Single Source Justification MPT to SAT_Redacted.pdf

Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 4 Acquisition ID# 36C248-25-AP-4193

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: 36C248-25-AP-4193

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health

Administration (VHA), Regional Procurement Office East, Network Contracting Office (NCO) 08 on behalf of Bay Pines VA Health Care System located at 10,000 Bay Pines Blvd., Bay Pines, FL 33744.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a brand name requirement. Contracting is seeking to acquire delivery, instrallation, training and manuals for the following:

QTY 2 - MEDRAD Centargo CT Injection System QTY 1 - Stellant FLEX- Medrad Stellant QTY 2 - Medrad Mark 7 Arterion Table Mount System

The procurement of the Medrad Centargo CT, Medrad Stellant FLEX and Medrad Mark 7 Arterion injection systems is critical for enhancing the quality and safety of our diagnostic imaging procedures. These systems will support our mission to provide high-quality healthcare services, ensure patient safety, and improve clinical outcomes. The key functions and benefits enabled by these Medrad injectors:

Enhanced Diagnostic Imaging Quality Improved Visualization: By delivering contrast media precisely, these injectors enhance the visualization of anatomical structures, tissues, and blood vessels, providing clearer and more detailed images. This is essential for accurate diagnosis and treatment planning.

Procedural Efficiency and Workflow Optimization Streamlined Procedures:

The automation and pre-programmable protocols of Medrad injectors streamline the injection process, reducing procedural time and improving overall workflow efficiency. This allows radiology departments to handle higher volumes of imaging procedures without compromising quality.

Patient Safety and Comfort Enhanced Safety Features:Medrad injectors come equipped with advanced safety features such as automated air detection and elimination, real-time pressure monitoring, and customizable alarms. These features significantly reduce the risk of adverse events, such as air embolism or excessive pressure, thereby ensuring patient safety.

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Reduced Patient Discomfort: Precise control over injection speed and pressure minimizes patient discomfort during the administration of contrast media.

Customizable Injection Protocols Tailored Protocols: The ability to create and store customized injection protocols allows healthcare providers to tailor contrast delivery to the specific needs of each patient and procedure, ensuring optimal image quality and patient care.

Integration with Imaging Systems DICOM Connectivity: Seamless integration with Picture Archiving and Communication Systems (PACS) and Electronic Health Records (EHR) through DICOM standards enables efficient data management, retrieval, and sharing. This integration supports better clinical decision-making and workflow continuity.

Versatility Across Multiple Imaging Modalities CT Imaging: For CT scans, the Medrad Stellant FLEX system enables high-quality imaging by delivering precise amounts of contrast media, which is critical for diagnosing a wide range of conditions, from vascular diseases to tumors.

Interventional Radiology: The Medrad Mark 7 Arterion system is specifically suited for interventional radiology procedures such as angiography, where precision and control over contrast media injection are crucial for visualizing blood vessels and guiding interventions.

Detailed Organs and Tissue Visualization: Contrast-enhanced CT scans can provide a higher level of detail in the imaging of organs, soft tissues, and blood vessels, facilitating the diagnosis of conditions such as cancer, cardiovascular diseases, and internal bleeding.

Angiography and Vascular Studies Clearer Blood Vessel Imaging: Accurate and controlled injections of contrast media are vital for angiographic procedures, allowing radiologists to visualize blood vessels clearly, identify blockages, aneurysms, and other vascular abnormalities.

Magnetic Resonance Imaging (MRI) Enhanced Tissue Contrast: While primarily designed for CT and angiography, some Medrad injectors, or similar injectors, may also be used to deliver gadolinium-based contrast agents during MRI scans, enhancing soft tissue contrast and lesion detection.

Interventional Procedures Guided Interventions: During interventional radiology procedures, precise contrast media delivery helps in guiding instruments and ensuring the success of minimally invasive treatments such as stent placements and embolization procedures.

Estimated Cost:

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3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Medrad injectors have a proprietary dual syringe design that allows for both simultaneous and sequential injection of contrast media and saline. This capability ensures optimal contrast delivery and image quality, which is not available in competitors’ systems. This feature is critical for our specific diagnostic requirements and is essential for achieving accurate and high-quality imaging results.

The Medrad injectors offer real-time pressure monitoring and automatic adjustment capabilities. This functionality ensures that the injection process is consistently safe and effective, automatically adjusting to the patient's needs to prevent any adverse effects. Other injectors on the market do not offer the same level of precise control and real-time adjustments, making Medrad's technology uniquely suitable for our patient safety standards.

The Medrad systems feature an exceptionally user-friendly touchscreen interface that simplifies operation and minimizes the risk of user error. This intuitive design is essential for high-throughput environments. Furthermore, the ability to create, store, and quickly recall patient-specific and procedure-specific protocols ensures efficiency and consistency in our imaging processes, which other systems lack.

The Medrad injectors possess distinct and essential features that are not available from other suppliers, making them indispensable for our diagnostic imaging requirements. The combination of their advanced dual syringe design, real-time monitoring and control, comprehensive safety features, seamless integration capabilities, proven reliability, and exceptional vendor support make Medrad injectors the only viable option for our department.

4. Description of market research conducted and results or statement why it was not conducted: Market research efforts include queries on Small Business Search, Veteran Small Business Certification (VetCert), Federal Procurement Data System (FPDS), General Services Administration and System for Award Management (SAM). The North American Industry Classification System (NAICS) code is 339112 (Surgical and Medical Instrument Manufacturing); 6515 (Medical and Surgical Instruments, Equipment, and Supplies).

There is no nonmanufacturer class waiver for the NAICS code 339112 for Surgical and Medical Instrument Manufacturing listed on the NMR Class Waiver Database.

An SDVOSB cannot qualify as a nonmanufacturer for this requirement because it cannot meet the four prong test of 13 CFR 121.406(b) where the fourth prong specifically requires the nonmanufacturer to supply products from a small business not a large business.

FPDS was queried utilizing the keywords “Medrad injector” and filtered for the Department of Veterans Affairs and 36C248. The most recent award was awarded

Effective Date: 11/15/2024 Page 4 of 4 Acquisition ID# 36C248-25-AP-4193 to Nexus Group LLC (SDVOSB) on 9/15/2025 under 36C24823P2580, to support Medrad Injector maintenance. A more detailed search was completed utilizing keywords “Mark 7 Arterion” and filtered for the Department of Veterans Affairs and 36C248. The most recent award was awarded to 1st American Medical Distributors INC (SDVOSB) on 10/19/2023 under 36C24824P0106, where (3) quotes were received under solicitation 36C24823Q2010. The Analytics, Data and Decision Support Unified Platform (ADDS UP) was also quired using the simple search “Mark 7 Arterion” and identified 38 active contracts. The contracts varied from equipment to preventive maintenance for the injector systems.

The review of the Supply Chain Management Catalog did not instill confidence that this requirement can be fulfilled through any mandatory contracts. A sources sought notice was not required, as market research indicated the availability of multiple small businesses capable of supporting the facility’s needs.

All market research leads to a brand name/sole manufacture requirement and market research confirms there are no SDVOSB/VOSB OEM distributors to provide this product at a fair & reasonable price. It is in the best interest of the government to award directly to the lowest priced OEM small business distributor

5. Contracting Officer's Certification: Purchase is approved in accordance with

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief

Date Contracting Officer