J_and_A_under_SAT.pdf

Control Number: 18-RHCO-C-45

Limited Sources Justification or

Sole Source Determination for Actions under the Simplified Acquisition Threshold (Currently $150K)

1. Contracting Activity: Regional Health Contracting Office-Central, US Army Health Care Acquisition Activity, San Antonio Military Medical Center, Fort Sam Houston, Texas 78234

2. Description of Action:

Requirement: D New � Repeat Pricing: � Firm-Fixed Price D Time & Materials D Cost Funds: � OMA, D Other Funds: Total Dollar Value: $ $9,915.00

Name of Intended Contractor: Edwards Lifesciences LLC Street Address: One Edwards Way City, State, Zip: Irvine, CA 92614-5688

Phone:

3. Description of Supplies/Services: Perimount Magna Ease Heart Valve

4. Authority Cited:

IZI (a) FAR 1.3.106-1 (b)(1 )(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

D (b) FAR 13.106-1 (b)(1 )(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

D (c) FAR 8.405-6(a)(1 )(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

D (d) FAR 8.405-6(a)(1 )(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

D (e) FAR 8.405-6(a)(1 )(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole source or limited-sources procedures.

5. Reason for Authority Cited: These implants are physician prescribed surgically applied medical devices selected for specific patient's health and lifestyle requirements and there are no other surgical implants available. The heart valve is a 21 mm Pericardial Tissue Heart Valve. The surgery

(17 March 2017)

Control Number: 18-RHCO-C-45 anticipated to treat aortic stenosis, is required to correct the heart valve stenosis and increase the patient's quality of life.

6. Actions to Increase Comp.etition: Due to the urgency of the requirement, time for ordering and shipping are less than allotted time needed. The J&A will be posted to FedBizOps no later than 14 days after the date of award. If future patients or treatments are required market research will be conducted to determine the availability of other manufacturers/distributors or other treatments.

7. Market Survey: The market survey conducted through previous buys shows the cost within market range for the type of implants requested by the surgeon.

8. Procurement History:

Previous Contract or Purchase Order Number: orD N/A Previously competed? D NIA DNo 0Yes Previous authority for less than Full & Open Competition:

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

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Submitted By:

Position Title :

Email address:

Date:

Chief, Material Management

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10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signatu .

Typed Nam .

Position Titl

Email address:

Date:

1racting Officer

(17 March 2017)