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Thermo Fisher Scientific Sorvall Legend Centrifuges Preventative Maintenance Services Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment NAICS Code: 811... Thermo Fisher Scientific Sorvall Legend Centrifuges Preventative Maintenance Services Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments and Laboratory Equipment NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance ($34M Average Annual Receipts) Place of Performance: Bethesda, MD 20892 POTS: 25-001314 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine, Center for Cellular Engineering Services intends to award a firm-fixed priced sole source award to Thermo Fisher Scientific located at 28 Schenck Parkway, Building 2B, Suite 400 in Asheville, North Carolina to perform preventative maintenance services on thirty-one (31) Thermo Fisher Scientific Sorvall Legend Centrifuges for a period of performance of one-year. List of Equipment: Sorvall Legend XTR Sorvall Legend XFR Sorvall X4R Pro-MD Multifuge X4 Pro-M Sorvall BP8 The Department of Transfusion Medicine, Center for Cellular Engineering Services requires continued preventative maintenance services on its thirty-one Thermo Fisher Scientific Sorvall Legend Centrifuges used in support of patient care. The Department of Transfusion Medicine, Center for Cellular Engineering Service manufactures cell-based therapies for patients enrolled on clinical trials at the National Institutes of Health, Clinical Center. The manufacturing operations of the Center for Cellular Engineering are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the Food and Drug Administration in 21 CFR 210, 211, 600 and 1271. The Food and Drug Administration mandates that critical equipment used in the manufacturing, processing, and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). Thermo Fisher Scientific is the original equipment manufacturer capable of performing these services and perform software updates. The Food and Drug Administration mandates that all firmware and software used to control devices are kept up to date to prevent security vulnerabilities from being exploited during manufacturing, potentially placing patients at risk. Only the original equipment manufacturer can perform the software and firmware updates. Thermo Fisher has been qualified and validated and the only vendor approved by the Center for Cellular Engineering Quality Assurance Team. Transitioning to a new vendor may cause a stoppage of work. The new vendor would be required to undergo the qualification process which is very lengthy and is not guaranteed should a vendor not meet the specific requirements of the Center for Cellular Engineering’s Quality Assurance Team. To qualify a new vendor would introduce delays to performing preventative maintenance on this critical equipment, which in turn will introduce delays to patient treatments, that could impact patient response to treatment. The equipment could not be used to manufacture patient treatments and patients would need to wait until a new vendor was qualified, the equipment was serviced, and a therapy could be manufactured. For patients with late-stage cancer, these delays are usually insurmountable. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1) and 41 U.S.C.For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested Parties: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Comments: Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date November 17, 2024 by 12:00 pm Noon EST and time marked in this notice. No phone calls will be accepted.