SSJ 36C241-25-AP-3625 Spectralis Tracking OCT System.pdf

Acquisition ID#: 36V241-25-AP-3625

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-25-AP-3625

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Boston Healthcare System, West

Roxbury Campus, Ophthalmology and Optometry Section. 2237 # 523-25-3-7077-0022

2. Nature and/or Description of the Action Being Processed: This procurement is for a Spectralis Tracking OCT System in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action being reviewed and approved is a one-time purchase order that will be awarded as a new firm-fixed-price contract to SDVOSB L1 Enterprises, Inc.

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

The SPECTRALIS system is an expandable diagnostic imaging platform that combines scanning laser fundus imaging with high-resolution optical coherence tomography (OCT).

Item

Part # Description Qty

0226-HRAOCT2-MC Spectralis Tracking OCT System - HRA+OCT w/OCT2

MultiColor 3

2 HEYEX2 HEYEX2 3

3 88024A OCT Angiography 3 4 0226-UWF Ultra-Widefield Angiography Module 3 5 0226-WFIMAGE Widefield Imaging Module 3 6 0226-ASM Spectralis Anterior Segment Module 3 7 0260-042 Trade-In- HRAOCT+OCT - SN 5501-10000 1 8 0260-032 Trade-In OCT + BP – SN 5501-7500 2

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

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

The SPECTRALIS HRA+OCT is a unique ophthalmic diagnostic imaging and angiography platform 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 platform 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.

• 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.

• Heidelberg Noise Reduction™ is a proprietary technology that reduces the noise inherent in scanning laser imaging by capturing multiple images in the exact same location.

• AutoRescan™ uses retinal recognition technology to automatically position the OCT scan in the same anatomic location at follow-up to precisely track change over time.

• Heidelberg Eye Explorer (HEYEX™) Networking Solutions allow remote image review and analysis.

• Scanning Laser Angiography (Fluorescein and Optional Indocyanine Green)provides high-resolution images and video sequences showing the dynamic movement of dye through the vessels and minute details of the parafoveal capillary network.

• BluePeak™ Blue Laser Autofluorescence is a noninvasive, scanning laser fundus imaging modality that provides a map of the retina. This can reveal metabolic malfunction of diagnostic significance in many conditions, such as AMD.

• The panning camera head allows the camera to move from side to side and tilt up and down to accommodate patient positioning and imaging in the periphery.

• Movie image capture provides CSLO videos in single-frame and high-speed modes.

• Touch panel enables the user to select acquisition modalities and settings easily.

The inability to acquire the Spectralis OCT 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 VA Boston 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 15 years, leading to an irreplaceable loss of historical eye health information. Other campuses within the VA Boston network would be unable to access or interpret new data, severely hindering continuity of care and collaboration across facilities.

Acquiring the Spectralis OCT 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.

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. L1 Enterprises, as the exclusive distribution partner, is the only source that can provide the Heidelberg Engineering Spectralis Tracking OCT System to the VA Healthcare System.

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

Sources Sought Synopsis Notice number 36C24125Q0454 was posted to SAM.gov from May 5, 2025, to May 9, 2025, searching for Spectralis Tracking OCT System sources. Only L1 Enterprises, Inc.

responded.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO anticipates that the contract cost will be considered fair and reasonable based on a comparison of proposed prices, which will be compared to a previous purchase at VISN 1 on June 15, 2023, under PO 36C24123P0817.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

A Sources Sought Synopsis was posted to SAM.gov from May 5, 2025, to May 9, 2025. L1 Enterprises responded as the exclusive Federal Government distributor for Heidelberg Engineering, the Original Equipment Manufacturer of this product. As the exclusive distribution partner, L1 Enterprises is the only source that can provide the Heidelberg Engineering Spectralis Tracking OCT System to the VA Healthcare System. No other sources responded.

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:

L1 Enterprises, Inc.

618 W. Patrick Street Frederick, MD 21701

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: At this time, no subsequent acquisitions for these supplies are planned.

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.

Cecily Belgrave Date Health System Specialist

VISN 1

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.

Sheryl Anthony Date Contracting Officer

NCO1

CECILY

BELGRAVE

Digitally signed by

CECILY BELGRAVE

Date: 2025.05.14 14:12:35 -04'00'

SHERYL ANTHONY

Digitally signed by

SHERYL ANTHONY

Date: 2025.05.20 07:30:32 -04'00' 5/20/25

5/14/25

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.

Pedro Lara Date Division Chief

NCO1

PEDRO

LARA

Digitally signed by

PEDRO LARA

Date: 2025.06.26 13:37:55 -04'00'

6/26/25