Amendment 1 to solicitation 36C10G25R0046 from the U.S. Department of Veterans Affairs, OPAL Strategic Acquisition Center, extends the deadline for proposal submissions to September 17, 2025, at 5:00 PM Eastern Daylight Time. This modification, issued on a Standard Form 30, officially updates the original solicitation. Offerors are required to acknowledge receipt of this amendment through specified methods to ensure their proposals are considered. The amendment was signed by Anthony Zibolski, Contracting Officer, affirming that all other terms and conditions of the initial solicitation remain unchanged.

The Department of Veterans Affairs (VA) is preparing to negotiate a sole source contract with TrillaMed, LLC for the GE MUSE Electrocardiograph (ECG) Data Management System (ECGDMS). This procurement is justified under FAR 6.302-1 due to the system's unique capabilities, which are crucial for maintaining the integrity and accessibility of over millions of ECG records utilized by VHA cardiologists for monitoring veterans' cardiovascular conditions. The current GE MUSE system is required to facilitate comprehensive historical data access, ensure data consistency, and allow for accurate diagnostics—features unavailable in any other ECG data management systems. The contract will cover various line items, including servers and support services, vital for seamless ECG data management across all VHA facilities that currently rely on this system. Switching systems would incur prohibitive costs and risk compromising patient care. This presolicitation notice highlights the importance of this acquisition in maintaining high-quality healthcare for veterans, ensuring continued access to essential patient data for accurate diagnoses and treatment.

The Department of Veterans Affairs Strategic Acquisition Center (SAC) intends to award a sole source Firm Fixed Price (FFP) contract to TrillaMed, LLC for the GE MUSE Electrocardiographs (ECG) Data Management System (ECGDMS). This decision, in accordance with FAR 6.302-1, is due to GE MUSE being the only system capable of providing comprehensive access to historic raw ECG data and essential tools for its utilization. All 170+ VHA facilities currently use GE MUSE and GE cardiac equipment, storing millions of veteran ECG records. Switching systems would result in the loss of critical raw data, compromising patient care and incurring significant, unrecoverable costs. The procurement falls under NAICS code 339112 and PSC 6515. This sole source acquisition is deemed essential for maintaining data integrity, ensuring patient safety, and upholding the high standards of veteran healthcare.

The provided document is a template for reporting contract and sales data for various VA Healthcare Systems and Networks across the United States, including a facility in Manila, Philippines. It outlines fields for contractor information, contract numbers, line items (CLIN/SLIN), item descriptions, part numbers, and prices inclusive of Service Level Agreement (SLA) fees. The document is structured to track quarterly sales for Fiscal Year 2025, detailing quantity sold per item and associated sales amounts, with and without SLA. It lists numerous VA facilities grouped by their respective VISN (VA Integrated Service Network) or healthcare network, indicating a comprehensive system for tracking procurement and sales within the Department of Veterans Affairs. The template also includes sections for total quarterly quantity sold, total quantity sold of all items, total quarterly sales inclusive of SLA, anticipated SLA, total sales amount without SLA, and SLA received (specifically for Hines Fiscal).

The Department of Veterans Affairs' Strategic Acquisition Center seeks a requirements contract for the GE MUSE ECG Data Management System (ECGDMS) for the Veterans Health Administration (VHA). This system will manage and store cardiovascular diagnostic data, specifically ECG waveforms, to aid diagnosis and facilitate data retrieval for comparison. The contract has a 12-month base period with four 12-month options. The Request for Proposal (RFP) outlines specific hardware (Dell servers), installation services, project management, and a comprehensive list of software modules and licenses. Key salient characteristics for evaluation include comprehensive access to historical raw ECG data, seamless connectivity with existing GE systems, adherence to medical performance standards, ADT data flow, raw ECG data for clinical research, advanced teaching tools, "turnkey" hardware implementation, and FDA 510(k) approval. Training services for various aspects of the MUSE system are also detailed.

VA Handbook 6500.6, Appendix C, outlines mandatory information security and privacy requirements for contractors working with the Department of Veterans Affairs. It ensures contractors adhere to the same federal laws, regulations, and VA policies as VA personnel regarding sensitive information and IT systems. Key provisions include unlimited government rights to data produced, strict rules on data usage and segregation, and the necessity of VA approval for any external use or disclosure of information. The handbook details rigorous security measures such as encryption, FIPS 140-2 compliance, and adherence to NIST guidelines. Contractors must undergo background checks, complete mandatory security and privacy training, and report security incidents within one hour. The document also specifies requirements for information system hosting, operation, maintenance, and development, emphasizing compliance with FedRAMP and VA's assessment and authorization processes. It addresses supply chain integrity, anti-tampering measures, and the need for robust patching governance and cryptographic controls. Special provisions apply to medical devices and data center operations, ensuring comprehensive security across all VA-related contracts. Non-compliance can lead to contract termination and liquidated damages.

This government file is an RFP or grant document detailing a comprehensive list of products and services, primarily from GE and Dell, for the MUSE and MUSE NX systems. The file outlines various components, including application, SQL, HL7, and web servers, alongside a wide range of installation, support, migration, and project management services. Key services cover hourly and daily support (normal business hours, after-hours, weekends, and holidays), server migrations (P to P, P to V, V to V), data management (extraction, synchronization, merging, PID changes), and volume record handling (small to enterprise). The document also includes details on various modules (Web Edit, Enhanced ECG Editor, Stress, Holter, Reanalysis, Criteria Based Routing, Advanced Charge Capture, XML Import/Export, DICOM Connect, eDOC Connect, Monitoring Gateway, Orders, Text Results, Waveform Image Results, ADT Query, Billing, Batch Data, Mobile ECG), and training services (virtual, onsite, technical, application, integrated, workflow engagement). It also includes networking integration fees and various types of training. The file mandates offerors to complete all highlighted spaces, provide manufacturer and part numbers for proposed solutions, and indicate N/A, None, or Zero (0) for irrelevant CLINs. Pricing sections are included for base and option years (1-4) with a 3% SLA. The overall purpose is to solicit proposals for the comprehensive implementation and ongoing support of MUSE and MUSE NX systems, likely for healthcare or clinical workflow management, with a clear emphasis on detailed itemization and pricing structure.

