Attachment 1- Brand Name Justification- OKC Zeiss Lumera 700 Microscopes.pdf

Justification Tracking Number: 2023 09 11T07:45:16

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

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: AP#

1. Contracting Activity: Organizational Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 (NCO 19) Oklahoma City VA Health Care System 6162 South Willow Drive, Suite 300 921 N.E. 13th Street Greenwood Village, CO 80111 Oklahoma City, OK 73104

2237#:

2. Nature and/or Description of the Action Being Processed: This Brand Name procurement is for a new firm fixed price for two (2) Zeiss Lumera 700 surgical microscopse system, complete with stand and accessories for the Oklahoma City VA Health Care System (OKC). The estimate total is

3. Description of Supplies/Services Required to Meet the Agency’s Needs: OKC Surgery Service urgently requires two (2) Zeiss Lumera 700 ophthalmology microscope systems and various accessories, used to assist surgeons in cataract, glaucoma, and cornea surgeries through precise and efficient markerless toric IOL alignment, biometry reference visualization, and reduced graft manipulation. The microscopes must meet the following characteristics and only the Zeiss Lumera 700 was determined to meet them:

The surgical guidance system features the ability to track the position of the eye with “markerless” technology via a reference image of the patient’s eye from the ZEISS IOLMaster® optical biometer to ensure the position of superimposed graphical overlays are properly positioned even with eye movement

The surgical guidance system features the ability to track the position of the eye based on the reference markers the surgeon places on the biometer to ensure the position of superimposed graphical overlays are properly positioned even with eye movement

The system that enables superimposing graphical overlays into the eyepieces of the surgical microscope is fully integrated into the surgical microscope with no exposed wiring or cabling*

The system provides graphical overlays that are displayed in multiple colors to enable clearer visualization of the displayed surgical aids

The surgical guidance system features the ability to superimpose graphical overlays onto the video image that assists with aligning toric intraocular (IOL) lenses

The surgical guidance system features the ability to superimpose graphical overlays onto the video image that assists with positioning of incisions and limbal relaxing incisions (LRIs) during cataract surgery

The surgical guidance system features the ability to superimpose graphical overlays onto the video image that assists with achieving the intended size and shape of the Capsulorhexis

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 5

The surgical guidance system features the ability to superimpose graphical overlays onto the video image that assists with visualizing corneal curvature* when used in conjunction with a surgical microscope equipped with an integrated keratoscope

The surgical guidance system features the ability to account for anterior chamber depth such that the Capsulorhexis ring is superimposed upon the capsular bag when viewed through the eyepieces of the surgical microscope.

The surgical guidance system features the ability to account for anterior chamber depth such that the Capsulorhexis ring is superimposed upon the capsular bag when viewed on the video image.

The surgical guidance system features the ability to account for optical offset such that the Capsulorhexis ring and other graphical overlays are shifted to center upon the patient’s visual axis as measured by an optical biometer.

The surgical guidance system features the ability to superimpose graphical overlays that assists with aligning toric intraocular (IOL) lenses onto the live image seen through the eyepieces of the surgical microscope

The surgical guidance system features the ability to superimpose graphical overlays that assists with positioning of incisions and limbal relaxing incisions (LRIs) onto the live image seen through the eyepieces of the surgical microscope

The surgical guidance system features the ability to superimpose graphical overlays that assists with achieving the intended size and shape of the capsulorhexis onto the live image seen through the eyepieces of the surgical microscope

The surgical guidance system features the ability to superimpose graphical overlays that assists with visualizing corneal curvature onto the live image seen through the eyepieces of the surgical microscope equipped with an integrated keratoscope*

The surgical guidance system features a 22” or larger HD capacitive touchscreen interface

The surgical guidance system features a 500GB or larger internal hard drive The surgical guidance system features the ability to record 1080p HD video The surgical guidance system features the ability to record 1080p HD video with the graphical overlays The surgical guidance system features the ability to capture still images at 2.1 megapixels or higher resolution The surgical guidance system enables the assigning of patient names to recorded video data The surgical guidance system enables export of recorded video or still frame images to an external hard disk drive or flash memory stick via a USB interface The surgical guidance system features the ability to record video or capture still images anytime during surgery without pre operative programming The surgical guidance system enables the import of CSV files with patient.

The surgical guidance system enables the import of patient and diagnostic data directly from the IOLMaster® biometer.

The surgical guidance system features the ability to control all functions of the surgical microscope utilizing its touchscreen interface* The surgical guidance system can be controlled via the handgrips and/or foot control panel of the surgical microscope* LIVE OCT Capability on MICROSCOPE:

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 5 o 27,000 A scans/second 27 frames a second o Axial Resolution for us 5.5microns o Fully integrated, everything is internal, no additional cabling.

o Staff or Surgeon have full control OCT functionality.

