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65--FLOTRAC/VIGILEO CABLE TO CONNECT AND POLE (EDWARDS LIFE SCIENCES) UNIQUE SOURCE

Solicitation Number:
Agency: Department of Veterans Affairs
Office: VA Caribbean Health Care System
Location: Department of Veterans Affairs Caribbean Health Care System
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Special Notice
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Added: Apr 29, 2010 6:44 am
DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval



For



Other Than Full and Open Competition





1. Contracting Organization: Department of Veterans Affairs, VISN 8, VACHS Medical Center



2. Description of Action: This is a request for other than full and open competition for the procurement of FLOTRAC SENSOR, VIGILEO CONTINOUS CARDIAC OUTPUT MONITOR; POLE MOUNT AND PATIENT CABLE.





3. Description of Supplies or Services: FLOTRAC SENSOR, VIGILEO CONTINOUS CARDIAC OUTPUT MONITOR, POLE MOUNT AND PATIENT CABLE.



Statutory Authority: FAR 6.302-1 (b) (2) the existence of limited rights in data, patent rights, copyrights, or secret processes;

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability

or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;



4. Validity of Use of Statutory Authority The new FloTrac sensor has been launched in the U.S. by Edwards Lifesciences Corporation (NYSE:EW) manufacturer and the world's leader in hemodynamic monitoring technology. The sensor, which connects to a catheter that is usually already in place in many critically ill patients' arteries, works with Edwards' new Vigileo monitor to combine data from the arterial pressure line with other patient parameters to automatically calculate a patient's cardiac output on a continuous basis.

A significant population of critically ill Americans may benefit from a unique, minimally invasive heart monitoring

device recently cleared for sale by the U.S. Food and Drug Administration

The new technology was designed to enable clinicians to more easily monitor patients' conditions in a critical care setting.





5. Actions to Promote Competition : None available.



6. Determination of Fair and Reasonable Price: The anticipated price to the Government is $39,240.00 this price is the same as items sold on substantial quantities to the general public.





7. Market Survey (FAR 10) Shows that this item is under patent hold by Edwards Lifesciences.



8. Listing of Sources that expressed, in writing, an interest in the acquisition: Edwards Lifesciences



9. Statement of Actions to Overcome Barriers to Competition: non existing see line item 8









10. Requirements Certification: I certify that the requirement outlined in this justification is a bonafide need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.



____________________ April 8, 2010

Pedro Soto Date

Chief Pulmonary

VACHS San Juan



13.Approvals in accordance with FAR 6.304



a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.



___________________________ April 8, 2010

Rolando Arce Date

Purchasing Agent

VACHS San Juan





b. Legal Review: I certify that the foregoing justification meets all of the statutory requirements for other than full and open competition.



___________________________ ___________________

Name Date

Title

Facility







c. One Level above Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. *This signature may be the VISN NCM if the Contracting Officer and Contracting Supervisor is the same individual.







_____________________________ ________________________

Name Date

Title

Facility



d. NCM : I certify the justification meets requirements for other than full and open competition.









___________________________ ___________________

Name Date

NCM

VISN 8







e. SAO East: I certify the justification meets requirements for other than full and open competition.









___________________________ ___________________

Jeffrey Ryan Date

Director

SAO East





f. VHA HCA's Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (over $50 million), approve (up to $ 50 million) for other than full and open competition.







______________________________ ________________________

Joseph A. Williams, Jr. RN, BSN, MPM Date

Head of Contracting Activity (HCA)





g. VHA Senior Procurement Executive Approval (over $50 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.
:
Department of Veterans Affairs;P&C Business Office;Tres Rios Blvd;27 Gonzalez Giusti Ave, Suite 600;Guaynabo PR 00968
:
Rolando ArcePurchasing Agent
(787)781-8700 Ext 4714

ROLANDO.ARCE@VA.GOV