Combined Synopsis 36C26226Q0128.docx

SUBJECT*

Medical Coding Software Subscription New Mexico VA Health Care System (NMVAHCS)

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs NCO 22 - Network Contracting 3601 S. 6th Avenue Tucson AZ 85723

POINT OF CONTACT*

Contract Specialist Katharine Robert katharine.robert@va.gov

PLACE OF PERFORMANCE

Cooperative Studies Program Clinical Research

Pharmacy Coordinating Center (CSPCRPCC)

2401 Centre Ave SE, Albuquerque, NM

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” 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, effective 10/01/2025.

This solicitation is set aside for 100% Small Business (SB).

The associated North American Industrial Classification System (NAICS) code for this procurement is 541511, with a small business size standard of $34.0 Million. The FSC/PSC is AN11.

All inquiries must be submitted no later than 1:00 PM MT, December 3, 2025, via email only to Katharine Robert; katharine.robert@va.gov . All vendor inquiries received prior to the deadline will be addressed through a consolidated Q&A Amendment posted to Sam.gov on or around December 5, 2025. No inquiries will be accepted after 1:00 PM MT, December 3, 2025.

All quotes must be submitted no later than 11:00 AM MT, December 12, 2025, via email only to Katharine Robert; katharine.robert@va.gov

This will be a Firm Fixed-Price Contract.

For all submission requirements, deadlines, and instructions: see the included FAR 52.212-1 “Instructions to Offerors – Commercial Products and Commercial Services”.

For all evaluation information: see the included FAR 52.212-2 “Evaluation- Commercial Products and Commercial Services”.

The services described below were previously procured and are currently being performed under Contract#36C10B21C0002. Interested parties may use this information to locate publicly available information. The Government will not provide additional information about the incumbent.

Statement of Work (SoW)

1. Title: Research Medical Coding Software Subscription

2. Background: The New Mexico VA Health Care System (NMVAHCS) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) is seeking a Research Medical Coding Software subscription, software license and support for multiple users, Dictionary Load (MedDra & WHODrug), and related software training. The software and associated support is critical to patient safety and reporting requirements. It allows coding against the standard, FDA accepted, medical and medication dictionaries. Medical coding facilitates timely and verifiable data collation, allowing for the creation of reports that are used in data monitoring committees, regulatory submissions, Clinical Trial.gov data uploads, and more.

The contractor must be an authorized distributor to provide MedCodr Software, or provide a similar software that meets the requirements listed in the Statement of Work. The Contractor must provide a SaaS solution that is already FedRAMP authorized or currently listed as Authorized or Authorized w/ Constraints in the VA Technical Reference Model (TRM).

3. Anticipated Period of Performance: This contract will be for one year, from January 11, 2026 – January 10, 2027.

4. Place of Performance: Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, 2401 Centre Ave SE, Albuquerque, NM 87106.

5. Scope: The Contractor shall provide the Research Medical Software License with two versions Dictionary Loads (MedDra & WHODrug), subscription/support for six users. If a new software is used, the Contractor shall install and migrate existing coded data to the newer Research Medical Coding format. The Contractor shall provide VA with user training for the Software. The Software and all data pertaining to the software shall be hosted on a VA system (VA Cloud is the intended system) which requires any vendor product to be approved for use on VA systems by the VA. VA requires software that is stand alone and is not part of a bundled software package. This requires either existing proof of FedRAMP certification or for the SaaS solution to be currently listed as Authorized or Authorized w/ Constraints in the VA Technical Reference Model (TRM).

a. RESEARCH MEDICAL CODING SOFTWARE REQUIREMENT: The software shall include the following:

1. The Software shall be certified within the WHODrug Software Certification for handling B3/C3 format data. The software shall have the ability to use multiple dictionaries including MedDRA and WHODrug.

