P03 Robot Visualization System JA - Kinevo 900 FAR 13.5.pdf

Acquisition Plan # 36C246-21-AP-3519

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-21-AP-3519

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 6 on behalf of Durham VA Medical Center (VAMC), PR/2237 # 558-21-3-102-0039.

2. Nature and/or Description of the Action Being Processed: Network Contracting Office (NCO) 6 intends to award a new, firm-fixed-price sole source contract to ProAim Americas, LLC a small business, for the Kinevo 900 system for Durham VAMC.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The requirement is to provide delivery and installation of Kinevo 900 system for Durham’s VAMC. The Durham VAMC Operating Room (OR) is currently using the OPMI Pentero microscope system which has reached the end of its Guaranteed support. This is a critical component for surgical procedures that require precision instrumentation and the enlarging of the anatomy being worked on. The Kinevo 900 is Carl Zeiss Meditec’s Inc. next generation surgical microscope system. The Kinevo 900 uses robotic technology to automatically adjust imaging areas and to limit image distortion.

This equipment will perform a variety of tasks that will assist our surgeons in critical surgeries that require a microscope. Also, the ability to record procedures in 4k video will allow surgeons the ability to train other surgeons on complex surgical procedures. Value is estimated at $660,871.65 and delivery is estimated 4 months after receipt of order.

Nomenclature Part # Quantity Kinevo 900 System 2216-914-10BASICP 1

Eyepiece 10X 2216-914-90EYEP10 1 Tilt Tube 180° with Eyepieces 2216-914-10TUBMTI 1 Coobervation L/R Fold Tube 2216-914-20COLRFO 1 Face-toFace w/Titable Tube 2216-914-20COFFTI 1

Blue 400 Preparation 2216-914-30BL400H 1 Blue 400 Module 2216-914-30BL400M 1

Infrared 800 Hardware 2216-914-30IR800H 1 Infrared 800 Module 2216-914-30IR800M 1 4K 3D Video Camera 2216-914-404K3DPA 1

Video Recording 2216-914-40HDRECO 1 External 4K Monitor 3D 2216-914-404K3DMO 1 Mobile Cart 4k Monitor 2216-914-404KCART 1

WLAN Module 2216-914-50WLANPA 1 Shipping Crate 2216-914-60TRSBOX 1

4. Statutory Authority Permitting Restricted Competition:

Original Date: 08/30/17

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This is a highly specialized surgical microscope. There are certain features incorporated within this system that competitors do not offer. The Kinevo system offers surgeon controlled robotics that other surgical microscopes do not offer. The robotic systems allow for pointlock and position memory. Pointlock enables the surgeon to perform keyhole movement to observe a larger area inside a cavity without the need to manually move the microscope. Position memory allows the surgeons to store microscope position, distance and focus. These features will reduce the workload and better assist our surgeons in microsurgery.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Sources sought notice RFQ 36C24621Q0684 was posted to Contract Opportunities on 5/14/2021 with a closing date of 5/20/2021. The Contracting Officer (CO) received one (1) response-vendor ProAim Americas LLC. Intent to sole source notice 36C24621Q0684_1 was posted to Contract Opportunities on 5/20/2021 with a closing date of 5/26/2021. The CO received zero (0) respondents.

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

Reasonable: The CO will determine that pricing will be fair and reasonable based on current price lists. Prior to award price analysis of the proposed contract price will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable.

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

Market Research Was Not Conducted: The following market research was conducted to identify potential sources to fulfill the requirement for Durham VAMC.

a. A search was conducted querying Government-wide database of contracts, other procurement instruments, and commercial databases. The requirement was not available via VA inventories including the VA supply stock program and VA excess, excess from other agencies, Federal Prison Industries (FPI), AbilityOne Program, Wholesale Supply Sources, Strategic Acquisition Center (SAC), and Technology Acquisition Center (TAC).

Original Date: 08/30/17

b. Veterans Information Pages (VIP): Search conducted on 5/14/2021 utilizing NAICS code 339113 showed 67 Service Disabled Veteran Owned Small Businesses (SDVOSB) and 6 Veteran Owned Small Businesses (VOSB). A sources sought notice was generated and emailed on 5/14/2021 to the SDVOSBs and VOSBs that populated from this search.

c. Electronic Catalog (ECAT) query found the Kinevo 900 system on Defense Logistics Agency (DLA)

ECAT contract.

d. Sources sought notice 36C24621Q0684 was posted to Sam.gov to solicit feedback from industry for equipment that would meet the Governments need. This notice was posted on 5/14/2021 with a closing date of 5/20/2021. The only response received was from ProAim Americas a small business concern.

e. Internet searches of companies that offer surgical microscopes was conducted. This search yielded 3 large businesses Alcon Inc., Stryker Sales LLC, Leica Microsystems Inc. that offer surgical microscopes. A request to be contacted was submitted to these companies on their “contact us” page. No responses were received from these companies.

f. Intent to sole source was posted on 5/20/2021 with a closing date of 5/26/2021, and no responses have been received to this notice.

g. In a review of the System for Award Management (SAM) website, ProAim Americas LLC (Duns No. 962568338) is listed as a small business under this requirement's NAICS code 339113 Surgical Appliance and Supplies Manufacturing with Size Standard of 750 employees.

h. During the period market research was being conducted, the CO reached out directly to ProAim

Americas LLC POC to further determine responsibility and capability to provide the Kinevo 900 system. Below are the findings:

i. Per the information provided by Carl Zeiss Meditec Inc., Carl Zeiss Meditec Inc. is the original equipment manufacturer and ProAim Americas LLC is the sole authorized small business distributor. An authorization letter was provided for ProAim Americas

LLC.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: ProAim Americas, LLC

(small business)

10. 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: NCO 6 will continue to conduct market research to ascertain if there are changes in the marketplace that would enable competition for future actions.

11. 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

Original Date: 08/30/17 belief.

5/27/2021 Reginald Devine Date Administrative Officer Durham VA Medical Center

12. 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.

Cherisse Hall Date Contracting Officer, NCO 6

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.

Keeshia Newman Date Division Chief, NCO 6

REGINALD R. DEVINE

525738

Digitally signed by REGINALD R. DEVINE 525738 Date: 2021.05.27 14:31:38 -04'00' https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx