36C25026P0502_2.docx

Sole Source Justification >SAT

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 10

5500 Armstrong Rd.

Battle Creek MI 49037

POINT OF CONTACT*

Contract Specialist Brooke Hansen brooke.hansen@va.gov Phoned inquiries will not be accepted

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

O R ELDER INC

NGC9PL57LMA3

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

ADDITIONAL INFORMATION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-26-AP-2516

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Battle Creek VA Medical Center at 5500 Armstrong Rd, Battle Creek, MI 49037 in support of LTC Charles S. Kettels VA Medical Center at 2215 Fuller Rd, Ann Arbor, MI 48105

PR 506-26-2-118-0136

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm fixed-price Purchase Order to acquire 3 Virectomy machines for the Ophthalmalogy department. This procurement will be conducted under Revolutionary FAR Overhaul (RFO) 12.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Ophthalmology department is requesting the acquisition of three (3) unity machines.

ITEM INFORMATION

UNITY VCS VLTP - VCS Console, Remote, Laser, Large Tray, VCS 6 button footswitch, CS 4 button footswitch, Laser footswitch, BSS Rack, 2 UNITY 4D Phaco handpieces, & Ozil Frag handpiece

LOCAL STOCK NUMBER: 900484665

Appropriation: 506-3660160-118-820200 Surgical Service-3131 Medical, Dental, and Scie-010044177

ALCON 4D PHACO HANDPIECES

LOCAL STOCK NUMBER: 8065000315

Appropriation: 506-3660160-118-820200 Surgical Service-3131 Medical, Dental, and Scie-010044177

GRAND TOTAL

Delivery date is anticipated 1 month from receipt of order.

Vitrectomy machines are crucial surgical tools in ophthalmology, utilized to address severe and vision-threatening issues. These procedures encompass the repair of retinal detachments, complications from diabetic retinopathy such as vitreous hemorrhage, macular holes, and epiretinal membranes, as well as eye trauma and the removal of foreign bodies, severe eye infections like endophthalmitis, and issues arising from cataract surgery. Many of these situations necessitate immediate action, particularly retinal detachment and retinal infections (endophthalmitis), to avert irreversible vision loss.

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

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Only One Responsible Source – The Ann Arbor VA Health Care System currently owns two Alcon Centurion that have reached end of life. Opthomology surgeons require a new machine for cataract surgery. The Unity VCS comes equipped with a dual peristaltic pump as well as the Venturi option. With two 7 roller pumps, one controlling aspiration and one controlling irrigation, the stability is extremely efficient by minimizing pulsatile waves. This technology is the first of its kind within this space. In an event where nitrogen was unavailable because of malfunction, the system is designed to function without, so the Surgeon could finish the procedure on that day. This machine has unprecedented technology and significant upgrades far beyond what is currently used or offered by the competitors.

Cataract Highlights -4D Phaco; nucleus removal is twice as fast as Ozil. (4 dimensional cutting rather than 2 dimensional (side to side)). 4 dimensional is what the Unity Offers, 2 dimensional is what is currently used. Less energy, faster cataract removal.)

-41% reduction in energy delivered to the eye -Unity Thermal Sentry, a pioneering technology that continuously monitors the temperature at the incision site and adjusts ultrasound power to minimize the risk of corneal burns.

Retina Highlights -Unity Hypervit, the fastest on the market with a dual blade vitrectomy probe capable of 30,000 cuts per minute, enhances efficiency and reduces retinal traction with a 50% increase in Cuts Per Minute (CPM).

-Unity TetraSpot, the first and only multi-spot illuminated laser probe that significantly decreases laser application time by up to 3.1 times.

27G Dynamic stiffener, the exclusive 27G dynamic stiffeners provide a stiffness rating of 25+ or higher, thereby enhancing surgical control.

-Enhanced oil injection and removal system -22G Framatome featuring ozil technology (smaller incision, more effective lens removal) -LED light source with a lifespan of up to 10,000 hours and customizable Red, Green & Blue (RGB) illuminators.

-Unifeye/Unipexy all-in-one sterile gas kits (for OR/Clinic) enhance accuracy by reducing the risk of delivering an incorrect or unintended gas-to-air mixture. This may potentially eliminate the need for tanks and regulators.

Retina & Cataract Highlights -Intelligent Intraocular Pressure (IOP), which offers precise real-time pressure sensing and compensation, helps maintain a more physiological IOP, leading to excellent patient outcomes.

-Unity Intelligent Aspiration, which increases pump speed to quickly elevate vacuum levels, enhances surgical efficiency.

-Unity Intelligent Sentry, featuring real-time occlusion break sensing and a dual venting system, reduces surge while ensuring followability.

The Unity is a combined anterior segment (cataract surgery) and posterior segment (retina surgery) machine. No other competitor currently offers this functionality. The advantage is, we have a smaller footprint in OR vs having two machines, and a cost savings due to potential for delays in repair if we have two separate machines vs one machine (Unity) and the intital cost of purchasing two machines vs one.

Currently, the situation regarding the service is that one of our machines is non-operational and will require approximately $40,000 for repairs. Both systems are due for replacement. The absence of a working backup machine raises concerns about patient safety and access. Surgical delays for urgent conditions could lead to irreversible vision loss for our veterans. We lack redundancy if our primary machine malfunctions during surgery or needs maintenance, which puts us at risk operationally and in terms of liability. In the absence of a backup vitrectomy machine, veterans would have to seek community care, resulting in delays and barriers to access. Accordingly, OR Elder is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

Nick Kurtz from the OEM, Alcon, confirmed that all capital equipment is only sourced through OR Elder.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: OEM was contacted and confirmed the only available source for the requirement is OR Elder. Sources sought results were reviewed from action 36C25626Q0440 ending March 3, 2026. The only response received was from OR Elder. An Intent to Sole Source will be posted to SAM.gov in accordance with RFO 5.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will ensure that the proposed price will be determined fair and reasonable in accordance with RFO 12.204(a).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Searched SBA Small Business Search database with NAICS 334510 with a VOSB restriction and received 635 results. Added keyword “Vitreoretinal Cataract System” and received 0 results. Although one SDVOSB, OR Elder, has been located separately and verified as an SDVOSB through SBA Small Business Search. Reviewed ADDSUP search results which revealed three prior purchases for the UNITY Vitreoretinal Cataract System since 2016 from OR Elder. A general search was completed on GSA Advantage for “Vitreoretinal Cataract System” and no results were found. NAC was also searched with keyword “Vitreoretinal Cataract System” with no results found. Reviewed sources sought 36C25626Q0440 (2/25/26-3/3/26) for same requirement in NCO 16 which revealed only one source, OR Elder. Contacted OEM, Alcon, and Nick Kurtz confirmed via email that all capital equipment is only available for purchase from OR Elder. The VA and SBA rules of two are not attainable with this procurement.

Buy American Act applies. Products are made in the United States.

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

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: For any subsequent procurement of this type of equipment and services, the marketplace will be surveyed to determine if there are any other sources which can provide equipment and services to satisfy the Government’s requirement.

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 belief.

Effective Date: 12/30/2025 Page 6 of 6 Revision: 02 Acquisition ID#: 36C250-26-AP-2516