4.2 JUSTIFICATION AND APPROVAL OPTOS_1.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Medical Research requirements.

2. Nature and/or description of the action.

The proposed action is for one Ultra wide-field non-mydriatic imaging system to be used at

Naval Aerospace Medical Research Lab (NAMRL; a directorate of Navy Medical Research

Unit- Dayton), specifically providing single shot panoramic ocular fundus images in the vision lane. The Government intends on awarding a Firm Fixed Price contract. The proposed source is

MellingMedical 658 South Columbus Street, Alexandria, VA 22314, Phone: 215 869-1450 Fax:

(703) 373-9584.

3. Description of Supplies or Services:

The Naval Aerospace Medical Research Lab has a critical need to replace a failing and unserviceable Kowa non-myd camera unit in the vision lane. The replacement unit shall have the ability to measure the following: single image capture of 80+% of retina and montage capability to far retinal periphery. Non-mydriatic optics must allow fundus capture through 2mm pupil and lens opacities. Multi-modal functionality must be provided in one physical unit

(Autofluorescence, color rg, color rgb, red-free, and choroidal imaging). Image overlay and ruler features are required for longitudinal comparison. Stereo-disc imaging and instantaneous exposure (less than 0.6 second)/auto-capture capabilities are required. Must be HIPAA compliant/password protected. Management Support Fiscal Year 2023 funds in the amount of

$107,321.96 will be used to procure the unit.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10

U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (Optos) acquisitions.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The OPTOS Optos California AF-RGB Ultra wide-field non-mydriatic imaging system is the only FDA-approved Ultra wide-field imaging system capable of providing 1) Color (rgb), IR, red-free, autofluorescent, and choroidal vasculature imaging 2) through a 2mm pupil 3) with a

200+ degree angle of view 4) in a single capture 5) with image overlay for longitudinal comparison and analysis 6) as a standalone unit. This level of capability is necessary for the approved, pending, and proposed research performed at NAMRL.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the government point of entry in accordance with FAR 5.202.

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

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the OPTOS/MellingMedical’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in the May-July 2024 timeframe. This research consisted of reviews of previous procurements for these types of non-mydriatic imaging systems and a market survey through search engines of open market contractors and Federal

Supply Schedule contractors. Search engines utilized include Google, Bing, and GSA Advantage using the following search words: non-mydriatic retinal imaging, ultra widefield non-myriatic imaging sytems. Finally, a search was conducted through evidence based journals for OCT comparisons (https://www.beye.com/compare/non-mydriatic-fundus-cameras, https://www.ophthalmologyscience.org/article/S2666-9145(23)00159-8/fulltext, https://www.reviewofoptometry.com/article/ultrawidefield-imaging-expand-your-horizons, https://www.nature.com/articles/s41598-022-21319-9) . OPTOS is the sole manufacturer of a unit meeting the above criteria and utilizes MellingMedical as their domestic and government sales distributor in Ohio. Consequently, the Government’s technical experts determined that

OPTOS/MellingMedical is the only source that can meet the Government’s requirements. The results of the market research are attached.

9. Other facts supporting the use of other than full and open competition.

The Kowa non-myd camera unit was procured as a bulk order around 2010 in coordination with

NMLC to standardize optometry equipment across the fleet. At that time, NAMRL was located in Pensacola. The current Kowa non-myd camera system was transferred to NAMRU-Dayton around 2012 in accord with BRAC. Original equipment custody documents are no longer available, however the current unit was tagged and logged into DMLSS here 27AUG2014.

No other non-myd camera on the market besides the OPTOS Optos California AF-RGB Ultra wide-field non-mydriatic imaging system has the ability to 1) take a single-shot picture as wide

(200 degrees+) 2) or as fast (0.6 seconds) 3) while offering all of the modalities (montage up to https://www.beye.com/compare/non-mydriatic-fundus-cameras https://www.ophthalmologyscience.org/article/S2666-9145(23)00159-8/fulltext https://www.reviewofoptometry.com/article/ultrawidefield-imaging-expand-your-horizons https://www.nature.com/articles/s41598-022-21319-9

95% of the retina visible, Color [rgb], IR, red-free, autofluorescent, and choroidal vasculature imaging) 4) in combination with image overlay as a 5) standalone unit.

Finally, the estimated cost to the government, as derived by the attached quote, is $107,321.96 for the OPTOS Optos California AF-RGB Ultra wide-field non-mydriatic imaging system. This quote includes 12 months of support/service and installation.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For the reasons set forth in Paragraph 5, NAMRL/NAMRU-D has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements are feasible.

This is a one-time buy.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management

Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

8/7/2024

X Erica Poole

CDR Erica Poole

Aerospace Research Optometrist

Signed by: POOLE.ERICA.LYNN.1391918372 937-938-3871 06AUG2024

Aerospace Research Optometrist Phone Date

Vision Science/ NAMRL mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

Requirements Cognizance

8/8/2024

X Richard D. Arnold

Dr. Richard Arnold

Director

Signed by: ARNOLD.RICHARD.DINWIDDIE.1050339552 937-938-3877 06AUG2024

Director Phone Date

Naval Aerospace Medical Research Lab

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Contracting Officer Phone Date