Attachment 1 FAR 13.5 Redacted- Justification _ Approval Over SAT.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Commercial Items Acquisition Plan# 36C245-23-AP-0818 Limited Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

JUSTIFICATION & APPROVAL UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C245-23-AP-0818 – ZEISS Artevo 800 OCT Ophthalmic 3D Microscope

1. Contracting Activity: Department of Veterans Affairs, Network Contract Office 5, Perry Point VA

Medical Center located at 101B Boiler House Road Perry Point, MD. 21902 in support of VISN 5, VA Health Care System at the Washington DC VA Medical Center located at 50 Irving Street NW Washington, DC. 20422 for the medical service within the BioMedical department. 2237 funding of

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2. Nature and/or Description of the Action Being Processed: The purpose of this requirement is to procure one (1) surgical ZEISS Artevo 800 OCT 3D ophthalmic microscope system to replace the currently outdated version that is presently in use and breaking down frequently at the the Washington DC VAMC. The requirement includes all parts, materials, labor, software/license, and travel to complete the full installation of the microscope system. The action is anticipated to be a new, firm-fixed price contract award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The requirement is for a 3D surgical microscope system that shall be able to interface with the facility’s ZEISS FORUM imaging picture archive and communication system PACS. It shall also be able to provide raw data, videos, and images via DICOM to ZEISS FORUM. The instrument must have high definition three-demensional feature as well as have dual cameras with a resolution of at lease 8 megapixels. While the instrument is in use the device must be able to switch between a high definition three-dimensional view and a traditional microscope view on demand by the surgical user. It is a requirement that the system shall come with a medical grade display with handgrips and foot controls that allow for the operation of the system. This specific has the ability to track the eye position using the reference markers placed by the end user on the eye and the superimposed image shall remain positioned when the eye moves. The Zeiss Artevo 800 has the ability to superimpose graphical overlays onto the video image to assist with visualizing corneal curvature and to assist with capsuolorhexis. Graphical overlays are visible in multi-color and is able to perform intra-operative optical coherence tomography (OCT) imaging. The Artevo’s display latency shall be very low as the human eye should not be able to observe latency. The contractor shall provide two copies of the operating and service manuals. The ZEISS Artevo 800 OCT instrument has been determined to meet the requirements is the Zeiss Artevo 800 system, including the following features, accessories and parts: ARTEVO 800 system on floor stand with intraoperative OCT, two 3 chip 4K cameras and 55" 4K screen. Continuous motorized zoom (range 1:6); Integrated camera laser filter; motorized focus with fast focus DeepView; depth of focus management system, XY coupling with long travel range. Motorized tilt, Xenon Superflux Eye, LED light source including wireless foot control panel. Assistant scope with elec. Zoom with a Intvertube for assistant scope.

10x eye pieces for the assistant scope.

4. 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

Effective Date: 02/01/2022 Page 2 of 3 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 Brand Name Only

( ) 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): Only the brand name products of ZEISS have been determined to meet all of the requirements of the Government. The Washington DC VAMC requires specific, specialized features in a surgical 3D microscope in order to provide advanced care for patients. Products that do not possess the aforementioned features and capabilities would not provide the standard of care and would not meet the surgical case needs of the Government. Products that do not have the features required would cause inefficiencies in workflow (for example, not having a toggle for the heads up display) or quality of care (for example, not having the ability to superimpose images or track markers). Products that cannot interface with the facility’s Zeiss FORUM with full data would require workarounds or present potential issues in patient health information processing and storage. Similar products that do not meet all of the Government’s requirements include the Alcon Luxor Ngenuity and the Leica Proveo. The Alcon Luxor Ngenuity cannot toggle between high definition 3D heads up viewing and traditional microscope without removing the unit and reattaching. The Ngenuity does not have intra-operative OCT. The Ngenuity does not have the ability to track reference markers. The Ngenuity has higher latency. The Leica Proveo does not have a 3D heads up camera/display. The Proveo does not have computer assisted guidance overlay. The Proveo’s scan depths are not ideal. The Proveo does not have the ability to track reference markers.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Research was done to determine if there are other products that can meet the requirements of the Government. Only the Zeiss Artevo 800 OCT was determined to meet all requirements. No other products were found to meet all critical elements.

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

Reasonable: The anticipated cost is considered fair and reasonable. The cost has been negotiated on an ECAT Government contracts that are not available for use for this particular requirement.

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

Market Research Was Not Conducted: Market research was conducted in December 2022 - January 2023 of the internet and government websites such as SAM, FPDS, GSA, VIP and SEWP. It was determined that only the products of ZEISSs could meet the Government’s full requirements.

Searches of GSA Advantage found that no sources could provide the Artevo 800. Searches of the Product Data Bank resulted in one Government contract available for the Artevo 800, ECAT, which could not be used as the procurement exceeds the SAT under VA.

Effective Date: 02/01/2022 Page 3 of 3

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No existing contracts were found other than ECAT to which a VA facility could not utilize.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None were requested although throught market research it was found the 2 small business in recent years has provided these Zeiss Artevo 800, PROAIM Americas LLC and CORP BIOLOGICS LLC.

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: Future actions will also be investigated to determine what sources are available that can meet all requirements.

Future surgical microscopes will not all require the same features and may be procureable through competition.

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.

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

a. Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for brand name or equal small business set-aside full and open competition.

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