A02. Part 06 - JA FAR Part 6 - _MEDUSA2 Bridge PTS - REDACTED_Redacted.pdf

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Control Number: JA-24-06-1580

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Source Selection Information - See FAR 2.101 and 3.104-4

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, Firm Fixed Price (FFP) contract with the Bridge Preclinical Testing Services (PTS) for the Advancement of Military Medicine for a research and development requirement. The Government projects award in August 2024, using Fiscal Year 2023-2024 Research, Development, Test and Evaluation (RDT&E) funds.

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 study will be a collaboration between Bridge Preclinical Testing Services (Bridge PTS) and the 59th Medical Wing.

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.

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:

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.

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

. This is a joint 59th Medical

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Source Selection Information - See FAR 2.101 and 3.104-4

Wing Clinical and Operational Space Medicine Innovation Consortium (COSMIC) and Bridge Preclinical Testing Services (PTS), Inc, partnership. Bridge PTS is providing their facility, institutional oversight, personnel, technical and research support, in close partnership with KBR, San Antonio.

3.1 Facilities: Bridge PTS specializes in contract preclinical research in wound healing, microbial biofilms and infections, and other specialized surgical models. Their company maintains an animal vivarium and operating rooms in Brooks City Base, San Antonio.

Bridge PTS maintains a U.S. Department of Agriculture (USDA) license as well as a federal license for the handling and use of controlled substances necessary for pain management in these in vivo studies and has received an Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International accreditation.

Bridge PTS has a Government Services Administration contract number already established for work at this facility.

3.2 Institutional Oversight: Bridge PTS provides the Institutional Animal Care and Use Committee (IACUC) required for animal research. Given the unique nature of this research project and no other protocol is approved by Bridge Surgent Animal Care and Use Review Office (ACURO). Bridge PTS will continue to work to ensure animal welfare throughout the MEDUSA 2 protocol.

3.3 Animal Procurement and Veterinary Care: Bridge PTS will procure the animals required for the MEDUSA 2 research process. Bridge PTS will provide daily veterinary care.

3.4 Personnel: Bridge PTS is providing personnel assistance and expertise regarding the animal operations of MEDUSA2. This involves animal management, animal technicians, and animal veterinarian expertise to assist in the management of pre-experimental procedure, daily care, animal welfare, pain management, laboratory testing, radiology testing, and

. Their experience and proficiency, developed through involvement in similar projects, are irreplaceable assets. Dr. Paul Attach, Bridge PTS is acting as a formal

3.5 Technical Support and Data Analysis: Bridge PTS is assisting with data analysis of equipment and physiologic readings of a wide variety of critical care medical equipment that will be placed into the swine during centrifugation.

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Source Selection Information - See FAR 2.101 and 3.104-4

3.6 : Exclusive Services: The MEDUSA 2 project is only possible at the

. BRIDGE PTS is the only animal facility that is

Failure to perform the MEDUSA 2 project at the KBR centrifuge will be mission ending as there are no other locations for project success.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category: Source Selection Limited Dissemination Control: FED Only POC: Tammy N. McRae 301-619-3771

Anticipated Period of Performance: 1 August 2024 30 September 2025 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), For DoD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-substantial duplication of cost to the Government that is not expected to be recovered through competition.

5. Reason for Authority Cited: Bridge PTS is the only source that can provide the required services in both a cost-effective and timely way. Bridge PTS is providing personnel assistance and expertise regarding the animal operations of MEDUSA2. This involves animal management, animal technicians, and animal veterinarian expertise to assist in the management of pre-experimental procedure, daily care, animal welfare, pain management, laboratory testing, radiology testing, and

. Their experience and proficiency, developed through involvement MEDUSA 1, and in similar projects, are irreplaceable assets.

Failure to perform the MEDUSA 2 project with Bridge PTS will be mission ending as there are no other locations for project success. Please see Se for additional details and justification.

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

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Source Selection Information - See FAR 2.101 and 3.104-4

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 3 days. There were 2 responses to the RFI.

align with the capabilities of the 59th, A second response was received from ; however, there was no capability statement accompanying the email received. The email received, mainly stated that has a keen interest in the Contract Opportunity. These documents are in the VCE-PCF.

The requirement was further synopsized to the GPE (SAM.gov) via a notice of intent (NOI) on 22 May 2024 for a period of 15 days. No responses to the NOI were received.

a. Effective competition. No effective competition is anticipated. This study was jointly written as a collaboration between 59 MDW/ST, KBR and Bridge PTS.

Collaborators are chosen during the preproposal stage based on supplies/services/labor expertise and research capability and experience.

b. Subcontracting competition. No subcontracting competition is anticipated.

7. Actions to Increase Competition: No actions have been taken to increase competition, as Bridge PTS is the only source available to provide these support services in support of the MEDUSA 2 study. The USAF 59th Medical Wing, Science and Technology Office will continue to monitor the marketplace for contractors/collaborators 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 search engines, attendance of scientific conferences, examination of historical contracts and discussions with key collaborators and trusted Government and academic contacts.

It was determined that no other entity could fulfil this requirement other than Bridge PTS for the reasons cited in above paragraphs.

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

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Source Selection Information - See FAR 2.101 and 3.104-4

A RFI and NOI were posted to GPE, SAM.gov for 3 days and 15 days, respectively.

Only 2 responses were received for the RFI (both deemed incapable), and no response was received for the NOI.

10. Other Facts:

a. Procurement history: MEDUSA2 is Phase 2 to MEDUSA1. 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. Phase 2 moves the study in to an animal model using the medical equipment validated in Phase 1 by KBR. Bridge PTS will manage the animal model portion of the study.

b. Exclusivity of Centrifuge for Animal Operations: The MEDUSA 2 project is only possible at the

Failure to perform the MEDUSA 2 project at the KBR centrifuge will be mission ending as there are no other locations for project success. Separate request has been submitted for contract with KBR in support of MEDUSA2.

c. Co-Location with KBR, San Antonio: The Bridge PTS vivarium is located within the Brooks City Base Complex, San Antonio, Texas. The facility is co-located with the KBR centrifuge. Importantly, KBR is 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 has extensive experience with joint operations with the 59th Medical Wing, as these three institutions actively collaborate on multiple ongoing research projects using

rs. These previous research collaborations show the unique research relationships between these organizations in supporting extreme flight environment research

. Failure of Bridge PTS to support operations at the will be mission ending as there are no other locations for project success.

d. Co-Location with 59th MDW Research Team:

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Source Selection Information - See FAR 2.101 and 3.104-4

e. 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 State 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

f. Institutional Oversight: Bridge PTS provides the Institutional Animal Care and

Use Committee (IACUC) required for animal research.

IACUC protocol is already approved by Bridge . Bridge PTS will continue to work to ensure animal welfare throughout the MEDUSA 2 protocol.