AN42--RESEARCH 7/3/24 - 7/2/25 with neg. 6 mo ext. final 1/2/26 688D50010

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: VA-24-00035539 Base plus 6-month extension, IGE $594,140.50 Contracting Activity: Department of Veterans Affairs, VISN 5, DC VAMC Research Contracting Agency: University of Maryland College Park and with service agreements to Baltimore campus leveraging the University of Maryland Strategic Partnership between these institutions. MPowering the State (MPower) is a collaboration between the state of Maryland s two most powerful public research engines: the University of Maryland, Baltimore (UMB) and the University of Maryland, College Park (UMD) Activity: Procurement of scientific expertise (cardiovascular physiology, biomechanics, neuromotor control, psychology, and cognition and executive function) through support of UMD staff as well as access to unique equipment and facilities to meet the Governments needs for cutting edge research of military environmental exposures. Nature and/or Description of the Action Being Processed: The War Related Illness and Injury Study Center in Washington, DC is a national post-deployment health resource for the Veterans Health Administration will contribute to the VHAs proactive response to emerging threats to the health of military personnel. DC WRIISC has been asked to start a new Center, entitled the Complex Exposure Threats Center (CETC) which will help VA take the lead on working with DoD and other partners to seek information related to these toxic exposures, leveraging established knowledge on environmental toxins while acquiring new knowledge on specific Veteran health concerns. UMD contains an established service agreement with the UMB Institute for Clinical Translational Research (ICTR), that enables analysis of cytokine profiling of samples as well as the potential to evaluate transcriptomic, genomic and proteomic (omic) features and basic bioinformatics and biostatistical support of UMD data. The primary performance site is with the Department of Kinesiology at the UMD which is the only known group that can fulfill the proposed scope of work based on 1) geographic location; 2) subject matter expertise; and 3) unique facilities and equipment with which to perform the work. Approval is requested to negotiate a contract without full and open competition. This is inclusive of labor as well as physical material costs associated with the project. Description of Supplies/Services Required to Meet the Agency s Needs: 1. The contract requires a research study of participants in close proximity to the Washington, DC VA Medical Center. The Department of Kinesiology is located ~6 miles from the Washington, DC VA Medical Center; thus, costs for transportation will be negligible, resulting in significant cost savings for this contract. 2. The UMD Department of Kinesiology is highly unique in that it is the only potential contractor in the geographical region with the combined expertise to execute this project. While there are 7 other Departments of Kinesiology within ~100 miles of the Washington DC VA Medical Center, 4 of these do not have adequate facilities for clinical research in Veterans and cannot be considered with the lead investigator (Dr. Prior) having direct connections to UMB as well as the Balimore VA. The remaining 3 potential contractors each lack at least one critical area of scientific expertise and specialization (cardiovascular physiology, biomechanics, neuromotor control, psychology, and cognition and executive function) required for this project. The UMD Department of Kinesiology is the only suitable contractor with the expertise to execute this contract. Beyond the activities at the UMD, the Government will also benefit from the relationship with the UMB Medical School s ICTR, a NIH Clinical and Translational Science Awards (CTSA) Program that integrates, coordinates, and enables research teams including scientists, patient advocacy organizations and community members to tackle system-wide scientific and operational problems in clinical and translational research that no one team can overcome. 3. The UMD Department of Kinesiology is the only potential contractor meeting the criteria specified in #1 and #2 above with adequate equipment and facilities to execute the proposed scope of work. Indeed, if any other collaborator meeting #1 and #2 above were identified, excessive expenditures would be required for the purchase of equipment. Specifically, the access to equipped with electroencephalography (EEG), electromyography (EMG), eye-tracking, motion analysis, and dynamometer, and examines brain dynamics of performers from a neurocognitive, affective, and psychomotor perspective. Veterans or performers cognitive performance are measured with psychophysiological tests that include cognitive/mental workload, mental stress and resilience, mental preparation, practice methodologies, biofeedback, mindfulness, sleep, and team dynamics. Moreover the faculty also have standing relationships with the Maryland Neuroimaging Center (MNC), that offers state-of-the-art neuroimaging capabilities, including imaging of the central nervous system development and aging, neuroinflammation, photodynamic therapies, and immune engineering with access to the newly upgraded Siemens 3 Tesla PRISMA system as a primary MRI assessment. Statutory Authority Permitting Other than Full and Open Competition: ( x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Aware of no other group of collaborators with their combined expertise that aligns perfectly with this project. The team is comprised of a) Dr. Prior, a clinical exercise physiologist with expertise in cardiovascular physiology in the conduct of acute and chronic exercise studies in Veterans with acquisition of blood specimens for analysis of markers of allostatic load; b) Dr. Sushant Ranadive with expertise in cardiovascular function, the assessment of vascular function, and autonomic nervous system function; c) Dr. Brown, an expert on the regulation of blood pressure and markers of systemic inflammation; d) Dr. Miller, an expert in human musculoskeletal biomechanics; e) Dr. Kiemel with expertise in neuromotor control of human movement, and f) Dr. Hatfield, an expert in sport psychology, assessments of executive function, linkages to physiological and biomechanical measures, and expertise in electroencephalography and cognitive load. We are unable to find the requisite expertise elsewhere in the Washington, DC area; thus, the UMD Department of Kinesiology is the only potential contractor fulfilling the requirements for the evaluation of Veterans in this project. Furthermore, the facilities environment is unlike any other we are aware of and suits the