2. Study Setup:

a. Must have a study specific version control so it can update study specific forms without losing previous coding.

b. Must have a static primary key identified for each dataset

3. Multiple users and roles, and multiple studies

4. Data Import:

a. Use delimited text and csv (comma-separated values) file formats

b. Coded data validity can be checked by system during import against dictionary

c. Import all records, retaining previously coded records and appending any new records

d. Update status for previously coded records if changed from previous status.

e. Create/edit Import configurations

5. Auto and manual coding

6. Coding workflow allowing custom statuses to be created

7. Multi-step verification process

8. Synonym list management

9. Query and comment management

10. Do not code list capabilities

11. Custom search support

12. Data Export:

a. User delimited text and csv

13. Report generation:

a. Clinical and Safety data Ability to segregate clinical safety data based on user groups

14. Dictionary version management

b. SUPPORT AND SUBSCRIPTION: The Contractor shall provide annual support/subscription for use of the Research Medical Coding Software:

1. The Contractor shall provide Annual software subscription.

2. The Contractor shall provide user subscription to support 6 users.

3. The Contractor shall perform Dictionary Load – MedDRA and WHODrug (2 dictionary versions per year).

4. The Contractor shall perform software maintenance to include software update or upgrade and helpdesk assistance to the users.

a. The Contractor shall provide 24/7 website access for self-initiated troubleshooting procedure and information on the Research Medical Coding Software

b. The Contractor shall provide a toll-free phone number where VA user can reach the technical helpdesk assistance during normal business hour (7am – 5pm mountain time).

c. INSTALLATION AND DATA MIGRATION: The Research Medical Coding Software shall be installed on VA owned/operated system. As part of the installation process, the Contractor shall deliver Installation Qualification, Production Qualification and Validation Summary Report upon successful User Acceptance Test (UAT) of the installation.

d. USER TRAINING: The Contractor shall coordinate with VA to plan and conduct a virtual User Level Training session for the licensed users. The Contractor shall provide Training Plan to include training schedule and training objective, and curriculum. The Contractor shall provide the user with knowledge, procedure and process to operate the Research Medical Coding Software. The Contractor shall provide a detailed overview of the content, strategy, approach, and organization of the Research Medical Coding Software. The Contractor shall deliver Training Materials, in the form of presentation slides. The Contractor shall coordinate the training date with VA within 10 business days of acceptance of the Training Plan and Materials. The Contractor shall provide VA with User Guide detailing actual use of software. The User Guide shall clearly outline the use of Research Medical Coding Software for the User Level.

6. NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS (SECTION 508) On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

7. SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: https://www.access-board.gov/ict/.

Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.section508.gov/develop/applicability-conformance/

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

· E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines)

· E204 Functional Performance Criteria E206 Hardware Requirements

· E207 Software Requirements

· E208 Support Documentation and Services Requirements

8. COMPATABILITY WITH ASSISTIVE TECHNOLOGY: The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

9. ACCEPTANCE AND ACCEPTANCE TESTING:

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery. 3.0

10. VA TECHNICAL REFERENCE MODEL: The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OI&T. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

11. ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).

2. The Contractor shall comply with FedRAMP (https://www.fedramp.gov/agency-authorization/) requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

4. The Contractor shall, where applicable, assist with the VA Authority to Operate (ATO) Process to help achieve agency authorization of the cloud service or migrated application.

5. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases.

6. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

7. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR)/Contracting Officer (CO).

8. Other considerations:

a. Trusted Internet Connection (TIC) The Contractor solution shall meet the requirements outlined in:

· Office of Management and Budget Memorandum M08-05 mandating Trusted Internet Connections (TIC) https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-05.pdf)

· M08-23 mandating Domain Name System Security (NSSEC) https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-23.pdf

(End of Statement of Work)

***PRICE/COST SCHEDULE***

Base Year: 01/11/2026 – 01/10/2027

**ABOVE PRICE/COST SCHEDULE IS REQUIRED**

(End of Price/Cost Schedule)

