6640--Brand Name or Equal Molecular Diagnostic Systems

Description

{"description":"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).  \nThe 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. \nNCO 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:\n\nThe 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.\nSubmissions 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.\nThis 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.\nAdditionally, 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.\n1. \nIdentify your organization's socio-economic category. \n2. \nIdentify 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.  \n3. \nFill 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.\n4. \nState 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.). \n5. \nAddress 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)). \n6. \nState if subcontracting is contemplated for this requirement and what percentage of the requirement will be subcontracted and for what tasks. \nRFO Clause 52.219-14 Limitations on Subcontracting may apply to this procurement.\nVAAR 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)\nVAAR 852.219-73 VA Notice of Total Set-Aside for Certified Service-Disabled Veteran-Owned Small Businesses may apply to this procurement if applicable.\nVAAR 852.219-74 VA Notice of Total Set-Aside for Certified Veteran-Owned Small Businesses may apply to this procurement if applicable.\n7. \nProvide estimated shipping and delivery information for the requested supplies (e.g. Expected lead time on delivery). \n\n*If applicable, VAAR 852.212-71 Gray Market Items, will apply to the potential solicitation.* \nIdentify 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). \nSTATEMENT OF WORK - Functional/Performance/Specification (Brand Name or Equal)\n\nPurpose. 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.\n\nScope. 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.\n\nRequirements.\na. The following Brand Name or Equal equipment is required at the location specified. \nEquipment\nBrand Name or Equal\nModules Required\nQuantity\nLocation\nMolecular Diagnostic System\nCepheid (GXIV-4-TSK) \n4\n2 Each\nMOPC and CCSC\nMolecular Diagnostic System\nCepheid (GXXVI-16-D-10C) \n16\n1 Each\nHCC\nMolecular Diagnostic System\nCepheid (GXIV-4-CLIA) \n4\n1 Each\nLOPC\nPrinter\nCompatible with Instruments\nN/A\n4 Each\nMOPC, CCSC, HCC, LOPC\nUninterruptible Power Supply\nCompatible with Instruments\nN/A\n4 Each\nMOPC, CCSC, HCC, LOPC\n\nAnalyzer capability and performance. The systems offered under this contract shall comply with all general requirements stated herein:\nFDA-cleared and approved at the time of contract award.\nTouchscreen, single, compact instrument that can run up to four tests at one time. \nFully automated sample extraction, PCR amplification, and detection\nSelf-contained cartridge\nBi-directional interface with laboratory information system (LIS) and point-of-care\ndata managers\nSystem monitoring, reporting, and remote IT troubleshooting\nBuilt-in barcode scanner and full-size touchscreen\nTest menu must include CoV-2/Flu/RSV\nMust be capable of printing/displaying calibration verification and all internal QC.\nFast, accurate PCR amplification\nTest results are available within 1 hour\nThe system should have technology to prevent sample carryover.\nThe system must include closed cartridge technology.\nConnectivity Requirements: (Note: Does not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XP.)\nSystem 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.\n\nInstrument space, electrical and ambient requirements\nEach system must fit within general space dimensions of a minimum (Width x Depth\nx Height) Countertop: 21 W x 30 D x 36 H.\nPower requirements for each system: 100-240 VAC, 50-60 Hz.\nContractor provided Uninterruptible Power Supply (UPS) for each system.\nAll 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.\nThe contractor must provide all updates to the hardware covered under standard warranty, without additional cost to the Government.\n\nd. Testing Requirements\nFunctionality and performance specifications of FDA-approved sample-to-answer\npathogen testing panels using a single patient sample with test results in about one\nhour as described below:\nCOVID 19\nInfluenza\nRespiratory Syncytial Virus (RSV)\nStrep A Does not require confirmation testing \nGI Panel (Campylobacter, Salmonella, STEC stx1, STEC stx2, Shigella, V. cholera, V. parahaemolyticus, Yersinia, Cryptosporidium, Giardia, Norovirus.)\nChlamydia trachomatis/Neisseria gonorrhoeae\nMultiplex panel testing turn-around time of about one hour.\nReagent panel test kits can be stored at room temperature.\nReagent panel test kits contain all necessary reagents for sample prep, PCR,\ninternal controls, and detection.\nAssay panels require less than 3 minutes of hands-on time.\nAll assays contain all necessary internal controls.\nVerification Kits included for all panel assays and applicable test validations.\n\nServices. The Contractor shall \nDeliver, install, and set up the instrument and components. \nProvide all test validation guidance, validation supplies, and support for molecular testing. \nProvide technical support and guidance. \nProvide set up for interfaced result reporting, including LIS physical connection and translation (drivers), and any required (additional) interface connection license(s). \nProvide instrument repairs and scheduled preventive maintenance for the instrument and system components. \nProvide basic and advanced operator training.\n\nDelivery location/time of instruments.\nDelivery 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.\nDelivery and Installation Locations.\nHarlingen Care Center (HCC)\n2601 Veterans Drive \nHarlingen, Texas 78550\n\nMcAllen Outpatient Clinic (MOPC)\n9010 E Hackberry Ave. \nMcAllen, Texas 78501\n\nLaredo Outpatient Clinic (LOPC)\n4602 N. Bartlett Ave. \nLaredo, Texas 78041\n\nCorpus Christi Specialty Clinic (CCSC)\n205 S. Enterprize Parkway\nCorpus Christi, Texas 78405\n\nDelays of shipments must be communicated to COR and arrangements made for earliest shipment. Allocation schedule subject to change due to allocation procedures, if any.\nThe 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.\n\nWarranty. The Contractor shall provide a standard Commercial warranty. All services must be covered under the standard warranty at no extra charge to the Government. \nUnlimited Technical Support: Access to phone-based support.\nRemote Access Support: Technical assistance via remote connection for system diagnostics.\nInstrument Repair/Parts: Coverage for repairs, including all labor and parts.\nOnsite Response Time: A two (2) business day onsite response time by an authorized Customer Service Engineer.\nAnnual Check: One (1) annual onsite preventive maintenance check to include recalibration and quality inspections during the warranty period.\nInstrument Swap: Option for an instrument swap if necessary, at the discretion of Technical Support.\n\nTraining. The contractor shall provide the following:\nInitial on-site operator training for analyzers. \nHandouts 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.\nAdditional on-site training as requested by VATXVCBHCS at no additional charge. \n\nContractor 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. \nInformation 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.  \nPrivacy 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.\n\n(End of Statement of Work)\n\n"}