needs of this project ideally. The laboratories have a unique combination of highly-specialized equipment and facilities that prevent VHA from acquiring the expense of this development. The Cardiometabolic Mechanisms Clinical Exercise Testing Laboratory has 2 Parvo metabolic carts, 2 electrocardiography systems, 2 treadmills, 1 cycle ergometer, and 2 phlebotomy stations for evaluation of acute responses to exercise with subsequent specimen collection (total cost > $125,000). The Human Integrative Physiology Laboratory had 2 hospital beds, 2 Doppler Ultrasound Systems (each > $120,000) for vascular and cardiac imaging and testing. The laboratory also has equipment to measure central blood pressures and arterial stiffness measures (SphygmoCor), non-invasive finger plethysmography equipment (AD Instruments) to measure beat-to-beat blood pressure and heart rate variability and muscle sympathetic nerve activity recording equipment to assess autonomic function (NeuroAmp) (total cost > $75,000). The Cognitive-Motor Neuroscience Laboratory consists of twelve fully equipped testing rooms with four electroencephalography (EEG) systems, two eye-tracking systems, and one electromyography (EMG) system in the Cognitive-Motor Neuroscience Lab. The Neuromechanics Research Laboratory is a ~ 3000 ft2 space housing 10 Kistler force platforms and 23 Vicon optical motion capture cameras (total cost >$300,000) capable of tracking patterns of human movement. The laboratory also has a 16-channel wireless surface electromyography system (Delsys Trigno), a portable telemetered pulmonary gas exchange system for measuring metabolic cost (CosMed K5), and a dynamometer (Biodex System 4) for complete biomechanical assessments (total cost > $100,000). In addition to these specialized services, the relationships on campus are of significant value to the government as the needs of the new CETC program develops. Specifically, the faculty mentioned above have attended campus-wide meetings related to CETC with organizations on the UMD campus from the following: Audiology Clinic/HESP: The department of Hearing and Speech Sciences (HESP) has established collaborations with Walter Reed and the National Intrepid Center of Excellence (NICoE) to investigate the impact of brain injuries on hearing. The HESP Clinic is equipped to assess audiology-related illness as observed in patients suffering from Havana Syndrome. UMD Center for Research on Military Organization (CRMO): CRMO combines basic research with policy applications through investigating the impact of military service on the life course and cooperating with the White House in support of programs for military families and veterans. One major goal of CRMO is facilitating the transition of veterans to civilian life, a mission shared with the VA WRIIISC team. These services are unique to UMD and may prove critical should the requirements of the Government change in relations to the demand of the COE application. Having established agreements will support the mission in timely responsiveness to the needs of VA. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A market survey determined was the only source capable of providing this service. See attached market research for more detail of the search. Based on the results of the research only one responsible source reached requisite capability of industry to meet our needs. (See FAR 6.303-2(b)(6)). Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Government estimate was prepared and provided by the Contracting Officer s Representative (COR). The anticipated price to the Government for the items is approximately Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. An initial search was done within the GSA/FSS staffing library. The available positions appeared to be focused on general office positions and did not consist of health, exposure, or computing research specialists that we require. From March 23, 2023 October 10, 2023, market research was conducted for Maryland, Virginia, West Virginia, and Washington DC localities in both Vetbiz and SAM search of the VA Market Research Assistant using the NAICS code 541715 (applied research). The searches revealed 12 businesses that required follow-up, however only one claimed to have any experience in recruitment for military scientific research protocols. This company, ClinFinder LLC, did not have a history of deployment related research paradigms which is necessary for CETC to satisfactorily conduct the presented environmental exposure protocols. Any Other Facts Supporting the Use of Other than Full and Open Competition: Establishing key cohorts of Veterans and evaluating each group during rest and in the context of a challenge, will enable approximation of cumulative military exposures health sequelae. Focus on homeostatic regulation and allostatic load associated with a spectrum of military exposures provides a foundational approach able to reveal opportunities for intervention and recovery. This is a very specialized topic of research so key academic collaborators are required. Central to this capability are the formation of core assessment batteries that deliver common data elements delivering a comprehensive characterization of biobehavioral wear and tear even in their subclinical state. These standardized batteries will be augmented by biomarkers that will be evaluated at UMD Department of Kinesiology. The CETC partnership with academic institutions is critical because this approach requires established infrastructure, resources, and expertise that these academic partnerships can provide to best characterize potential health effects linked to these complex and emerging threats. The mechanistic basis as to how environmental exposures influence health is still not completely understood, but the concept of subclinical allostatic load which is defined as the biological cost that may result from cumulative exposure stress, can serve as an intermediate indicator of exposure load prior to diseases. This conceptual framework can accommodate many forms of exposures or threats and as well as the factors that influence allostatic burden and health outcomes. This can advance the military exposure science and required detailed and specialized knowledge that cannot be found outside of UMD. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other sources formally expressed interest in this Acquisition. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No other actions are planned, given the specialty of UMD s expertise related to allostatic load. Seeking other sources during the planned duration of the contract would result in increased costs to the government through loss of productivity and efficiency in accomplishing the goals described in section 5.