J&A_redacted.pdf

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD to meet the requirements of the Material Management Department (MMD) in the Contracting Division at Naval Medical Center

Portsmouth (NMCP), VA.

2. Nature and/or description of the action being approved.

The proposed action is a contract for Pyramesh Instrument Set, Tall C Pyramesh Implant Set with C-Stone

PSR/Verte-Stk XS, PSR/Verte-Stack XS set, Vertex Select RS Screw Module, and ZEVO ACP Self Drilling Set for a surgical team to perform a follow-up spinal surgery. The procedures in FAR subpart 13.5 will be implemented for this requirement; as an urgent and compelling for an emergency spinal surgery.. Absence of an immediate surgery would result in unacceptable delays rendering irreversible damage to the patient. The MMD will return unused instruments and implant sets to the contractor upon the completion of the emergency surgical procedures. Once instruments and implant sets are returned to the contractor, the Government will only be charged for instruments and implants used. The proposed source is Medtronic Sofamor Danek USA, Inc, 1800 Pyramid Place, Memphis, TN, 38132-1703.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

Medtronic Sofamor Danek USA, Inc. will provide Pyramesh Instrument Set, Tall C Pyramesh Implant Set with C-

Stone PSR/Verte-Stk XS, PSR/Verte-Stack XS set, Vertex Select RS Screw Module, and ZEVO ACP Self Drilling

Set to perform the spinal surgery.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is FAR 13.501(a)(1)(ii), Prepare sole source (including brand name) justifications modified to reflect that the procedures in FAR subpart

13.501 were used in accordance with 41 U.S.C. 1901.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

During surgical planning and patient pathophysiology performed by the surgeon, it was determined that the patient required a spinal implant in order to restore function and mobility. In the interest of time, the physician elected to use the Medtronic Sofamor Danek USA surgical system because s/he was familiar with it and the expected patient outcomes derived from using it. To research and purchase a potential alternative could result in unacceptable delays rendering irreversible damage to the patient. Therefore, a sole source acquisition for surgical instruments and implants manufactured by Medtronic were requested.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. The proposed action will not be posted to

FedBizOpps, in accordance with FAR 5.202(a)(2). This Justification and Approval will be posted on FedBizOpps within 30 days after contract award.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Form 02.4G.AB 18 Apr 2016

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis prior to acceptance of an invoice for the instruments and implants used.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Due to the unusual and compelling urgency of this requirement, the contract specialist has conducted limited market research on this requirement. A market survey was not conducted because absence of an immediate surgery would result in unacceptable delays, rendering irreversible damage to the patient. It was determined during surgical planning and patient pathophysiology performed by the surgeon, it was determined that the patient required the

Medtronic Sofamor Danek USA surgical system in order to restore function and mobility of the patient and to ensure the best possible outcome. The most cost effective means to obtain this equipment is from the manufacturer rather than a distributor.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

This justification will be posted on FebBizOpps within 30 days after contract award in accordance with

13.501(a)(1)(iii).

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

It is the intent of the Government to compete future contracts for the types of supplies/services covered by this document. Further future requirements will be synopsized in accordance with FAR 5.203.