W81XWH-16-R-0024_Solicitation.docx

W81XWH-16-R-0024

Section B - Supplies or Services and Prices

Research Activities Support Services

FFP

Contractor shall provide support services in accordance with (IAW) the Performance Work Statement (PWS).

The Base Ordering Period is for 5 years.

FOB: Destination

NET AMT

Base Period Other Direct Costs - Travel

COST

The Contractor may be required to travel during CONTRACT performance in accordance with (IAW) the Performance Work Statement (PWS).

ESTIMATED COST

Base Period Transition Out Services

This is an Optional Service to be issued at the TASK ORDER level. The Contractor shall perform Transition-Out services in accordance with (IAW) the Performance Work Statement (PWS). Transition-Out services may occur at any time during the performance period.

NET AMT

Base Period CMR

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research, US Army Medical Research Institute of Chemical Defense, Army Public Health Command (Provisional) and DoD/VA Extremity Trauma and Amputation Center of Excellence via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October of each calendary year, beginning with 2017. Contractors may direct questions to the help desk at at http://www.ecmra.mil.

Contractor shall provide the estimated total price (if any) incurred to comply with annual CMR requirement.

The Unit Identification Code (UIC) and the Department of Defense (DoD) Activity Address Code (DoDAAC) for USAMRAA is as follows:

UIC: TBD

DoDAAC: TBD

CMR Reporting Certification. The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each Government fiscal year to the Contracting Officer's Representative (COR) and Contract Administrator.

NET AMT

FFP

Contractor shall provide support services in accordance with (IAW) the Performance Work Statement (PWS).

The Option Ordering Period is for 5 years.

NET AMT

COST

The Contractor may be required to travel during CONTRACT performance in accordance with (IAW) the Performance Work Statement (PWS).

The Option Ordering Period is for 5 years.

ESTIMATED COST

FFP

This is an Optional Service to be issued at the TASK ORDER level. The Contractor shall perform Transition-Out services in accordance with (IAW) the Performance Work Statement (PWS). Transition-Out services may occur at any time during the performance period.

NET AMT

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research, US Army Medical Research Institute of Chemical Defense, Army Public Health Command (Provisional) and DoD/VA Extremity Trauma and Amputation Center of Excellence via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October of each calendary year, beginning with 2022. Contractors may direct questions to the help desk at at http://www.ecmra.mil.

Contractor shall provide the estimated total price (if any) incurred to comply with annual CMR requirement.

The Unit Identification Code (UIC) and the Department of Defense (DoD) Activity Address Code (DoDAAC) for USAMRAA is as follows:

UIC: TBD

DoDAAC: TBD

CMR Reporting Certification. The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each Government fiscal year to the Contracting Officer's Representative (COR) and Contract Administrator.

NET AMT

SERVICES AND PRICES

B.1. CONTRACT

B.1.1. This acquisition is a 100% set-aside for the 8(a) Business Development (BD) program in accordance with (IAW) Federal Acquisition Regulation (FAR) Part 19 – Small Business Programs.

B.1.2. The CONTRACT awards shall be multiple award Indefinite Delivery Indefinite Quantity (IDIQ) type CONTRACTS. TASK ORDERS awarded under the CONTRACTS will be Firm-Fixed Price (FFP) with cost reimbursement Contract Line Items (CLINs) for Other Direct Costs (ODCs) to be utilized for travel expenditures only. No other costs other than travel are permissible under the ODC CLIN.

B.2. GUARANTEED TASKING

B.2.1. The maximum amounts identified in B.4. below are placeholder values assigned to facilitate the issuance of TASK ORDERS. These maximum amounts shall not be construed as a commitment on the part of the Government for guaranteed tasking value.

B.2.2. The guaranteed minimum per IDIQ Contract Holder is $100,000.00 for this entire acquisition.

B.3. ISSUANCE OF TASK ORDERS

B.3.1. All services to be performed under the resulting CONTRACT shall be set forth in individual TASK ORDERS. All orders will be issued in accordance with (IAW) the provision of Section C, Section H, and all clauses listed in Section I. Clauses 252.216-7006 Ordering, 52.216-19, Order Limitation, 52.216-22 Indefinite Quantity, and 52.219-14 Limitations on Subcontracting shall be applicable to each TASK ORDER.

B.3.2. “Unit of issue” for each FFP CLIN issued on each TASK ORDER under this CONTRACT shall be “Job.” Multiple payments are authorized against each “Job” unit of issue. Each payment; however, shall not exceed the maximum amount as stated in each CLIN Description of the TASK ORDER issued under this CONTRACT.

B.4. CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and the minimum amount for all orders issued should not be less than the minimum quantity and the mininimum amount stated in the following table. The maximum quantity and the maximum amount for all orders issued shall not exceed the maximum quantity and the maximum amount stated in the following table.

MINIMUM MINIMUM MAXIMUM MAXIMUM

QUANTITY AMOUNT QUANTITY AMOUNT

1.00 $100,000.00 500 $249,000,000.00

B.5. TASK ORDER Labor Rates

No TASK ORDER will be awarded with labor rates higher than those approved in the Base Contract inclusive of options. Fully loaded FFP Labor Rates approved in the Base Contract are the maximum ceiling for each rate that the Government will allow on each TASK ORDER issued under this IDIQ Contract.

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

Performance Work Statement

Research Activities Support Services(RASS)

Version 3 21 June 2016

PERFORMANCE WORK STATEMENT (PWS)

Research Activities Support Services (RASS)

Vision Statement

The research activity support services CONTRACT will fully support the following agency visions:

The United States Army Institute of Surgical Research (USAISR) (also referred to as “the Institute”) vision as the Nation’s premiere Tri-Service research organization that integrates safety into planning and executing registry-based and transitional Research providing innovative solutions for burn, trauma, and combat casualty care from time of injury through rehabilitation.

The vision of the United States Army Medical Research Institute of Chemical Defense (USAMRICD) is to be a recognized Center of Excellence, a national asset, and the world leader for medical chemical defense, education, and training. Additionally, the USAMRICD vision is to mitigate the medical consequences of being exposed to chemical warfare agents (CWAs) and toxins. Intrinsic in the USAMRICD vision is a dedication and a commitment to quality and continuous improvement.

The vision of the U.S. Army Public Health Center (Provisional) (APHC (Prov)) is to be a world-class provider of public health services across DA and DoD. The APHC (Prov)’s institutional and operational missions encompasses measures to protect, promote, improve, or conserve the mental and physical well-being of Soldiers, DA Civilians, Family, Military Working Dogs and other animals. These measures enable a healthy and fit force, prevent injury and illness, and protect the force from health hazards and include the prevention aspects of a number of Army Medical Department functions such as preventive medicine, including, medical surveillance and occupational and environmental health (OEH) surveillance; veterinary services, including the food inspection and animal care missions, and the prevention of transmissible zoonotic diseases; biosurveillance, epidemic and out-break response; combat and operational stress control (COSC); dental services (preventive dentistry); and laboratory services.

The vision of the EACE is to serve as the nation’s premiere center for our Service Members and Veterans with traumatic extremity injuries.

1. Introduction

The USAISR is one of six research laboratories within the U.S. Army Medical Research and Materiel Command (USAMRMC) of the U.S. Army Medicine Command. The Institute is the Army's lead research laboratory for improving the care of combat casualties.

The requirements of the USAISR are to provide support services to the Combat Casualty Care Research, Joint Trauma System, Resource, and Quality Management Directorates.

The USAMRICD requires support services to allow USAMRICD to continue to be a recognized leader in the development of chemical warfare countermeasures. This is a non-personal services contract to provide skilled professional, technical and administrative personnel in accordance with the requirements of the USAMRICD and its mission. The Contractor shall provide the support services required to perform all of the tasks and deliverables listed in this Performance Work Statement (PWS). The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

The APHC (Prov) requires support services to enable APHC (Prov) to continue to promote health and prevent disease, injury, and disability of Soldiers and military retirees, their Families, and Department of the Army civilian employees; and assure effective execution of full spectrum veterinary service for Army and Department of Defense Veterinary missions.

1.1. Mission

1.1.1. The USAISR’s mission is to provide combat casualty care medical solutions and products for wounded warriors, from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense beneficiaries and civilians; and provide Burn Flight Teams. The USAISR does this through three unique missions: (1) To provide requirements driven innovations in combat casualty care advance medical care for injured services members; (2) as the only Burn Center in the DoD provide state of the art burn, trauma and critical care to injured war fighters and DoD beneficiaries around the world; (3) through the Joint Trauma System, provide a performance improvement system dedicated to ensuring that medical care is organized according to the needs of the patient.

1.1.2. The USAISR has a new requirement to procure non-personal professional, research, and administrative support services on a competitive basis. This service CONTRACT will fully support the Institute’s mission in planning, synchronizing, and providing services to support the warfighter.

1.1.3. The USAMRICD is a world leader in the discovery and development of medical products and knowledge solutions against chemical threats through research, education and training, and consultation. It is through successful partnerships with outside agencies that we are able to maintain our high level of excellence. This personnel based service Contract will provide the USAMRICD with the required resources in order to staff and maintain mission critical operations. Failure to provide the support services needed to carry out and complete routine requirements would be extremely detrimental to the mission.

1.1.4. The U.S. Army Public Health Center (Provisional)’s mission is to promote health and prevent disease, injury, and disability of Soldiers and military retirees, their families, and the Department of the Army civilian employees; and assure effective execution of full spectrum veterinary service for Army and Department of Defense Veterinary missions. This service contract will provide USAPHC (Prov) with mission required subject matter experts to supplement and enhance the existing workforce with training and operational support.

