ATTACHMENT E_JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400

Fredericksburg, VA 22408

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for other than full and open competition”:

This Justification and Approval (J&A) for Other than Full and Open Competition is executed by the Department of Veterans Affairs (VA), Office of Procurement, Acquisitions, and Logistics (OPAL), Strategic Acquisition Center (SAC) in partnership with Veterans Health Administration (VHA) Procurement and Logistics Office, Equipment Life Cycle Management Program.

2. Nature and/or description of the action being approved:

This activity proposes to negotiate a non-competitive award (sole-source) to TrillaMed, LLC (UEI: GW9FLBWB5625), a Service-Disabled Veteran-Owned Small Business (SDVOSB), for the procurement of the GE MUSE Electrocardiographs (ECG) Data Management System (ECGDMS) under the issuance of a VA-wide (otherwise referred to as “national”) single award Requirements Contract. TrillaMed, LLC is the only authorized distributor of the GE MUSE ECG Data Management System manufactured by GE Healthcare.

The GE Muse Cardiology Information System (CIS) platform is used in all VHA Medical Centers as the repository for electronic Electrocardiographs. The CIS interfaces with Veterans Health Information Systems and Technology Architecture (VistA), Computerized Patient Record System (CPRS), VistA Imaging and VistA Clinical Procedures software package. VistA provides VHA with vital clinical financial, infrastructure and management tools. The ECG equipment must permit bi-directional communication with CIS to quickly retrieve, manage, and archive patient data to limit patient identification errors, improve both efficiency and patient outcomes, and to protect the integrity of the historical ECG data of our Veterans. In addition, the Information Technology Management Reform Act of 1996 (Public Law 104-1 06) and the Computer Security Act of 1987 (Public Law 100-235) require that all wireless network transmissions be in accordance with Federal Information Processing (FIPS) 140-2 Standards. Accordingly, all ECG data must be transmitted electronically in accordance with FIPS 140-2. Furthermore, to ensure privacy and security of Veteran health information, VA requires under VA Handbook 6500 that ECG equipment be FIPS 140-2 certified. In conjunction with the FIPS 140-2 certification, the ECG equipment must support WPA2 and PSK encryption to ensure compatibility with the VA wireless infrastructure. WPA2 and PSK are IEEE 802 11 i-2004 standards for Wi-Fi encryption. IEEE 802.11 is a set of industry standards for implementing wireless local area network (WLAN) computer communication in the 2.4, 3.6 and 5 GHz frequency bands and specifies security mechanisms for wireless networks. In addition, VA requires installation services to ensure interoperability with all requisite VHA information systems and training for users of the new ECG equipment.

As a trusted partnership spanning over 20 years across all 170+ VA facilities, the GE MUSE ECG Data Management System has been integral to enhancing cardiovascular care for Veterans. Any current & future GE MUSE purchase would simply be an upgrade to the existing GE MUSE infrastructure. The cost to change & replace the GE MUSE would undertake a very significant amount of capital, time, and effort – and is not in any way prudent.

3. A description of the supplies or services required to meet the agency’s needs

(including the estimated value):

GE MUSE is a proprietary software platform designed to manage and analyze cardiac data, including Electrocardiograms (ECGs), from various sources like resting ECGs, stress tests, and Holter monitors, allowing healthcare providers to access and review a patient's complete cardiac history in one place. Essentially, it's a centralized system for managing and interpreting ECG data across different modalities within a healthcare facility.

In addition to the GE MUSE software, this action also includes installation, hardware (i.e., servers), clinical training, technical training, technical service, and software upgrades/releases. The period of performance will be for one 12-month base period and four 12-month option periods. The Independent Government Cost Estimate (IGCE) for this requirement is $46,574,117.20 (inclusive of all options).

4. An identification of the statutory authority permitting other than full and open competition:

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Section 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements”.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited:

All 170+ VHA facilities currently use GE MUSE as their ECG Data Management System along with GE cardiac equipment, including resting ECGs (MAC VU360), stress tests

(CASE), and Holter monitoring (SEER), using GE’s proprietary Marquette 12SL algorithm.

Millions of veteran ECG records are stored on this system. This includes data and values, like heart frequency, RR interval, PR interval, whether or not the patient is in sinus rhythm and the

QT duration and corrected QT duration (QTc). Accurate data transfer and consistency between the baseline reading and later readings are essential in monitoring trends.

Cardiologists depend on prior ECG data to track cardiovascular conditions over time and this data is crucial for accurate diagnoses of potentially life-threatening conditions.

GE MUSE is the only ECG Data Management System that provides comprehensive access to historic raw ECG Data and specific tools to fully utilize the historical data. The Marquette

Serial Comparison Program detects clinically significant changes by comparing the current

ECG with the previous one for the same patient. It does so by utilizing interpretive statements, ECG measurements, and waveform comparison techniques using prior patient data. This feature requires the use of GE MUSE. No other system can access and interpret this data. Switching to a different ECG Data Management System would result in losing this raw data, leaving only images. Maintaining and interpreting raw ECG data is essential for

Veteran’s health and safety and allows VHA cardiologists to continue providing world-class care to veterans.

