Limited Sources J A-final _ redacted.pdf

Control Number: 19-RHCO-C-33

For Official Use Only

(See FAR 2.101 and 3.104-4)

(25 February 2016)

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 intends on issuing a sole source Blanket Purchase Call (BLA) to Boston Scientific against established Blanket Purchase

Agreement (BPA) W81K00-17-A-0014. The call will provide BAMC with various neuromodulation implants and supplies for upcoming scheduled surgical procedures. Purchase Request (PR) number

0011417995 in the amount of $350,000 has been provided for this requirement. Government Purchase

Card (GPC) payments are authorized and FY20 funds have been certified in the amount listed on the PR.

3. Description of Supplies/Services: Spinal Cord Stimulators (SCS) Implants are 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. The delivery period for this call will not exceed 3 months and the estimated total value is Not to Exceed (NTE) $350,000.

Model Description

SC-1132 Spectra Implantable Pulse Generator (IPG)

SC-1140 Precision NOVI Implantable Pulse Generator (IPG)

SC-1160 WaveWriter Implantable Pulse Generator (IPG)

SC-1200 Montage MRI Safe Implantable Pulse Generator (IPG)

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: This Boston Scientific implant is a physician prescribed surgically implanted medical device specifically suited to meet the needs of the patient. These devices were chosen because in the surgeon’s opinion, they meet specific requirements and will provide the desired surgical outcome. The surgery is to treat chronic pain in varied locations of the body following an injury, trauma, or surgical procedures, and often used in cases where no relief is obtained following traditional neurostimulation, surgery, pain medications, nerve blocks or other pain management therapies. The physician prescribed these implants because the Boston Scientific Spectra WaveWriter is the first SCS system designed to personalize pain relief through the power of combination therapy and the simplicity of waveform automation. The Spectra WaveWriter SCS System is engineered to automatically rotate through waveforms to help simplify personalization and deliver the most effective therapies with the lowest energy usage from the time implanted and as pain changes over time.

(25 February 2016)

The Spectra WaveWriter SCS System's Contour Field Shaping Algorithm delivers sub- perception therapy by shaping the stimulation field over multiple vertebral levels to each patient's individual spinal anatomy.

The Spectra WaveWriter SCS System is the first SCS system with combination therapy and has the ability to layer waveforms simultaneously. The particular supplies being requested have been deemed a medical necessity for patients in order to layer more than one therapy at the same time and deliver multiple therapies over time, combination therapy is designed to provide more thorough and longer-lasting relief to patients.

The intended contractor has the physician prescribed products available and can meet the timeline needed for this requirement.

An amount of NTE $350,000.00 represents BAMC's estimated usage utilizing direct vendor delivery and just-in-time inventory business processes. The estimate was based on the total amount of real time currently scheduled cases at the BAMC Military Treatment Facilities (MTF). In addition, the increase in patient population needing chronic pain therapy has led to increases in expenditures leading into FY19.

6. Efforts to Obtain Competition: - Solicitation Number W81K00-17-T-0426 was posted to FEDBIZOPS on 22 September 2017. Two (2) quotes were received (Boston Scientific, St Jude Medical S.C.

Incorporated). The technical evaluation and the Source Selection Participation Agreement determined that the quotation submitted by Boston Scientific and St Jude Medical S.C. Inc., met the technical specifications stated in the solicitation and therefore was technically acceptable.

The solicitation resulted in a multiple award blanket purchase agreement’s (BPA), W81K00-17-A-0014

(Boston Scientific) & W81K00-17-A-0015 (St Jude Medical) for Neuro-modulation.

a. Effective competition. It is anticipated that only one vendor is capable of meeting this particular requirement due to the proprietary nature of the supply item. Boston Scientific has been capable of meeting the requirement, and it is unlikely any other vendor will be capable of meeting this requirement.

b. Subcontracting competition. The requirement does apply in accordance with FAR 19.702(a)(1).

7. Actions to Increase Competition: After award, this justification will be available at the GPE, www.fedbizopps.gov. If in the future other compatible products 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 the any renewal related to this requirement. Pricing, availability and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings http://www.fedbizopps.gov/

8. Market Research: Market research was conducted via; internet, brochures, literature review, a comprehensive analysis of different neurological implants, rods, cages, and other ancillary products found on (https:/www.va.gov/nac/MedSurg/List and Federal Supply Schedules), surgeon experiences and actual historical data usage. However, this research did not reveal any other sources comparable to the

SCS implants requested and did not meet the surgical requirements.

9. Interested Sources: A Notice of lntent to Sole Source this action to Boston Scientific was posted to the GPE on 05 December 2019. No responses were received. 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:

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

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

W81K00-17-A-0014 – BPA Call - W81K00-18-F-0185, awarded on 10 Aug 2018

W81K00-17-A-0014 – BPA Call - W81K00-18-F-0193, awarded on 13 Aug 2018

W81K00-17-A-0014 – BPA Call - W81K00-19-F-0069, awarded on 15 Nov 2018

W81K00-17-A-0014 – BPA Call - W81K00-19-F-0101, awarded on 13 Feb 2019

W81K00-17-A-0014 – BPA Call - W81K00-19-F-0189, awarded on 21 Jun 2019

2) The competitive status of these actions.

W81K00-17-A-0014, Competition via FED BIZ OPPS, Full and Open

W81K00-18-F-0185, Approved J & A

W81K00-18-F-0193, Approved J & A

W81K00-19-F-0069, Approved J & A

W81K00-19-F-0101, Approved J & A

W81K00-19-F-0189, Approved J & A

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

Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

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.

Full and Open competition was used to establish BPA W81K00-17-A-0014. All calls have been justified and approved under Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

http://www.va.gov/nac/MedSurg/List

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.

No change in circumstances. BPA calls are supported by approved J&As under the authority Federal

Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

6) Historical Acquisition Information in procuring supplies of this type:

No change in circumstances. BPA calls are supported by approved J&As under the authority Federal

Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

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

8) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

No significant changes. Full and Open competition was used to establish BPA W81K00- 17-A-0014.

All calls have been justified and approved under Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

b. Other facts. None.

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.

Signature:

Typed Name: Mariam K Sabas

Title: Perioperative Logistics Coordinator Email:

mariam.k.sabas.mil@mail.mil

12. Requirements 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.

Typed Name: Mariam K Sabas Title:

Supply Technician

Email: mariam.k.sabas.mil@mail.mil

13. Fair and Reasonable Cost Determination:

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

Typed Name: Sonja M. Hagins Title:

Contracting Officer

Email: sonja.m.hagins.civ@mail.mil

14. Contracting Officer Certification:

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

Typed Name: Sonja M. HAGINS Title:

Contracting Officer

Email: sonja.m.hagins.civ@mail.mil mailto:mariam.k.sabas.mil@mail.mil mailto:mariam.k.sabas.mil@mail.mil mailto:sonja.m.hagins.civ@mail.mil mailto:sonja.m.hagins.civ@mail.mil