1.1.5. The mission of the EACE is to serve as the joint Department of Defense and Veterans Affairs lead element focused on the mitigation, treatment, and rehabilitation of traumatic extremity injuries and amputations. The EACE will implement a comprehensive plan and strategy, to conduct clinically relevant research, foster collaboration and build partnerships across the multidisciplinary international, federal and academic networks to optimize the quality of life of Service Members and Veterans.

1.2. Background

1.2.1. Past efforts in contracting for support services (professional research and administrative) to the USAISR and USAMRICD have been performed through firm-fixed price CONTRACTS. This multiple award Indefinite-Delivery Indefinite-Quantity (IDIQ) will encompass all the professional research and administrative serviced performed under the CONTRACTS for USAISR, USAMRICD, APHC (Prov) and EACE.

1.2.2. This opportunity represents a full and open competition after exclusion of sources, specifically as a set-aside for the Small Business Administration (SBA) 8(a) Business Development (BD) Program. This IDIQ contract will replace all competitive contracts identified in Table 1. Total award value of the contracts to date is approximately $249 million. Contract services are to support the following USAISR, USAMRICD, APHC (Prov) and EACE core competencies:

1.2.2.1. Extremity Trauma and Regenerative Medicine Research. This competency requires conducting, coordinating, and assisting in the research of orthopedic injury including associated infection; bone tissue regeneration using stem cell therapy and bioengineered scaffolds; and by evaluating and improving currently available therapies and implementation into the clinic with the goal of returning wounded warriors to full function.

1.2.2.2. Coagulation and Blood research. This competency requires conducting, coordinating, and assisting in the research of diagnostics and therapeutics to treat the Coagulopathy of Trauma with safe and effective blood products far forward of fixed medical facilities.

1.2.2.3. Damage Control and Resuscitation Research. This competency requires conducting, coordinating, and supporting research identifying solutions to deficits associated with the control of bleeding and the stabilization of injured soldiers with the emphasis of treatments far forward of fixed Medical facilities.

1.2.2.4. Battlefield Pain Management Research. This competency requires conducting, coordinating, and supporting research to improve combat related pain control, the elimination of Post-Traumatic Stress Disorder (PTSD) and chronic pain development through controlling acute pain and evaluating new products for effective pain relief.

1.2.2.5. Ocular Trauma Research. This competency requires conducting, coordinating, and supporting research to improve comprehension, modeling, detection and treatment of the full range of diseases and conditions that influence the ability of Military personnel to see optimally; function on the modern battlefield; and influence their ability to return to duty after injury.

1.2.2.6. Clinical Trials in Burns and Trauma Research. This competency requires conducting, coordinating, and supporting research on trauma patients (including those with burns) to improve functional survival among Military service members and civilians who sustain burn injury and/or concomitant trauma.

1.2.2.7. Comprehensive Intensive Care Research. This competency requires conducting, coordinating, and supporting research that provides evidence based guidelines, practices and technologies in support of emergency care research and tactical combat casualty care.

1.2.2.8. Systems of Care for Complex Patients Research. This competency requires conducting, coordinating, and supporting research in the development of medical practices, interventions and devices to improve medical care administered for both out of hospital settings and from point of combat injury, including care under fire, tactical field care and patient movement.

1.2.2.9. Tactical Combat Casualty Care research. This competency requires conducting, coordinating, and supporting research development of new technologies designed for early diagnosis and treatment of traumatic injury that will aid in saving lives both on the battlefield and in civilian scenarios.

1.2.2.10. Statistics and Epidemiology. This competency provides knowledge and expertise to plan, design, analyze and interpret quantitative and qualitative research data in order to discriminate between patterns of significance versus randomness; and to plan and conduct epidemiological studies to determine the cause, incidence distribution and behavior of infection and disease affecting human populations.

1.2.2.11. Dental and Trauma Research. This competency requires conducting, coordinating, and supporting research and solutions for the prevention, treatment and rehabilitation of craniofacial trauma and infectious dental disease.

1.2.2.12. Research Support Laboratory, Veterinary and Animal. This competency requires the care services in support of all combat casualty care research task areas. Provide support for laboratory services for biomedical research sample analysis in areas of chemistry, coagulation, histology, microbiology; provide support for the full-spectrum of research animal care to include medical and surgical care; and daily husbandry requirements.

1.2.2.13. Agent Mitigation. Research into approaches that mitigate the medical consequences of exposure to chemical threats by removing or detoxifying them in vivo. Develop and evaluate methods and materials for detoxification or removal of chemical threats from biological matrices. Efforts to develop and characterize proteins or other compounds that can bind or catalyze the hydrolysis of organophosphate nerve agents in vivo.

1.2.2.14. Nerve Agent Countermeasures. Research into approaches to eliminate or mitigate the acute and long-term toxic effects of nerve agent exposure. Protect acetylcholinesterase from inhibitory binding; reactivate inhibited acetylcholinesterase; Antagonize the effects of excess acetylcholine; control nerve agent-induced seizures; protect neurons from nerve agent-induced injury.

1.2.2.15. Toxin Countermeasures. Research to discover and develop medical countermeasures and knowledge solutions against toxins and agents of biological origin.

1.2.2.16. Toxicant Countermeasures. Research to discover and develop medical countermeasures and knowledge solutions against non-nerve agent chemical threats. Vesicant Countermeasures (Injury to dermal and ocular systems); Metabolic Poison Countermeasures (Injury to metabolic processes); Pulmonary Threat Countermeasures (Injury to respiratory system).

1.2.2.17. Analytics. Research to develop and implement analytical methods to support chemical countermeasure research and development. Develop, validate and implement definitive analytical methods: Verification of human exposure to chemical warfare agents; Absorption Distribution Metabolism Excretion Toxicology (ADMET) Center of Excellence: To elucidate ADMET and pharmacokinetics (PK) of candidate chemical and biological medical countermeasures to support drug discovery and development for the Chem Bio Defense Program.

1.2.2.18. Emerging Threats. Research to discover and develop medical countermeasures and knowledge solutions against emerging threats.

1.2.2.19. Chemical Casualty Care/Training. Training to educate medical professionals and first responders in the management of chemical casualties and to provide consultation to military and civilian authorities.

1.2.2.20. Quality Management. Implement, maintain and improve quality systems within the USAMRICD with a primary focus on customer needs and expectations. Maintain high quality standards, provide education and training opportunities, and continually improve internal processes to provide customers with value added service that leads to quality products.

1.2.2.21. Information Management. Graphical and technical support services to produce critical, observational, quantitative, analytic and educational layouts for USAMRICD Research Science.

1.2.2.22. Safety Management. Management of technical requirements for developing and management and control processes for radiation program.

1.2.2.23. Animal Husbandry Management. Provide support services for veterinary and animal care in support of all research task areas. Provide support for laboratory services for biomedical research sample analysis in areas of chemistry, coagulation, histology, microbiology; provide support for the full-spectrum of research animal care to include medical and surgical care; and daily husbandry requirements.

1.2.2.24. Business Operations. Provide software programming management support for the Activity Based Costing Models and Cost Analysis and Integration of General Fund Enterprise Business Systems. Conduct maintenance of budget tool for Research areas integrating data from updated ABC models.

1.2.2.25. Public Health Science. This competency requires knowledge and expertise across the spectrum of Public Health: Environmental Health, Occupational Health, Surety Medicine, Occupational and Environmental Medicine, Health Promotion and Wellness, Epidemiology and Disease Surveillance, Toxicology, Industrial Hygiene, Health Physics, Sanitation and Hygiene, Hearing and Vision Conservation and Veterinary Services – in order to achieve complete our mission as a World-Class Provider of Public Health Services across DA and DoD.

1.2.2.26. Public Health Statistics and Epidemiology Support. This competency provides knowledge and expertise to plan, design, analyze and interpret quantitative and qualitative study data in order to discriminate between patterns of significance versus randomness; and to plan and conduct epidemiological studies to determine the cause, incidence distribution and behavior within the scope of Army Public Health.

1.2.2.27. Laboratory, Veterinary and Animal Support. This competency requires care services in support of laboratory services for Public Health Laboratory analysis; provide laboratory support for a wide spectrum of requirements (e.g., organic, inorganic, food safety, metals, water, soil, air); this competency includes providing support for small animal populations to include daily husbandry requirements.

1.2.2.28. Analytics. Evaluation, analysis and synthesis of complex data systems to support Public Health Program review, determine new and emerging health threats based on health surveillance and other vector data, identify best practices based on current program performance and build models as required within the Operational environment (.e.g. workload models, budget models, study models, etc.).

1.2.2.29. Emerging Threats. Research to discover and develop mitigation strategies and knowledge solutions against emerging Public Health threats.

1.2.2.30. Program Implementation and Evaluation. This capacity includes skills, knowledge and ability with respect to implementing Public Health programs as a result of emerging trends and surveillance analysis; includes robust project management practices and succinct program evaluation that provides decision-makers with the information they need to make prioritizing and resourcing decisions.

1.2.2.31. Quality Management. Implement, maintain and improve quality systems within the APHC(P) with a primary focus on customer requirements and expectations. Maintain high quality standards for all work by-products (i.e., technical reports, laboratory analyses, program evaluations, etc.), provide education and training opportunities, and continually improve internal processes to ensure the highest standards of quality and customer responsiveness are employed.

1.2.2.32. Information Management. Graphical and technical support services to produce critical, observational, quantitative, qualitative, analytic and educational layouts for APHC(P) Public Health scientists.

1.2.2.33. Safety Management. Management of technical requirements for oversight of radiation programs to include identification of best practices and required mitigation processes.

1.2.2.34. Animal Husbandry Management. Provide support services for veterinary and animal care in support of all Public Health studies. Provide support for the full-spectrum of research animal care to include medical care, daily husbandry requirements and lab support functions such as histology.

