FBO_Posting_Sole_Source_J&A.pdf

Log #18-10081

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Research Unit San Antonio (NAMRU-SA) requirements.

2. Nature and/or description of the action being approved.

The proposed action is for an indefinite delivery, indefinite quantity contract that provides for the delivery of up to 500 Emergency Room Resuscitative Endovascular Balloon Occlusion of the Aorta (ER-REBOA) catheters and 500 ER-REBOA catheter convenience kits. The proposed source is Combat Medical Systems, LLC, 5555 Harrisburg Industrial Park Drive, Harrisburg, NC, 28075.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

NAMRU-SA has a requirement for an indefinite delivery, indefinite quantity (IDIQ) contract that provides for the delivery of up to 500 occlusion balloon catheters and 500 catheter convenience kits. The occlusion balloon catheters shall be capable of fully occluding vessels up to 32 mm in diameter. The occlusion balloon catheters shall also be capable of monitoring blood pressure while occluding vessels. The occlusion balloon catheters shall be capable of being inserted into the vessel via minimally invasive procedures to temporarily control hemorrhage and augment afterload in traumatic arrest and hemorrhagic shock states. These supplies are required to continue hemorrhagic shock studies on swine in order to examine the use and outcomes with REBOA as a component to augment treatment.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed supplies.

The total estimated value of this IDIQ contract is $1,066,687.20 for the 60 month ordering period.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.501(a), Sole Source (including brand name) acquisitions.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Based on market research, outlined in Paragraph 8, the ER-REBOA catheter and catheter convenience kits are the only occlusion balloon catheters on the market capable of being inserted into a vessel via a minimally invasive procedure and fully occluding a vessel. Prytime Medical developed the ER-REBOA technology and has the proprietary knowledge in manufacturing the technology. Additionally, Prytime Medical is the sole manufacturer of the ER-REBOA catheters and catheter convenience kits used in current NAMRU-SA studies for hemorrhage resuscitation and trauma research studies. In order to ensure consistency in the follow-on studies, the same ER- REBOA catheters and catheter convenience kits utilized during the initial studies must be used for future studies. Use of another type of catheter and catheter convenience kits introduces inconsistencies into the studies, invalidating past results and requiring the former studies to be re-conducted. Further, there are no other occlusion balloon catheters on the market capable of fully occluding a vessel during minimally invasive procedures.

Therefore, Prytime Medical is the only manufacturer capable of produceing the ER-REBOA catheters and catheter convenience kits capable of fully occluding a vessel. Prytime Medical has a distributor agreement with Combat Medical Systems, LLC who is the exclusive distributor and source of both the ER-REBOA Catheters and Catheter Convenience Kits to the DoD and Federal Law Enforcement agencies throughout the United States. Thus, Combat

Log #18-10081

Form 02.4G.AB 18 Apr 2016

Medical Systems, LLC is the only vendor capable of providing the supplies capable of meeting the government’s minimum requirements.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.102(a)(6).

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

NAMRU-SA conducted a market research in February 2018. It included a search of the Internet and phone call to vendors. A search of the internet determined that the Emergency Room-Resuscitative Endovascular Balloon Occlusion (ER-REBOA) catheters are the only occlusion balloon catheters on the market capable of being inserted into a vessel via a minimally invasive procedure and fully occluding a vessel. A search of the FDA website determined that Prytime Medical developed the ER-REBOA catheters and has the proprietary knowledge to manufacture the technology. Therefore, Prytime Medical is the only manufacturer that can provide ER-REBOA catheters and catheter convenience kits.

The three vendors that NAMRU-SA contacted during the market research were Combat Medical Systems LLC, Medline, and Teleflex. Teleflex responded by email that they can only offer catheters that can partially occlude the aorta and can only respond by inflating or deflating the subject’s heartbeat. Medline also informed NAMRU-SA that they do not offer REBOA catheters as well. Combat Medical Systems, LLC notified NAMRU-SA that they can provide ER-REBOA catheters and catheter convenience kits that meets all the minimum government requirements given that they are the sole, authorized distributor of the ER-REBOA catheters and catheter convenience kits, for Prytime Medical, to the DoD and Federal Law Enforcement agencies throughout the United States. Thus, Combat Medical Systems, LLC is the only vendor capable of meeting the government’s minimum requirements.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted to FedBizOpps in accordance with FAR 5.201.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements may be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of supplies covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.