SAM #36C25726Q0421

VA Seeks Molecular Diagnostic Testing Systems (Cepheid GeneXpert or Equal) for Texas Facilities

The Department of Veterans Affairs, Network Contracting Office 17, is seeking to procure four (4) Molecular Diagnostic Testing Systems and accessories for the Texas Valley Coastal Bend Healthcare System. - Government Buyer: - Department of Veterans Affairs, Network Contracting Office 17, Texas Valley Coastal Bend Healthcare System - OEMs and Vendors: - Cepheid (referenced as the brand name standard for the GeneXpert Express System) - Products/Services Requested: - Four molecular diagnostic systems, brand name or equal to Cepheid GeneXpert Express System - 2 units (4-module, part number GXIV-4-TSK) for McAllen Outpatient Clinic and Corpus Christi Specialty Clinic - 1 unit (16-module, part number GXXVI-16-D-10C) for Harlingen Care Center - 1 unit (4-module, part number GXIV-4-CLIA) for Laredo Outpatient Clinic - 4 compatible printers (one per facility) - 4 uninterruptible power supplies (UPS, one per facility) - Delivery, installation, and setup at each facility - Technical support, test validation guidance, interfaced result reporting, instrument repairs, preventive maintenance, and operator training - Unique or Notable Requirements: - Equipment must be FDA-cleared and utilize PCR techniques - Full interfacing with VistA via Data Innovations is required - Warranty coverage, annual preventive maintenance, and unlimited technical support - Operator training (initial and as requested) - Compliance with VA security and privacy protocols - Delivery and installation required at four VA healthcare facilities in Texas (Harlingen, McAllen, Laredo, Corpus Christi)

Description

Veterans Affairs North Health Care System Molecular Diagnostic Testing Systems Procurement The Veterans Affairs North Health Care System requires four (4) Brand Name or Equal Molecular Diagnostic Testing Systems and accessories with the salient characteristics listed below in the Statement of Work (SOW). The Department of Veterans Affairs, Network Contracting Office (NCO) 17, on behalf of VA Valley Coastal Bend Healthcare System, is issuing this Sources Sought Notice in accordance with RFO 10.001 to determine the availability and technical capabilities of qualified sources. NCO 17 is seeking a qualified source to provide brand name or equal to the Cepheid GeneXpert Express System. NCO 17 intends to award a Firm-Fixed Price (FFP) contract to a supplier of this equipment. Equipment includes: The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing, Small Business Standard Size 1,000 Employees; Product Service Code: 6640 Laboratory Equipment and Supplies. The RFO Provision found at 52.204-7 requires that all interested Offerors must be registered in SAM.gov prior to submitting an offer or quotation. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://certifications.sba.gov/ at the time of proposal submission. Submission Deadline: Submissions for this source sought shall be submitted by email no later than April 15, 2026, at 1:00 pm EST. If you are a vendor that can provide the requested information and required supplies described below with competitive pricing, send your information (including your organization's Unique Entity Identifier number) with a description of proof of capability to kathryn.prose@va.gov. Note: This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. No awards for a contract will be made from this announcement. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. Questions for Respondents Please provide answers as appropriate to the following questions in the table below with your response to this sources-sought. Failure to respond to the following questions may affect the acquisition strategy. Identify your organization's socio-economic category. Identify if your organization is the manufacturer of the requested supplies. If not, identify the manufacturer, their socio-economic category, and provide a letter showing your organization is an authorized distributor. Complete the certificate under RFO Provision 52.225-6, Trade Agreement Certificate, identifying the item and its country of origin. If the product is a US domestic end product, write "USA" for the item's country of origin. The certificate must be completed for each proposed line item. State whether any of the requested supplies may be ordered against a government contract awarded to your organization (e.g., Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii), and (b)(1)(iii). See here. State if subcontracting is contemplated for this requirement, the percentage subcontracted, and the tasks involved. RFO Clause 52.219-14 Limitations on Subcontracting may apply. Provide estimated shipping and delivery information for the requested supplies (e.g., expected lead time on delivery). If applicable, VAAR 852.212-71 Gray Market Items will apply to the potential solicitation. Identify whether any foreign end products, as defined in FAR Provision 52.225-2, would be provided to meet this requirement. See here. Statement of Work - Functional/Performance/Specification (Brand Name or Equal) Purpose The Texas Valley Coastal Bend Healthcare System (TXVCBHCS) requires four (4) Molecular Diagnostics Testing Systems for molecular testing at four (4) Pathology & Laboratory Medicine Service (P&LMS) locations: Harlingen Care Center (HCC) McAllen Outpatient Clinic (MOPC) Corpus Christi Specialty Clinic (CCSC) Laredo Outpatient Clinic (LOPC) The molecular analyzers shall include all system software, UPS, monitor, scanner, printer, technical support, customer training, and a business hours service plan. Scope The Molecular Diagnostics Testing Systems shall identify pathogens by detecting their unique genetic material (DNA or RNA) using Polymerase Chain Reaction (PCR) techniques. The equipment should meet or exceed the specifications below for brand name or equivalent to the Cepheid GeneXpert Express System. Requirements Equipment Brand Name or Equal Modules Required Quantity Location Molecular Diagnostic System Cepheid (GXIV-4-TSK) 4 2 Each MOPC and CCSC Molecular Diagnostic System Cepheid (GXXVI-16-D-10C) 16 1 Each HCC Molecular Diagnostic System Cepheid (GXIV-4-CLIA) 4 1 Each LOPC Printer Compatible with Instruments N/A 4 Each MOPC, CCSC, HCC, LOPC Uninterruptible Power Supply Compatible with Instruments N/A 4 Each MOPC, CCSC, HCC, LOPC Analyzer Capability and Performance FDA-cleared and approved at the time of contract award. Touchscreen, single, compact instrument that can run up to four tests at one time. Fully automated sample extraction, PCR amplification, and detection. Self-contained cartridge. Bi-directional interface with laboratory information system (LIS) and point-of-care data managers. System monitoring, reporting, and remote IT troubleshooting. Built-in barcode scanner and full-size touchscreen. Test menu must include CoV-2/Flu/RSV. Capable of printing/displaying calibration verification and all internal QC. Fast, accurate PCR amplification with test results available within 1 hour. Technology to prevent sample carryover. Closed cartridge technology. Connectivity Requirements: Fully interfaced with VistA via Data Innovations; accommodates automated reporting to eliminate manual data entry. Does not use Windows XP Embedded SP3, Windows Server 2003, or Windows XP. Instrument Space, Electrical and Ambient Requirements Dimensions (Width x Depth x Height): Countertop minimum 21" W x 30" D x 36" H. Power requirements: 100-240 VAC, 50-60 Hz. Contractor provided Uninterruptible Power Supply (UPS) for each system. Performance at laboratory temperature 59 to 89 °F (15 to 32 °C) and relative humidity less than 80% without condensation. Contractor must provide all hardware updates covered under standard warranty at no additional cost. Testing Requirements Functionality and performance specifications of FDA-approved sample-to-answer pathogen testing panels using a single patient sample with test results in about one hour: COVID-19 Influenza Respiratory Syncytial Virus (RSV) Strep A (does not require confirmation testing) GI Panel (Campylobacter, Salmonella, STEC stx1, STEC stx2, Shigella, V. cholera, V. parahaemolyticus, Yersinia, Cryptosporidium, Giardia, Norovirus) Chlamydia trachomatis/Neisseria gonorrhoeae Additional details: Multiplex panel testing turnaround time of about one hour. Reagent panel test kits stored at room temperature. Reagent kits contain all necessary reagents for sample prep, PCR, internal controls, and detection. Assay panels require less than 3 minutes of hands-on time. All assays contain necessary internal controls. Verification kits included for all panel assays and applicable test validations. Services Deliver, install, and set up the instrument and components. Provide all test validation guidance, validation supplies, and support for molecular testing. Provide technical support and guidance. Set up interfaced result reporting, including LIS physical connection and translation (drivers), and any required interface connection licenses. Provide instrument repairs and scheduled preventive maintenance. Provide basic and advanced operator training. Delivery Location and Time Delivery of new analyzers, including duplex housing, modules, and hardware accessories, will be delivered to each location Monday through Friday (excluding weekends and holidays) during regular business hours (07:30-16:00) within ten (10) business days after receipt of the award. Delivery and Installation Locations Harlingen Care Center (HCC)2601 Veterans DriveHarlingen, Texas 78550 McAllen Outpatient Clinic (MOPC)9010 E Hackberry Ave.McAllen, Texas 78501 Laredo Outpatient Clinic (LOPC)4602 N. Bartlett Ave.Laredo, Texas 78041 Corpus Christi Specialty Clinic (CCSC)205 S. Enterprize ParkwayCorpus Christi, Texas 78405 Delays of shipments must be communicated to the Contracting Officer Representative (COR) and arrangements made for earliest shipment. Allocation schedule subject to change due to allocation procedures, if any. The contractor must provide all operational updates to the equipment's hardware and operating system software that materially affect performance under the standard warranty at no additional charge. Warranty Standard Commercial warranty covering all services at no extra charge. Unlimited phone-based technical support. Remote access support for system diagnostics. Instrument repair and parts coverage including labor. Two (2) business day onsite response time by authorized Customer Service Engineer. One (1) annual onsite preventive maintenance check including recalibration and quality inspections during warranty period. Option for instrument swap if necessary, at discretion of Technical Support. Training Initial on-site operator training for analyzers. Provision of handouts and training materials in sufficient quantity for each participant. Off-the-shelf courses with lesson plans, course materials, media (DVDs, CDs, videos, etc.), and editable procedures at no additional cost. Additional on-site training as requested by VATXVCBHCS at no additional charge. Contractor Security Contract Requirements No access to VATXVCBHCS or any VA information system. Analyzer interfaced to VATXVCBHCS information system through Data Innovations. Supervised access when physically present for technical support, service calls, and scheduled preventive maintenance. No access to VA Desktop computers or online government resources during services. If equipment removal is required, memory storage devices (hard drives, solid state drives, non-volatile memory units) remain in VA control and custody. No access to protected Patient Health Information (PHI) or capability to access patient information during services. All research data available for Contractor analyses is de-identified. (End of Statement of Work)

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