A.02.04_JA_18-RHCO-P-112.pdf

Control Number:

18-RHCO-P-112

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: This requirement is for Madigan Army Medical Center (MAMC).

The contracting activity is Joint Base Lewis-McChord Health Contracting Command, 673 Woodland Square Loop, Suite 101, Lacey, WA 98503-1066

2. Description of Action: The WaveLight EX500 Excimer Laser installed at Madigan Army Medical Center (MAMC) in the Warfigter Refractive Eye Surgery Clinic uses the intellectual property of Alcon Laboratories, Inc. to perform corneal refractive surgery on eligible active duty service members. The intellectual property is proprietary and permits the use of the patented procedures that are available only on Alcon Wavelight EX500 Excimer Laser. Procedure fees for use of Alcon’s intellectual property are paid through the use of WaveCards. The requirement is for WaveCard EX500 GOLD treatment cards, which are required in order to continue patient care using the Alcon Vario Conoura topography-guided treatment planning system. Existing WaveCards in the ECAT system (WaveCard EX500 SILVER) are not compatible and do not permit use of the Contoura topography-guided treatments.

3. Description of Supplies/Services: Existing Government-owned equipment enables the physician to perform a procedure to correct vision problems (refractive error) and improve medical readiness. The laser requires licensing to use the system, paid through procedure fees. The laser system contains a mechanism for counting the number of licensed procedures performed and will not operate without the use of a valid prepaid license in the for of a WaveCard EX500, GOLD or SILVER models. Each type of card corresponds to a different treatment planning capability. Laser procedures may be guided by a generic algorithim that is not specific to an individual patient, and those are covered by the WaveCard SILVER. However, recently acquired Government-owned equipment (Alcon Vario Topolyzer with installed Contoura topography-guided treatment planning software) enables the performance of customized treaments which are specific to an individual patient, and which have been shown to improve visual outcomes and reduce surgical complications. These Contoura-guided treatments require the purchase of WaveCard GOLD cards. Provider of the license is Alcon Laboratories, Inc. or their sole ECAT licensee: O.R. Elder inc. New York. Currently, EX500 SILVER WaveCards are available in ECAT, but EX500 GOLD WaveCards are not. The requirement is the WaveLight EX500 WaveCard GOLD cards which are necessary to appropriately treat patients with certain types of refractive error. This is a fixed-priced contract for a base plus two one-year option periods. The cost is calculated using the following data: It’s estimated that Madigan will use eleven (11) of the fifty (50) proceedure Wavecards per year. The cost for one 50 procedure WaveCard GOLD is $10,750.00 . Estimate cost = 11 Wavecards x $10,750.00 per card = $118,250.00 per year.

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

28 Septemeber 2017

28 September 2017

4. Authority Cited: IAW FAR 13.500 Test Program for Certain Commercial items, and 13.501(a), Sole Source Alcon Vario Topolyzer acquisition. PL 104-106 Section 4202 (Clinger-Cohen Act).

5. Reason for Authority Cited: Only Alcon can provide the licensing for use of their patented procedure. There are no other sources that can support the selected laser system platform.

6. Efforts to Obtain Competition: Market research will be conducted on a continual basis for new companies that can provide the requested licensing agreement that will support MAMC and will provide the Government with the most benefit

7. Actions to Increase Competition: There is currently no effort to increase competition as there is only one source capable of meeting the requirement. Alcon Laboratories, Inc. is the only company that can provide the rquested licensing agreement in order to meet the needs of the Government. Based on this information, there is no effort to increase competition at this time.

8. Market Research: Market research indicates that this is a patented procedure and may be performed only with licesing from Alcon. No other company can provide the licensing since licenses are not cross-company compatible. This requirement is for licensing to accommodate existing Government-owned equipment with proprietary information, which precludes award to unauthorized licensing companies.

9. Interested Sources: A notice of intent to sole source as required by FAR 5.201 will be published on FedBizOps and any proposals received will be considered for furture acquisitions.

10. Other Facts:

a. Procurement history.

(1) W91YU0-09-D-004, Base plus Four Option Years (23 Sep 2009 – 22 Sep 2014);

W91YU0-14-C-0015, Base plue Two Option Years (23 Sep 2016 – 22 Sep 2017)

(2) Procured as a Sole Source Contract.

(3) The previous requirement was awarded a sole source contract based on the following reasons: 1) Alcon Laboratories, Inc. is the conly company available that can provide a valid prepaid license to use with Government-owned Alcon equipment.

Additionally, there are no other companies available that can provide this license to be used in support of patient procedures at MAMC. 2) The Government-owned equipment contains a mechanism for counting; software that monitors the number of uses of the equipment and counts the number of licensed procedures conducted. Thereby, this equipment will not operate without the use of a valid prepaid license. Alcon Laboratories, Inc. is the only provider of the license.

(4) The previous contract was awarded as a sole source.

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:

COL Michael J. Mines Chief, Ophthalmology Service Date:

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:

COL Michael J. Mines Chief, Ophthalmology Service Date:

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. Costs will be compared to competitor laser system licensing fees. Certified pricing 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.

Approval

Based on the foregoing justification, I hereby approve the procurement of Alcon WaveLight EX500 Excimer Laser WaveCard GOLD ($354,750) 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.