Justification and Approval for Cataract Packs - signed.pdf

DHA PGI 206.3, Attachment 1 (06-21-2018)

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A)

for FAR Subpart 6.3 Other Than Full and Open Competition

6 January 2025

Justification and Approval for Other than Full and Open Competition

J&A Tracking No.

1. Identification of the agency and contracting activity: US Naval Hospital, Guam, Defense Health Agency, Contracting Activity, Bldg. 50 Farenholt Road Suite 1Y02, Agana Heights, GU 96910. Purchase Request (PR) number 0012174387-0001.

2. Nature and/or Description of Action being approved: The US Naval Hospital, Guam has a requirement for purchase of customized ophthalmic supplies from Alcon Vision, LLC for 48 cases of P/N AS13120-18, Hi-Infinity Phaco-Emulsification Cataract Packs. The government intends to enter into a purchase order that will require justification for other than full and open competition.

3. Description of Supplies/Services: The US Naval Hospital, Guam, Ophthalmology Department is requesting a sole source procurement with Alcon Vision, LLC to supply 48 cases of P/N AS13120-18, Hi-Infinity Phaco-Emulsification Cataract Packs at an estimated total amount of $132,888.00. Estimated delivery date of 31 January 2025.

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition (see FAR 6.302), or the Specification of the Statutory and Regulatory Provision Providing Exception to 8(a) Program Competitive Requirements (see FAR 19.805-1): 10 U.S.C.

2304(c)(1) 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Rationale Justifying Use of the Statutory Authority Cited: Alcon Vision, LLC is the sole manufacturer of these Phaco-Emulsification Cataract Packs. A purchase order is needed to provide these Packs for uninterrupted patient care. Without these Packs, medical procedures have the potential of being cancelled because the necessary supplies would be unavailable.

6. Efforts to Obtain Competition: Several eye care companies were contacted if they were able to supply this type of Cataract Pack and they could not meet the requirement.

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

Contracting Officer has determined that the price is fair and reasonable to the Government based on the Independent Government Cost Estimate (IGCE) submitted by the customer and previous prices paid in the past.

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

8. Market Research: Market research was conducted pursuant to FAR part 10. Supplies were not found at UNICOR, AbilityOne, and GSA Advantage.

Alcon Vision, LLC has a GSA Contract Number 36F79722D0040, it is for the purchase of ophthalmic surgical equipment and does not cover Cataract Packs.

9. Other Facts: Full and open competition was not utilized for this procurement due to the reasons stated in paragraph 4 and 5 above. Alcon Vision, LLC has been determined to be the sole source provider.

10. Interested Sources: No other sources as stated in lines 5, 6, and 8 above.

11. Actions to overcome barriers: No actions are planned because Alcon Vision, LLC is the manufacturer of these Phaco-Emulsification Cataract Packs. The manufacturer is the only source that can provide these customized packs and meet our requirement. Failure to utilize the manufacturer for this supply may jeopardize patient care.

COORDINATION:

12. Customer:

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

Andrew L. Ward 1/6/2025

[Insert Name (Printed)] Date

Department Head, Ophthalmology Department

13. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A). Include the following statement:

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

Jocelyn Layson-Castillo 1/6/2025

[Insert Name] Date

Contracting Officer, U.S. Naval Hospital, Guam