RFI Coversheet and Questions - NDTP-AI v.2.1.pdf

Request for Information (RFI) 36C10B26Q0472

THIS IS A RFI ONLY. This request is for planning purposes only, and does not constitute a Request for Quote, a Solicitation, or an indication that the Government will award a contract for the items contained in this RFI.

This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government does not reimburse respondents for any costs associated with submission of the information being requested or, reimburse expenses incurred for responses to this RFI. Companies are encouraged to respond if they have the capability and/or capacity to provide the items identified below. Offerors/Bidders/Respondents should identify their company name, address, email, telephone number and a name and telephone number of a point of contact having the authority and knowledge to clarify responses with government representatives.

Offerors/Bidders/Respondents are requested to identify the applicable contract vehicle, contracts and any additional information applicable to this RFI. Submissions are due NO LATER THAN June 23, 2026 at 10:00 am Eastern Standard Time and may be made by submitting your response through email response to the Contract Specialist Samantha McIntyre via email at Samantha.McIntyre2@va.gov and the Contracting Officer Peter T. Lewandowski via e-mail at Peter.Lewandowski@va.gov. This RFI notice is part of the Government’s market research, a continuous process for obtaining the latest information from industry, with respect to their current and near-term abilities. If there are not multiple responses to this RFI from preferred socioeconomic categories, any future Request for Proposals or Quotations for this requirement will be open to ALL vendors under the applicable North American Industry Classification System (NAICS) codes. The Government requests information regarding whether vendors can provide any/all of the products identified, please see the attached Draft Performance Work Statement (PWS).

The NAICS for this requirement is 541519. The Small Business Size Standard $34.0 million.

Small Business companies with the capability to perform this requirement, in total or in part, are encouraged to participate. If you are interested only in subcontracting opportunities, please indicate this fact clearly in your submission. If you believe a different NAICS code better applies to the requirements required under this RFI, please include your suggestions in your response to the RFI. Please indicate your company size and socio-economic status for applicable NAICS codes.

Be advised that set-aside decisions may be made based on the information provided in response to this RFI. Responses should be as complete and informative as possible.

mailto:Samantha.McIntyre2@va.gov

REQUIREMENT

The Department of Veterans Affairs (VA), Veterans Health Administration, National Pathology and Laboratory Medicine Program, in coordination with Veterans Integrated Service Network (VISN) 1, is conducting market research to identify commercially available off-the-shelf Artificial Intelligence (AI) pathology solutions and cloud storage capabilities to support the National Digital Telepathology – AI initiative.

VA is seeking information regarding solutions capable of:

• Providing the Food and Drug Administration (FDA) cleared AI assisted analysis of digital pathology images for the detection and characterization of prostate and gastric cancer.

• Integrating with the existing Philips IntelliSite Pathology Solution (PIPS) digital pathology platform.

• Supporting pathologist workflows through image analysis, case triage, diagnostic decision support, and standardized reporting.

• Providing scalable cloud-based storage, archival, and retrieval of Whole Slid Images.

• Operating within VA Enterprise Cloud environment and meeting applicable VA cyber security, Technical Reference Model, network connectivity, and Authority to Operate requirements.

• Providing implementation, configuration, clinical validation support, training, maintenance, and ongoing technical support.

• Supporting future expansion to additional VA facilities and VISNs.

The Government is interested in understanding industry capabilities, interoperability approaches, FDA clearance status, cloud architecture, implementation timelines, licensing models, and support strategies. Information received will be used to refine the requirements, assess market capabilities, determine the appropriate acquisition strategy, and evaluate potential socioeconomic set-aside opportunities.

The Contractor shall provide the specific deliverables listed within the performance period specified in Section 5.1 through 5.3.13, as well as 6.1.12 through 6.2.2 of the PWS. VA is contemplating a firm-fixed-price contract for 1 12-month base period of the Philips IntelliSite Pathology Solution, Image Management System Brand Name or Equal Solution for 12 months After Receipt of Order, with 4 12-month option periods under the attached PWS. This contract is not expected to exceed five years.

