NOI - MALDI Biotyper Sirius CA System

Description

{"description":" Description: \n\n This is a Notice of Intent, not a request for quotation (RFQ). A solicitation document will not be issued, and quotations will not be requested. \n\n The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC), on behalf of the Department of Laboratory Medicine (DLM), intends to award a Firm-Fixed-Price (FFP) sole source purchase order to: \n\n Bruker Scientific, LLC \n\n 40 Manning Road \n\n Billerica, MA 01821 \n\n \n\n Requirement Description: \n\n The Microbiology Service requires the MALDI Biotyper Sirius CA System to support the rapid and accurate identification of microorganisms, including bacteria, fungi, and mycobacteria, from clinical cultures. \n\n \n\n Background: \n\n The Department of Laboratory Medicine currently utilizes a Bruker MALDI Biotyper Smart System as its primary platform for microbial identification from clinical patient specimens. This system is essential for the identification of bacteria from clinical cultures and is also used for identification of fungi and mycobacteria. \n\n The MALDI Biotyper Sirius CA System, manufactured exclusively by Bruker Scientific, LLC, is the direct successor to the currently deployed platform and is uniquely capable of meeting the Government’s requirements while maintaining continuity of operations. The system must be a direct successor to the existing platform to minimize validation requirements and avoid disruption to clinical laboratory operations. \n\n The Sirius system is compatible with existing consumables, reagents, workflows, and validated methodologies currently in use within the Microbiology Service. Transitioning to a different manufacturer’s platform would require substantial validation and verification of clinical assays to meet regulatory and accreditation requirements, as well as retraining of personnel and modification of laboratory processes. This would result in significant duplication of effort, increased costs, and potential delays in diagnostic testing. \n\n Additionally, the current system is approaching the end of its service life, with manufacturer support scheduled to end in March 2027, and is experiencing increased maintenance needs. Failure to replace the system in a timely manner may result in increased downtime and risk to continuity of laboratory operations. \n\n For these reasons, Bruker Scientific, LLC is the only responsible source capable of providing a system that meets the Government’s requirements without unacceptable delays, duplication of effort, or disruption to mission-critical clinical services. \n\n \n\n Rationale for Sole Source: \n\n Market research was conducted through review of commercially available microbial identification systems and vendor capabilities. While multiple vendors offer systems for microbial identification, these systems differ in methodology, workflow, and compatibility with existing laboratory processes. \n\n No alternative vendor was identified that could provide a system compatible with the existing Bruker MALDI Biotyper platform while minimizing validation requirements and avoiding disruption to ongoing clinical laboratory operations. \n\n Based on this research, Bruker Scientific, LLC is the only source capable of meeting the Government’s requirements. \n\n \n\n Authority: \n\n This acquisition is being conducted in accordance with: \n\n FAR Part 13 – Simplified Acquisition Procedures \n\n FAR 13.106-1(b)(1) – Soliciting from a single source \n\n For acquisitions not exceeding the Simplified Acquisition Threshold (SAT), contracting officers may solicit from one source if only one source is reasonably available. \n\n \n\n Interested Parties: \n\n Interested organizations may submit a capability statement demonstrating their ability to meet this requirement. \n\n Capability statements shall include: \n\n • Relevant experience providing similar diagnostic testing equipment \n\n • Technical capability to support MALDI Biotyper Sirius CA System or equivalent systems \n\n • Business size classification under NAICS 334516 \n\n \n\n Submission Information \n\n Responses to this notice shall be submitted electronically to: \n\n Gregory Noland \n\n Office of Acquisition and Logistics Management (OALM) \n\n Email: gregory.noland@nih.gov \n\n Response Due Date: \n\n April 27, 2026, at 4:00 PM EST \n\n \n\n Disclaimer: \n\n This notice is for informational purposes only and does not constitute a solicitation. The Government reserves the right to not compete this requirement based on responses received. The determination to proceed with a sole source award is at the sole discretion of the Government. \n"}