The Department of Veterans Affairs (VA) is seeking a sole-source acquisition from TrillaMed, LLC for the GE MUSE Electrocardiographs (ECG) Data Management System (ECGDMS). This system is crucial for all 170+ VHA Medical Centers as it serves as the repository for electronic ECGs, integrating with existing VA health information systems like VistA. TrillaMed, LLC is the only authorized distributor of the GE MUSE system, which is essential for maintaining historical ECG data, ensuring data integrity, and enabling critical diagnostic comparisons. The estimated value of this contract, spanning a base year and four option years, is $46,574,117.20. The justification for this non-competitive award is based on 41 U.S.C.3304(a)(1) (Only One Responsible Source), as the GE MUSE system's unique capabilities and its proprietary Marquette 12SL algorithm are indispensable for existing infrastructure and patient care. Market research confirmed TrillaMed, LLC as the sole authorized distributor, and efforts will be made to ensure the cost is fair and reasonable despite the lack of competition. Future market research will continue to assess potential changes in the marketplace for future acquisitions.

Attachment F, titled "Certification of Recall or Safety Issues," is a mandatory form for offerors responding to Solicitation Number 36C10G25R0046 for the GE MUSE Data Management System. This document requires companies to certify that the medical equipment proposed has no outstanding recalls or known safety issues. Additionally, it ensures compliance with all relevant regulations and standards, and that thorough checks for safety and performance have been conducted. The form must be completed, signed by an authorized company representative, and submitted with the proposal. The certification emphasizes that providing false or misleading information can lead to disqualification and legal penalties, underscoring the importance of product safety and regulatory adherence in federal procurements.

Attachment G, titled "PAST PERFORMANCE REFERENCES" for Solicitation 36C10G25R0046, focuses on the GE MUSE ECG Data Management System. This document is a template for offerors to provide detailed information about their past performance relevant to the solicitation's requirements. It outlines three distinct past performance reference sections, each requiring comprehensive details such as the offeror's name, the company that performed the work, their relationship and role on the contract (offeror/subcontractor, prime/subcontractor), the contracting organization, contract/task order numbers, contract type, total awarded/projected prices, and period of performance. Additionally, it asks for contact information for the Contracting Officer and Program Manager, the NAICS code, and whether CPARS was completed. Crucially, each reference demands a concise description of the work's relevance to the solicitation and an explanation of any performance issues, corrective actions taken, and results, especially those discussed in CPARS reports. The document also includes an option for offerors to indicate "No record of relevant or recent past performance."

Attachment H, a Past Performance Questionnaire for Solicitation No. 36C10G25R0046 (GE MUSE Data Management System), is issued by the Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC). This document is sent to references provided by offerors to evaluate their past performance on previous contracts. The questionnaire requires references to rate the offeror on Quality of Service, Cost Control, Timeliness of Performance, and Business Relations, using a rating scale from 1 (Unsatisfactory) to 3 (Excellent). References must also provide contract details, a brief description of services, and indicate if any negative actions like show cause orders or terminations occurred. The completed forms are to be emailed to Anthony.Zibolski@va.gov with the specific solicitation number in the subject line. This questionnaire is critical for the VA SAC to fairly assess offeror proposals for the contract award.

This Business Associate Agreement (BAA) between the Department of Veterans Affairs Veterans Health Administration (VHA) and a contractor establishes requirements for the use and disclosure of Protected Health Information (PHI) in accordance with HIPAA and HITETECH Acts. The contractor, acting as a Business Associate, will provide services involving PHI to VHA, the Covered Entity. Key terms like "Business Associate," "Covered Entity," and "PHI" are defined according to HIPAA Rules. The agreement outlines strict terms and conditions for PHI handling, emphasizing VHA's ownership of PHI. The Business Associate must only use or disclose PHI as permitted by the agreement or law, adhere to minimum necessary policies, and implement safeguards. Obligations include notifying VHA within 24 hours of any PHI violation or breach, providing a detailed written report within ten business days, and mitigating harm. The Business Associate must ensure that subcontractors are US-based and also enter into HIPAA-compliant agreements. They must also assist VHA with individual requests for PHI access, amendment, or accounting. Upon termination, all PHI must be returned or destroyed. VHA's obligations include not requesting impermissible PHI uses and promptly notifying the Business Associate of any restrictions or changes in privacy practices. The agreement can be amended or terminated, with provisions for automatic termination or termination for cause in case of material breach. The agreement is reviewed every two years and is effective on the last signature date.

This document is a comprehensive Request for Proposal (RFP) from the U.S. Department of Veterans Affairs (VA) for a nationwide Requirements Contract for the GE MUSE ECG Data Management System, including accessories, consumables, and warranty. It outlines detailed terms and conditions for contract administration, invoicing, and reporting, emphasizing electronic submission via Tungsten Network. The RFP specifies mandatory clauses covering information security, data handling, and privacy, particularly for sensitive VA information, and details requirements for contractor personnel security. It also addresses ordering limitations, product refresh procedures, and recall protocols. A significant aspect is the mandatory 3.0% Service Level Agreement (SLA) fee, which must be embedded in all prices and reported quarterly. The contract has a potential total duration of five years, including option periods, with liquidated damages for delays. The document prioritizes secure and compliant management of medical equipment and associated data within the VA healthcare system.