Description
The Department of Veterans Affairs, VA Boston Healthcare System, intends to negotiate a commercial (FAR Part 12) sole source contract with St. Jude Medical Inc. under the authority of FAR 6.302-1. Please refer to the Sole Source Justification. This is not a solicitation; it is notice of intent to sole source a requirement.Inquiries/information received after the established deadline shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.302-1. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1. Identification of the agency and the contracting activity. Electrophysiology Laboratory, Medical Service, V.A. Boston Healthcare System, West Roxbury, MA 2. Nature and/or description of the action being approved. Respectfully request the procurement of an U.S. Field Installation Kit for the EnSite Electro-anatomical Cardiac Mapping System. This software Registration Module enhances the existing hardware with Fusion capacity. The EnSite Fusion Kit and the Assurance Plus Warranty is solely available from St. Jude Medical, Saint Paul MN. 3. Description of the supplies or services required to meet the agency's needs (including the estimated value). This sophisticated software upgrade enhances a complex Electrophysiology Cardiac Mapping System which is already on station and in frequent demand for use in the Medical Service Division of the V.A. Boston Healthcare System. The EnSite Fusion Dynamic Registration feature enables the operating physician to optimize the anatomical fit acquired from the EnSite NavX cardiac navigation field to the CT model, providing precise delineation of dynamic cardio-thoracic anatomy in real-time interventional procedural settings. Comprehensive registration to the cardiac model is facilitated through Lesion Application, Anatomical Labeling, Voltage and/or Latency Activation Mapping as well as through Complex Fractionated Cardiac Potential Mapping, all resultant to this requested EnSite Fusion software upgrade. As an alternative to rigid cardiac registration systems, the EnSite Fusion upgrade offers Dynamic Registration, providing the Attending Medical Physician to actively make dynamic adjustments for size and shape of EnSite NavX anatomical field to precisely fit a 3-D CT Scan, a beneficial feature not available from alternative sources. Maximal system operating function is a unique by-product the Registration Tool upgrade brings to the St. Jude Medical EnSite Fusion Registration Module. St. Jude Medical S.C., Incorporated is the sole manufacturer and distributor of the EnSite NavX Fusion Registration Module. St. Jude Medical maintains sole proprietary rights to this software system upgrade. Failure to utilize this sophisticated software upgrade has the potential to adversely effect patient care and procedural outcomes, potentially resulting in patient mortality or worsening existing medical condition secondary to protracted procedural times. This purchase is advantageous to V.A. Boston Healthcare System. (Estimated Cost: $59,075.00) 4. Identification of the statutory authority permitting other than full and open competition. FAR 6.302-1 ONLY ONE RESPONSIBLE SOURCE 5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. The EnSite Fusion enhancement utilizes an EnSite NavX System DWS3 and version 7.0.1 field-scaled, multi-surface model as the base for registry with this level of detail and accuracy, facilitating system operation. The existing EnSite NavX Cardiac Mapping System currently possess these specifications, minimizing acquisition costs while providing a more intuitive electro-anatomical cardiac mapping system in the provision of optimal patient care under deleterious therapeutic interventions. EnSite Fusion precision facilitates transition between registered cardiac models and EnSite geometries while retaining acquired data. System function is maximized subsequent to software upgrade providing display of electrical information and labeling model facilitating medical diagnosis and efficacious treatment. Fiduciary diagnostic landmark mapping functions, including the MultiPoint Data Collection feature is inclusive of the entire range of cardiac maps appearing on the registered model. The EnSite Fusion Cardiac Navigation System allows for the most detailed mapping of cardiac anatomy available for the precise electrophysiologic interventional procedures performed in the E.P. Laboratory today, providing an unsurpassed technological advantage which is efficient, safe and informative. St. Jude Medical is the only vendor who makes and can provide this specific therapeutic software upgrade. 6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a Commerce Business Daily notice was or will be publicized as required by subpart 5.2 (copy attached) and, if not, which exception under 5.202 applies. a.) Biosense-Webster, Incorporated. b.) Boston Scientific Corporation. c.) Medtronic Corporation. 7. Determination by the contracting officer that the anticipated cost to the government will be fair and reasonable. Determination was conducted and the anticipated cost to the government is fair and reasonable based on commercial price for products would be $69,500.00 a discounted price for the government @ 15% total being of purchase is $59,075.00 8. Description of the market survey conducted (i.e., names of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted. A market survey was not conducted due to the fact that this is the only system currently available on the market capable of being used for our specific needs. These details of these unique features are described under 3 above. 9. Any other facts supporting the use of other than full and open competition, such as an explanation why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. Equipment previously procured, readily available and frequently utilized for complex ablative interventional procedures meets specifications for EnSite Fusion Registration Module with Dynamic Registration software upgrade, minimizing cost of this acquisition. The Medical Director of the Electrophysiology Laboratory has demonstrated the exponential increase of complex therapeutic procedures provided to the VISN 1 Veteran patient population in successful treatment of Congestive Heart Failure, CHF and Paroxysmal and Persistent Atrial Fibrillation, AF. As the primary referral center for Electrophysiology Services in VISN 1, this software acquisition promotes stateof-the-art care to care for the people who have served. The EnSite Fusion upgrade facilitates provision of patient care with the hope of minimizing increased morbidity and acute hospitalizations for the treatment of CHF and AF. 10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. None only one available source 11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. Contracting Activity will continue to encourage brand name or equivalent specifications.