J and A - Signed.pdf

FACTS SUPPORTING A REQUEST TO ENTER INTO AN ACQUISITION USING OTHER THAN FULL

AND OPEN COMPETITION – SIMPLIFIED ACQUISITION (UNDER $150,000)

REQ no. POTS #: T181902 Requestor Guy Foster Office Code 00527 Phone no. 301 905-7423

Introduction: Pursuant to Federal Acquisition Regulation 13.106-3(b)(3)(i), the following data is furnished to the Contracting Officer to support the requisitioning office’s request that the items/services identified on the above-mentioned Requisition be obtained using other than full and open competition. The requisitioning office understands that a contract may not be awarded on a sole source/brand name only basis unless the Contracting Officer approves Other than Full and Open Competition.

1. Identification of the Agency: HHS/NIH/NEI/OCD/CSS

2. Nature and or/Description of Action Being Approved. Brand name only

An operating microscope or surgical microscope is an optical microscope specifically designed to be used in a surgical setting, typically to perform microsurgery.

Design features of an operating microscope are: magnification typically in the range from 4x-40x, components that are easy to sterilize or disinfect in order to ensure cross-infection control.

There is often a prism that allows splitting of the light beam in order that assistants may also visualize the procedure or to allow photography or video to be taken of the operating field.

The OPMI LUMERA i Surgical Microscope is equipped with Stereo Coaxial Illumination (SCI) for red reflex used in anterior segment work and providing detail recognition for cataract/ refractive surgeries.

3. Proposed Contractor’s unique qualifications.

a. The need for CARL ZEISS MEDITEC, INC. | OPMI LUMERA I FLOOR

STAND -OPMI LUMERA I SYSTEM

b. Must have illumination technology for the red reflex. Contours are better visible and you can see details of the ocular anatomy that you have never seen before.

With this illumination technology, very little light is required to generate the red reflex.

c. The surgical microscope must have touch screen controls both, the microscope head and the video

d. The unit must be Small and easy to move in our NEI 5NW examination space compact suspension system is essential

e. The unit must have wireless foot control technology for small surgical clinical space

4. Proprietary data: Only PROAIM Americas, LLC.. can provide the follow-on service or maintenance because of Zeiss proprietary data, parts and service.

Brand Name only: While other vendors provide similarly specified OPMI LUMERA I FLOOR surgical microspe units the sole vendor for consideration for this purchase. CARL

ZEISS MEDITEC, INC. | OPMI LUMERA I FLOOR STAND -OPMI LUMERA I SYSTEM

was chosen for the following reasons:

• Has the ability to import and integrate the our existing NEI owned Zeiss ophthalmic equipment

• Unit must utilize Stereo Coaxial Illumination (SCI): red reflex illumination and surrounding field illumination, both are adjustable,.

The unit must have a 61 mm x 61 mm adjustment range

• Halogen light source with fully automatic lamp change in case of lamp failure

• DeepView: depth of field management system

• Compact floor stand Maximum with load capacity: 14 kg

b. PROAIM Americas, LLC.. only sells Zeiss equipment directly and there are no resellers.

c. The proposed action is a brand name only. Competition will be obtained through PROAIM Americas, LLC..

I hereby certify that the supporting data above forms the basis for this justification, is complete and accurate to the best of my knowledge and belief.

Certification by Requirements\Technical Personnel:

I concur and approve this justification for other than full and open competition.

Contracting Officer Date