Shockwave_JA Sole Source FAR Part 13 _Redacted final.pdf

CUI//SP-SSEL

Control Number:

CUI//SP‐SSEL

(Source Selection Information ‐ See FAR 2.101 and 3.104‐4)

1 1 SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Ossa Tron High Energy Extracorporeal Shockwave Therapy (ESWT) procedures, equipment, and support for Evans Army Community Hospital, Fort Carson, Colorado 80913

Authority: 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.

Amount: $

Prepared by:

Contract Specialist Email: Date: 01 August 2023

Contracting Officer:

Typed Name:

Date Reviewed: 01 August 2023 E-Mail:

Technical/Requirement Representative:

Title: Chief of Podiatry Date Reviewed: 01 August 2023

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

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2 2 SEP 2021

Command Advocate for Competition

Signature: Date:

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office – West

2. Description of Action: Evans Army Community Hospital (EACH), Fort Carson, CO 80913. EACH requests a non-personal service contract with Premier Shockwave, Inc.

DBA Premier Shockwave. The Government projects award for 01 September 2023.

This action will be accomplished for this acquisition using a Firm Fix Price (FFP) contract funded with Defense Health Program (DHP) Operation and Maintenance (O&M) FY23 funds.

3. Description of Supplies/Services: The Department of Surgery, Orthopedic Services at (EACH) has a need to provide for orthopedic and podiatry non-personal services to treat chronic tendonitis, fasciitis, and other related ailments. The requirement is for High Energy Extracorporeal Shockwave Therapy (ESWT) procedures, equipment, and support. Estimated dollar value of $ Period of Performance 15 Sep 2023 – 14 Sep 2026, with 52.217-8 that allows for an additional 6-month option, 15 Sep 2026 – 14 Mar 2027.

Base 15 SEP 23 – 14 SEP 24 $ Option 1 15 SEP 24 – 14 SEP 25 $ Option 2 15 SEP 25 – 14 SEP 26 $ Option 52-217-8 Est. 15 SEP 26 – 14 MAR 27 $

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: Shockwave is a service which requires a certified technician from Premier Shockwave to operate the OssaTron during medical procedures. The OssaTron is the only FDA approved high energy shock wave system that provides a non-invasive surgical alternative (requires anesthesia but no incisions) for patients diagnosed with chronic proximal plantar fasciopathy (severe heel pain), achilles tendonitis, patella tendonitis, and chronic lateral epicondylitis (tennis elbow) when these conditions have failed to respond to other treatments during medical procedures. This treatment is a one and done treatment that can allow for quick return to duty and to increase readiness for service members. It also significantly reduces the

Control Number: ‐ ‐ ‐

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3 2 SEP 2021

need for further surgical intervention.

Premier Shockwave Inc. is currently the owner of the “OssaTron” the only (ESWT) equipment that is FDA approved to treat chronic proximal plantar fasciopathy. The use of any other equipment could result in lowering the standard of care and in extreme cases may in further injury to the patient.

6. Efforts to Obtain Competition: A Source Sought Notice was issued on 14 June 2023 and closed on 21 June 2023. No interested sources responded. Premier Shockwave is the only nationwide mobile provider of the OssaTron: an FDA approved, Class III high-energy shockwave device that provides a non-invasive surgical alternative for physicians whose patients are diagnosed with chronic plantar fasciitis and/or lateral epicondylitis.

7. Actions to Increase Competition: For future actions, the Government will reassess the market for available vendors, including but not limited to, issuing a Sources Sought Notice to determine market availability for this requirement. A Special Notice of Intent for the proposed sole source award will be posted on Contract Opportunities for which any responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency for future requirements. EACH in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's services to provide items that are of the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries.

8. Market Research: Market research was conducted by assessing historic data from PIEE - EDA, FPDS, PCF, SBA-DSBS, and Sam.gov Government data bases. Available contract, CAR, Small Business Coordination (DD form 2579), J&A, and Basis for Award data was assessed. Market research revealed that the suggested vendor, Premier Shockwave Inc. a small business, was the only company that could provide all the products that are FDA certified that are needed for this requirement; as determined by the Department of Surgery, Orthopedic Services to meets the medical, health, and wellness of the patients.

9. Interested Sources: A sources sought notice was posted to https://SAM.gov from 14 June 2023 through 21 June 2023 with the minimum requirements and the draft performance work statement. There were no responses to the sources sought other than the preferred vendor. To date, no other sources have written to express interest in the acquisition.

10. Other Facts: Procurement history. Reasonable efforts were made to retrieve contract files, competition documents, and open-source information that is relevant to this requirement.

a. Procurement history. Reasonable efforts were made to retrieve contract files, competition documents, and open source information that is relevant to this requirement.

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(1) Contract numbers and dates of all awarded contracts for these same requirements.

Contractor Contract Contract Value Date Awarded Premier Shockwave, Inc.W81K0020P0079 $69,000.00 02 April 2020 Premier Shockwave, Inc.W81K0021P0020 $400,002.00 01 JAN 2020 Premier Shockwave, Inc.W81K0019P0232 $440,000.00 01 JUL 2019 Premier Shockwave, Inc.W81K0020P0314

(2) The competitive status of these actions.

$500,000.00 01 Oct 2020

The following contracts resulted in a sole-source award to Premier Shockwave, Inc.

W81K0019P0232 W81K0020P0079 W81K0021P0020 W81K0020P0314

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

Same authority used for this requirement.

(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.

Premier Shockwave, Inc. has been determined to be the only company that can currently provide the required FDA approved products that are needed for this requirement; as determined by the Department of Surgery, Orthopedic Services in order to meet the medical, health, and wellness of the patients.

(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.

There was only one response to the action, Premier Shockwave Inc. The contract specialist conducted current market research which noted that Premier Shockwave Inc. has the only FDA approved equipment to treat chronic plantar fasciitis (heel pain) and chronic lateral epicondylitis (tennis elbow). The Contract Specialist received only one response to the sources sought, Premier Shockwave Inc., a small business. Therefore, Premier Shockwave, Inc. has

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5 2 SEP 2021

been determined to be the only company that could provide all of the products that are needed for this requirement; as determined by the Department of Surgery, Orthopedic Services in order to meet the medical, health, and wellness of the patients.

Premier has provided a sole source letter stating that they own 70 of 72 know OssaTron devices in the U.S. and they are the sole nationwide mobile provider of services.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

There are no unusual patterns of consecutive purchases.

(7) 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.

There are no unusual patterns of consecutive purchases.

b. Other facts. Premier Shockwave, Inc. has been determined to be the only company that can currently provide the required FDA approved products that are needed for this requirement; as determined by the Department of Surgery, Orthopedic Services in order to meet the medical, health, and wellness of the patients.

11. Technical/Requirement Certification:

P

Date:

Typed Name: Title: Chief of Podiatry

12. Fair and Reasonable Cost Determination:

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

This determination will be made using the following: propriety and historical acquisition data.

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Signature:

. 20413677

Date:

‐05'00'

Typed Name: Title: Contracting Officer

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1. Contracting Officer Certification:

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

Signature:

.1 Date:

31:

Typed Name: Title: Contracting Officer

Control Number: ‐ ‐

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7 2 SEP 2021

Approval

Based on the foregoing justification, I hereby approve the procurement of (Ossa Tron High Energy Extracorporeal Shockwave Therapy (ESWT) and total dollar value $ on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501 and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Title: Command Advocate for Competition