Signed - 36C242-23-AP-2759 - Mako Service Requirement - Sole Source Justification.pdf

Attachment 7: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-23-AP-2759

1. Contracting Activity: Department of Veterans Affairs, VISN 2, Syracuse VA Medical

Center, 800 Irving Avenue, Syracuse, NY 13210.

2237 is 528-24-1-7823-0018.

2. Nature and/or Description of the Action Being Processed:

This new firm-fixed price contract is for full-service support of a MAKO Robotic Arm system at the Syracuse VA Medical Center located at 800 Irving Avenue, Syracuse, NY 13210. The period of performance is 10/01/2023 to 09/30/2024 to include four (4) option years. This requirement shall include hardware, firmware, installation, parts, labor, preventative maintenance, on-site response, loaner equipment, and replacement parts.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Equipment List

Manufacturer Model EE# Serial #

Stryker Corp Mako 326471 ROB1602

Price/Cost Schedule

Year POP QTY UNIT PRICE Base Year 10/01/2023 to

09/30/2024

1 JB $118,00.00

Option Year 1 10/01/2024 to 09/30/2025

1 JB $123,900.00

Option Year 2 10/01/2025 to 09/30/2026

1 JB $130,095.00

Option Year 3 10/01/2026 to 09/30/2027

1 JB $136,600.00

Option Year 4 10/01/2027 to 09/30/2028

1 JB $143,430.00

Total $652,025.00

VHAPG Part 806.3 OFOC Page 2 of 4

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Servicing a MAKO Robotic Arm is highly specialized and must be serviced by factory trained technicians. Stryker is the sole source, direct provider of MAKO Robotic Arm service maintenance, and Stryker’s service on the Mako Robotic Arm system is proprietary, therefore it cannot be performed or acquired from any other source.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Notice of Intent to Sole Source, 36C24223Q1099, was posted to SAM.gov on 08/16/2023.

No responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

Price reasonableness shall be determined by comparing the current quote to contract, 36C24723P0419, for the the same services at the Charleston VAMC from 06/15/2023 to 06/14/2024 plus four (4) option years in the amount of $652,025.00. The price of the current quote is the same as contract 36C24723P0419, therefore the current quote is considered fair and reasonable.

VHAPG Part 806.3 OFOC Page 3 of 4

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

Reasons Market Research Was Not Conducted:

A Search of NAICS code 811210 on SBA’s VetCert database identified 73 vendors that matched the NAICS code.

To narrow down the number of vendors, a search of VA’s VetBiz database using NAICS code 811210 and keyword “MAKO Robotic Arm” was conducted. The search identified zero (0) capable vendors.

A search of SBA’s DSBS using NAICS code 811210 and keyword “Mako robotic arm” identified zero (0) vendors that match the search criteria.

A search of GSA eLibrary using keyword “Mako robotic arm” identified zero (0) contracts that matched the search criteria.

A Google search of “Mako robotic arm” identified Howmedica Osteonics Corp dba Stryker Orthapaedics (Large Business) as the Original Equipment Manufacturer (OEM) and sole provider of service maintenance for Mako robotic arms.

A proprietary letter was received from Stryker Corp stating that they are the OEM and their services for Mako robotic arms are proprietary and cannot be performed or acquired by another source.

A Notice of Intent to Sole Source, 36C24223Q1099, was posted to SAM.gov on 08/16/2023. No responses were received.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

N/A

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

1. Howmedica Osteonics Corp., dba Stryker Orthapaedics 325 Corporate Dr, Mahwah, NJ 07430-2006

UEI – E5DLYCJBNYX7

11. 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:

There is no action that can be taken as this requirement involves proprietary technology.

Only Howmedica Osteonics Corp., dba Stryker Orthapaedics certified technicans can perform the services required in this procurement.

VHAPG Part 806.3 OFOC Page 4 of 4

12. 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.

Cemre Shinci Date Contracting Officers Representative (COR) Syracuse VAMC

13. 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.

Kimberly Wiatrowski Date Contracting Officer NCO2/RPO East

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.

Joseph Cellino Date Services 1 Branch Chief

NCO2/RPO East https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx