DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA251-16-AP-0955 1. Contracting Activity: Department of Veterans Affairs, VISN 10 West, Ann Arbor Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105. 2. Nature and/or Description of the Action Being Processed: Sole source justification to Elekta for firm-fixed price contract. Stereostatic System to support Deep Brain Stimulation treatment. 3. Description of Supplies/Services Required to Meet the Agency's Needs: This is a positioning system for Deep Brain Stimulations (DBS). It is mechanical and is designed to very specifically support DBS procedures. This positioner could support other neurological cases, but other positioners cannot support DBS procedures. Estimated value is $186,495.68. Delivery Date is 30 days after date of award or sooner. The complete system consists of Frame G Kit, Stereotactic Arc, MR-Indicator, Open CT-Indicator, Cross Hairs Kit, Clamps, Adapters, CT-Table, installation and training. 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): DBS procedures probe deep into the brain and place stimulators into the brain in order to treat disorders such as Parkinson's Disease or brain injuries. The positioning system must be extremely precise and not interfere with the imaging equipment used to place the stimulator. This is the only positioner known to either this VA or the Surgeons who will conduct these procedures. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An internet search was conducted using the following terms: a. Deep Brain Stimulation positioner b. Deep Brain Stimulation positioning c. Deep Brain Stimulation equipment None of the searches identified any positioner options within the first two search pages. Sources Sought was conducted on GSA eBuy, with zero responses. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: There is no indication that the quoted price is unreasonable. There is government discount included of $7,819.32. FA860115P0081 purchase through the Department of the Air Force with same system purchases in Feb 24, 2015. IAW FAR 13.106-3 price was found reasonable on this previous purchase. 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 with no other company identified that can provide similar equipment. As described in Section VI above, market research, in accordance with FAR Part 10, was conducted by posting on GSA eBuy with zero responses. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The surgeons who perform these procedures also perform these procedures at the medical affiliate, The University of Michigan Health System and use the same equipment as this request. It is safer for patients when the surgeons have an intimate knowledge of the equipment they are using. The VAAAHS does not wish to inject any possible confusion about equipment usage into any surgical suites and believes that this request is in the best interest of the patient. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None found. Equipment was posted on GSA eBuy with zero responses. 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: DBS is still a new technology with limited suppliers. As the practice becomes more common and equipment more available, VAAAHS will consider other equipment options. 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. Jeffery K. Thomas Digitally signed by Jeffery K. Thomas DN: cn=Jeffery K. Thomas, o=VAAAHS Ann Arbor, ou=Pharmacy Service, [email protected], c=US Date: 2016.01.22 14:16:08 -05'00' January 22, 2016 Jeffery K. Thomas Date Program Analyst/COR VAAAHS Ann Arbor, MI Station 506 13. Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. a. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Darrell T. Digitally signed by Darrell T. Maxwell 1011049 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=darrell.maxwell@v a.gov, cn=Darrell T. Maxwell 1011049 Date: 2016.01.22 14:30:28 -05'00' Darrell T. Maxwell Date Contract Specialist NCO 10 West, Ann Arbor, MI b. Director of Contracting /Designee (Required $150K and above): I certify the justification meets requirements for other than full and open competition. James J. Hallock 320728 Digitally signed by James J. Hallock 320728 DN: dc=gov, dc=va, o=internal, ou=people, [email protected], cn=James J. Hallock 320728 Date: 2016.01.25 05:47:09 -05'00' James Hallock Date Supervisor Contracting Officer NCO 10 West, Indianapolis, IN

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