A.02__J_and_A_Treatment_Card_Authorization_SignedKO_-_Copy.pdf

Control Number: 19-RHCO-A-162 RFQ Number: W91YTZ19Q0093

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

(10 October 2018)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Activity-Atlantic (RHCO-A), Bragg Health Contracting Cell, 6021 5th Street, Building 1467, Fort Belvoir, VA 22060-5505.

2. Description of Action: Womack Army Medical Center (WAMC), Warfighter Refractive Eye Surgery Program (WRESP), requests approval for a Firm Fixed Price (FFP) contract to purchase Star S4 Treatment and Calibration Cards, on a sole source basis from AMO Sales & Service, Inc. The type of funds will be Operation and Maintenance, Army (OMA) funds as stated on the purchase request.

3. Description of Supplies/Services: Johnson & Johnson Vision brand treatment cards include: CustomVue with High Myopia Treatment Cards, product number 0040- 7000, and License Fee, Conventional Treatment Cards, product number 0040-1010-11, and License Fee, and Calibration Cards, product number 0030-6728. The period of performance is a base year commencing 6 March 2019 through 30 Sept 2019 plus two 12 month option years beginning 01 Oct 2019 through 30 September 2021. The total estimated value of the requirement for the base year and two 12 month option years is $1,428,360.00.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Star S4 Treatment and Calibration Cards is the only type of its kind on the market which is Johnson & Johnson Vision’s patented material.

Johnson & Johnson Vision is the manufacturer and AMO Sales & Service, Inc. is the sole distributor of the Star S4 Treatment and Calibration Cards to the Government. No other company but Johnson & Johnson Vision makes these cards and can rightfully be integrated with the Star S4 Excimer Laser. Due to design and licensure, no other product can be integrated with the Star S4 Excimer Laser. The Government owns this laser and it has a life expectancy of seven years. One CustomVue Treatment Card can treat 10 eyes. One Conventional Treatment Card can treat 10 eyes. Two Calibration Cards can be used to calibrate the Star S4 Excimer Laser on each surgery day. The average number of patients treated per month is 91 patients (182 eyes/treatments).

6. Efforts to Obtain Competition: Based on the results of market research and the posting of the Presolitation Notice on 27 Dec 2018, there have been no inquiries or responses made to the Presolitation Notice to date. Johnson and Johnson Vison brand is the manufacturer and AMO Sales is the Distributor and the Awardee. As a result of previous contracts being sole-sourced and market research, the Warfighter Refractive Eye Clinic was not able to obtain competition.

Mary.A.Martin Highlight

Star S4 Treatment and Calibration Cards, Womack Army Medical Center (WAMC)

a. Effective competition: AMO Sales & Service, Inc. is currently the sole provider of these products.

Johnson & Johnson Vision is the manufacture of the product and are proprietary in nature of refractive products. Additionally, the products are sold to the Department of Defense refractive centers within the continental United States.

b. Subcontracting competition. There are no subcontracting possibilities for this requirement. This requirement is to be sole sourced to AMO Sales & Service, Inc. who is currently the sole provider of the Star S4 Treatment and Calibration Cards to the Government.

7. Actions to Increase Competition: This requirement is to be sole sourced to AMO Sales & Service, Inc. who is currently the distributor of the Star S4 Treatment and Calibration Cards to the Government. The manufacturer for these products is Johnson and Johnson Vison Brand. There are no other products like this available for competition at this time.

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

Market research indicates Johnson and Johnson Vision is the sole source vendor of the Star S4 Treatment and Calibration Cards. Johnson and Johnson Vision sales representative was contacted and they provided a letter stating: Currently, AMO Sales & Service, Inc. is currently the sole provider of these products to military centers.

Johnson & Johnson Vision refractive products include:

• STAR Excimer Laser Systems and associated treatment cards

• INTRALASE Femtosecond Laser Systems and patient interfaces (i.e. iFLAP)

• WAVESCAN Wavefront System

• IDESIGN Advanced WaveScan Studio

Because of the proprietary nature of the STAR and INTRALASE laser software, only Johnson & Johnson Vision diagnostics, patient interfaces, and treatment cards can rightfully activate the capabilities of these systems.

9. Interested Sources: To date, no other sources have expressed an interest, in writing or otherwise.

10. Other Facts:

a. Procurement history. This is a recurring requirement that has historically been awarded on a sole source basis to AMO Sales and Service INC, the sole distributor of the Star S4 Treatment and Calibration Cards. There was an Electronic Centralized Acquistion Tool Website (ECATS) contract and the cards were being purchased through the contract. The ECATS contract has expired.

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

W91YTZ-10-P-0783, 13 SEPT 2010

W91YTZ-13-C-0110, 05 SEPT 2013

(2) Previous contracts listed above were sole sourced to AMO Sales and Service Inc.

From 2014 through 2018 the cards were available through ECATS.

(3) Authority previously cited for exemption for sole sourced competition was FAR 6.302-1; Only one responsible source and no other supplies or services will satisfy agency requirements.

(4) The previous requirement was advertised on Federal Business Opportunities website (FED BIZ OPS) as “Name Brand Only”. The system and the software that is part of the card package are proprietary to Johnson & Johnson Vision and distributed by AMO Sales and Service INC.

(5) All prior contracts for this requirement was accomplished using other than sole sourced procedures.

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

(7) Johnson & Johnson Vision is the only company that makes the Star S4 Treatment and Calibration Cards which are distributed to the Government by AMO Sales and Service, Inc. There have been no significant changes and no other company but Johnson & Johnson makes these cards, which has been determined the only product that can rightfully be used with the Star S4. Active U.S. Patent Numbers listed on company website: 6,254,595; 6,344,040; 6,373,571; 6,623,476; 6,676,653; 6,863,667;

6,899,707; 6,991,629; 7,018,376.

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: Kyle T. Packer, CPT, MC Title: Chief, 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: Kyle T. Packer, CPT, MC Title: Chief, 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 based on previous prices paid on past contracts for the same supplies. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: _______________________________ Date: _________________________

Typed Name: ____________________________Title:__________________________

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: ____________________________Title:__________________________

Approval

Based on the foregoing justification, I hereby approve the procurement of Star S4 Treatment and Calibration Cards from AMO Sales and Service Inc. for a 31 month duration and total dollar value, $1,428,360.00 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 supplies and property herein described have otherwise been authorized for acquisition.

__________________________________ Date:

Liza J. Esmond Special Advocate for Competition

Mary.A.Martin Highlight