6525--NOX T3 Home Sleep Testing Systems or Equal

Description

Page 5 of 5 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 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing size standard of 1,250 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 (20) NOX T3 Home Sleep Testing Systems or Equal. The VA Greater Los Angeles Medical Service-Pulmonary and Sleep Division requires to assist patients who need these to test for sleep apnea. Additionally, the vendor is to install these devices and train staff. **Please Review the PWS for Salient Characteristics in this document*** 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 11310 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 Country of Origin ( COO ) 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 Jonathan.Ford1@va.gov telephone responses shall not be accepted. Please respond by July 14, 2026, 10:00AM PT. 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-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." Line Item� No. 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) The Following below is a description of the Salient Characteristics for the Supplies Needed For This Requirement: Salient Characteristics - Physical & Functional NOX T3 Home Sleep Testing Systems ( Stock # 511112 ) or EQUIVALENT Portable and ambulatory Must be able to capture respiratory flow via RIP technology, oxygen saturation, pulse, snoring and optional cardiac or muscle activity signals Capability on integration with software-allow data to be downloaded and analyzed using polysomonography software and provide customizable, AASM compliant reports for clinical interpretation Allow for clinicians to perform Type III sleep studies in home environments Must be able to measure airflow, oxygen saturation, breathing effort and heart rate Be to able to continuously record signals during sleep Capability to connect to a computer or cloud platform for secure data transfer to a sleep specialist Industry Standard for Bilevel Positive Airway Pressure Non-Invasive ventilation system typically includes: Per AASM, A technically adequate HSAT device must include at least one of the following sensor combinations: * Nasal pressure + chest/abdominal respiratory inductance plethysmography + oximetry * Peripheral arterial tonometry (PAT) + oximetry + actigraphy * must have FDA clearance via 510(k) or de novo pathway, with a focus on safety, clinical effectiveness and performance * AASM technical guideline on Home Sleep Testing system, i.e. a technically adequate home sleep testing system minimally must include nasal pressure, chest and abdominal respiratory inductance plethysomography (RIP) * oximetry or peripheral arterial tonometry (PAT) with oximetry and actigraphy PWS (PERFORMANCE WORK STATEMENT) SCOPE: The Contractor shall deliver and install 6 units of Bilevel Positive Airway Pressure Non-Invasive ventilation devices at 11301 Wilshire Blvd., Los Angeles, CA 90073, Bldg. 500, 3 North, Room 3025 with essential/significant physical, functional, or performance characteristics listed PERFORMANCE: * The Contractor shall ensure all equipment delivered are fully operational to manufacturer s specification and free from defect. * The Contractor shall provide delivery, set up, and technical support for clinical staff and clinician training for use the system. * The Contractor 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 Contractor shall coordinate with VA Supply Chain Management or facility appropriate contact agree upon delivery day and arrival to the facility.