Attachment IV- Initial Task Order PWS Amended.docx

PERFORMANCE WORK STATEMENT

Initial Task Order

Operational Medicine Research Modeling Services

Research Support Services for the Operational Readiness Directorate Single Award Task Order (SATO) Indefinite Delivery, Indefinite Quantity (IDIQ) Contract

C.1. INTRODUCTION AND BACKGROUND:

C.1.1. The purpose of this Initial Task Order (ITO) Performance Work Statement (PWS) is to supplement the PWS contained in the base Indefinite Delivery Indefinite Quantity (IDIQ) contract and further define what is required for each of the positions being executed with the ITO. The base IDIQ PWS remains in effect, and the requirements listed in this ITO PWS provide further elaboration and clarification pertaining to duties, tasks, work schedule, work location, and any additional requirements that may be necessary for each of the required positions in this ITO.

C.1.2. Naval Health Research Center (NHRC) performs medical modeling and simulation research for Department of Defense (DoD), homeland defense, humanitarian assistance, peace-keeping and disaster relief activities including casualty projection, medical planning factor development, identification of weapons effects (both ground and shipboard-based), projection of resource requirements, database development and maintenance, and quality of life outcome studies.

C.1.3. This acquisition will provide contractor support services for research modeling such as casualty projection in support of operational medicine. It is heavily data driven and depends upon the collection, characterization, analysis, and reporting of data from multiple sources, including both in-house sources such as the Expeditionary Medical Encounter database (EMED) and external sources such as the Military Health System (MHS), the VA, civilian/homeland defense data, tactical data, operational data, and personnel data. Services for this ITO will primarily take place at NHRC located in San Diego, CA. Travel locations are listed in Section C.4 of this PWS.

C.1.4. This ITO is for non-personal services and considered a severable effort.

C.1.5. This ITO will be an incrementally-funded Cost Plus Fixed Fee (CPFF) task order.

C.1.6. The Period of Performance (PoP) is for two 12- months periods consisting of a base period of 12 months and option period of 12 months.

C.1.7. There is no anticipated potential OCI within this task order.

C.1.8. There is no anticipated Government Furnished Equipment/Property (GFE/P) within this task order.

C.2. SCOPE OF WORK

C.2.1. The Modeling and Simulation (M&S) department at NHRC conducts analysis and develops models to provide medical decision support to operational commanders, medical logisticians, and field medical personnel as they determine the resources required to support combat and peacetime deployments. M&S works with medical planners, providers, and logisticians to develop projects that assist in field medical services planning, systems analysis, operational risk assessment, wargaming, and the determination of the best course of action for treating a particular patient stream using the available resources.

The contractor shall perform the following activities:

C.2.1.1. Support both in-house and external medical modeling and simulation data sets, monitor for data integrity, and perform statistical analysis of these data sets. The contractor shall draft NHRC technical reports, informational/marketing material, and articles for peer-reviewed journals based on the results of the analyses of these data sets. The performer must assist in development of operationally-relevant research ideas, operationally-relevant research designs, and be capable of interpreting research results in terms of operationally-relevant concepts, products and recommendations. Contractor shall support a variety of physical, physiological and psychological performance research projects. The goals of these efforts are to improve fitness, human performance, or develop surveillance markers of Traumatic Brain Injury (TBI), or recommend return-to-duty criteria for wounded service members. The Contractor shall assist with recruiting subjects, conducting relevant data collection, administering and maintaining exercise and physical exertion in field and laboratory settings to include assistance with: setting up equipment for conducting and running specified experiments, collecting and analyzing data in accordance with established methods and procedures, performing bio-chemistry analyses, and contributing to data analysis and report submission.

C.2.1.2. Provide support for studies, analyses and reporting. Assemble, examine, and abstract relevant clinical data from service member medical records, theater medical data, event data, and large DoD/VA databases from both in-house and remote locations such as DoD/VA Medical Treatment Facilities (MTFs) and enter data into the EMED or other DoD, homeland defense, humanitarian assistance, disaster relief and Dept. 161 databases.

C.2.1.3. Develop database structures, monitor data integrity, perform data quality assurance, support databases, and write data queries to extract data from both in-house and large, external DoD (including Internal Revenue Service Data, Health and Human Services Data, and Census Data), homeland defense, humanitarian assistance, and disaster relief databases. All quality assurance duties are subject to Government approval. Data will not be utilized from non-Governmental entities.

