A.02_J_&_A_-_NTE.pdf

Control Number: 20-RHCO-A-6

RFQ#: W91YTZ20Q0008

Sole Source Justification For Acquisitions under the Simplified Acquisition Threshold (Currently $250K)

1. Contracting Activity:

Regional Health Contracting Activity-Atlantic (RHCO-A) Contracting Cell 6021 5th Street, Building 1467 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $249,000.00

Name of Intended Contractor: Medtronic USA, Inc.

Street Address: 710 Medtronic Pkwy City, State, Zip: Minneapolis, MN 55432-5603

Phone: Aaron Yeary (336)259-7888

PERIOD OF PERFORMANCE: 21 October 2019 – 20 April 2020

3. Description of Supplies/Services: Womack Army Medical Center (WAMC) has a requirement to purchase lumbar and cervical surgical supplies for surgical procedures scheduled from 21 October 2019 through 20 April 2020 with Dr. Andrew Cleveland. Items used during these surgical procedures are not to exceed the total amount requested of $249,000.00

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: The physician has determined that the Medtronic surgical systems will produce the best outcomes for these particular patients. Multiple systems are available through this vendor which provide implants for Anterior and Posterior Cervical and Lumbar Procedures. The Medtronic Divergence Fusion System is specifically designed for an anterior lumbar approach and is the first plate/interbody all-in-one system which has a large footprint with multiple height and lordosis options, is intended to provide desired disc height and segmental lordosis, preserves the patient’s psoas muscle when treating the lumbar levels of the spine and gives surgeons easier access around the patient’s iliac crest. The Sovereign Interbody Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease of the lumbar spine. This system is similar to the Divergence system however it is developed with integrated screws and does not require implantation of the plate. It also have the ability to support supplemental fixation. The Clydesdale Lateral Interbody Fusion system provides a complete, minimally invasive solution for the treatment of degenerative lumbar conditions, specifically for the superior lumbar region. By utilizing a direct lateral approach to the spine, this procedure enables placement of a large interbody graft into the disc space or anterior column support while avoiding the obstacles associated with traditional anterior or posterior approaches. Artic-L implants are titanium based and improves the mechanical load and distribution across the implant. The system is designed to require only 1 instrument for insertion and positioning in the transverse approach. Medtronic’s’ CD Horizon Solera provides low profile multi-axial screws designed for use with multiple rod types. The Voyager Spinal System allows for a percutaneous method of rod and multiaxial screw placement. The Infinity OCT Spinal System is designed to simplify posterior cervical spine surgery and is used to immobilize and stabilize the spine while it fuses.

The Medtronic Spine & Biologics products are proprietary technology. Medtronic Spine & Biologics holds exclusive product rights and licensing as a manufacturer and supplier of the Medtronic Divergence Lumbar Fusion System, Clydesdale Lateral Interbody Fusion System, and Related Surgical Supplies (see Proprietary Letter). Failure to provide the needed supplies for these surgeries will result in diminished healthcare for the patients.

6. Actions to Increase Competition: Sources sought will be posted on the Federal Business Opportunities (FedBizOpps) website for increased competition.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339113 and found no small business contractors having the capability to provide the parts. On 19 September 2019 an on-line search was conducted on the Small Business Administration (SBA) Quick Market Research on and nothing was revealed using the words “Artic L- Interbody,” “Multiaxial Reduction Screw,” “Clydesdale Interbody,” and “Cervical Disc Arthorplasty.”

Results of the search using the key words “Arctic L Interbody” “Multiaxial Reduction Screw” “Clydesdale Interbody” and “Cervical Disc Arthroplasty :

Economic Group Number of Firms Found

Service-Disabled Veteran 0

Currently SDB Certified 0

Currently HUBZone Certified 0

Currently 8(a) Certified 0

Woman or Women Owned 0

Veteran 0

Results of the search using the NAICS code 339113:

Economic Group Number of Firms Found

Service-Disabled Veteran 725

Currently SDB Certified 18

Currently HUBZone Certified 134

Currently 8(a) Certified 84

Woman or Women Owned 888

Veteran 1050

The items are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History:

a. Previous Contract or Purchase Order Number:

- W91YTZ-18-P-0206 dated 01 May 2018 for $149K

- W91YTZ-19-P-0006 dated 15 Oct 2018 for $149K

- W91YTZ-19-P-0030 dated 15 Nov 2018 for $249K

- W91YTZ-19-P-0238 dated 10 May 2019 for $249K

b. Previously competed? N/A No Yes

c. Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

d. Subcontracting Plan is not required in accordance with 52.219-9.

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. I certify the required services and supplies are not available using mandatory sources and delivery cannot be made by the required delivery date

Submitted By: Joshua I. Emmick Position Title : SGT, AN, Surgical Logistics

Email address: joshua.i.emmick.mil@mail.mil Date: 19 Sep 2019

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: Cheryl A. Ricker Position Title: Contracting Officer

Email address:

Date: