J A_Lens_Polishing_Redacted.pdf

LOG # 16-10180

Form 02.4G.AB / N6343915RC1P505 / TDP 15-169 Page 1 of 4 22 May 2015

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

(Brand Name Only)

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, Fort Detrick, MD to meet the requirements of the Naval Ophthalmic Support & Training Activity (NOSTRA).

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

The requirement is for an ophthalmic lens polishing system for NOSTRA. The Government intends on awarding a Firm, Fixed-Price contract. The proposed source is Satisloh North America, Inc., N106

W13131 Bradley Way Suite 200, Germantown, WI, 53022-4442.

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

The proposed NOSTRA acquisition is for an ophthalmic lens polishing system.

The system shall be capable of processing all organic materials and lens formats, such as high index plastic, CR-39, Trivex, and polycarbonate material lenses. The unit shall be capable of processing two lenses at one time. The polisher shall be compatible with existing Lab Management RX Software

(VisionStar). Through the connection to VisionStar, the system shall be capable of identifying lens curvature, allowing automated polishing tool selection and use. The unit shall have at least 20 different specialized lens tools on reserve for the automated polishing system. The system shall be capable of cleaning and drying each lens after polishing processes. The solution, provided by the vendor, shall include the necessary polishing slurry and slurry feed system. The unit shall be capable of equally distributing polish slurry. A polish slurry chiller shall be included with the automated, computer numerical controlled (CNC) lens polishing system.

The system shall have the ability to cohesively operate with the installed base of NOSTRA lens polishers.

The systems shall be capable of integrating with the water main, compressed air, and power supply of the optical laboratory. Power input requirements are 200V-480V, 50/60 Hz, 30A, three phase. Air source input requirements can be no higher than 90 psi, or about 6 bar.

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, in 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.

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

Form 02.4G.AB / N6343915RC1P505 / TDP 15-169 Page 2 of 4 22 May 2015 interim storage is required, the vendor shall make arrangements for the storage. The system shall be installed in compliance with OSHA requirements.

Defense Health Program Operations and Maintenance (DHP O&M) (FY16) funds in the amount of will be used to fund the requirement.

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 13.501(a), Sole Source (including brand name) Acquisitions.

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

Satisloh North America, Inc. is the only vendor that can provide an ophthalmic lens polishing system, specifically an automated, computer numerical controlled (CNC) lens polishing system that meets the minimum requirements of the Government. Satisloh is the only vendor that can provide a CNC polishing system that is compatible with the existing utilities in the facility. The Satisloh Duo-FLEX will integrate with the existing VisionSTAR optical lens fabrication laboratory software, unlike other products, and integrate with the installed base of lens polishers at NOSTRA. If another vendor’s product was procured, existing workflow would require alteration and productivity would be stunted. This is not feasible, as this would cause undue downtime for Department of Defense lens fabrication and create significant, additional costs. Satisloh North America, Inc. 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 FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

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 in March 2016. It included a search of the Internet using Google, Yahoo, Bing, GSA Advantage, and the ECRI Sourcebook. Other possible polishers were analyzed in this market research, including non-automated, PLC polishers. Products manufactured or distributed by Optical

Works Corporation, OptiPro Systems, Coburn Technologies, & Optek International were all reviewed.

Optical Works Corporation (OWC) produces the FPZ and FPZ-2 lens finers/polishers. Both units are not computer-numerically-controlled (CNC) and cannot interface with the existing VisionStar ophthalmic lens production software platform. Thus, they do not meet the minimum requirements of the

Form 02.4G.AB / N6343915RC1P505 / TDP 15-169 Page 3 of 4 22 May 2015

Government. Coburn Technologies manufactures the Acuity Plus and Cobalt DP lens polishers. Like the two OWC polishers, the Acuity Plus is not computer-numerically-controlled. The Cobalt DP only utilizes three lap tools. Polishers manufactured by Coburn Technologies do not meet the minimum needs of the

Government. Optek Technologies offers the Criterion MAX lens polisher. This system is manually operated via a programmable logic controller, vice being fully-automated and computer-numerically-controlled. It does not have the ability to connect to the existing VisionStar lens fabrication laboratory software. The Criterion MAX does not meet the minimum requirements of the Government. OptiPro produces three CNC-automated polish systems, the PRO 80P, Pro 160P and ePX 200. The three polishers require an input air supply pressure of 100 PSI, which is higher than the 90 PSI available at NOSTRA.

OptiPro’s lens polishers do not meet the requirements of the Government. No vendor or distributor, other than Satisloh, can provide an automated, computer-numerically-controlled (CNC) lens polishing system that meets NOSTRA requirements.

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. 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.

Form 02.4G.AB / N6343915RC1P505 / TDP 15-169 Page 4 of 4 22 May 2015

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.106-3(b)(3)

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.

Phone Date

Technical Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this Justification and

Approval to be legally sufficient, based on these facts, to the best of my knowledge and belief.

Office of Counsel Code OOL