THE FOLLOWING CONTRACT CLAUSES APPLY TO THIS ACQUISITION:

· FAR 52.212-4 Contract Terms And Conditions—Commercial Products And Commercial Services (Nov 2023)

· Addendum To FAR 52.212-4 Contract Terms And Conditions—Commercial Products And Commercial Services

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services” (Oct 2025)(Deviation Feb 2025)

· The following subparagraphs of FAR 52.212-5 are applicable: (b) (5), (12), (18)(i), (26)(i), (31), (36)(i), (39)(i), (46), (55), (59)

· FAR 52.217-8 Option To Extend Services (Nov 1999)

· FAR 52.240-91 Security Prohibitions And Exclusions (Nov 2025) (Deviation)

· VAAR 852.232-72 Electronic Submission Of Payment Requests (Nov 2018)

· This is accomplished through the Tungsten Network located at: http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

· VAAR 852.242-71 Administrative Contracting Officer (Oct 2020)

· FAR 52.203-17 Contractor Employee Whistleblower Rights (Nov 2023)

· FAR 52.204-13 System For Award Management Maintenance (Oct 2018)

· VAAR 852.203-70 Commercial Advertising (May 2018)

· VAAR 852.239-70 Security Requirements For Information Technology Resources (Feb 2023)

· VAAR 852.239-73 Information System Hosting, Operation, Maintenance, Or Use (Feb 2023)

· VAAR 852.239-74 Security Controls Compliance Testing (Feb 2023)

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THE FOLLOWING SOLICITATION PROVISIONS APPLY TO THIS ACQUISITION:

· FAR 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023)

· Addendum to FAR 52.212-1 Instructions To Offerors – Commercial Products And Commercial Services

· FAR 52.212-2 Evaluation – Commercial Products and Commercial Services

· FAR 52.240-90 Security Prohibitions And Exclusions Representations And Certifications (Nov 2025) (Deviation)

· FAR 52.204-7 System For Award Management (Nov 2024) FAR 52.212-3 Offeror Representations And Certifications—Commercial Products And Commercial Services (Oct 2025) (Deviation Feb 2025)

· Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

· VAAR 852.239-71 Information System Security Plan And Accreditation (Feb 2023)

· VAAR 852.239-75 Information And Communication Technology Accessibility Notice (Feb 2023)

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 and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

Addendum to FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(a) Submission of quotes. Submit signed and dated quotes to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, quotes shall include—

(1) The solicitation number and due date;

(2) The name, address, telephone number, and size status 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) All required submittals listed under Additional Instructions;

(6) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and

(7) 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 quotes, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of quotes.

(1) Offerors are responsible for submitting quotes and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any quotes, modification, or revision received after the time specified for receipt of offers is “late” and will not be considered. However, a late modification of an otherwise successful quotes 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 quotes cannot be received at the Government office designated for receipt of quotes 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 quotes 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 quotes by written notice to the Government received at any time before award.

(d) Contract award. The Government intends to evaluate quotes and award a contract without discussions. Therefore, the Offeror’s initial quote 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 quotes if such action is in the public interest, accept other than the lowest quote, and waive informalities and minor irregularities in quotes received.

(e) Notification. The CO will not notify unsuccessful offerors that responded to this Request for Quotation (RFQ).

ADDITIONAL INSTRUCTIONS

Offerors should review this entire solicitation before submitting a quote to ensure that their quote meets all requirements. Failure to understand the contract requirements shall not relieve the successful Offeror from performing in accordance with the strict meaning and intent of the specifications.

Format of Quote: In order to be considered for selection, the Offeror must submit a complete quote in response to this solicitation using the sequence and format instructions provided. Offers shall be clear and concise and logically assembled (with all pages appropriately numbered). To reduce submission size, the Offeror shall confine submission to essential matters. Quotes should address the criteria contained in FAR 52.212-2, Evaluation – Commercial Items. Unnecessarily elaborate or lengthy quotes are not desired.

