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65--Topera FIRMap Medical Supplies

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VA26216Q0792Federal

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The VA Network Contracting Office in Long Beach plans to award a sole source contract to Topera, Inc. for the purchase of Topera FIRMap Catheters in various sizes, totaling an estimated $58,800. This procurement is conducted under the authority allowing single source awards for purchases not exceeding the simplified acquisition threshold. The catheters are essential for use with the existing Topera RhythmView Workstation, a proprietary system designed to enhance cardiac ablation procedures for patients with arrhythmias. Since the catheters are exclusively manufactured by Topera, Inc. and are specifically designed to function only with the Topera system, no alternative suppliers or products can fulfill these requirements. The decision for sole source procurement is based on the unique and proprietary nature of the supplies, as verified by the contracting officer. Market research was deemed unnecessary because the catheters are compatible solely with Topera’s proprietary workstation and no substitutes exist in the market. The contract incorporates all applicable provisions and clauses and complies with Federal Acquisition Regulations governing single source procurement. The action aims to ensure the continuation of specialized cardiac care within the VA by securing necessary medical supplies from the sole qualified manufacturer.

General Info

Sole source contract awarded to Topera, Inc. for proprietary cardiac catheters, totaling $58,800.

Agency

N/A

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

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Organization & Contact Information

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AgencyN/A
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Full Description

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The VA NCO22 Long Beach, Network Contracting Office intends to enter into sole source procurement with Topera, Inc. This proposed contract action is being conducted under the authority of 13.106-1(b), Justification for Single Source Awards; COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).incorporates provisions and clauses as those in effect. This procurement is for: Topera FIRMap Catheter - 50mm; 2 each Topera FIRMap Catheter - 60mm; 7 each Topera FIRMap Catheter - 70mm; 3 each This notice of intent is not a request for competitive quotes. A determination by the Government not to compete this proposed contract based on responses to this notice is solely by the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No solicitation document exists and no telephone inquiries will be accepted. Inquires will only be accepted by email at contact@example.gov. JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3K) BUT NOT EXCEEDING THE SAT ($150K)) IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase. 1. PURCHASE REQUEST OR REQUISITION NUMBER: 664-16-3-056-7015 1A. PROJECT/TASK NUMBER N/A 1B. ESTIMATED AMOUNT: $58,800 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: Topera FirMap Catheters are electrophysiology medical supplies that are currently being used with the existing VA Topera RhythmView Workstation for the Cardiac ablation procedure where catheters are placed in the heart and RF energy is delivered through the catheter. This neutralizes (ablates) the cardiac cells that are causing an arrhythmia by creating a block which the electrical impulses can no longer cross. This restores the normal electrical pathways of the heart and allows it to beat normally again. The VA San Diego Electrophysiologist (EP) treats patients with failing cardiac conditions. Topera RhythmView Workstation demonstrates a significant improvement in procedural success with detection and targeted ablation of patient-specific drivers of atrial fibrillation. The Topera RhythmView Workstation will increase our ability to rapidly map, ablate, and potentially cure atrial conditions. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: This proposed contract action is being conducted IAW FAR13.106-1(b), only one responsible source and no other supplies or services will satisfy agency requirements, incorporates provisions and clauses as those in effect. 4. REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE, WHICH CAN PROVIDE THE SUPPLIES OR SERVICES: The required Topera catheters are made for a system specifically designed to function with the Topera RhythmView Workstation and will not function independently or with any other system. These products are specific and exclusively manufactured by Topera, Inc. who own proprietary right to the products they manufacturer. To ensure effective patient healthcare for the reasons stated above, award shall be made to Topera, Inc. 5. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: These supplies are used with an existing system and are proprietary in nature to the Topera,Inc.. FAR 13.106(1)(b) 6. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Signature: ______________________________ Date:___05/11/2016_________________ Name: Rosetta Quintons Title: Contracting Officer Facility: NCO22

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