P03 - J and A Optos - redacted.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans through 2237# seeks to purchase a brand-name only OPTOS Silverstone Retinal camera on a non-competitive acquisition.

2. Nature and/or Description of the Action Being Approved:

The proposed action is to purchase as a sole source, firm-fixed award OPTOS Silverstone Retinal camera for from Melling, LLC, an SDVOSB vendor.

The required OPTOS Silverstone Retinal camera is needed to replace end-of-life (EOL) equipment at the facility which is unable to be repaired. The existing equipment is not OPTOS brand, but the staff is already familiar with this equipment. The Ultra-Wide Field Retina camera will provide the ophthalmology service with a state-of-the-art system that can capture a wide view retinal image providing views of more than 80% or 200 degrees of the retina in a single capture.

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

to purchase an OPTOS Silverstone Retinal camera for the replacement at all Three NYH campuses, one each. The estimated delivery date is 45 days. The existing equipment is not an OPTOS brand, which is at “End-of-life and the equipment is beyond repair, so the facility decided to replace obsolete equipment with this OPTOS Silverstone Retina Camera to better care for patients. The unique characteristics of the OPTOS Silverstone SS- OCT provide a single image that 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 the 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.

The following unique technical specifications for this system are:

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Revision 03 Eff Date: 04/03/2020

Ref. # Item Description

Technical Specification (Detailed description)

A10750 OPTOS

Silverstone SS OCT (One per Campus)

Combined UWF (200°) fundus imaging and image guided, Swept Source OCT Single image captures 82% of the retina (927mm2) Single capture covers 200° of the internal surfaces of the retina Single capture image reaches beyond the equator showing vortex vessels and ampullae Ultra-widefield (200°) image capture in less than. second Montage image shows up to 97% of the retina (1166mm2) Ellipsoidal mirror with virtual point technology enables maximum imaging field of view Clinically validated color imaging –proven equivalent to color fundus photography for pathology detection (1) A Scan rate up to 100k cycles, active eye tracking, automatic scan position. OCT scan types: line scan widths (6mm, 14mm, 23mm), volume & high-density volume scans (height: min 3.5mm, max 9mm, width: min: 6.0mm, max (14mm) Multiple wavelength color imaging provides color, red-free, choroidal, and true-color views with a single capture Ease of use validated in multi-site clinical studies Proven to enhance clinic flow Proprietary software presents images in a consistent geometry that accurately represents anatomical features across the retina and allows for accurate measurements across the retina Auto-capture capability Non-mydriatic, cSLO technology images through 2 mm pupil cSLO technology images through most cataracts Light source wavelengths: red 635 nm, green 532 nm, blue 488 nm, IR 802nm•DICOM compliant as per the DICOM Conformance Statement System is listed on the VA’s “VistA Imaging Approved DICOM Modality Interfaces” list found at:

http://www.va.gov/HEALTH/imaging/docs/VistA_Imaging_DICOM_ Modality_Interfaces.pdf Able to perform fundus autofluorescence (AF) with green laser Able to perform fluorescein angiography (FA) Able to perform indocyanine green angiography (ICGA) All functions (color photo, red-free photo, choroidal imaging, AF imaging, FA, and ICGA) are included in a single compact system Includes alignment software to ensure that pictures are taken in the same place each time and that images in the same place taken with different modalities

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Revision 03 Eff Date: 04/03/2020 and/or on different dates can be accurately overlaid for clinical comparison Includes image overlay software for accurate comparison of images from different days and in different modes Includes HIPAA compliant, browser-based image review software Includes image measurement tools Capable of stereo disc imaging Capable of combined FA and ICG A capture Connects with OPTOS Advance image management software and allows access to raw data via OPTOS Advance software Connects to 3rdparty image management systems and allows review of images via the 3rdpartysoftware System includes an automatic, wheelchair accessible table Powered via connection to standard AC outlet (100 to 240V) System requires minimum maintenance

OPTOS

Dicom Modality Worklist MWL) and Live

Enables capture station to query for and receive Modality Worklist (MWL) data from a suitable MWL server. DICOM C is included. This capability does not include the Modality Worklist as a "Service Content Provider" (SCP) but where the scan heads are "users of the worklist"

Here is the OPTOS Silverstone Retinal camera equipment NYHHS intends to purchase:

OPTOS Silverstone SS OCT (Part Number: A10750) OPTOS Dicom Modality Worklist MWL) and Live Store to Third Party PACS (Part Number:

FEATURE_A10750_05 - Silverstone) Installation, Calibration & On-Site Training (Part Number: INSTALL)

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(x) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or () 819.7008 Sole source awards to a verified veteran-owned small business

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

Melling LLC., an SDVOSB vendor is the only official distributor from the OPTOS OEM where no other supplier available to supply the requirement. 38 U.S.C. 8127(c) and 819.7003, the authority allows CO to sole source awards to Melling, LLC.

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

A review of all Government search engines was conducted to find as many potential sources as possible. They were Veterans Information Pages (VIP), Small business dynamics (SBS), Non-expendable (NX) Equipment, E-CAT, Strategic Acquisition Center (SAC) mandatory contracts, GSA E-library, and Contract Opportunities. A Source sought notice was posted to Contract Opportunities. CO received one (1) response from Melling, LLC an SDVOSB vendor.

Based on the above criteria, of sections III, V, and VI the facility’s investment is greatly reduced by not using a different manufacturer, as the staff are familiar with the OPTOS system and the unique requirement about the retina Camera to assist our Veterans within the facility.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The price from the OPTOS OEM is the same as Melling LLC, the only official distributor.

A recent similar procurement of an OPTOS 200DTX Ultra-Wide Field Retina Camera was awarded

, the purchase price is the same as the OEM with no additional add-on fee to the VA which shows the cost is fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research was conducted using VIP, FPDS, SBA, and GSA to find the requested items. VIP showed a potential of 0 vendors under the NAICS code 339115 and keyword OPTOS Silverstone. FPDS showed numerous VA orders made also directly to OEM and Authorized vendor. SBA showed a potential of 0 vendors that can supply the items under the same NAICS code and keyword. On GSA, there was 0 vendor that can supply the items. A sources sought notice was posted to GSA eBuy and 0 vendors responded. A sources sought was posted on BetaSam which received a response from authorized Further market research was conducted the OEM (OPTOS INC) is an SB with one official SDVOSB distributor (Melling Medical LLC). As a result of market research, the findings show an SDVOSB Sole Source to authorized vendor Melling LLC thru an open market would be in the best interest of the Government.

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:

Melling, LLC.

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:

To remove or overcome barriers to competition in future acquisitions for this requirement, the agency and the Ophthalmology department will continue checking and researching for a possibility of a better Retina Camera to serve our Veterans. Currently, there is no other source that can provide the proprietary components required to meet the Government’s need. CO will continue to monitor the market.

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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.

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.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.