0029 - JA - Kemper.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C250-26-AP-0255

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-25-AP-2899

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland Medical Center Network

Contracting Office (NCO) 10.

2237: 541-26-1-575-0029

2. Nature and/or Description of the Action Being Processed: This award is for a firm-fixed price contract for a Mako Robotic Arm System Service Agreement with Stryker Corporation, in accordance with FAR 13.5 Simplified Procedures for Certain Commercial items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This action will be awarded as a new contract.

Description of Supplies/Services Required to Meet the Agency’s Needs: This acquisition is for a new firm-fixed-price service agreement with Stryker Corporation for a Mako Robotic Arm Agreement. The Mako Robotic Arm System enhances orthopedic procedures such as knee and hip replacements by providing surgeons with advanced pre-operative planning and real-time, intra-operative guidance. The period of performance will be for one year with four option periods. The estimated value of the proposed acquisition is $598,000.00.

3. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

4. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the

Authority Cited Above (applicability of authority): Stryker Corporation is the only firm in existence capable of providing the hardware and service support implementation described in Section III above without the Veterans Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition. There would be unacceptable delays in fulfilling this requirement though a different source.

This is the only vendor found through market research that offers this solution. Stryker Corporation has the proprietary software and hardware currently in use with which this implementation must interface. Stryker Corporation has provided an endorsed proprietary letter on company letterhead demonstrating there are no other qualified businesses capable of working on their equipment. It is imperative to keep the system functioning at its

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C250-26-AP-0255 best in order to provide orthopedic services to our veteran patients, and at this time it can only be achieved through Stryker Corporations solution.

5. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Stryker Corporation is the sole provider of the services requested in this contract because of the proprietary nature of its services. Checks were made to ensure there were no available agreements on FSS or GWAC listings. This action will be solicited as an intent to sole source with Stryker Corporation to provide vendors with the ability to inform the contracting officer of any capable parties.

6. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research

Was Not Conducted: The Contracting Officer (CO) searched the internet for applicable contracts or an open market competitor that could provide the services required and was unable to locate one. A query of the Small Business Administration Small Business Search (SBS) was conducted using business name "Stryker" in their profile, SBA certified as SDVOSB, designated small in NAICS code(s) 811210, and including keyword(s) "Mako" in their profile returned zero concerns. The VA/SBA Rule of Two cannot be met. Stryker Corporation is the only responsible source capable of performing the requirement.

In accordance with FAR 25, the BAA was not considered applicable to this procurement because it pertains to services being performed domestically within the United States and the vendor is not a prohibited source.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

7. Any Other Facts Supporting the Use of Other than Full and Open Competition: The contract is unrelated to information technology and the stipulations and oversight mechanisms mandated by FITARA are not applicable.

Product Service Code (PSC) identified for this requirement is J065.

8. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Howmedica Osteonics Corp dba Stryker Orthopaedics

325 CORPORATE DR

MAHWAH, NJ 07430-2006

9. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The VA will research the market prior to any purchases for these services to determine if there are any other sources with the capabilities to meet the Government’s requirements.

10. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the

Department of Veterans Affairs and 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.

Laura Willett Date Management and Program Analyst

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C250-26-AP-0255

John D. Dingell VA Medical Center

11. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Chad Kemper Date Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Kelly Poole Date Branch Chief – Services Team Two

Network Contracting Office (NCO) 10 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx