JA -21-RHCO-P-395_Redacted.pdf

- Control No. 21-RHCO-P-395

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 WA is requesting an 03 Priority on Implants for a specific patient surgery.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(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:

Spinal Elements, Inc.

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

Phone:

3. Description of Supplies/Services: Madigan Army Medical Center, Department of Anesthesia & Operative Services (DOAS), Tacoma WA is requesting Spinal Elements Spine Interbody Device Implant, and various screws and plate Implants which are for specific patients that will be going through surgery. The required implants prescribed for the patients’ and determined by the Surgeon & Surgical Team are best suited to promote and meet their medical, health & best surgical recovery outcome.

4. Period of Performance: 03 May 2021 – 30 SEPT 2021

Total Value: $50,000.00

For Actions with Options: N/A

Base Period: to _ Value: $ Option Period 1: to Option Period 2: to Option Period 3: to Option Period 4: to Option Period 5: to

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

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

Version – March 2017 FOR OFFICIAL USE ONLY

Total: $

5. 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).

6. 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 implants and supplies offered by Spinal Elements, Inc. best meets the specific patients’ needs for surgery & full recovery. The surgeon is trained on the technical procedures for using these implants and supplies which will result in reduced liability risk, administrative and training time that will represent a cost savings to the Government. Increased likelihood of successful surgery, recovery, and positive quality of life derived from the most appropriate implants and supplies based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command.

7. Efforts to Obtain Competition: In accordance with FAR 5.201 this action with the J & A will be posted as a Presolicitation Notice.

8. 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.

9. 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 several vendors on implants surgical products to insure product quality, safety, capability, & FDA approval certification as the requirements for patient surgery.

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

CUI Version – March 2017 FOR OFFICIAL USE ONLY

11. Other Facts:

a. Procurement History

Previous Contract or Purchase Order Number: W81K02-21-0019 or N/A

Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b) (1) (i)

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

Submitted By;

Position Title:

Email Address:

Date: 08 April 2021

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated 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: Prior award action representing similar or exact requirements for these procedures under award: W81K0221P0019

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.

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

Signature Typed Name:

Position / Title: Contracting Officer Email Address:

Date: 29 April 2021

CUI - Control No. 21-RHCO-P-395

CUI Version – March 2017 FOR OFFICIAL USE ONLY