best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received.
(e) Debriefings.  If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:
(1) The agency s evaluation of the significant weak or deficient factors in the debriefed Offeror s offer.
(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.
(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.
(4) A summary of the rationale for award.
(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.
(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities.
(End of provision)
ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52 (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) 52. 204-7 System for Award Management (Nov 2024) 52.225-18 Place of Manufacture (AUG 2018) 52.229-11 Tax on Certain Foreign Procurements Notice and Representation (Jun 2020) 52.233-2 Service of Protest (Sep 2006) (a) Receipt from Jonathan Kilgore, Contracting Officer. 852.215-72 Notice of Intent to Re-solicit (Oct 2019) 852.233-70 Protest Content/Alternative Dispute Resolution (Oct 2018) 852.233-71 Alternate Protest Procedure (Oct 2018) 852.239-75 Information and Communication Technology Accessibility Notice (Feb 2023)
FAR 52.212-2 Evaluation-Commercial Products and Commercial Services
ADDENDUM to 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Basis for Award. The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: Technical Capability Veterans Involvement Price
Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting alternate quotations however quoters may present alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart  4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Any exceptions taken by the quoter must be clearly identified in writing. The evaluation will consider the following: Technical Capability: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation. Veterans Involvement: In accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.215-70 (DEVIATION), Service-Disabled Veteran-Owned and Veteran-Owned Small Business (VOSB) Evaluation Factors, the Government will assign evaluation credit for a Quoter (i.e., prime contractor) which is a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a VOSB. To receive credit, an offeror must be registered and verified in the Small Business Administration s (SBA) Small Business Search database at time of quotation submission and at time of award (https://search.certifications.sba.gov/) and must meet federal small business size standards for the North American Industry Classification System (NAICS) code assigned to this solicitation. Non-SDVOSB/VOSB quotations that use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. Quoters must state in their quotations the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the SBA s Small Business Search database (https://search.certifications.sba.gov/) and must meet federal small business size standards for the NAICS code assigned to this solicitation at time of both quotation submission and at time of award. Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Total Evaluated Price will be that sum. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s). Notice of award. A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Authorized Distributor. If the vendor is not the original equipment manufacturer (OEM) for the proposed equipment/system, they shall be an authorized dealer, authorized distributor, or authorized reseller, verified by an authorization letter or other documents from the OEM. Quoters shall submit this documentation with their quote. (End of Provision) The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (Nov 2025)
Addendum to 52.212-4 Contract Terms and Conditions Commercial Products and Commercial Services (NOV 2025)
Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52 (FAR) and
http://www.va.gov/oal/library/vaar/index.asp (VAAR)
52.204-13 System for Award Management Maintenance (Oct 2018)
52.216-18 Ordering (Aug 2020) (a) March 1, 2026 through February 28, 2031.
52.216-19 Order Limitations (Oct 1995) (a) $20,000.00 (b)(1) $140,000.00 (b)(2) $140,000.00 (b)(3) seven days (d) seven days
52.216-22 Indefinite Quantity (Oct 1995) (d) August 28, 2031
52.217-8 Option to Extend Services (Nov 1999) 30 calendar days
52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) 30 calendar days; 60 calendar days (c) five years
52.229-3 Federal, State, and Local Taxes (Feb 2013)
852.201-70 Contracting Officer s Representative (Dec 2022)
852.203-70 Commercial Advertising (May 2018)
852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JAN 2023) (DEVIATION)
852.215-71 Evaluation Factor Commitments (OCT 2019)
852.222-71 Compliance with Executive Order 13899 (Deviation) (Apr 2025)
852.232-72 Electronic Submission of Payment Requests (Nov 2018)
852.242-71 Administrative Contracting Officer (Oct 2020)
852.246-71 Rejected Goods (Oct 2018)
852.247-71 Delivery Location (Oct 2018) Buffalo VA Medical Center 3495 Bailey Avenue Buffalo, NY 14215
852.247-73 Packing for Domestic Shipment (Oct 2018)
(End of Clauses)
If the vendor is not the original equipment manufacturer (OEM) for the proposed equipment/system, they shall be an authorized dealer, authorized distributor, or authorized reseller, verified by an authorization letter or other documents from the OEM. Quoters shall submit this documentation with their quote.
All quotes shall be sent to the Network Contracting Office 2 (NCO 2), Jonathan Kilgore, Contracting Officer at •••••@•••••.•••Sign up to see this detail.
Award will be based upon a comparative evaluation of quotes in accordance with the simplified procedures of FAR 12. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. Options will be evaluated at time of award.
The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions.
See FAR 52.212-1 Instructions to Offerors Commercial Products and Commercial Services section above for a complete explanation of the instructions to offerors.
See FAR 52.212-2 Evaluation Commercial Products and Commercial Services section above for a complete explanation of how submissions will be evaluated.
To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any.
Submission of your response shall be received not later than December 1, 2025 at 12:00 PM Eastern Standard Time at •••••@•••••.•••Sign up to see this detail. Submissions must be received at this email address to receive consideration. Only electronic submissions will be accepted.
Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(c).
The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ).
This requirement is being solicited using FAR Part 12 Acquisition of Commercial Products and Commercial Services. FAR Part 12 does not require formal detailed debriefings, and detailed debriefings are not provided for requirements solicited using these procedures.
Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below no later than November 19, 2025 at 12:00PM Eastern Standard Time. Telephone calls will not be accepted. Status updates will not be provided. Point of Contact Jonathan Kilgore, Contracting Officer, •••••@•••••.•••Sign up to see this detail.