P02 RFI.docx

Request for Information: 36C10B27Q0056 Veterans Health Information Systems and Technology Architecture Blood Establishment Computer Software Operations and Maintenance Support II

1. Introduction

This Request for Information (RFI) is for planning purposes only and shall not be considered a Request for Quote, Request for Proposal, or Task Execution Plan. Additionally, there is no obligation on the part of the Government to acquire any products or services described in the RFI. Your response to this RFI will be treated only as information for the Government to consider. You will not be entitled to payment for direct or indirect costs that you incur in responding to this RFI. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. Responses will be treated as market research information only; not as a proposal. No funds have been authorized, appropriated or received for this effort. The Government does not intend to pay for any information submitted in response to this RFI. In accordance with Federal Acquisition Regulation 15.101(c), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract.

The North American Industry Classification System (NAICS) for this requirement is 541519 with a size standard of 150 employees.

The purpose of this RFI is to identify qualified vendors, who can meet Department of Veterans Affairs (VA) requirements for Veterans Health Information Systems and Technology Architecture (VISTA) Blood Establishment Computer Software (VBECS) Operations and Maintenance Support II. Responses to this RFI will be treated only as information for the Government to consider. The Government is not responsible for any cost incurred by industry in furnishing this information. All costs associated with responding to this RFI will be solely at the interested vendor's expense. Not responding to this RFI does not preclude participation in any future solicitation should one be issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions will become Government property and will not be returned. Interested vendors are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. VA is under no obligation to provide feedback to the company, or to contact the company for clarification of any information submitted in response to this RFI.

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.

2. Background:

VBECS is a Food and Drug Administration (FDA) 510(k) certified Class II Medical Device developed by the VA to support blood banking and transfusion services across VA healthcare facilities. VBECS enables safe, accurate, and efficient management of blood products, automating key workflows to reduce human error and enhance patient safety. The VBECS solution must continuously meet all regulatory requirements, maintaining compliance with agencies such as the FDA, the International Council for Commonality in Blood Bank Automation, and the American Association of Blood Banks (AABB).

3. RFI Response Instructions:

All responsible sources may submit a response in accordance with the below information:

NO MARKETING MATERIALS ARE ALLOWED AS PART OF THIS RFI.

CAPABILITY STATEMENTS that are not tailored to the requirements of this RFI will not be accepted or reviewed.

a. Interested Vendors shall at a minimum provide the following information in the initial paragraph of the submission (note acronyms used in the table are defined below the table):

Name of Company:

Address:

Point of Contact:

Phone Number:

Email Address:

For VOSB and SDVOSBs, proof of certification with SBA:

For SDVOSB / VOSB 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 concerns.

*NAICS code(s):

Company Business Size & Status:

If a small business, please identify socio-economic category(ies).

Unique Entity Identifier (UEI):

Existing Contractual Vehicles (GWAC, FSS or MAC):

* If you believe there is a more appropriate NAICS code, please provide that to the Government with your rationale.

Acronyms:

· FSS - Federal Supply Schedule,

· GWAC - Government-wide Acquisition Contract

· NAICS – North American Industry Classification

· NASA SEWP - National Aeronautics and Space Administration Solutions for Enterprise Wide Procurement

· SBA – Small Business Administration

· SDVOSB – Service-Disabled Veteran-Owned Small Business

· VOSB – Veteran-Owned Small Business

For SDVOSB/VOSB vendors: Your company’s intent and ability to meet the set aside requirement in accordance with VAAR 852.219-73 (JAN 2023) (DEVIATION) VA Notice of Total Set-Aside For Certified SDVOSBs and 13 CFR §125.6, which states the contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

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.

b. Brief summary (not to exceed 15 pages and the email file size shall not exceed 5 MB), describing your company’s capability and technical approach to meeting the requirements identified in the attached Draft Performance Work Statement (PWS).

c. With this RFI, VA seeks to determine:

· The availability of sources that are able to meet the requirements identified in the Draft PWS;

· If set-aside opportunities exist; and

· The appropriate Government point of entry to use.

In response to this RFI, respondents are requested to also address the following:

· Narrative: Provide a written narrative describing the respondent’s recommended approach to securely operate and sustain VBECS in Microsoft Azure Government while maintaining reproducible and validated environments. Address Azure DevOps CI/CD, Infrastructure as Code, Desired State Configuration.

· Experience: Provide an example from the previous five years demonstrating your organization’s experience supporting Food and Drug Administration-regulated Class-II medical-device software or a comparable regulated healthcare or laboratory system. Explain how your team will maintain the VBECS Quality Management System and execute 21 Code of Federal Regulations Part 820 and International Standards Organization 13485 activities, including 510(k) support, Medical Device Reporting, Corrective and Preventative Actions/Corrective Action Requests processing, hazard analysis, validation, requirements traceability, document control, and management reviews.

· Rough Order of Magnitude: Demonstrate the Respondent’s approach for each task, including identifying the primary positions, their assigned responsibilities, relevant VBECS or comparable regulated-system experience, required certifications, and availability at award for the base period and each option period.

d. Question concerning this RFI shall be submitted electronically no later than 4:00 PM Eastern Standard Time (EST), November 17, 2026, via email to the Technology Acquisition Center (TAC) points of contact below.

e. Responses to this RFI shall be submitted electronically no later than 1:00 PM EST, November 30, 2026, via email to the TAC points of contact below.

TAC Points of Contact:

Contract Specialist, Richard.Melton2@va.gov; and Contracting Officer, Diana.Armesto@va.gov

Please note VBECS Operations and Maintenance Support II in the subject line of your response. Mark your response as “Proprietary Information” if the information is considered business sensitive. All proprietary/company confidential material shall be clearly marked on every page that contains such.

RESPONDENTS ARE ADVISED THAT THIS REQUIREMENT MAY BE DELAYED, CANCELED, OR REVISED AT ANY TIME.