J A_(Brand_Name_only)_DERM_NdYAG_Laser_NHC_Charleston_REDACTED.pdf

Form 02.4G.AB / N6264516RCES018// TDP 16-035 Page 1 of 5 1 Nov 2012

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 (NMLC), Fort Detrick, MD to meet the requirements of Naval Health Clinic Charleston (NHCC).

2. NATURE/DESCRIPTION OF CONTRACT ACTION: The requirement is for one

(1) laser, Nd:YAG, frequency-doubled, dermatologic [18-218] for NHCC. The Government intends on awarding a firm, fixed-price contract. The proposed manufacturer is Quanta USA, 384 Inverness Parkway Suite 125, Englewood, CO 80112.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The proposed acquisition is for one (1) frequency-doubled Nd:YAG dermatologic laser manufactured by Quanta USA.

NMLC has a requirement for one (1) frequency-doubled Nd:YAG dermatologic laser for NHCC.

The system shall feature a neodymium-dosed yttrium aluminum garnet (Nd:YAG) laser operating at a wavelength of 1064 nm. The system shall also feature a potassium titanyl phosphate (KTP) crystal to allow for use at a wavelength of 532 nm. The system shall be capable of removing hair and treating vascular lesions and dermal and epidermal pigmented lesions. The system shall be capable of function as a short- and long-pulsed Nd:YAG laser with variable spot sizes up to 12 mm and pulse durations in the millisecond range. The system shall also feature an integrated sapphire contact skin-cooling system. The power requirement is 220 VAC, 60 Hz. The vendor shall provide operator training and technician service training.

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 systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

4. IDENTIFICATION OF THE STATUTORY EXCEPTIONS 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), FAR 13.106-

Form 02.4G.AB / N6264516RCES018// TDP 16-035 Page 2 of 5 1 Nov 2012

1(b)(1), and FAR 6.302-1, brand name only. There are multiple distributors capable of providing equipment that meets the minimum requirements of the Government.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF

THE AUTHORITY CITED: Only products manufactured by Quanta USA are capable of meeting the minimum requirements of the Government. Quanta USA is the only manufacturer capable of providing a short- and long-pulsed Nd:YAG laser with pulse durations in the millisecond range indicated for hair removal and the treatment of vascular and pigmented lesions. For effective hair removal, laser pulse durations must be equal to or shorter than the thermal relaxation time of hair follicles, which has been estimated to be in the millisecond range (between 10-100 milliseconds). With pulse durations significantly shorter than the thermal relaxation time of hair follicles, nanosecond- and picosecond-pulsed Nd:YAG lasers (also referred to as Q-switched Nd:YAG lasers) are capable of hair reduction but incapable of long-term hair removal. Only Nd:YAG lasers with pulse durations in the millisecond range are capable of meeting the minimum requirements of the Government. No other manufacturer can provide a short- and long-pulsed Nd:YAG laser with pulse durations in the millisecond range indicated for hair removal and the treatment of vascular and pigmented lesions. Only Quanta USA is capable of meeting the minimum requirements of the Government. There are multiple Quanta USA authorized distributors that could potentially meet the minimum requirements of the Government.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE: 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. DESCRIPTION OF THE MARKET SURVEY CONDUCTED AND THE

RESULTS, OR STATEMENT OF THE REASONS A MARKET SURVEY WAS NOT

CONDUCTED: Market research was conducted in December 2015-February 2016 using Google, GSA Advantage, and the ECRI Sourcebook. It was determined that frequency-doubled Nd:YAG dermatologic lasers can be provided by Candela Corporation, Cutera, Inc., Cynosure, Inc., Fotona, Lutronic Corp, and Quanta USA. Candela Corporation, Cynosure, Inc., Fotona, and Lutronic Corp can only provide nanosecond- or picosecond-pulsed Nd:YAG lasers. Additionally, Lutronic Corp cannot provide a system indicated for the treatment of other than minor vascular lesions and epidermal pigmented lesions, and Candela Corporation cannot provide a system indicated for the treatment of pigmented lesions. Candela Corporation, Cutera, Inc. and Lutronic

Form 02.4G.AB / N6264516RCES018// TDP 16-035 Page 3 of 5 1 Nov 2012

Corp are incapable of providing a system FDA-approved for hair removal. Therefore, these manufacturers cannot meet the minimum requirements of the Government. Only products manufactured by Quanta USA are capable of meeting the minimum requirements of the Government.

Products manufactured by Quanta USA are distributed by multiple vendors, including Medfinity LLC. Thus, only vendors capable of providing systems manufactured by Quanta USA can meet the minimum requirements of the Government. The requiring activity certifies that the requirement can be met by a commercial item and provides supporting documentation, which is attached.

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.

11. 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. POINT OF CONTACT: The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Dema Assaf, who may be contacted at (301) 619-6268 or Anthony Metzger who can be contacted at (301) 619-1101.

Form 02.4G.AB / N6264516RCES018// TDP 16-035 Page 4 of 5 1 Nov 2012

TECHNICAL AND REQUIREMENTS CERTIFICATION

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

Clinical Engineer Code 03

Requirements Cognizance

Senior Clinical Engineer Code 03

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Code 05

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__________

APPROVAL BLOCK COMPETITION ADVOCATE

($700,000 to $13.5M)

Form 02.4G.AB / N6264516RCES018// TDP 16-035 Page 5 of 5 1 Nov 2012

____N/A______________________________________________________________________ Name Phone Date Competition Advocate

APPROVAL BLOCK COMPETITION ADVOCATE