JA_Redacted.pdf

Form 02.4G.AB 18 Apr 2016

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 the requirements of Naval Medical Center Camp Lejeune.

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

The proposed action is for one (1) phacoemulsification cataract extraction unit for Naval Medical Center

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

Naval Medical Center (NMC) Camp Lejeune has a requirement for one (1) phacoemulsification cataract extraction unit. The unit shall be capable of performing phacoemulsification cataract surgery, including diathermy and anterior vitrectomy. The unit shall be capable of cortex removal. The unit shall be capable of torsional phacoemulsification, such that energy generation is decreased and thermal damage to the eye is lessened. The unit shall allow for setting and maintaining a target intraocular pressure. The unit shall allow for continuous irrigation. The unit shall feature peristaltic pumps with a maximum vacuum pressure of at least 500 mmHg. The unit shall be capable of operation using a footswitch. The unit shall allow for saving customizable surgeon-specific settings. The unit shall be compatible with the currently installed

Alcon Infiniti machine. The unit shall be capable of maintaining the minimum annual workload of 129 procedures. The power requirements are 110 VAC, 60 Hz. The unit shall include six (6) hand pieces. The vendor shall be responsible for providing operator training and two (2) operator manuals.

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.

Contractor 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.

Upon delivery, the contractor 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. The vendor is also responsible for the initial instrument operational and performance validations

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 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. A 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.

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 5.202.

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 by technical experts in September 2017. This research consisted of reviews of similar previous procurements and a market survey, using search engines to review open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. Manufacturers that can provide phacoemulsification cataract extraction units include Alcon Laboratories, AMO Sales and Service, Bausch & Lomb, Johnson & Johnson, Dutch Ophthalmic, Geuder, Howard Instruments, and Optikon.

Geuder and Optikon cannot provide units that have received 510(k) clearance from the FDA, thus do not meet the minimum requirements of the Government. The remaining manufacturers, AMO Sales and

Service, Bausch & Lomb, Johnson & Johnson, Dutch Ophthalmic, and Howard Instruments, cannot provide a phacoemulsification cataract extraction unit that allows for setting and maintaining intraocular pressure. Additionally the vendors listed above are not capable torsional phacoemulsification. Thus, only products manufactured by Alcon Laboratories can meet the minimum requirements of the Government.

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

Only.

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, Naval Medical Logistics Command 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.