FBO_J&A.doc

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 (NMC) Portsmouth requirements.

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

The proposed action is for one (1) aspirator, surgical liposuction [17-103] for NMC Portsmouth. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Solta Medical, Inc. of 7031 Koll Center Parkway, Pleasanton, CA 94566.

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

The NMLC has a requirement for one (1) aspirator, surgical, liposuction [17-103] for (NMC) Portsmouth. The surgical liposuction system shall be capable of significant fat reduction, precise sculpting, and precise contouring procedures for all body parts (ex. abdomen, arms, back, hips, knees, cheeks, neck and chin, etc.) via vacuum suction. The minimally invasive system shall be capable of precise contouring procedures in breast cancer reconstruction and be capable of removing both small and large volumes of tissue. The unit shall utilize ultrasound energy to emulsify fat, while keeping the surrounding connective tissue relatively intact. The unit shall be capable of fluid tracking and aspiration management via control of suction pressure. Overall, the system shall be capable of infusion, emulsification, and aspiration of body fats.

The unit shall be a single, all-inclusive platform, comprised of a precision fluid management system, an ultrasound amplifier, infiltration and aspiration console, wireless foot switches, and all necessary accessories (i.e. ultrasound probes, and aspiration cannulas). The requirement shall also include liposuction advanced peer-to-peer training, installation training, and a one (1) year service contract. 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, with 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. The system shall be installed in compliance with OSHA requirements.

Navy Operation and Maintenance Fiscal Year 18 funds in the amount of $100,713.00 will be used to procure the liposuction aspirator.

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 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.

Solta Medical, Inc. is the only manufacturer that can provide a surgical aspirator system that can provide a single-integrated platform with ultrasonic infusion, emulsification, and aspiration for body sculpting and precision fat reduction procedures. Compared to traditional liposuction, ultrasonic liposuction reduces postoperative edema and ecchymosis. Ultrasonic liposuction also allows for treatment of patients with large areas of fibrous tissue. No other manufacturer can provide a single-integrated platform with ultrasonic infusion, emulsification, and aspiration for body sculpting and precision fat reduction procedures. Thus, Solta Medical, Inc. is the only manufacturer 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 5.2.

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 December 2017. Research included references and information derived from Internet searches via Google, Defense Medical Logistics Standard Support (DMLSS), and the ECRI Sourcebook. It was determined that surgical aspirator liposuction equipment can be provided by the following vendors: HK Surgical, Mentor Worldwide, LLC, MicroAire Surgical Instruments, and Solta Medical, Inc.

The liposuction equipment (i.e. aspiration and infiltration pumps, cannulas, tubing) manufactured by HK Surgical are designed for the traditional tumescent liposuction functionality, which does not utilize ultrasound technology. Although the liposuction system (i.e. liposuction tower, filter, cannulas) designed by MicroAire Surgical Instruments is for small or large volume fat extraction and body contouring, it utilizes power-assisted liposuction, and does not include or utilize ultrasound technology for fat emulsification. While Mentor Worldwide, LLC manufactures surgical systems that are capable of fluid tracking and provide infiltration and aspiration applications, the systems are not available in a single-integrated platform, and do not have the capability for ultrasound-assisted liposuction. Furthermore, Solta Medical, Inc. can provide a surgical aspirator liposuction system that is a single-integrated platform which utilizes ultrasound energy for infusion, emulsification, and aspiration for body sculpting procedures. Thus, only Solta Medical, Inc. manufactures a surgical aspirator liposuction system 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, NMLC 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.

Form 02.4G.AB

18 Apr 2016