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PRE-SOLICITATION NOTICE OF INTENT - NON-COMPETITIVE INTRODUCTION: PURSUANT TO FAR Subpart 5.2 Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWAR... PRE-SOLICITATION NOTICE OF INTENT - NON-COMPETITIVE INTRODUCTION: PURSUANT TO FAR Subpart 5.2 Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The U.S. Department of Veterans Affairs, Strategic Acquisition Center (SAC), on behalf of the Veteran Hospital Administration (VHA), intends to procure on a sole source bases Electrophysiology Catheters or EP Catheters with Johnson & Johnson Health Care Systems Inc, from BIOSENSE WEBSTER INC, 3333 S DIAMOND CANYON RD, DIAMOND BAR CA 91765. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS code 339112 Surgical and Medical Instrument Manufacturing, with a Size Standard of 500 employees. This procurement is unrestricted. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses of the Federal acquisition Regulation FAR 13.5 Simplified Procedures for Certain Commercial Items: The authority for applying FAR 13.501 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). STATUTORY AUTHORITY: The Statutory Authority for this action is 11.105(a)(1) The particular brand name, product, or feature is essential to the Government s requirements, and market research indicates other companies similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency s needs. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. PURPOSE AND OBJECTIVES: The Department of Veteran Affairs Strategic Acquisition Center (SAC) is interested in procuring multiple Electrophysiology Catheters or EP Catheters. Standardization of Electrophysiology (EP) Catheters ensures continuity of care from one Department of Veterans Affairs (VA) hospital to another across the United States and Puerto Rico. The Government seeks to establish a Blanket Purchase Agreement (BPA) that will provide Electrophysiology (EP) Catheters and products from Johnson and Johnson of Biosense Webster to include a manufacturer s complete product line for Electrophysiology Catheters and products. PROJECT DESCRIPTION: Electrophysiology is a medical branch related to the study of electrical activity within the heart. These catheters are slim, bendable or deflectable multi-electrode wires used in recording intra-cardiac electrical signals or in ablation of cardiac tissues responsible for heart rhythm disorders. In addition, sheaths are tubes that are used to direct the catheters to specific areas in the heart and connectors linking the catheters to monitoring or ablation systems. DESCRIPTION OF REQUIREMENT: The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care. These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures. The Contractor shall furnish all necessary equipment, supplies, and materials to provide EP Catheters and products to VA Medical Centers (VAMCs) in the continental United States and Puerto Rico. For standard delivery, the Contractor shall provide the requested items within 3 business days. The vendor must have the capability to receive payment upon delivery utilizing the Government Purchase Card (GPC). To maintain the highest standard performance, original equipment manufacturer (OEM) is required from the original manufacturer, Johnson and Johnson. The unique attributes of the Biosense Webster EP Catheters are that they integrate with and enable the use of the Biosense Webster CARTO® 3 System, a capital equipment mapping system. Many Electrophysiology programs within VA Medical Centers currently utilize Biosense Webster s CARTO® 3 System to map, diagnose and treat cardiac arrhythmia patients which is only possible in conjunction with the Biosense Webster EP Catheters. Biosense Webster EP Catheters are exclusive to Biosense Webster. EP catheters from other manufacturers in the marketplace do not integrate with the CARTO® 3 capital equipment to facilitate navigation or therapy delivery. The CARTO® 3 System uses current and magnetic based technologies which integrate with a broad portfolio of diagnostic, ultrasound and therapeutic products, as well as related accessories. Much like a Global Positioning System (GPS), the CARTO® 3 System technology relies on proprietary Biosense Webster disposable catheters which are equipped with internal navigation sensors. These internal navigation sensors provide the specialized capabilities of enabling real-time navigation, ensuring +1mm of location accuracy in maps and integrating 3D ultrasound images. These capabilities make it possible for Electrophysiologists to utilize the CARTO® 3 System to generate 3D cardiac maps from which they can diagnosis a myriad of cardiac arrhythmias and deliver immediate therapy. Use of the CARTO® 3 System is not possible without Biosense Webster disposable products. Disposable products of other Original Equipment Manufacturers (OEMs) are not functional for cardiac navigation, map generation, ultrasound image integration or therapy delivery with Biosense Webster s CARTO® 3 System. Additionally, the proprietary Biosense Webster catheters with navigation sensors enable visualization of the expanded portfolio of non-sensor based Biosense Webster products through the hybrid current and magnetic framework of the CARTO® 3 System. Through Biosense Webster s Connection of Choice functionality, use of the non-sensor based Biosense Webster products with the CARTO® 3 System ensures a seamless interface and more efficient set-up process as compared to other items available in the market from other OEMs. These unique qualifications of Biosense Webster EP Catheters are not prevalent in the marketplace from other vendors. To be eligible for award of a BPA, the Contractor shall ensure that any product provided under this BPA meet the following minimum technical requirements: Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures in accordance with the minimum technical requirements (MTRs) below MTR Number Minimum Technical Requirement MTR 1 Diagnostic electrophysiology catheters: Multi-pole, non-deflectable or multiple deflectable MTR 2 Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters MTR 3 Intracardiac Ultrasound imaging catheters (equipment specific) MTR 