Medtronic_StealthStation_JEFO_-_FINAL_Redacted.pdf

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY (JEFO)

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment

Division, is the contracting activity.

(2) The action submitted for approval is a JEFO for the acquisition of the StealthStation System under Medtronic, Inc. Contract SPM2D1-13-D-8307, valid through October 2017.

(3) The required item is a neurosurgical image-guided stereotactic system with integrated three-dimensional (3D) imaging for the Naval Medical Center Portsmouth, VA (NMC Portsmouth). The total estimated dollar value of this action is .

(4) The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(b), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

Only Medtronic can meet NMC Portsmouth’s requirements for a spinal surgical image-guided stereotactic system with integrated mobile 3D imaging. The system is needed to replace the Medtronic StealthStation, which was being rented by NMC Portsmouth. NMC Portsmouth, as a major DoD Medical Center, is called upon to perform specialized neurosurgery procedures and needs the best clinical solutions to perform such procedures. The Medtronic StealthStation is the state of the art system to do this and improve the outcome of specialized spinal surgeries. The required spinal surgical image-guided stereotactic system is capable of real-time surgical navigation during spinal procedures and features a camera, and all instruments necessary for navigating spinal procedures. The system includes a mobile 3D imaging unit and a stereotactic system capable of conducting computed tomography (CT)-like scans of the full spine and features a flat panel detector with an area of at least 800 cm2, which is the size required to image the entire spine. These requirements were developed by the Navy based on clinical and patient need. Medtronic is the only known supplier under the DLA Radiology and Imaging Systems program that can offer a spinal surgical image-guided stereotactic system with mobile 3D imaging.

(5) The Medtronic StealthStation is available on the Medtronic, Inc. radiology Contract SPM2D1-13- D-8307. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing. The Contracting Officer determined that the subject procurement represents the best value to the Government.

(6) Market research performed by both the Navy and DLA Troop Support included review of information compiled by the Emergency Care Research Institute (ECRI), manufacturer product brochures, and a review of all vendors and products under our Radiology and Imaging Systems Program. It was determined that only Medtronic can offer a spinal surgical image-guided stereotactic system with mobile 3D imaging under the DLA Radiology and Imaging Systems program.

DLA Troop Support continues to perform market research on the availability of spinal surgical image-guided stereotactic systems with integrated 3D imaging. The results of the market research indicate that Medtronic is the only known supplier that can provide the necessary equipment and therefore meet the requirements of NMC Portsmouth.

(7) There are no other facts supporting the use of this JEFO.

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY (JEFO)

(8) We will continue to monitor our radiology program contract holders to ensure that we identify any new neurosurgical image-guided stereotactic system with integrated three-dimensional (3D) imaging system they develop and make sure the system is part of their contract. We will continue to monitor the market and in the event that another vendor outside our radiology program develops a similar system, we will encourage any such vendor to seek a contract under our radiology program.

(9) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge.