J A_N6264516R0062_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 to meet the requirements of the Naval Medical Center (NMC) San Diego, CA.

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

The requirement is for two (2) Liposuction units (Aspirators, Surgical, Liposuction [17-103]) for the Naval Medical Center (NMC) San Diego. The Government intends on awarding a Firm, Fixed-Price contract. The proposed manufacturer is MicroAire Surgical Instruments, 3590 Grand Forks Blvd., Charlottesville, VA, 22911. Authorized distributors of MicroAire Surgical Instruments include: Advanced Scientific, Carlsbad Medical Supplies, Tryco Medical Products and T.Q.M., Inc.

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 two (2) Liposuction units (Aspirators, Surgical, Liposuction [17-103]). The units shall be capable of liposuction and fat harvesting/grafting, to assist during surgical removal of bodily tissue or fluid, by suction lipoplasty. The units shall be capable of performing procedures which include: fragmentation, emulsification and aspiration of soft tissue, localized deposits of subcutaneous fat, Gynecomastia, Lipomas and Lymphedema. The units shall also be capable of performing procedures which include: mastectomy, contouring, fat grafting and adipose reinjection for aesthetic and reconstructive surgeries. The liposuction units shall have a dual pump for fluid infiltration and aspiration. The units shall include an adjustable vacuum source and a tumescent pump. The liposuction hand pieces shall utilize reciprocating motion, applying the Power-Assisted Liposuction (PAL) technique which minimizes damage to fat cells, does not require a large incision, does not introduce the risk of thermal injury and allows skin contraction following adipose aspiration. The liposuction units shall have the ability to operate continuously for periods up to 20 minutes, over a period of 1-2 hours.

The liposuction units shall include Power-Assisted Liposuction (PAL), a control cable, control box, surgical cart used for tumescent liposuction, 2000cc ring holder, 2000cc waste canister, infiltration tubing and flared curved cannulas 4mm x 30 cm and 3mm x 30cm. The system shall pass the Underwriter Laboratories safety testing for water safety. The power requirement is 120VAC, 60Hz.

The units, 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.

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 multiple distributers 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

MicroAire Surgical Instruments is the only manufacturer that can provide a PAL liposuction unit that meets the requirements of the NMC San Diego. There are no other manufacturers that can provide PAL liposuction units capable of utilizing a reciprocating motion that minimizes damage to the fat cells, does not require a large incision, will not introduce the risk of thermal injury and allows skin contraction following adipose aspiration. There are no other manufacturers that can provide a PAL liposuction unit that has passed the Underwriter Laboratories safety testing for water safety. MicroAire Surgical Instruments 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 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. 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. MicroAire Surgical Instruments is the only manufacturer that can provide a PAL unit that meets the requirements of NMC San Diego. Authorized distributors of MicroAire Surgical Instruments include: Advanced Scientific, Carlsbad Medical Supplies, Tryco Medical Products and T.Q.M., Inc.

Other vendors that manufacture liposuction units include Medco Manufacturing, Solta Medical, Cynosure, Sciton, Zeltiq, Human Med, and Novo Surgical.

Medco Manufacturing only offers manual powered liposuction units, which do not meet the minimum requirement of applying the PAL technique. The liposuction unit offered by Solta Medical only operates as an Ultrasound-assisted liposuction (UAL) system, which requires larger incisions and introduces the risk of thermal injury which does not meet the minimum requirements of the government. The liposuction units available from Cynosure and Sciton only operate as a Laser-assisted liposuction (LAL) unit which is not a FDA approved technique and has a risk of thermal injury; therefore, the liposuction units available from Cynosure and Sciton do not meet the minimum requirements of the government. The liposuction units available from Zeltiq only operate in Cryolipolysis, a medical treatment used to destroy fat cells, which does not meet the minimum requirements of the government. The liposuction units available from Human Med only operate as a Water-Assisted Liposuction (WAL) unit which does not provide inherent skin contraction following adipose aspiration and therefore, does not meet the minimum requirements of the government. Novo Surgical Inc. only provides liposuction cannulas and accessories and as a result, does not meet the minimum requirements of the government.

MicroAire Surgical Instruments is the only manufacturer capable of providing a liposuction unit capable of utilizing a reciprocating motion that minimizes damage to the fat cells, does not require a large incision, does not introduce the risk of thermal injury and allows skin contraction following adipose aspiration. The MicroAire PAL Liposuction System is the only liposuction unit that has passed the Underwriter Laboratories safety testing for water safety.

MicroAire Surgical Instruments is the only manufacturer that can meet the minimum requirements of the Government. There are multiple MicroAire Surgical Instruments authorized distributors that could potentially meet the minimum requirements of the Government.

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. 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. 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 contracts 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.