Thermo Fisher Scientific Preventative Maintenance Agreement for Centrifuges

Title: Thermo Fisher Scientific Preventative Maintenance Agreement for Centrifuges Product Service Code (PSC): J066 – Maintenance, Repair, and Rebuilding of Equipment – Instruments and Laboratory Equipment NAICS Code: 811210 – Electronic and Precision Equipment Repair and Maintenance Place of Performance: National Institutes of Health Clinical Center Bethesda, MD 20892 POTS: 26-002861 Description This notice is issued for informational purposes only and does not constitute a request for quotations.

A solicitation will not be issued, and quotations will not be requested.

The National Institutes of Health (NIH), Clinical Center, Office of Acquisition and Logistics Management (OALM), on behalf of the Center for Cellular Engineering (CCE), intends to award a firm-fixed-price contract on a sole-source basis to Thermo Fisher Scientific (Asheville) LLC for a preventative maintenance agreement covering the following centrifuge models: SorLegendXTRCent12 Sorvall Legend XTR Sorvall Legend XFR Sorvall X4RF Pro-M Multifuge X4 Pro-M Sorvall BP 8 1P Sorvall X4R Pro-MD The preventative maintenance agreement will ensure the continued operation, calibration, and manufacturer-approved servicing of this critical laboratory equipment.

The Center for Cellular Engineering (CCE) manufactures cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. CCE manufacturing operations are regulated by the U.S. Food and Drug Administration (FDA), and federal regulations mandate that critical equipment used in the manufacturing, processing, and testing of drug products must be maintained in a controlled and validated manner in accordance with 21 CFR 211.63 and 21 CFR 211.67.

Thermo Fisher Scientific has been providing maintenance services for these devices and other related equipment within the Center for Cellular Engineering and is familiar with the policies, procedures, and environmental requirements necessary to operate within the CCE cleanroom facilities. The vendor has also completed vendor qualification with the CCE Quality Assurance group and is approved to perform services within the facility.

Maintaining continuity of service is essential to avoid disruptions to manufacturing operations. Delays in procuring this preventative maintenance agreement could result in interruptions to equipment availability, which may negatively impact the production of cell therapies and ultimately affect patient care. Background Thermo Fisher Scientific is the original equipment manufacturer (OEM) of the centrifuge instruments listed above.

As the manufacturer, Thermo Fisher Scientific has exclusive access to the proprietary parts, software updates, diagnostic tools, and technical expertise required to maintain these systems in accordance with manufacturer specifications.

Because of this proprietary knowledge and access to OEM components, Thermo Fisher Scientific is uniquely qualified to provide the preventative maintenance services required to ensure the continued reliability and validated status of these instruments with minimal disruption to laboratory operations.

Authority This acquisition is being conducted in accordance with: FAR 13.106-1(b)(1) – Soliciting from a Single Source Under this authority, the Contracting Officer may solicit from a single source when it is determined that only one source is reasonably available to meet the Government’s requirements. Acquisitions conducted under FAR Part 13 – Simplified Acquisition Procedures are exempt from the competition requirements of FAR Part 6. Responses This notice is not a request for quotations.

However, interested parties may submit a capability statement demonstrating their ability to provide equivalent preventative maintenance services for the Thermo Fisher Scientific centrifuges identified above.

Capability statements must clearly demonstrate the ability to provide: Preventative maintenance services for Thermo Fisher Scientific centrifuges Access to OEM-certified parts, software updates, and diagnostic tools Technicians trained and certified to service the specified centrifuge models Maintenance documentation sufficient to maintain regulatory compliance in cGMP environments The Government will evaluate capability statements received in response to this notice.

The determination not to compete this requirement is solely within the discretion of the Government. Submission Instructions Responses referencing POTS: 26-002861 must be submitted electronically no later than March 20, 2026, at 11:00 AM EST to:

Shasheshe Goolsby Team Leader Hospital and Laboratory Support Division Office of Acquisition and Logistics Management (OALM)

NIH Clinical Center Email: shasheshe.goolsby@nih.gov