JA-Sole-Source-ABL90-36C25726Q0645 CO signed.pdf

DEPARTMENT OF VETERANS AFFAIRS

Network Contracting Office 17 (NCO 17) – Lab Services Support (LSS)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Justification and Approval (J&A) for Sole Source Award

In Accordance With FAR 6.302-1 (41 U.S.C. 3304(a)(1)) and FAR 6.303-2

Agency: Department of Veterans Affairs (VA) Contracting Activity: Network Contracting Office 17 (NCO 17), Lab Services Support (LSS), RPO West Address: 5441 Babcock Rd., Suite 302, San Antonio, TX 78240 Solicitation / Contract No.: 36C25726Q0645 Procurement Request No.: 36C257-26-AP-3663 JOFOG Log Number: FY26 - NCO 17 - 1576 Product or Service Code: J066 – Maintenance, Repair, and Rebuilding of Equipment – Medical, Dental, and Veterinary Equipment and Supplies NAICS Code: 811210 – Electronic and Precision Equipment Repair and Maintenance Size Standard (NAICS 811210): $34 million (average annual receipts) Contract Type: Firm-Fixed-Price (FFP) Estimated Total Contract Value (Base + Option): $47,788.21 Base Period of Performance: July 1, 2026 – June 30, 2027 Option Period of Performance: July 1, 2027 – June 30, 2028 Intended Awardee: Radiometer America, Inc.

UEI: F7XJTQQJT663

Date: June 18, 2026

1. NATURE AND DESCRIPTION OF THE ACTION BEING APPROVED [FAR 6.303-2(b)(2)] The Contracting Officer requests approval to award a sole source Firm-Fixed-Price (FFP) contract to Radiometer America, Inc. (Large Business; UEI: F7XJTQQJT663) for preventive maintenance (PM) and repair services for three (3) Government-owned Radiometer ABL90 FLEX Blood Gas Analyzers at the Central Texas Veterans’ Health Care System (CTVHCS), without providing for full and open competition, pursuant to the authority of 41 U.S.C. 3304(a)(1) and FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements). This action is conducted under FAR Part 12 commercial item/service procedures.

2. DESCRIPTION OF SUPPLIES OR SERVICES AND ESTIMATED VALUE [FAR 6.303-2(b)(3)] The VA requires full-service preventive maintenance and repair coverage for the following Government-owned analyzers at CTVHCS:

Serial Number Model Description Location

092R0643N016 ABL90 FLEX Analyzer: Lab: Blood Gas CTVHCS

092R0643N018 ABL90 FLEX Analyzer: Lab: Blood Gas CTVHCS

092R0587N002 ABL90 FLEX Analyzer: Lab: Blood Gas CTVHCS

Services to be provided include: all parts, labor, and technical support; 24/7 telephone technical support; on-site response within 48 hours for routine service calls; on-site emergency response within two (2) business days when patient safety is at risk; OEM-trained and certified field service engineers (FSEs) for all on-site work; written assurance of FSE credentials within 10 calendar days of award; and online access to field service reports. All services are commercial in nature and offered in the commercial marketplace.

Estimated Total Contract Value: $47,788.21 (Base Period + Option Period 1)

3. STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION [FAR 6.303- 2(b)(4)] Authority: 41 U.S.C. 3304(a)(1), as implemented in FAR 6.302-1 — Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Full and open competition need not be provided when the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements.

Under the FAR Revolutionary Overhaul (RFO), this authority has been preserved and is codified in RFO FAR 6.103(a)(1). The substantive standard is unchanged: the Government must demonstrate that only one responsible source exists and that no other supplies or services will satisfy agency requirements.

4. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE

NATURE OF THE ACQUISITION REQUIRES USE OF THIS AUTHORITY [FAR 6.303-2(b)(5)]

a. OEM Exclusivity Radiometer America, Inc. is the exclusive United States subsidiary of Radiometer A/S (Copenhagen, Denmark) and the sole OEM-authorized distributor and service provider for Radiometer products in the United States. As confirmed in the Sole Source Letter dated April 29, 2026, signed by Brian Vazquez, Director of Field Service and Technical Support, Radiometer America, Inc. is the only entity authorized to service Radiometer analyzers in the United States. No other company, dealer, or distributor has been granted OEM service authorization for the ABL90 FLEX platform in the United States.

