JEFO- Medtronic Stealth Station ENT Cart - 10-6-20 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 two surgical navigation systems under Medtronic contract SPM2D1-19-D-0018.

(3) The required items are hardware and software neurosurgical intracranial surgical navigation systems (Stealth Station ENT Cart Kits) for Brooke Army Medical Center (BAMC). 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. The surgical navigation system identified above is the only product that can meet the customer’s needs.

This procurement is necessary to meet Government requirements for surgical navigation systems to be used for sinus and brain surgical procedures at Brooke Army Medical Center. The required items are highly complex medical devices that are mainly software driven and only provided by Medtronic.

The Stealth Station ENT Cart Kit provides unique features including patient registration software and advanced visualization with 3D electromagnetic tracking capabilities. This proprietary software creates tumor models, allows for rapid visualization of anatomy and structures, and can merge radiographic images from CT, SPECT, MRI, MRA, PET, functional MRI and O-Arm equipment currently at BAMC. Seamless integration between the Stealth Station ENT Cart Kit and the existing Medtronic O-Arm is necessary for deep brain stimulation procedures. Only Medtronic can offer this seamless integration due its proprietary software. Further, the Medtronic Stealth Station is the only platform that can be used by multiple surgical platforms including neurosurgery, otolaryngology, and spine surgery, and able to utilize passive tracking as well as active tracking. Active tracking provides the ability to precisely track in real-time the location of surgical instruments throughout a procedure. Active tracking is a required capability for patient care because it is critical in treating extensively injured patients including trauma patients transported in from contingency operations.

Medtronic is the only vendor that offers the surgical navigation system identified above that can meet the requirements of BAMC for a hardware and software neurosurgical intracranial surgical navigation system to be used with the existing Medtronic equipment at BAMC. No other vendors offer equipment with all the above required surgery capabilities.

(5) The Medtronic items required are available on the Medtronic radiology contract SPE2D1-19-D-

0018. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing and other than cost or pricing data. The Contracting Officer determined that the subject procurement represents the best value to the Government.

(6) DLA Troop Support continues to perform market research on the availability of surgical navigation systems. The results of market research indicate that presently, Medtronic is the only known supplier that can meet the requirements of Brooke Army Medical Center. No other Radiology program contract holders offer all required cranial surgery, spinal neurosurgery, and endoscopic

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY (JEFO)

sinus surgery capabilities such as Chiari surgery, pituitary tumor removal, tumor resection or biopsy, and shunt placement.

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

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

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s minimum needs and that this justification is accurate and complete to the best of my knowledge.