VA Form 10091: The VA Financial Services Center (VA-FSC) released a web version of its legacy VA Form 10091, VA-FSC Vendor File Request Form. To apply for payment via EFT, complete the "PAYEE/VENDOR INFORMATION" and "EFT/ACH" sections of VA Form 10091 via the VA-FSC Customer Engagement Portal located: https://www.cep.fsc.va.gov/. Registration is not a requirement for quote submission. Awardee can only receive payment through the EFT.

Offer Due Date: Submission of your RFQ response shall be received no later than December 12, 2025, 11:00 AM MT. Subject line shall include “RESPONSE TO RFQ 36C26226Q0128” for consideration. Each Offeror shall submit only one quote which addresses all Government requirements outlined in this solicitation. The Offeror shall submit their quote electronically to Contract Specialist, Katharine Robert, email: katharine.robert@va.gov .

· Zip Files or hyperlinks will not be accepted

· Facsimile offers will not be accepted

The Offeror submitting a quote is responsible for ensuring that the Contract Specialist has received the quote before the deadline for receipt of quotes, and the government will not be responsible for delays or failures of either the offeror’s email system or the Government’s email system.

Required Submittals:

· General Information and Price Schedule: The offeror shall submit its pricing within the schedule provided in the solicitation. The offeror shall affirm that they are able to mobilize at full capacity by 01/11/2026.

· Technical Submission: The offeror shall provide a technical submission identifying the Software-as-a-Service solution being proposed, describing how the solution meets the solicitation’s requirements, and provide verifiable evidence of the solution’s current FedRAMP or TRM status.

· Past Performance: The offeror shall submit a narrative demonstrating their recent and relevant past performance providing services similar in scope and complexity to the present requirement. Recent means within the last five (5) years from the date this solicitation closes. The Government will determine relevance based on similarity of work, magnitude, and technical complexity. Offeror shall submit the following for at least two, but not more than five, Government or Commercial contracts:

a. Contract, task order, or purchase order number [if applicable].

b. Contract, task order, or purchase order value.

c. Period of performance dates.

d. Customer point of contact (name, title, and phone/email).

e. Brief description of the services performed.

· Joint Ventures: Any offeror submitting a quote as a joint venture must provide the initial certification of compliance in accordance with 13 CFR 128.402(e)(1). The certification must come from each certified SDVOSB partner and affirm that: (1) it is a certified SDVOSB; (2) it, together with its affiliates, is small under the NAICS in this requirement; and (3) that it will comply with the limitations on subcontracting. Failure to submit the certification with the quote will render the offeror ineligible for award. The apparent successful awardee will be required to submit an additional certification prior to award in accordance with 13 CFR 128.402(e)(2).

NOTICE OF COMPLIANCE CHECK: A preliminary review of quotes will be conducted; if all documentation is not submitted or is incomplete the quote will not be forwarded for evaluation; this will preclude the quote from any further consideration for award.

Any questions or concerns regarding this solicitation should be directed to Contract Specialist Katharine Robert, email: katharine.robert@va.gov.

(End of Provision)

FAR 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Basis for Award. The Government will award a contract resulting from this solicitation to the responsible offeror whose quote will be the most advantageous to the Government, price and other factors considered.

(b) The following factors shall be used to evaluate quotes:

1. Technical

2. Past Performance

3. Price

(c) 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 or accepting alternate quotations. The evaluation will consider the following:

1. Technical: The government will evaluate the offeror’s technical submission by assessing the proposed Software-as-a-Service solution, the extent to which the solution meets and/or exceeds the solicitation’s requirements, and the verifiable evidence of the solution’s current FedRAMP authorization or VA TRM approval.

2. Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis. Offerors without recent or relevant past performance will receive a neutral rating; a neutral rating is neither favorable nor unfavorable.

3. Price: The Government will evaluate reasonableness of the offeror’s proposed pricing.

(d) Options. The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(End of Provision)

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