S03 Intent to Sole Source 36C24126Q0777 GE VSCAN_CO 09-04-26.docx

SUBJECT*

VSCAN AIR CL and SL Portable Handheld Ultrasounds: INTENT TO SOLE SOURCE:

SDVOSB Sole Source VAAR 819.7008/Brand Name FAR 12.102-1(a)

GENERAL INFORMATION

SET-ASIDE

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

DESCRIPTION

36C24126Q0777 INTENT TO SOLE SOURCE: 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 INTENT 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 sole 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.

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 on 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 CASE and GE MUSE 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. A Letter of Authorization has been provided by the large business OEM designating TrillaMed LLC as the sole authorized SDVOSB distributor to the Government for GE VSCAN AIR CL and SL Handheld Ultrasound Equipment.

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 at:

DEPARTMENT OF VETERANS AFFAIRS

Justification for Sole 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,

· GE’s distribution restrictions,

· VA’s Veterans First SDVOSB set‑aside requirements, and

· 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.

· Emergency & Critical Care: Performs rapid FAST exams, lung assessments for trauma, and checks for conditions like gallstones, kidney blockages, or abdominal aortic aneurysms.

· Workflow Efficiency: Seamless workflow. Connects via Wi-Fi to iOS and Android mobile devices, allowing doctors to make fast treatment decisions and reduce “patient wait” times.

· Image Management: Features color Doppler, M-mode, and options to securely save, anonymize, and share or upload scans to cloud networks. Unsurpassed image quality seamless workflow

OEM certification establishes that only Trillamed LLC, a verified SDVOSB, is authorized by GE Healthcare as the sole SDVOSB distributor to the Federal Government for GE cardiology‑class products, including the VSCAN Air family. Per a Letter oof Authorization from the OEM (Original Equipment Manufacturer) GE Healthcare, Trillamed, LLC is GE Healthcare’s sole Service-Disabled Veteran Owned Small Business partner. Trillamed the only capable and eligible distributor for this requirement.

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 Sole 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.

4. Description of market research conducted and results or statement why it was not conducted (cont’d):

Market Research Findings:

· 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 distributed Open Market.

· GSAR 538.7104-3 Determination: Market research was conducted IAW FAR 10.001 and VAAR 810.001. Trillamed as the only GE authorized SDVOSB distributor to the US Government. Trillamed is 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. Because the NMR and the LOS are satisfied, VAAR 819.7008 can be leveraged for a sole source procurement from Trillamed. The brand name requirement is justified per RFO 12.102-1(a): one reasonably available source.

NMR: Market research confirms that only one OEM‑authorized SDVOSB source is reasonably available to supply the GE VSCAN. Under VAAR 819.7003(d) and VAAR 819.7008, an SDVOSB sole source may be used when only one verified SDVOSB can meet the requirement for a brand‑name medical device. Consistent with FAR 12.102‑1(a), the GE VSCAN is available from a SOLE responsible SDVOSB distributor. The Nonmanufacturer Rule (13 CFR 121.406(b)) is satisfied through the SDVOSB’s qualifications and the Class NMR Waiver for NAICS 334510 (72 FR 72433), which covers diagnostic, ultrasound, and patient‑monitoring equipment—including the VSCAN—thereby meeting all NMR and subcontracting limitations. Because no additional SDVOSBs are authorized to distribute this brand‑name item, the Rule of Two under 38 U.S.C. 8127(d) cannot be met. Accordingly, the GE VSCAN requirement meets the criteria for “one reasonably available source” and supports an SDVOSB sole‑source award.

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. The brand name sole source is authorized via RFO 12.102-1(a): “one reasonably available source.”

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR (RFO) 12.102-1(a), formerly FAR 13.106-1(b) and VAAR 819.7008. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer VAMC White River Junction VT, RPOE NC01

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