A.02_Sole_Source_Justification_Redacted.pdf

Control No: 19-RHCO-C-414

Version – February 2017 1

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Regional Health Contract Office-Central, Fort Carson Health Contracting Cell, 1681 Specker Ave, Building 1011, Fort Carson CO.

2. Description of Action: Oxinium Advanced Bearing System with oxidized zirconium

Nature: New Requirement Follow-on Requirement

Purchase Request: 11348194

Contract Vehicle: Purchase Order Number TBD

Pricing/Contract Type: Firm Fixed Price

Funds: DHP Operations & Maintenance, Army (OMA)

FY: 2019

Name of Proposed Contractor(s) and Address: Smith & Nephew, Inc.

1450 Brooks Rd.

Memphis, TN 38116

Brand Name Buy: X Yes No

3. Description of Services or Supplies: Evans Army Community Hospital is requesting a sole source contract to Smith and Nephew for the purchase of the Oxinium Advanced Bearing System with oxidized zirconium to be used by the Department of Surgery for Service Members requiring knee and hip arthroplasty surgeries with metal sensitivities.

Base Period: 1 October 2019 to 30 September 2020 Value:

Option Period 1: 1 October 2020 to 30 September 2021 Value:

FAR Clause 52.217-8 option: 1 October 2020 to 31 March 2021Value:

Total:

4. Authority: FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: The Department of Surgery, Orthopedic Section has a need for Oxinium Advanced Bearing System with oxidized zirconium implants to perform knee and hip arthroplasty surgeries with metal sensitive patients. The requested items are prescribed by the patient’s physician/surgeon and determined by

Version – February 2017 2 the physician to be the best suited to meet the medical, health, and life-style needs of the specific patent for whom it is required. Smith and Nephew is the patent holder and manufacturer of oxinium products.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 apply and will be followed.

7. Market Research: A Dynamic Small Business Search was conducted from Small Business Administrative website under the NAICS code 339112 using the keywords “orthopedic” and “implants.” The research shows there were sixteen (16) small businesses. Further research was conducted with the keywords “Oxidized Zirconium.”

The search results did not identify small businesses that carry Oxidized Zirconium orthopedic implants. A search of the Marketplace/internet; there are several manufacturers of artificial knee and hip implants, such as Smith and Nephew, Zimmer/Biomet, and Stryker. Of these manufactures, Smith and Nephew is the only one that carries the implants with oxidized zirconium. A sources sought notice was posted on FedBizOps on 6 to 13 May 2019. The notice generated zero (0) responses.

On 23 May 2019, the contract specialist contacted Smith & Nephew. The vendor stated they were the patent holder and manufacture of oxinium products.

8. Other Facts: These supplies were previously procured under Contract . The contract was awarded on 23 September 2018 under full and open competition. The current period of performance is 1 Oct 2018 to 30 Sep 2019.

9. Technical/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.

10. Contracting Officer Certification/Approval: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon the Independent Government Estimate, Market Research and Historical Contract Pricing.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Version – February 2017 3