7274360 - JA - FE.pdf

Justification for Other than Full and Open Competition Brand Name at or Below the Simplified Acquisition Threshold

Project Title: Spectralis Optical Coherence Tomography (OCT) Eye Imaging Equipment

Identification of the agency and contracting activity

DHHS, NIH, NEI, VFC

Vision Function Core, National Eye Institute 10 Center Drive, Bldg. 10, Rm 5C101 Bethesda, MD 20892

Background and Justification

A. Project Background

Eye imaging (including fundus and Optical Coherence Tomography image) provides non-invasive approach to view and exam structure and integrity of the eye. This approach is widely used in eye clinic and vision research labs for study structure and function of the eye. The Visual Function Core (VFC) facility at the National Eye Institute (NEI) has been using eye imaging by many researchers, both within NEI and other ICs on the NIH campus, on a number of research projects with a variety of animal models.

B. Project Description

The purpose of this procurement is to order a new Optical Coherence Tomography (OCT) eye imaging equipment to replace the current outdated equipment at the VFC. As part of this new equipment purchase, the VFC will trade-in the current equipment onsite for a discount or credit.

C. Description of the supplies to be purchased:

Part# Manufacturer Description of item (Be as clear as possible)

Quantity Unit of Measure

0226-

HRAOCT2-

MC

Heidelberg Engineering

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

1 each

88025A Heidelberg Engineering

OCT Angiography, OCTA SHIFT (85 & 125 kHz)

1 each

HEYEX2 Heidelberg Engineering

HEYEX 2 Software Platform 1 each

0260-042 Heidelberg Engineering

Trade-In- HRAOCT+OCT - SN 4501 or higher

1 each

Statement of Work

Vendor will also be responsible for the services below:

1. Assemble and install the instrument at the NIH-designated location.

2. Connect the instrument to data server at NEI in coordination with NEI IT Team.

3. Provide training for using the instrument to NEI users.

4. Warranty the instrument for one year.

Name of manufacturer, producer, or distributor of each brand name product referenced:

Heidelberg Engineering, Inc.

10 Forge Parkway

Franklin, MA, 02038-3137

Statutory authority permitting other than full and open competition

☒ 41 USC 253(c)(1) and FAR Part 6.302-1: Brand Name Requirement

Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited above:

The VFC is in need of replacing the current outdated Spectralis OCT equipment with a new eye imaging instrument.

The VFC currently uses the Spectralis eye imaging device and has ongoing research experiments using the instrument. Ensuring the same manufacturer of the instrument will ensure the continuity of current research projects and comparability of existing data.

The Spectralis instrument offers unique features that is not widely available in the commercial marketplace. It combines two technologies, confocal scanning laser ophthalmoscopy (cSLO) and spectral-domain optical coherence tomography (SD-OCT). It is the only Spectral-Domain OCT imaging system to incorporate all the essential features listed below.

• Active Eye Tracking: Actively follows the patient’s eye during the scan, minimizing motion artifact and allowing targeted OCT scan placement.

• AutoRescan™: A baseline image is selected, and the follow-up scan is automatically placed in precisely the same location.

• Heidelberg Noise Reduction™: Combines multiple scans taken at the same location and eliminates noise from the image.

• Six (6) imaging modes: Infrared, red-free, BluePeak autofluorescence, fluorescein angiography, ICG angiography, and spectral-domain optical coherence tomography.

• Nine (9) simultaneous imaging options: ICGA + IR, RF + IR, FA + IR, FA + ICGA, IR + OCT, RF + OCT, BluePeak +

OCT, FA + OCT, ICGA + OCT.

• Four (4) separate light sources at the following wavelengths:

o 870 nm SLD for SD-OCT o 488 nm laser diode o 790 nm laser diode o 820 nm laser diode

Utilizing a vendor that distributes the Sprectralis instrument also presents opportunity for NIH to trade-in the existing equipment for a discount/credit, which presents additional cost savings for the Government.

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date

Contracting Officer Approval

Addison Miller Contracting Officer

9/17/2025