JA_SL1_(2)_Redacted.pdf

Form 02.4G.AB / N6890616RC7L002 / TDP 16-033 Page 1 of 4 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Naval Medical

Center San Diego.

2. NATURE/DESCRIPTION OF CONTRACT ACTION: The requirement is for one (1) femtosecond pulse laser for cataract surgery [28-161] for Naval Medical Center San Diego. The Government intends on awarding a Firm Fixed-Price contract. The proposed source is AMO Sales and Service, Inc. 1700 E St. Andrews Pl, Santa

Ana, CA 92705.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The proposed acquisition is for one (1) femtosecond pulse laser for cataract surgery manufactured and distributed by AMO Sales and Service, Inc.

The system shall be a diode-pumped solid state ophthalmic laser with a wavelength in the near-infrared spectrum designed for use in cataract surgery. The system shall be FDA-approved for anterior capsulotomy, single- and multi-plane corneal cuts/incisions, and phacofragmentation for nuclear, subcapsular, and cortical cataracts. The system shall be indicated for use in patients diagnosed with glaucoma. The system shall be capable of performing each of these operations individually and consecutively. The system shall feature pulse durations in the femtosecond range

(<600 femtoseconds) and pulse frequencies greater than 100 Hz. The system shall be capable of conducting three-dimensional Fourier-domain (spectral-domain) optical coherence tomography (OCT) for visualization during the operation. The system shall feature a nonapplanating liquid patient interface (docking system) with intraocular pressure increases no greater than 15 mmHg. The system shall feature automated tilt correction. The system shall include a safety feature to prevent veering from the desired operating area. The system shall include an integrated patient bed. The system shall run an approved operating system and include all hardware and software necessary for full system functionality. Electrical requirements are 220 VAC, 60 Hz.

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 systems 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 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.

4. IDENTIFICATION OF THE STATUTORY EXCEPTIONS 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), Only One Responsible Source.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS

OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED: AMO Sales and Service, Inc. (AMO) is the only vendor capable of meeting the minimum requirements of the Government. Only

AMO is capable of providing a femtosecond pulse laser for cataract surgery indicated for use in those diagnosed

Form 02.4G.AB / N6890616RC7L002 / TDP 16-033 Page 2 of 4 1 Nov 2012 with glaucoma with pulse frequencies greater than 100 Hz that can perform anterior capsulotomy, form single- and multi-plane corneal cuts/incisions, and perform phacofragmentation for nuclear, subcapsular, and cortical cataracts.

AMO is the only vendor that can provide such a system with three-dimensional Fourier-domain OCT, automated tilt correction, and a nonapplanating liquid patient interface. Higher pulse frequencies shorten procedure times and pulse separation distances, which is instrumental in reducing the required energy for the operation and thus reducing collateral tissue damage. Automated lens tilt correction ensures proper alignment for the anterior capsulotomy. This helps prevent incomplete capsulotomies and damage to the posterior capsule. Nonapplanating patient interfaces have been shown to reduce patient discomfort and intraocular pressure increases during the operation and decrease the risk of subconjunctival hemorrhages. Further, nonapplanating patient interfaces prevent the formation of corneal folds, which diminish intraocular imaging quality. No other vendor can provide a femtosecond cataract laser that meets the minimum requirements of the Government. AMO is the only vendor that can meet the minimum requirements of the Government.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS

MANY POTENTIAL SOURCES AS PRACTICABLE: Market research was performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202. The

Government will evaluate any responses received.

7. 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. DESCRIPTION OF THE MARKET SURVEY CONDUCTED AND THE RESULTS, OR

STATEMENT OF THE REASONS A MARKET SURVEY WAS NOT CONDUCTED: Market research was conducted in February 2016. It included a search of the Internet using Google, GSA Advantage, and the ECRI

Sourcebook. It was determined that AMO Sales and Service, Inc. (AMO); Alcon Laboratories, Inc; Lensar, Inc;

Bausch & Lomb; and Ziemer Usa, Inc. can provide femtosecond pulse lasers used for cataract surgery. Though

Alcon Laboratories, Inc. and Bausch & Lomb can provide systems with three-dimensional Fourier-domain OCT, they are incapable of providing systems with automated tilt correction and nonapplanating patient interfaces.

Systems provided by Ziemer Usa, Inc. feature a liquid nonapplanating patient interface for lens operations, but they require a flat applanating patient interface for corneal operations. Systems provided by Lensar, Inc. feature a non-applanating low-pressure suction ring patient interface, but they are contraindicated for treating glaucoma.

Additionally, systems provided by Lensar, Inc. cannot perform three-dimensional Fourier-domain OCT. Bausch &

Lomb cannot provide a system with FDA approval for phacofragmentation of cortical and subcapsular cataracts, only nuclear cataracts. Therefore, Alcon Laboratories, Inc; Lensar, Inc; Bausch & Lomb; and Ziemer Usa, Inc. do not meet the minimum requirements of the Government. Only AMO can meet the minimum requirements of the

Government.

9. OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN

COMPETITION: None

10. LISTING OF SOURCES, IF ANY, WHICH 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. STATEMENT OF 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 contracts for the types of supplies/services covered by this document. If another potential source emerges, Naval Medical Logistics Command will assess whether competition for future requirements is feasible.

Form 02.4G.AB / N6890616RC7L002 / TDP 16-033 Page 3 of 4 1 Nov 2012

However, there is constant attention to the market to insure that shall technology change, the source selection is reconsidered. U.S. Navy Subject Matter Experts are required to take into consideration the impact on the installed base of equipment when source selection occurs. All necessary components of integrated logistics support are taken into consideration.

Form 02.4G.AB / N6890616RC7L002 / TDP 16-033 Page 4 of 4 1 Nov 2012

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.

(301)619-1101

Tony Metzger Phone Date

Technical Reviewer

(301)619-7002

Anthony Angelo Phone Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

________________________________________________301/619-9333___________________________

Shannon Lertora Phone Date

Contracting Officer

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

_______________________________________________301/619-2150____________________________

Julia P. Hatch Phone Date

Office of Counsel

Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

Name Phone Date

Competition Advocate