A.02 J&A Redacted.pdfko.pdf

Control Number: 21-RHCO-A-210

RFQ/RFP #: W91YTZ21Q0036

Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Regional Health Contracting Office – Atlantic (RHCO-A) Fort Bragg Health Contracting Cell 6021 5th Street, Building 1469 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:

Name of Intended Contractor: Aesculap Implant Systems, LLC Street Address: 3773 CORPORATE PKWY STE 200 City, State, Zip: CENTER VALLEY, PA, 18034-8218, Phone: POC: Colin Miller EMAIL: colin.miller@rtpmedical.com

Period of Performance: 22 December 2020 – 21 March 2021.

3. Description of Supplies/Services: Womack Army Medical Center (WAMC) has a requirement to purchase lumbar disc replacement/implants for spinal surgical procedures.

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 mailto:colin.miller@rtpmedical.com

(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: Womack Army Medical Center (WAMC) has a requirement to purchase Aesculap Implant System for Spinal Surgical Procedures with a period of performance from 22 December 2020 through 21 March 2021. Per the Aesculap Active L FDA Approval Letter, the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved commercial distribution of the ActivL Artificial Disc for patient use. The ActivL Artificial Disc is solely manufactured through Aesculap Implant Systems, LLC. The Contractor shall provide ActivL Implant needed for scheduled surgical procedures. The ActivL Implants are lumbar artificial discs with a mobile ultra-high molecular weight polyethylene core. The ActivL Implants combine natural motion with mechanical stability which allows translational and rotational movement. The implants provide the widest range of endplate configurations and construct heights to meet diverse anatomical needs.

These implants are a third generation motion preservation device for degenerative disc disease (DDD) patients. They are designed to more closely mimic the natural biomechanics of the healthy human spine, thereby significantly reducing the impact on adjacent level anatomy. Aesculap is the world’s largest manufacturer of surgical instruments. Failure to provide the needed supplies for these surgeries will result in diminished healthcare for the patients.

6. Actions to Increase Competition: Combined Synopsis Solicitation will be posted on the Beta.SAM.gov 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-line search was conducted on the Small Business Administration (SBA) Quick Market Research on 02 December 2020 and nothing was revealed using the words “lumbar disc replacement.”

Economic Group Number of Firms Found Service-Disabled Veteran 1053 Currently SDB Certified 13 Currently HUBZone Certified 196 Currently 8(a) Certified 141 Woman or Women Owned 1475 Veteran 1457

Key word Search “Lumbar Disc Replacement”

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

The medical supplies and services are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History:

a. Previous Contract or Purchase Order Number: None

b. Previously competed? N/A No Yes

c. Previous authority for less than Full & Open Competition: FAR 13.106-1(b) (1) (i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

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.

Submitted By: Christen M. Barnhill Position Title : SGG CPT, AN, Surgical Logistics

Email address: christen.m.barnhill.mil@mail.mil Date: 10 Oct 2018

Stefan Lin

SGT

stefan.lin.mil@mail.mil 02 December 2020

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: Donna L. Blossom Position Title: Contracting Officer

Email address: donna.l.blossom.civ@mail.mil Date:

mailto:stefan.lin.mil@mail.mil mailto:donna.l.blossom.civ@mail.mil