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Thermo Fisher Scientific Sorvall Legend Centrifuges and Heracell Vios 160i CO2 Incubators Preventative Maintenance Services Product Service Code: J066-Maint/repair/rebuild Of Equipment- Instruments an... Thermo Fisher Scientific Sorvall Legend Centrifuges and Heracell Vios 160i CO2 Incubators 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: 25-001812 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 Department intends to award a firm-fixed priced contract to Thermofisher Scientific to perform preventative maintenance services on Heracell Vios 160i CO2 incubators and Sorvall centrifuges. List of Equipment: Thermofisher Heracell Vios 160i CO2 incubators Quantity 36 Thermofisher Sorvall Centrifuges Quantity 17 Serial Numbers 43072425 43095884 43107182 43049226 43107185 43095886 43124291 43136687 43049225 43098091 43134068 43095882 43107160 43095885 43107183 43095881 43124292 43134069 43072430 43068198 43072424 43072422 43079838 43068216 43068215 43068212 43068225 43072431 43067007 43079842 43068207 43068214 43089823 43089824 43068224 43072420 43072429 43068219 43079839 43072419 43068218 43076993 43072427 43068222 43079843 43068220 43072423 43072421 43089825 43089829 43068221 43068201 43068223 The Department of Transfusion Medicine, Center for Cellular Engineering Services requires continued preventative maintenance services on fifty-three combined Thermo Fisher Scientific Sorvall Legend Centrifuges and Heracell Vios 160i CO2 incubators used for testing 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. The manufacturing operations of the Center for Cellular Engineering Services 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 and the only source 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 Scientific 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 Services 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 30, 2024 by 12:00 pm Noon EST and time marked in this notice. No phone calls will be accepted.