6640--Brand Name or Equal Molecular Diagnostic Systems

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. You may access the website at SAM.gov | Home. 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. 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 (to include your organization's Unique Entity Identifier number) with a description of proof of capability to kathryn.prose@va.gov. 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. This is a sources-sought looking for businesses to provide the supplies listed below for market research purposes. 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. It is emphasized that this is a notice solely for planning and informational purposes. Additionally, 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. 1.  Identify your organization's socio-economic category.  2.  Identify if your organization is the manufacturer of the requested supplies. If you are not the manufacturer, identify the manufacturer of the supplies that you will provide, their socio-economic category and a letter showing that your organization is an authorized distributor for the requested supplies.   3.  Fill out the certificate under RFO Provision 52.225-6, Trade Agreement Certificate, identifying the item and its country of origin. (https://www.acquisition.gov/far/part-52#FAR_52_225_6). A description of designated countries can be found at RFO Clause 52.225-5, Trade Agreement (https://www.acquisition.gov/far/part-52#FAR_52_225_5) If the product is a US domestic end product, write in USA for the item's country of origin. The certificate must be completed for each proposed line item. 4.  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.).  5.  Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)).  6.  State if subcontracting is contemplated for this requirement and what percentage of the requirement will be subcontracted and for what tasks.  RFO Clause 52.219-14 Limitations on Subcontracting may apply to this procurement. VAAR 852.219-76 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to the potential solicitation if set-aside, if applicable. Veterans Affairs Acquisition Regulation (VAAR) VAAR 852.219-73 VA Notice of Total Set-Aside for Certified Service-Disabled Veteran-Owned Small Businesses may apply to this procurement if applicable. VAAR 852.219-74 VA Notice of Total Set-Aside for Certified Veteran-Owned Small Businesses may apply to this procurement if applicable. 7.  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 (https://www.acquisition.gov/far/part-52#FAR_52_225_2__d3401e52).  STATEMENT OF WORK - Functional/Performance/Specification (Brand Name or Equal)
Purpose. The Texas Valley Coastal Bend Healthcare System (TXVCBHCS) has a requirement for four (4) Molecular Diagnostics Testing Systems for molecular testing. These instruments are required for four (4) Pathology & Laboratory Medicine Service (P&LMS) locations to include Harlingen Care Center (HCC), McAllen Outpatient Clinic (MOPC), Corpus Christie Specialty Clinic (CCSC) and 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). The systems shall use 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. a. The following Brand Name or Equal equipment is required at the location specified. 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. The systems offered under this contract shall comply with all general requirements stated herein: 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 Must be capable of printing/displaying calibration verification and all internal QC. Fast, accurate PCR amplification Test results are available within 1 hour The system should have technology to prevent sample carryover. The system must include closed cartridge technology. Connectivity Requirements: (Note: Does not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XP.) System is fully interfaced with VistA via Data Innovations: System accommodates automated (interfaced) reporting through Data Innovations (DI) to eliminate the need for manual interpretation and manual data entry.
Instrument space, electrical and ambient requirements Each system must fit within general space dimensions of a minimum (Width x Depth x Height) Countertop: 21 W x 30 D x 36 H. Power requirements for each system: 100-240 VAC, 50-60 Hz. Contractor provided Uninterruptible Power Supply (UPS) for each system. All models shall perform satisfactorily at recommended laboratory temperature between 59 to 89 degrees F (15 to 32 degrees Celsius) and recommended laboratory relative humidity of less than 80% without condensation. The contractor must provide all updates to the hardware covered under standard warranty, without additional cost to the Government.
d. 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 as described below: 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 Multiplex panel testing turn-around time of about one hour. Reagent panel test kits can be stored at room temperature. Reagent panel test 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 all necessary internal controls. Verification Kits included for all panel assays and applicable test validations.
Services. The Contractor shall 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. Provide set up for interfaced result reporting, including LIS physical connection and translation (drivers), and any required (additional) interface connection license(s). Provide instrument repairs and scheduled preventive maintenance for the instrument and system components. Provide basic and advanced operator training.
Delivery location/time of instruments. Delivery of new analyzers, including, duplex housing, modules, and hardware accessories will be delivered to each location (Monday-Friday (M-F), excluding Weekends and Holidays during regular business hours from 0730-1600 within ten (10) business days after receipt of the award. Delivery and Installation Locations. Harlingen Care Center (HCC) 2601 Veterans Drive Harlingen, 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 Parkway Corpus Christi, Texas 78405
Delays of shipments must be communicated to 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 affects the performance of the equipment covered under the standard warranty, without additional charge to the government.
Warranty. The Contractor shall provide a standard Commercial warranty. All services must be covered under the standard warranty at no extra charge to the Government. Unlimited Technical Support: Access to phone-based support. Remote Access Support: Technical assistance via remote connection for system diagnostics. Instrument Repair/Parts: Coverage for repairs, including all labor and parts. Onsite Response Time: A two (2) business day onsite response time by an authorized Customer Service Engineer. Annual Check: One (1) annual onsite preventive maintenance check to include recalibration and quality inspections during the warranty period. Instrument Swap: Option for an instrument swap if necessary, at the discretion of Technical Support.
Training. The contractor shall provide the following: Initial on-site operator training for analyzers. Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required), and editable procedures at no additional cost. Additional on-site training as requested by VATXVCBHCS at no additional charge.
Contractor Security Contract Requirements: This Contractor requires no access to VATXVCBHCS or any VA information system. The analyzer will be interfaced to the VATXVCBHCS information system through Data Innovations. There will be supervised access when the Contractor is physically present for technical support, service calls, and scheduled preventative maintenance. Information Systems Officer, Information Protection. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.   Privacy Officer. The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.   All research data available for Contractor analyses is de-identified.
(End of Statement of Work)