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Contract Opportunity

Request for Information (RFI)

1. RFI Number: W81XWH-24-RFI-RTD

2. RFI Title: An Assessment of an Accelerated Clinical Protocol for Rapid Return to Duty after Pneumothorax or Hemothorax

3. Agency: Defense Health Agency (DHA)

4. Office: The United States Air Force (USAF) 59th Medical Wing,

Science and Technology Office located at Joint Base San Antonio – Lackland Air Force

Base, Texas

5. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD.

6. Location:

Site 1: To be determined (TBD)

Site 2: U.S. Army Institute of Surgical Research, Joint Base San Antonio, Texas

Site 3: Collaborative for Emergency Care in Africa (CECA)

7. Background: The USAF 59th Medical Wing, Science and Technology Office has a requirement for research and development services. This research study is titled ‘An Assessment of an Accelerated Clinical Protocol for Rapid Return to Duty after Pneumothorax or Hemothorax’ (ST1177 Return to Duty). The approach to management of pneumothorax (PTX) and hemothorax (HTX) is complex and nuanced.1 Tension PTX is the third leading cause of potentially preventable battlefield death. HTX presents in one-third of thoracic injuries and is the fourth most common thoracic injury in modern combat. 7 In the U.S., civilian and military in-patient PTX and/or HTX (PTX-HTX) clinical management often lasts 13.7 ± 11.9 days before the patient is discharged, resulting in protracted morbidity.2 In the deployed environment, U.S. service members with PTX-HTX are often prioritized for evacuation and thus are unable to return to duty, further straining combat capabilities.3 In the future battlespace of anti-access, area denial and extended (>72hrs) evacuation to definitive care (i.e., prolonged care settings), an accelerated protocol to manage the safe return to duty of U.S. military personnel with PTX-HTX may conserve the fighting force and increase readiness where maximizing return-to-duty is paramount.3,4 An accelerated PTX-HTX protocol may also reduce morbidity and health system costs for civilian populations across all income brackets. All references can be found in the official contract file within the Statement of Objectives (SOO) and Statement of Work (SOW) documents.

The intent for this study is to assess the safety and effectiveness of an existing accelerated, nurse-driven, physician-supervised clinical protocol that uses a dry-seal intercostal drain system, alleviating the need for external wall suction, and emphasizes early mobilization. This protocol is designed to promote ambulatory discharge within 72 hours in a real-world, resource-limited, austere setting in the Western Cape of South Africa in which we have an established research network and infrastructure.

8. Major Objectives:

The main objectives are summarized as follows:

1. Define the demographics and injury characteristics of patients enrolled in the PTX-HTX protocol who experienced the best outcomes from the protocol.


2. Evaluate relevant clinical endpoints of patients enrolled in the PTX-HTX protocol (time from injury and admission to discharge, emergency department disposition, intensive care and hospital length of stay, final hospital disposition, and mortality).


3. Establish the rates of adverse events (non-infectious and infectious complications, re-admissions) of the PTX-HTX protocol.

9. Information Requested: This RFI is issued for informational and planning purposes only. Contact with Government personnel, other than those specified in the RFI, by potential vendors or their employee’s regarding this requirement is not permitted. This is not a Request for Proposal (RFP). It is not to be construed as a formal solicitation or an obligation on the part of the Government to acquire any products or services. The information requested by this RFI, will be used within USAMRAA to facilitate decision making and will not be disclosed outside of USAMRAA. Any information provided to the Government is strictly voluntary and will be provided at no cost to the Government.

If the information provided contains propriety information, such information must be identified with appropriate disclaimers.

10. North American Industry Classification System (NAICS) Code: The NAICS code for this potential action is: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

11. Response Due Date: Interested parties should submit their RFI response electronically by 12:00 pm Eastern on 25 April 2024 via e-mail to Ms. Tammy McRae at tammy.n.mcrae.civ@health.mil.

12. Instructions to Responders:

12.1 The Government appreciates responses from all capable and qualified sources.

12.2 The Government welcomes input and will accept questions pertaining to this RFI; however, the Government reserves the right to answer or not answer all questions pertaining to this RFI. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained.

12.3 The subject header of the e-mail for submission of questions and/or the RFI response shall be: W81XWH-24-RFI-RTD.

12.4 Interested firms should submit a response (Capability Statement) that demonstrates the Offeror’s capabilities identified in this RFI. The Capability Statement shall not exceed five (5) typed pages; additional sheets for cover page, table of contents, tables, and charts will not be counted toward page limitation.

12.5 Fill in the below table when responding to this Sources Sought / RFI.

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If 8(a), date that the company graduates from the program.

13. Disclaimer and Important Notes:

In accordance with Federal Acquisition Regulation (FAR) 15.201, "Exchange with industry before receipt of proposals," and FAR 52.215-3, "Request for information (RFI) or Solicitation for Planning Purposes (SFP)," this RFI is for information and planning purposes only, at this time, and shall not be construed as a solicitation or obligation on the part of the USAMRDC. The purpose of this RFI notice is to gain market knowledge. This RFI is not expected to be a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received.

The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its responses are complete and sufficiently detailed to allow the Government to determine the organization's solution. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential vendor to monitor SAM.gov for the release of any solicitation or synopsis. Responses to this notice will not be considered adequate responses to a solicitation.

14. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in submitted responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Original Point of Contact (POC): Tammy McRae, tammy.n.mcrae.civ@health.mil

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