1.2.2.35. Business Operations – Information Technology. Provide software programming management support for the Activity Based Costing Models and Cost Analysis and Integration of General Fund Enterprise Business Systems as applied to Army Public Health. Provide support to APHC(P)-maintained database systems as required and provide additional training as needed.

1.2.2.36. Business Operations – human resources, logistics, resource management, security. Provide support as needed to the operational missions of the organization; conduct the operations process (plan, prepare, execute), conduct knowledge management, inform decision-makers.

1.2.2.37 Research and Surveillance. Identify relevant research gap areas, direct and execute a patient-centric intramural research program within the Advanced Rehabilitation Centers. Provides coordination and oversight for extramural research initiatives approved for conduct within the ARCs. Assures research outcomes from intramural and extramural efforts are translated to clinical practice through the dissemination of salient findings to key stakeholders.

1.2.2.38 Clinical Care. Fosters improved coordination of care (surgical, non-surgical, and rehabilitation) between the DoD, VA, and civilian resources to improve efficiency and maintain compassionate, high-quality care for all service members and Veterans. Operates to analyze and disseminate the most current standards of care and evidence based practices and provides policy guidance for the treatment, management, and rehabilitation of extremity injuries and amputations in order to mitigate co-morbidities and maximize the functional return of patients.

1.2.2.39 Clinical Informatics and Technology. Supports clinical care and research efforts designed to improve the health outcomes of extremity trauma and amputee service members through the use of clinical information, healthcare data systems, and modern technology. Builds upon the Federated Registry Data Warehouse through linkages with existing data systems such as the Joint Theater Trauma Registry, Military Orthopedic Trauma Registry, and the VA Amputation System of Care Outcome Repository. Identifies individuals, demographics, and practices to study variations among and effectiveness of acute and rehabilitation care practices, prosthetic technology and services, incidence of complications, mitigation of secondary disabilities, patient outcomes and quality of life.

1.2.2.40 Global Outreach. Serves to build relationships with applicable national and international entities to maintain clinical readiness, enhance education, develop research partners and support efforts related to traumatic extremity injuries and amputations. A key mission of the Global Outreach Division is supporting Unified Commanders and the medical aspects of theater security assistance which may include development of amputation systems of care in coalition countries.

1.3. Scope

The Research Activities Support Services (RASS) multiple award IDIQ CONTRACT requirement is to provide continuous research and administrative support services in the core competencies described above. The Performance Work Statement (PWS) has been reviewed and contains no services that are inherently governmental functions, as defined in Federal Acquisition Regulation (FAR) Part 2.1. The general scope of the RASS requirements are organized into twenty (20) separate support areas as listed below by Agency:

1.3.1. Area 1: USAISR Combat Casualty Care Research Directorate Support Services

Combat Casualty Care Research Directorate Support Services contribute to the efficient and effective operation of all research programs. Services may be used by the Research Directorate to help achieve maximum effectiveness and efficiency in research operations. Services may include, but are not limited to:

1.3.1.1. Conducting, coordinating, and supporting the research of multiple core competencies in providing solutions for the prevention, treatment and rehabilitation of relevant battlefield medical problems;

1.3.1.2. Providing knowledge and expertise to plan, design, analyze and interpret quantitative and qualitative research data;

1.3.1.3. Obtaining the opinions, special knowledge, or skills of noted experts;

1.3.1.4. Enhancing the understanding of, and developing alternative solutions to, complex issues;

1.3.1.5. Researching and reviewing existing standards and assisting in developing new policies and procedures; and

1.3.1.6. Assisting in developing policy strategies, implementing plans and assisting in policy implementation.

1.3.2. Area 2: USAISR Joint Trauma System (JTS)

The JTS evaluates the current delivery of care in the deployed combat environment; ensuring opportunities to improve care are recognized and acted upon. Services may include, but are not limited to:

1.3.2.1. Providing the ability to perform data driven battlefield level process improvement of trauma care that drives morbidity and mortality to lowest possible levels.

1.3.2.2. Expanding across DoD to bring trauma systems into fixed facility care as well as theater care thus enhancing readiness to provide optimal trauma care to deployed Service members.

1.3.2.3. Emphasizing continuous improvement in medical record documentation quality.

1.3.2.4 Capturing and sharing patient data across all levels of care, and enabling evaluation, and adherence to theater clinical practice guidelines and Standard Operating Procedures (SOPs).

1.3.2.5 Identifying training requirements, capturing injury epidemiology, support research initiatives, and assess success of interventions and outcomes.

1.3.3. Area 3: USAISR Resource Directorate

Developing and maintaining an operational plan containing essential program/project planning information for use by executive management, analyzing program/project progress, identifying and resolving issues, accounting for resources and, reporting. This area also includes planning and conducting life-cycle management reviews, impact assessments, as well as management planning support for analyzing, developing and updating policy and planning documents. This is achieved through combined efforts of administrative, budgetary, manpower, logistical, audio-visual, Operations, Security & Training and library support services.

