Terumo BCT Spectra Optia Apheresis Systems Preventative Maintenance Services
Closed Pre-Solicitation Posted
- Solicitation number
- 25-005917
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 811210 Electronic and Precision Equipment Repair and Maintenance
- Place of performance
- Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH) Clinical Center, Office of Purchasing and Contracts intends to award a sole source firm-fixed price purchase order to Terumo BCT, Inc. for preventative maintenance services on two Spectra Optia Apheresis Systems used by the Department of Transfusion Medicine's Center for Cellular Engineering. The procurement is specifically for maintaining specialized medical equipment used in blood collection and cell-based therapy processes, which must comply with FDA regulations under 21 CFR 210, 211, 600, and 1271. The contract will be executed using FAR Part 13 Simplified Acquisition Procedures, which allows for single-source procurement when only one vendor is deemed reasonably available. Interested parties capable of providing similar services may submit a capability statement by May 17, 2025, to Emeka Onyejekwe at Emeka.onyejekwe@nih.gov. The government retains sole discretion to determine whether to competitively procure the contract based on received capability statements.
The pre-solicitation notice indicates no specific set-aside designations for this procurement. Terumo BCT, located in Lakewood, Colorado, is the sole manufacturer of the equipment and the only vendor approved by the Quality Assurance Team to perform these maintenance services. The contract structure includes a base year with two optional years, all to be executed as a firm-fixed price purchase order. The place of performance will be in Bethesda, Maryland, specifically at the NIH Clinical Center. While specific award values are not disclosed, the procurement falls under the simplified acquisition threshold and involves maintaining two critical medical systems used for blood and cell-based therapeutic processes. The contract's primary objective is to ensure continuous, compliant maintenance of specialized medical equipment critical to the Department of Transfusion Medicine's operations.
Notice text
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: 25-005917
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 May 17th, 2025, and time marked in this notice.
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