SAM #26-000723

Sole Source Preventive Maintenance for Sefia S-2000 Devices at NIH Clinical Center

This opportunity is for a sole source preventive maintenance service contract for Sefia S-2000 devices at the NIH Clinical Center. - Department of Health and Human Services, National Institutes of Health (NIH), Clinical Center is the procuring agency - Sole source award to Global Life Sciences Solutions, LLC (dba Cytiva) - Cytiva is the original equipment manufacturer (OEM) and sole authorized provider - Services include: - Preventive maintenance, repairs, and software upgrades for Sefia S-2000 devices - Work performed by OEM-qualified technicians - Devices are used in cell-based therapy manufacturing for NIH-sponsored clinical trials - FDA regulations require maintenance by qualified, authorized technicians - No other vendors are considered capable of meeting these requirements - Place of performance: NIH Clinical Center, Bethesda, MD 20892 - Contracting office: NIH Clinical Center, 6707 Democracy Blvd, Suite 106, Bethesda, MD 20892

Description

This acquisition is for a preventive maintenance service contract for the Sefia S-2000 devices that will be used in the manufacturing of cell-based therapies for patients enrolled on National Institutes of Health (NIH) sponsored clinical trials at the Clinical Center Department of Transfusion Medicine, Center for Cellular Engineering.

•             Product Service Code: 6515 – Medical Instruments, Equipment, and Supplies

•             NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing

•             Place of Performance: Bethesda, MD 20892 USA

POTS: 26-000723

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 (NIH) intends to award a fixed price purchase order to Global Life Sciences Solutions, LLC, located at 100 Results Way, Marlborough, MA 01752, on a firm fixed price sole source award basis to provide a preventive maintenance service contract  to the National Institutes of Health.

The proposed vendor, Global Life Sciences Solutions, USA, doing business as Cytiva. Cytiva is the original equipment manufacturer and the sole distributor of their equipment and supplies. The FDA mandates that all repairs and maintenance are carried out by qualified technicians. Cytiva/Global Life Sciences Solutions USA LLC is the only source of technicians qualified to service these devices and upgrade their software. The Sefia S-2000 streamlines isolation, harvesting, and final formulation of cellular products. The system also contains an embedded computer system which periodically requires updates. The device and software are proprietary and only Cytiva/Global Life Sciences Solutions USA LLC is capable of providing service, upgrades and repairs.

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), 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 may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Kristin Nagashima, Contract Specialist via email to Kristin.nagashima@nih.gov by April 20, 2026 at 11am EST.

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