J_&_A_Sole_Source_Apr_4_Redacted.pdf

Control Number:

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: This requirement is for Brooke Anny Medical Center (BAMC), Operating Room,.JBSA - Fort Sam Houston, TX. 78234

2. Description of Action: The Regional Health Contracting Office - Central requests approval to place a BPA call under W8 l K00-17-A-OO 15 with St. Jude Medical, with a maximum call amount not to exceed $350,000.00. The call will provide BAMC with various neuromodulation implants and supplies.

3. Description of Supplies/Services: Brooke Army Medical Center (BAMC) has a requirement for St.

Jude Medical manufactured neuromodulation supply and implants. This request provides for surgical case support by providing for products necessary for pain management of spinal injuries by means of spinal cord stimulation. The result is relief from chronic pain caused by disease or injury without the need for full surgical correction that is both costly and much more involved for the patient in terms of recovery and rehabilitation. Products required cover neuromodulation surgery supply as well as trauma neuromodulation surgery supply. When needed, instrumentation should be made available 48 hours in advance to support the consumable stock needed and picked up 24 hours after surgical case is completed. The period of performance for this call is 4 April 2018 - 4 May 2018.

'Period of Performance Estimated Total

April 2018-4 May 2018 $350,000.00 rroTAL AMOUNT $350,000.00

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation

13.50 l (a)(l)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items".

5. Reason for Authority Cited: Dorsal Root Ganglion (DRG) is the anatomic location in the spine where the spinal nerve bodies lie. Stimulation of this region has resulted in near complete pain reduction in patients with painful neuropathic pain such as CRPS. St. Jude Medical offers the only neuro-stimulation device designed for DRG therapy and targeted relief of certain difficult-to-treat chronic pain. The products offered by St. Jude Medical is required because no other company has the capability to effectively stimulate this region of the spinal cord. There is no other option for stimulation of the dorsal root ganglion. While other forms of spinal cord stimulation such as dorsal column stimulation are available, these have historically failed in controlling CRPS pain, groin/pelvic pain, and pain of the feet.

Whereas DRG stimulation has been shown to be superior for such purposes. This is a clinical decision to choose the most appropriate therapy ( dorsal root ganglion over dorsal column) for the patient's pain pathology. Once DRG stimulation is identified to be the most effective therapy for that pathology, St.

Jude Medical is the government's only option.

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number:

Neurostimulation supplies and implants for Brooke Army Medical Center (BAMC, Operating Room, JBSA

Fort Sam Houston, TX)

11. Technical Certification:

I certify that the supporting data under !DY cognizance, which are included in the justification are accur te and complete to the best of my knowledge and belief.

Typed Name: Title: Deputy Chief, Supply Chain Management Branch

12. Requirements Certification: Include the following statement:

I certify 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.

Signature: Date: 3April 2018

Typed Name: Title: Deputy Chief, Supply Chain Management Branch

Only the most senior persons within the organization responsible for acquiring the supplies or services described in the justification (e.g. program manager, depot commander, or senior program engineer) and with specific knowledge of the individual requirement (commodity, technology, and/or function) shall sign the technical and requirements certifications.

13. Fair and Reasonable Cost Determination: Include the following determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The IGE, historical procurement data and market research was used to determine that the price was fair and reasonable. Certified cost or pricing data is not required per FAR 15.403-l(b) (3).

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Typed Name: Title: Contracting Officer

14. Contracting Officer Certification: This certification shall be made by the contracting officer who certify

: Contracting Officer

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

3 April 2018