6515--Equipment: Pulsed Electric Field Ablation System
ID: 36C24825Q0455Type: Combined Synopsis/Solicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF248-NETWORK CONTRACT OFFICE 8 (36C248)TAMPA, FL, 33637, USA

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

PSC

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES (6515)

Set Aside

Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14) (SDVOSBC)
Timeline
    Description

    The Department of Veterans Affairs is seeking proposals from qualified Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) for the procurement of a Pulsed Electric Field Ablation System intended for non-thermal pulmonary soft tissue ablation in bronchoscopy settings at the North Florida/South Georgia Veterans Health System in Gainesville, Florida. The system must meet specific technical requirements, including FDA approval for endoscopic treatment of lung nodules, the ability to deliver high-voltage electrical energy for localized cellular disruption while preserving surrounding tissue integrity, and integration with a 4-lead cardiac monitor for synchronized energy delivery. This procurement is crucial for enhancing medical treatment capabilities for veterans, emphasizing advanced technology in healthcare. Interested vendors must submit their quotes by March 10, 2025, at 4:30 PM Eastern Time, and can contact Contracting Officer Heidi Parrish at heidi.parrish@va.gov or 352-278-5990 for further inquiries.

    Point(s) of Contact
    Heidi ParrishContracting Officer
    (352) 278-5990
    heidi.parrish@va.gov
    Files
    Title
    Posted
    The Department of Veterans Affairs is issuing a solicitation to acquire a Pulsed Electric Field Ablation System for the North Florida/South Georgia Veterans Health System, located in Gainesville, Florida. The solicitation (number 36C24825Q0455) is set for responses by March 10, 2025, at 4:30 PM Eastern Time, with offers expected from Service-Disabled Veteran-Owned Small Businesses (SDVOSBC). The package includes several attachments detailing requirements, including salient characteristics and a price delivery schedule, as well as limitations on subcontracting. This procurement underscores the VA's commitment to enhancing medical treatment capabilities through advanced technology in veteran healthcare. Interested parties can reach the contracting officer, Heidi Parrish, via email or phone for further inquiries. More information can be found on the VA's official website.
    The document outlines a Request for Quotes (RFQ) from the Department of Veterans Affairs for the purchase of a Pulsed Electric Field Ablation System. It adheres to federal guidelines under FAR subpart 12.6, targeting Service-Disabled Veteran-Owned Small Businesses, with a specific NAICS code (334510) applicable to the procurement. Interested companies are required to provide quotes that include technical specifications and pricing details, with a delivery timeline of 30 days post-order. Key evaluation factors for selecting quotes include technical qualifications, delivery efficiency, and pricing, emphasizing a comprehensive understanding of requirements and prompt delivery. The procurement process also emphasizes adherence to multiple federal contracting provisions, including those concerning subcontracting and equal opportunity. Quotes should be submitted electronically to the designated Contracting Officer, and late submissions will be treated per FAR regulations. The intent is to ensure a fair, competitive evaluation to achieve the best value for the government while supporting small businesses, particularly those led by veterans.
    The document outlines the requirements for a Pulsed Electric Field (PEF) Ablation System intended for non-thermal pulmonary soft tissue ablation in bronchoscopy settings. Key specifications include FDA approval for endoscopic treatment of lung nodules, the ability to deliver high-voltage electrical energy for localized cellular disruption, and maintaining surrounding tissue integrity. The system should support immune activation and predictably control ablation size. Additionally, it must integrate a 4-lead cardiac monitor to synchronize energy delivery with the patient's heartbeat, ensuring precise ablation timing. The proposed package includes essential components such as a generator, cardiac monitor, user manual, electrodes, and specialized needles. The display features an LCD touch screen to present vital operating information. The manufacturer is also required to provide a minimum one-year warranty and onsite staff training for clinical personnel. This RFP emphasizes technical specifications and operational safety, highlighting the government's focus on advanced medical equipment to enhance treatment protocols while ensuring compliance with health regulations.
    The document outlines a government Request for Proposal (RFP) for medical equipment supplies intended for the Department of Veterans Affairs, specifically the North Florida/South Georgia Veterans Health System. It includes a Price/Delivery Schedule featuring five items: a Pulsed Electric Field Ablation Generator, a Cardiac Monitor, and various electrode and needle packs. Each item is listed with its quantity, unit price, and total cost left blank for bidders to complete. The principal North American Industry Classification System (NAICS) code for all items is 334510, related to Electromedical and Electrotherapeutic Apparatus Manufacturing, indicating the specialized nature of the required supplies. The delivery of all items is directed to a specified address in Gainesville, Florida, with a request for the vendor to provide the best delivery schedule. This document serves as a formal solicitation for suppliers to submit their proposals, detailing their pricing and timelines, while reinforcing the importance of compliance with federal procurement standards for medical and surgical instruments.
    The document outlines the VA's compliance requirements for offerors under 38 U.S.C. 8127 concerning limitations on subcontracting for contracts related to supplies and products. Offerors must certify their adherence to requirements that restrict them from paying more than 50% of the government contract amount to firms that are not verified Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) or Veteran-Owned Small Businesses (VOSBs) unless specific conditions apply. It differentiates between manufacturers and nonmanufacturers, establishing certification criteria for each, including the necessity for domestic sourcing unless a waiver is issued. Offerors will be expected to submit documentation upon request to verify compliance, and failure to cooperate may lead to penalties. A formal certification must be completed and submitted with proposals for offers to be considered valid. This compliance framework is essential for promoting small business participation in government contracts while ensuring integrity in the procurement process.
    Lifecycle
    Title
    Type
    Combined Synopsis/Solicitation
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