SPECIAL NOTICE
65 -- Biosense Webster Carto XP System - Justification and Approval - FAR 6.302-1
- Notice Date
- 6/10/2009
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs, Brecksville (Cleveland) VAMC, Department of Veterans Affairs Medical Center, Department of Veterans Affairs;Brecksville Division;Cleveland VA Medical Center;10000 Brecksville Road;Brecksville, Ohio 44141
- ZIP Code
- 44141
- Archive Date
- 8/9/2009
- Point of Contact
- Andy NeissContract Specialist Intern<br />
- E-Mail Address
-
Contract Specialist Intern
(andy.neiss@va.gov)
- Small Business Set-Aside
- N/A
- Description
- Louis Stokes ClevelandDepartment of Veterans Affairs Medical Center VISN 10 Contracting Management Justification and Approval for Other than Full and Open Competition Upon the basis of the following justification, the use of other than full and open competition for the proposed contract action is hereby recommended for approval pursuant to the authority of 41 U.S.C. 253(c) (1), and FAR 6.302-1, only one responsible source. 1.Identification of Agency and Contracting Activity The Louis Stokes Cleveland, Department of Veterans Affairs Medical Center (VMAC), Brecksville, Ohio, 44141, VISN 10 Contracting Activity, Acquisition Management Service 2.Nature/Description of Action This activity proposes to use sole source procurement procedures to purchase a Carto XP Navigation System from Biosense Webster for the Wade Park Cardiac Lab. 3.Description of Supplies/Services The Carto XP Navigation System is an electroanatomical navigation system used to view the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. It is a irrigated cardiac catheter ablation system that will be used for catheter ablation of atrial fibrillation. 4.Identification of Statutory Authority (X) 41 U.S.C. 253 (c) (1) Only One Responsible Source ( ) 41 U.S.C. 253 (c) (2) Unusual and Compelling Urgency ( ) 41 U.S.C. 253 (c) (3) Industrial, Mobilization, Engineering, Developmental, or Research Capability or Expert Services ( ) 41 U.S.C. 253 (c) (4) International Agreement ( ) 41 U.S.C. 253 (c) (5) Authorized or Required by Statute ( ) 41 U.S.C. 253 (c) (6) National Security ( ) 41 U.S.C. 253 (c) (7) Public Interest 5.Demonstration of Contractor's Unique Qualifications This is the only system that uses ablation catheters approved for atrial fibrillation by the FDA. Recently, other catheters, such as St. Jude, (previously approved for Biosense Webster and Hansen Medical Systems) were found to cause life-threatening complications when performing catheter ablation of atrial fibrillation. We currently have the Hansen Medical cardiac catheter system, so this system will no longer be used to perform catheter ablation of atrial fibrillation. 6. Publicized Requirements The intent to sole source notice will be posted on FBO. 7.Determination of a Fair and Reasonable Cost The list price for all equipment for this system, as well as a one year service agreement is $477,000.00. The price being offered to the government is $253,000.00. 8.Market Survey The FDA adverse event report for the Hansen Medical catheter ablation system, as well as the FDA letter approving the Biosense Webster catheters were sent to the contract specialist intern. In addition, an article was found that confirmed that these are the first and only ablation catheters approved for the treatment of atrial fibrillation. 9.Other Supporting Data None 10. Actions taken to remove barriers to competition None 11. Acquisition Plan: An Acquisition Plan ( ) is (X) is not required for this acquisition. 12. IT Approval: IT Approval ( ) is (X) is not required for this acquisition. If it is, include appropriate approvals. The assertions and recommendations in support of the justification have been prepared by: _______________________________________________________________________ Technical Representative Date Phone Contracting Officers Certification The Contracting Officer has determined that the justification is accurate and complete to the best of the Contracting Officer's knowledge and belief. __________________________________________________ __________________ Contracting Officer Not exceeding $500K Date ______________________________________________ _______________ One Level above Contracting Officer, Exceeding $500K Date CONCURRED BY: _____________________________________________________________________ Head of Contracting Activity Over $500K not exceeding $10 MilDate
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/36ccff226e30f7a5ace182c4968a3b67)
- Record
- SN01841484-W 20090612/090610235710-36ccff226e30f7a5ace182c4968a3b67 (fbodaily.com)
- Source
-
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