A_02_04_Brand_Name_JA_-_Redacted,_17-T-0302,_31_Jul_17.pdf

Control Number: 17-RHCO-A-603

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

(26 July 2017)

Brand Name Justification and Approval Under FAR 13.501

1. Contracting Activity: US Army Regional Health Contracting Office-Atlantic, Bragg Health Contracting Cell, 6021 5th Street, Building 1467, Fort Belvoir, VA 22060-5505

2. Description of Action: Approval to award a new contract for LenSx Surgical Suite is requested. This requirement will be awarded as a Firm Fixed Price (FFP) supply contract utilizing three-year FY15 (exp. FY17) Defense Health Program, Defense funds.

3. Description of Supplies/Services: The requirement is to procure the LenSx Surgical Suite, detailed below. The total estimated value of this requirement is (no options).

Serial Number Nomenclature Quantity 8065998162 LenSx Femtosecond Laser w/Flap 1

8065751763 CENTURION VISION SYSTEM 2

8065998240 VERION REFERENCE UNIT 1

8065998185 LenSx UPS 120v 1 8065751761 CENTURION Ozil HP 7

8065998245 VERION MOBILE STAND 1

8065998244

VERION DIGITAL MARKER M

ZEISS/LUXOR 1

8065998241 VERION DIGITAL MARKER LX 1

8065998225 LENSX LASER SOFTFIT PI'S 20

8065998249 Digital Marker System Fee - 1st Unit 1 8065998247 Reference Unit System Fee - 1st Unit 1

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code (U.S.C.) 1901 as implemented in Federal Acquisition Regulation (FAR) 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 LenSx Surgical Suite is a unique Laser Assisted Cataract Surgery (LACS) system. LACS offers many advantages over traditional cataract surgery, including reduced post-operative flare and less surgically induced endothelial cell damage, resulting in better surgical outcomes. LACS is quickly becoming the new standard in cataract surgery and while there are several similar opthalmological laser systems on the market, LenSx is the only one which also includes two phacoemulsification machines, a corneal analyzer, and patient/laser interface devices making it a complete LACS System.

This is a brand name requirement. Not approving this brand name justification would result in increased costs as more patients would be referred to off post facilities who offer LACS instead of traditional cataract surgery. Currently, Tricare reimburses $1,193 per cataract surgery (CPT 66984). In the last year, the Opthalmology Clinic has performed 274 cataracts surgeries .

Purchased care dollars spent on cataract surgery would be $326,882 over last year if this equipment is not purchased and all of these patients get referred off post for care.

Control Number: 17-RHCO-A-603 – LenSx Surgical Suite – Fort Bragg, NC

(See FAR 2.101 and 3.104-4)

(26 July 2017)

Additionally, procuring this requirement as a brand-name or equal could result in drastically increased costs as other comparable LACS systems on the market do not include the phacoemulsification machines, corneal analyzer, and patient/laser interface devices.

6. Efforts to Obtain Competition: The manufacturer, Alcon Laboratories was contacted on 3 July 2017 and a listing of their authorized distributors was requested. There is only one authorized distributor of this equipment, aside from the manufacturer, and the requirement will be competed among the manufacturer and their distributor. The combined synopsis/solicitation will be posted to FedBizOpps to ensure maximum visibility to industry.

7. Actions to Increase Competition: Though the Government will continue to conduct on-going research of the industry marketplace to determine if there are new entrants into this product arena; however this item is currently only distributed by the manufacturer and one distributor.

8. Market Research: Market Research was conducted 2-5 July 2017 in accordance with (IAW) FAR Part 10 and included searching the following websites: Ability One, UNICOR, and GSA.

The manufacturer of this equipment was contacted via email on 3 July 2017 asking for a listing of authorized distributors of this equipment to determine if this requirement could be met by a small business. On 5 July 2017, the manufacturer indicated that there is only one authorized small business distributor of this equipment. As such, there is no reasonable expectation of receiving two or more quotes from small businesses.

9. Interested Sources: To date, no other sources have written to express an interest. The notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered. Additionally, this approved justification will be made publically available by being posted to the Federal Business Opportunities website (www.fbo.gov) IAW FAR 13.201(a)(1)(iii).

10. Other Facts: None – this is a new requirement, there is no previous competition data available.

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: ate: __________ Typed Name:

Title: Civilian Ophthalmology Supervisor

26 July 2017

(See FAR 2.101 and 3.104-4)

(26 July 2017)

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:

Title: Chief, Ophthalmology Clinic

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 as the techniques listed at FAR 13.106-3(a) will be utilized to determine a fair and reasonable price. Certified cost or pricing data is not required per FAR 15.403(b)(3).

Signature: Date: __________ Typed Name: Cheryl A. Ricker Title:Contracting Officer

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: Cheryl A. Ricker Title:Contracting Officer

7/26/2017

20170727

(See FAR 2.101 and 3.104-4)

(26 July 2017)

Approval Based on the foregoing justification, I hereby approve the procurement of a LenSx Surgical Suite in an estimated amount of 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: Cheryl A. Ricker Title:Contracting Officer