Thermo Fisher Scientific Preventative Maintenance Agreement For Incubators

presolicitation

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Title: Thermo Fisher Scientific Preventative Maintenance Agreement for Incubators 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: 26-003182 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 Purchasing and Contracts, 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 incubator equipment: 48 Thermo Scientific HERAcell VIOS 160i CO? Incubators 2 Thermo Scientific STERI-CULT INC 8 Incubators The preventative maintenance agreement will ensure the continued operation, calibration, and manufacturer-approved servicing of this critical laboratory equipment. Background Thermo Fisher Scientific is the Original Equipment Manufacturer (OEM) for the incubators listed above and is the only vendor capable of providing manufacturer-authorized preventative maintenance services, proprietary software updates, and firmware upgrades required for proper system operation. The Center for Cellular Engineering manufactures cell-based therapies for patients who have limited or no remaining treatment options. Manufacturing activities are regulated under Current Good Manufacturing Practices (cGMP) and must comply with FDA regulations under 21 CFR Parts 210, 211, 600, and 1271. Maintaining validated equipment and current software/firmware versions is essential to ensure regulatory compliance and prevent cybersecurity vulnerabilities that could affect manufacturing systems. Only the OEM can provide the required proprietary updates and certified maintenance services necessary to maintain system validation. Thermo Fisher Scientific has been qualified and validated by the Center for Cellular Engineering Quality Assurance Team as the approved vendor for servicing this equipment. Transitioning to an alternate vendor would require the vendor to undergo a comprehensive qualification and validation process, which could result in significant delays and is not guaranteed to be successful. During this period, preventative maintenance activities could not be completed, and the incubators would be unavailable for use in manufacturing patient therapies. Any disruption to these systems could delay the production of life-saving cell therapies. For patients with advanced or late-stage cancer, such delays may be critical and could negatively impact patient treatment outcomes. 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 incubators identified above. Capability statements must clearly demonstrate the ability to provide: Manufacturer-authorized maintenance services for Thermo Fisher incubators OEM-certified technicians trained on HERAcell VIOS 160i and STERI-CULT INC 8 systems Access to proprietary diagnostic tools, firmware, and software updates Preventative maintenance and calibration services compliant with cGMP laboratory environments Documentation sufficient to maintain FDA regulatory compliance and validated system status 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: 26-003182 must be submitted electronically no later than March 20, 2026, at 8:30 AM EST to: Shasheshe Goolsby Team Leader Office of Purchasing and Contracts NIH Clinical Center Email: shasheshe.goolsby@nih.gov

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