SAM #NOI-OLAO-CC-26-005158

Sole Source Preventative Maintenance and Repair for Terumo BCT Optia Apheresis Machines at NIH Clinical Center

This opportunity involves a sole source preventative maintenance and repair service contract for Terumo BCT Optia apheresis machines at the NIH Clinical Center. - Agency: National Institutes of Health (NIH), Clinical Center, Blood Services Section - Scope: Preventative maintenance, repair, and emergency servicing for up to four Optia apheresis machines and two Spectra OPTIA Cell Separators - Includes biannual preventive maintenance, emergency repairs (labor and parts, excluding disposables and parts for devices over 10 years old), and telephone support - Contractor must respond to emergencies within 1 hour and provide on-site service within 1 business day - All labor and travel costs included - OEM: Terumo BCT is the sole qualified vendor and manufacturer of the Optia apheresis machines - Regulatory Compliance: Services must meet FDA and AABB requirements for clinical equipment - Contract Value: Estimated at $84,836.56 for the base year - Period of Performance: One-year base period with two option years (potential total of three years) - Place of Performance: NIH Clinical Center, Bethesda, MD - No market research was conducted due to the proprietary nature of the equipment - Commercial Opportunity: While this is a sole source procurement, capability statements from other sources may be considered

Technical and Business Details: - Service covers maintenance and repair for up to six Optia/Spectra OPTIA machines - No specific part numbers listed; services are for existing equipment - Emergency response and on-site service requirements are strict - All maintenance must be documented and compliant with regulatory standards - Estimated contract value is provided for business planning - Place of performance is a federal facility in Bethesda, MD

Description

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Terumo BCT.

Acquisition Descripton:

The National Institutes of Health, Office of Purchasing and Contracts on behalf of Clinical Center (CC), Blood Services Section (BSS) has a need to approve a "Justification for Other Than Full and Open" requirement in accordance with FAR 8.3, Other Than Full and Open Competition.

This procurement action in accordance with IAW FAR 6.302-1 is based on the need to procure a service agreement for our apheresis machines which are used in a patient care capacity. Service Agreement is for a one-year period with the two option years.

Approval of this purchase is for service agreement for a specific type of instrument which is used to separate blood and blood products on donors and patients in the NIH Clinical Center.

The DTM 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 their medical condition. These two (2) apheresis machines are used to perform extracorporeal therapy in which the blood of donors or patients is passed through the device to separate blood components. Numerous regulatory authorities, specifically the Food and Drug Administration (FDA) and AABB set policy and enforce this policy for care and maintenance of equipment that is used, in support of donors and patients per the above.

The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-OLAO-CC-26-005158) by 12:00 PM eastern standard time on 05/13/2026 to: valerie.gregorio@nih.gov.

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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