J_ _A_for_Endoscopic_Ultrasonic_Scanning_System_and_Expansion_-_REDACTED_dtd_17_June_2016.pdf

Log#16-10145

Form 02.4G.AB / N6264516RCES049 / TDP 16-131 Page 1 of 5 18 Apr 2016

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 Hospital Jacksonville and Naval Medical Center San Diego.

2. NATURE and/or DESCRIPTION OF THE ACTION BEING APPROVED: The requirement is for one (1) scanning system, ultrasonic, endoscopic for Naval Hospital Jacksonville and one (1) expansion to an existing scanning system, ultrasonic, endoscopic for Naval Medical Center San Diego. The Government intends on awarding a Firm, Fixed-Price contract. The proposed manufacturer is Olympus America Inc, 3500 Corporate Pkwy, Center Valley, PA 18034. 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: The proposed acquisition is for one (1) endoscopic ultrasonic scanning system and one (1) expansion to an existing endoscopic ultrasonic scanning system manufactured by Olympus America, Inc.

The Naval Medical Logistics Command has a requirement for one (1) endoscopic ultrasonic scanning system [20-378] for Naval Hospital Jacksonville. The system shall be an ultrasound processor, utilizing a radial ultrasound probe to diagnose and stage lung cancer and other diseases of the chest cavity, including sarcoidosis, tuberculosis, and fungal infections. The system shall be capable of endobronchial ultrasound transbronchial needle aspiration (EBUS- TBNA) to obtain pathology samples, particularly of mediastinal and hilar lymph nodes. The system shall be capable of real time video streaming at the needle tip. The system shall be capable of operation at multiple frequencies between 5 and 10 MHz, with a scanning angle of at least 60°, and a channel diameter between 2.0 and 2.5 mm. The system shall be capable of capturing 360° ultrasound images. The system shall be capable of sampling endobronchial abnormalities, enlarged mediastinal and hilar lymph nodes, diffuse parenchymal opacities and infiltrates, and large nodules and masses. The system shall be compatible with the installed base of endoscopy equipment manufactured by Olympus America, Inc. The vendor shall also provide a starter set of consumables necessary for full system functionality. The electrical requirements are 120 VAC, 60 Hz.

The Naval Medical Logistics Command has a requirement for one (1) expansion to an existing endoscopic ultrasonic scanning system [20-378] for Naval Medical Center San Diego. The expansion shall include a radial ultrasound probe to diagnose and stage lung cancer and other diseases of the chest cavity, including sarcoidosis, tuberculosis, and fungal infections. The system shall be capable of EBUS-TBNA to obtain pathology samples, particularly of mediastinal and hilar lymph nodes. The system shall be capable of real time video streaming at the needle tip. The system shall be capable of operation at multiple frequencies between 5 and 10 MHz, with a scanning angle of at least 60° and a channel diameter between 2.0 and 2.5 mm. The system shall be capable of capturing 360° ultrasound images. The system shall be capable of

Form 02.4G.AB / N6264516RCES049 / TDP 16-131 Page 3 of 5 18 Apr 2016

Acquiring the endoscopic ultrasonic scanning system from a manufacturer other than Olympus Inc. would not guarantee compatibility with the installed base of endoscopic equipment and thus would necessitate replacement of the installed base. The installed base of endoscopy equipment in the Surgical Suite Main Operating Room of Naval Hospital Jacksonville is

The installed base of endoscopy equipment in the Pulmonary Medicine Department of Naval Medical Center San Diego is . Since this type of equipment is often used in conjunction with other similar equipment located throughout the hospital, determining the exact value of available endoscopy equipment at each medical treatment facility is difficult. Thus, these value estimates may be conservative.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS 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 Federal Business Opportunities (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 (see FAR PART 10)

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 FUJIFILM Medical Systems U.S.A, Inc, Olympus America Inc, and Pentax of America, Inc. can provide endoscopic ultrasonic scanning systems. FUJIFILM and Pentax, however, cannot provide endoscopic ultrasonic scanning systems that are compatible with the installed base of endoscopy equipment at Naval Hospital Jacksonville and Naval Medical Center San Diego. Thus, FUJIFILM and Pentax do not meet the minimum requirements of the Government. Olympus America Inc. is the only manufacturer that can meet the minimum requirements of the Government. Only a vendor that can provide a system manufactured by Olympus America Inc. can meet the minimum requirements.

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.

Form 02.4G.AB / N6264516RCES049 / TDP 16-131 Page 4 of 5 18 Apr 2016

11. A 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.

Form 02.4G.AB / N6264516RCES049 / TDP 16-131 Page 5 of 5 18 Apr 2016

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, WHICH FORM A BASIS FOR THIS

JUSTIFICATION, ARE COMPLETE AND ACCURATE.

Technical Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

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.

Name 301-619-XXXX Date Office of Counsel Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

____N/A______________________________________________________________________ Name Phone Date Competition Advocate