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 compliant: (i) Contract number and order number, if applicable; (ii) Identification of whether this disclosure relates to paragraph (c) on covered telecommunication equipment or services, or to paragraph (d) on FASCSA orders; (iii) A description of the products or services that the Contractor identifies or has reason to suspect is prohibited (include brand; model number, such as the original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable); (iv) The entity that produced the product or service (include entity name, unique entity identifier, Contractor and Government Entity (CAGE) code, facilities responsible for design, fabrication, assembly, packaging, and test of the product, and whether the entity was the OEM or a distributor (provide manufacturer codes and distributor codes used for the product)); (v) Description of the functionality of the product or service and how that functionality impacts the risk to the product or service; (vi) An explanation of any factors relevant to determining if the product or service should be permitted by an applicable exception, exemption, or waiver (if the offeror would like the Government to consider a waiver); (vii) Whether alternative products or services are available that would be compliant with the prohibition; (viii) If the product or service is related to item maintenance, include the following information on the item being maintained: (A) Brand; (B) Model number, OEM number, manufacturer part number, or wholesaler number; and (C) Item description, as applicable. (ix) Any readily available information about mitigation actions undertaken or recommended. (2) If a disclosure is required to be submitted to a contracting office, the offeror shall submit the disclosure as follows: (i) If a Department of Defense contracting office, the offeror shall submit the disclosure to the website at https://dibnet.dod.mil. (ii) For all other contracting offices, the Offeror shall submit the disclosure to the Contracting Officer. (3) If the disclosure provided does not contain any of the information required by paragraph (1), and the Offeror later discovers new information that is required by paragraph (1), then the Offeror shall submit a subsequent disclosure within 72 hours of discovering the new information. (h) Executive agency review of disclosures. The Contracting Officer will review disclosures provided in paragraph (g) to determine if any applicable waiver may be sought. The Contracting Officer may choose not to pursue a waiver and may instead make an award to an Offeror that does not require a waiver. (End of Provision) E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with 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 offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ (End of Provision) FAR Number Title Date 52.203-11 CERTIFICATION AND DISCLOSURE REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS SEP 2024 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS REPRESENTATION JAN 2017 52.204-7 SYSTEM FOR AWARD MANAGEMENT REGISTRATION (DEVIATION) NOV 2025 52.214-21 DESCRIPTIVE LITERATURE APR 2002 52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS NOTICE AND REPRESENTATION JUN 2020 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE FEB 2023 (End of Addendum to 52.212-1) System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations and certifications based on provisions that are not included in this solicitation. Examples include 52.240-90 Security Prohibitions and Exclusions Representations and Certifications, 52.242-91 Security Prohibitions and Exclusions, 52.240-92 Security Requirements, and 52.240-93 Basic Safeguarding of Covered Contractor Information Systems. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services [NOV 2025] Addenda is attached. ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses 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 clauses are incorporated into 52.212-4 as an addendum to this contract: C.1 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (DEVIATION 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) C.2 52.223-23 SUSTAINABLE PRODUCTS (NOV 2025) (DEVIATION) (a) Definitions. As used in this clause Sustainable products means (1) A product that contains recovered material designated by the EPA under the Comprehensive Procurement Guidelines (42 U.S.C. 6962) (40 CFR part 247) (https://www.epa.gov/smm/comprehensive-procurement-guideline-cpg-program#products). (2) An