Interested vendors may submit “Equal” solutions that meet or exceed the Government’s Salient Characteristics as defined in PWS Section 3.1.

RFI RESPONSE INSTRUCTIONS

Note: Provide a capability package that is clear, concise, and thorough/comprehensive. VA is under no obligation to provide feedback to the company or to contact the company for clarification on any information/material submitted in response to this RFI.

There is a page limitation for this RFI of 15 pages or less. The Government will not review any other information or attachments included, that are in excess of the 15-page limit (Page count excludes the cover page, title pages, and table of contents). Vendors may also submit additional information not specifically requested above, which would provide value and insight to the Government. NO MARKETING MATERIALS ARE ALLOWED AS PART OF THIS RFI.

Generic capability statements will not be accepted or reviewed. Your response must address capabilities specific to the services required in the attached draft PWS and must include the following:

a. Interested Vendors shall at a minimum provide the following information in the initial paragraph of the submission:

Name of Company Address Point of Contact Name Phone Number Fax Number Email address Unique Entity Identifier System for Award Management (ueiSAM) under which the company is registered in SAM/VetBiz.Gov NAICS code(s) Commercial and Government Entity Code (CAGE Code) Company Business Size and Socioeconomic Status If your business is an 8a, please provide your cognizant small business office and small business representative's information Existing Contractual Vehicles the contractor holds for providing these products and/or services (GWAC, FSS, other agencies GWACs or MAC, etc.). If there are any existing contractual vehicles, please submit their details.

Do you anticipate proposing as a prime contractor?

Will you be using subcontractors with this effort?

For Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-Owned Small Businesses (SDVOSB), proof of certification in the U.S. Small Business Administration website.

For SDVOSB/VOSB business concerns indicate whether at least 50 percent of the cost of performance incurred is planned to be expended for employees of your concern or employees of other eligible SDVOSB/VOSB business concerns.

All responses should be submitted electronically using PDF with subject line “RFI Response – NDTP-AI – Company Name” and submitted NO LATER THAN June 23, 2026, at 10:00 am Eastern Standard Time. Submissions may be made by submitting your response through email response to Samantha.McIntyre2@va.gov and Peter.Lewandowski@va.gov. Total e‐mail file limit size is restricted to 5MB. Files exceeding this threshold must be submitted over multiple email messages, and be identified as "Email #x of #y."

mailto:Samantha.McIntyre2@va.gov

RESPONSES:

Please respond to this RFI certifying capability if you can provide the necessary supplies or services.

The following information details the Government’s intent and requests information for this acquisition:

Included with your response, VA requires a reply to each of the questions posted below;

responses should be as complete and informative as possible:

Please do not submit general marketing information for capability statements.

1. Does the AI software have FDA 510 (K) clearance? Yes or No (If yes, please provide documentation)

2. Integration and compatibility with VA owned existing PIPS? Yes or No (If yes, please describe how so.)

3. Does the viewer allow VA pathologists to access diagnostics tools to support:

a. Triage: Case triage and prioritization via a case list? Yes or No (If yes, please describe how so.)

b. Diagnostic Tools: WSI viewer, tools (e.g. heatmaps, measurements and AI results)? Yes or No (If yes, please describe how so.)

c. Reporting: Pre-populated reporting of AI results? Yes or No (If yes, please describe how so.)

4. Does Vendor application analyze pathology Whole Slide Images (WSIs) from the PIPS?

Yes or No

5. Does Vendor application connect with PIPS WSIs via a fully automated process for AI

Vendor analysis? Yes or No (If yes, please describe the process.)

6. Are the WSIs and associated AI Vendor tools and results accessible from the PIPS Viewer once the analysis is complete? Yes or No (If yes, please describe how so.)

7. Is there a limit of concurrent users for the AI software? Yes or No (If yes, what is the limit?)

8. Are there automated online Workflow tools to triage cases and generate standardized reports? Yes or No (If yes, please list those reports and provide short examples.)

