J A_Corneal_Topography_Final_Redacted.pdf

LOG # 16-10159

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

(Brand Name Only)

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Naval Medical Center Portsmouth and Naval Ophthalmic Support and Training Activity

(NOSTRA).

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

The requirement is for three (3) corneal topography units for Naval Medical Center Portsmouth and one

(1) corneal topography unit for NOSTRA. The Government intends on awarding a firm, fixed-price contract. The proposed manufacturer is Oculus, Inc., 17721 59th Avenue NE, Arlington, WA 98223.

There are multiple distributors capable of providing equipment that meets the minimum requirements of the Government.

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

Naval Medical Center Portsmouth has a requirement for three (3) corneal topography units. The units shall be capable of refractive surgery planning, cataract surgery planning, keratoconus detection, and contact lens fitting. The units shall be accurate within ±0.1 diopters. The units shall feature x-y-z automatic focus and correction capabilities for enhanced manual positioning. The units shall feature a

Scheimpflug camera for corneal topography, corneal thickness and curvature measurement, and astigmatism determination. The units shall be capable of generating anterior and posterior corneal elevation maps to help in the diagnosis of corneal ectatic disorders, such as keratoconus. The units, which will be located at branch clinics, shall be compatible with the installed base of corneal topography units used for refractive and cataract surgery planning located at the Naval refractive surgery centers. The units shall include computers with acceptable operating units and corresponding mice, keyboards, and printers.

The units shall include all power supplies, cables, computer tables and additional hardware, software, and licenses necessary for full corneal topography unit functionality. The vendor shall be responsible for installation and clinician training. The power requirements are 120 VAC, 60 Hz.

NOSTRA has a requirement for one (1) corneal topography unit. The unit shall be capable of refractive surgery planning, cataract surgery planning, keratoconus detection, and contact lens fitting. The unit shall be accurate within ±0.1 diopters. The unit shall feature x-y-z automatic focus and correction capabilities for enhanced manual positioning. The unit shall feature a Scheimpflug camera for corneal topography, corneal thickness and curvature measurement, and astigmatism determination. The unit shall be capable of generating anterior and posterior corneal elevation maps to help in the diagnosis of corneal ectatic disorders, such as keratoconus. The unit shall be compatible with the installed base of corneal topography units used for refractive and cataract surgery planning located at the Naval refractive surgery centers. The unit shall include a computer with acceptable operating corneal topography unit and corresponding mouse and keyboard. The unit shall include a DICOM interface. The unit shall include a power supply, cables, computer table and additional hardware, software, and licenses necessary for full functionality. The vendor shall be responsible for installation and clinician training. The power requirements are 115 VAC, 60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment shall be in accordance with the OEM terms and conditions.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the

FDA, with respect to products for marketing and delivery of a medical product for use in the United

States of America, even should delivery be requested outside of the United States. The unit shall be installed in compliance with OSHA requirements.

Upon delivery, the vendor shall be responsible for uncrating the unit, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

FY 2016 Operation and Maintenance Navy (O&M, N - 1 year) funds in the amount of will be used to procure the four (4) corneal topography units.

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

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1) and FAR 13.501(a), Sole Source (including brand name) Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 (section 4202 of the Clinger-Cohen

Act of 1996). There are multiple distributors capable of providing the equipment that meets the minimum government requirements.

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

Oculus, Inc. is the only manufacturer that can provide a corneal topography unit with a Scheimpflug camera, automatic focus and correction capabilities, and the ability to generate anterior and posterior corneal elevation maps that is compatible with the installed base of corneal topography units used in

Naval refractive surgery centers. With unit accuracy in the range of microns, consistency in data measurement and display is necessary to prevent misinterpretation. This is especially true for more complicated cases where consultation from a refractive surgery center is necessary. All seven (7) Naval refractive surgery centers, located at Naval Hospitals Bremerton, Camp Lejeune, Camp Pendleton, and

Jacksonville and Naval Medical Centers Portsmouth, San Diego and Walter Reed use the Pentacam HR, manufactured by Oculus, Inc., for refractive and cataract surgery planning. Only measurements taken from the same imaging platform can be compared for refractive and cataract surgery planning, thus all clinics that refer patients to these seven (7) centers must use the imaging platform for consistency in measurement. Otherwise, patients would have to endure a second scan prior to surgery. Thus, only corneal topography units manufactured by Oculus, Inc. can ensure measurement consistency between sites. Oculus, Inc. is the only manufacturer that can meet the minimum requirements of the Government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart

5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

7. A 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 vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted in March-April 2016. It included correspondence with knowledgeable personnel within Navy Medicine and a search of the Internet using Google, GSA Advantage, and the

ECRI Sourcebook. Manufacturers that can provide corneal topography units include AMO Sales and

Service, Carl Zeiss Meditec, EyeSys Vision, Haag-Streit USA, I-Optics, Nidek, Medmont International, Oculus, Optikon 2000, Rexxam, S4OPTIK, SCHWIND eye-tech-solutions, Tomey, Topcon Medical

Systems, Veatch Ophthalmic Instruments, VISIONIX (distributed by Latham & Phillips Ophthalmic

Products), and Ziemer Usa. Of these manufacturers, AMO Sales and Service, Carl Zeiss Meditec, EyeSys

Vision, Haag-Streit USA, I-Optics, Nidek, Medmont International, Optikon 2000, Rexxam, S4OPTIK, Tomey, Topcon Medical Systems, and Veatch Ophthalmic Systems cannot provide corneal topography units with Scheimpflug cameras. Scheimpflug cameras are used to image the posterior surface of the cornea, important for identifying posterior keratoconus or other posterior corneal ectatic disorders. The alternative would be a unit with Placido disk technology, which has a different application than what is required for this particular requirement. Additionally, Haag-Streit USA, I-Optics, Rexxam, and Tomey cannot provide corneal topography units with automatic focus and correction capabilities. Auto focus is important for enhancing manual positioning of the eye for image capture. Without this, the clinicians would have to manually position the eye with no account for movement after initial positioning. This feature was listed as essential on ECRI’s guide for buying corneal topographers. Thus, they do not meet the minimum requirements of the Government. Though SCHWIND eye-tech-solutions can provide a corneal topography unit with a Scheimpflug camera, it cannot provide a corneal topography unit with

FDA 510(k) clearance, thus does not meet the minimum requirements of the Government. Though

VISIONIX (distributed by Latham & Phillips Ophthalmic Products) and Ziemer Usa can provide corneal topography units with Scheimpflug cameras and automatic focus and correction capabilities, they cannot provide a corneal topography unit that is compatible with the installed base of corneal topography units at the Naval Refractive Surgery Centers. Corneal topography units manufactured by VISIONIX and Ziemer

USA cannot provide data consistent with that provided by the installed base of Oculus Pentacam HR corneal topography units, particularly when consultation by the refractive surgery centers is needed.

Purchase of either the VISIONIX or Ziemer USA corneal topographers would necessitate additional scans for patients undergoing surgery at the seven (7) Naval refractive surgery centers. Thus, Oculus is the only manufacturer that can provide a corneal topography unit compatible with the installed base of corneal topography units, thus meeting the minimum requirements of the Government. Only vendors that can provide a corneal topography unit manufactured by Oculus, Inc. can meet the minimum requirements of the Government.

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

None.

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

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the 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.

Future requirements will be synopsized in accordance with FAR 5.203.