6515--AIRVO 3 RESPIRATORY SUPPORT SYSTEM

Sources Sought Synopsis Only THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT/RFI IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (hubzone, 8(a), small, small disadvantage, veteran owned small business (VOSB), service-disabled veteran owned small business (SDVOSB), or large business relative to NAICS 339112 with size standards of 1000 employees. This sources sought is neither a request for competitive proposals nor solicitation of offers. This synopsis is to assit the VA in determining sources only and a solicitation is not currently available. Note that if VA s pending market research establishes that two or more VOSB or SDVOSB, who are certified in U.S Small Business Administration site https://www.sba.gov can perform the project, VA will set aside the underlying solicitation per 38 U.S.C. §8127.� Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Synopsis, a solicitation announcement may be published on SAM, and/or GSA eBuy. Responses to this Sources Sought Synopsis are not considered adequate responses to the solicitation announcement. General Requirements: The Department of Veterans Affairs (VA), VA Long Beach Healthcare System, has a need for the AIRVO 3 Respiratory System and various accessories. The system being requested will be used to provide mechanical ventilation to patients who require respiratory support due to breathing distress among other issues. The requirement is for brand name or equal to: Airvo 3 Respiratory Support Device Please Identify any domestic alternatives (meaning manufactured in the United States) Nomenclature: Respiratory Support Device MANUFACTURE FISHER & PAYKEL HEALTHCARE, INC CLIN Item # Description Qty Unit of Measure 1 PT301US Airvo 3 Base Respiratory Support Device 13 EA 2 900PT421 Pole Stand, Hospital Pole for myArivo 2 and Airvo2 on wheels 13 EA 3 900PT460D Airvo 3 HPO Dual-Input Manifold (DISS) 13 EA 4 900PT930 Airvo 3 Outlet Elbow 12 EA 5 900PT445 Airvo 3 Mobile Pole Stand Handle 13 EA 6 900PT427 Oxygen Bottle Holder 13 EA 7 900PT428 C-Clamp 25 mm 13 EA 8 900PT426 Basket, Accessory for Airvo 13 EA 9 900PT620 Airvo 3 disinfection Kit US 13 EA 10 HA-U1C4-02414 10 DISS female hex by female hand tight 13 EA 11 HA-U1C4-00894 2 DISS female hex by female hand tight 26 EA REQUIREMENTS: The Respiratory Therapy department requests the acquisition of respiratory therapy equipment for the purpose of providing patients in acute respiratory distress or with low blood oxygen. The Salient Characteristics must include: Shall provide heated, humidified high-flow respiratory therapy for spontaneously breathing adult and pediatric patients. Shall deliver flow rates up to 70 L/min with adjustable flow and oxygen concentration. Shall provide integrated heated humidification without requiring a wall air supply. Shall include an integrated touchscreen or equivalent user interface for operation and therapy adjustments. Shall include integrated temperature control with adjustable humidity settings. Shall support invasive and non-invasive respiratory therapy applications as indicated by the manufacturer. Shall include audible and visual alarms for system faults and therapy interruptions. Shall be compatible with standard hospital oxygen (DISS) connections. Shall include a mobile pole stand with wheels and handle for transport within patient care areas. Shall include oxygen bottle holder and accessory basket. Shall include dual-input manifold (DISS) and outlet elbow required for clinical operation. Shall include disinfection kit and all accessories required for initial operation. Shall operate on standard 120 VAC, 60 Hz hospital electrical power. Shall be FDA-cleared for use in the United States. Shall include manufacturer s standard warranty. Shall be supplied new (not refurbished) with all manuals and documentation. Shall be capable of replacing existing end-of-life Precision Flow high-flow respiratory support systems without reducing clinical capability. Participating Healthcare Facilities: VISN 22 West VA Long Beach Healthcare System 5901 East 7th Street, Long Beach, CA 90822-5201 In response to this announcement, please complete the information below: Company: Address: Contact Name: Phone No: Email: DUNS: Business size information Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HubZone Woman Owned Certified Service-Disabled Veteran Owned Small in Vetbiz.gov Certified Veteran Owned Small Business in Vetbiz.gov Large Business Other:____________ All offered items must be listed on vendor FSS contract FSS/ GSA Contract Holder of the requested item(s) Yes No FSS/ GSA Contract Number Effective Date / Expiration Date Country of Origin (COO) Does your company manufacture the requested product(s)? If no, answer the questions below. Yes No Does your company exceed the 500-employee alternative size standard for nonmanufacturers? Yes No Is your company primarily engaged in the retail or wholesale trade and normally sell the type of product(s) being supplied? Yes No Does your company take ownership or possession of the products(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? Yes No Does your company supply the end product(s) of a small business manufacturer or processor made in the US, or obtain a waiver of such requirement? Yes No Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Not applicable List: Note* The Non-Manufacturer Rule (NMR) in accordance with 13 CFR § 121.406, September 4, 2019 applies to this acquisition. Additionally, as prescribed on 25.1101(a)(1). FAR 52.225-1 Buy American Supplies and FAR 52.225-2 Buy American Certificate 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. FAR 52.225-1 Buy American American-Supplies (Oct 2022) (a) Definitions. As used in this clause Commercially available off-the-shelf (COTS) item (1) Means any item of supply (including construction material) that is (i) A commercial product (as defined in paragraph (1) of the definition of commercial product at Federal Acquisition Regulation (FAR) 2.101); (ii) Sold in substantial quantities in the commercial marketplace; and (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and (2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Component means an article, material, or supply incorporated directly into an end product. Cost of components means (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or (2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product. Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105 . Domestic end product means (1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both- (i) An unmanufactured end product mined or produced in the United States; (ii) An end product manufactured in the United States, if- (A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or (B) The end product is a COTS item; or (2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of "cost of components". End product means those articles, materials, and supplies to be acquired under the contract for public use. Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws. Foreign end product means an end product other than a domestic end product. Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign. Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners. Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements. United States means the 50 States, the District of Columbia, and outlying areas. (b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for an end product that is a COTS item (see 12.505(a)(1)), except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners. (c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting Officer will treat as domestic for this contract. (d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled Buy American Certificate. (End of Clause) FAR 52.225-2 Buy American Certificate (Oct 2022) (a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component. (2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select no . (3) The Offeror shall separately list the line-item numbers of domestic end products that contain a critical component (see FAR 25.105). (4) The terms commercially available off-the-shelf (COTS) item, critical component, "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies." Item # Description Country of Origin Exceeds 55% domestic content (yes/no) (b)Foreign End Products: (b)[List as necessary] (c) Domestic end products containing a critical component: Line Item No. ___ [List as necessary] (d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. (End of provision) Domestic Alternative Product Do you have domestic alternatives? (Equal product that is manufactured within the United States) If so, please state the item, description and place of manufacture (country of origin) in the spaces below Yes No Item # Description Country of Origin This notice is neither a request for competitive proposals or solicitation of offerors. This notice is to assist the VA in determining sources only and a solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from this response. Responses to this Sources Sought is not a 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 to conduct competitive procurement. This notice does not represent a commitment by the Government to pay for costs incurred in the preparation and submission of information or any other costs incurred as a response to this announcement. Inquiries will only be accepted in writing via email to Rochelle.Malveaux@va.gov on or before Wednesday, August 19th, 2026, by 6:00 am PST Local Time.