A07_PWS.docx

CONTENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Walter Reed Army Institute of Research, Preventive Medicine Branch, the Department of Epidemiology and the Accession Medical Standards Analysis and Research Activity (AMSARA)

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. BACKGROUND

In support of the Surgeon General’s responsibility to conduct research and operational health studies that have the goal of improving readiness, combat effectiveness, and soldier health, the Department of Epidemiology (within the Preventive Medicine Branch) conducts epidemiologic studies of health threats and of various clinical, laboratory, behavioral, and administrative approaches involved with managing these threats. The studies involve both infectious and non-infectious disease issues. A full range of epidemiologic methodologies are used in quantifying absolute and relative risk, identifying risk factors and trends, documenting natural history, validating assays and other measurement techniques, determining the validity, reliability and overall accuracy of screening tests. Studies to support policy development, such as cost effectiveness and cost-benefit studies, are also performed. Included in the Department of Epidemiology is the Accession Medical Standards Analysis and Research Activity (AMSARA), whose core mission is to support the Accession Medical Standards Working Group (AMSWG), under the Medical Personnel Executive Steering Committee (MEDPERS), by providing data reports to support the revisions of DoD Instruction 6130.03, “Medical Standards for Appointment, Enlistment, or Induction in the Military Services.” This requires receiving and analyzing data from multiple data sources and providing tables of data for subject matter experts to review prior to AMSWG meetings.

2. SCOPE

The AMSARA was established in 1996 within the Preventive Medicine Branch at WRAIR to support the effort of the AMSWG. The Contractor shall assist AMSARA in supporting the development of evidence based medical standards by conducting of epidemiologic analyses and integrating relevant operational, clinical, and economic considerations into policy recommendations. The Contractor shall follow WRAIR protocols for accession, attrition, and morbidity studies. These protocols require acquiring data from multiple military sources, cleaning and merging data to create an analytic dataset, performing statistical analyses, generating results, and preparing reports and presentations.

The Department of Epidemiology has been tasked by the Assistant Secretary of Defense Health Affairs, Clinical Program and Policy office to perform an audit and a study of the DoD Disability Evaluation System (DES). The Contractor shall support an audit that analyzes the DES process to include the Medical Evaluation Board (MEB), the Physical Evaluation Board (PEB), the Physical Disability Agency (PDA) review and final disposition from fit for duty or discharge from service. The DES study will examine the relationship between accession, pre-existing conditions defined as medical disqualification and/or medical waiver, service related factors such as military occupation, accidents, and deployment with disability dispositions by diagnostic categories, adjusting for demographic factors, service, year, and length of service. Scientists in the department of epidemiology may receive funding for new studies in which case the Contractor’s support will be required. Contract personnel assigned to such projects will work jointly with the Department of Epidemiology staff.

3. OBJECTIVES

The main purpose of this IDIQ type contract is to provide epidemiological, statistical, and limited administrative support for AMSARA, funded projects of the Department of Epidemiology, and WRAIR researchers. The Department of Epidemiology and AMSARA support a collaborative and iterative process on research protocols supported by the work outlined in this PWS. The goal of these projects and this PWS is to produce multiple large scale annual reports per fiscal year and to produce ongoing epidemiologic analyses, approximately 15-20 per year; which may result in scientific presentations and peer-review publications. These publications will be primarily authored by the Government with assistance and support from the contract personnel.

The three (3) main tasks of this requirement shall flow through the issuance of Task Orders individually negotiated and issued pursuant to the contract by the Contracting Officer (KO). The work statement for each required outcome will be detailed in each task order. More than one task order can be issued at any one time with overlapping periods of performance. The first is to provide overall support of AMSARA. This support entails the Contractor helping conduct epidemiological analyses and integrating relevant operational, clinical, and economic considerations into policy recommendations. The second task consists of the audit and study of the Disability Evaluation System (DES). The audit will analyze the DES process to include the Medical Evaluation Board (MEB), Physical Evaluation Board (PEB), Physical Disability Agency (PDA) review and final disposition from fit for duty or discharge from service. Analysis will be performed by service and fiscal year and will examine trends and variations in diagnosis categories, time to completion, disposition, and disability rating. The DES study will examine the relationship between accession, pre-existing conditions defined as medical disqualification and/or medical waiver, service related factors such as military occupation, accidents, and deployment with disability dispositions by diagnostic categories. The third task is to provide support to the Department of Epidemiology funded research studies. The proposals are pending approvals for these research studies. The contractors who are assigned to these projects will work alongside the staff of the Department of Epidemiology to acquire data from multiple military sources, clean and merge data to create an analytic datasets, perform statistical analyses, generate results, and prepare manuscripts, reports and presentations.

4. PERIOD OF PERFORMANCE

The overall length of contract is five (5) years. This includes a base year plus four (4) 12 month option periods.

5. REQUIRED TASKS

The requirements for this contract include but are not limited to the following:

5.1 Task 1: Support to AMSARA

The Contractor shall assist AMSARA in supporting the development of evidence based medical standards by conducting of epidemiologic analyses and integrating relevant operational, clinical, and economic considerations into policy recommendations. The Contractor shall follow WRAIR protocols for accession, attrition, and morbidity studies. These protocols require acquiring data from multiple military sources, cleaning and merging data to create an analytic dataset, performing statistical analyses, generating results, and preparing reports and presentations. AMSARA may be asked to conduct research and prepare operational responses as directed by AMSWG and MEDPERS. This work takes place at WRAIR. The potential exists for intermittent, short term work at other sites (Appendix A). This project is heavily dependent on good epidemiologic study design, the use of appropriate and valid means for data collection, effective and efficient data base management, technically demanding statistical analysis and interpretation, and the effective communication of findings to a variety of interested parties.

5.2 Task 2: Disability Evaluation System (DES) Audit Study

The Department of Epidemiology has been tasked by the Assistant Secretary of Defense Health Affairs, Clinical Program and Policy office to perform an audit and a study of the DoD Disability Evaluation System (DES). The Contractor shall support an audit that will analyze the DES process to include the Medical Evaluation Board (MEB), Physical Evaluation Board (PEB), Physical Disability Agency (PDA) review and final disposition from fit for duty or discharge from service. Analysis will be performed by service and fiscal year and will examine trends and variations in diagnosis categories (i.e. musculoskeletal, psychiatric, etc.), time to completion, disposition, and disability rating. The DES study will examine the relationship between accession, pre-existing conditions defined as medical disqualification and/or medical waiver, service related factors such as military occupation, accidents, and deployment with disability dispositions by diagnostic categories, adjusting for demographic factors, service, year, and length of service. Databases available to AMSARA under task 1 will be utilized for this task, as well as the potential addition of service medical evaluation board, the Defense Safety Enterprise System (DSES) data, and Military Health System data repository.

5.3 Task 3: Support to the Department of Epidemiology Funded Research Studies (proposals are pending approval).

The Department of Epidemiology research is directed toward a wide spectrum of public health issues affecting military readiness and national security. Scientists in the department of epidemiology may receive funding for new studies in which case the Contractor’s support will be required. Contract personnel assigned to such projects will work jointly with the Department of Epidemiology staff. The tasks may require acquiring data from multiple military sources, entering, cleaning and merging data to create an analytic dataset, performing statistical analyses, generating results, and preparing reports and presentations.

5.4.5.6 Assist with maintenance and updates of the AMSARA/DES website.

5.4.5.7 Assist with maintenance of inventories of Government Furnished Equipment (GFE) used by the contractors.

5.4.5.8 Coordinate request and distribution of contractor’s supplies.

5.4.5.9 Coordinate the contractor’s software requests, updates, and maintenance.

5.4.6 Subtask 6 – Contractor shall provide advice and recommendations for the technical sections of proposals for new studies aligned with AMSARA/DES’s mission in response to funding opportunities.

5.4.7 Subtask 7 – Contractor must perform and be in compliance with the regulations, policies, and directives of the Department of Defense (DoD), the Department of Army (DA), the Office of the Surgeon General (OSG), Medical Research and Material Command (MRMC), and Human Subjects Protection Branch (HSPB) at WRAIR. The Contractor must also comply with Preventive Medicine Branch Standard Operating Procedures (SOP) and Data Use/Sharing Agreements (DUA/DSA). The Contractor must be accountable for maintaining and returning scientific materials with purchase values of $100 or more.

5.5 Task 4

The contractor shall provide additional requirements that are necessary in accordance with the timelines provided. Specifically, the contractor shall provide a Quality Control Plan (QCP). The QCP shall document how the Contractor will meet and comply with the requirements and performance objectives.

6. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table”.

DELIVERABLES TABLE

Task 1: Support to AMSARA

By the end of the calendar year during each period of performance or by established deadline date for specific source.

Task 1: Support to AMSARA

Task 1: Support to AMSARA

Task 1: Support to AMSARA

http://www.amsara.amedd.army.mil/AMSARAAR.aspx.

By 6 months after receipt or established study specific deadline date.

Task 1: Support to AMSARA

By 8 months after data receipt or by established study specific deadline date.

Task 1: Support to AMSARA

Task 1: Support to AMSARA

Task 1: Support to AMSARA

Task 1: Support to AMSARA

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

By 4 months after data receipt or established study specific deadline date.

Task 2: Disability Evaluation System Audit Study

By 6 months after data receipt or established study specific deadline date.

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

Task 2: Disability Evaluation System Audit Study

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

By 1 month after publication or by established deadline date.

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

Tasks 1-4

By 12 months after the data receipt or established study specific deadline date.

Tasks 1-4

Within 21 days after the contract is awarded.

