N6264517RCES013-Cataract_Extraction_Units-Pend-Jax-Attachment_V-J&A_Redacted.pdf

LOG #: 17-10069

PR N6264517RCES013 Page 1 of 4 1 Nov 12

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, on behalf of the Navy, to meet the requirements of Naval Hospitals Camp Pendleton and Jacksonville.

2. Nature and/or description of the action.

The proposed action is for three (3) phacoemulsification cataract extraction units [17-596], two (2) for

Naval Hospital Camp Pendleton and one (1) for Naval Hospital Jacksonville. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Alcon Laboratories, Inc. of 6201 S.

Freeway, Fort Worth, TX 76134.

3. Description of the supplies/services required.

The Naval Medical Logistics Command (NMLC) has a requirement for three (3) phacoemulsification cataract extraction unit [17-596], two (2) for Naval Hospital Camp Pendleton and one (1) for Naval

Hospital Jacksonville. The units shall be capable of performing phacoemulsification cataract surgery, including diathermy and anterior vitrectomy. The units shall be capable of torsional phacoemulsification, such that energy generation is decreased and thermal damage to the eye is lessened. The units shall allow for setting and maintaining a target intraocular pressure. The units shall allow for continuous irrigation.

The units shall feature peristaltic pumps with a maximum vacuum pressure of at least 500 mmHg. The units shall be capable of operation using a footswitch. The units shall allow for saving customizable surgeon-specific settings. The power requirements are 100-240 VAC, 60 Hz. The vendor shall be responsible for providing operator training and two (2) operator manuals.

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.

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 all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

Specific Requirements for Naval Hospital Camp Pendleton:

NMLC has a requirement for two (2) phacoemulsification cataract extraction units for Naval Hospital

Camp Pendleton. In addition to the above specified requirements, the units shall include eight (8) hand pieces capable of torsional phacoemulsification. The unit shall also include eight (8) irrigation/aspiration hand pieces. Though trade-in of the existing phacoemulsification cataract extraction unit is not required, two (2) Alcon Infiniti units (Serial #s: 1102632401X, 0701824201X) are available for trade-in.

Specific Requirements for Naval Hospital Jacksonville:

NMLC has a requirement for one (1) phacoemulsification cataract extraction unit for Naval Hospital

Jacksonville. In addition to the above specified requirements, the Bausch & Lomb Stellaris (Serial

#SYS00493) is available for trade-in, though trade in of the existing phacoemulsification cataract extraction unit is not required.

PR N6264517RCES013 Page 2 of 4 1 Nov 12

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 6.302-1 sole source (including brand name) acquisitions OR FAR 13.106-1(b)(1) soliciting from a single source.

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

Alcon Laboratories, Inc. is the only manufacturer that can provide phacoemulsification cataract extraction units that meet the minimum requirements of the Government. It is the only manufacturer that can provide units capable of setting and maintaining intraocular pressure during phacoemulsification cataract extraction. This feature automatically accommodates different surgeon preferences for flow rate and vacuum while maintaining anterior chamber stability, ensuring avoidance of cornea, iris, and lens capsule trauma. No other unit allows for setting and maintaining intraocular pressure during phacoemulsification cataract extraction. Only Alcon Laboratories, Inc. manufactures units that meet the minimum requirements of the Government.

There are multiple vendors that could potentially provide phacoemulsification cataract extraction units manufactured by Alcon Laboratories. Competing this requirement Brand Name Only is recommended.

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 the 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 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 2016. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Manufacturers that can provide phacoemulsification cataract extraction units include Alcon Laboratories, AMO Sales and Service, Bausch & Lomb, Dutch

Ophthalmic, Geuder, Howard Instruments, and Optikon. Of these manufacturers, Geuder and Optikon cannot provide units that have received 510(k) clearance from the FDA. The remaining manufacturers, AMO Sales and Service, Bausch & Lomb, Dutch Ophthalmic, and Howard Instruments, cannot provide a phacoemulsification cataract extraction unit that allows for setting and maintaining intraocular pressure.

Thus, only products manufactured by Alcon Laboratories can meet the minimum requirements of the

Government.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

PR N6264517RCES013 Page 3 of 4 1 Nov 12

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.

PR N6264517RCES013 Page 4 of 4 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

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

Phone Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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