JA_(15-10134)_Surgical_Ceiling_Lights_Redacted.pdf

Log# 15-10134

Form 02.4G.AB/N6264515RC04027/RC04028/RC04029 1 Nov 2012

JUSTIFICATION AND APPROVAL

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, on behalf of the Navy to meet Navy Expeditionary Medical Logistics (USS Dwight D.

Eisenhower-CVN69, USS Kearsarge-LHD3, USS Bataan-LHD5, and USS Tripoli-LHA7) requirements.

2. Nature and/or description of the action.

The proposed action is for nine (9) LED Surgical Ceiling Light Operating Room Retrofit Kits to be installed in the Main Operating Rooms onboard:

USS Dwight D. Eisenhower - CVN69; QTY 1 Kit, USS Kearsarge – LHD3; QTY 4 Kits, USS Batann) – LHD5; QTY 4 Kits.

The proposed action is for two (2) LED Surgical Ceiling Light Operating Room Kits to be used in the Main Operating Room 1 and Main Operating Room 2/Battle Dressing Station (BDS) on board:

USS Tripoli – LHA-7: Qty 2 Kits.

The Government intends on awarding a Firm Fixed Price contract. The proposed manufacturer is

Maquet Inc., 45 Barbour Pond Drive, Wayne, NJ 07470-2094. Maquet Medical Systems, USA will not sell directly to the government as there is only one authorized distributor capable of providing the equipment that meets the Government’s minimum requirements, PROAIM

Americas LLC, 209 Bountiful Pointe Cir, Grover, MO 63040.

3. Description of Supplies or Services:

The following ships require a LED Surgical Ceiling Light Operating Room Retrofit Kit; CVN-69

(USS Dwight D. Eisenhower) QTY 1 KT, LHD-3 (USS Kearsarge) QTY 4 Kits and LHD-5

(USS Batann) QTY 4 Kits LED to be used in their Main Operating Rooms. Each kit shall contain two (2) U.S. FDA market approved single head, LED surgical ceiling lights; the light heads shall be independently mounted via an existing single down tube that is already installed on the ship; shall be independently controlled via an included single, wall/bulkhead mounted dual dimmer power supply that wil replace the existing power supply and shall not consume more than 100 watts per light head; each individual light head shall be a fixed focus type, have

360 dgrees of rotation, shall not exceed 20 inches in diameter nor exceed 20 pounds in weight, provide an illuminance of greater than 100,000 lux, a Color Rendering Index (CRI) of at least 95, an LED R9 value of at least 95 and a color temperature greater than 3700 Kelvin; LEDs shall have at least a 40,000 hour life expectancy. Light head mounting kits shall provide hardware for attachment of the lights to the existing ceiling posts and a replacement wall/bulkhead mounted power supply new cales and sterilizable handles. The power supply shall have touchpad controls and be capable of being operated from a 120VAC, 60Hz, 20 Amp electrical circuit.

LHA-7 (USS Tripoli) has a need for two (2) LED Surgical Ceiling Light Operating Room Kits to be used in the Main Operating Room 1 and Main Operating Room 2/Battle Dressing Station

(BDS). Each kit shall contain two (2) U.S. FDA market approved single head, LED surgical ceiling lights; the light heads shall be independently mounted via a single post and single fork arms; shall be independently controlled via an included single, wall/bulkhead mounted dual dimmer power supply and shall not consume more than 100 watts per light head; each individual light head shall be a fixed focus type, have 360 dgrees of rotation, shall not exceed 20 inches in diameter nor exceed 20 pounds in weight, provide an illuminance of greater than 100,000 lux, a

Color Rendering Index (CRI) of at least 95, an LED R9 value of at least 95 and a color temperature greater than 3700 Kelvin; LEDs shall have at least a 40,000 hour life expectancy.

Light head mounting kits shall be provided that allow for field adjustment of the fixed support tubes for ceiling heights ranging from 81 to 88 inches and shall provide hardware for attachment of the lights to the ceiling and power supply to the wall/bulkhead. Power supply shall have touchpad controls and be capable of being operated from a 120VAC, 60Hz, 20 Amp electrical circuit.

