S03 Intent to Sole Source Amendment P0001 36C24126Q0777 GE VSCAN_CO 09-17-26 CON OP.docx

SUBJECT*

Amendment P0001 VSCAN Portable Handheld Ultrasound INTENT TO SOLE SOURCE SDVOSB Sole Source VAAR 819.7008/Brand Name FAR 12.102-1(a)

GENERAL INFORMATION

VAMC Togus

1 VA Center

CONTACT INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

POINT OF CONTACT*

Contract Specialist Carlos Ortiz carlos.ortiz3@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Amendment to a Previous Combined Solicitation Amendment to a Previous Combined Solicitation

DESCRIPTION

Page 1 of

Amendment to a Previous Combined Solicitation

36C24126Q0777 INTENT TO SOLE SOURCE AMENDMENT P0001: 819.7008 SDVOSB/BRAND ONLY FAR 12.102-1(a): ONE-TIME PROCUREMENT OF GE VSCAN CL AND SL HANDHELD ULTRAOUND, PLUS ACCESSORIES & TRAINING: 36C24126Q0777

Amendment P0001 clarifies the Intent to Sole Source to the SDVOSB Trillamed. Trillamed is the sole NAC (National Acquisition Center) IDIQ (Indefinite Delivery Indefinite Quantity) holder for the VSCAN manufactured in Austria. No other GE reseller holds a government contract, which is required to satisfy the VA Procurement Hierarchy and to provide for the application of the TAA (Trade Agreements Act).

NTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored.

The Department of Veterans Affairs VA Medical Center intends to award a one-time, Firm Fixed Price, Sole-Source contract for a GE VSCAN AIR CL AND SL HANDHELD ULTRAOUND, PLUS ACCESSORIES & TRAINING for VAMC Togus.

This is to be a Name Brand Only Sole Source procurement from the OEM (Original Equipment Manufacturer)-authorized, SDVOSB distributor TrillaMed LLC. The GE VSCAN AIR CL and SL Handheld Ultrasounds are the only brand/models that will meet the need at VAMC Togus. Trillamed as the holder of the non-FSS (Federal Supply Schedule), NAC IDIQ 36H79719D0007, is the only OEM-authorized SDVOSB distributor that can provide TAA compliance, and which will satisfy the VA Procurement Hierarchy.

VAMC Togus is incorporating the VSCAN AIR devices into the GE Cardiology Diagnostics System to which VAMC Togus has standardized. The Cardiology department at Togus has standardized to the GE CASE and the GE MUSE cardiac systems. VSCAN, CASE and MUSE are proprietary and exclusive to GE Healthcare. The GE VSCAN AIR CL and SL are the only handheld ultrasound devices that will interface with the facility's existing GE systems. This is the only handheld ultrasound device grouping that is compatible with proprietary GE Healthcare communication protocols to provide fit-form-function integration.

The GE VSCAN AIR CL and SL Handheld Ultrasounds are proprietary and exclusive to the OEM GE Healthcare. The large business OEM has confirmed that TrillaMed LLC as the sole authorized SDVOSB distributor to the Government for GE VSCAN AIR CL and SL Handheld Ultrasound Equipment, due to Trillamed’s NAC IDIQ.

The authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41 U.S.C. 1901. The brand name statute is implemented by restricting competition on this procurement via FAR 12.102-2(a): One reasonably available source. The SDVOSB Sole Source is authorized by VAAR 819.7003(d) and VAAR 819.7008. There is an NMR Waiver for this diagnostic and imaging device (72 Federal Register 72433).

The intent is to procure these services on a sole-source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334510: Electromedical and Electrotherapeutic Apparatus Manufacturing. The most current Business Size Rating for this NAICS is 1250 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 18th at 11:00 AM (EDT).

A determination by the Government not to compete for this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Please submit any follow-ups or questions to:

Contracting Specialist: Carlos Ortiz: carlos.ortiz3@va.gov Please copy Contracting Officer: Deidra Thomas: deidra.thomas@va.gov on any email communications:

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12.102(a) For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID:36C241-26-AP-2252

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VISN1 VAMC Togus Medical Center.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The equipment procurement includes several VSCAN ultrasound imaging systems and related accessories for use by qualified and trained healthcare professionals or practitioners at the Togus VA Medical Center. These systems will enable ultrasound imaging guidance, visualization, and measurement of anatomical structures and fluid.

