FAR-Part13-5-Sole-Source-JA_ACC shockwave_Redacted.pdf

Control No: 21-RHCO-C-30 Contractor Premier Shockwave Inc.

Program/Equipment: High Energy Extracorporeal Shockwave Therapy (ESWT)

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: High Energy Extracorporeal Shockwave Therapy (ESWT) procedures, equipment and support for General Leonard Wood Army Community Hospital, Fort Leonard Wood, MO 65473

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $ for a base and four options and IAW FAR 52-217-8, pricing for the six-month option for a total proposed dollar amount of $ .

Prepared by: DSN:

Contract Specialist Date: 19 August 2020 Email:

Contracting Officer: DSN:

Contracting Officer Date: 19 August 2020 Email:

Technical: Office:

Chief of Podiatry Date: 19 August 2020 Email:

Requirements: Office:

Chief of Podiatry Date: 19 August 2020 Email:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole

Source Justification and Approval

1. Contracting Activity: Region Health Contracting Office-Central

2. Description of Action: General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, MO 65473 requests a non-personal services contract with Premier Shockwave, Inc. DBA Premier Shockwave. The Government projects award for October 2020 and fiscal year 2021. This action will be accomplished for this acquisition through the use of a non-personal services FFP contract funded with Defense Health Program (DHP) Operation and Maintenance (O&M) funds.

� An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: The Department of Surgery, Orthopedic Services at GLWACH 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.

For Actions with Options*:

Base Period: 10/01/2020 to 09/30/2021 Value: $100,000.00 Option Period 1:10/01/2021 to 09/30/2022 Value: $100,000.00 Option Period 2:10/01/2022 to 09/30/2023 Value: $100,000.00 Option Period 3:10/01/2023 to 09/30/2024 Value: $100,000.00 Option Period 4:10/01/2024 to 09/30/2025 Value: $100,000.00 FAR Clause 52.217-8 option: 10/01/2025 to 03/31/2026 Value: $50,000.00 Total: $550,000.00

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Other: FAR Subpart 13.5: Only one source currently available to provide the requested Government services.

5. Reason for Authority Cited:

The requirement is to treat chronic tendonitis, fasciitis and other related ailments. The requirement is for High Energy Extracorporeal Shockwave Therapy (ESWT) procedures, equipment and support. The OssaTron is a high energy shock wave system that provides a non-surgical alternative for patients diagnosed with chronic proximal plantar fasciopathy (severe heel pain) and chronic lateral epicondylitis (tennis elbow) when these conditions have failed to respond to other treatments.

https://en.wikipedia.org/wiki/Shock_wave https://en.wikipedia.org/wiki/Lateral_epicondylitis

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

In accordance with FAR 15.403-1(b)(3) certified cost or pricing data is not required for acquisition of commercial items.

Currently W81K0019P0339 is in place for this service at GLWACH. The current requirement at GLWACH was solicited as a 100% small business set aside as the contract specialist noted that at the time there were two (2) or more small businesses that could meet the Government’s requirements. Solicitation W81K0019Q0261 was put on the Government Point of Entry from 6 August 2019 through 20 August 2019. A singular vendor responded to the solicitation and a purchase order was awarded for one year only for a total dollar value of $100,000.00. Currently there are several other MTF’s that have this particular equipment in place and have made the procurement as a sole source action as there have been no other businesses that can currently meet the FDA requirements and are FDA approved to treat chronic plantar fasciitis (heel pain) and chronic lateral epicondylitis (tennis elbow).

6. Efforts to Obtain Competition:

a. Effective Competition: Premier Shockwave Inc. is currently the only vendor with the Extracorporeal Shock Wave Technology (ESWT) system approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple orthopaedic conditions.

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 brand name, or equal requirements. A Special Notice of Intent for the proposed limited source award will be posted on Federal Business Opportunities for which any responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency for future requirements. CRDAMC in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's services in order 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: A sources sought notice was posted to https://beta.SAM.gov from 20 July 2020 through 27 July 2020 with the minimum requirements and the draft performance work statement. There were no responses to the sources sought other than the preferred vendor. Further market research revealed that the suggested vendor, Premier Shockwave Inc. small business, was 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 to meets the medical, health, and wellness of the patients.

https://en.wikipedia.org/wiki/Lateral_epicondylitis https://en.wikipedia.org/wiki/Plantar_fasciitis https://en.wikipedia.org/wiki/Lateral_epicondylitis https://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administration https://beta.sam.gov/

9. Interested Sources: A sources sought notice was posted to https://beta.SAM.gov from 20 July 2020 through 27 July 2020 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:

a. Procurement History

W81K0019P0339 General Leonard Wood Army Community Hospital 1 October 2019 through 30 September 2020

The competitive status of this action, FFP, full and open.

The previous contract was accomplished using full and open competition. There was only one response to the previous 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, Prdoesnemier Shockwave Inc., a small business.

Therefore, Premier Shockwave, Inc. has 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.

(End of page) https://beta.sam.gov/ https://en.wikipedia.org/wiki/Plantar_fasciitis https://en.wikipedia.org/wiki/Lateral_epicondylitis

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.

Typed Name: Date:

Title: Chief of Podiatry Signature:

X Right-Click "Signature Setup"

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: Date:

Title: Chief of Podiatry Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price 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.

Typed Name: Date:

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Contracting Officer Signature: