Maintenance of Baxter CVVH Prismax and Thermax system by Baxter/Vantive US Healthcare LLC (Notice of Intent to sole source)

Acquisition Description:

This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with: Vantive US Healthcare LLC

The National Institute of Health Clinical Center (NIH-CC) requires maintenance operation of Baxter branded equipment specifically 5 PRISMAX CVVH hemofiltration devices and 5 Thermax blood warmers to the current Baxter maintenance standards. Continuous Veno-Venous Hemofiltration (CVVH) is a temporary treatment for patients with acute renal failure who are unable to tolerate traditional hemodialysis and are unstable. The machines have a legacy interface with the hospital EMR, CRIS. NIH Clinical Center Biomedical Engineering and Instrumentation Service ensure that medical devices in the select inventory are inspected, tested and maintained as scheduled per the manufacturer's recommendations. Baxter created the company Vantive US Healthcare LLC ( Vantive: ) to lead or spinoff a part of their business, and Vantive is the manufacturer and sole service provider for their Prismax Dialysis equipment.

Justification:

Baxter/Vantive US Healthcare LLC is the manufacturer of the equipment that needs to be serviced. They are the only Original Equipment Manufacture (OEM) service provider and can provider OEM parts. The use of OEM parts and qualified service providers is important to ensure the equipment runs as originally intended. Baxter's PRISMAFLEX and PRISMAX machines have been the only CVVH equipment used in the Clinical Center, since 2008. Baxter is the manufacturer and sole source provider in the United States for the Prismax Dialysis Equipment, Product Number 955626. Baxter has proprietary rights to the software on the Prismax Dialysis Equipment. These products have been solely maintained by Baxter (their servicing department is now known as Vantive US Healthcare LLC).

According to Baxter/Vantive US Healthcare LLC's sole source letter, they do not have any formal business relationships with any third-party businesses to provide servicing of their systems of supply of OEM parts. There may be third party contractors that have Vantive certifications to service this equipment, but they would be liable for any errors. If a third-party service organization maintain the Prismax Dialysis Equipment, the third-party provider would be liable for an incident with a patient or customer since they provided the service. This would absolve Baxter from further providing technical and clinical support such as interpretation from internal machine logs of the device and potentially nullify any future maintenance service from Baxter/Vantive. Furthermore, third parties would not have a supply of OEM parts on hand and would have to order from the manufacturer, causing potentially significant delays. Thus, we intend to sole source this maintenance requirement to the manufacturer Baxter/Vantive.

List of equipment to be serviced:

Model Name, Product ID, serial number:

Prismax 955626 101427

Prismax 955626 101420

Prismax 955626 101328

Prismax 955626 101293

Prismax 955626 101448

Thermax 955630 101406

Thermax 955630 101404

Thermax 955630 101358

Thermax 955630 101402

Thermax 955630 101403

See Statement of Work/Bill of Materials for more details.

Place of Performance or Delivery:

The Period of Performance is one (1) base year and four (4) option years.

Base Year: 09/23/2024 09/22/2025

Option Year 1: 09/23/2025 09/22/2026

Option Year 2: 09/23/2026 09/22/2027

Option Year 3: 09/23/2027 09/22/2028

Option Year 4: 09/23/2028 09/22/2029

Place of Performance: NIH Clinical Center in Bethesda, MD

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-24-008156) by 11:00 AM eastern standard time on 09/11/2024 to: lu-chang.lu@nih.gov

All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.