Equipment Information:

· Qty: 2 H8031VA, Description: VSCAN Air CL Base Package

· Qty: 1 H45621CD, Description: VSCAN Air Charger – Accessory

· Qty: 2 H8034GP, Description: VSCAN Air SL Govt Package

· Qty: 1 H8045SF, Description: Venue Sprint FOCUS R6

· Qty: 1 H45234CGD, Description: Caption Cardiac Guidance

· Qty: 1 H45445PCUC, Description: C7 United States and Canada Power Cord,

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Cardiology department at VAMC Togus ME requires two (2) GE Healthcare VSCAN CL and two (2) SL, handheld, wireless ultrasound systems. The VSCAN CL and SL devices are peculiar in their capability of providing rapid point‑of‑care diagnostic imaging for Emergency Medicine, Primary Care, Critical Care, Cardiology, and bedside procedural guidance. VAMC Togus has standardized to GE Cardiology Systems, including the GE Muse and the GE CASE systems with which the VSCAN will integrate.

Market research confirms that only GE Healthcare’s VSCAN Air CL and VSCAN Air SL handheld ultrasound systems meet the clinical, technical, cybersecurity, and integration requirements of the Togus medical service. The VSCAN Air CL and SL are unique and highly specialized ultrasound imaging systems peculiar to GE Healthcare. They provide capabilities that are unmatched by other manufacturers, ensuring high-quality diagnostic imaging essential to our medical staff. Furthermore, extensive research confirms no other brand meets our specifications and existing equipment integration requirements, justifying brand-specific procurement.

Unique Characteristics Peculiar to GE Healthcare (FAR 12.102‑1(a)(2)): The GE VSCAN Air CL and SL units are highly specialized battery‑powered handheld diagnostic imaging devices that best support the VA mission by performing rapid FAST exams, lung assessments, gallstone checks, kidney obstruction checks, AAA screens. The VSCAN handhelds connect via Wi‑Fi to iOS/Android for fast triage and support Color Doppler, M‑mode; secure save, anonymization, and cloud/DICOM imaging uploads. VSCAN offers technological trademarked processes proprietary to GE: SignalMaxXDclear architecture, dual‑probe design, or Verisound workflow ecosystem. These capabilities are trademarked and are peculiar to the VSCAN:

· SignalMax™ high‑intensity processing, XDclear™ single‑crystal transducers, exceptional penetration/resolution.

· Dual‑headed probes (sector/linear or curved/linear) enabling deep and shallow scanning with a single device.

· High‑Definition Speckle Reduction Imaging (HD‑SRI) for enhanced diagnostic clarity.

· Military‑standard durability, IP67 waterproofing, ambulance‑capable, 3‑year OEM warranty.

· DICOM‑network wireless transmission, automated workflow tools, anonymization, encrypted export.

These capabilities exceed the performance of competing handheld devices, none of which

Required Integration with existing GE Systems: The Togus Medical Center has standardized to GE cardiology platforms and GE software. GE handheld ultrasounds are peculiar in compatibility, fit, form, and function with existing equipment integration requirements with existing GE cardiology equipment and GE software platforms. The GE handheld devices integrate directly into Togus workflows:

· GE Verisound / ViewPoint / MyImageCloud / MyDeviceHub / DICOM

· DICOM Network Server upload (directly compatible with GE’s Centricity imaging archive).

· MyImageCloud secure cloud PACS hosting for remote review.

· MyDeviceHub (fleet management of GE probes).

· ViewPoint 6 MobileConnect (ultrasound reporting and billing integration at the bedside).

· MyRemoteShare (live ultrasound collaboration across GE platforms).

GE confirms that the VSCAN Air product line supports enterprise GE systems deployed at Togus, enabling unified workflow, cybersecurity, image management, and documentation solutions. No other handheld manufacturer offers seamless compatibility with GE cardiology suites and GE enterprise imaging solutions.

FAR 12.102‑1(a) Determination: Only One Reasonably Capable SDVOSB Source: A Letter of Authorization from the large business OEM GE, establishes that Trillamed LLC is the only SDVOSB capable of meeting:

· OEM authorization requirements: Trillamed is the sole holder of a government contract, NAC IDIQ 36H79719D0007 carrying the VSCAN on its imaging contract.

· Due to the Buy American Act requirement and because the VSCAN is manufactured in in Austria, a WTO (World Trade Organization country, the VSCAN must be procured via the NAC IIDIQ Imaging Contract carrying the VSCAN to apply the TAA (Trade Agreement Act).

· The VA Procurement Hierarchy requires procurement from government contracts over procurement via open market.