9. Are templates available for quantitative and semi-quantitative grading for reporting (e.g.

Gleason scoring, tumor percentage, gastritis grading)? Yes or No (If yes, please list those reports and provide short examples.)

10. Are those templates editable by the user and will be able to transfer to other pathology reports such as Veterans Health Information System Technology Architecture and Millennium? Yes or No (If yes, please describe how the transfer is accomplished.)

11. Is the Integrated AI Software for Prostate and Gastric Cancer Detection system suitability to be offered as an enterprise cloud computing service by adhering to VA’s Cloud First Policy? Yes or No

12. How accurate is the AI software in detecting prostatic adenocarcinoma in prostate biopsy specimens? (Please provide percentage.)

13. Does your digital pathology platform feature validated AI algorithms, capable of detecting and classifying, both prostate and gastric pathology, specifically, including the detection of malignancies? Yes or No (If yes, how does your software convey its diagnostic inferences to the reviewing pathologist?)

14. How accurate is the AI software providing prognostic information including Gleason grading, tumor burden, and perineural invasion? (Please provide percentage.) Is there at least a 95% concurrence rate? Yes or No

15. Does or will all hardware and software comply with VA’s Office of Information Technology (OIT) Technical Reference Model (TRM), network security, and Authority to Operate requirements within 75 days of award? (Note: Failure to obtain TRM and OIT network connectivity approval within 75 days of award without significant progress as determined by VA, shall be cause for termination.) Yes or No

16. Describe the hardware and software warranty. Description should include all equipment service programs, such as remote diagnostics and equipment replacement. Please explain the level and duration of coverage.

17. What unique analytical capabilities does the proposed AI solution provide beyond traditional pathology workflows? Describe how the solution assists pathologists in detecting prostate and gastric cancer, including any evidence demonstrating improved detection rates, diagnostic confidence, workflow efficiency, or clinical outcomes.

18. Interested vendors are requested to provide a Rough Order of Magnitude (ROM) estimate for planning and market research purposes. The ROM should identify estimated costs associated with the proposed solution, including, as applicable:

• Software licensing/subscription costs

• Implementation, configuration, and integration services

• Clinical validation support

• Training services

• Maintenance and sustainment/support services

• Cloud storage and archival services

• Optional capabilities or future expansion costs

• Any travel or on-site support costs

The ROM should identify any key assumptions, dependencies, limitations, or pricing drivers used in developing the estimate.

The Government requests estimated pricing for:

• One-time implementation/startup costs

• Annual recurring costs

• A one-year base period and four one-year option periods

Note: The requested ROM is for market research purposes only and shall not be considered a binding quote, proposal, or commitment. Information received will be used solely to assist the Government in acquisition planning, budgeting, and requirement development.

19. Based on your knowledge, are you aware of any other solutions that meet all stated requirements?

20. Provide any recommended adjustments to improve competition or feasibility.

21. Are there any requirements that are overly restrictive or uniquely aligned to a specific vendor?

22. Does the draft PWS adequately define the Government’s technical and functional requirements? If not, please identify any gaps, limitations, ambiguities, concerns, areas that need clarification, recommended revisions, or industry best practices that the

Government should take into account in order to strengthen the requirement and promote competition.

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is market as proprietary will be handled accordingly. In accordance with Revolutionary Federal Acquisition Regulation Overhaul 15.101(c), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Not responding to this RFI does not preclude participation in any future solicitation, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned.

Proprietary information and trade secrets, if any, must be clearly marked on all materials. All information received that is marked Proprietary will be handled accordingly. Please be advised that all submissions become Government property and will not be returned. All government and contractor personnel reviewing submitted responses will have signed non-disclosure agreements and understand their responsibility for proper use and protection from unauthorized disclosure of proprietary information as described 41 USC 423. The Government shall not be held liable for any damages incurred if proprietary information is not properly identified.