4 Electrophysiology introducer sheaths: no deflectable or deflectable MTR 5 Trans-septal catheterization needles MTR 6 3D mapping electrodes and patches (equipment specific) MTR 7 3D mapping catheters (equipment specific) MTR 8 CARTO® 3 System APPLICABLE DOCUMENTS The following document applies to this requirement and shall be adhered to by the Contractor on all items offered. CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 Premarket Approval of Medical Devices REQUIREMENTS The Contractor shall furnish all supplies, and materials to provide EP Catheters and products as defined by the Minimum Technical Requirements (MTRs). Contractor shall provide a Product Listing of all items and sizes relating to Electrophysiology Catheters provided by their company. The Contractor shall ensure that all products provided are new and free from defect. The Contractor shall ensure that the products are properly packaged to maintain the item s integrity (e.g., sterilization); and shall clearly identify the item and the expected shelf-life on the outside of the packaging. Emergency Turnaround When identified on the individual order, the Contractor shall provide emergency shipping service for the requested item(s) within 24 hours after receiving the Emergency Order Request. FDA Approvals The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. Product Recalls The Contractor shall report all equipment recalls in writing, within 48 hours of discovery to the Contracting Officer. Package Marking The Contractor shall ensure the addressee information for any delivered item includes the Ordering Office point of contact(s) information on the outside packaging to ensure delivery to the correct location and correct person. WARRANTY The Contractor shall provide a commercial warranty to industry standards for all products under this effort. ENVIRONMENTAL REQUIREMENTS The Contractor shall comply with all environmental federal, state, and local laws and regulations; and policies, instructions, and plans. RETURNED UNITS In the event a procedure is cancelled, or an item is otherwise not needed, the Contractor shall accept unopened and undamaged EP Catheter packages in salable condition returned for full credit to the Government. In addition, the Contractor shall accept returned products for full credit to the Government where the shelf-life has reached expiration for unopened and undamaged products. Unused products shall be returned to the Contractor within 30 calendar days by the Ordering Official. NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS The Contractor shall notify the Ordering Office point of contact within one (1) business day for non-emergency Orders and within four (4) hours of an emergency Order if any parts/materials cannot be delivered in accordance with the individual BPA Order delivery requirements. To ensure that the correct EP Catheter items are shipped, the Contractor shall not substitute items without prior approval by Ordering Official. Instances where the Contractor cannot meet the Government s requirement(s), the Contractor shall notify the Ordering Office of the shortest delivery period available. If the Contractor s shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources. This effort includes a product refresh provision whereby the Contractor provides notification of new FDA-approved products, and if approved by the Government, the new products are included for ordering under this effort. Product Refresh: A. All consumable items offered shall be state-of-the-art. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. B. If upgrades of the consumable items become available after establishment of this Agreement, the contractor will substitute them for the initial items per Item C below. C. The Contractor will provide to the contracting officer the following information: (1) A list of specific initial items which shall be updated. (2) Product literature for the new items and a detailed description of the differences between the initial items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. D. The Contracting Officer will provide the information to the Program Office for approval. Upon approval, this Agreement will be modified to acknowledge the updated items. E. All new products that replace initial items and released to the market during the term of the contract will be made available to the Government at a discount price agreed to upon based on commercial sales practices disclosure. If pricing for new products is unacceptable, medical centers will continue to use current products on Agreement and contractor will be required to continue to supply the contracted item. F. All other new products that are added to a vendor's catalog and released to the market during the term of the Agreement will be made available to the Government at a discount price agreed to base on commercial sales practices disclosure. Pricing on new technologies will be negotiated separately. The Contractor shall provide a commercial warranty to industry standards for all products under this effort. The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 Premarket Approval of Medical Devices. Period of Performance The period of performance shall be for a 60-month ordering period after establishment of the BPA. The government will only establish BPA's with firms who comply with the above criteria, offer a competitive price, and who the government determines represents a benefit to the government to establish the BPA. All vendors must be registered in the System for Award Management (SAM) database. Closing Statement: THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality, no proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Gwennifer Epps, Contract Specialist, via e-mail to gwennifer.epps@va.gov., and to Mr. Brian Shepard, Contracting Officer, via e-mail to brian.shepard@va.gov. Please include a point of contact, company name, business size standard, phone number, e-mail address and website information in your response to the RFI. Responses must be received by this office on or before 10:00 PM EST on January 19, 2021 and must reference the solicitation number. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information.