SDVOSB Sole Source - Alcon System - R_Redacted.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9

AP: 36C247-26-AP-1551

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 3 Revision: 05 Effective Date: 12/15/2025

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C247-26-AP-1551

1. Contracting Activity: Department of Veterans Affairs, NCO 07, Birmingham VA Medical Center, VA2237: 521-26-2-237-0014

2. Nature and/or Description of the Action Being Approved: The government intends to award a new FFP-Supply Purchase Order in support of Birmingham VAMC.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The primary objective is to provide the Ophthalmology Service Line at the Birmingham VA Medical Center with the Unity Vitreoretinal Cataract System (VCS) to treat patients with cataracts and other ocular system conditions. This system will replace the outgoing PHACO system by Alcon, which has been in use since 2018 and has become obsolete. The system has become unreliable and has failed during multiple procedures.

Part Number Description Qty Price Extended Amount 900484665 Unity VCS VLTP 2

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by RFO 6.103-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR

819.7009 (DEVIATION)- up to $5,000,000. Check the specific VAAR clause used below:

(X) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; or ( ) 819.7009 Sole source awards to a certified veteran-owned small business

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The authority allows sole source awards to SDVOSB concerns based on 38 U.S.C. 8127(c), and O.R. Elder, Inc. has been determined to be a responsible source with respect to performance. Additionally, O.R. Elder, Inc.

meets all eligibility requirements. The ALCON UNITY VCS (Vitreoretinal Cataract System) is a surgical system platform, not an intraocular lens (IOL). The ALCON UNITY VCS is the first and only integrated platform designed to perform both high-performance vitreoretinal and cataract surgeries with superior efficiency and enhanced stability, consolidating capabilities that usually require separate, specialized machines.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by RFO 6.301 and, if not, which exemption under RFO 5.101(b)(1) applies: The ALCON UNITY VCS references specific salient characteristics which are truly unique and are not available from any other company. There are no opportunities for manufacturing competition, and based upon the

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 3

Effective Date: 12/15/2025 estimated dollar figure, dealer/distributor competition is not plausible based on the inability to meet Non-Manufacturing Rule (NMR) and Limitations on Subcontracting (LOS) requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Quoted pricing submitted by O.R. Elder, Inc. will be compared to historical pricing for the same or similar equipment.

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, which documented the ALCON UNITY VCS references specific, unique salient characteristics which are not available from any other manufacturer. No other manufacturers, regardless of socioeconomic status, were identified as being capable of meeting or exceeding the unique stated salient characteristics of the brand name ALCON UNITY VCS.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None, authority under 38 USC 8127(c).

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: O.R. Elder, Inc.

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: Market research will be conducted for future requirements to determine any changes to the market which would facilitate manufacturing 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.

Herschel Holden Date Business Manager Operation Room Birmingham VA Medical Center

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 3 of 3

Effective Date: 12/15/2025

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.

Jacob A. Tackett Date Contracting Officer

RPO-E / NCO 07

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Joseph M. Locke Date Senior Contracting Officer

RPO-E / NCO 07