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Form 02.4G.AB / PR#N6264513RCD0039/TDP 13-007-13 Page 1 of 3 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD on behalf of Naval Medical Center San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

Negotiations will be conducted on other than full and open competitive basis with St. Jude Medical

Inc, 1 Saint Jude Medical Dr, Saint Paul, MN 55117.

3. Description of the supplies or services.

The requirement is for mechanical heart valves, both mitral and aortic, as well as an aortic valve graft, which consists of an aortic valve with a length of vessel graft to replace a portion of the aorta.

These mechanical prostheses shall include a sewing cuff to aid in attaching the valve to the vessel.

The requirement is for the following specific mechanical heart valves manufactured by St. Jude

Medical; heart valves are available only on order of a physician or otherwise licensed practitioner.

These valves include the Regent aortic valve with flex cuff, the Master mitral valve, the Master HP aortic valve, and the Masters HP Valved Graft. The estimated quantity is three (3) prostheses of each type per year.

The product shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.

Fiscal Year 2013 funds in the amount of approximately to be used for the initial delivery order. The value of the contract for the five (5) year ordering period is estimated at .

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is FAR

13.501 and U.S.C. 2304(c)(1) – Only one responsible source.

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

Valve prostheses are selected according to their hemodynamics, thromboresistance (resistance to blood clot formation), ease of insertion, anatomic suitability, and patient acceptability. The St. Jude

Medical bi-leaflet mechanical heart valve has unique design features that allow implantability in a wide range of patients and a low thromboembolic rate. These design features include specific cuff position, geometric orifice area, opening angle of leaflets, and valve size availability. Valve prostheses are available via physician prescription only and are determined to be suitable, at a make, model, and size level, for a patient on a case-by-case basis. Substitution of another valve for a physician-prescribed prostheses would result in negative outcomes for the patient, including patient-prosthesis mismatch, increased risk of thrombogenesis (blood clot formation), and valve dysfunction; any of these factors increase the risk of morbidity and mortality for the patient.

Additionally, unauthorized substitution of a prescribed medication or device may not only cause harm to a patient but can also leave healthcare providers liable for medical malpractice. Only St.

Form 02.4G.AB / PR#N6264513RCD0039/TDP 13-007-13 Page 2 of 3 1 Nov 2012

Jude Medical can provide St. Jude Medical heart valves; heart valves are FDA-cleared to be available via prescription only.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8.

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

The Contracting Officer has determined 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 of previous procurements. In addition, the Government anticipates that the negotiated contract price will reflect a discount from St. Jude Medical’s commercial price list and will be determined fair and reasonable meets all of the government requirements.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in July 2013. This research consisted of reviews of previous procurements for these types of heart valves and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage. Finally, a search was conducted through the ECRI sourcebook catalog. No possible sources were identified for St. Jude

Medical heart valves. Only St. Jude Medical can provide the required heart valves.

Other heart valves are available from various companies, including Medtronic, Sorin Carbomedics, and On-X Life Technologies. Heart valves from these manufacturers may be prescribed for other patients that come through Naval Medical Center San Diego; alternate contracting methods will be used to procure those prostheses.

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

None

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of 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.

The actions are taken prior to the source selection to insure compliance. Actions cannot and shall not be taken after source selection to increase competition. However, there is constant attention to the market to insure that shall technology change, the source selection is reconsidered. U.S. Navy

Subject Matter Experts are required to take into consideration the impact on the installed base of equipment when source selection occurs. All necessary components of integrated logistics support are taken into consideration.

12. Point of Contact

The point of contact at the NMLC, Fort Detrick, Frederick, MD, regarding the contents of the sole source justification is , who may be reached at .

Form 02.4G.AB / PR#N6264513RCD0039/TDP 13-007-13 Page 3 of 3 1 Nov 2012

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.501

I certify that the facts and representations under my cognizance which are included in this justification, which form a basis for this justification, are complete and accurate.

Phone Date

Technical Reviewer Code 03

Requirements Cognizance

Code 03

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Code 02