6525--Cardiac Electrophysiology (EP) Mapping & Ablation Generator

Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.201-1, Simplified procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01 March 13, 2026. This solicitation is set-aside for unrestricted. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1,250. The FSC/PSC is 6525. The West Roxbury VAMC is seeking to purchase a Cardiac Electrophysiology (EP) Mapping & Ablation Generator System CARTO TRUPULSET brand name or equal. All interested companies shall provide quotations for the following: Supplies/Services ITEM NUMBER DESCRIPTION QUANTITY UOM MANUFACTURER PART NUMBER 0001 FAM Dx Expansion Pack (for CARTOr 3 v6 base software)Enables catheter visualization, point acquisition and Fast Anatomical Mapping (FAM) without first connecting a therapeutic catheter. 1 EA KT5400165 0002 CARTOSOUND SONATAT Module 1 EA C3SONATA 0003 TRUPULSET Generator delivers a unique bi-polar, bi-phasic pulse sequence specifically tailored for the VARIPULSET Catheter design. TRUPULSET SuperKit includes: TRUPULSET Generator TRUPULSET RemotE Monitor Multigenerator Adapter CARTO 3 System V8 Phase 3 Kit 1 EA TRUPULSE 0004 TRUPULSET SW Kit, VARIPULSE Plus Service Pack 1 EA M728002 0005 nGENSystem (SuperKit) 1 EA NGENSYS Place of Performance/Place of Delivery Address: 1400 VFW PKY, WEST ROXBUTY MA Postal Code: 02132 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The following provisions are incorporated into 52.212-1 as an addendum to this solicitation: E.1 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION) The Government contemplates award of a Firm-Fixed-Price contract resulting from this solicitation. (End of Provision) E.2 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021) (a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements." (b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products. Other End Products Line item No. Country of origin [List as necessary] (c) The Government will evaluate offers in accordance with the policies and procedures of Part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation. (End of Provision) E.3 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) Consist of providing goods or services that are used only to promote health or education; or (6) Have been voluntarily suspended. Sensitive technology (1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically (i) To restrict the free flow of unbiased information in Iran; or (ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and (2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)). (b) Procedures. (1) Covered telecommunications and video surveillance. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) at https://www.sam.gov for entities excluded from receiving federal awards for covered telecommunications equipment or services. (2) FASCSA Orders. (i) The Offeror shall search in SAM for the phrase FASCSA order for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (e) of FAR 52.240-91, Security Prohibitions and Exclusions. (ii) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM but are effective and apply to the solicitation and resultant contract (see FAR 40.204-1(c)(2)). (iii) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation. (c) Covered telecommunications equipment or services representations. By submission of its offer, the Offeror represents that, after conducting a reasonable inquiry (that looks at any information in the Offeror s possession but does not need to include an internal or third-party audit) (1) It will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation, except as waived by the solicitation, or as disclosed in paragraph (g); and (2) It does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services, except as waived by the solicitation, or as disclosed in paragraph (g). (d) FASCSA Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this solicitation any covered article, or any products or services produced or provided by a source, if the covered article or the source is prohibited by an applicable FASCSA order in effect on the date the solicitation was issued, except as waived by the solicitation, or as disclosed in paragraph (g). A reasonable inquiry will look at any information in the offeror s possession but does not need to include an internal or third-party audit. (e) Sudan certification. By submission of its offer, the offeror certifies, after conducting a reasonable inquiry (that looks at any information in the offeror s possession but does not need to include an internal or third-party audit), that the offeror does not conduct any restricted business operations in Sudan. (f) Iran Representation and Certifications. (1) Except as provided in paragraph (f)(2) of this provision or if a waiver has been granted in accordance with FAR 40.203-3, the offeror, after conducting a reasonable inquiry (that looks at any information in the offeror s possession but does not need to include an internal or third-party audit), by submission of its offer (i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran; (ii) Certifies that the offeror, or any person (as defined at section 15 of the Iran Sanctions Act of 1996, Pub. L. 104-172, 50 U.S.C. 1701 note) owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Act. These sanctioned activities are in the areas of development of the petroleum resources of Iran, production of refined petroleum products in Iran, sale and provision of refined petroleum products to Iran, and contributing to Iran s ability to acquire or develop certain weapons or technologies; and (iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds $15,000 with Iran s Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (see OFAC s Specially Designated Nationals and Blocked Persons List at https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx) (2) Exception for trade agreements. The representation and certification requirements of paragraph (f)(1) of this provision do not apply if (i) This solicitation includes a trade agreements notice or certification (e.g., 52.225-6, Trade Agreements Certificate); and (ii) The offeror has certified that all the offered products to be supplied are designated country end products or designated country construction material. (iii) The offeror shall email questions concerning sensitive technology to the Department of State at CISADA106@state.gov. (g) Disclosure. (1) If the Offeror is not able to represent compliance with the prohibitions in paragraphs (c) or (d), then the Offeror shall disclose within 72 hours to the contracting office identified in paragraph (g)(2) the following information for each product or service not complian