Brand Name Justification.pdf

Request for Exception to Fair Opportunity Memo FAR 16

Effective Date: 12/30/2025 Page 1 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID: 36C250-26-AP-1720

1. Contracting Activity:

Department of Veterans Affairs, NCO 10, 2780 Airport Dr., Suite 340, Columbus, OH 43219, in support of VISN 10 and the medical facilities listed below:

Indianapolis VA Medical Center 1481 W. 10th St Indianapolis, IN 46202

Shelbyville Clinic 2158 Intelliplex Dr.

Shelbyville, IN 46176

Wakeman VA Clinic 3791 10th Street, Bldg. 1010 Edinburgh, IN 46124-2553

2237: 583-26-3-997-0033

2. Description of Action:

Brand Name Justification for three (3) Spectralis Optical Coherence Tomography Systems and equipment. The Department of Veterans Affairs (VA) intends to procure the SPECTRALIS

Optical Coherence Tomography (OCT) System and equipment from Alvarez, LLC via the NASA

SEWP Government-Wide Acquisition Contract (GWAC). Alvarez, LLC through L1 Enterprises, Inc. is the authorized SDVOSB vendor to manage SEWP Contracted items under SEWP Contract

NNG15SD19B.

3. Description of Supplies or Services

This action utilizes the SEWP contract vehicle to ensure a compliant and efficient procurement.

The estimated contract value is $572,447.00

The current Spectralis optical coherence tomography (OCT) equipment at the Richard L.

Roudebush VA Medical Center, as well as the Shelbyville and Wakeman clinics, have reached the end of its useful lifecycle and no longer meets the operational and clinical requirements

Effective Date: 12/30/2025 Page 2 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971 for modern ophthalmic care. The existing units are experiencing increased maintenance issues, limited compatibility with updated software platforms, and reduced efficiency in diagnostic imaging, which impacts patient throughput and care quality. Additionally, advancements in OCT technology now offer enhanced imaging resolution, faster scan times, and improved integration with electronic health record systems, all of which are critical for accurate diagnosis and treatment planning for conditions such as glaucoma, macular degeneration, and diabetic retinopathy. Replacing the outdated equipment will ensure compliance with current VA standards, improve reliability, and support the delivery of high-quality, timely eye care to veterans across these facilities.

Estimated Period of Performance (POP): July 06, 2026 – August 06, 2026

Spectralis Tracking OCT System - OCT Plus w/OCT2 BluePeak - Advanced 1 EA

HEYEX2 1 EA

GMPE SOFTWARE 1 EA

GMPE SOFTWARE-INSTALLATION & ON-STIE TRAINING 1 EA

SPECTRALIS SOFTWARE-REGION FINDER 1 EA

SPECTRALIS SOFTWARE-SCAN PLANNING TOOL 1 EA

HEYEX2 DATA MIGRATION SERVICE 1 EA

Spectralis Tracking OCT System - OCT Plus w/OCT2 BluePeak - Multicolor 1 EA

Spectralis Tracking OCT System - HRA+OCT w/OCT2-MultiColor 1 EA

Trade-In - HRA+OCT - SN 10001 or higher 1 EA

Widefield Imaging Module 1 EA

OCT Angiography 1 EA

GMPE Software 2 EA

GMPE Software - Installation & On-Site Training (Software sold separately) 1 EA

Effective Date: 12/30/2025 Page 3 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

Spectralis Software - Region Finder 2 EA

Spectralis Software - Scan Planning Tool 2 EA

HEYEX 2 2 EA

HEYEX 2 Data Migration Service 1 EA

Upgrade SPECTRALIS Software (HEYEX2) 8 EA

HEYEX 2 Extended Image Management Backend (Professional) 1 EA

HEYEX 2 Data Migration Service 1 EA

HEYEX 2 Project Management (hourly) 27 EA

Software Protector - USB 1 EA

Computer, HP Z2G9 Tower 64GB, Windows 11, Fire Wire 3 EA

Spectralis Tracking OCT System - OCT Plus w/OCT2 BluePeak - Advanced 1 EA

HEYEX 2 1 EA

GMPE Software 1 EA

GMPE Software - Installation & On-Site Training (Software sold separately) 1 EA

Spectralis Software - Region Finder 1 EA

Spectralis Software - Scan Planning Tool 1 EA

HEYEX 2 Data Migration Service 1 EA

HEYEX 2 Annual Maintenance & Licensing Fee (per device) 8 Devices 1

The mandatory HEYEX 2 Annual Maintenance & Licensing Fee, per device, will follow the 1-year time frame of HEYEX 2 Warranty 1

Effective Date: 12/30/2025 Page 4 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is

Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation Overhaul

(RFO) 16.507-6(b)

( ) RFO 16.507-6(b)(1): Agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(X) RFO 16.507-6(b)(2): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. BRAND NAME ONLY

(X) (RFO) 16.507-6(b)(3): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(X) RFO 16.507-6(b)(4): It is necessary to place an order to satisfy a minimum guarantee.