1.3.4. Area 4: USAISR Quality Management Division

The USAISR Quality Management Division supports all USAISR directorates with a variety of activities that include, but are not limited to:

1.3.4.1. Support personnel, processes and materiel performing quality-driven scientific clinical and pre-clinical research through auditing of research protocols

1.3.4.2 Provide oversight and auditing for the development, manufacturing, and use of medical devices, assuring the USAISR meets all Food and Drug Administration (FDA) requirements

1.3.4.3. Manages, maintains and supports the FDA Quality Management System (QMS) for the development of medical devices throughout their life cycle to include document control management

1.3.4.4. Responsible for Quality Improvement activities throughout the USAISR

1.3.4.5. Lead for the Strategy Working Group and managing the Balanced Scorecard and other Strategic and Quality systems in place for the USAISR.

1.3.5. Area 5: USAMRICD Quality Management Office supports all USAMRICD staff offices and divisions with a variety of activities that include, but are not limited to:

1.3.5.1. Ensure quality laboratory practices as implemented.

1.3.5.2. Maintain quality compliance.

1.3.5.3. Improve quality processes to limit cost and increase benefit to researchers while accomplishing client’s needs.

1.3.5.4. Introduce and incorporate new quality regulations and guidance, as needed.

1.3.5.5. Manage regulatory compliance with FDA regulations when Good Laboratory Practice studies are conducted by the USAMRICD

1.3.6. Area 6: USAMRICD Safety Office supports all USAMRICD staff offices and divisions with a variety of activities that include, but are not limited to:

1.3.6.1. Provide command-wide safety and intelligence support for intramural and extramural research relative to the handling, disposal, transport, use and storage of chemical surety material (CSM) and exempt chemical surety material (SCSM).

1.3.6.2. Provide occupational safety and health, and environmental support. Serve as principal advisor to the Commander on all occupational health and safety issues.

1.3.7. Area 7: USAMRICD Logistics Office supports all USAMRICD staff offices and divisions with a variety of activities that include, but are not limited to:

1.3.7.1. Maintain and manage a mission supply support activity for the receipt, distribution, stock and disposition of consumable items.

1.3.7.2. Provide, coordinate, and monitor the ordering of all supplies and equipment by in-house staff, host installation support, and/or through contractual programs.

1.3.8. Area 8: USAMRICD Information Management supports the research, training, and collaboration mission of USAMRICD through the timely delivery of information resources that include, but are not limited to:

1.3.8.1. Information Assurance (IA) incident response.

1.3.8.2. Hardware, SharePoint, software and technical support.

1.3.8.3. Audiovisual support services; teleconference management; videography; photography.

1.3.8.4. Book and journal collection development; editorial and library services; records management; translations and medicated literature searches.

1.3.9. Area 9: USAMRICD Business Operations Office supports all USAMRICD staff offices and divisions with a variety of activities that include, but are not limited to:

1.3.9.1. Providing Activity Based Costing (ABC) Policies, objectives, procedures and reporting criteria to Institute personnel and staff. Maintain ABC models and standard activity definitions.

1.3.9.2. Creating new cost tables derived from the updated USAMRICD ABC model as required supporting new functions/activities.

1.3.9.3. Provide training on new Budget Tool functionality.

1.3.10. Area 10: USAMRICD Research Division supports research for medical solutions to protect the Warfighter.

1.3.10.1. Conducts basic and applied research on chemical threat agents.

1.3.10.2. Participate and provide data for the evaluation of the efficacy of countermeasures against chemical warfare agent exposure using endpoints of physiology, behavior, molecular biology, and neuroanatomy.

1.3.11. Area 11: USAMRICD Analytical Toxicology Division (ATD) supports research for medical solutions to protect the Warfighter with a variety of activities that include but are not limited to:

1.3.11.1 Conducts basic and applied research on chemical threat agents

1.3.11.2. Participate and provide data for the evaluation of the efficacy of countermeasures against chemical warfare agent exposure and botulinum toxin using the areas of medical toxicology, neurobehavioral toxicology, medical diagnostics and pathophysiology.

1.3.11.3. Provides administrative support services to ATD’s staff.

1.3.12. Area 12: USAMRICD Research Support Division supports all medical chemical defense countermeasure research task areas.

1.3.12.1. Mitigates the medical effects of CWA by providing quality veterinary medical care, laboratory animal husbandry and research program support, training and consultation to the USAMRICD investigators.

1.3.12.2. Provide comprehensive veterinary medical care, to include surgery, radiology, diagnostics, and pharmacy support, for all laboratory animals maintained within the USAMRICD.

1.3.12.3. Procure and issue various species of research quality laboratory animals and supplies in a timely manner for use by the USAMRICD investigators.