b. Proprietary Technology and Restricted Access The ABL90 FLEX analyzer incorporates proprietary hardware, embedded firmware, diagnostic protocols, and software systems that are owned exclusively by Radiometer A/S. Access to the tools, diagnostic software, firmware update capabilities, and OEM replacement parts necessary to properly maintain and repair these analyzers is restricted solely to Radiometer America, Inc. and its authorized personnel. Non-OEM service providers do not have access to these proprietary systems and cannot perform maintenance to manufacturer specifications.

c. Patient Safety and Regulatory Compliance The use of non-OEM reagents, accessories, quality control materials, or non-OEM-authorized service personnel voids the manufacturer warranty and eliminates Radiometer America, Inc.’s ability to verify instrument performance characteristics and accept product liability claims. Blood gas analyzers are Class II medical devices subject to FDA 21 CFR Part 820 and CLIA requirements (42 CFR Part 493). Maintenance performed outside OEM standards creates direct risk of erroneous patient diagnostic results and CLIA laboratory deficiencies, directly endangering the health and safety of Veterans receiving care at CTVHCS.

d. Relationship to Prior Acquisition In August 2025, NCO 17 awarded IDIQ contract 36C25725D0067 for reagents and consumables used in these same analyzers. That prior acquisition established that Radiometer America, Inc. is the OEM and sole authorized maintenance provider. The current requirement for maintenance services is a separate and distinct procurement. Radiometer America, Inc. maintains authorized distributors for reagents and consumables (The Janz Corporation, Government Scientific Source, and Veterans’ Healthcare Supply Solutions); however, those distributors hold no authorization to perform maintenance or repair services on the equipment.

5. EFFORTS TO ENSURE OFFERS SOLICITED FROM AS MANY POTENTIAL SOURCES AS

PRACTICABLE [FAR 6.303-2(b)(6)] The following efforts were made to identify potential alternate sources and to ensure offers were solicited from as many sources as practicable:

• Notice of Intent (NOI) to Sole Source, Notice ID 36C25726Q0645, was posted on SAM.gov/Contract Opportunities on June 8, 2026, for ten (10) calendar days in accordance with FAR 5.201 and FAR 5.207.

The notice closed on June 18, 2026. Zero (0) capability statements, responses, or objections were received.

• SBA VetCert database was searched using keywords "ABL90 Service" and "Radiometer" under NAICS 811210. Zero (0) certified SDVOSB or VOSB firms capable of providing OEM-authorized Radiometer ABL90 maintenance were identified.

• GSA Advantage was searched using keywords "ABL90 Service." Zero (0) results were returned.

• SBA Dynamic Small Business Search (DSBS) was searched using NAICS 811210 and keywords "ABL90 Service." Zero (0) results were returned.

• UNICOR (Federal Prison Industries) was searched. Zero (0) results were returned.

• AbilityOne.gov was searched. Zero (0) results were returned.

• SAM.gov entity/award search was conducted. The only result was the NOI posted by this office.

The synopsis requirement of FAR 5.201 has been satisfied through the publication of the Notice of Intent.

Consistent with FAR 5.202, no exception to the synopsis requirement applies. The NOI fulfilled the Government’s obligation to publicize this proposed sole source action and provide interested parties an opportunity to demonstrate their ability to satisfy the requirement. No interested parties responded.

6. DETERMINATION THAT ANTICIPATED COST WILL BE FAIR AND REASONABLE [FAR 6.303-

2(b)(7)] The Contracting Officer has determined that the anticipated cost of $47,788.21 for the full period of performance (base and option periods) will be fair and reasonable. This determination is based on:

• Comparison to historical pricing for Radiometer ABL90 FLEX maintenance services at VA medical facilities under prior contracts;

• The Independent Government Cost Estimate (IGCE) prepared using historical unit pricing and current market information obtained directly from Radiometer America, Inc.; and

• The Firm-Fixed-Price contract type, which establishes maximum price certainty for the Government.

A formal price/cost analysis will be performed prior to award to confirm fair and reasonable pricing in accordance with FAR 15.404-1. The lack of competitive pricing data is acknowledged; accordingly, the price analysis will rely on the techniques at FAR 15.404-1(b)(2), including comparison to prior prices paid by the Government for the same or similar services.

7. DESCRIPTION OF MARKET RESEARCH AND RESULTS [FAR 6.303-2(b)(8)] Market research was conducted in accordance with FAR Part 10, VAAR 810, and VAAM M810.002-70, and is fully documented in Market Research Report No. 36C257-26-AP-3663, dated June 16, 2026, which is incorporated herein by reference. In summary:

• All searches of VetCert, GSA Advantage, SBA DSBS, UNICOR, AbilityOne.gov, and SAM.gov returned zero results for alternative OEM-authorized Radiometer ABL90 service providers.

