Terumo BCT Spectra Optia Apheresis Systems Preventative Maintenance Services

Terumo BCT Spectra Optia Apheresis Systems 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

Place of Performance: Bethesda, MD 20892

POTS: 25-007126

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), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Center for Cellular Engineering intends to award a base year with two-years options firm-fixed price purchase order to Terumo BCT, Inc. on a sole source basis located at 10811 W. Collins Avenue, in Lakewood, Colorado 80215-4440 to perform preventative maintenance services.

The Department of Transfusion Medicine, Center for Cellular Engineering has a requirement for preventative maintenance services on two (2) Spectra Optia Apheresis Systems. The Department of Transfusion Medicine, Blood Services Section is a unique blood center which collects blood and blood components from healthy donors for patients participating in many protocols. However, blood and blood products are also withdrawn from patients when prescribed by a physician, which may have a therapeutic benefit to treat medical conditions. The Food and Drug Administration (FDA) regulates equipment that is used to manufacture cell-based therapies in accordance with the following codes of Federal Regulations 21 CFR 210,211,600 and 1271. 21 CFR 211.67 which state that all equipment shall be maintained as appropriate. Terumo BCT is the sole manufacture of its equipment and proprietary software and the only approved vendor by the Quality Assurance Team to perform these services.

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: 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, 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 Emeka Onyejekwe, Contract Specialist, Emeka.onyejekwe@nih.gov by the due date June 02nd, 2025, and time marked in this notice.