J A_rev_28_Jun_16_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR 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 the Naval Medical Center (NMC) San Diego, CA.

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

The proposed action is for one (1) Ultrasonic Liver Stiffness Scanning unit for NMC San Diego. The Government intends on awarding a Firm, Fixed-Price contract. The proposed sources are Echosens North America, Inc.

(manufacturer) of 1050 Winter Street, Waltham, MA 02451 and Fidelis Sustainability Distribution (distributer) of 204 West Spear Street Suite 3319, Carson City, NV 89703.

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

NMC San Diego has a requirement for one (1) ultrasonic liver stiffness scanning unit. The unit shall be capable of Vibration Controlled Transient Elastography (VCTE) for non-invasive measurement of liver fibrosis and cirrhosis.

The unit shall be capable of diagnosis and surveillance of chronic liver diseases, such as Hepatitis B, Hepatitis C, Autoimmune Hepatitis and Fatty Liver Disease, by utilizing VCTE to measure shear wave velocity passing through liver tissue. VCTE shall be performed with an external handheld probe, which emits a low-amplitude, low-frequency signal in the direction of the human liver. Probes for adults and overweight patients shall be included.

The requirement shall include installation and user training.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, regarding 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 of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor shall be responsible for all necessary labor and materials for installation.

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.

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 13.106-1(b)(1) – brand name only. There are at least two vendors 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.

Echosens North America Inc. is the only manufacturer that can provide a FDA approved non-invasive, VCTE ultrasonic scanning unit that meets the requirements of NMC San Diego. Echosens North America Inc. is the only manufacturer that can provide an ultrasound unit for a non-invasive measurement of liver fibroses and cirrhosis, and monitor status of chronic liver diseases, including Hepatitis B, Hepatitis C, Autoimmune Hepatitis and Fatty Liver Disease. There are no other manufacturers that can provide a FDA approved non-invasive VCTE ultrasonic scanning unit capable of meeting the minimum requirements. Echosens North America Inc. is the only manufacturer that can meet the minimum requirements of the Government. Fidelis Sustainability Distribution is an authorized distributor of Echosens North America Inc.

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. 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 April 2016. It included a search of the Internet using Google, Bing, GSA Advantage, and the ECRI Sourcebook. Echosens North America Inc is the only manufacturer that can provide a non-invasive Vibration Controlled Transient Elastography (VCTE) ultrasonic scanning system that meets the requirements of Naval Medical Center San Diego. Echosens North America Inc.is the only manufacturer that can provide a non-invasive measurement of liver fibrosis and cirrhosis and surveillance of chronic liver diseases, including Hepatitis B, Hepatitis C, Autoimmune Hepatitis and Fatty Liver Disease. Fidelis Sustainability Distribution is an authorized distributor of Echosens North America Inc.

Other vendors which can provide ultrasound units capable of elastography techniques include Carestream Health Inc, Fujifilm Sonosite Inc., GE Healthcare Inc., Hitachi Medical Systems America, Olympus America, Philips Healthcare, Siemens Healthcare Diagnostics Inc, Toshiba, Esaote, and Supersonic Imagine, Inc. The ultrasound units offered by Carestream Health Inc, Fujifilm Sonosite, Inc, Olympus America, GE Healthcare Inc., Philips Healthcare, Siemens Healthcare Diagnostics Inc, Toshiba, Hitachi Medical Systems America, Esaote, and Supersonic Imagine, Inc. only offer real-time elastography (RTE) capabilities. RTE does not meet the minimum requirements because it does not utilize the VCTE technique, and thus these units do not meet the minimum requirements. The ultrasound units offered by Siemens Healthcare Diagnostics Inc and Philips Healthcare only offer acoustic radiation force impulse elastography (ARFI). ARFI does not meet the minimum requirements because it does not utilize the VCTE technique, thus these units do not meet the minimum requirements. The ultrasound units offered by Supersonic Imagine, Inc. only offer shear wave elastography (SWE). SWE has been shown to have similar results as ARFI and it does not utilize the VCTE technique, thus these units do not meet the minimum requirements.

Echosens North America Inc. is the only manufacturer that can provide an ultrasound unit capable of diagnosing and monitoring liver fibroses, cirrhosis, and chronic liver diseases, utilizing non-invasive VCTE. Echosens North America Inc. is the only manufacturer that can meet the minimum requirements of the Government. Fidelis Sustainability Distribution is an authorized distributor of Echosens North America Inc.

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

None

10. Listing of Sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. A notice of intent (NOI) 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. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future requirements 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. 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.