JA_19-RHCO_P_594.pdf

Control #: 19-RHCO-P-594

Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

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 a 03 Priority on Implants for a specific patient surgery.

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $25,000.00

FAR 52.217-8 Option to Extend Services, (Included); or N/A:

FAR 52.217-9 Option to Extend the Term of the Contract; (Included), or N/A:

Name of Intended Contractor: Aziyo Biologics, Inc.

Street Address: 12510 Prosperity Dr Ste 370 City, State, Zip: Silver Spring, MD, 20904-1624

Phone:

Description of Supplies/Services: Madigan Army Medical Center, WA is requesting Viable Bone Matrix Implant for specific patients that will be going through surgery. The required implants prescribed by the patients’ and determined by the Surgeon are best suited to meet the medical, health and life-style needs of the patient.

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

(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: 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 Aziyo Biologics, Inc. best meets the specific patients’ needs for surgery as determined by the salient characteristics of the requirement and the Surgeon. The surgeon is trained on the surgical procedures for using these implants. Reduced liability risk, administrative and training time 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.

6. Efforts to Obtain 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. The intended contractor is the only source capable of meeting the surgeon’s requirements prescribed for the patient.

7. Actions to Increase Competition: This J & A will be posted to FBO.

8. Market Survey: this requirement is for surgical supplies (Class VIII). Detail, including key work searches described in the Market Research report which supports this J & A can be found in PCF under Market Research. Market Research has been conducted by searching the Dynamic Small Business search using NAICS Code: 33913. Results from the research did not locate any other small businesses that could provide the above products. The Surgeon has evaluated other vendors on implants to surgical products to determine the ones that will be best met the patient’s needs during surgery. The Surgeon is to ensure that they meet FDA guidance, safety and overall for the patient.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K02-19-P-0040 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b) (1) (i)

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:

Position Title : Supply Management Specialist

Email address: Debbie.y.Haynes.civ@mail.mil Date: 13 August 2019

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

mailto:Debbie.y.Haynes.civ@mail.mil

Signature:

Typed Name: Richard J. Meadows Position Title: Contracting Officer

Email address: Richard.j.Meadows3.civ@mail.mil Date: 15 August 2019 mailto:Richard.j.Meadows3.civ@mail.mil