J_&_A.pdf

Control Number: 18-RHCO-C-322

(17 March 2017)

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: New Repeat W81K00-18-T-0134 Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $ _

Name of Intended Contractor: St Jude Medical LLC Street Address: 1 Saint Jude Medical Dr.

City, State, Zip: Saint Paul, MN 55117-1789

Phone:

3. Description of Supplies/Services: Pacemakers, Heart Valves and Accessories

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(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

(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) 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

(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: Required pacemakers are physician prescribed medical implants selected for specific patients’ health and lifestyle requirements. The Assurity MRI pacemaker assists the physician in monitoring patient disease status and device performance daily with automatic remote monitoring. The scheduled surgeries are to replace existing pacemakers manufactured by St.

Control Number: 18-RHCO-C-322

(17 March 2017)

Jude with MRI safe devices. The physician prescribed St. Jude manufactured pacemakers due to the patient’s individual historical success with their existing pacemaker and changing manufactured pacemakers during the replacement process would potentially impact the patients’ health.

6. Actions to Increase Competition: 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: Market research identified multiple manufacturers, Biotronik, Boston Scientific, and Medtronic, that provide pacemakers and accessories on the market. No distributors of St Jude pacemakers and accessories were identified that could provide the required products. As a result of market research acquiring from the manufacturer is the only procurement method available.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K00-18-P-0078 or N/A Previously competed? N/A No Yes 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 is accurate and complete to the best of my knowledge and belief.

Signature:

Submitted By:

Position Title : Chief, Email address:

Date:

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

Signature:

Typed Name: Caesar Trevino Position Title: Contracting Officer

Email address: Caesar.trevino.civ@mail.mil Date:

15 March 2018

TREVINO.CAES

AR.1126299466

Digitally signed by

TREVINO.CAESAR.1126299466

Date: 2018.03.15 09:30:33 -05'00'