C.2.1.4. Develop injury/ICD-9/ICD-10 (International Classification of Diseases 9th/10th edition/revision) profiles for various operational scenarios and model weapons effects and medical resource requirements.

C.2.1.5. Develop clinical ICD-9/ICD-10 based treatment profiles for operational scenarios and model weapons effects and medical resource requirements.

C.2.1.6. Assign medical supplies to ICD-9/ICD-10 treatment profiles for various operational scenarios and model weapons effects and medical resource requirements.

C.2.1.7. Develop data sets and methodologies to project casualty rate estimations using both current methodologies as well as developing new methodologies. Identify medical planning factors and model their effects on DoD operational scenarios, humanitarian assistance, homeland defense and disaster relief missions.

C.2.1.8. Code data abstracted from member medical records with the utilization of the Military Abbreviated Injury Scale-2008 using the following taxonomies: International Classifications of Diseases, Abbreviated Injury Scale, Injury Severity Score, and DSM-IV (Diagnostics and Statistical Manual of Mental Disorders 4th edition) Axis Codes.

C.2.1.9. Develop and support longitudinal, large cohort studies of casualty experiences, clinical, rehabilitative, long term, and quality of life outcomes. This includes senior epidemiological scientist, study manager/analyst/writer, interviewers, development and maintenance of subject identification and tracking methodologies, website design, advanced scientific analysis techniques, drafting of scientific papers and publishing of scientific papers in peer review publications.

C.2.1.10. Examine, interpret, and prepare reports on various aspects of casualty clinical records, including subject areas of general surgery, orthopedic surgery, neurology, pathology, and radiology. The contractor shall examine and interpret casualty clinical records; code injury data into diagnostic and severity categories; analyze both in-house and external DoD data; and write reports describing findings in scientific peer review publications.

C.2.1.11. Assist research efforts utilizing large DoD/VA clinical, operational and personnel data bases for performing epidemiological research. The contractor shall utilize programs such as (but not limited to) Statistical Analysis System (SAS) and Statistical Package for the Service Solutions (SPSS) to perform advanced statistical analyses on large DoD/VA data sets. These data sets include the Theater Medical Data Store (TMDS), Military Health System Data Repository (MDR), Clinical Data Repository (CDR), Armed Forces Health Longitudinal Technology Application (AHLTA), and Armed Forces Health Longitudinal Technology Application-Theater (AHLTA-T), Veteran Affairs (VA), Expeditionary Medical Knowledge Warehouse (EMedKW), and the Expeditionary Medical Encounter Database (EMED).

C.2.1.12. Provide information technology to support: in-house and external database infrastructure development, maintenance, and querying of the EMED.

C.2.1.13. Provide technical support to other commands to install, instruct, and support NHRC developed software and applications to facilitate expansion of functional capabilities into the training and exercise support domains, including federating NHRC medical models into larger DoD war-gaming simulations. Provide support between NHRC and operational commands. Provide on-site support of Department 161 activities at commands outside NHRC.

C.2.1.14. Provide programming support for integrating NHRC modeling and simulation tools into both service-specific and DoD simulation tools and suites.

C.2.1.15. Support and develop plans to modernize NHRC developed software and applications, including casualty forecasting and injury projection. The contractor shall utilize programs such as (but not limited to) EMedKW, Enterprise Estimating Supplies Program (ESP), ReSupply Validation Program (RSVP), Joint Medical Planning Tool (JMPT) and Medical Planners Toolkit (MPTk) clinical modeling tools.

C.2.1.16. Assist in the design and development of new tools and applications in support of DoD, VA, homeland defense, humanitarian assistance, and disaster relief modeling and simulation.

C.2.1.17. Conduct epidemiology support to ongoing and future projects by developing testable research hypotheses, reporting data trends and data management of longitudinal data sets using TMDS, MDR, CDR, AHLTA, Pharmacy Data Transaction Service (PDTS), AHLTA-T, EMED, MPTk, and JMPT.

C.2.1.18. Provide editorial and clerical support for the aforementioned projects to include editing, word processing, and project maintenance requirements and budgeting elements.

C.2.1.19. Monitor theater medical data collection activities and provide theater data collection support and training.

C.2.1.20. Develop procedures, identify data sets, and perform studies and analyses using clinical and tactical event data. Contractors must meet the minimum requirements stated at Section C.2.6. in the basic contract.