· VA’s Veterans First SDVOSB set‑aside requirements for a sole source are supported by VAAR 819.7003(d) and VAAR 819.7008.

· The technical integration needs of Togus Medical Service

Per FAR 12.102‑1(a), commercial item acquisitions may limit consideration to one reasonably capable source if only that source can meet the VA’s minimum requirements for performance, compatibility, integration, safety, and clinical functionality.

4. Description of market research conducted and results or statement why it was not conducted: Market research conducted pursuant to FAR Part 10 and VAAR 810.001-70 indicated that the VSCAN Air system is peculiar to one manufacturer, GE Healthcare. This equipment fulfills the medical needs of Togus VA Medical Center due to its specific capabilities and integration into existing workflows.

Market Research Findings:

· VFCP (Veterans First Contracting Program): The LB OEM GE Healthcare has provided a LOA designating Trillamed LLC, an SDVOSB, as the sole authorized distributor of the GE VSCAN Handheld Ultrasound. Per 72 FR 72433, there is an NMR Waiver for NAICS 334510. The NMR and LOS are satisfied per VAAR 819.7003(d). An SDVOSB Single Source is authorized IAW VAAR 819.7008. Because there is only one OEM-authorized SDVOSB distributor, an SDVOSB Set-Aside (SDVOSB SA) cannot be applied.

· NAC (National Acquisition Center): A search of the National Acquisition Center (NAC) does not list the GE VSCAN Handheld Ultrasound; it is not available through the NAC.

· GSA Advantage: A GSA Advantage search displayed zero results for the VSCAN CL and SL Handheld Ultrasounds, Accessories, and training requirement. Trillamed also indicated that the VSCAN is currently not available on FSS.

· DLA ECAT (Trillamed Contract SPE2D121D7004): Per Trillamed, the GE VSCAN Handheld Ultrasound is only available on the open market. VSCAN is not carried on the ECAT.

· GSA e-Library (36F79720D0041): A GSA e-Library search listed all FSS contracts carrying the GE VSCAN Handheld Ultrasound.

· SAC Contract Catalog: A search of the SAC Contract Catalog using the keyword "ergometer" returned no results. No current SAC catalog contract covers this requirement.

· SCMC (VA Supply Chain Master Catalog): Checked as part of ADDS Up market research. The VSCAN is primarily distributed Open Market, except for the Trillamed NAQ IDIQ.

· FAR 12.102-1(a) Determination: Market research was conducted IAW FAR 10.001 and VAAR 810.001. Trillamed is the only GE authorized SDVOSB distributor to the US Government who meets the Procurement Hierarchy for holding a government contract; and who also via their NAC IDIQ provide the only capability to apply the TAA to procure the required VSCAN the only reasonably available source for this requirement. Brand-name substitution is not an option.

· VAAR 819.7006/ 819.7008: Because the Rule of 2 cannot be met, an SDVOSB SA cannot be applied. The NMR and the LOS are satisfied; VAAR 819.7008 can be leveraged for a single source brand procurement. Brand name is justified per RFO 12.102-1(a): one reasonably available source.

NMR: The Class NMR Waiver for NAICS 334510 (72 FR 72433) satisfies all Nonmanufacturer Rule and subcontracting limitations. Per VAAR 819.7003(d) and VAAR 819.7008, an SDVOSB sole‑source award is fully justified; only one verified SDVOSB can meet the VA’s brand‑name need. FAR 12.102‑1(a) authorizes limiting consideration to “one reasonably available source” based on OEM authorization, compatibility, and integration requirements. There is only one (1) SDVOSB OEM-authorized distributor that can provide TAA compliance and which will satisfy the VA Procurement Hierarchy.

Recommendation: The recommendation is for a SDVOSB Sole Source to Trillamed LLC: The recommendation is for a VAAR 819.7008 sole source award to the GE SDVOSB distributor Trillamed LLC. The Rule of 2 cannot be met. Per 72 FR 72433 an NMR Waiver can be applied to purchase the GE VSCAN Handheld Ultrasound. The VSCAN is peculiar to one manufacturer; GE and is distributed via only “one reasonably available source:” Trillamed LLC. Trillamed is the sole OEM-authorized, GE licensed, SDVOSB distributor to the Government holding a government contract. The non-FSS NAC IDIQ per the Procurement Hierarchy, and due to the requirement to apply TAA, establishes Trillamed as the one reasonably available resource via RFO 12.102-1(a).