Tasks 1-4

Tasks 1-4

Tasks 1-4

6.1. Inspection and Acceptance

The COR delegated oversight of specific technical, functional, and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

6.2. Acceptance Criteria

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary

5.2 DoD Disability Evaluation System (DES) Audit and Study

Research meets mission timelines

Milestones will be met 95% of the time

5.3 Support of Department of Epidemiology Funded Research Studies (proposals are pending approvals)

Contractor personnel will assist in new studies as required

Contractor study participation 100%

17.14 SHARP Contract Requirements and Deliverables Contractor shall meet SHARP Contract Requirements and Deliverables

Contractor shall meet SHARP Contract Requirements and Deliverables 100% of the time

8. TRANSITION SUPPORT

8.1. Outgoing Transition Plan

In accordance with this solicitation, the Contractor shall provide an outgoing transition plan (Deliverable 32) for 90 day of outgoing transition for transitioning work from an active award to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. This transition plan shall include, but is not limited to:

· Coordination with Government representatives,

· Transfer of hardware warranties and software licenses (if applicable),

· Transfer of all necessary business and/or technical documentation,

· Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches (if applicable),

· Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance (if applicable),

· Applicable WRAIR debriefing and personnel out-processing procedures.

· Turn-in of all government keys, ID/access cards, and security codes.

· Return all scientific materials including those with purchase values of $100 or more

· Summarized Final Report

9. QUALITY CONTROL

The Contractor shall prepare and adhere to a Quality Control Plan (QCP) (Deliverable 31). The QCP shall document how the Contractor will meet and comply with the requirements and performance objectives. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

10. KEY PERSONNEL

10.1 The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key Personnel table.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel.

KEY PERSONNEL TABLE

10.2 The contractor shall provide and maintain sufficient personnel to accomplish the work required by this contract and ensure the contract personnel have the skills, technical knowledge, and experience to perform the work.

10.3 Contract personnel shall reach full professional proficiency in reading, writing, speaking, and understanding English.

10.4 The effort requires access to various Department of Defense (DoD) records and databases. Contract personnel shall have a favorable background check (National Agency Clearance) without evidence of criminal activity prior to employment under this contract. The Government, at contract award, will furnish passwords needed to enter the databases to the Contractor.

10.5 The contractor shall provide an on-site individual to act in the capacity of contract program manager who shall be responsible for the overall management and coordination of work under this contract. The contract manager shall be available during normal duty hours. After duty hours, the contract manager shall be available by phone. The contract manager shall remain at the contract work site at all times unless meetings at the contractor's office are necessary. These meetings shall not exceed 8 hours per month unless prior approval is received.

10.6 The Contractor shall not employ any person identified as a potential threat to health, safety, security, general well-being, or mission of the WRAIR. The Contractor shall not employ off-duty military personnel or persons who may present a conflict of interest.

10.7 The Contractor shall be able to access the Defense Health Agency (DHA) PHI via Military Health System Data Repository (MDR). To obtain access to the Defense Health Services Systems (DHSS) Computing Environments contract personnel are required to have U.S. citizenship and an Automated Data Processing Level II (ADP-II)/National Agency Check with Law and Credit (NACLC), or better, position sensitivity designation.

10.8 The Contractor shall assure that all contractor personnel performing on this contract are familiar with and observe all safety regulations and Standing Operating Procedures including but not limited to annual security and fire safety and that such personnel take part in mandatory training deemed necessary by the Government including, but not limited to annual fire safety, physical security, Health Insurance Portability and Accountability Act (HIPAA), information assurance, human subject research protection training, and any other training required by SOPs or data agreements. In order for contractor personnel to access Army networks, all contractor personnel must take the required Information Assurance training prior to employment. This training will be made available to the successful offeror personnel during the transition period on site at the WRAIR facility. Otherwise, the DoD required training is provided at no cost to the successful offeror and can be completed during the work day utilizing GFE. The contractor shall be responsible for ensuring personnel filling the requirements of this PWS possess the required training and certifications to ensure competent performance. The following is a listing of DoD required training:

MEDCOM

HQDA 350-1 Mandatory Training

Walter Reid Army Institute of Research (WRAIR)

Army Human Subjects Protection Requirements; 32 CFR 219; 21 CFR 50; Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects Research, 1979; Office of Human Research Protections (OHRP) Guidance on Engagement of Institutions in Human Subjects Research, 16 Oct 2008; USAMRMC Policy #2010-33 Requirements for Initial and On-going Education and Training in the Protection of Human Subjects in Research, 10 Dec 2010; and WRAIR Policy Letter #11-49 Initial and Continuing Human Subjects Protection Education and Training Requirements, 21 Oct 2011.

Initial and Refresher every 3 years

10.9 Additional training may be required as identified by the respective Command Units. Contractor personnel shall be notified if additional training is required at any time during the performance of this effort.

10.10 The contractor is responsible for the security of all Government Furnished off-site equipment, to include laptop computers, when used by contract personnel at remote sites.

10.11 Travel funding for contractors will include air fare, car rental or taxi (as appropriate), hotel and per diem for meals and incidentals. Per diem shall be at the established GSA per diem rate for the respective location.

11. SUGGESTED SUPPORT