ATTACHMENT 3 - Brand Name Justification_Redacted.pdf

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Optos Daytona Retina Camera Warm Springs Service Unit
Solicitation number
75H71325Q00013
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This document is a Simplified Acquisition Brand-Name Justification for acquisitions under $250,000 from the Department of Health and Human Services, Indian Health Service (IHS). The procurement is for an Ultra-Wide Field (UWF) Fundus Imaging system from Optos Inc., specifically the Optos Daytona model, to aid in diagnosing and tracking retinal disease states for conditions like diabetes, glaucoma, and macular degeneration. The justification emphasizes that the Optos device is the only camera capable of capturing over 200 degrees of the retina in a single image, with clinically validated imaging that increases retinal visualization by over 50% compared to other devices.

The document highlights unique capabilities that make the Optos Daytona essential, including its ability to capture a complete 200-degree retinal image without stitching, which could potentially lose critical details. The procurement has a proposed performance period of 60 days after order receipt. If the Optos Daytona model is not awarded, the Warm Springs Health and Wellness Center Optometry department will experience reduced optometry services, potentially leading to poor health outcomes and substandard patient care. The document includes sections for Program Office and Contracting Officer certification, though these are currently unsigned.

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ATTACHMENT 1 - SPECIFICATIONS SHEET.docx DOCX document
ATTACHMENT 2 - IHS IEE Representation.pdf PDF

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SIMPLIFIED ACQUISITION BRAND-NAME JUSTIFICATION

FOR ACQUISITIONS UNDER $250K

Activity: The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a purchase order on a basis of an item peculiar to one manufacturer as implemented by FAR Subpart 13.106-1(b)

1. Requisition#: To be determined

2. Description of Supplies or Services: Supply and delivery Ultra-Wide Field (UWF) Fundus Imaging that will aid in the diagnosis of and tracking of retinal disease states for Diabetes, glaucoma, macular degeneration and more.

3. Period of Performance: Sixty (60) days after receipt of order, estimated.

4. Estimated Value of Procurement:

5. Recommended Sources:

Optos Inc.

500 Nickerson Rd. Ste 201 Marlbourgh, MA 01752

6. Reason for Sole Source/Limited Sources/Expedited Processing:

[ ] Only one source (unique capabilities) [ ] Proprietary drawings, specifications, and/or engineering data, patents, copyrights.

[X] Brand Name essential to the Government’s needs.

[ ] Standardization Program supported by Agency Head Determination and Findings (D&F).

[ ] Unusual and Compelling Urgency [ ] Authorized or required by statute

a. Justification Narrative:

Optos, Model Daytona is the only source that has unique capabilities required by the Government for the following reasons:

1) This camera is able to take one image of the retina and visualize over 200 degrees of retina, including peripheral retina, other fundus cameras do not have this capability.

2) Optos is the only manufacturer that makes a camera that can take a 200-degree image in a single capture as opposed to stitching together images to make a 200-degree image. Because of the sensitive nature of the eye, details can be lost when stitching together the image. It is also more efficient to only need a single image than 3 images stitched together.

3) The Optos UWF Camera is the only true clinically-validated ultra-wide-field retinal imaging that can capture >81% or >200 degrees of the retina in a single image. This is an increase of over 50% from any other imaging device of its kind. This is actually the only JVN recommended device for this type of imaging.

2) Optos is the only manufacturer that can complete this wide-field imaging capabilities.

File details come from the government source that posted it. Updated .