36C24126Q0587.docx

SUBJECT*

INTENT TO SINGLE-SOURCE RFQ: 36C24126Q0587 GE Stress Test eBike

GENERAL INFORMATION

SET-ASIDE

VA Boston Healthcare System

West Roxbury Campus, Cardiology Department

1400 VFW PKWY

West Roxbury MA

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

THIS IS NOTICE OF INTENT TO SINGLE-SOURCE FOR ONE-TIME PROCUREMENT OF GE STRESS TEST E-BIKE RFQ: 36C24126Q0587. PLEASE SEE ATTACHED.

Presolicitation Notice Presolicitation Notice

Presolicitation Notice

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, Single-Source contract for a GE Stress Test e-Bike Ergometer for VAMC, West Roxbury, MA.

This is to be a Name Brand Only Single Source procurement from the sole OEM (Original Equipment Manufacturer)-authorized, SDVOSB distributor TrillaMed LLC. The GE brand Stress Test e-Bike Ergometer is the only brand/model of ergometer that will meet the needs at VAMC West Roxbury. VAMC West Roxbury is reestablishing the Stress Test segment of cardiac care and patient monitoring. The Cardiology department at West Roxbury has standardized on the GE CASE and the GE MUSE cardiac systems. CASE and MUSE are proprietary and exclusive to GE Healthcare. The GE Stress e-Bike is the only ergometer that will interface with the facility's existing GE CASE and GE MUSE systems. It is the only ergometer that is compatible with proprietary GE Healthcare communication protocols to provide fit-form-function integration.

The GE Stress Test Ergometer is 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 Diagnostic Cardiac Equipment. TrillaMed is also the sole, non-GE FSS (Federal Supply Schedule) holder for the GE Stress Bike under FSS: 36F79720D0041.

The authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41 U.S.C. 1901. This statute is implemented by restricting competition on this procurement via GSAR 538-7104-4: One reasonably available source.

The intent is to procure these services on a single-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 June 30th at 16:30 PM (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 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-26-AP-2000

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 01, VA Boston Healthcare System (HCS), West Roxbury Campus, Cardiology and Healthcare Technology Management (HTM) Departments.

PR: 523-26-2-7821-0018

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: VAMC West Roxbury, MA requires the purchase of one (1) GE e-Bike EL ergometer, a commercially available, medically calibrated stationary cycle for cardiac stress testing of patients unable to perform treadmill-based exercise. The purchase includes delivery to and installation at VAMC, West Roxbury, MA.

The scope of this purchase includes White Glove Delivery, installation with verified integration into the existing GE CASE Cardiac Stress Testing System and GE MUSE Diagnostic Cardiology Study Management System. The purchase will also provide one (1) day onsite clinical training and four (4) hours of remote clinical training.

The GE Stress Test e-Bike stores no PHI; it is a peripheral input device that transmits real-time stress data (watts, heart rate, pedaling resistance) to GE CASE, which processes the data within the GE Healthcare MUSE NX R2 SP4 authorization boundary (RITM13198700; FDA 510(K) K152993; ERAR signed 06/17/2025.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: VAMC West Roxbury has standardized to the GE CASE and the GE MUSE cardiac systems. CASE and MUSE are proprietary and exclusive to GE Healthcare. The GE Stress Test e-Bike EL is required to reestablish this segment of cardiac care and patient monitoring at VAMC West Roxbury. The GE Stress e-Bike is the only ergometer that will interface with the facility's existing GE CASE and GE MUSE systems. It is the only ergometer that is compatible with proprietary GE Healthcare communication protocols to provide fit-form-function integration.

This brand-name single source requirement is justified by GSAR 538.7104-4(b)(1): the GE Stress Test e-Bike is peculiar to one manufacturer; there is no commercially available alternative.

Other ergometers in the market are not compatible with the GE cardiac systems in place at VAMC West Roxbury. These brands of e-Bikes cannot be modified to meet the need. Procurement of any non-GE device would render the echo/stress room non-functional and create a direct gap in cardiac care for veterans served at this campus.

This requirement would typically qualify for a Straight SBSA (Small Business Set-Aside). For this requirement, the Rule of Two (2) (38 USC 8127(d)) cannot be met. Per a Letter of Authorization (LOA) issued by GE, the OEM (Original Equipment Manufacturer), there is only one (1) OEM-authorized SB class distributor, TrillaMed LLC. TrillaMed is the only SB class distributor licensed to sell GE Diagnostic Cardiology equipment. TrillaMed holds the only non-GE GSA (General Services Administration) FSS (Federal Supply Schedule) contract: 36F79720D0041. No alternative distribution channel exists. TrillaMed is the only reasonably available source for the GE e-Bike. A single-source strategy via the Veterans First Contracting Program (VFCP) is authorized per VAAR 819.7008 and VAAR 819.7003(d).

4. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by Contracting in accordance with (IAW) FAR 10.001 and VAAR 810.001. The GE Stress Test e-Bike is not available from any mandatory source, no VA inventories, no other Government agencies, and no mandatory SAC (Strategic Acquisition Center) or GWAC (Government-Wide) contracts. AbilityOne cannot supply this request. Contracting conducted market research to identify competitive opportunities via VFCP, via the SBA NMR Exception SBSA, and via FSS or other GWAC contracts. Market research results are detailed below:

· VFCP (Veterans First Contracting Program): The LB OEM GE Healthcare has provided an LOA designating TrillaMed LLC, an SDVOSB, as the sole authorized distributor of the GE e-Bike EL. 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.

· NAC (National Acquisition Center): A search of the National Acquisition Center (NAC) using the search terms "ergometer" and "GE e-Bike" returned no results. The GE e-Bike EL ergometer is not available through the NAC.

· GSA Advantage: A GSA Advantage search for “ergometers” identified four (4) brands available via FSS contract. None of these brands are compatible with VA Boston CASE/MUSE systems. Per TrillaMed, the GE e-Bike is one of 300 GE Healthcare items currently undergoing a price refresh on GSA Advantage. All products, including the GE e-Bike, will be restored to the GSA Advantage catalogue upon completion. The CS contacted TrillaMed via email to verify the e-Bike's availability under FSS Contract #36F79720D0041 and the applicable Part #s to locate the e-Bike. TrillaMed confirmed Quote No. T290508 pricing is consistent with typical TrillaMed pricing under FSS 36F79720D0041, indexed as an exact match to GE Healthcare FSS 36F79721D0154 contract pricing, with no added markups or fees and the ability to discount further.

4. Description of market research conducted and results, or statement why it was not conducted:

· DLA ECAT (TrillaMed Contract SPE2D121D7004): Per TrillaMed, the GE e-Bike EL is also available on TrillaMed’ s DLA ECAT contract. The FSS contract offers the best value to the Government.

· GSA e-Library (36F79720D0041): A GSA e-Library search listed all FSS contracts carrying the GE e-Bike” FSS contract 36F79720D0041 (TrillaMed), 36F79721D0154 (GE), and 36F79721D0007 (Dated Ohmeda [a GE Holding]). Pricing on FSS 36F79720D0041 is indexed against GE Healthcare FSS contracts.

· 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): Archived contract No. 36C10G-19-D-0067 (Ergometers: Body Exercisers) is no longer active. Part No. 2058879-176 (EBIKE EL, US; $11,457.29 VA price) identified in SCMC under GE FSS 36F79721D0154; per the GE LOA, only accessible to VA Medical Centers through TrillaMed LLC via FSS 36F79720D0041.

· GSAR 538.7104-3 Determination: Market research was conducted IAW FAR 10.001 and VAAR 810.001. TrilllaMed, as the only SDVOSB FSS holder for the GE e-Bike, is the only reasonably available source for this requirement. Brand-name substitution is not an option; no equivalent ergometer can interface with the GE CASE and GE MUSE systems at VAMC Roxbury.

· VAAR 819.7006/ 819.7008: Because the Rule of 2 cannot be met, an SDVOSB set-aside cannot be applied. Because the NMR and the LOS are satisfied, VAAR 819.7008 can be leveraged for a single-source procurement from TrillaMed. The brand name requirement is justified per GSAR 538.7104-4.

Nonmanufacturer Rule (NMR): The applicable NAICS code is 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), and per 72 FR 72433, an NMR waiver applies to the purchase of a GE Stress Test e-Bike, which is considered patient monitoring equipment; accordingly, under VAAR 819.7003(d), both the NMR and the Limitations on Subcontracting (LOS) are satisfied, as the NMR waiver waives the fourth prong of the NMR requirement for a distributor to be similarly situated with the OEM, the requirement typically qualifies for an SDVOSB set-aside and a VAAR 819.7008 SDVOSB single source, and the NMR is met because (1) TrillaMed LLC has fewer than 500 employees, (2) TrillaMed distributes GE Healthcare products in the normal course of business as a GE-designated distributor, and (3) TrillaMed will take possession of the GE e-Bike EL upon shipment; however, because TrillaMed LLC is the sole OEM-authorized SDVOSB distributor, the Rule of Two (38 U.S.C. § 8127(d)) cannot be met and an SDVOSB set-aside under VAAR 819.7006 cannot be applied, so an SDVOSB single source may be used in accordance with VAAR 819.7008, and the brand-name procurement is supported by GSAR 538.7104-4.

Recommendation: Single-Source SDVOSB to TrillaMed LLC: The recommendation is for a VAAR 819.7008 single-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 Stress Test e-Bike. The GE e-Bike is peculiar to one manufacturer; TrillaMed LLC, as the sole OEM-authorized, GE-licensed, SB class distributor, is the only reasonably available source capable of providing the GE e-Bike EL ergometer. GSAR 538.7104-4 supports a brand-name, single-source SDVOSB award to TrillaMed LLC. VAMC West Roxbury has standardized on the GE CASE and MUSE cardiac systems. The GE Stress Test e-Bike is the only brand of ergometer that can fully integrate with the CASE and MUSE systems: fit, form, and function. The GE ergometer is the only e-Bike compatible with the GE cardiac systems.

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