1.3.12.4. Provides administrative support services to ATD’s staff.

1.3.13. Area 13: USAMRICD Chemical Casualty Care Division supports the Institute mission through education, medical consultative services and policy and doctrine development in the area of medical management of chemical warfare agents and toxins. Provides direct medical assistance and advice to the Command and other Institute assets working collaboratively with the US Army, USAMEDCOM, the DoD and federal agencies.

1.3.13.1. Provides state of the art training in the medical management of chemical casualties.

1.3.13.2. Evaluates educational effectiveness of teaching modalities used educational training programs.

1.3.13.3. Maintains continuing education accreditation.

1.3.13.4 Executes marketing activities.

1.3.14 Area 14: USAMRICD Security Office develops and provides guidance for the protection of USAMRICD personnel, facilities, and assets from various threats and educates USAMRICD personnel on the proper security procedures in accordance with all Federal, DoD, DA and local policies and directives.

1.3.14.1 – Facilitates support in the areas of Industrial, Information and Operations Security.

1.3.14.2 – Facilitates support in the areas of Physical Security and Antiterrorism.

1.3.14.3 – Facilitates support in the areas of counter and foreign intelligence.

1.3.14.4 – Facilitates support in the areas of personnel security.

1.3.15. Area 15: APHC (Prov) Technical Directorates include Health Promotion, Clinical Public Health and Epidemiology, Animal Health and Food Protection, Workplace Hazard Assessment and Control, Environmental Health, Laboratory Sciences, Toxicology and Public Health Information. These Directorates perform the following functions in support of the APHC(P) mission:

1.3.15.1. Provides operational and strategic services & expertise to the Army and DoD.

1.3.15.2. Assists the DCoS-PH Directorates in the development and oversight of Public Health programs, products, and services.

1.3.15.3. Conducts technical studies, surveys, and consultative services.

1.3.15.4. Monitors, evaluate, and reports quality of Public Health programs.

1.3.15.5. Assists the DCoS-PH Directorates in developing Public Health policy and guidance.

1.3.15.6. Evaluates regional Public Health programs.

1.3.15.7. Conducts recurring and periodic training for Regional Health Commands, Regional Public Health Commands, and Military Treatment Facilities.

1.3.15.8. Identifies and assesses current and emerging Public Health issues.

1.3.15.9. Develops and implements technical Public Health solutions.

1.3.15.10. Develops and disseminates Public Health information and evidence-based practices.

1.3.15.11. Assures effectiveness and quality of the Public Health Enterprise.

1.3.15.12. Evaluates and assures standardization and quality of Army Public Health.

1.3.15.13. Provides technical services in support of the APHC mission.

1.3.16. Area 16: APHC (Prov) Business Operations includes Human Resources, Intelligence, Operations, Logistics, Information Operations and Resource Management. The following services are provided by Business Operations:

1.3.16.1. Facilitates the development, procurement, and sustainment of standardized Public Health equipment and supplies across the enterprise.

1.3.16.2 Maintains central archive for all PHE related technical deliverables and reports.

1.3.16.3 Provides support in the area of Human Resources (HR for the Civilian and Military workforce throughout the organization.

1.3.16.4 Provides superior intelligence and security support throughout the organization.

1.3.16.5 Provides integrate operational support throughout the organization to ensure smooth and efficient accomplishment of the mission.

1.3.16.6 Provides logistics support services in the areas of facilities, property and procurement, equipment, maintenance and contract management.

1.3.16.7 Provides comprehensive information technology support to facilitate the technical mission.

1.3.16.8 Provide services pertaining to planning, programming, budget, accounting, execution, fiscal law, manpower management, cost and economic analyses, agreements, workload analysis, program analysis and evaluation and performance measurement.

1.3.17 Area 17: EACE Program Management Support Services

1.3.17.1 Provide programmatic support to the EACE executive element in the areas of human resource support, agreements management, logistics management, support budget analysis, contract management, facilities, and infrastructure management, event coordination, and knowledge management software content management.

1.3.17.2 EACE requires programmatic support to the EACE Office for Research and Surveillance, program strategy development support, research program evaluation capability, and development and execution support for research reporting requirements.

1.3.17.3 Program Management Support Services means service in support of EACE that contributes to the efficient and effective operation of programs. Services may be used at all organizational levels to help managers achieve maximum effectiveness or economy in their operations. Services may include, but are not limited to: human resource support, data use and program agreements management, logistics management, support budget analysis, facilities, and infrastructure management, event coordination, and knowledge management software content management.

1.3.17.3.1 Program management expertise to meet the EACE’s requirement for centralized support and shared services across the EACE and linked to the Army and Defense Health Agency.

1.3.17.3.2 The centralized and shared services include contract administration, facilities and infrastructure management; medical supply chain and logistics management support for prosthetics, report and study analysis capability, information technology and information management; service support for limited human capital (civilian and military) management, and financial/budget, agreements, data analytics, research program and portfolio management and manpower management.

