Sole Source Notice - MALDI Biotyper Sirius CA system

The Government hereby submits a notice of intent to make a FFP sole source award to purchase one a MALDI Biotyper Sirius CA system for microbial identification/characterization from Branch Medical a SDVOSB. 1. Identification of the agency and the contracting activity. Requesting Agency:USDA APHIS WS NWRC 4101 Laporte Ave Fort Collins, CO 80521 2. The nature and/or description of the action being approved. The NWRC has created the new Wildlife Disease Diagnostic Laboratory through an initative funded by the American Rescue Plan. This laboratory will specialize in laboratory testing to detect and characterize pathogenic micoroganisms associated with wildlife. Acquisition of key major equipment is essential for building testing capacity. Here, we seek to acquire a MALDI Biotyper Sirius CA system for microbial identification/characterization to be purchased from Bruker’s SDVOSB Distributor, Branch Medical. 3. A description of the supplies or services required to meet the agency’s needs (including the estimated value). The equipment to be purchased is a MALDI Biotype Sirius CA system. This equipment obtains a mass spectral profile of an unknown microorganism, and compares this profile to a reference database of mass spectra from well characterized microorganisms. The system will computationally assess spectral similarity of the unknown and reference. Highly similar spectra are matched, allowing unknown organisms to be identified to the genus and species level. Additionally, some microorganisms may be further subtyped to strain-levels using this system. 4. The statutory authority permitting other than full and open competition. 41 U.S.C. 3304(a)(5), as implemented by FAR 6.302-5, titled "Authorized or required by statute." Sole source awards under the Veterans Benefits Act of 2003 ( 15 U.S.C.657f) 5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority. Unique Features of Bruker’s MALDI-Biotyper Microorganism Identification System • Vertically integrated single-source provider for system components including MALDI TOF mass spectrometer, microorganism reference library, ongoing service support, and applications training and support. • Open platform for integration into clinical/ veterinary microbiology laboratory workflows where multiple systems are used for antibiotic susceptibility testing, blood culture analysis, robotic automation, LIS reporting etc. • Available solution for direct analysis of positive blood cultures. STAT Test Capability. Mass Spectrometer Features • Self-contained bench-top linear MALDI TOF mass spectrometer with a footprint not to exceed 20.1 X 26.8 X 43 in and weight not to exceed 185 lbs. • Powered by a single standard US 110 VAC power cord. • Self-cleaning ion source via automated software-controlled IR laser heating without breaking vacuum and complete in about 15 minutes (to reduce maintenance and service requirements). • Gridles ion source for superior ion transfer into the analyzer region. • 60 Hz nitrogen cartridge laser directed to target via fiber optic cable (to reduce maintenance and service requirements). Includes variable power attenuator and UV optics. • Oil-free diaphragm roughing pump (for ultra-quiet operation and reduced maintenance and service requirements). • Patented PANtm technology for high mass resolution over a wide mass range, which minimizes required flight tube length. • Single computer for instrument control, data acquisition, data analysis and reporting. • Potential to integrate additional tablet PCs for high-volume workflows. • Multiple MALDI target plate options including reusable stainless steel 48 and 96 spot or disposable 96 spot configurations. • Fast (~2 minutes) target loading and removal from instrument (improves overall time-to-result). • Minimal heat output (1364 BTU/Hr.) avoiding installation of special venting • Calibration and QC performed on every run (BTS) Biotyper RUO Library Features • RUO Microorganism library with more than 7,800 entries, 2,609 species and 483 genera • Library generated using a single MALDI matrix (HCCA) • Continuously growing library including one RUO update each year. • Library containing isolates of clinical, veterinary, food and environmental origin (RUO) • Open library so that user can add organisms that are not yet represented in the commercial Bruker library. • Additional Fungi and Mycobacteria libraries available for full coverage of microorganisms (RUO) • Additional Security library available that includes bioterrorism organisms (RUO) • Subtyping Module available for resistance detection in S. aureus, B. fragilis, and K. pneumoniae, L. monocytogenes confirmation and M. chimaera/M. intracellular differentiation. (RUO) Biotyper Accessory Hardware and Software • Accessory instrument available for performing quality-controlled, automated deposition of the MALDI matrix onto the target plate with seamless integration into the system – Bruker GALAXY • Accessory instrument available for light-guided manual target preparation using projection to indicate the next position for preparation on the MALDI target with a complete, barcoded and paperless workflow – Bruker PILOT. • The only system in the market that is compatible with BioMerieux Vitek-II , Beckman Microscan and BD Phoenix Additional Specifications Unique to Biotyper CA (FDA cleared) instrument • FDA clearance of 488 microorganisms covering 597 species for FDA instrument • FDA claim data – overall accuracy 99.78% to genus and 98.19% to species/complex level, misidentifications 0.13% genus and 1.72% species level • One computer includes FDA Cleared and RUO libraries at no additional charge for FDA instrument 6 . A description of efforts made to ensure offers are solicited from as many potential sources as is practicable. N/A. The MALDI BioTyper Sirius CA is the only instrument with the above features.No response from other small business who are authorized to sell/install this equipment/system other than Branch Medical. 7. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted. N/A. The MALDI BioTyper Sirius CA is the only instrument with the above features 8. Any other facts supporting the use of other than full and open competition. N/A 9. A listing of the sources, if any, that expressed a written interest in the acquisition. Bruker - large business Branch Medical - SDVOSB 10. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated. As a commercial item with an exclusive patent license there are no barriers to competition to overcome --------- This is NOT a request for quotes or proposals.The determination not to compete this proposed contract action is solely within the discretion of the Government. Information received will normally be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice. Questions or comments to this Notice of Intent should be directed to Contracting Officer, Kim Yen Tu, at [email protected] via e-mail only (no phone calls/voice mail messages regarding questions will not be accepted and will not receive a response).