(X) RFO 16.507-6(b)(5): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

(X) RFO16.507-6(b)(6): For orders exceeding the SAT, a statute expressly authorizes or requires that the purchase be made from a specified source

5. Rationale Supporting Use of Authority Cited Above:

This brand name justification is in support of RFO 11.204, Items Peculiar to One Manufacturer. Alvarez LLC (NNG15SD19B) through L1 Enterprises is the only authorized SEWP vendor to distribute Spectralis Optical Coherence Tomography Systems and Equipment.

The Spectralis Tracking OCT System is a unique ophthalmic diagnostic imaging and angiography system used primarily to examine the structures of the retina, macula, and optic nerve. It combines two technologies: confocal scanning laser ophthalmoscopy (cSLO) and spectral domain optical coherence tomography (SD-OCT). It is the only SD-OCT imaging system to incorporate all the essential features listed below.

• Confocal Scanning Laser Ophthalmoscope combines the selectivity of laser light with the pinpoint resolution of confocal scanning to provide image detail and clarity not available from traditional fundus photography.

Effective Date: 12/30/2025 Page 5 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

• TruTrack™ Active Eye Tracking is a patented imaging technology that utilizes two beams of light simultaneously to track and image the eye. Actively tracking the eye in real time throughout image capture mitigates the effects of eye motion, resulting in more accurate OCT scan data.

• Touch panel enables the user to select acquisition modalities and settings easily. The inability to acquire the Optical Coherence Tomography System would significantly impact the mission of providing high-quality eye care to veterans. The device is essential, being used in 90% of eye examinations. Currently, all of the VA utilizes the

Heidelberg brand exclusively, ensuring consistency and data integration. Switching to a different brand would result in several critical issues, such as data loss accumulated over 10 years, leading to an irreplaceable loss of historical eye health information.

Other campuses within the VA network would be unable to access or interpret new data, severely hindering continuity of care and collaboration across facilities.

Acquiring the Optical Coherence Tomography System is crucial to maintaining the integrity of historical data, ensuring smooth operational workflows, and upholding the high standard of eye care services for our veterans.

The Spectralis OCT System incorporates rigorously developed proprietary normative databases derived from extensive population studies. These datasets establish clinically validated thresholds for detecting and managing ocular diseases such as glaucoma.

Alternative imaging systems rely on different normative datasets that vary in accuracy, scope, and reliability, creating a risk of inconsistent diagnostics and reduced clinical confidence.

The Spectralis OCT System also provides a fully integrated multimodal imaging suite, including OCT, OCTA, angiography, and autofluorescence with dependable image registration and the ability to back-track and align images across encounters.

Competing devices may excel in isolated areas but do not offer the same level of multimodal integration, interoperability, or cross-facility consistency required for VISN

10 operations.

Selecting a different imaging system would introduce unnecessary duplication of equipment, elevate lifecycle maintenance costs, and increase staff training burdens.

Most critically, it would disrupt continuity of care for Veterans who routinely receive care across multiple VISN 10 facilities. Non-interoperable imaging systems result in inconsistent datasets, delayed clinical decision-making, and diminished patient care quality.

Effective Date: 12/30/2025 Page 6 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

Heidelberg Engineering, Inc., is a wholly-owned subsidiary of Heidelberg Engineering

GmbH, the equipment manufacturer, and is the only U.S. source for this equipment.

Switching to another manufacturer’s brand would introduce significant compatibility issues due to differences in both hardware and software design. The existing system contains more than ten (10) years of accumulated operational data, which would not be transferable to an alternative platform. Loss of this data would directly impact patient safety protocols, historical performance, calibration records, trend analysis, and other critical reference information would no longer be available.

6. Efforts to Obtain Competition:

Market Research was conducted, details provided in Paragraph 8 below. This effort found one (1) authorized vendor (L1 Enterprises, Inc) for open market procurements, and one (1) authorized vendor (Alvarez, LLC, through L1 Enterprises, Inc) on NASA SEWP. This action will be awarded as a sole source on SEWP contract NNG15SD19B.

7. Actions to Increase Competition:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research:

The Contract Specialist conducted reasonable and thorough efforts to identify domestically manufactured alternatives, including searches of SBA Small Business Search tool (SBS), GSA Advantage, NAC Contract Catalog Search Tool (CCST), VA Supply Chain

Master Catalog (SCMC), SAM.gov, AddsUp (a VA contract directory), and general industry sources.

Searched SBA SBS under NAICS 339112 and located 974 vendors. I then restricted the search to SD/VOSB vendors and there were 0 vendors located. Searched SBA SBS under NAICS 339112 and keywords “Optical Coherence Tomography systems” and there were no vendors found.

