P03 - Justification and Approval_Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C261-27-AP-0168

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-27-AP-0168 RPOW JOFOC Tracker:

1. Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement

Office West (RPOW), Veterans Integrated Service Network (VISN) 5, Health Service Area (HSA) 5.2, Network Contracting Office (NCO) 21, in support of VA Palo Alto Health Care System (VAPAHCS) located at 3801 Miranda Avenue Palo Alto, CA 94304-1207.

2. Nature and/or Description of the Action Being Approved: The proposed action being reviewed and approved is to issue a new sole source firm-fixed price, purchase order for the acquisition of Remote Automated Laboratory System (RALS) Software and Support to the original equipment manufacturer (OEM) Abbott Rapid Diagnostics Informatics, Inc.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VAPAHCS has a requirement for continued RALS middleware support, connectivity, maintenance, upgrades, and licenses used to connect multiple point-of-care devices and laboratory instrumentation to VA systems which is crucial for the accurate and timely transfer of lab results to Veterans health records. The anticipated contract structure is firm-fixed-price, with one 12-month base period and four 12-month option periods IAW FAR 52.217-9. The estimated period of performance with cost are:

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4. Statutory Authority Permitting Other than Full and Open 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;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The requirement is for continued software licenses, middleware, and OEM maintenance/support for the Abbott RALS Software and Support, which is a highly specialized, proprietary data management platform already implemented and operational within the VAPAHCS. The existing RALS environment provides point-of-care device connectivity, result transmission to the laboratory information system and electronic medical record, and established interfaces and workflows that are specific to Abbott’s proprietary software and configuration. Prior market research and OEM documentation demonstrate that Abbott Rapid Diagnostics Informatics, Inc. is the developer and sole provider of the RALS platform, including software licenses, maintenance, upgrades, and technical support, and that there are no authorized resellers or alternate distributors for this solution in the United States.

Because RALS is already fully integrated into VA laboratory and clinical workflows, replacing the incumbent solution with a different vendor’s middleware would require acquisition, validation, and deployment of an entirely new platform, including device re-interfaces, Laboratory Information System (LIS) / Electronic Health Record (EHR) interface development, extensive system testing and validation, staff retraining, and parallel operations to mitigate patient safety risks. These activities would entail substantial duplication of cost that could not reasonably be expected to be recovered through competition and would introduce unacceptable delays in fulfilling the VA’s ongoing requirement to maintain continuous, compliant point-of-care testing operations.

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Acquisition ID#: 36C261-27-AP-0168

Accordingly, this requirement qualifies as a follow-on for highly specialized software and middleware services under RFO 6.103-1, Only One Responsible Source. Abbott Rapid Diagnostics Informatics, Inc. is the only responsible source capable of providing the proprietary RALS software, licenses, and support required to maintain compatibility, continuity of operations, and compliance with accreditation requirements for the existing RALS environment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Reviewed the market research supporting 36C261-27-AP-0216, a similar requirement for the VA San Francisco Health Care System, where the Contracting Officer determined a sole-source commercial (FAR Part 12) procurement was warranted due to the specialized, unique, and proprietary nature of the RALS items.

A Small Business Administration (SBA) Dynamics Smal Business Search (DSBS) search under North American Industry Classification System (NAICS) 518210 identified numerous SDVOSBs and VOSBs in the broader market, none were identified with documented authorization to manufacture or supply the required RALS solution; therefore, the VA Rule of Two is not satisfied for this requirement.

On July 23, 2026, the contractor’s representative emailed a sole source letter stating that Abbott Rapid Diagnostics Informatics, Inc. is the exclusive seller and provider of the RALS System and that Abbott is also the only authorized source for RALS System maintenance and support services.

Issued an intent to sole source presolicitation notice on Contracting Opportunities from July 27, 2026, to August 10, 2026, to allow for potential vendors to submit alternatives which will be evaluated upon submission.

Searched Contracting Opportunities located at SAM.gov for the keywords “Remote Automated Laboratory System” which resulted in the following results:

Notice ID: PANHCA26P0000031247 - Notice of Intent to Sole Source - Abbott Remote Automated Laboratory System, from the Department of Defense published on July 21, 2026.

Notice ID: 36C26126Q0619 – Presolicitation Notice 7E20--Remote Automated Laboratory System Software and Support, from the Department of Veterans Affairs published on Jun 26, 2026.

Notice ID: 36C25726Q0390 - Notice of Intent to Sole Source - 7A20-NEW -

RALS Abbott, from the Department of Veterans Affairs published on Jun 26, 2026.

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Acquisition ID#: 36C261-27-AP-0168

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer anticipates that the price resulting from this sole source acquisition will be fair and reasonable. Price reasonableness will be established using a combination of historical pricing analysis and comparison to the Independent Government Cost Estimate (IGCE). Historical prices previously paid by the Government for the same or similar Abbott RALS software licenses, middleware, and OEM maintenance/support will be reviewed and, as appropriate, adjusted for differences in quantity, period of performance (including base and option years), terms and conditions, and known market or inflationary changes.

These adjusted historical prices will then be compared to the proposed pricing and the IGCE to ensure the proposed prices are consistent with prior procurements for this highly specialized requirement.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Abbott Rapid Diagnostics Informatics, Inc., 915 E High St. Ste. 500 Charlottesville, Virginia 22902-4818

10. 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: In order to remove or overcome barriers to competition in future acquisitions for this requirement, VA will monitor industry developments in point-of-care middleware and data management solutions, including emerging standards-based interfaces and platforms, and will reassess the marketplace prior to any subsequent re-procurement to determine whether multiple vendors can meet the requirement without incurring substantial duplication of cost or unacceptable mission risk. Additionally, the VA will in coordination with Office of Information and Technology (OIT) and the laboratory program office, to adopt or influence the use of open standards for device connectivity and data exchange;

document lessons learned and technical constraints from the current RALS environment to inform any future requirements

11. 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.

Date

Laboratory, Administrative Officer VA Palo Alto Health Care System

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12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Network Contracting Office (NCO) 21

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Branch Chief, NCO 21 Supply Network Contracting Office (NCO) 21