Urolift Justification.pdf

CUI

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

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

FAR Subpart 6.3 Other Than Full and Open Competition

Justification and Approval for Other than Full and Open Competition

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 Naval Medical Center San Diego (NMCSD).

2. Nature and/or Description of Action being approved: New/one-time delivery requirement of specialty urolift kits in support of urology department

3. Description of Supplies/Services:

UL2-C UROLIFT 2 IMPLANT CARTRIDGE (4 PER BX), Qty 15 Bx; UL2-CHK UROLIFT 2 IMPLANT CARTRIDGE HANDLE KIT Qty 15EA; and UL400-ATC ADVANCED TISSUE CONTROL DEVICE, Qty 3 EA.

Delivery Date: 31 August 2023

Estimated value:

Type of contract: Firm Fixed Price

Type of Funding: Operations and Maintenance (O&M)

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): Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Rationale Justifying Use of the Statutory Authority Cited:

The requirement is for Neotact Urolift kit for the prevention of blocked urethra due to benign hyper trophic prostate tissue. Technical Communities Inc is currently the sole distributor of this new product/kit. Based on market research, Technical Communities Inc. is the only source that can meet the Government’s minimum requirements to provide requested products in the urolift kit.

6. Efforts to Obtain Competition:

Market research was performed to compare other competitors with similar or equal equipment was available to purchase through government agency. In conclusion, this is the only product to fit the needs of the Urology clinic for this type of procedure.

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:

Project manager visited each website provided via market research and determined that there were no other products suitable for the procedures that will be preformed utilizing Urolift kit.

Project manager also consulted with representative to determine that this in fact is the only product on the market of its kind.

9. Other Facts: N/A

10. Interested Sources: Technical Communities Inc is the only source identified that can meet the Government's minimum requirements.

11. Actions to overcome barriers: DHA Western Markets Contracting Division will continue to survey and engage the market of any potential vendors that can provide the Urolift Kit 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.

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.

Project Manager 6/15/2023 Date Program Manager

13. Requirements Certification:

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

6/15/2023

Business Manager Date

14. Fair and Reasonable Cost Determination:

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

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APPROVAL:

15. Contracting Officer:

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

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