6525--Brand Name Only - Carto 3 Mapping System

Solicitation / RFP / RFQ

This document is a "Justification for Restricting Competition" (IAW RFO FAR 12.102(a)) for a Brand Name Only CARTO3 Mapping System and associated components. The VA Iowa City Health Care System requires this system, which is proprietary to Biosense Webster. The existing infrastructure at the facility includes Biosense Webster equipment, including a SmartAblate system, necessitating compatible components for continued support, maintenance, upgrades, and expansion.

• Brand Name Only CARTO3 Mapping System and associated components.

• Equipment must be proprietary to Biosense Webster.

• Software, hardware, accessories, and interface components must be designed as an integrated system with the Biosense Webster environment.

• Must be compatible with existing Biosense Webster equipment and the SmartAblate system.

• Period of Performance: 120 ARO (After Receipt of Order).

• Estimated Amount: Not specified in this document.

This document is a justification for restricting competition, not a solicitation for proposals. Therefore, submission and evaluation details are not applicable here.

This justification is for restricting competition to a brand name. Market research identified Biosense Webster Inc. (Large Business) and Geo-Med LLC (Authorized Distributor - Service-Disabled Veteran Owned Small Business) as potential sources.

• The acquisition is over the Micro-Purchase Threshold but not exceeding the Simplified Acquisition Threshold.
• The Contracting Officer certifies that the justification is accurate and complete.

Form / Attachment / Pricing Sheet

This document is the "Buy American Certificate" provision (FAR 52.225-2), which requires offerors to certify the origin of end products and their components. It is used to ensure compliance with the Buy American Act.

• Domestic End Product Certification: Offerors must certify that each end product is a domestic end product, except for those listed in paragraph (b).
• Critical Component Identification: Offerors must list domestic end products that contain a critical component.
• Foreign End Product Reporting: Offerors must list foreign end products and indicate if they exceed 55% domestic content (unless COTS).
• Definitions: Key terms like "COTS item," "critical component," "domestic end product," "end product," and "foreign end product" are defined in the "Buy American-Supplies" clause.
• Addendum: For CLINs 0001-0008, items manufactured in Yokneam, Israel, are considered "Made in the USA" upon delivery to California with added software and equipment.
• Signature Block: Requires offeror's signature, printed name, and position.

Bidders must complete and submit this certificate to affirm their compliance with the Buy American Act. The addendum provides specific guidance for certain CLINs, indicating how foreign-origin items with domestic additions will be treated. Failure to properly complete this certificate may impact proposal evaluation and award.

Solicitation / RFP / RFQ

This solicitation is for a one-time purchase of a Carto 3 Mapping System, including the nGEN and TRUPULSE systems, for the Iowa City VA Health Care System. The requirement is for brand-name-only equipment, new, and includes all necessary software, hardware, and accessories for full operational capability. Professional installation, clinical education, and on-site training are also required.

• Carto Mapping System: Must support 3D electroanatomical mapping of cardiac chambers for arrhythmia diagnosis, real-time visualization, catheter navigation, activation mapping, voltage mapping, substrate mapping, integration with CT/MRI/fluoroscopic images, and compatibility with RF and cryo-mapping catheters.

• nGEN System: Includes an RF Generator for cardiac ablation, capable of temperature and power-controlled ablation up to 90W, with multiple independent power channels and seamless integration with the Carto3 system. Also includes a peristaltic irrigation pump and a touchscreen control interface.

• TRUPULSE Generator: For Pulsed Field Ablation (PFA) energy delivery, compatible with PFA and RF energy, and featuring controlled electrical pulses for non-thermal ablation.

• Warranty: Minimum one-year manufacturer warranty.

• Installation: Required by the contractor, coordinated with Biomedical Engineering.

• Training: Clinical education and on-site training by the vendor.

• Contract Type: Firm-Fixed-Price, one-time supply contract.

• Period of Performance: 120 Days After Receipt of Order (ARO).

• Submission: Quotes must be submitted electronically to dennis.salmonsen@va.gov by the date and time specified in Block 8.

• Format: Files must be readable using Microsoft Office 2007 or later (Word, Excel). PDF files should have a resolution of at least 300 dpi. Zipped files are not acceptable.

• Evaluation: Offers will be evaluated based on PRICE ONLY.

• Key Deadlines: Offer Due Date is May 7, 2026, at 17:00 MDT.

• The acquisition is unrestricted.

• NAICS Code: 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing).

• Size Standard: 1250 Employees.

• Offerors must be registered in the System for Award Management (SAM) and have a Unique Entity Identification (UEI).

• Brand Name Only requirement for all equipment.

• Delivery is FOB Destination to Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA 52246.

• FAR 52.212-1, 52.212-3, and 52.212-5 are attached. Addenda are attached.

Solicitation / RFP / RFQ

Network Contracting Office 23 intends to issue a Request for Quote (RFQ), 36C26326Q0595, for a Brand Name Only – CARTO 3 Mapping System. This is a firm-fixed-price solicitation conducted under FAR Part 12.201-1, Simplified Procedures.

• The primary requirement is for a CARTO 3 Mapping System.

• Offerors must provide an itemized quote.

• Sufficient technical supporting documentation is mandatory to demonstrate the quoted service meets the salient characteristics required by the solicitation.

• Contract Type: Firm-fixed-price.

• Place of Performance: Iowa City VA Health Care System, 601 Highway 6 West, Iowa City IA 52246, USA.

• Offerors are instructed to follow the instructions within RFQ document 36C26326Q0595.

• All quotes must be sent via email to dennis.salmonsen@va.gov.

• Quotes are due by the date and time specified in Block 8 on page 1 of the solicitation.

• This is a "Brand Name Only" requirement.

• NAICS Code: 334510.

• Product Service Code: 6525.

• The solicitation is expected to be posted soon, with a response date of May 7, 2026, 17:00 Mountain Time, Denver, USA.

• The contracting office is Network Contracting Office 23, located at VA Black Hills HCS Fort Meade Campus, 113 Comanche Rd, Fort Meade SD 57741.

• The Contract Specialist is Dennis Salmonsen (dennis.salmonsen@va.gov).