A.02.04_LSJ_Sharepoint__0029_signed_by_greenburg.pdf

Control Number: 19-RHCO-A-45 Solicitation: W91YTZ19Q0019

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity Regional Health Contracting Office – Atlantic, (RHCO-A), Fort Bragg Health Contracting Cell, Fort Bragg, NC.

2. Description of Action: This is a new requirement for Implantable Contact Lens (ICL) to be used in the Womack Army Medical Center Ophthalmology Clinic, Fort Bragg, North Carolina. The contract will be firm fixed price (FFP) procured with FY19 Operations and Maintenance Army (OMA) funds.

3. Description of Supplies/Services: Womack Army Medical Center, Fort Bragg, NC has a requirement for Visian ICL (Implantable Collamer Lens). Visian ICL is one of the latest technological advancements in vision correction providing excellent visual quality.

Based on estimated quantities of 400 lenses for the base year the estimated price is $343,600.00 and $171,800.00 for a total quantity of 200 lenses per year for the two 12 month option years. The total estimated value of the procurement for a base period and two 12 month option periods is $687,200.00.

4. Authority Cited The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: This lens is being used for the deploying warfighter because of the minimal surgical cut to the eye allowing quicker healing time than other types of lenses which is critical for a deploying warfighter. The 100 percent pure collagen copolymer lens material is not viewed by the body as a foreign object by the body’s immune system which makes it biocompatible. Unlike traditional contact lens, once the Visian ICL lens is implanted in the eye, there is no additional maintenance needed. The Visian ICL is designed to be permanently placed in the eye; however, the lens can be removed if the patient’s vision changes or if it otherwise needs to be removed or replaced.

6. Efforts to Obtain Competition: The Visian ICL is considered a sole source product based on Staar Surgical developing and patenting the Collamer lens and Visian design.

There is no other product like this available for competition on the market at this time.

Based on the above information there has been no actions taken to remove/overcome barriers. A sources sought notice was posted on Federal Buniness Opportunities (FBO) website on 27 September 2018

a. Effective competition. NA

Implantable Contact Lens (ICL) Womack Army Medical Center Ophthalmology Clinic, Fort Bragg, North Carolina.

For Official Use Only (See FAR 2.101 and 3.104-4)

b. Subcontracting competition. There are no subcontracting possibilities for this requirement IAW FAR 19.702(a)(1).

7. Actions to Increase Competition: The Visian ICL is considered a sole source product based on Staar Surgical developing and patenting the Collamer lens and Visian design. There is no other product like this available for competition at this time.

8. Market Research: Market research was conducted in accordance with FAR Part 10.

Market research indicates there are two Food and Drug Administration (FDA) approved companies that provides implantable lenses. AMO USA manufactures the Verisyse Implantable Lens and Staar Surgical manufacturers the Visian ICL (Implantable Collamer Lens). The Verisyse implantable lens is made of a type of hard acrylic called polymethylmethacrylate (PMMA) whereas the Visian ICL is made from Staar Surgical’ s blend of collagen and copolymer called Collamer. The Verisyse lens is attached to the color part of the eye (the iris) whereas the Visian ICL by Staar Surgical is inserted behind the eye’s iris and in front of the natural lens and requires no sutures to be attached to the eye. The Visian ICL is more practical for a deploying war fighter. The Ophthalmology Clinic has reviewed both types of lens and has determined that the Visian ICL is more suitable for deployable soldiers.

9. Interested Sources: “To date, no other sources have written to express an interest.”

The notices required by FAR 5.201 have been published, and that any bids or proposals received shall be considered. A sources sought notice was posted on Federal Buniness Opportunities (FBO) website on 27 September 2018

10. Other Facts:

a. Procurement history. This is a recurring requirement that has historically been sole sourced to Staar Surgical Company, the manufacturer and sole distributor of these lens.

The Contracting Officer Cheryl A. Ricker has determined more cost effective to issue a requirements contact with option years as this is a continuing requirement for deploying soldiers.

(1) Contract numbers and dates of the last several contracts for these same requirements.

(a) W91YTZ-16-D-0005 awarded 1 October 2016 for a total price of $1,030,800.00.

(b) W91YTZ-14-D-0002 awarded 1 October 2013 for a total price of $797,940.00.

(c) W91YTZ-13-C-0090 awarded on 12 July 2013 for a total price of $192,000.00.

(2) The previously awarded contracts were sole sourced to Staar Surgical.

(3) Authority previously used for less than full and open competition was PL104-106 sec 4202 (Clinger-Cohen Act) and FAR 13.501(a); only one source reasonably available.

(4) The Visian ICL is considered a sole source product based on Staar Surgical developing and patenting the Collamer lens and Visian design. There was no other product like this available for competition on the market at that time. Based on the above information there has been no actions taken to remove/overcome barriers.

(5) All prior awards were accomplished using other than full and open competition procedures.

(6) There are no unusual patterns that may be revealed by the history of the previous buys.

(7) Staar Surgical is the only vendor that makes the Collamer lens. There have been no significant changes and no other company makes this type of lens which has been determined the best choice for soldier’s.

b. Other facts. No actions has been taken to develop a performance work statement suitable for full and open competition. Based on market research there are no other vendors that produce the Collamer lenses or anything superior to them.

(The Visian ICL is considered a sole source product based on Staar Surgical developing and patenting the Collamer lens and Visian design. There is no other product like this available for competition at this time.)

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date: __________

Typed Name: LTC David L. Greenburg Title: Chief, Ophthalmology/WRESP

12. Contracting Officer Certification:

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

Signature: ________________________________Date: __________

Typed Name: Cheryl A. Ricker Title: Contracting Officer