P03 - Arveo Microscope J_A.pdf

Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:__ 36C242-22-AP-0912

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Syracuse VA Medical Center, 800 Irving Avenue, Syracuse, New York 13210.

2237: 528-22-2-7085-0017

2. Nature and/or Description of the Action Being Processed: The Syracuse VA Medical Center requests a new surgical microscope that is designed to provide high contrast and detailed imaging of all regions of the anatomy during surgical procedures. The specific surgical microscope being requested is the Leica ARveo Surgical microscope (OH-103).

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Syracuse VA is requesting a new Leica ARveo Surgical microscope (OH-103). The surgical microscope is designed to provide high contrast and detailed imaging of all regions of the anatomy during surgical procedures. The equipment’s fluorescence harnesses the high contrast of ICG and integrates with the white light image to create a striking visual distinction between anatomy and blood flow. A Surgeon can identify the natural color of tissue anatomy, experience full depth perception, and get a real-time augmented view of vascular flow, for enhanced confidence to make precise treatment decisions. The technology provides a real-time augmented reality view of the surgical field to assess and perform procedures with accuracy. The cost of the Leica ARveo Surgical microscope (OH-103) is $708,707.03.

Estimated delivery and installation is to be 60-90 days.

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): The Leica ARveo Surgical microscope (OH-

103) uses the latest proprietary technology beneficial to surgeon’s needs. Specifically, the GLOW800 augmented reality (AR) fluorescence is the first fluorescence modality based on GLOW AR technology. This allows surgeons to observe cerebral anatomy in natural color, augmented by real-time vascular flow, with full depth perception. This device has hybrid functionality allowing the end user to choose to either work through the eyepieces or work heads-up and achieve a comfortable upright posture by positioning the optics carrier and cart-mounted 3D monitor.

The Leica ARveo surgical microscope is versatile and will allow various spine and neurosurgical procedures. It can be used as a microscope and an exoscope. The focal length is longer which will help with anterior cervical procedures in shorter, thicker necks. It will also allow better ergonomic positions for the surgeon and assistant given increased focal length and better mobility of the eye pieces. Based on the information provided by Biomed, the new microscope needs to have windows 10 for it to be compatible with VA information and security systems. The Biomedical Department had conducted market research and was able to determine that there were two available options that could potentially meet the Syracuse VA’s needs;the Leica Arveo and Zeiss Tivato. Based on the researrch Leica Arveo has 360 degree rotation of surgeons eye piece while Zeiss Tivato has 180 degrees of movement. Leica Arveo has same brightness at multiple working distances and Zeiss Tivato does not indicate that. Leica Arveo microscope arm has better mobility than the Zeiss Tivato- 4 axes vs 3 axes. Light source is brighter in Leica Arveo at 400 W Xenon light and the Zeiss Tivato at 300 w Xenon light. Leica Aarveo can be used as an exoscope while Zeiss Tivato cannot be used as an exoscope.

Additionally, the following salient characteristics:

1. Independent Rear Fine Focus

2. GLOW800 - Augmented Reality ICG fluorescence for visualizing real time perfusion in cerebrovascular cases.

3. Two 400w xenon bulbs with independent electronic boards and power supply. For safety, bulbs can be switched intraoperatively without interruption.

4. Fusion Optics – patented design that provides simultaneous high resolution and depth of field.

5. Narrow/Small Angle Illumination – system provides coaxial light with narrow angle of illumination to brighten shadowed areas in the field of view while retaining depth perception.

6. CaptiView image injection - 500:1 contrast ratio.

7. Full 360-degrees rotation of all binoculars that allows surgeons to maintain straight, ergonomic posture even when the Optics Carrier is tilted.

8. Brightcare - enhanced patient safety system with built-in Luxmeter that provides real-time objective light data so that light intensity is measured from the bulb output.

9. Intraoperative balancing - full auto-balance achievable without the need to interact with the GUI and after sterile drape has been applied.

10. Rotatable handles – allows resident/fellow to control handle from side observer and/or opposite observer.

11. Passive damping system - reduces vibration to under two seconds of vibration by not being electronically dependent on a reference point.

12. Longest reach - provides more than 150 cm reach.

13. Electromagnetic shielding – reduces neuromonitoring interference.

14. Compatibility with third-party video systems and universal cabling: SDI, HDMI, VGA.

15. Non-computer related buttons for lamp, that can be used even in the event of GUI failure.

16. Non-computer related buttons for Auto-balance that can be used even in the event of

GUI failure.

17. Light (illumination) and stand computers are independent, allowing the microscope to be used in the event of computer failure.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Due to the very specific nature of this type of surgical microscope and the necessary compliance with VA OIT security protocols, there are only two or three machines that will actually qualify as potential items to meet the criteria set fourth in the statement of needs. The using service originally requested the Zeiss Pentero 800; however, it did not align with VA’s security requirements. Further research was conducted and based on the technical specifications, it was determined that the best options were the Leica ARveo and the Zeiss Tivato.

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

Reasonable: Fair and reasonable pricing will be determined by doing a comparison of proposed prices with prices obtained through market research for the same or a similar product purchased by the VA and other Government agencies via FPDS award data.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The using service originally requested the Zeiss Pentero 800; however, it did not align with VA’s security requirements. Further research was conducted and based on the technical specifications, it was determined that the best options were the Leica ARveo and the Zeiss Tivato. These two machines were presented to the using service and after evaluation the surgeons preferred the Leica ARveo due to its technical capability and its hybrid ability and requested a trial. During the trial, the vendor also discussed the Leica OHX with the using service as another alternative for spinal and ENT surgeries, but it was determined that the ARveo was the only device capable of performing cranial surgeries whereas the OHX cannot.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Please reference market research documentation above.

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

• Melling Medical

• Leica Microsystems

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: In the future when the need arises for the replacement of a surgical microscope at the Syracuse VA Medical Center personnel will be required to conduct extensive market research to determine if the market has changed and to determine if other solutions are available to meet the mninmum needs of the Government.

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.

Courtney Ogando TCF Biomedical Engineer Date 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.

Sam DeMuzio Date Contracting Officer

NCO2

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.

David Warunek Date NCO2 Branch Chief

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

d. VHA Senior Procurement Executive Approval (over $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Name Date Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs