4.2 Justification and Approval Template ZOCT_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.

EXAMPLE TEXT: The proposed action is for one Ocular Coherence Tomography unit to be used at Naval Aerospace Medical Research Lab (NAMRL; a directorate of Navy Medical Research Unit- Dayton), specifically providing ocular thickness measurements in the vision lane.

The Government intends on awarding a Firm Fixed Price contract. The proposed source is PROAIM Americas, LLC., 16024 Manchester Road, Suite 200, Saint Louis, MO 63011.

3. Description of Supplies or Services:

The Naval Aerospace Medical Research Lab has a critical need to replace a failing and unserviceable Optical Coherence Tomography unit in the vision lane. The replacement unit shall have the ability to measure the following: Corneal profile and thickness, Anterior Chamber depth, Macula and Optic nerve thickness (raster, cube/3D toggle, line, HD, starburst/radial) Nerve fiber layer, Ganglion cell complex, interface surfaces (en Face), and angiography of the deep/sub- retina. This unit shall provide normative database comparisons, as well as a guided progression analysis toolbox. As such, this unit must be backwards compatible, allowing for migration of subject data collected on the current model to the new model, seamlessly, for longitudinal analyses. Management Support Fiscal Year 2023 funds in the amount of $96,500.00 will be used to procure the monitors, and $16,953.84 will be used to purchase three years of Optime service support.

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 (Zeiss) acquisitions.

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

The Zeiss HD-OCT 6000 with Angioplex is the only FDA-approved Spectral Domain Optical Coherence Tomographer offering axial resolution of 5 microns in tissue with 100,000 A scans/second. This level of resolution is necessary for the approved, pending, and proposed research performed at NAMRL. Additionally, this is the only current model that is backwards compatible with previously collected (On Cirrus HD-OCT 4000 Model) subject measurements and Angiography capability.

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 Zeiss/PROAIM’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 tomography 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: Optical Coherence Tomography. Finally, a search was conducted through evidence based journals for OCT comparisons (Conquer These OCT Technology Choices and Challenges (reviewofoptometry.com). Carl Zeiss Meditec Inc. is the sole manufacturer of a unit meeting the above criteria and they utilize PROAIM as their domestic and government sales distributor in Ohio. Consequently, the Government’s technical experts determined that Zeiss/PROAIM 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 Zeiss HD-OCT 4000 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 Zeiss HD-OCT 4000 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.

Again, in an effort to retain records of occupational health baselines, laser safety measurements, and research subject data, it is crucial that we continue using Zeiss HD-OCT products. No other OCT on the market has the ability to scan with the same resolution/speed using Spectral Domain modality, nor do other brands allow for backwards compatibility (seamless transfer of previous measurements to new unit).

https://www.reviewofoptometry.com/article/conquer-these-oct-technology-choices-and-challenges https://www.reviewofoptometry.com/article/conquer-these-oct-technology-choices-and-challenges

Finally, the estimated cost to the government, as derived by the attached quote, is $96,500.00 for the Zeiss HD-OCT 6000 with Angioplex, and $16,953.84 for three years worth of planned maintenance and support.

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

X CDR Erica Poole Aerospace Research Optometrist

937-938-3871 01AUG2024

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

8/1/2024

X Richard D. Arnold Dr. Richard Arnold Director Signed by: ARNOLD.RICHARD.DINWIDDIE.1050339552 937-938-3877 01AUG2024

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

Technical Cognizance