• A ten-day Notice of Intent (NOI) posted June 8, 2026 received zero capability statement responses.

• Personal knowledge from the prior reagents/consumables procurement (IDIQ 36C25725D0067, August 2025) confirmed Radiometer America, Inc. is the sole OEM service provider for the U.S. market.

• The Sole Source Letter dated April 29, 2026, from Brian Vazquez, Director of Field Service and Technical Support, Radiometer America, Inc., provides written OEM confirmation of this exclusivity.

Market research confirmed no other responsible source exists that can fulfill this requirement while maintaining OEM service authorization, warranty validity, and patient safety compliance.

8. OTHER FACTS SUPPORTING USE OF OTHER THAN FULL AND OPEN COMPETITION [FAR 6.303- 2(b)(9)]

a. Technical Data / Specifications for Competition Not Available No technical data package, specification, or statement of work exists or could be developed that would permit a non-OEM service provider to perform maintenance on the ABL90 FLEX analyzers to manufacturer specifications. Radiometer A/S retains exclusive proprietary rights over all service documentation, firmware, and diagnostic tools for the ABL90 FLEX platform. These are not publicly available and cannot be obtained by third parties. Accordingly, no specification suitable for full and open competition can be developed for this requirement. [FAR 6.303-2(b)(9)(i)]

b. Commercial Service – FAR Part 12 Applicability This acquisition is conducted under FAR Part 12 commercial item/service procedures. Preventive maintenance and repair services for medical analyzers are offered and sold commercially in the marketplace.

The use of FAR Part 12 procedures is consistent with the commercial nature of the services and does not diminish the sole source justification. Under the RFO FAR Part 12 framework, sole source documentation requirements for commercial services at or below the Simplified Acquisition Threshold (SAT) are satisfied by a written determination on file; however, this J&A is being prepared as a precautionary measure to ensure the complete sole source record is documented to the standard of FAR 6.303-2.

c. No Duplication of Cost Issue This is not a follow-on to a prior maintenance contract. No prior sole source maintenance contract for these three analyzers has been identified. The issue of duplicated cost under FAR 6.302-1(a)(2)(ii) does not apply;

the basis for the sole source authority is the OEM’s unique qualifications and the proprietary nature of the requirement under FAR 6.302-1(b)(1)(i).

9. LISTING OF SOURCES THAT EXPRESSED WRITTEN INTEREST IN THE ACQUISITION [FAR 6.303- 2(b)(10)] No sources expressed written interest in this acquisition. The Notice of Intent (NOI) to Sole Source, Notice ID 36C25726Q0645, posted on SAM.gov/Contract Opportunities on June 8, 2026 and closed on June 18, 2026, received zero (0) capability statements, responses, or objections from any source.

10. ACTIONS TO REMOVE OR OVERCOME BARRIERS TO COMPETITION FOR FUTURE

ACQUISITIONS [FAR 6.303-2(b)(11)] The Contracting Officer recognizes that the current sole source condition stems from OEM exclusivity over the ABL90 FLEX platform and is not a condition created or sustained by the Government. The following actions are noted for future acquisitions:

• At the expiration of the performance period (June 30, 2028), the requirement will be re-evaluated and a new market research effort will be conducted to determine whether any alternate OEM-authorized service providers have entered the market.

• If CTVHCS equipment is replaced or upgraded to non-Radiometer platforms at any point, future maintenance acquisitions will be structured to permit full and open competition where possible.

• The Contracting Officer will monitor Radiometer America, Inc.’s authorized service network during the performance period for any changes that may affect competition on follow-on actions.

No action available to the Contracting Officer at this time would effectively overcome the barrier to competition created by the OEM’s proprietary control over service access for the ABL90 FLEX platform.

11. TECHNICAL / REQUIREMENTS CERTIFICATION [FAR 6.303-2(c)] I certify that the supporting data forming the technical and requirements basis for this Justification, including the description of the requirement, the sole source rationale, and the equipment identification information, are accurate and complete to the best of my knowledge and belief.

Signature: ___________________________________ Requirements Official: Burke, Molly E.

Title: Biomedical Engineering

12. CONTRACTING OFFICER CERTIFICATION [FAR 6.303-2(b)(12)] I certify that this justification is accurate and complete to the best of my knowledge and belief.

Name: Ognian D. Ivanov Title: Contracting Officer, Lab Support Team Office: Network Contracting Office 17 (NCO 17) – Lab Services Support (LSS) Location: San Antonio, Texas Date: June 18, 2026 CO Signature: ___________________________________