36C26026Q0635.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

POINT OF CONTACT*

Contract Specialist Nick Heintz Nicholas.Heintz@va.gov

PLACE OF PERFORMANCE

1660 S Columbian Way

Seattle, WA 98108

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Responses to this Sources Sought Announcement must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential businesses interested and capable of providing the services described below.

Background:

The Puget Sound VA Medical Center, located in Seattle, WA is seeking a contractor to provide a MALDI (Matrix-Assisted Laser Desorption Ionization) Mass Spectrometry (Microbial Identification System). The contractor shall provide an FDA-approved automated testing system that identifies microorganisms using Matrix Assisted Laser Desorption Ionization Mass. The testing system must include the instrumentation necessary to identify common microorganisms encountered in clinically relevant patient samples through analyses of protein fingerprint spectra from Gram negative and Gram positive bacteria, yeast and fungi from any patient specimen source suspected of bacterial or fungal infection. The testing system must be able to meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). (See Salient Characteristics Below) The System shall include the following application/product features:

· MALDI Biotyper sirius CA System

· MBT Compass HT

· MBT HT Filamentous Fungi Module

· MBT Filamentous Fung Library Extension

· MBT HT Sepsityper Module

· MBT Sepsityper Kit US IVD

Salient Characteristics Essential/significant physical, functional, or performance characteristics.

• The MALDI Biotyper CA System identifies microorganisms using MALDI-TOF (Matrix- Assisted Laser Desorption/Ionization Time-of-Flight) mass spectrometry to measure a unique proteomic fingerprint of an organism. The characteristic patterns of these highly abundant proteins give the unique fingerprint of an organism and are used reliably and accurately to identify a particular microorganism by matching the respective pattern with an extensive FDA-cleared reference library.

• The MALDI Biotyper CA FDA-cleared reference library should include at least 488 microbial species including 199 gram-positives, 248 gram-negatives, and 41 yeasts, and including Candida auris.

• Also available is a non-clinically validated/research-use only library that covers approximately 2,200 reference strains of bacteria and yeast that have not been clinically validated and are validated locally.

• The FDA-cleared MBT Sepsityper® Kit US IVD is used in conjunction with the Bruker MALDI Biotyper CA System, allowing highly confident species level identification (ID) direct from positive blood culture. A rapid, accurate and cost-effective micro-organism ID becomes available within 15-20 minutes after the blood culture alerts positive and requires only 10 minutes of hands-on time to prepare the sample. When compared to traditional methods, ID results can be reported up to 48 hours earlier to critical care providers. This system must also be compatible with use of the non-clinically validated/research-use only library.

• Due to having a robust Mycology department, available modules must include Filamentous Fungi and Fungi Library Extension allowing for at least 220 different species, including Coccidioides which is prevalent in our patient population and can be performed using solid or liquid media for identification workup.

• Option to expand our testing should also include libraries for Mycobacteria, Strain typing and rapid assessment of Beta-lactamase activity in bacterial isolates. Also, machine-learning of new organisms to build an in-house database must be available to the client.

• The instrument should be a light (75kg or less) benchtop solution for seamless installation and maintenance in the laboratory. Integrated pumping system including vacuum measurement and control unit: 70 L/sec turbomolecular pump including diaphragm-pump rather than mechanical pump so that oil-changes are not required.

• Instrument must run off standard 110V power outlets to avoid costly lab renovations that might result from adding high current 220V outlet and dissipate no more than 400 Watts (1364 BTU/hr).

• The laser should have an extensive lifetime of use of 500 million laser shots or seven years to prevent replacement down-time.

• The instrument should operate quietly in a laboratory environment at < 50 db and should perform within a broad operating temperature and humidity range of 16 – 30°C and 20 – 75%, non-condensing.

• Time between plate loading and data acquisition must be less than 4 minutes to increase throughput and reduce instrument idling time and performance of instrument should enable fast analysis producing a final organism identification of up to 600 samples per hour using either reusable-target or disposable-target options to allow for a flexible, optimized workflow and reduce operational costs.

• The instrument should have Self-Cleaning Ion Source Laser to reduce downtime and extend intervals between service calls and Gridless ion source with integrated and automated source cleaning via IR laser to maximize instrument up-time.

• Slides utilized by the system(s) must have at least 45 target spots per run. The system(s) shall have the capabilities to perform identification of a single organism during a run in less than 2 minutes. The system(s) take no more than 15 minutes time from loading a slide to starting identification (vacuum adjustment time).

Manufacturer name – Bruker Scientific, LLC Complete generic identification – Bruker Biotyper Sirius CA System MBT Compass HT MBT HT Filamentous Fungi Module MBT Filamentous Fungi Library Extension MBT HT Sepsityper Module MBT Sepsityper Kit US IVD

UPS POWERVAR ABCE602-11 120VAC

Applicable model/make/catalog number – 1890132 1890605 1889531 1901194 1889528 1867565 8605553

If you are interested and capable of providing the required or comparable product(s) please provide the following information:

Company:

Contact Name:

Phone No:

Email:

UEI:

Business size information

Select all that applies:

☐ Small Business ☐ Emerging Small Business ☐ Small Disadvantaged Business ☐ Certified under Section 8(a) of the Small Business Act ☐ HubZone ☐ Woman Owned ☐ Certified Service-Disabled Veteran Owned Small in Vetbiz.gov ☐ Certified Veteran Owned Small Business in Vetbiz.gov ☐ Large Business ☐ Other:____________

FSS/ GSA Contract Number that would be used for this contract.

Effective Date / Expiration Date

List:

Brand Name and Model Number you would provide to meet the requirement.

General pricing for your products/solutions for market research purposes.

Manufactured Country of Origin

The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this Sources Sought Announcement. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service Disabled Veteran Owned Small Businesses. However, if there are insufficient Service Disabled Veteran Owned Small Business responses, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 334516.

After review of the responses to this Sources Sought Announcement, a solicitation may be published on the sam.gov or GSA eBuy websites. Responses to this Sources Sought Announcement will not be considered adequate responses to the solicitation. All interested offerors must respond to the solicitation in addition to responding to this Sources Sought Announcement. Prospective bidders must be authorized re-sellers in order to participate in the solicitation process.

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov. Additionally, all Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses must be listed as SDVOSB under NAICS code 334516 listed in the Small Business administration (SBA) (Dynamic Small Business Search)

Responses to this notice shall be submitted via email to Nicholas.Heintz@VA.gov Subject Line: MALDI Biotyper. Telephone responses will not be accepted. Responses must be received no later than 05/13/2026 1000 PST.

Sources Sought Notice

Sources Sought Notice