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 3 Acquisition ID# 36C248-26-AP-0560

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($350K)

Acquisition Plan Action ID: 36C248-26-AP-0560

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 comprehensive Bayer Healthcare Medrad Intego PET Infusion System maintenance and certification agreement (DirectCARE Basic (DCB)). This is a Base Plue (2) Year Requiement.

QTY 1 - Medrad Intego PET Infusion System QTY 2 - Medrad MRXperion MR Injection System

The DirectCare Basic service for Medrad injectors is a maintenance and support program offered by Bayer to ensure the optimal performance and longevity of Medrad medical injectors. Medrad injectors are used for various imaging procedures, such as CT, MRI, and angiography, to inject contrast media into patients. Key components of the DirectCare Basic service for Medrad injectors typically include:

Preventive Maintenance: Scheduled maintenance visits to inspect, calibrate, and service the injector systems to prevent potential issues and ensure they are operating within specified parameters.

Technical Support: Access to technical support services, often available via phone or online, to assist with troubleshooting and resolving any system issues or user questions.

Software Updates: Provision of software updates to keep the injectors running with the latest features, security patches, and performance improvements.

Parts Replacement: Replacement of certain parts that may wear out or fail over time, ensuring the injector systems continue to function reliably. The specifics of what parts are covered can depend on the service agreement.

Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID# 36C248-26-AP-0560

Service Documentation: Maintaining detailed records of all maintenance and service activities performed on the injectors, which can be useful for compliance and operational tracking.

Estimated Cost: (Base Plus (2) Option Years

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The DirectCare Basic service for the Medrad Intego PET Infusion System and Medrad MRXperion MR Injection System has unique characteristics that limit availability to only Bayer or authorized service providers.

Both the Medrad Intego PET Infusion System and Medrad MRXperion MR Injection System are proprietary technologies developed and manufactured by Bayer. The maintenance, software updates, and repairs often require access to proprietary tools, diagnostic equipment, and software that are unique to Bayer. Bayer’s service technicians possess specialized training and expertise specific to Medrad systems, ensuring they can diagnose and fix issues efficiently. The company often offers certified training programs that are not available to independent service providers.

Authorized service providers have assured access to genuine Bayer replacement parts specifically designed for the Medrad systems. Using authentic parts is crucial for maintaining the performance, safety, and longevity of the equipment.

Unauthorized providers may use non-genuine parts that could compromise system integrity and patient safety.

Maintenance and repair work performed by authorized service providers ensures that the systems’ warranties remain valid. Using unauthorized providers can void warranties, leading to higher long-term costs for system owners due to loss of coverage for parts and labor under warranty.

Ensuring compliance with health and safety regulations, such as those from the FDA or equivalent in other countries, often mandates that maintenance and repairs are performed by technicians authorized by the OEM (Bayer). This ensures that all services meet rigorous regulatory standards, which unauthorized service providers may fail to meet, leading to potential risks and liabilities.

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 811210

- Electronic and Precision Equipment Repair and Maintenance; J065 - Maintenance,