Rapid Return to Duty after Pneumothorax or Hemothorax

NOTICE OF INTENT TO SOLE SOURCE: This is a Notice of Intent to Sole Source award on the basis of other than full and open competition in accordance with the Federal Acquisition Regulation (FAR) 6.302-1, as the unique services are only available from one source and awarding to any other source would not fulfill the agency's requirements. This is not a Request for Quotes or Proposals. No contract award will be made on the basis of the responses to this notice. The purpose of this notice is to allow interested parties to assert and explain their capability to perform the work described. The U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 808 Schreider Street, Fort Detrick, MD on behalf of the U.S. Air Force (USAF) 59th Medical Wing, Science and Technology (ST) Office at U.S. Army Institute of Surgical Research (USAISR), Joint Base San Antonio, TX intends to award a sole source firm fixed price contract to the University of Colorado Anschutz Medical Campus (CU Anschutz) to provide research for a study titled - An Assessment of an Accelerated Clinical Protocol for Rapid Return to Duty after Pneumothorax or Hemothorax. PROGRAM DESCRIPTION The approach to management of pneumothorax (PTX) and hemothorax (HTX) is complex and nuanced. Tension PTX is the third leading cause of potentially preventable battlefield death after exsanguination and airway obstruction. The USAF 59th Medical Wing, ST Office has a requirement for research and development (R&D) services. The objective of this study is to assess the effectiveness and safety of an existing nurse-driven, physician-supervised protocol to promote self-ambulatory discharge of traumatic pneumothorax or hemothorax within 72-hours. Effectiveness will be measured by the time from injury and admission to discharge, emergency department disposition, intensive care and hospital length of stay, and final hospital disposition. Safety will be measured by non-infectious, infectious complications, and re-admissions results. This research will be conducted 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. Preparation for future combat operations will require the U.S. military health system to adopt innovative, evidence-based strategies to address capability gaps (i.e., limited number of medical personnel to provide high-quality care during massive casualty events), capacity (i.e., field hospitals to treat and hold casualties for extended periods), and the ability to expedite patients to definitive treatment facilities as needed.7,15 This effort assesses the effectiveness and safety of a new paradigm (an accelerated protocol to manage PTX-HTX in a military-relevant, resource-limited austere setting) and will provide new perspectives in PTX-HTX patient REQUIRED CAPABILITIES Research preparation: Development and pilot testing of new REDCap data collection form for PTX-HTX specific variables Pilot testing of methods to track cases post-discharge and obtain 30-day complication data Hiring and training of research assistants dedicated to this study. These personnel will be trained to screen patients for study eligibility and to gather real-time data about patient engagement in early mobilization activities. Technical: Define the demographics and injury characteristics of patients enrolled in the PTX-HTX protocol who experienced the best outcomes from the protocol.? 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). Establish the rates of adverse events (non-infectious and infectious complications, re-admissions) of the PTX-HTX protocol. ELIGIBILITY The applicable NAICS code for this requirement is (541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The Product Service Code is AN42 - Health R&D Services; Health Care - Other; Applied Research. SUBMISSION DETAILS Responses should appear on company letterhead and include affirmation of active registration in the System of Award Management (SAM), your qualifications and any other applicable data or information. Additionally, respondents should indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, woman-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S. or foreign owned. If your organization has the potential capacity to provide the required services, please provide the following information: 1) Organization name, address, primary points of contact (POCs) and their email address, FAX, Web site address, telephone number, and type of ownership for the organization, DUNS number; and 2) a tailored capability statement addressing the requirements of this notice, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capabilities, organizations should address the administrative and management structure of such arrangements. Interested businesses should submit a brief capabilities statement package (no more than ten pages, with font no smaller than 10 point) demonstrating ability to provide the services listed in the required capabilities description. Documentation should be in bullet format. Your response to this Notice of Intent, including any capabilities statement, shall be electronically submitted to the Contract Specialist, Tammy McRae, in either Microsoft Word or Portable Document Format (PDF), via email to tammy.n.mcrae.civ@mail.mil no later than 1:00 p.m. Eastern Standard Time on 20 May 2024 and reference this Notice ID number in the subject line of your e-mail and on all enclosed documents. Information and materials submitted in response to this request WILL NOT be returned. DO NOT SUBMIT CLASSIFIED MATERIAL. All data received in response to this Notice of Intent that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government. Responses to this notice will be used to determine the availability of this type of service. All responsible sources may respond to this notice and all responses will be considered by the agency.