SPECIAL NOTICE
65 -- superDimension Navigation System with Fluoroscopic Navigation Technology and Obsolescence Protection (the "System") and Level 3 Warranty.
- Notice Date
- 5/29/2019
- Notice Type
- Synopsis
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Columbus;Chalmers P. Wylie Ambulatory Care Center;420 North James Road;Columbus OH 43219-1834
- ZIP Code
- 43219-1834
- Solicitation Number
- 36C25019Q0853
- Archive Date
- 7/28/2019
- Point of Contact
- (614) 257-5267
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs intends to negotiate a sole source contract to purchase one (1) superDimension Navigation System with Fluoroscopic Navigation Technology and Obsolescence Protection (the System ) with a Level 3 Warranty. The Louis Stokes Cleveland Veterans Affairs Medical Center (LSCVAMC) requires an upgrade for the state-of-the-art pulmonary fluoroscopy software and hardware which allows the Cleveland VA Medical Center to perform Electromagnetic Navigation Bronchoscopy (ENB) procedures. These procedures are able to assess difficult to reach areas of the lung with a minimally invasive approach, leading to earlier intervention and more personalized treatment. ENB or EMN bronchoscopy is a medical procedure utilizing electromagnetic technology designed to localize and guide endoscopic tools or catheters through the bronchial pathways of the lung. Using a virtual, three-dimensional (3D) bronchial map from a recently computed tomography (CT) chest scan and disposable catheter set, physicians are able to navigate to a desired location within the lung to biopsy lesions, stage lymph nodes, insert markers to guide radiotherapy or guide brachytherapy catheters. As mentioned this will be an upgrade to the current ENB system along with a service agreement. The North American Industry Classification System Code (NAICS) is 339112, Surgical and Medical Instrument Manufacturing. The Government believes that Covidien Sales LLC, a Medtronic company and their Authorized Service- Disabled Veteran-Owned Small Business (SDVOSB) Distributors are the only providers that can satisfy the agency requirements. Therefore, the Government intends to proceed with a sole source award for the superDimension Navigation System with Fluoroscopic Navigation Technology and Obsolescence Protection (the System ) with a Level 3 Warranty. This procurement is being conducted in accordance with FAR 6.302 only one responsible source and no other vendor will satisfy agency requirements. To the best of our knowledge, Covidien Sales LLC, a Medtronic company and their Authorized SDVOSB Distributors are the only sources that can provide the above indicated services/supplies. No solicitation document is available; however, any firm that believes it can meet these requirements may give written notification to the Contracting Officer within three (3) calendar days from the date of publication of this synopsis. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Information can be sent to the Contracting Officer, VA Ambulatory Care Center, 420 N. James Road, Columbus, Ohio 43219-1834 or faxed to 614.388.7500 or emailed to gina.crank@va.gov. Responses received will be evaluated, however a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses, other than those of the Authorized SDVOSB Distributors are received, the VA Ambulatory Care Center Columbus will proceed with the sole source negotiation with the Authorized SDVOSB Distributor that offers the lowest priced technically acceptable (LPTA) Quote. DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C250-19-AP-3709 Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center is submitting to Network Contracting Office (NCO) 10 for Sole-Source Contract. The funding document is for 541-19-3-250-0293 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Cleveland VA Medical Center requires an upgrade for the state-of-the-art pulmonary fluoroscopy software and hardware which allows the Cleveland VAMC to perform Electromagnetic Navigation Bronchoscopy (ENB) procedures. These procedures are able to assess difficult to reach areas of the lung with a minimally invasive approach, leading to earlier intervention and more personalized treatment. The Cleveland VA Medical Center uses the superDimension to perform electromagnetic bronchoscopies. ENB or EMN bronchoscopy is a medical procedure utilizing electromagnetic technology designed to localize and guide endoscopic tools or catheters through the bronchial pathways of the lung. Using a virtual, three-dimensional (3D) bronchial map from a recently computed tomography (CT) chest scan and disposable catheter set, physicians are able to navigate to a desired location within the lung to biopsy lesions, stage lymph nodes, insert markers to guide radiotherapy or guide brachytherapy catheters. This request is an upgrade to the current ENB system along with a service contract. The separation of overlaying static CT images and continuously changing live patient anatomy has led Medtronic to the development of their latest Fluoroscopic Navigation Technology. We now no longer have to rely on CT images alone which helps to increase navigational accuracy, comparable to cone beam CT. Their new technology uses a Local Registration tomosynthesis scan to model 3D distances on 2D images, enhancing Real Time lesion visibility. The ability to adjust for CT to body divergence means the virtual target becomes the real lesion. Fluoroscopic Navigation technology is the platform in which Medtronic is building on for delivering future therapeutic modalities during our minimally invasive procedures. The Enhanced visualization, accurate target alignment and improved Physician confidence during sampling were focal innovations required by the FDA as we move towards adding therapeutic modalities. Accurately diagnosing early stage lung cancer increases patient survivorship and reduces the cost of care on our health systems. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: ENB is now widely accepted as the recommended methodology to obtain lung tissue biopsies from peripheral regions of the lungs. With this technology and software, the providers ability will have better visualization of soft tissue objects (e.g. lung lesions), three-dimensional modeling of distances on imaging from two-dimensional imaging, ability visualize smaller nodules, use of technology to compensate for CT to body divergence and real time catheter location. Description of market research conducted and results or statement why it was not conducted: Market Research was conducted by search of VIP, GSA, FPDS and the Internet. Market Research determined that Covidien Sales LLC, a Medtronic company and their Authorized SDVOSB Distributors are the only providers of this requirement. This requirement will be purchased from their SDVOSB Distributor that offers the lowest price technically acceptable to the VA. 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. ____________________________ 05/28/2019 Gina P. Crank Date Contracting Officer NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (29-MAY-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/CoVAOPC757/CoVAOPC757/36C25019Q0853/listing.html)
- Record
- SN05325050-F 20190531/190529230023 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |