A02 Redacted J A Immunopathogoly MAMC Final.pdf

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

MCMR-AAP-SA 24 July 2020

ENCLOSURE 1

Control No: JA-20-06-00156

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD.

2. Requiring Activity: The Requiring Activity for this action is the Department of

Clinical Investigation, Madigan Army Medical Center

3. Nature of Action:

_ Commercial Item Non-Commercial _Item New Requirement _Follow-on Requirement _Mod to Existing PurchaseOrder/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm FixedPrice:

**Time &Materials:

* Cost:

Funds: DHP Funds Operations and Maintenance, Army(OMA) Other Funds:

Fiscal Year of Funds: _FY20

Estimated Total Dollar Value includingOptions: $ $100,012.20

4. Contractor Name:

Name of Proposed: Wake Forest University Health Sciences

Street Address: Medical Center Blvd City, State, Zip: Winston Salem, NC

DUNS: 937727907

Cage Code: 1WEZ6

5. Description of Supplies/Services: The purpose of this effort is to provide Analysis

Services in Immunopathology, Histomorphometry and Fluorescent Imaging of tissues (nerve, muscle or other) collected from rats following various treatments (MSC, MSC-IL10, Dihexa, G-CSF, Platelet rich plasma, low energy shockwave); Conduct Histopathology and Cellular/Molecular Analysis of harvested tissues and biopsies for various bio-markers for nerve/muscle regeneration and immune cellular bio-markers for graftrejection/acceptance.

Department of Clinical Investigation, Madigan Army Medical Center requests a firm-fixed-price contract with Wake Forest University Health Sciences, Medical Center Boulevard, Winston- Salem, NC 27157. The Government projects award for August 2020 and fiscal year 2020 RDT&E funds will be used.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(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

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

X_ FAR 13.501(a) (1) (i): Only one source reasonably available (including brand name); OR

FAR 13.501(a) (1) (ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: Dr. Vijay Gorantla, MD, PhD of Wake Forest University Health Sciences is the lead researcher for “Immunopathology, Fluorescent Imaging, and Histomorphometry Analysis Services”. Dr. Gorantla will oversee the histopathologic evaluation of study samples, data analysis of nerve samples, and interpretation of histologic, histomorphometric, and immunofluorescense staining outcomes data. Dr. Gorantla, with his specialized background in microsurgery and transplant immunology (basic and clinical transplant) with specific expertise in Vascularized Composite Allograf, will oversee the histopathologic evaluation of study samples, data analysis of nerve samples, and interpretation of histologic, histomorphometric, and immunofluorescence staining outcomes data. The objective of this research is the basic science knowledge in convergent technologies that involve disruptive or transformation strategies in the restoration or rehabilitation of disabilities secondary to limb loss, traumatic brain injury or vision loss.

8. Efforts to obtain Competition Market research was conducted on 10 March 2020 via internet research to identify all possible vendors to provide the necessary services. However, no feasible alternative could be found related to the unique and highly specialized expertise of Dr. Gorantla with his team at Wake Forest University Health Sciences.

a. Effective competition. MAMC will continue to monitor market development to monitor market development to identify potential labor category that may offer the same services in the future

b. Subcontracting competition. N/A

9. Actions to Remove or Overcome Barriers to Competition: MAMC will continue to monitor market development to identify potential labor category that may offer the services in the future.

10. Market Survey: Market research was conducted on 10 March 2020 via internet research.

11. Interested Sources: On 2 July 2020, a Notice of Intent to Sole Source was posted in BetaSAM. As of closing due date of 13 July 2020, no responses were received from the industry.

12. Procurement History and any other facts: This is a newrequirement.

Previously competed? N/A

Previous authority for less than Full & Open Competition: N/A

RIVARD.MICHAEL.P.113199842

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief. 2

Contracting Officer Representative Signature: _RIVARD.MICHAE Dgitally signed by

Michael Rivard Contracting Officer Representative, MAMC

Email: michael.p.rivard.civ@mail.mil Date: 24 July 2020

L.P.113199842 Date: 2020.07.24 09:16:39 -07'00'

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

TOMITZ.LAURA.A.10 Digitally signed by TOMITZ.LAURA.A.1016349271

Laura A. Tomitz 16349271 Date: 2020.07.24 14:14:40 -04'00'

Agency/Position: Contracting Officer, EMail Address: laura.a.tomitz.civ@mail.mil mailto:michael.p.rivard.civ@mail.mil mailto:laura.a.tomitz.civ@mail.mil