1.3.17.3.3 Support day-to-day operational activities which includes, but is not limited to, tracking and responding to data and information calls, developing reporting formats and corresponding reports/briefings, establishing recommended schedules, and operational planning.

1.3.17.3.4 Provide strategic planning session(s) facilitation and balanced scorecard development assisting the EACE Director and staff with ensuring the long-term objectives are in-line IAW SEC. 723 of the Duncan Hunter NDAA for FY 2009 and other directives from the COE Oversight Board and DoD/VA Health Executive Board are established and maintained.

1.3.17.3.5 Provides research program management expertise, report writing and advisory support to the EACE Executive Element.

1.3.17.3.6 Provide support to the EACE’s four (4) other sections and support functions with developing day-to-day operational activities, which includes, but is not limited to, developing business and operational processes; issue resolution; preparing operational documents (e.g., develop position descriptions, presentations on key operational issues, etc.), verification and validation of data and findings; improving Quality Assurance/Quality Control processes; and program evaluation and protocols. This includes but is not limited to support for: writing information papers, creating informational and decision briefings, and preparing support documentation such as progress reports on the EACE, After Action Reports, informational documents targeted to various stakeholder groups and concepts of operations, and clinically focused information papers and reports.

1.3.18 Area 18: EACE Clinical Research Management and Administrative Support

1.3.18.1 Provide comprehensive management and administrative support to the EACE Research and Surveillance Division to facilitate the conduct of clinical research of benefit to the extremity trauma and amputation population. This capability requires knowledge of the Military Health System (MHS) and its clinical investigation and research capabilities. Additionally, this capability requires experience in basic, applied, and translational research

1.3.18.2 Management and administrative support to the Research and Surveillance Division encompasses: bio-statistical support, grant proposal development, scientific review capability, scientific writing/editing, Subject Matter Experts (SME) in outcome measurement, rehabilitation sciences, quality of life assessment, prosthetic and orthotic advancements, development of surveillance capability, secondary health issues and long-term comorbidities, functional limb loss, and medical-surgical innovations, Human Subject Research Protection program support, and research/academic collaboration development.

1.3.18.3 Reviews research documentation and provides detailed technical written notes, recurring analyses of research portfolio to identify critical gaps, exceptional results, and/or lack of progress as needed, throughout project lifecycles. Preparing manuscripts for publication and other dissemination materials, such as abstracts for presentations, posters, copyrighted materials.

1.3.18.4 The EACE requires Subject Matter Experts (SMEs) with research program management and clinical expertise to include experts in rehabilitation; physical and occupational therapists and prosthetists/orthotists; and other expertise such as physiologists, epidemiologist, biomedical engineers, regenerative medicine specialists, tissue engineers, imaging specialists, etc. Support from SMEs for clinical trials is also required.

1.3.19 Area 19: EACE Informatics Program Support - Provide capability for assisting the EACE Clinical Informatics and Technology Division in coordinating and executing information technology project activities.

1.3.19.1 This capability requires knowledge of the principles of project management in the government technology system application area and the policies and procedures of the Army Medical Command (MEDCOM), the Defense Health Agency, the Military Health System, and the DoD/VA. A major support mission will be the creation and sustainment of the DVEAR registry capability and development and management of internal knowledge management and external website(s).

1.3.19.2 Provide the EACE technical representation for functional requirement determination and registry sustainment to include design and data capture for EACE analytical purposes.

1.3.19.3 Provide Information Technology (IT) and IM security services, such as Defense Information Assurance Certification and Accreditation Process (DIACAP), prepare data use/transfer and other necessary documentation, including data use agreement, for data capture, usage and dissemination, security and privacy of sensitive health information.

1.3.19.4 Conduct data abstraction from multiple sources. Data abstraction is done in accordance with established SOPs, policies, specific guidance, criteria and procedures, and relevant quality assurance, utilization review, medical records and utilization management regulations. Uses Current Procedural Terminology (CPT) and International Classification of Diseases (ICD-9) codes in obtaining information for reviews. Collects other QM/UM data through focused studies, clinical indicator data sets, retrospective audits, individual clinical record review and other clinical data sources.

1.3.19.5 Design and deploy an external website for the EACE. Maintain, improve and refresh as needed, the EACE website, social media responses, develop mobile applications and other tools to promote the various EACE programs.

1.3.20 Area 20: EACE Clinical Affairs Support

1.3.20.1 EACE requires a capability for determining the best delivery methods to sustain identified extremity trauma and amputation treatment and rehabilitation core competencies. In addition, the EACE requires a capability for continually evaluating and updating core competencies and clinical practice guidelines (CPGs).

1.3.20.2 This capability requires clinical experience to understand the clinical requirements. This capability requires knowledge of the various disciplines involved in extremity trauma and amputation treatment and rehabilitation along with a comprehensive knowledge of effective means of educating a distributed audience.

1.3.20.3 Clinical Affairs support also requires program management support with expertise in the following areas: functional outcomes, wellness and comorbidities, core competency training pipeline assessment, clinical…