A.01.09_St_Jude_Sole_DBA_Abbott_Medical_(4).pdf

Control Number: 18-RHCO-C-159

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: This requirement is for Brooke Army 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 W81K00-17-A-0015 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 for upcoming scheduled surgical procedures. Purchase request number 0011120057 has been provided with FY18 DHP funds.

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 8 Jan 2018 through 8 Mar 2018.

Period of Performance Estimated Total

15 Jan 2018 – 31 May 2018 $350,000.00

TOTAL AMOUNT $350,000.00

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

13.501(a)(1)(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 neurostimulation 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)

Neurostimulation supplies and implants for Brooke Army Medical Center (BAMC, Operating Room, JBSA‐ Fort Sam Houston, TX)

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

6. Efforts to Obtain Competition: A Sources Sought notice was posted to the government point of entry (FedBizOpps) on 11 Dec 2017. This notice resulted in one interested source response from Abbott

Medical, which is DBA; St Jude Medical. Therefore, the response provided by Abbott Medical meets the needs of the government.

a. Effective competition. It is anticipated that only one vendor is capable of meeting this particular requirement due to the dorsal root ganglions (DRG). St. Jude Medical offers and only neurostimulatin device designed for DRG therapy and targeted relief of certain difficult-to-treat chronic pain. DRG patients had an average of 81.4% reduction in their pain at 12 months.

b. Subcontracting competition. The requirement does not yield itself to any subcontracting opportunities based on the nature of the required product(s), results of the sources sought along with the historical data of procuring supplies of the type required.

7. Actions to Increase Competition: After contract award, this justification will be available at the Government Point of Entry, www.fedbizopps.gov. If in the future other compatible products/implants become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to award of any calls related to these reocurring requirements. Pricing, availability and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings.

8. Market Research: Market research was conducted via internet, brochures, literature review, a comprehensive analysis of different neurological implants, rods, cages, and other ancillary items as well as http://www.hoovers.com/, https://www.va.gov/nac/MedSurg/List, surgeon experiences and requirements, and historical usage data.

9. Interested Sources: A Notice of Intent to Sole Source this action to St. Jude Medical was posted to the

GPE on 11 Dec 2017. One response was received by Abbott Medical, which is DBA; St Jude Medical.

Future requirements of this type will be researched within the market to ascertain if additional vendors have entered the market offering the required products.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve information from the following computer records, contract files, competition advocate office files or other sources:

(1) Contract numbers and dates of the last several contracts for these same/similar requirements:

W81K00-17-A-0015, awarded on 01 October 2017

W81K00-17-A-0015-0001, awarded on 16 November 2017

W81K00-17-A-0015-0002, awarded on 22 November 2017 http://www.fedbizopps.gov/ http://www.hoovers.com/ http://www.va.gov/nac/MedSurg/List

Fort Sam Houston, TX)

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

W81K00-17-A-0015-0003, awarded on 01 December 2017

(2) The competitive status of these actions.

W81K00-17-A-0015, Full and Open Competition via FED BIZ OPPS

W81K00-17-A-0015-0001, awarded on 16 November 2017, Sole Source J&A <150K

W81K00-17-A-0015-0002, awarded on 22 November 2017,Sole Source J&A <150K

W81K00-17-A-0015-0003, awarded on 01 December 2017, Call made against single award BPA

(3) Authority previously cited if less than full and open competition was used.

None – Competed.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

No justification was prepared for the previous procurement (Call 0003).

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

(6) There have been no unusual patterns related to this requirement regarding urgency or competition.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated.

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Fort Sam Houston, TX)

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

SCOTT.LINDA.A.1009637059

Digitally signed by SCOTT.LINDA.A.1009637059

TREVINO.CAESAR.1126299466

11. Technical Certification:

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.

Digitally signed by

Signature: SCOTT.LINDA.A.1009637059 Da_te: 2_018_.01_.08 _10:3_4:5_8 -0_6'00_' Date: _8 Jan 2018_

Typed Name: Linda Scott 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: SCOTT.LINDA.A.1009637059 Dat_e: 20_18._01.0_8 10_:35:_24 -_06'0_0' Date: 8 Jan 2018

Typed Name: Linda Scott 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 15.403-1(b) (3).

TREVINO.CAESAR. Digitally signed by

TREVINO.CAESAR.1126299466

Signature: _1_1_2_62_9_9_4_6_6 Da_te_: 20_18_.01_.0_8 0_9:5_4:_20_-0_6'0_0' Date: 8 Jan 2018

Typed Name: Caesar Trevino Title: Contracting Officer

14. Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

TREVINO.CAESAR.112 Digitally signed by

Signature:6_2_99_4_66 D_ate_: 2_018_.01_.08_09_:54_:39_-0_6'0_0' _ Date: 8 Jan 2018

Typed Name: Caesar Trevino Title: Contracting Officer