Redacted_J A_Final.pdf

Form 02.4G.AB Page 1 of 5 1 Nov 2012

LOG#15-10194

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 (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Treatment Facility requirements.

2. NATURE/DESCRIPTION OF CONTRACT ACTION:

The proposed action is for supporting newly procured Abbott Medical Optics (AMO) AMO laser refractive surgery suites at Naval Aerospace Medicine Institute (NAMI), Naval Hospital

Pensacola (NHP), and Navy Refractive Surgery Centers (NRSC), including Naval Hospitals at

Bremerton, Camp Lejeune, Camp Pendleton, and Jacksonville, and Naval Medical Centers at

Portsmouth and San Diego. The maintenance contract will include all corrective maintenance, preventive maintenance, parts, labor, and travel. The Government intends on awarding a Firm

Fixed Price (FFP) contract. The proposed source is Abbott Medical Optics, 1700 East St.

Andrew Place, Santa Ana, CA 92705.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

The requirement is for supporting AMO laser refractive surgery suites at Navy Medical

Treatment Facilities (MTF). The equipment in the surgical suites includes AMO’s Star S4 IR

Excimer Laser, WaveScan WaveFront System, and iFS Advanced Femtosecond Laser. All devices and systems are utilized to restore vision in optical refractive surgery. Support for these devices shall include telephone support, on-site field support, and system hardware and software updates, as mandated by the OEM, in accordance with the performance work statement. All parts, labor, and travel will be included. Support shall be provided for a period of performance spanning from 30 Sept 2015 through 29 Sept 2016, with option years starting 30 Sept 2016 and extending through 29 Sept 2020.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor 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.

Defense Health Program Operations & Maintenance FY15 funds in the amount of $524,322.85 will be used to fund the base year of the maintenance contract.

FY 2015 FY 2016 FY2017 FY2018 FY2019 Total

$524,322.85 $595,000.00 $595,000.00 $595,000.00 $595,000.00 $2,904322.85

4. IDENTIFICATION OF THE STATUTORY EXCEPTIONS PERMITTING OTHER

THAN FULL AND OPEN COMPETITION:

Form 02.4G.AB Page 2 of 5 1 Nov 2012

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:

Only Abbott Medical Optics can provide the requested service and maintenance contract on the listed pieces of equipment in the required timeframe. Abbott Medical Optics is the original equipment manufacturer that has proprietary access to technology and software upgrades required to keep the equipment fully functional and meet all applicable standards. The Star S4

IR Excimer laser features proprietary algorithms (Variable Spot Scanning and Variable

Repetition Rate) to reduce unwanted effects on corneal tissue caused by the laser in vision correction treatments. The WaveScan System and iFS Advanced Femtosecond Laser are also proprietary systems. AMO does not provide training or OEM parts to any third-party vendors.

Thus, Abbott Medical Optics is the only vendor capable of servicing the medical equipment to

OEM standards and Government requirements. Without coverage by this vendor, a significant patient safety risk would be presented, as equipment would not be maintained appropriately.

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 March and April of 2015. The market research conducted included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook.

Market research also included consulting refractive surgical specialists and Abbott Medical

Optics professionals to inquire about individual devices and services provided. It was found 31

March 2015, on Abbott Medical Optics website, that Variable Spot Scanning and Variable

Repetition Rate algorithms of the STAR S4 IR Excimer Laser are only provided and supported by AMO. Further, AMO provides proprietary maintenance and parts to the WaveScan

WaveFront System and iFS Ophthalmic Femtosecond Laser. AMO does not train any other third-party vendors to service their excimer laser, WaveFront system, and femtosecond laser.

Form 02.4G.AB Page 3 of 5 1 Nov 2012

Only Abbott Medical Optics can provide OEM approved services, under a maintenance contract, per the government’s requirements. A sole source document is included to indicate no other providers can meet the minimum requirements of the Government.

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

COMPETITION:

Sole Source Document from manufacturer indicates that Abbott Medical Optics is the proprietary provider of OEM approved preventative and corrective services for the devices included in this maintenance request.

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. 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.

12. POINT OF CONTACT:

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Kasey Carroll who may be reached at

301-619-8895.

Form 02.4G.AB Page 4 of 5 1 Nov 2012

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83H

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

Anthony Metzger, Code 03 Phone Date

Technical Reviewer

301-619-7002

Anthony Angelo, Code 03 Phone Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

Shannon Hess 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.

Form 02.4G.AB Page 5 of 5 1 Nov 2012

__________________________________ _301-619-2150___________________________________

Julia Hatch Phone Date

Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

________________________________________ 301-619-3095____________________________

Darin Callahan Phone Date

Competition Advocate