Justification_and_Memo_11269343_KO_Signed.pdf

19-RHCO-P-85

Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

1. Contracting Activity:

The Department of Anesthesia and Operative Service (DOAOS) Madigan Army Medical Center, (MAMC) is requesting approval of a sole source contract to Spinal Elements, Inc. for multiple specific patient surgeries.

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: Total Dollar Value: $100,000.00

Name of Intended Contractor: Spinal Elements, Inc.

Street Address: 3115 Melrose Drive, Suite 200 City, State, Zip: Carlsbad, CA 92010

Phone:

3. Description of Supplies/Services: The doctor/surgeon under the Department of Anesthesia and Operative locate at Madigan Army Medical Center, (MAMC) is requesting a surgical Spine Interbody Device implant for a specific patient that will be going through surgery. The required invasive spinal implant prescribed by the patients’ physician/surgeon and determined by the physicians to be best suited to meet the medical, health and life-style needs of the specific patient.

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.

Control Number:

5. Reason for Authority Cited: This urgent required endoskeleton titanium interbody device implants are prescribed by the patients’ physician/surgeon and have been determined to be best suited to meet this patient’s medical, health and life-style needs. The doctor/surgeon is both skilled and trained on these products to ensure they meet the patient critical care needs.

6. Actions to Increase Competition: A general competitive effort is made by the surgeon and attending team throughout the requirement review process which considers the applicability of products from various sources to determine which product that best meets the needs of the patient. This effort at the requirement definition level is not publicized on Federal Business Opportunities in accordance with FAR 5.201, but is standard industry practice. Efforts to obtain competition are not practical because this requirement is needed for surgery scheduled based on patient needs, and does not lend itself to pre-planning. Due to the critical nature of patient care the Spinal Elements interbody device implants for spinal fusion surgery is considered mission critical to the MAMC health care mission. In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements in a timely manner.

This will be posted on ASFI to increase competition.

7. Market Survey:

8. Procurement History:

Previous Contract or Purchase Order Number:W81K02-18-P-0029 or competed? N/A No Yes Previous authority for less than Full & OpenCompetition:

N/A Previously

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.

Digitally signed by

KOWALSKI.SARAI.PAOLA.1029553

Signature: AOLA.1029553560 560 Date: 2018.10.28 15:06:36 -07'00'

Typed Name: Sarai Kowalski Position Title : Supply Management Specialist

Email address: sarai.p.kowalski.civ@mail.mil Date: 28 October 18

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

This requirement is for surgical supplies (Class VIII). Details, including key word searches described in the Market Research report which supports this J&A can be found in PCF A.01.01_Market Research.

Market research has been conducted by searching the Dynamic Small Business search using NAICS Code 399113. Results from the research identified both small and large businesses that could provide the products. The doctor/surgeon has evaluated several vendors on implants /surgical products to determine the ones that will best meet the patient's needs during surgery. The doctor/surgeon is both skilled and trained on these products to ensure that they meet the patient critical careneeds.

KOWALSKI.SARAI.P

Control Number:

Signature:

Typed Name:

Position Title: Contracting Officer

Email address:

Date: