J A_Redacted.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 Naval Medical Center San Diego (NMCSD) requirements.

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

The proposed action is for one (1) ultrasonic cardiac output unit [17-190] for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is USCOM, Inc. of 340 S.

Lemon Avenue #1701, Walnut, CA 91789.

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) cardiac output unit, ultrasonic [17- 190] for Naval Medical Center San Diego. The unit shall be capable of monitoring patient hemodynamics noninvasively using Doppler ultrasound technology. The unit shall not require any invasive methods for operation, including catheter or esophageal tube insertion. The unit shall be capable of measuring heart rate (HR), cardiac output (CO), stroke volume (SV), oxygen saturation (SpO2) and oxygen delivery (DO2). The unit shall be mounted to a portable rolling stand. The power requirements are 120 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 system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, in 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.

Navy Operation and Maintenance Fiscal Year 16 funds in the amount of $31,000 will be used to procure the ultrasonic cardiac output unit.

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.

USCOM, Inc. is the only vendor that can provide a fully-noninvasive, portable ultrasonic cardiac output unit that can measure HR, CO, SV, SpO2, and DO2. No other vendor can provide a fully-noninvasive, portable ultrasonic cardiac output unit that can measure HR, CO, SV, SpO2, and DO2. USCOM, Inc. is the only vendor that can meet 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 April 2016. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors that can provide ultrasonic cardiac output units include Deltex Medical, SC, Inc, Transonic Systems Inc, and USCOM, Inc. Units provided by Deltex Medical, SC, Inc. require esophageal tube placement for operation. Units provided by Transonic Systems Inc.

transmit ultrasonic signals between catheters placed in arteries and veins to create an arterial and venous loop. Thus, units provided by Deltex Medical, SC, Inc. and Transonic Systems Inc. do not meet the minimum requirements of the Government. Only USCOM, Inc. can provide a fully-noninvasive, portable ultrasonic cardiac output unit that meets the minimum 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

Name Phone Date Title Department/Command

Requirements Cognizance

Name Phone Date Title Department/Command

CONTRACTING OFFICER CERTIFICATION

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

First & Last Name Phone Date Code 05 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.

_N/A__________________________________________________________________________ Julia Hatch Phone Date Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

_N/A__________________________________________________________________________ Darin L. Callahan Phone Date Competition Advocate