0078_Sole_Source_Justification_under_13.501_(25Feb16)STAAR_(2)a_20160706.pdf

Control Number: 16-RHCO-A-348

Supply: Visian ICL (Implantable Collamer Lens) Womack Army Medical Center (WAMC) Fort Bragg, NC 28310

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 Activity-Atlantic (Provisional) [(RHCO-A) (P))], Bragg Health Contracting Cell, 6021 5th Street, Building 1469, Fort Belvoir, VA 22060-5505.

2. Description of Action: Womack Army Medical Center (WAMC), Department of Ophthalmology, requests approval for a follow on Firm Fixed Price (FFP) delivery order contract to purchase, on a sole source basis, the Visian ICL implantable contact lenses.

The type of funds will be Overseas Contingency Operation (OCO) funds as stated on each purchase request for each delivery order requested.

3. Description of Supplies/Services: “Brand Name only” Visian ICL (Implantable Collamer Lens), 100 percent pure collagen copolymer lens material, Proprietary Collamer, FDA approved.

Visian ICL is one of the latest technological advancements in vision correction providing excellent visual quality. Proprietary Collamer is a unique lens material created and used exclusively by STAAR® and is FDA approved. The estimated quantity is a maximum of 1,200 lenses @ $859.00 each (FOB Destination) for a total contract estimated value of $1,030,800.00 for the three month base and two 12 month option years.

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: The Visian ICL implantable lens is the only type of its kind on the market using collamer which is Staar Surgical’ s patented material. Staar Surgical is the manufacturer and sole distributor of the Visian lens. 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. 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.

6. Efforts to Obtain Competition: A Pre-Solicitation Notice was issued on the Federal Business Opportunities (FedBizOpps) website on 11June 2016 with a response due date of 30 June 2016. No responses were received.

a. Effective competition. Based on the results of the market research and the posting of the Source Sought Notice there is no effective competition anticipated for this acquisition.

b. Subcontracting competition. There are no subcontracting possibilities for this requirement.

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 (2) FDA approved companies, AMO USA who manufactures the Verisyse lens and Staar Surgical, who manufacturers the Visian. 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 expressed an interest, in writing, or otherwise. The other source referenced above cannot provide the collamer lens requested by the Ophthalmology Department as this technology is patented. The notices required by FAR 5.201 have been published and no other responses were received.

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.

It has been 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-14-D-0002 awarded 1 October 2013 for a total price of $797,940.00.

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

(c) W91YTZ-12-D-0005 awarded on 20 August 2012 for a total price of $235,700.00.

(d) W91YTZ-11-P-0624 awarded 25 August 2011 for unit price of for a total price of $141,600.00 (a one time delivery). (3)

(e) W91YTZ-10-P-0776 awarded 24 September 2010 for a total value of $142,710.00.

(2) Previous contracts listed above were sole sourced to Staar Surgical.

(3) Authority previously cited for exemption for 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.

(5) All prior contracts for this requirement was accomplished using other than full and open competition.

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

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

b. Other facts. None.

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: Scott D. Barnes, COL, MC Title: Chief, Ophthalmology/WRESP

12. Requirements 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: Scott D. Barnes, COL, MC Title: Chief, Ophthalmology/WRESP

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The pricing for previous contract W91YTZ-14-D-0002 was $818.40 each. That price remain the same from October 2013 through September 2015. Staar Surgical’ s current published commercial price for the lens is $1,285.00. Staar Surgical is offering the lens to the government for a cost of $859.00. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: ________________________________Date: __________

Typed Name: Peter J. Terek Title:Deputy RHCO-A (P)__________

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: __________

Typed Name: Peter J. Terek Title:Deputy RHCO-A (P)__________

Peter.Terek Typewritten Text 7/6/16

Peter.Terek Typewritten Text 7/6/16

Approval

Based on the foregoing justification, I hereby approve the procurement of Staar Lens (Visian ICL Phakic Lens) being procured at a cost of $1,030,800.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ________________________________Date: ________________________

Typed Name: _Joseph S. Peck________ Title: Special Advocate for Competition

Joe.Peck

11July 2016

Joe.Peck