6515--691 ULTRASONIC CARDIAC SCANNING SYSTEMS

Page 5 of 5 Page 1 of 2 SOURCES SOUGHT SYNOPSIS ONLY This request for information (RFI) and sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI in accordance with FAR 15.201(e). The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources, their socioeconomic status, and their size classification relative to NAICS 334516 Analytical Laboratory Instrument Manufacturing size standard of 1000 employees. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. This synopsis is neither a request for competitive proposal nor a solicitation of offers. This synopsis is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from responses to this RFI and sources sought. The Department of Veterans Affairs Veterans Integrated Service Network (VISN) 22 is seeking potential sources capable of supplying, delivering, and installing The Optis Mobile Next System from Abbot Laboratories Inc or Equivalent. This system will be used in the Catheterization Lab, which is part of Cardiology and within Medical Service at the VA Greater Los Angeles. The proposed action is for a firm-fixed price, one-year contract. The Government contemplates issuing one (1) solicitation for these supplies to be provided to the following facilities: VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073 Contractor shall provide the following information: Vendor: Address: Telephone Number: Business Size: Socioeconomic Category (i.e. SDVOSB, 8a, VOSB, etc.): UEI Number: FSS/ GSA Contract Holder Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Responses to this sources sought are not request to be added to a prospective bidders list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for cost incurred in the preparation and submission of information or any other cost incurred as a response to this announcement. Inquiries will only be accepted in writing via email to contact@example.gov telephone responses shall not be accepted. Please respond by July 16, 2025 at 9:00am PT. Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR § 121.406, September 4, 2019 applies to this acquisition. a) For small business set-asides other than construction or service contracts the prime contractor that s supplying products to the government is required to cover at least 50 percent of the cost of manufacturing those products. The non-manufacturer rule is an exception to that requirement. The rule allows a small business to supply products it did not manufacture as long as those products come from another small business. b) A manufacturer is defined as a business that, with its own facilities, performs primary activities in transforming inorganic or organic substances, including the assembly of parts and components, into the end product being acquired. In other words, a manufacturer makes or produces products. Businesses may qualify as a non-manufacturer if it meets the following criteria: Does not exceed 500 employees Is primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied Will supply the end products of a small business manufacturer or processor made in the United States, or obtains a waiver of such requirement See Title 13 Part 121.406 of the Code of Federal Regulations (CFR) for detailed information about the non-manufacturer rule. The Following below is a description of the Salient Characteristics for the Supplies Needed For This Requirement: The Optis Mobile Next System or Equal Salient Characteristics: OPTIS Mobile Next system includes imaging engine; high-performance data acquisition and image processing PC; application software; Mobile drive-motor and optical controller (DOC); keyboard or mouse click control of system; two monitors (17 and 19 ); additional outputs for external video monitor viewing; and angiography connection to enable angio co-registration. Ultreon 1.0 Software: RFR, FFR, Physiology Pullback, OCT: automaticmeasurements (diameter, length, expansion, apposition), angiography co-registration with OCT image, cybersecurity features (PersonallyIdentifiable Information Security) Compatibility with facility DICOM Wireless/Wired Tableside controller for control of system in the sterilefield OPTIS Mobile Next Installation Kit for integrating OPTIS Mobile Next intoone Cath Lab Boom Video Installation Kit Angio Video Installation Kit OPTIS Mobile Next Connectivity Cables OPTIS Mobile Next Connectivity Box One (1) Wi-Box Transmitter and two (2) Wi-Box Cables Service Coverage: Includes initial one year manufacturer s warranty Software for OPTIS Next System, powered by AI, provides users with actionable optical coherence tomography (OCT) and angiographic insights. Ultreon 2.0 Software measures physiological indices at stress (FFR) or rest (RFR). Installation/implementation and Training (SOW) After delivery of the Optis Mobile Next System, the vendor shall: Delivery must be with thirty (30) days of ordering. Complete installation and go live must be completed within sixty (60) of delivery. The vendor shall ensure all equipment delivered is fully operational to manufacturer s specification and free from defect. The vendor shall provide delivery, set up, and technical support for clinical staff and clinician training for use the system. The vendor shall report all recalls, removals, modifications and safety notices from the manufacturer, distributor and FDA, and provide immediate notices (within 48 hours) to the Contracting Officer and the facility point of contact and the VHA Product Recall Office for any notices identified for medical devices. The vendor shall coordinate with VA Supply Chain Management or facility appropriate contact agree upon delivery day and arrival to the facility. The vendor shall provide digital format operation manual include the care, handling, set up, and cleaning instruction of the mobile and multi-modality guidance intravascular imaging system.