JA MEDUSA HT9425-24-C-0114.pdf

Control Number:

OCT 2023

Justification and Approval for Other than Full and Open Competition – FAR Part 6

1. Contracting Activity: U.S. Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702-5014

2. Description of Action: The United States Air Force (USAF) 59th Medical Wing, Science and Technology Office located at Joint Base San Antonio – Lackland Air Force Base, Texas requests a sole source non-commercial firm fixed price type contract with KBR Wyle Services, LLC (KBR) for a research and development requirement. The Government projects award in September 2024 and Fiscal Year 2023-2024 Research, Development, Test and Evaluation (RDT&E) funds will be used for the research and development requirement.

3. Description of Supplies/Services: The USAF 59th Medical Wing, Science and Technology Office has a requirement for research and development services. This research study is titled ‘Medical Evacuation During Sustained Acceleration (MEDUSA):

Validating Critical Care During Simulated Point-to-Point Spaceflight’ (AC21EM02

MEDUSA2).

The objective of the MEDUSA projects is to perform an initial evaluation of medical evacuation of critically injured personnel in sustained acceleration environments.

However, as this is a complex task, it was divided into two different projects/phases:

MEDUSA 1 and MEDUSA 2. First, MEDUSA 1 was funded by the 59th MDW through the FY22 Defense Health Agency’s Restoral Call to evaluate critical care equipment in acceleration environments, as this basic understanding is required to ensure that lifesaving equipment continues to function in this unusual environment. MEDUSA 1 was performed by a joint team of USAF and KBR personnel. MEDUSA 1 was a success and significant insight was gained about medical equipment performance. Using this direct knowledge from MEDUSA 1, the research team is set up for project success with MEDUSA 2, which will use the same equipment obtained for MEDUSA 1, to evaluate how an animal model performs in a sustained acceleration environment.

Controlled by:

Controlled by:

CUI Category:

Limited Dissemination Control:

POC:

There is limited research supporting medical equipment or medical pathology in a sustained acceleration environment. The Medical Evacuation During Sustained Acceleration (MEDUSA): Validating Critical Care During Simulated Point-to-Point Spaceflight #2 project is the first known research project that will assess the impacts of sustained acceleration on an animal model of critical care. This is a continuation of a joint 59th Medical Wing (MDW)’s Clinical and Operational Space Medicine Innovation Consortium (COSMIC) and KBR San Antonio partnership on a project known as MEDUSA 1, which is ending Q2 FY 2024.

The main objective of this study is to determine the impacts of sustained acceleration on the hemodynamics on a swine model of critical care medical evacuation.

Anticipated Period of Performance: 15 September 2024 –14 January 2026 Estimated Total Value:

4. Authority Cited: 10 USC 3204(a)(1) as Implemented in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(iii)(A), Substantial duplication of cost to the Government that is not expected to be recovered through competition.

5. Reason for Authority Cited: KBR is the only source that can provide the required services in both a cost-effective and timely way. Award to any other source would result in duplication of cost to the Government and delay moving from Phase I (MEDUSA1) to Phase II (MEDUSA2) of the project. The KBR team’s participation in the initial phase of the project (MEDUSA1) provides them with extensive knowledge and understanding of the requirements, reducing the risk of disruptions and ensuring continuity. KBR already has extensive understanding of how Critical Care Air Transport Team equipment performed in the centrifuge, the centrifuge profile, issues encountered during initial testing, etc. This knowledge is critical to continue into the MEDUSA 2 project.

The MEDUSA 2 project is only possible at the KBR centrifuge as it is the only large research centrifuge in the United States capable of supporting advanced animal research and simulating the flight conditions required by the research protocol. Failure to perform the MEDUSA 2 project at the KBR centrifuge will be mission ending as there are no other locations for project success. Please see Section 10, “Other Facts” for additional details and justification.

A total of has been invested by the Government on Phase I of this project.