The use of the GE MUSE system across all VHA facilities, coupled with the intricacies of integrating GE cardiac equipment and managing extensive veteran ECG records, underscores the necessity of a sole source procurement under FAR 6.302-1. The unique capabilities of the GE MUSE system, which are essential for maintaining data integrity and ensuring patient safety, cannot be replicated by any other system without incurring significant costs and potential risks. Switching to an alternative system would not only involve prohibitive costs that would not be recovered through the competitive solicitation process but also compromise the quality of care provided to veterans. Therefore, to ensure continuity and uphold the high standards of veteran healthcare, a sole source acquisition is both justified and imperative.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies:

There is no competition anticipated for this acquisition since GE is the sole manufacturer of GE MUSE and TrillaMed LLC is the sole authorized distributor of the product. The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed; however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy. Section 8 of this document addresses the market research to support efforts made to solicit from others.

Additionally, the proposed action will be synopsized on SAM.gov in accordance with FAR

5.201. Any proposals that are received will be evaluated in accordance with the solicitation provisions. Market research and dialogue with GE Healthcare concluded that TrillaMed, LLC is the only vendor that could meet VHA’s GE MUSE requirements.

7. A determination by the contracting officer that the anticipated cost to the

Government will be fair and reasonable:

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. In accordance with FAR 15.305(a)(1), normally, competition establishes price reasonableness; however, since this is a Sole Source acquisition, no competition is anticipated. Therefore, the proposed prices will be evaluated, supported, and analyzed to determine whether they are fair and reasonable by any one or combination of the following:

• Comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items.

• Comparison with competitive published price lists of similar products published market prices of commodities, similar indexes, and discount or rebate arrangements.

• Comparison of proposed prices with Independent Government Cost Estimates.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted:

Market research established that the Government’s need may be met by a type of item or service customarily available in the commercial marketplace that would meet the definition of a commercial item IAW FAR 10.002. Market research was conducted IAW FAR 10.002(b)(2), and TrillaMed, LLC has been determined to be a responsible source with respect to performance. In addition, the Integrity (formerly FAPIIS) report was reviewed and shows no reports for TrillaMed, LLC that would indicate defective pricing, instances of contractor fault or recipient not-qualified, terminations for cause, default, material failure to comply, or non-responsibility of the contractor. They are registered and certified in Vetcert.gov as a SDVOSB. The NAICS code for this requirement is 339112 – Surgical and Medical Instrument Manufacturing. The small business size standard for NAICS code 339112 is 1,000 employees.

A Request for Information 36C10G25Q0067 was also published on March 21, 2025, in SAM.gov for 10 days; only one company, TrillaMed, LLC submitted a response by the closing date and time. Upon evaluation, the Government determined that TrillaMed, LLC can meet the minimum requirements.

The Market Research reinforces TrillaMed, LLC’s claim of being the sole SDVOSB authorized distributor of GE MUSE ECG Data Management Systems in the United States.

This was also verified through the manufacturer, GE Healthcare®. The sole distributor letter from GE is located in the contract file.

9. Any other facts supporting the use of other than full and open competition:

TrillaMed, LLC’s approach to meet the requirement includes GE MUSE manufactured by GE Healthcare® ,the manufacturer of GE MUSE, is a standalone company that offers integrated solutions for hospitals, clinicians, and patients. GE Healthcare referred the Government to TrillaMed, LLC (its sole approved distributor) for this procurement, rather than submitting an offer. Awarding the subject action to a SDVOSB satisfies important VA and governmental policies as it fulfills the VA’s overwhelming preference to award to an SDVOSB pursuant to 38 U.S.C. §8127 (a).

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition:

No other sources have expressed an interest in this acquisition in writing. VA is not aware of any other contractor except for TrillaMed, LLC; (UEI: GW9FLBWB5625, Address: 30100 Telegraph Road, Suite 366, Bingham Farms, MI 48025), a Service-Disabled Veteran-Owned Small Business (SDVOSB) authorized distributor.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. All future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

12. Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel:

I certify that the supporting data under my cognizance, which are included and form the basis of this justification, are accurate and complete to the best of my knowledge and belief.

Signature: __________________________________

Daniel Crespo

Deputy Program Manager Equipment Life Cycle Management

13. Contracting officer certification that the justification is accurate and complete to the best of the contracting officer ’s knowledge and belief:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Furthermore, I determine that the anticipated price to the Government for this action will result in fair and reasonable prices paid based on the rationale provided herein.

Signature: ____________________________________

Anthony Zibolski Contracting Officer Strategic Acquisition Center

Approval

I Based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $75M, the certification below required by FAR 6.304 serves as approval.

Signature: ____________________________________ Christopher D. Parker Head of Contracting Activity Strategic Acquisition Center and National Acquisition Center