JA Brand Name - Centurion Vision System - Redacted.pdf

CUI

DHA PGI 213.5, Attachment 1 (06-21-2018)

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR Subpart 13.5

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition

Sole Source Acquisition J&A Tracking No.

1. Identification of the agency and contracting activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Navy to meet the requirements of the United States (U.S.) Naval Hospital Okinawa Japan.

2. Nature and/or Description of Action being approved:

Approval is being requested for the purchase of an OEM Alcon, Centurion Vision System with Active Sentry Enabled M/N: 900198090 including delivery, installation and training.

3. Description of Supplies/Services:

This requirement is for the purchase of 1 each, Centurion Vision System with Active Sentry Enabled to be procured by Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD) to support US Naval Hospital Okinawa Japan. The requested delivery date is 31 August 2023. The total estimated value of this effort is Centurion Vision is used for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection.

4. Statutory Authority Cited permitting other than full and open competition:

The statutory authority exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1), as implemented by FAR Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements (including brand name). The procedures in FAR Subpart 13.501 and 41 U.S.C. 1901, Simplified Acquisition Procedures were used.

5. Rationale Justifying Use of the Statutory Authority Cited:

The Original Equipment Manufacturer (OEM), Alcon, Centurion Vision System is the new system and will be a direct replacement of Infinity Vision System. Naval Hospital Okinawa Ophthalmology currently has only one Centurion Vision System due to an Infinity Vision System has recently been DRMO’d for past life expectancy. Two Centurions are essential to operate the clinic properly for their patient care purposes in case one goes down. The Centurion Vison System uses “Active Fluidics” technology which anticipates intra-ocular pressure changes in the eye. It keeps a constant state of pressure which eliminates chances of post-occlusion surge.

This capability is not present in the current system. Manufacturers are transitioning to fluidic controls and although there are other equipment brands in the market that now uses this technology, Centurion is the only phacoemulsification machine uses INTREPID Balanced Tip that provides more effective phacoemulsification than others. It is designed to lower the risk of damage to the capsular bag and other tissues. It reduces tip movement at the incision, lowering thermal risk during surgery, which can result in less tissue damage at the incision site. Centurion Vision System with Active Sentry allows surgeons to operate at a lower, more physiological intraocular pressure (IOP) and significantly higher vacuum levels. Using the Active Sentry reduces post-occlusion surge, controls for real-time IOP fluctuations, and facilitates operating at near physiological IOP, which supports ocular safety. Therefore, this specific phacoemulsification machine is essential for the clinic to provide high quality patient care service. Also, all users are trained for this brand unit and this request is for direct replacements to procure the latest model Centurion Vision System. Our resident Ophthalmologists also have extensive experience and are trained with Alcon products. Purchase of a different equipment will require re-training of our Ophthalmologists and staffs. Using two or more different Vision Systems will undoubtedly cause errors/confusion and may negatively impact patient care.

Maintaining standardization to a single Vision System will ensure that care is provided efficiently and effectively. All efforts must therefore be employed to maintain uniformity of the Vision System.

6. Efforts to Obtain Competition:

Contract specialist conducted a mandatory search throughout June 2023 and determined via internet searches that this requirement is customarily available in the commercial marketplace.

Through research and mandatory sources: AbilityOne, UNICOR, ECAT, GSAXcess and GSA Advantage. A small business dynamic search for additional small business firms meeting the requirement resulted in negative results under NAICS code 339112 and search terms “Centurion System Vision”. A search on FPDSNG found has been awarded a contract for Centurion System Vision and was set aside for small business. Included in the PR package was an authorized distribution letter from OEM Alcon Vision. The recommendation is a small business set aside with a brand name basis.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price found reasonable on previous purchases and a comparison of the price to the Independent Government Cost Estimate (IGCE) provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

As stated above, several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online search engines reviewed by United States Naval Hospital Okinawa and DHA Western Markets Contracting Division in June 2023. A combined synopsis with a small business set aside under solicitation HT941023Q2036 will be posted on SAM.gov for 15 days.

9. Other Facts:

None.

10. Interested Sources:

Any source expressing interest in response to the combined synopsis will receive consideration.

11. Actions to overcome barriers:

Naval Hospital Okinawa and the DHA Western Markets Contracting Division will continue to survey and engage the market of any potential vendors that can provide a Centurion Vision System (with Active Sentry) and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for Centurion Vision System.

COORDINATION:

12. Technical/Functional Representative:

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

Date

13. Requirements Certification:

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

14. Fair and Reasonable Cost Determination:

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

APPROVAL:

15. Contracting Officer:

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