Single Source Justification MPT to SAT - 3Mensio.doc

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-25-AP-2040

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Richard L. Roudebush VA Medical Center (RLR VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. 2237 #: 583-25-2-071-0029.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The RLR VAMC currently uses brand name 3mensio workstations and software during pre-operative planning for cardiac procedures. The subscription for this software expires on 02/28/2025. This new request is for a 1-year subscription renewal of the software licenses. The following line items are included in this renewal request.

· 3ME400s - 3mensio Base Module – Subscription – Quantity of 1

· 3ME410s - 3mensio Aortic Root – Subscription – Quantity of 1

· 3ME420s - 3mensio Mitral Valve – Subscription - Quantity of 1

· 3ME400FLs – Floating License Seat for 3mensio Base Module – Subscription - Quantity of 2

· 3ME410FLs – Aortic Root Floating License Seat – Subscription – Quantity of 1

· 3ME420FLs – Mitral Valve Floating License Seat – Subscription – Quantity of 1

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The 3mensio is cardiac-focused computed tomographic (CT) post-processing software that is the world-wide standard of care in pre-operative sizing and planning for all kinds of Structural Heart procedures. 3mensio is used by the major medical device vendors (i.e., Medtronic, Edwards Lifesciences, Boston Scientific and Abbott), and provides a direct comparison of reproducible and reliable measurements. This is unique because the VA will be able to compare 3mensio reports as a direct, one-to-one comparison with the mentioned device vendors, allowing for accurate and efficient analysis required for these procedures. 3mensio is the only software capable of a one-to-one comparison with the device vendors because the device vendors only use 3mensio for these procedures. If the VA chooses to move forward with another software platform, the ability for a direct comparison is lost. 3mensio is also the structural heart post-processing software of choice at many clinical centers within the VA system. VAMC Minneapolis, Atlanta, Miami, Pittsburgh, New York, Houston relies on 3mensio to provide accurate measurements prior to performing catheter-based procedures. Developed in close collaboration with both physicians and device companies, it is tailored to plan any transcatheter device and provide the most detailed procedural planning.

With its sophisticated reporting capabilities 3mensio provides an overview of all relevant screenshots and measurements in PDF format that can be used as a communicator between the major vendors and the clinical center. This will minimize any potential complications related to size mismatch between prosthetic valve and the patient.

In addition to being the standard of care for Transcatheter Aortic Valve Replacement (TAVR) imaging postprocessing, 3mensio is also a leader in additional transcatheter-based therapies (e.g., Mitral Valve replacement and repair, Tricuspid Valve replacement and repair and Pulmonary Valve interventions). These are non-invasive treatments that will save many veterans’ lives who are poor surgical candidates. Purchasing renewal of 3mensio software licenses will be vital to the facility’s goal of providing the best patient care, patient outcomes, and clinical adoption.

3mensio software allows loading of the entire ECG cycle, which will assist in determining presence/absence of bicuspid valve and characterization of bicuspid valve type. Not recognizing the presence of bicuspid valve may result in placing a mismatched prosthetic valve into a patient.

This technology has received Enterprise Risk Analysis (ERA) Approval number RITM7939145 and has a FITARA approval request pending. There are no other known software applications that are compatible with the existing workstations and software that is capable of fulfilling this requirement.

4. Description of market research conducted and results or statement why it was not conducted: Limited market research was conducted by the requesting Clinicians because 3mensio is the standard of care in cardiac CT post-processing.

Market research queries were conducted by the Contracting Specialist using VetCert, SBA DSBS, SEWP, FPDS-NG, GSA Advantage, and VA NAC databases, AbilityOne online catalog and other sources. The market research findings found 0 business concerns with contracts. The product NAICS code is not listed in the NMR Class Waiver.

The original equipment manufacturer (OEM), Pie Medical Imaging is a large business and does not sell to the public. A letter on file dated 02/18/2025 identifies Esaote North America, Inc (LB) as its authorized distributor of 3mensio products. There are no SD/VOSB or SB resellers available. The VA and SBA Rules of Two cannot be obtained. This requirement will be sole sourced to the OEM distribution partner. An intent to Sole Source will be published to the GPE on SAM.gov.

Revision: 01

Effective Date: 11/15/2024 Acquisition ID#: 583-25-2-071-0029