36C10G25R0046.docx

See attached document: ATTACHMENT A_ QUARTERLY SALES REPORTING TOOL.

See attached document: ATTACHMENT B_PRODUCT DESCRIPTION.

See attached document: ATTACHMENT C_CONTRACT SECURITY HANDBOOK 6500_6_APPENDIX C.

See attached document: ATTACHMENT D_PRICE COST SCHEDULE.

See attached document: ATTACHMENT E_JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION.

See attached document: ATTACHMENT F_CERTIFICATION OF RECALL OR SAFETY ISSUES.

See attached document: ATTACHMENT G_PAST PERFORMANCE REFERENCES.

See attached document: ATTACHMENT H_PAST PERFORMANCE QUESTIONNAIRE.

See attached document: ATTACHMENT I_DRAFT BUSINESS ASSOCIATE AGREEMENT.

The Department of Veterans Affairs Strategic Acquisition Center (SAC) intends to negotiate a Firm Fixed Price (FFP) sole source award in accordance with Federal Acquisition Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements” 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

The applicable North American Industry Classification System (NAICS) code 339112 – Surgical and Medical Instrument Manufacturing is most appropriate for this requirement. The size standard is 1,000 employees. The Product Service Code (PSC) is 6515 – Medical and Surgical Instruments, Equipment, and Supplies.

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.