P03 Redacted Brand Name Justification Revised Jan22.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 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: 36C224-22-AP-1889

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Corporal Michael J. Crescenz VA

Medical Center (Mailing Address: 3900 Woodland Avenue, Philadelphia, PA 19104)

2. Nature and/or Description of the Action Being Processed: This action is for the Brand Name Only procurement of Carl Zeiss, Meditec, Inc. Floor Stand Zeiss Microscope (Artevo 800); also included is the Artevo 800 software system to ensure continuity and consistency of eye surrey. The Corporal Michael J. Crescenz VA Medical Center provides Eye Care/Surgery Services as part of the “Ophthalmology” program for eligible veterans.

The scope includes the following: ARTEVO 800 OCT - The pinnacle of digital surgery visualization for all specialties, Motorized microscope tilt mechanism (+90° / -20°), Xenon Superflux Eye for Stereo Coaxial Illumination (SCI®) system with HaMode® filter and Retina protection filter, CARL ZEISS MEDITEC, INC. | SECOND LIGHT SOURCE WITH LED LIGHT SOURCE AND LIGHT GUIDE FOR AUXILIARY ILLUMINATION SYSTEM (E.G. VISULUX), Ergonomic wireless foot control panel with 14 functions, Cable 3m for foot control panel (backup for wireless version), Objective lens f=200, apochromatic, for intra-operative OCT, Invertertube E electronically rotates inverted images into an upright position when working with fundus viewing system RESIGHT 700. Including a set of asepsis caps, 2x Widefield push-in eye pieces 10x, Assistant Scope w/ Elec. Zoom Integrated assistant microscope with electrical zoom system. The electrical assistant's zoom can be set to work independently of, or in parallel with, the surgical microscope's zoom. Supports Invertertube E, Invertertube E electronically rotates inverted images into an upright position when working with fundus viewing system RESIGHT 700. Supported by assistant microscope with electrical zoom. Including a set of asepsis caps, 2x Widefield push-in eye pieces 10x, OCT Software 2.0.3, Integrated keratoscope ring provides intra-operative visualization of corneal curvatures. Works together with CALLISTO eye ASSISTANCE function K TRACK for estimation of the local corneal curvature, RESIGHT 700 - Electrical Fundus Viewing System for optimal retina workflow supporting automatic image inversion during posterior surgery in combination with Invertertube E. Including Dovetail mount set , RESIGHT lens holder f=200mm with fast and sterile access to a second lens with different magnification via the innovative lens turret, Resterilizable 128D aspheric wide-field lens for RESIGHT providing peripheral visualization and a clear overview of the retina , Resterilizable 60D aspheric macular lens for RESIGHT providing high magnification, Metal Tray for resterilization of RESIGHT lens holder and aspheric lenses, Set Stereo-Polarisation Glasses, 5 pairs, CALLISTO eye Software version 3.7.1 with Panel PC II and support of intra-operative OCT, CALLISTO eye Software ASSISTANCE markerless V3.7 license supporting:

- Markerless cataract assistance functions for the alignment of toric IOLs (Z ALIGN), access and limbal relaxing incisions, and capsularhexis

- K TRACK for estimation of the local corneal curvature in combination with the integrated keratoscope option Basic set including:

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Revision 03 Date: 02/11/2021

- 22mm asepsis caps: 2 packs of 6

- resterilizable handgrips: 1 pack of 6

248.27 1 248.27 Resterilizable handgrips, pack of 6 135.53 1 135.53 Cable fixation set

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Operating Room is looking to procure the gold standard of care of Surgical Microscopes for the Ophthalmology Services at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia. The microscope must have the ability to perform Cataract Surgeries, Anterior Chamber Surgeries, Posterior Chamber Surgeries including Retinal Surgeries and run both the Artevo and Callisto Eye Software packages. The estimated value is approximately $ which include one floor stand microscope and all options necessary to successfully perform surgeries in the Ophthalmology Section of Surgical Services. Delivery needs to occur between June 2022 – September 2022.

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 ( ) 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 Brand Name Only authorization for purchase of a surgical microscope for the Corporal Michael J. Crescenz VA Medical Center. The Microscope is not available through eCAT or GSA schedule. Brand name only request of the Carl Zeiss floor stand microscope is being requested due to the need of the microscope to be able to network with the health care centers FORUM software as well as the IOL Master, this provides specific data to be displayed during surgery to assist with the capsularexis portion as well as provide accuracy of the placement of the toric lenses in our veterans. The Carl Zeiss floor microscope can perform topography of the retina which allows an image to be displayed for epiretinal retinal membrane peeling. Currently, FORUM and IO Master are used in the Ophthalmology Outpatient Clinic and if another product were considered, then the department would lose the ability to network the microscope to obtain raw data. The display for the Carl Zeiss floor microscope is the only unit that provides 3D/4K medical grade sensor resolution on a mobile stand which would decrease neck strain for the surgeon since they would not need to look through the oculars to perform the surgery.

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The Carl Zeiss Floor Stand microscope is the only product that offers fully integrated OCT viewing during a surgery. The surgical microscope can be configured such that activation of the fundus viewing system automatically results in activation of the inverters and any affiliated user profile settings (light intensity, starting zoom and focus values, etc.) to speed transitioning between microscope setups optimal for anterior and posterior segment visualization equipped with zero to 180-degree views with the Resight option being included. With the ReSight System, the surgeon no longer needs to refocus when the fundus viewing system is slid in or out of position which allows the surgeon to be more efficient during surgery. The equipment required by this procurement is essential to the continuity of direct patient care. Awarding a contract to another company would severely delay patient care as no other source or brand is able to fulfill the requirement without changing VA-owned equipment, as well as having to conduct installation and training. This equipment is critical to providing care to veterans who require services from the Ophthalmology Care Program. These microscopes are upgraded to provide additional functions that would increase the accuracy of the placement of the toric lenses, as well as provide coherent tomography imaging of the surface of the retina when removing epiretinal membranes. They will also provide overlay for capsular excision which would reduce complications during surgery. By purchasing these microscopes, it allows for continuity for the biomedical engineers for repairs, upgrades and for collateral items on hand, for example, LED bulbs or other accessories.

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

The VA has found 2 Small Business vendors authorized to distribute the Zeiss Artevo 800

1. PROAIM – Jackie Brown (636-324-3702)

2. Corps Biologics – Rob@CorpsBiologics (512-391-9569)

The Corporal Michael J. Crescenz VA Medical Center has no control of which vendor(s) is chosen.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost will be considered fair and reasonable. Seeking any competition for this acquisition would increase the governments cost of integrating the microscope and software through an extensive vetting process used to vet vendors and products that integrate within VistA.

The product can only be sold by authorized distributors. Obtaining the product though a third party might increase the cost to the government.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Corporal Michael J. Crescenz VA Medical Center previously submitted for a different Zeiss Microscope. Only 2 small businesses were found to be able to meet the requirement as they are authorized vendors. Market Research included searches for alternative items, but no alternative items were found to meet the requirement. We are requesting one new microscope for the Operating Room.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Purchasing this microscope allows for continuity for our Biomedical Engineers for repairs/upgrades and for collateral items on hand such as LED bulbs or other accessories. As mentioned earlier this integrates seamlessly with our IOL Master for optimum intraocular measurements as well as our FORUM software.

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Revision 03 Date: 02/11/2021

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.

Caroline Robinette Date Branch Chief, Commodities 1 Network Contracting Office 4

Caroline L.

Robinette 135596

Digitally signed by Caroline L. Robinette 135596 Date: 2022.02.01 07:49:57 -05'00'