6515--LIAISON XL ANALYZER

are System (PVAHCS), requires the purchase of a Diasorin, Liaison XL analyzer. This requirement is for a one-time purchase for one (1) instrument for testing purposes only. There is a new separate services contract being implemented VISN wide that will cover the required QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing. This equipment must be able to use the supplies as-is from the OEM without modification. This will allow the PVAHCS test for TB on site and not have to send samples to a reference lab. This will provide a faster response time for continued veteran healthcare services. (See Attachment A - Statement of Work (SOW) herein for further details). Diasorin, Inc., is the only known source that is capable of providing the necessary equipment/instrument fully compatible with QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. The North American Industry Classification System (NAICS) for this requirement is, 334516 Analytical Laboratory Instrument Manufacturing. Product/Service Code for this requirement is 6515 medical and surgical instruments, equipment, and supplies. The Small Business Administration (SBA) size standard for this sector is 1,000 employees. 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 on the basis of 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 synopsis 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 not to 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 e-mail to Marcos Diaz at Marcos.Diaz@va.gov with the following information referenced in the subject line, 36C26225Q1188 Liaison XL Analyzer. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 7:00 AM Pacific Time (PT) on July 21, 2025 to Marcos Diaz at Marcos.Diaz@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt. SDVOSB/VOSB respondents. If respondent is or SDVOSB or VOSB, respondent is encouraged to provide proof of https://veterans.certify.sba.gov certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR clause 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Further SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause. Please provide the information below: Company Name: UEI Number: Address: Point of Contact Name: Phone No: Email: Business size information Select all that applies: o Small Business o Emerging Small Business o Small Disadvantaged Business o Certified under Section 8(a) of the Small Business Act o HubZone o Woman Owned o Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov) o Veteran Owned Small Business (registered in VetBiz.gov) FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date NASA SEWP Contract Holder Yes No NASA SEWP Contract Number Effective Date / Expiration Date STATEMENT OF WORK DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined within this statement of work. The instrument will be able to simultaneously perform the complete profile as described below and 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). Equipment shall maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, Phoenix VAMC technical evaluation panel will determine if instrumentation proposed meets needs of using facility. DEFINITIONS: Capital Equipment Purchase: Capital purchases, also known as capital expenditure or capex, are used to make a substantial investment in long-term fixed assets. This can include purchasing machinery and equipment, land, buildings or other infrastructure, and furniture and fixtures. For the purposes of this acquisition, the Liaison XL Analyzer is Capital Equipment. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of protected health information (PHI), or that provides certain services involving the disclosure of PHI. VHA is a covered entity under the HIPAA Privacy Rule. HIPAA regulations require VHA to execute HIPAA- compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Parameter definitions High throughput immunoassay analyzer SALIENT CHARACTERISTICS AND GENERAL REQUIREMENTS TEST MENU: The capability of performing QuantiFERON Gold Plus (QFT-G) Tuberculosis (TB) testing QFT testing is FDA Cleared with the following characteristics: Primary screening Sample specimens Interferon gamma release assay (IGRA) General Requirements: Technical Features - The instrumentation shall be approved by the Food and Drug Administration (FDA) and shall have the following: Due to limited space, instrument dimensions must fit within the following: Footprint less than or equal to: 60 x 80 x 48 (W x H x D), dimensions in inches. Ability to monitor instrument performance. On board reagent inventory system. The vendor shall have the capability to provide limited carryover or disposable tips. Ready to use reagents allow Medical Laboratory Technicians in the operation and testing instead of Medical Technologists which helps relieve the impact on staffing. Ability to load sufficient reagents to complete a run, with the ability to load/add reagents while the instrument is running. On board reagent stability sufficient to accommodate both high volume (>100 per shift) and low volume (1 sample plus required controls per 24-hour period). Reagen