Preventive Maintenance Service for Sefia S-2000 Devices

The National Institutes of Health (NIH) intends to award a fixed price purchase order to Global Life Sciences Solutions, LLC, for a preventive maintenance service contract for Sefia S-2000 devices. These devices are used in the manufacturing of cell-based therapies for NIH-sponsored clinical trials at the Clinical Center Department of Transfusion Medicine, Center for Cellular Engineering, located in Bethesda, Maryland.

Global Life Sciences Solutions, USA, doing business as Cytiva, is the original equipment manufacturer and sole distributor of the Sefia S-2000 devices and their supplies. The FDA mandates that repairs and maintenance must be performed by qualified technicians, and only Cytiva/Global Life Sciences Solutions USA LLC is qualified to provide these services, including software upgrades and repairs, due to their proprietary systems. The acquisition is conducted in accordance with Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures, permitting a sole source award when only one source is deemed reasonably available.

While this notice is not a request for quotations, interested parties may submit their interest and capabilities. The government's decision not to compete is based on the unique circumstances of the contract and the proprietary nature of the equipment.