A02. Part 06 - JA FAR Part 6 - V3 OCT 2023 59th MW Phase II Study Control No. JA-24-03-1515__Redacted.pdf

Control Number: JA-24-03-1515

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 cost type contract with the Henry M. Jackson Foundation (HJF) for the Advancement of Military Medicine for a research and development requirement. The Government projects award in April 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 “Biometric and Team Performance, Measurements During Simulated Missions to Improve En Route Critical Care (ERCC) Skill Sustainment.”

The intent for this follow-on Phase II requirement is to develop an evidence-based nontechnical skills educational tool for ERCC, and then assess the impact on technical team performance, nontechnical team performance, and individual cognitive load in ERCC simulated mission environments.

The study is a complex, multi-institution project that builds upon the current research team’s prior Phase I study titled “Development of Enhanced Simulation Model with Biometric Cognitive Load Measurements for More Efficient En Route Care Training” to introduce an educational intervention to provide formative feedback to participants.

The Phase II study will continue the collaboration among human factor researchers and ERCC Subject Matter Experts (SME) at HJF in collaboration with the Brigham and Women's Hospital Harvard Medical School in Boston, Massachusetts; the University of Edinburgh in Edinburgh, Scotland; and the University of Colorado Anschutz Medical Center in Aurora, Colorado. This Phase II study will introduce an educational intervention based on assessments to provide formative feedback to participants. It is anticipated that this personalized feedback will improve retention of skills gained during training as demonstrated by improved nontechnical skills performance in future operational medicine settings.

The main Objectives of this Phase II study include:

1. Compare behaviors among teams with good nontechnical performance versus those with poor nontechnical performance. Multidisciplinary research team of human factors scientists and ERCC SMEs will identify behaviors leading to poor and improved performance in the En Route Care Nontechnical Skills (ERC NTS) Tool domains of situational awareness, decision making, task management, and team working.

2. Develop a Training-the-Trainers curriculum utilizing mixed methods of didactics and real-time coaching based on the knowledge product from Objective 1.

3. Describe the applicability and challenges of transitioning physiologic monitoring and Spaceflight Resource Management Medical Tool (SFRM-MED) scoring to ERCC field training exercises.

Anticipated Period of Performance: 01 May 2024 – 30 March 2025 Estimated Total Value:

4. Authority Cited: 10 United States Code 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: HJF 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 to Phase II of the project. HJF, in collaboration with its researchers and SMEs from the universities completed the Phase I study in December 2023. In order to maintain integrity of the data, continuity of research and prevent loss of time and dollars, the Phase II study must be completed by HJF and its Phase I collaborators. This will continue the Phase I study initiated by HJF and its collaborators under U.S. General Services Administration (GSA) Contract Number 47QFWA20C0012 to fulfill the Phase II study requirements.

HJF, in collaboration with the Brigham and Women's Hospital Harvard Medical School in Boston, Massachusetts; the University of Edinburgh in Edinburgh, Scotland; and the

University of Colorado Anschutz Medical Center in Aurora, Colorado completed the Phase I study. Working through the subawards and data agreements between HJF and each institution was a multi-month process to get agreeable language from legal for each institution. Changing HJF would result in a large amount of duplicative effort from the USAF 59th Medical Wing, Science and Technology Office and each collaborating institution to work through these processes again. Additionally, a change of vendor would require a modification to the already approved Institutional Review Board (IRB) for each collaborating site. IRB requests and modifications can take anywhere from a month to a year for approval and range from $1,000.00 to $5,000.00 per request.

Changing from HJF to another vendor would cost the Government up to $20,000.00 in modification fees.

Finally, the Phase I study required equipment purchases to enable this platform, and the equipment (watch systems, cameras, laptops, analysis software, aero med kits) is currently in possession of HJF and HJF would be able to utilize it for the Phase II study.

Switching to a different vendor would create a large amount of additional effort and costs from the USAF 59th Medical Wing, Science and Technology Office, and between HJF and each collaborator. $50,000.00 has been invested in subscriptions and memberships with platforms necessary to enable this type of research. New memberships would be required if moved to a new vendor.

A total of $671,000.00 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 working with the multiple collaborators required for the Phase II study.

Additionally, delays would be detrimental to the closure of gaps related to en route care skill sustainment and task saturation events during transport of warfighters. The military medical community is not currently engaged in an active war environment, thus continuous practice to remain current in skills needed to treat and care for as many injured warfighters during prolonged transport in a stressful environment is lacking. The training information resulting from this research project will provide simulated training on a regular, repetitive basis allowing medical providers to retain information necessary to save lives while in austere, stressful environments.

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 29 February 2024 for a period of 5 days. Two responses to the sources sought notice were received. Both responses were from firms that have an interest in and some potential capabilities for performing Research & Development, but neither response was in any way indicative of their ability to perform this specific Phase II study.

The requirement was synopsized to the GPE (SAM.gov) via a notice of intent (NOI) to Sole Source on 6 March 2024 for a period of 15 days. No responses to the NOI to Sole Source notice were received.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. This Phase II study is a follow-on to the previous Phase I study that was completed by HJF in collaboration with the Brigham and Women's Hospital Harvard Medical School in Boston, Massachusetts; the University of Edinburgh in Edinburgh, Scotland; and the University of Colorado Anschutz Medical Center in Aurora, Colorado. The researchers from HJF and universities will continue the research completed under the Phase I study titled “Development of Enhanced Simulation Model with Biometric Cognitive Load Measurements for More Efficient En Route Care Training”. Historical knowledge of this study suggests that a limited scope of subcontracting opportunities exist for this requirement. In this instance, the prime contractor does not possess a specialized capability to continue with the Phase II study without the SMEs from the universities.

7. Actions to Increase Competition: No actions have been taken to increase competition, as HJF 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.

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

A RFI and NOI to Sole Source were posted to GPE, SAM.gov for 3 days and 15 days, respectively. As discussed in Section 6, two responses were received from the RFI and zero responses were received from the NOI to Sole Source.

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 the Henry M. Jackson Foundation (HJF) for the Advancement of Military Medicine for completion of the Phase I effort referenced above.

b. Other facts. Not applicable.

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

Based on the foregoing justification, I hereby approve the procurement of research and development services in the amount of on an other than full and open competition basis pursuant to the authority of 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(A), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for this acquisition.