65--Lease of Ventricular Assistance Devices

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, NCO 12, Great Lakes Acquisition Center. Justification for Other than Full and Open Competition for the Madison VA Hospital, transaction number 607-13-1-129-0003. 2. Nature and/or Description of the Action Being Processed: The Madison VA Hospital requires the lease and purchase of VAD support equipment for use with heart transplant candidates. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The Madison VA Hospital Transplant/Surgical Service is required to rent/purchase Thoratec VAD system supporting equipment and expendable items, for all heart transplant candidates who require mechanical support. VAD devices are implanted in patients at the University of Wisconsin Hospital and Clinics and the supporting equipment must be compatible with devices in order to sustain the cardiac function of the patients until a heart transplant is performed. 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; 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 due to the Madison VA's contract with the University of Wisconsin Hospitals and Clinics (UWHC) for transplant services (Contract number VA69D-P-1750). UWHC only uses the Thoratec VAD system for heart transplant surgeries and the Thoratec LVAD device is the only one that is FDA approved. Consequently, we must lease devices and procure expendables that are compatible with the Thoratec system. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A notice of intent to sole source this procurement was posted to FedBizOpps.gov. No other equipment is compatible with the Thoratec VAD system. As previously stated, 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 13.106-3(a)(2). 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. Thoratec is the only company that is FDA approved. 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 is 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 website 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: None. 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 supporting equipment as it is the only equipment that is compatible with the Thoratec VAD system. 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.