The Government intends to avoid duplication of costs and time delays, which would cause significant risk in completing the study within the restricted timeline, given the complexities of testing the medical equipment required for the Phase II study.

6. Efforts to Obtain Competition: Extensive market research to identify potential sources was completed by the USAF 59th Medical Wing, Science and Technology Office and USAMRAA to identify potential sources in the marketplace that could meet the Government’s requirement. Please reference Paragraph 8 of this document, for further discussion of market research.

A Request for Information (RFI) was posted to the Government Point of Entry (GPE, SAM.gov) on 16 May 2024 for a period of 5 days. One response was received from an entity that expressed interest in the project but did not provide any capabilities.

The requirement was synopsized to the GPE (SAM.gov) via a notice of intent (NOI) on 23 May 2024 for a period of 15 days. No response to the notice of intent was received.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. No subcontracting competition is anticipated.

7. Actions to Increase Competition: No actions have been taken to increase competition, as KBR is the only source available to provide these support services to continue Phase II of the study. The USAF 59th Medical Wing, Science and Technology Office will continue to monitor the marketplace for contractors with the necessary knowledge base to provide the unique support services required. If similar or related requirements in the future may be fulfilled via competitive acquisition procedures, the USAF 59th Medical Wing, Science and Technology Office and USAMRAA will pursue the appropriate level(s) of competition.

8. Market Research: USAF 59th Medical Wing, Science and Technology Office and USAMRAA conducted extensive market research to identify potential sources that could meet the Government’s requirement. Market research consisted of querying online search engines, attendance of scientific conferences, examination of historical contracts and discussions with key collaborators and trusted Government and academic contacts.

Additionally, the above mentioned RFI was posted to the GPE.

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

A RFI and NOI were posted to GPE, SAM.gov for 5 days and 15 days, respectively.

One response was received to the RFI, as previously mentioned, but no capabilities were provided. No responses to the NOI were received.

10. Other Facts:

a. Procurement history: Contract Number 47QFWA20C0012 was awarded to ABSS Solutions, Inc. by the U.S. General Services Administration (GSA), in support of the USAF 59th Medical Wing, Science and Technology Office. ABSS Solutions, Inc. entered into a subcontract agreement with KBR Wyle Services LLC (KBR) for the Advancement of Military Medicine for completion of the Phase I effort referenced above.

b. Co-Location with Bridge, PTS: The KBR centrifuge is located within the Brooks City Base Complex, San Antonio, Texas. The facility is co-located with Bridge PTS, an animal evaluation and testing organization. Bridge PTS are also critical members of the MEDUSA2 project. Importantly, KBR is providing expertise on centrifugation and engineering and Bridge PTS is providing animal and veterinary expertise. The co-location of these organizations within the same complex allows for this protocol to occur within mission relevant times. KBR and Bridge PTS have extensive experience in joint operations with the 59th Medical Wing, as these three institutions actively collaborate on multiple ongoing research projects using Bridge PTS’s animal facilities and KBR’s altitude chambers. These previous research collaborations show the unique research relationships between these organizations in supporting extreme flight environment research using animal models.

c. Co-Location with 59th MDW Research Team: The KBR centrifuge is co-located in San Antonio, Texas, approximately 20-minutes from the 59th Medical Wing at Lackland Air Force Base, Texas. There are no other civilian research centrifuges that could support this research in the United States, much less in the local San Antonio region.

d. No Impact of USAF Training Operations: The only DoD-owned centrifuge is the centrifuge at Wright-Patterson Air Force Base, Dayton, Ohio. The USAF centrifuge is not currently rated for animal research and cannot be used.

Modifying the United States Air Force centrifuge at Wright-Patterson Air Force Base, Dayton, Ohio, is estimated to cost millions of dollars to support animal research operations. Importantly, the KBR centrifuge is not currently used by USAF personnel for flight training operations. By performing this research at the KBR centrifuge, we are guarantee no impacts on USAF flight operations.