20-RHCO-P-531 JA_ABYRX INC.pdf

Control No: 20-RHCO-P-531

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES

COMMERCIAL ITEMS – UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

(Simplified Acquisition Threshold is $250K)

JUSTIFICATION AND APPROVAL

1. Contracting Activity: Regional Health Contracting Office-Pacific, Health Contracting Cell, Joint Base Lewis-McChord (JBLM), 673 Woodland Square Loop SE, Lacey WA 98503.

2. Description of Action: Madigan (MAMC) Army Medical Center, Dept. of Anesthesia and Operative Services, (DOAS) Joint Base, Lewis-McChord Tacoma WAis requesting a 03 Priority on for urgent delivery of surgical implant products that are for specific patient surgeries.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement207.103(d)(i)(B).

(Insert approval authority title) approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on (insert date).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting (insert approval authority title) approval.

Name of Intended Contractor: ABYRX, Inc.

Street Address: 1 Bridge STE 121

City, State, Zip: Irvington, NY 10533-1553

3. Description of Supplies/Services: Madigan Army Medical Center, Department of Anesthesia & Operative Services (DOAS), Tacoma WA is requesting a Sole Source on ABYRX INC various Montage and Hemasorb restorable hemostatic bone putty which are for specific patients that will be going through surgery. The required supplies and implants products prescribed for the patients’ and determined by the Surgeon & Surgical Team are best suited for the patients’ medical health & best surgical recovery outcome.

Period of Performance: 21 AUG 2020 – 30 SEPT 2020 Total Value: $ 25,000.00

For Actions with Options: N/A

Base Period: to Option Period 1: to Option Period 2: to Option Period 3: to Option Period 4: to Option Period 5: to

Value: $ Value: $ Value: $ Value: $ Value: $ Value: $

FAR Clause 52.217-8 option: to or (insert completion date) N/A Value: $ Total: $

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C.1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Only one source reasonably available, as determined by the

Surgeon for the well-being and surgical recovery outcome of the patient(s).

5. Reason for Authority Cited: Based on comparison with similar products in the marketplace, the surgeon in consultation with the attending surgical team has determined the devices and supplies offered by ABYRX INC best meets the specific patients’ needs for surgery. The surgeon is trained on the surgical procedures for using these implants and tissue products which will provide reduced liability risk, administrative and training time represent that will represent a cost savings to the Government.

Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implants and tissues based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command.

6. Efforts to Obtain Competition: In accordance with FAR 5.201 this J & A will be posted to Beta SAM FBO.

7. 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 the product that best meets the needs of the patient. In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements prescribed for the patients.

8. Market Research: This requirement is for surgical supplies, FSC 6515 (Class VIII).

Detail, including key work searches described in the Market Research report which supports this J & A can be found in the PCF File under Market Research. Market Research has been conducted by searching the Dynamic Small Business search using NAICS Code: 339113. Results from the research did not locate any small businesses that could provide the above products meeting the salient characteristics as determined by the Surgeon. The Surgeon has evaluated other vendors on Plastic Surgery and Regenerative Medicine to insure product quality, safety, and capability along with FDA Approval certification as the requirements for selection to perform patient surgery.

9. Interested Sources: To date, other than ABYRX Inc. no other sources have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History

Previous Contract or Purchase Order Number: NONE or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b) (1) (i)

11. Technical / Requirements Certification: I certify that the supporting data undermy cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

SULLIVAN.PATRI Digitally signed by

SULLIVAN.PATRICK.TYRONE.

Submitted By; CK.TYRONE.1119 1119831578

Position Title: Supply Specialist 831578 Date: 2020.08.14 07:03:16 -07'00'

Email Address: patrick.t.sullivan.civ@mail.mil Date:

12. Fair and Reasonable Cost Determination: I hereby determine that theanticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis IGCE audit: other: Salient Characteristics, represented in the decision by the Surgeon in exact usage of these products for specific surgeries.

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

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

Signature:

Typed Name: Scott A. Barr Position Title: Contracting Officer Email Address: Scott.a.barr.civ@mail.mil Date: 20 August 2020

BARR.SCOTT.A.

1078903208

Digitally signed by

BARR.SCOTT.A.1078903208

Date: 2020.08.20 11:48:47 -07'00'