JA17093_USAARL_Redacted.pdf

Control No: JA17093

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

Oculus Pentacam High Resolution (HR) Scheimplug Camera

1. Contracting Activity: The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Requiring Activity: The requiring activity for this action is the U.S. Army Aeromedical Research Laboratory (USAARL), BLDG 6901 Farrell Road, Fort Rucker, Alabama.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: _______ **Time & Materials: ________

* Cost: ________

Funds:

Fiscal Year of Funds:

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed Contractor(s): Oculus, Inc.

Street Address: 17721 59th Avenue NE City, State, Zip: Arlington, WA 98223-1337 Phone:

DUNS: 122924348

Cage Code: 8AJX5

"For Official Use Only”

5. Description of Supplies: The U.S. Army Aeromedical Research Laboratory (USAARL) has a requirement for the purchase of one (1) Oculus Pentacam High Resolution (HR) Scheimplug Camera. The Pentacam camera provides crisp images of cornea, iris and crystalline lens. In addition, the camera measures the anterior and posterior corneal topography and elevation, total corneal refractive power, corneal power distribution, automatic chamber angle measurement in 360°, chamber depth and volume, Horizental White-to-White (HWTW), corneal and crystalline lens optical opacities.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited:

The Oculus Pentacam HR corneal tomography system is a unique state of the art Food and Drug Administration (FDA)-approved experimental laboratory testing device that provides shape-based information for both the front and back of the human eye’s cornea. The device uses the Scheimpflug scanning slit principle in which numerous cross sectional images of the human cornea are recorded along various meridian angles and then combined to form a composite 3-dimensional volume image (a tomograph) of the total cornea in thickness. This unique device provides precise numerical information about corneal shape and elevation of the front and back surfaces of the cornea that are not available from a wave front analyzer or corneal topography device. The Pentacam also provides a color-coded pachymetric map of the total thickness of the cornea at every location. In addition to the shape data that can be analyzed for normality and abnormalities, it can calculate the wave front error for both the front and back corneal surfaces independently or together as a common system.

This Oculus Pentacam is the only camera capable of providing high resolution data that can numerically and graphically describe the shape and optical performance of the living human cornea for USAARL’s research program. The Oculus Pentacam will be used to assess all psychophysical and ocular physiology experimental test subjects for research studies conducted at the USAARL Vision Protection and Performance laboratories. It will evaluate normal test participants and those who have had documented histories of impaired or altered vision (e.g., past histories of concussions).

"For Official Use Only”

In particular, the device is needed to record corneal optics baseline data for participants in the CANagliflozin cardioVascular Assessment Study (CANVAS) study which will be conducted at USAARL. The CANVAS study will fully characterize the vision system of U.S. Army aviators and aircrew. Specifically, this device will be used to determine the wave front aberrations and corneal topography maps of study participants who have undergone laser vision correction procedures such as photorefractive keratectomy (PRK) for myopia in the past. This device will screen for post-surgical eyes so that they may be classified as a separate sub-category within the CANVAS study.

In addition, the device will be used to screen participants of the Degraded Vision Environment (DVE) studies for any corneal anomalies that may affect visual acuity or contrast sensitivity, such as subclinical ectasia from undiagnosed disease or past refractive surgery, or corneal edema from past injuries. Oculus Inc. is the sole source for development, manufacture, and delivery of the Pentacam Scheimplug Camera System.

8. Efforts to obtain Competition: A review of the marketplace for comparable Pentacam Scheimplug Camera systems did not uncover any that can meet all of the Minimum Essential Characteristics (MECs) as required by USAARL. Oculus Inc. is the only source available in the marketplace for the Oculus Pentacam HR Scheimplug Camera, there are no resellers. No effort will be made to solicit offers from any other potential sources as it is impracticable as there is only one source capable of meeting USAARL’s requirement. No effective competition is anticipated.

a. Effective competition. There is not a reasonable expectation for competition since Oculus Inc. provides the only Pentacam Scheimplug Camera System capable of meeting USAARL’s requirement.

b. Subcontracting competition. Not Applicable

9. Actions to remove or overcome barriers Competition: USAARL will continue to monitor the commercial market and will also consider open for future procurement actions if the opportunity is possible. Additionally competition, the Government may post a Request for Information (RFI) for any future procurement to FedBizOpps to determine if there are sources available in the marketplace that can meet the Government’s need.

If responses from an RFI posting show that there are competitors in the marketplace, future acquisitions may be competed.

10. Market Survey: In preparation for this requirement, USAARL staff researched other commercially-available anterior segment cameras. No other vendors were identified except for Oculus, Inc. with the required specifications. The survey of the marketplace included a search of General Services Administration (GSA) Advantage!

and numerous Google Internet searches.

11. Interested Sources: To date, no other sources have expressed or advertised equipment that meets the MECs for the Pentacam required by USAARL. A Notice of

"For Official Use Only”

Date: 14 February 2017