J&A.pdf

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

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 (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the requirements of Naval Medical Center (NMC) San Diego.

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

The proposed action is for one (1) electroretinograph system [11-482] and one (1) analyzer, physiologic, visual function [14-382] for NMC San Diego. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is LKC Technologies, Inc. of 2 Professional Drive Suite 222, Gaithersburg, MD 20879.

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

The Naval Medical Logistics Command has a requirement for one (1) electroretinography system [11-482] and one (1) analyzer, physiologic, visual function [14-382] for NMC San Diego. The electroretinography system shall be able to record electrical signals from the cornea to aide in the diagnosis of glaucoma, age-related macular degeneration (AMD), and diabetic edema. The system shall be able to perform multifocal ERG, full-field ERG, electrooculography (EOG), visual evoked potential (VEP), and dark adaptometry testing. The system shall have an infrared (IR) camera to view the eye during testing to enable easier alignment. The system shall include a computer with software configured for International Society for Clinical Electrophysiology of Vision (ISCEV) standard protocols, flash and pattern ERG, flash and pattern VEP and EOG protocols. The system shall include a color printer. The system shall include initial electrodes for ERG, VEP, and EOG.

The system shall be able to perform tests on adult and pediatric patients, whether conscious or sedated. The system shall be on a mobile cart, allowing transport between multiple, local operating rooms and other exam rooms. The system shall include an adjustable mounting arm to allow testing on supine patients. The system shall include an LCD pattern monitor.

The visual function analyzer unit shall be a handheld testing device. The unit shall have an IR camera to view the eye during testing to enable easier alignment. The handheld unit shall be able to test on dilated or un-dilated pupils. The unit shall be able to run flicker and flash ERGs and VEPs. The unit shall be able to use sensor strips for all ERG tests as a less invasive alternative to corneal electrodes.

The power requirements are 120 V, 60 Hz, 5 A, single phase.

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

The system, including claims made for the product, shall be compliant with FDA regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, 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.

Navy Operation and Maintenance Fiscal Year 19 funds in the amount of $86,576.50 will be used to procure the electroretinography system.

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 U.S.C.

2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a single source.

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

LKC Technologies is the only vendor that can provide an electroretinography (ERG) system that is able to perform all required tests and includes a handheld testing device with an infrared (IR) camera for viewing the eye during testing, which enables easier alignment with the patient’s pupil. Additionally, LKC Technologies is the only vendor that can provide a unit that is able to test dilated or not dilated eyes, and that uses sensor strips for ERG tests. No other vendor can provide a system that includes a handheld testing device with an IR camera that is able to test both dilated and not dilated pupils. Thus, LKC Technologies is the only vendor that meets 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.

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 October 2018. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors that can provide an electroretinography system and visual function analyzer include LKC Technologies, Inc. (LKC), Diopsys, Inc. (Diopsys), Diagnosys LLC (Diagnosys), Metrovision, Konan Medical Usa, Inc. (Konan), and Welch Allyn, Inc. (Welch Allyn).

Systems provided by Diopsys and Metrovision do not have EOG or multifocal ERG capability and do not offer a handheld visual function analyzer. Systems provided by Konan do not have EOG or dark adaptometry testing capability. Systems provided by Welch Allyn do not offer the handheld visual function analyzer in the United States. Systems provided by Diagnosys do not offer a handheld visual function analyzer with an IR camera. Additionally the handheld analyzer offered by Diagnosys is not able to test on both dilated and un-dilated pupils. Only LKC can provide a system that meets all of the requirements. LKC is the only vendor that can meet the present 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. 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. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

301-619-1101 Dr. Anthony Metzger, Code 03 Phone Date Clinical Engineer, NMLC

Requirements Cognizance

301-619-7002 Anthony Angelo, Code 03 Phone Date Senior Clinical Engineer, NMLC

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

301-619-8594 Carrie E. Gaither, Code 05 Phone Date Contracting Officer