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

U.S.C. 2304(c)(1) and FAR 13.501(a) sole source (including brand name) acquisitions.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The Maquet Medical Systems, USA ALM267800340C Surgical Light Kit has been modified from their regular commercial product, at no additiaonl cost to the government, specifically for the diminished ceiling heights and installation requirements found on U.S. Navy combat ships.

Maquet Medical Systems, USA is the only manufacture of this surgical ceiling light replacement kit. These Kits will allow the ship to replace the older Halogen Lighting kit without having to replace the ridged mount that is attached to the ceiling called a down tube. No other manufactures kit will directly attache to these down tubes. This will save $3K per Kit and eliminate the labor hours to replace the ceiling down tubes. Total savings estimated to be

$50,0000 across the 3 ships by eliminating the need to buy new down tubes and the additional labor hours to incorporate a new light into the ships’ infrastructure.

The Maquet Medical Systems, USA ALM267800033C Surgical Light Kit has been modified from their regular commercial product at no additional cost to the government specifically for the diminished ceiling heights and installation requirements found on U.S. Navy combat ships. This particular solicitation was identified as official NAVSEA Government Furnished Information

(GFI) in relation to a U.S. Navy/Huntington Ingalls Industries Ship Project Directive contract for

LHA-7 USS Tripoli. Contract guidance drawings, overhead foundations, and electrical supply are specific to the Maquet OR Kit System. Any deviation or substitution of the specified product could result in a significant cost increase to the U.S. Government due to having to mitigate delays in meeting contractually required material delivery dates; impeding shipbuilder production delivery schedules due to the issuance of stop work orders; modifying the current logistics footprint to accurately reflect all pertinent ship's drawings and structural changes; and creating a new requirement for the development of new part support packages, U.S. Navy preventative maintenance procedures, and operator and maintainer technical manuals. The additional costs associated with any deviation could result in additional costs in excess of

$50,000.00.

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.

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 Proaim Americas, LLC commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

USS Dwight D Eisenhow, USS Kearsarge and USS Bataan - Market research was conducted by technical experts in the March 2015. This research consisted of reviews of previous procurements for these types of surgical lighting systems and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, Bing and GSA Advantage using the following search words:

Surgical Ceiling Light retrofit to LED. Finally, a search was conducted through the ECRI 2015 sourcebook catalog. A review was conducted of 53 LED model surgical lights from 11 different vendors. Since this acquisition will require the down tube struction to remain, none of the 10 vendors on the ECRI spreadsheet meet the minimum requiremnts. The Maquet PowerLED300 is the only light kit that will connect directly to the existing down tubes that are to remain attached to the ship’s overhead. The results of the market research are attached.

USS Tripoli - Market research was conducted by technical experts in the March 2015 timeframe.

This research consisted of reviews of previous procurements for these types of surgical lighting systems and a market survey through search engines of open market contractors and Federal

Supply Schedule contractors. Search engines utilized include Google, Yahoo, Bing and GSA

Advantage using the following search words: LED Surgical Ceiling Light. Finally, a search was conducted through the ECRI 2015 sourcebook catalog. A review was conducted of 53 LED model surgical lights from 11 different vendors. The Maquet PowerLED300 and the Dr Mach

GmbH & Co Mach LED 2 MC and Mach LED 2 SC were the only systems further evaluated beyond the initial review because of their similarities with the essential charatcteristics. The Dr

Mach GmbH & Co is located in Germany and had no listed U.S. distributors. More detailed information regarding their model specifications indicated their systems could not be installed on a ceiling below 106 inches in height which is not consistent with the diminished ceiling heights found on U.S. Navy combat ships. Consequently, the Government’s technical experts determined that Maquet Medical Systems, USA is the only source that can meet the

Government’s requirements. The results of the market research are 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. 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.

The Government (or Program Office) expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items.)

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

12. Point of Contact.

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

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

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.