P03 - JOFOC 26-AP-2283 Data Management Signed redact Redacted for posting.pdf

Acquisition ID#: 36C259-26-AP-2283

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH RFO 12.102(b)

Acquisition Plan Action ID: 36C259-26-AP-2283 J&A Tracking # FY26 – NCO 19 - 2132

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office (NCO) 19

6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 in support of the Salt Lake City Health Care System (SLCVAHCS) located at 500 Foothill Drive, Salt Lake City, UT 84148

2. Nature and/or Description of the Action Being Processed: This is a follow-on procurement for a new firm-fixed price contract for the purchase of Ancillary Point of Care (POC) Data Management System, The current contract 36C25921C005, with Abbott Informatics, is set to expire on 8/31/2026.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The SLCVAHCS Pathology and Laboratory Department requires the Ancillary Point of Care (POC) Data Management System, This service encompasses ongoing software usage, maintenance and upgrades, ensuring continued compatibility and operational integrity.

The Government owned are: 6 Cepheid GeneXpert 2 Express, 9 Abbott ID Now Point of Care Analyzers, 1 AVOXimeter, 15 Clinitek, 2 Hepcon HMS Plus, 14 i-STAT, and 60 Abbott Glucose (POC) analyzers.

Estimated period of performance and total cost for base plus four (4) option years is $488,235.00

4. Statutory Authority Permitting Restricted Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

The results of recent market research for similar requirements were reviewed, including contract history and pricing. The incumbent contractor is Abbott Rapid Diagnostics Informatics, Inc., which holds the current sole source contract for the RALS system.

The Contracting Specialist queried government-wide databases (GSA eLibrary, FPDS, SAM.gov) using relevant keywords. Searches returned either “no matches found” or notices of intent to sole source to Abbott Rapid Diagnostics Informatics, Inc.

Web searches identified several companies offering point-of-care data management solutions, such as Roche Diagnostics, Siemens Healthineers, Danaher Corporation, BD, and Clinisys. However, none were authorized or technically capable of providing the proprietary Abbott RALS system, nor could they ensure compatibility with the VA’s existing laboratory instruments and infrastructure.

The market research confirmed that Abbott Rapid Diagnostics Informatics, Inc. is the sole provider of the RALS system, the owner of the current system licenses, and the only entity capable of delivering the continued maintenance and support necessary for the customized Ancillary Testing Service interface. No other vendor can offer compatibility with the existing configuration or maintain the validated connectivity essential to uninterrupted laboratory operations.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Specialist reviewed prices paid for similar goods or services in the past, comparing them to current market rates to check the contractor’s quote for accuracy. Based on this analysis, the Contracting Officer will be ablve to determine the price will be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: The Contract Specialist (CS) conducted a search in the Small Business Dynamic Search (SBDS) database on July 29, 2026, using NAICS Code 541519 (Other Computer Related Services). The search identified 324 small business concerns. However, Abbott’s RALS (Remote Automated Laboratory System) is a proprietary, web-based point-of-care data management software owned and developed by Abbott Rapid Diagnostics Informatics, Inc.

A search of SAM.gov (Entity Reporting for Federal Awards) conducted on July 29, 2026, using the keyword Ancillary (Point of Care) Data Management System” and “Ancillary Data Management System”, resulted in “no matches found”.

The CS conducted a Google search using “Ancillary (Point of Care) Data Management System companies” and found eight (8) leading companies providing these specialized connectivity and software solutions.

TELCOR Inc: Offers an industry-standard, dedicated point-of-care data management system that handles remote device integration, operator certification, and test result tracking.

Roche Diagnostics: Provides the cobas IT middleware and POC solutions, connecting a wide array of decentralized analyzers and blood gas systems.

Siemens Healthineers: Manages point-of-care connectivity through platforms like the RAPIDComm Data Management System.

Abbott Point of Care: Delivers informatics and data management via tools designed for the i-STAT system and related decentralized platforms.

Nova Biomedical: Supplies dedicated net-based data management software tailored for whole blood testing and handheld meters in hospitals.

Orchard Software: Provides clinical and point-of-care laboratory information systems focused on data interoperability.

A search of the GSA eLibrary conducted with keywords “Ancillary (Point of Care) Data Management System” and “Ancillary Data Management System” in GSA eLibrary on July 29, 2026, returned with “no matches found”.

Because Abbott’s RALS (Remote Automated Laboratory System) is a proprietary, web-based point-of-care data management platform owned and developed solely by Abbott Rapid Diagnostics Informatics, Inc., independent or third-party vendors cannot legally distribute or license the core software. Abbott does not permit external entities to sell, modify, or support the RALS platform. In addition, the VA’s current infrastructure—including connected point-of-care devices and established integrations with VISTA/CPRS—relies heavily on the RALS system. Introducing an alternative solution would disrupt operations, jeopardize data flow integrity, and require significant redevelopment to revalidate device interoperability.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts supporting this justification.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Abbott Rapid Diagnostics Informatics, Inc. Unique Entity ID (UIE): HSWPJJDF8Q81.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: NCO 19 will strengthen future competition by expanding market research efforts, engaging industry to identify additional viable sources, and refining requirements to ensure they are not unnecessarily restrictive. The Agency may also reassess and update its acquisition planning strategies, explore alternative procurement approaches, and issue Requests for Information or Sources Sought notices to increase vendor awareness and participation. Together, these actions aim to identify capable vendors, lower barriers to entry, and promote full and open competition in upcoming acquisitions.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Brittanie Bennett Date Program Specialist Laboratory Service