Searched GSA using keywords “Optical Coherence Tomography systems” and no vendors were found.

Searched SCMS using keywords “Optical Coherence Tomography System” and there were two (2) procurements listed. For both procurements, PROAIM was the vendor, and Carl

Zeiss was the manufacturer. Carl Zeiss manufactures its product in Germany.

Effective Date: 12/30/2025 Page 7 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

Searched the National Acquisition Center (CCST) with “Optical Coherence Tomography systems” and there were no results.

Searched ADDSUP with keywords “Optical Coherence Tomography Systems” and there were 10 procurements listed since 2015:

Two (2) were sold by Lombart Brothers, Inc., and manufactured by the Cannon

Corporation, in Singapore.

One (1) sold by Melling LLC and manufactured by Topcon in Japan.

One (1) sold by Metrex Research LLC and manufactured by Orascoptic in the U.S.

Two (2) sold and manufactured by Optos, Inc. This product is manufactured in the U.S.

One (1) sold by Optovue, Inc., manufactured by Thorlabs in the U.S.

One (1) sold by PROAIM Americas, LLC, manufactured by Zeiss, manufactured in

Germany.

One (1) sold by Stereo Optical Company, Inc, manufactured by Optec in Italy.

One (1) sold and manufactured by Visionix USA, Inc., in the U.S.

Searched the DLA Electronic Catalog (ECAT) with key words Optical Coherence

Tomography System, and there were 0 results. Searched again using Optical Coherence

Tomography and there were 2 procurements listed. The supplier in both procurements was Melling Medical, LLC and the manufacturer was OPTOS.

Searched SAM.gov using “Optical Coherence Tomography systems” and there were three (3) contracts awarded since 2015:

L1 Enterprises, Inc - 36C26120P1410

Corps Biologics, LLC - 36C26218P3533

Metro Medical Equipment and Supply, Inc - VA69D16P2231

A Google search shows several manufacturers for Optical Coherence Tomography systems:

Carl Zeiss (Germany) https://sam.gov/workspace/contract/award/view/36C26120P1410?agencyID=3600&modNumber=P00001&transactionNumber=0&refIdvPiid=null&idvAgencyID=null&contractType=AWARD https://sam.gov/workspace/contract/award/view/VA69D16P2231?agencyID=3600&modNumber=0&transactionNumber=0&refIdvPiid=null&idvAgencyID=null&contractType=AWARD

Effective Date: 12/30/2025 Page 8 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

Topcon Corporation (Japan)

Cannon Inc. (Japan)

Nidek (Japan)

Optovue (U.S.) -Optovue is now part of Zeis

Abbott (U.S.)

Thorlabs (U.S.)

The Contract Specialist contacted Heidelberg Engineering GmbH, the OEM. They confirmed they do not sell directly to the government, and advised L1 Enterprises, Inc. is their only authorized distributor for this equipment. Alvarez LLC through L1 Enterprises is the authorized SDVOSB vendor to manage SEWP Contracted items under SEWP Contract NNG15SD19B.

On March 04, 2026, a Sources Sought Notice (36C25026Q0300) was posted on SAM.gov and closed on March 13, 2026. No inquiries or capability statements were received. On

March 19, 2026, a Google search was completed. The search yielded several results that included Marco Lombart, OTS Spectrum, Basque Center on Cognition, Brand and

Language (BCBL), and OculaMed. However, the requested system is proprietary, and not compatible with other systems.

All market research indicates that there are similar U.S.-manufactured products available. However, switching to another manufacturer’s brand would introduce significant compatibility issues due to differences in both hardware and software design.

The existing system contains more than ten (10) years of accumulated operational data, which would not be transferable to an alternative platform. Loss of this data would directly impact patient safety protocols, historical performance, calibration records, trend analysis, and other critical reference information would no longer be available.

Market research indicates that neither the VA Rule of Two nor the SBA Rule of Two can be satisfied for this procurement. Based on these results, and in accordance with RFO

16.507-6(b)(2), this requirement will be awarded as a sole-source, on SEWP contract

NNG15SD19B.

9. Other Facts:

N/A

Effective Date: 12/30/2025 Page 9 of 9 Revision: 03 Acquisition ID#: 36C250-26-AP-2971

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Jonathan Sheeman

Program Analyst

Indianapolis VAMC

Determination that Anticipated Cost is Fair and Reasonable:

Pricing available on the SEWP contract vehicle has already undergone fair and reasonable price analysis at the contract level. Additionally, the quotes received will be compared to the pricing information provided by the end-user to further support price reasonableness. In accordance with FAR 8.405-4, a price reduction will be sought because the total anticipated value exceeds the Simplified Acquisition Threshold.

11. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Percy Johnson

Contracting Officer

NCO 10