Sources Sought Notice 36C26226Q0128.docx

Sources Sought Notice Sources Sought Notice

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

ADDRESS

Department of Veterans Affairs

Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center

2401 Centre Ave SE, Albuquerque NM

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response.

1. Responses to this sources sought must be sent to Contract Specialist, Katharine Robert, via email only to katharine.robert@va.gov, NLT 3:00 PM MT, 11/21/2025.

2. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. The results of this sources sought announcement will be used for set-aside determination.

3. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition.

4. Responses to this notice shall include the following to be considered: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) SAM UEI number (f) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (g) a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

5. These services were previously procured under Contract 36C10B21C0002. 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. FedRAMP certification is required prior to the start of performance.

6. If there are no authorized distributors for MedCodr Software or no other FedRAMP certified vendors willing and able to provide a similar software that meets the requirements listed in the attached Statement of Work at a fair and reasonable price, the Government intends to issue an award to the OEM.

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.

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. The contractor must either be an authorized distributor to provider MedCodr Software, or provide a similar software that meets the requirements listed below. 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 becoming FedRAMP certified prior to January 11, 2026.

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 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.accessboard.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/finalrule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request.

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.access-board.gov/guidelines-andstandards/communications-and-it/about-the-ict-refresh/final-rule.

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

Sources Sought Notice