W--Rental: Ventricular Assistance Device Support Equipment

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, VISN 12, William S. Middleton Memorial Veterans Hospital (Station 607). Transaction number 607-13-1-129-0001 and 607-13-1-129-0002. 2. Nature and/or Description of the Action Being Processed: The Transplant/Surgical Service is required to rent/purchase Thoratec VAD devices, and all supporting expendable items, for all heart transplant candidates who require mechanical support. The Dual Drive Console (DDC) system that is rented here is the controller for the Thoratec TLC ventricular assist device that helps to support the patient's cardiac function. Without the system, the result would be a dramatic drop in the cardiac output and thus put the patient at risk of cardiac failure and arrest. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The Madison VA is required to rent the Thoratec DDC as it is the only device that controls the Thoratec TLC VAD device. This VAD device is implanted in patients at the University of Wisconsin Hospital and Clinics and without the DDC portion of the system we would not be able to control the cardiac output of the patients. The device is rented on a monthly basis at $7,500.00/month. 4. Statutory Authority Permitting Other than Full and Open Competition: ( 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; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Thoratec VAD system is specifically requested since we currently have a contract with the University of Wisconsin Hospitals and Clinics (UWHC) for transplant services (Contract number VA69D-P-1750). Part of that contract includes the cost of the VAD device itself as well as the surgical procedure to implant and remove the device. UWHC only uses the Thoratec VAD system and we must procure devices and expendables that are compatible with the Thoratec system. The Thoratec system mentioned here is the only system that will be compatible for us to provide the necessary care and life support required for veterans requiring ventricular assistance. Our need is to provide the highest quality care in the most cost effective manner. Because patients are scheduled for this procedure with very little notice, our need for this equipment is usually of an urgent nature and we are compelled by the request from the Chief of Staff and Directors Office to emergently provide this equipment. Thoratec can provide this equipment within 24 hours which meets the needs of the patient, facility and contract with UWHC and they are the only VAD device that is FDA approved. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: None. No other system is compatible with the Thoratec VAD system. UWHC exclusively uses Thoratec devices and supplies and under our contract agreement with them we are required to use this product. 7. Determination by the Contracting Officer that the Anticipated Cost to the government will be Fair and Reasonable: The contracting officer anticipates the cost will be considered fair and reasonable and provides the following basis for this determination IAW FAR Part 13.106(a). Cost is deemed reasonable due to prior awards to Thoratec for the same/similar pricing and based on commercial catalog pricing available to the general public. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted pursuant to FAR Part 10. Market research revealed that Thoratec is the only company that is FDA approved. There are 9 prior actions for same/similar items on FBO. The Medical Staff at VA Madison and UW Madison currently use this equipment and are knowledgeable about the medical equipment available on the commercial marketplace thru medical conferences and networking. The medical staff are subject matter experts and they know there is no other company that can provide the needed equipment. No other companies were found on the internet that were compatible with Thoratec equipment that is implanted in patients. A search of the FDA revealed that Thoratec has the only FDA-approved LVAD for Destination Therapy, or permanent support. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The VA is required to use the Thoratec TLC DDC system as it is the only device that is compatible with the Thoratec TLC VAD device. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. 11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None. We are required to use the Thoratec TLC DDC system as it is the only device that is compatible with the Thoratec TLC VAD device. 12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide 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.