Justification and Approval.pdf

Tracking #DFBA

Justification and Approval

For Other than Full and Open Competition Sole Source Acquisition

1. Identification of the agency and contracting activity: Defense Health Agency, Contract Operations Division – National Capital Region (DHA, COD-NCR)

2. Nature and/or Description of Action being approved: Approval is being requested for a new contract to support existing level of effort. The Government intends to negotiate a new sole source contract with Mizuho OSI, 30031 Ahern Avenue, Union City, California 94587-1234, to provide support to the existing level of effort for the Main Operating Room located at, 8901 Wisconsin Avenue, Bethesda, Maryland, 20889.

3. Description of Supplies/Services: DHA, Walter Reed National Military Medical Center (WRNMMC) requires preventive maintenance and software upgrades for surgical tables for cases. The service agreement should provide the following; from rapid delivery of parts for preventive maintenance and software upgrades, their experienced staff is fully qualified to serve Walter Reed which meets FDA regulation 21CFR820. Their team of field-based service engineers and in-house service experts know the Mizuho OSI tables inside and out and are on hand to answer your questions and respond quickly to resolve any service issues.

4. Statutory Authority Cited: Authority cited for this action is 41 U.S.C. 1901 Simplified Acquisition Procedures.

5. Reason for Authority Cited: Acquisition conducted under SAP at FAR 13.501(a) are exempt from the requirements at FAR Part 6. In accordance with FAR 13.501(a) (1) (ii) using the format at 6.303-2.

6. Efforts to Obtain Competition: This notice will be posted to the Government-wide point of entry in accordance with FAR 5.201 allowing all registered vendors who are interested to submit their bid, proposal, quotation, or capability statement for consideration.

7. Actions to Increase Competition: Due to the unique and proprietary nature of this requirement, there are no efforts that can be made to increase competition in the future as the manufacturer has not authorized any other company to distribute their products and there are no practical alternatives available for this requirement. Terumo Cardiovascular Systems Corporation has proprietary rights to this service contract.

8. Market Research: In accordance with FAR Part 10, a Market Survey was conducted using several sources including the ECRI Sourcebook 2014, and also included a search of the Internet using Yahoo, Alta Vista, Google, no other source could provide the requested product. The requested service contract, which has been determined to be a medical necessity by the attending surgeon based on each individual patient’s condition. Unacceptable delays in fulfilling the operating room’s requirements could cause unnecessary cost to the Main Operating Room.

9. Other Facts: Technical data packages, specifications, engineering descriptions, statements of work, and purchase descriptions suitable for full and open competition are not available due to patent laws.

Historical data:

10. Interested Sources: N/A

11. Methods to overcome barriers: N/A

Coordination:

12. Technical/Functional Representative: I certify that the supporting data under my cognizance which are included in the justification is accurate and complete to the best of my knowledge and belief.

Typed Name: __Kevin Coca Diaz_________ Date: _____12/29/2023_________________

Title: ____Inventory Manager_____________ Signature: ___________________________

13. Requirements Certification:I certify that the supporting data under my cognizance which are included in the justification is accurate and complete to the best of my knowledge and belief.

Typed Name: __Eltjon Nuredini_________ Date: ___12/29/2023_________________

Title: ___Business Manager______________ Signature: ___________________________

14. Fair and Reasonable Cost Determination: Provide the basis for this determination (e.g., describe techniques to be used to determine fair and reasonable price, such as cost analysis, price analysis, audit, should cost, independent Government estimate, etc.). As part of this basis, indicate whether certified cost or price data will be required or if one of the exceptions in FAR Part 15.403 will apply. If applicable, was certified cost or pricing data required? Contracting Officer to include the following determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Typed Name: __________________________ Date: _______________________________

Title: _________________________________ Signature: ___________________________

15. Legal Review: I have reviewed this J&A and it is deemed to be legally sufficient. (Note: All J&A’s must be reviewed by Office of General Counsel (OGC)/Legal Review.)

Typed Name: __________________________ Date: _______________________________

Title: _________________________________ Signature: ___________________________

Approval:

Note: The below approval block(s) shall be moved to the above “Coordination” phase based on the approval level required. (See PD 06-01, J&A, Enclosure 3 for the J&A approval dollar thresholds.)

16. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A). I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: __________________________ Date: _______________________________

Title: _________________________________ Signature: ___________________________

17. Competition Advocate (CA): Based on the foregoing justification, I hereby approve the procurement of (state supplies/ services being procured) on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) (insert authority), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

18. Head of Contracting Activity (HCA) (or designee): Based on the foregoing justification, I hereby approve the procurement of (state supplies/ services being procured) on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) (insert authority), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Typed Name: __________________________ Date: _______________________________

Title: _________________________________ Signature: ___________________________

19. Director of Defense Health Agency (DHA), Senior Procurement Executive (SPE) or designee.

(Authority is not delegable, except in the case of the Under Secretary of Defense for Acquisition, Technology, and Logistics, acting as the SPE for the DoD). Based on the foregoing justification, I hereby approve the procurement of (state supplies/ services being procured) on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) (insert authority), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.