Wet Integrated Chemistry Analyzer

Closed Pre-Solicitation Posted

Solicitation number
HT940625Q0023
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Hampton, Virginia 23665, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Defense Health Agency (DHA) intends to award a sole source firm-fixed price Purchase Order to Roche Diagnostics Corporation for a wet integrated chemistry analyzer. The analyzer is designed to process multiple clinical testing capabilities, including clinical chemistry, immunochemistry, and ISE testing, with specific requirements for autocalibration and processing of quantitative tests such as Beta hCGs, metabolic panels, and troponin. The system must interface with the Genesis laboratory information management system (LIMS) and demonstrate high analytical sensitivity with capabilities for automated calibrations and processing of small sample volumes. The procurement is classified under the Analytical Laboratory Instrument Manufacturing NAICS category (334516) and Chemical Analysis Instruments PSC category (6630). The pre-solicitation notice was posted on February 4, 2025, with responses due by February 11, 2025.

The contract is not set aside for any specific type of business and will be a sole source award directly to Roche Diagnostics Corporation, who is identified as the only vendor capable of providing this specific integrated chemistry analyzer. The contract structure includes a base year and four additional option years, focusing on cost-per-test reagents for the chemistry analyzer. The system must meet rigorous performance standards, including sufficient peer data for validation, verification checks, and continuous regulatory compliance. Roche Diagnostics will provide analyzers with integrated wet chemistry systems, deionized water, drainage systems, and the ability to process multiple stat samples efficiently. The procurement represents a targeted solution for advanced medical diagnostic testing equipment within the Defense Health Agency's laboratory infrastructure.

Notice text

The Defense Health Agency (DHA) intends to award a sole source firm-fixed price Purchase Order (PO) contract with a base year and four (4) option years for cost-per-test reagents chemistry analyzer to Roche Diagnostics Corporation for wet integrated chemistry analyzer.

Roche Diagnostics Corporation is the only vendor able to provide a wet integrated (combines clinical chemistry, immunochemistry, and ISE testing) chemistry analyzer. The analyzer has autocalibration capabilities and is capable of processing quantitative Beta hCGs, basic/comprehensive metabolic panel, and troponin in a timely manner.  The analyzers shall have an integrated wet chemistry system, deionized water, and a drainage system. Analyzers shall have sufficient peer data to support validation and verification check and to ensure acceptable scores for continuous regulatory compliance.  Analyzers shall have high analytical sensitivity, be capable of processing multiple stat samples, and process small sample volumes.  The analyzers shall interface with the laboratory Genesis laboratory information management system (LIMS).  Analyzers shall perform automated calibrations and include a water system.  Analyzers shall process cardiac assays, basic metabolic panels, and HCG <15 minutes.  The analyzers shall use 2-point calibrations for immunochemistry.  System shall include lab workstation for monitoring QC, calibrations issues, test menu, downtimes, testing volumes, maintenance, and patient reporting.  The system shall have at least a 6-month onboard stability for immunochemistry reagents and at least 4-month onboard stability for chemistry reagents.  Instrument must have QC lockout, which prevents samples from processing if there are QC failures.  Analyzers shall be stationary and in within a space of:  Height 5.8 ft, Depth 2.6 ft, and Width 8.04ft.  The equipment requires single phase AC 200/208/220/230/240 V 50/60 Hz and a compatible uninterruptible power supply.

This contract action is for supplies for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services. The period of performance is with a base period of 12 February 2025 –11 February 2026 and four option years from 12 February 2026 – 11 February 2030.  

The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. The vendor shall be required to provide documentation from the manufacturer stating the vendor is an authorized service provider on the required equipment/system. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

This Notice of Intent is neither a formal solicitation, nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made based on unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the Government. The intent of this notice is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government to not compete this action based on this notice is solely within the discretion of the Government. All inquiries and concerns must be addressed in writing via email to Gillian Dell at gillian.j.dell.civ@health.mil with the following information referenced in the subject line, HT940625Q0023– wet integrated chemistry analyzer.  All interested parties who are responsible, certified, and capable may identify their interest and may submit a capabilities statement no later than 10:00AM Eastern Time (EST) 11 February 2025 gillian.j.dell.civ@health.mil. The interested parties bear full responsibility to ensure complete transmission and timely receipt.

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