SSJ_-_RATT_Simulators-Signed_Redacted.pdf

Single Source Justification (Simplified Acquisition)

March 2018 Page 1 of 2

Section A: General Contract Information

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Contracting Activity: 1st Special Operations Contracting Squadron/PKC

Project/Program Name: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) Access Task Trainer Pulsatile Simulator

Purchase Request/Identification Number: F2FT508121AW01

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

The Special Operations Surgical Team (SOST) uses the REBOA Catheter in deployed environments for critical life-saving capabilities.

The training mannequins, REBOA Access Task Trainer (RATT) Pulsatile Simulator, are being requested to ensure that all members of the teams that use the REBOA Catheter are proficient with the device. Three (3) RATT simulators, with replacement parts, are being requested: one (1) for Hurlburt Field, one (1) for the SOST team at UAB, and one (1) for the SOST team in Miami.

CLIN 0001: RATT Pulsatile Simulator, QTY - 3 (EA) Mfg: Prytime Medical Devices, Inc.

Part No.: RATT401

Section C: Justification for Soliciting from a Single Source or Brand Name

The REBOA RATT Trainer has been specifically designed for the REBOA Catheter and Introducer Kits. Prytime Medical is the sole manufacturer of the REBOA Catheter and of the RATT being requested. The RATT ensures that SOST members are proficient in the skill set that is required with the REBOA catheters at all times and are adequately trained for deployments.

Having the RATT also prevents the additional costs that are accrued when members need to attend REBOA training, which costs $2,000 per student/per class, plus any travel costs and per diem.

The Catheters referenced are manufactured by Prytime Medical Devices. They provide a flexible catheter inserted through an introducer and into the femoral artery, maneuvering it into the aorta and inflating a balloon at its tip. This technique/ Endovascular Balloon Occlusion of the Aorta Catheter will be used in traumatic injured patients that are rapidly bleeding to death from injuries to their chest, abdomen or pelvis. This stops blood flow beyond the balloon, essentially halting any bleeding, while also stopping all blood flow distal to the balloon. The REBOA Catheter has potential in stopping internal hemorrhage, increasing the chance of survivability of war fighters suffering battlefield traumatic injuries. The REBOA is an FDA approved catheter that can be used outside of a hospital, emergency room or clinical setting.

The REBOA Catheters have been previously purchased through the 1SOCONS Contracting Office in Fiscal Year 2016 and Fiscal Year 2017. Sources sought notices were issued via Federal Business Opportunities to determine if there were other catheters in the industry that meets the requirements listed. On each occasion, no acceptable responses were received and the catheters were purchased on a Single Source basis.

Section D: Efforts to Obtain Competition

Market research completed by the requesting office revealed that Prytime Medical Devices is the only acceptable manufacturer of the REBOA catheter and the trainers required under this purchase. A sources sought notice was issued via Federal Business Opportunities on 30 May 2018 with responses due 7 June 2018, one response was received from Laerdal Medical Corporation and immediately sent to end-user for technical review. The SimMan Vascular Mannequin from Laerdal was deemed unacceptable due to size, weight and cost restrictions. The full size unit, approximately 5'8” is twice the size requested as well as twice the weight at 85-100lbs plus it's price at $170K per unit versus the proposed price of $8,500 per unit from Prytime Medical Devices.

Single Source Justification (Simplified Acquisition)

March 2018 Page 2 of 2

Section E: Steps to Preclude Future Single Source or Brand Name Awards

Through every available means, AFSOC/SG and 720 OSS/SOST will continue to monitor market information and technical publications to determine whether any other products can meet the 720 OSS/SOST needs. The single source award notice will be issued to industry on FBO.gov. Interested parties are invited to submit capability statements and product specifications in response to the award notice and J&A. The Government will retain all information received and apply the information to future requirements for market research purposes.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

19-Jun-2018

Typed Name and Rank/Grade of Contracting Officer

JESSE M. CAPIK / GS-12, DAF

Signature of Contracting Officer Digitally signed by

CAPIK.JESSE.M.1037959975

Date: 2018.06.19 14:12:21 -05'00'