A.01 JA under SAT_PENTACAM AXL.docx signed_03.02.21_Redacted.pdf

J&A Control# 21-RHCO-A-243 Purchase Request#:

Purchase Order#: W91YTZ-21-P-0056

Sole Source Justification

For Acquisitions under the Simplified Acquisition Threshold

1. Contracting Activity: Department of the Army US Army Medical Command (USAMEDCOM) US Army Health Contracting Activity (USAHCA) Regional Health Contracting Office – Atlantic (RHCAO-A) Gordon Contracting Branch (GHCB) Fort Gordon, GA 30905

2. Description of Action:

Name of Intended Contractor: Melling LLC, dba Melling Medical Street Address: 658 South Columbus Street City, State, Zip: Alexandria, VA 22314

Phone: (703) 625-2234

3. Description of Supplies/Services: Ophthalmic diagnostic devices for the EENT-Optometry Clinic at Eisenhower Army Medical Center, Fort Gordon, GA. Pentacam is a diagnostic tool for pathology of the cornea and anterior segment of the eye. It is used to diagnose blinding diseases such as keratoconus, corneal ectasia, narrow angle glaucoma etc. It is also vitally important in astigmatic measurement with regard to preoperative planning for intra-ocular implantation of corrective lenses as well as laser refractive surgery correction.

4. Authority Cited:

(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 8.405-6(a) (1) (i) (A): An urgent and compelling need exists, and followingthe procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a) (1) (i) (B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique orhighly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

Requirement: New Repeat Pricing:

Funds: OMA

Firm-Fixed Price Other Funds:

Time & Materials Total Dollar Valu

Cost e:

5. Reason for Authority Cited:

The EENT-Optometry Clinic has a need for the PENTACAM AXL, which will be used in the Optometry Clinic, the Pentacam AXL is a systematic enhancement of the time-tested Pentacam® HR technology. In addition to anterior segment tomography, the original function of its predecessor, the Pentacam® AXL has integrated axial length measurement, a feature which allows you to make accurate IOL calculations. All using one device with one measurement procedure and reliable Pentacam® software. The Pentacam AXL is the only device that currently meets the Government’s requirements. The device has been determined by the Optometrist to meet the medical, health, and wellness of the patients of the optometry clinic. Melling Medical is the exclusive authorized distributor for all Oculus Products into the Federal Government. The use of any other service providers could result in lowering the standard of care provided and cause delays in access to healthcare.

6. Publicizing Contract Actions: Market Research and personal knowledge support that thereare no distributors for the above listed other than Melling Medical dba Melling Medical LLC for this requirement. No additional action will be taken to increase competition for this requirement.

7. Market Research:

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition:

9. Technical / Requirements Certification: I certify that the supporting data under my cognizance which are included in this justification are accurate and complete to the best of my knowledge and belief. I certify this this product is not available using mandatory sources.

Submitted By:

Position Title :

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurateand complete to the best of my knowledge and belief.

Typed Name:

Position Title:

Email address:

Date:

Additional market research information: Called and spoke with , used google, quote is attached. Market research showed that Melling Medical, LLC is the only authorized distributor for the PENTACAM AXL. The Government will synopsize this requirement using a sole source notice of intent for the proposed acquisition, total small business set-aside on beta.SAM.gov.