22-RHCO-P_JA 258_Redacted.pdf

re Control No. 22-RHCO-P-258

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES

COMMERCIAL ITEMS – UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

(Simplified Acquisition Threshold < $250K)

JUSTIFICATION AND APPROVAL

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

Description of Action: Madigan (MAMC) Army Medical Center, Dept. of Anesthesia and Operative Services, (DOAS) Joint Base, Lewis-McChord Tacoma WA is requesting a 03 Priority OssaTron High Energy Shockwave Orthotipsy 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: Premier Shockwave Inc

Street Address: 3360 Martin Farm Road STE 100 B City, State, Zip: Suwanee GA 30024-2292

Phone:

2. Description of Supplies/Services: Madigan Army Medical Center, Department of Anesthesia & Operative Services (DOAS), Tacoma WA is requesting a Sole Source BPA Call for OssaTron High Energy Shockwave and consumable supplies that are not available through Mandatory Sources such as Prime Vender or ECAT. These will be for specific patients that will be going through surgery. The required items are prescribed for the patients’ and determined by the Surgeon & Surgical Team to be best suited to promote and meet their medical, health, well-being & best surgical recovery outcome.

Period of Performance: 01 JUN – 30 Sept 2022 Total Value: $ 150,000.00

For Actions with Options: N/A Value: $ Total: $ $150K.

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3. 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).

4. 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 items and supplies offered by Premier Shockwave Inc. best meets the specific patients’ needs for surgery. The surgeon is trained on the surgical procedures for using these items and supplies 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 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.

5. Efforts to Obtain Competition: In accordance with FAR 5.201 this action with the J & A will be posted to SAM.Gov.

6. 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.

7. 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: 334510. 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 for OssaTron High Energy Shockwave to insure product quality, safety, capability & FDA Approval certification as the requirements for patient surgery.

8. Interested Sources: To date no other sources have written to express interest in the acquisition.

9. Other Facts:

a. Procurement History

Previous Contract or Purchase Order Number: W81K0222F0021 or N/A

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

10. 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:

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Date:

11. 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 W81K0221F0021

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.

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