P03_Justification and Approval_Red.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C248-21-AP-0794

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 8 in support of VISN 08, VA Caribbean Healthcare System, 2237 Reference Number: 672-21-1-103-0023

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Request for Brand Name only for an OPTOS 200DTX Ultra-Wide Field Retina Camera for the VA Caribbean Healthcare System in San Juan, PR.

The Ultra-Wide Field Retina camera will provide the ophthalmology service with a state-of-the-art system that has the ability to capture a wide view retinal image providing views of more than 80% or 200 degrees of the retina in a single capture. The Ultra-Wide Field Retina Camera will help clinicians discover more evidence of disease and guide their treatment decisions. It will also serve as an important tool for medico-legal documentation of initial patient condition prior an elective eye surgery, particularly when the outcome of a case does not meet patient’s expectations. For example, doing cataract surgery in a patient with advanced diabetic retinopathy, macular degeneration or glaucoma.

Estimated Dollar Value: $133,809.86

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The unique characteristics to the OPTOS 200DTX provides a single image which captures 82% of the retina (927 mm2). A single capture covers 200° of the internal surfaces of the retina. This is the essential difference as physicians will use this equipment for screening of retinal disease. Using a system to produce a photo with a smaller field of view will miss crucial retinal pathology. A single capture image reaches beyond the equator showing vortex vessels and ampullae. The Ultra-widefield (200°) single image capture in less than ½ second. The montage image shows up to 97% of the retina (1166 mm2) and multiple wavelength color imaging provides color, red-free, choroidal, and true-color views with a single capture. Physicians will find the ease of use to validate in multi-site clinical studies. It is proven to enhance clinic flow as one photo per eye is needed for screening.

The proprietary software presents images in a consistent geometry that accurately represents anatomical features across the retina and allows for accurate measurements across the retina. The color imaging with red/green lasers to minimize exposure to blue light.

In comparing with the Clarus Retina Camera on the mandatory Strategic Acquisition Center, the Clarus only provides a widefield of 133 degrees in a single photograph and then the Clarus requires six photos montage compared to OPTOS which only requires three photo images to capture true retinal anatomy/landmarks. Clarus only offers red, green and blue led lights, which OPTOS color composite use confocal red and laser. Also avoids the use of blue light which has been linked to https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Page 2 of 3

Revision 02 Eff Date: 03/31/2020 ocular pathology such as macular degeneration. In the Optos, a single photo shot provides all information needed for screening with a high definition photo with 200 degrees with less time and cooperation from patient, compared to Clarus as 2-3 photos are required to obtain a 200 degrees montage which requires more time and cooperation from patients. Also requires more input from technicians. The Clarus will decrease workflow as it will require several images per eye to produce the same information.

OPTOS VS CLARUS COMPARISON

OPTOS CLARUS

PUPIL DILATION NON MYDRIATIC NON MYDRIATIC

SINGLE PHOTOGRAPH VIEW ANGLE 200 DEGREES (ULTRAWIDE

FIELD)

133 DEGREES (WIDEFIELD

ONLY)

Cannot achieve 200 with a single shot photograph.

EXAMPLE: IMAGE OF THE SAME

PATIENT AND EYE. OPTOS SHOWS

→ A HORSESHOE TEAR NOT SEEN

IN CLARUS DUE TO VIEWING

ANGLE

FOR ULTRAWIDE FIELD PHOTOS

BEYOND 200 DEGREES

FOR ULTRAWIDE FIELD PHOTOS

BEYOND 200 DEGREES

OPTOS MONTAGE REQUIRES 3

PHOTOS AND RESPECTS TRUE

RETINAL

ANATOMY/LANDMARKS

CLARUS REQUIRES UP TO 6

PHOTOS FOR MONTAGE

VHAPM Part 813.106 Page 3 of 3

Revision 02 Eff Date: 03/31/2020

LIGHT SOURCE AND COLOR COLOR COMPOSITE USING

CONFOCAL RED AND LASER.

AVOIDS THE USE OF BLUE LIGHT

WHICH HAS BEEN LINKED TO

OCULAR PATHOLOGY SUCH AS

MACULAR DEGENERATION

USES RED, GREEN AND BLUE LED

LIGHTS

TIME TO PERFOM STUDY A SINGLE PHOTO SHOT

PROVIDES ALL INFORMATION

NEEDED FOR SCREENING WITH

A HIGH DEFINITION PHOTO

WITH 200 DEGREES. TAKES LESS

TIME AND COOPERATION FROM

PATIENT. VERY USER FRIENDLY

FOR TECHNICIAN

AS 2-3 PHOTOS ARE REQUIRED

TO OBTAIN A 200 DEGREES

MONTAGE, REQUIRES MORE

TIME AND COOPERATION FROM

PATIENT. ALSO REQUIRES MORE

INPUT FROM TECHNICIAN

4. Description of market research conducted and results or statement why it was not conducted:

Market research found a similar requirement on the Strategic Acquisition Center as a mandatory contract. Per the Ophthalmologist in San Juan, PR they stated the following: “A similar equipment was found which is the Zeiss Clarus Camera. This system is NOT a TRUE Ultra-Wide-Field as it only captures a Wide-Field photo up to 133 degrees of view in a single photo vs OPTOS which captures a 200 degrees photo. Therefore, the OPTOS field is the only system which provides a real ultra-wide field photo with a single shot in an un-dilated pupil”.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

____________________________ 12/31/2020 Pedro J. Catinchi Date Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466