Staff thru Callisto Screen or surgeon.

Surgeon thru foot pedal for all surgeries.

o OCT must be able to Black and White or full Color Scanning o Must below can offer 3 different scan types

2 Line Cube (horizontal and vertical scam simultaneously 5 Line Raster Scan o Scans must be able to be rotatable by 360 Degrees o Must be able adjust length of scan down to 3mm for supreme image and magnification and increase to 16mm o Assistant Binoculars must be able to do 180 degree o Must be able to offer LED, Halogen, Xenon. Xenon lasts longer than Halogen, and Xenon is preferred by surgeons at this time.

o Must be able to have 60 degree and 128 degrees wider.

Workflow o Surgical microscope must feature apochromatic optics throughout the entire visual pathway to eliminate spherical and chromatic aberrations.

o Zeiss Callisto Eye:

Only Zeiss Lumera can accept Data from IOL Master 700 for Markerless Cataract Surgery for TORIC IOL Patients.

o Zeiss, 3.6 Software: This software will be included at no additional charge o 2 scan depths anterior and cornea specific applications

2.9mm and 5.8mm (benefit allows of entire anterior chamber viewing and deeper penetration to retina o Enhanced scan quality thru digital image processing o Eye Tracking which will allow scan to lock onto selected anatomy and move with eye as it is manipulated during surgery o Will allow the OCT functionality and Marker less surgical navigation through

Callisto eye to be available on the same microscope

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 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

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 4 of 5

( ) 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): Zeiss is the only manufacturer able to meet the required characteristics listed in paragraph 3 that the facility requires for an integrated solution. The items would provide an integrated solution to provide surgeon efficiency, and enhance patient outcomes, with preventive measures for/ against wrong implant/ eye surgeries, lastly the ability for corneal and retinal surgeries to have live visualization of tissue during surgery via live OCT scanning capabilities, which leads to more efficient and better patient outcomes. The products desired are Lumera 700 with Callisto Eye with RESCAN capabilities. Due to its small and delicate nature, eye surgeries must be performed using a binocular ophthalmic surgical microscope. It is not possible to perform intraocular surgeries without one. When residents are involved in the surgery, an observer scope attachment is required, in order to properly supervise them and ensure quality surgery is performed. The current microscopes are near their end of life and are having issues with the observer scope. The view through it is variable, and requires the microscopes to be restarted with increasing frequency. This causes delays in patient care, and the increasing frequency of the error causes potential safety issues for the patients 6 months down the road if the pattern continues to worsen. The vendor has previously come out to service the microscopes and stated that they are unable to fix this problem. Both microscopes are affected. One microscope also has difficulty with stabilizing the heigh adjustment due to chronic wear on the knob. Replacing the microscopes emergently now is more prudent over waiting for total breakdown resulting in complete work stoppage. VA implemented FORUM nationwide. It is a ZEISS software that links all of them together. The Lumera 700 will be able to communicate with lens measurement devices in clinic and full up their calculations during surgery. This will drastically decrease the amount of HIPAA paperwork that currently has to be printed to confirm proper lens selection. Only a Lumera can do that. The Lumera microscope also has handles that can be sterilized by SPS and other microscope were found to not be compatible with the facilitie’s SPS.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted to identify Zeiss authorized distributors able to full this requirement. were both identified as potential distrbutors able to fullfil the requirement. Since the manufacturer is also a small business, the Non Manufacturer Rule can be met on a small business set aside. Therefore, recommendation is to solicit this Brand Name requirement on an SB set aside to allow competition for the requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: It is anticipated that a fair and reasonable price determination will be found with the pricing received on quotes due to this requirement planned to be competitive to the manufacturer and authorized distributors. A determination of fair and reasonable pricing will also be prepared prior to award of the subsequent contract.

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 using GSS, FSS, ECAT, VetBiz, GSA Advantage, and communications to potential vendors. Three vendors were identified:

. These companies are able to provide the required systems, with all of its many components, attachments, and instruments, as listed in paragraph 3 of this document.

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 5 of 5

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

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

a.

b.

c.

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: This requirement is recommending competition to fulfill the requirement. Future requirement will continue to consider additional small businesses for 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.

Date

Administrative Officer Oklahoma City VA Health Care System

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.

Date

Contracting Officer Network Contracting Office (NCO) 19

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.

Date

Branch Chief, Supply 1 Network Contracting Office (NCO) 19