Brand Name Only Justification - Final Signed.pdf

Justification and Approval for Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.

National Institutes of Health (NIH).

b. Sponsoring organization. National Eye Institute (NEI)

c. Project Officer information.

• Denise Cunningham

• 10 Center Drive, Building 10, Room 10C404, Bethesda, MD

20892

• cunninghamd@nei.nih.gov

• 301-905-7302

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The intended use of the Heidelberg in vivo Corneal Microscope with Rostock Module (HRT3-RCM) is to acquire images of the anterior segment of the eye for the purpose of diagnosing diseases of the anterior segment. Purchase of the HRT3-RCM essential to the clinicians at the National Eye Institute (NEI) in providing care to NEI Consult Service subjects with disease and disruption of the ocular surface and for conducting cellular level research on the cornea.

b. Project background.

A decade ago, Heidelberg Engineering, Inc. and its competitor (Nidek) sold similar in vivo Corneal Microscopes (IVCMs) but both manufacturers eventually stopped producing these instruments. In early 2020, Heidelberg introduced an updated version of its in vivo Corneal Microscope (HRT3-RCM), Currently, the HRT3-RCM is the only camera system on the market today, at any price, that can record the ocular surface microstructures, both in health and disease.

The HRT3-RCM is used to (1) document anterior segment (AS) ocular conditions, (2) compare AS conditions longitudinally, (3) provide quantitative means for follow-up of ocular conditions or lesions in the anterior segment of the eye, and (4) guide treatment. Because no other vendor has a comparable device, Heidelberg is the sole source for this instrument.

mailto:cunninghamd@nei.nih.gov

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Heidelberg in vivo Corneal Microscope with Rostock Module

b. Project description.

• Requirement type. Research & development (R&D)

R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number.

Quote: Heidelberg # 00029204

c. Total estimated dollar value and performance/delivery period.

The cost of a Heidelberg in vivo Corneal Microscope with Rostock Module (HRT3-RCM) is $70,000.00.

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

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(_1_) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1__.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor(s).

Heidelberg Engineering, Inc., 10 Forge Parkway, Franklin, MA 02038

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The acquisition of a Heidelberg in vivo Corneal Microscope with Rostock Module (HRT3-RCM) is essential for clinical care and research in subjects and will fulfill an unmet need to document and diagnose ocular conditions and visualize and analyze structural changes is NIH subjects with graft versus host disease (GVHD), dry eye disease, and other debilitating ocular surface diseases.

Because Heidelberg is the only manufacturer and distributer of an in vivo corneal microscope (IVCM), in today’s market at any price, they are the uniquely qualified sole source for this product.

6. Demonstration that the proposed contractor(s) unique qualifications or the nature of Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart

5.2 and, if not, which exception under FAR 5.202

The Heidelberg in vivo Corneal Microscope with Rostock Module is a unique instrument. There are no other camera systems on the market today, at any price, that can image corneal structures at high magnification (x400) magnification with a field of view of 400 × 400 µm when used with a ×63 objective lens that has a numerical aperture of 0.9 and uses a 670 nm red wavelength helium-neon diode laser as its illumination source. Heidelberg is the lone source for the HRT3-RCM.

A Notice of Intent/Sources sought will be posted.

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

This is the only currently available in vivo confocal microscope for imaging the cornea, so no cost comparisons can be made with other instruments. The NEI did purchase a similar Heidelberg instrument, for imaging the retina, and pricing was higher than the quote for this instrument. Pricing is also made available to the public online.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

At the time of this writing, the Heidelberg Corneal Microscope with Rostock Module (HRT3-RCM) is the only commercially available in vivo laser-scanning confocal microscope being manufactured that has been found. There are no comparable devices on the market and only Heidelberg sells the HRT3-RCM device. This information was obtained while attempting to conduct market research. A Sources Sought notice will also be posted for companies to submit capability statements.

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

N/A

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Other than Heidelberg Engineering, Inc., no sources expressed an interest in this acquisition.

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

Any future needs for this equipment will be assessed by conducting market research at the time the need is discovered.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Denise Cunningham, Chief of Imaging Services Section

4/27/2020

Project Officer’s

Immediate Supervisor

William R. O’Donnell

Head of the Sponsoring

Program Office

N/A

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer