SAM #36C26226Q0861

VA San Diego Medical Center Impedance Planimetry System Procurement

This opportunity from the Department of Veterans Affairs seeks a new, FDA-approved Impedance Planimetry System for the Gastroenterology Department at the VA San Diego Medical Center. - Government Buyer: - Department of Veterans Affairs, Network Contracting Office 22, VA San Diego Healthcare System, Gastroenterology Department - Products Requested: - Impedance Planimetry System (current generation, FDA-approved) - Must measure pressures and dimensions in the esophagus, stomach, and anus - Includes pump/drive unit, display unit, and compatibility with single-use balloon catheters - Must be new, not refurbished, with latest software/hardware updates and manufacturer support - User and service manuals required - Services Requested: - Delivery, assembly, and installation at VA San Diego Medical Center - Protection of finished spaces during installation - Coordination with VA points of contact - All tools, labor, and materials included - Notable Requirements: - Small business set-aside under NAICS 339112 - Only new, original equipment manufacturer (OEM) items accepted; no gray market or refurbished products - Offerors must be authorized dealers or resellers - Compliance with Buy American requirements - Delivery within 30 days after receipt of order; installation during normal business hours - All shipping and installation costs must be included in quoted prices - Place of Performance and Delivery: - VA San Diego Medical Center, 3350 La Jolla Village Drive, San Diego, CA 92161 - OEMs: - No specific OEMs named; offerors must provide OEM equipment meeting salient characteristics - Estimated Contract Value: - Typical value for similar medical systems ranges from $50,000 to $150,000 - Potential Competitors: - Well-known manufacturers of impedance planimetry systems include Medtronic and Diversatek Healthcare - Competing Products: - Medtronic's Functional Lumen Imaging Probe (FLIP) system - Diversatek's EndoFLIP system

Description

Page 2 of 2 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued. (ii) The solicitation number 36C26226Q0861 is issued as a Request for Quotation (RFQ) in conjunction with FAR -- Part 12 Acquisition of Commercial Products and Commercial Services and constitutes the only solicitation. The Government intends to award a single Firm-Fixed Price (FFP) award contract. (iii) The provisions and clauses in this document are in effect through the Revolutionary FAR Overhaul (RFO). (iv) This solicitation intends to award a contract through competition set-aside for Small Businesses associated with NAICS North American Industrial Classification System Code 339112. (v) See Attachment A Schedule of Pricing for a list of product information, line-item numbers, items, quantities and units of measure. (vi) The Department of Veterans Affairs (VA) seeks to make a procurement for an Impedance Planimetry System for the Gastroenterology Department located at VA San Diego Healthcare System. See Attachment B Statement of Work for a listing of salient characteristics and other requirements. Offeror quotations must demonstrate meeting the salient physical, functional, or performance characteristic specified in this solicitation, otherwise it will be considered non-responsive. The information provided is intended to be descriptive, not restrictive and to indicate the quality that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the supplies being requested. (vii) Delivery Requirements: Place of Delivery: Department of Veterans Affairs VA San Diego Medical Center Warehouse Bldg 1 ATTN: Anna Macdonald - Gastroenterology 3350 La Jolla Village Drive San Diego, CA 92161 Period of Performance/Delivery Timeframe: Delivery of the items is expected to be within 30 days After Receipt of Order (ARO). Additional Delivery Requirements: All shipping shall be inclusive of prices within the schedule and FOB Destination. (viii) The provision at 52.212-1, Instructions to Offerors Commercial Products and Commercial Services, applies to this solicitation. Addendum: All offeror quotes for this solicitation must be received electronically through email no later than Monday, June 15, 2026, 1:00 PM Pacific Time. Ensure to reference solicitation number 36C26226Q0861 within subject line of the email. Any offeror quotes received after the prescribed date/time shall be considered non-responsive and will not be considered for award. Any questions regarding this solicitation must be received electronically through email no later than Monday, June 8, 2026, 1:00 PM Pacific Time. Offers shall be sent by email to Samuel Han at Samuel.Han@va.gov. Offerors shall submit the following via email: Completed Attachment A Schedule of Pricing Offerors shall fill out all unlocked fill-ins/tabs of Attachment A conforming to requirements stated by the salient characteristics and the instructions below. Offerors shall complete column H of tab 1 for unit prices. Offerors shall additionally complete columns C E of tab 1 with the offered product that meets all salient characteristics found on Attachment B. Attachment B Statement of Work Section B - Salient Characteristics. Offerors must provide clear information/narrative/reference regarding how their product meets each of the salient characteristics in: Attachment B; or alternatively may state where in the offeror's overall submission that information can be found. CLIN prices shall include all shipping and installation costs (no separate shipping and installation fees). Completed Buy American Certificate (see FAR 52.225-2 below). Include reference of Offeror's SAM Unique Entity ID number (UEI). OFFERORS WHO FAIL TO COMPLY WITH THESE QUOTE SUBMITTAL REQUIREMENTS MAY HAVE THEIR OFFERS REJECTED AND BE REMOVED FROM FURTHER CONSIDERATION FOR CONTRACT AWARD. (End of Provision) (ix) 52.212-2 Evaluation -- Commercial Products and Commercial Services (Nov 2021) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Lowest priced quotation that meets all salient characteristics in Attachment B and additional delivery requirements that is both responsive and responsible. Acceptability of equipment/services shall be established by review of each submitted quotation by the designated evaluator(s) and verification that any items meet the salient characteristics included in this solicitation. Submissions to this solicitation must show clear, compelling and convincing evidence that equal-to items meet all the salient characteristics (see Attachment A and B). Offers that include any items that are not determined to meet all salient characteristics shall result in an unacceptable offer. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified with a minimum of at least sixty days, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) (x) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition. (xi) The following provisions and clauses also apply: 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (APR 2026) (a) Definitions. As used in this clause Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations; or similar opportunities that are sponsored or established by the contractor or subcontractor. Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources. (b) In connection with the performance of work under this contract, the Contractor agrees as follows: (1) The Contractor will not engage in any racially discriminatory DEI activities; (2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause; (3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the Contractor or subcontractor may be declared ineligible for further Government contracts; (4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and (5) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause. (6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4). (c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States. (End of clause) 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, 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) 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." (b) Foreign End Products: Line Item No. Country of Origin Exceeds 55% domestic content (yes/no) ___________ ___________ ___________ ________ ___________ ___________ ________ ___________ _____________ (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. 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS AND CERTIFICATIONS (NOV 2025) (DEVIATION) (a) Definitions. As used in this provision Backhaul, covered article, covered telecommunications equipment or services, critical technology, FASCSA order, Intelligence community, interconnection arrangements, national security system, roaming, sensitive compartmented information, sensitive compartmented information system, source, and substantial or essential component have the meanings provided in the clause 52.240-91, Security Prohibitions and Exclusions. Business operations means engaging in commerce in any form, including by acquiring, developing, maintaining, owning, selling, possessing, leasing, or operating equipment, facilities, personnel, products, services, personal property, real property, or any other apparatus of business or commerce. Marginalized populations of Sudan means (1) Adversely affected groups in regions authorized to receive assistance under section 8(c) of the Darfur Peace and Accountability Act (Pub. L. 109-344) (50 U.S.C. 1701 note); and (2) Marginalized areas in Northern Sudan described in section 4(9) of such Act. Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate (1) Are conducted under contract directly and exclusively with the regional government of southern Sudan; (2) Are conducted under specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization; (3) Consist of providing goods or services to marginalized populations of Sudan; (4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization; (5) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and (6) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause. (6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4). (c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States. (End of clause) 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, 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)

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