C.2.1.21. The awarded contractor must have an active Data Sharing Agreement (DSA) in place before commencement of services with the Office of the Secretary of Defense (OSD) (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A DSA must also include full access to protected health information. Obtaining an active DSA is a minimum requirement for the awarded contractor as failure to have a current DSA with OSD (Tricare Management Agency - TMA) before commencement of services would result in a work stoppage in NHRC department 161 and a failure for the Government to meet funding sponsor requirements for product delivery.

C.3. LABOR CATEGORIES AND EDUCATION/EXPERIENCE/OTHER REQUIREMENTS AND DUTIES

C.3.1. Labor Categories: All labor categories shall conduct their duties as outlined in the base contract SOW/PWS. All labor categories shall meet the Education/Experience/Other Requirements provided in the base contract SOW/PWS.

C.3.2. The Contracting Officer reserves the right to review the qualifications of all personnel performing or to be performing on this contract.

C.3.3. The estimated direct labor mix to accomplish the aforementioned research is included below:

*Considered key personnel in performance of this task order

Resumes are provided for all key personnel positions. Key personnel shall demonstrate sufficiently enough to the Government that the person proposed has the knowledge and experience relevant to accomplish the aforementioned tasks.

The Government estimates a full time equivalent (FTE) at 1920 hours (One FTE = 1920 hours (2080 hours – 80 hours holidays – 80 hours PTO)) for the purposes of the estimated level of effort that is provided at the task order level.

C.4. TRAVEL AND OTHER DIRECT COSTS

C.4.1. Travel approval must be processed in accordance with NHRC procedures, in accordance with Joint Travel Regulations, documented and submitted with monthly reports and correlated with a corresponding line item in the invoice for payment. All travel must be endorsed by the COR in writing via e-mail prior to the Contractor incurring any costs. Travel destinations may include, but are not limited to:

C.4.2. Other Direct Costs (ODCs): There may be ODCs (includes items incidental in performance such as costs associated with executing research studies) required to perform this PWS (NTE $200,000 per year before contractor burdens), and will be endorsed by the COR, in accordance with NHRC procedures, for this contract.

C.4.3. Subcontracts: There may be subcontracts for consultants (NTE $670,000 per year before contractor burdens) required to perform this PWS. The Government estimates this would equate to 6700 hours (or less) per each period of performance (base and option). In order to further research goals, consultants would provide the following capabilities:

a. Project management

b. Data Analysis

c. Manuscript writing

d. IT/database support

C.5. DELIVERABLES

C.5.1. Data deliverables shall have been reviewed in accordance with the Department of the Navy Policy on Digital Product/Technical Data, Assistant Secretary of the Navy for Research, Development and Acquisition, ASN (RDA), memo of 23 October 2004.

C.5.2. Data Deliverables will include (but are not limited to):

· Monthly Invoices: All monthly invoices must be submitted to the TPOC and COR. In addition, Quarterly Status Reports (see bullet below) are to be submitted on a quarterly basis accompanying the monthly invoice. Upon approval of invoice and receipt of a signed DD250, the Contractor must upload it electronically through Wide Area Work Flow (WAWF). The Contractor shall submit invoices/cost vouchers for payment per terms of the contract; the Government shall process invoices/cost vouchers for payment per terms of the contract; and for each invoice/cost voucher submitted, the Contractor shall email WAWF automated invoice notice to the Government point(s) of contact outlined in the contract.

· Quarterly Status Report: The Contractor shall submit to the COR a quarterly status report beginning with 90 calendar days after award of the contract until completion of the period of performance. The Contractor shall outline progress made under the contract within the 90-day period, as well as highlight achievements and problem areas that impact the performance and progress of the effort. These reports shall contain, at a minimum, discussion of any significant issues, copies of any abstracts or reports sent out for presentations or publications, and a short report/status of each task.

C.6. METHODS OF QUALITY ASSURANCE SURVEILLANCE

C.6.1. This Quality Assurance Surveillance Plan (QASP) serves as the principal basis for assessing overall performance quality by the Contractor and is delineated in the table below. This document will be used by the Government to assess the effectiveness of the Contractor’s performance, including on a risk rated basis. This QASP provides the methodology by which the Contractor's performance will be monitored to determine compliance with established performance objectives and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed so that surveillance is limited to that which is necessary to verify the Contractor is performing satisfactorily and relates directly to performance objectives of the performance objectives delineated in the PWS.

C.6.2. The QASP applies to severable task orders only.

C.6.3. QASP Matrix

TASK/

DELIVERABLE

ACCEPTABLE LEVEL OF PERFORMANCE (ALP)

METHOD OF SURVEILLANCE

AND RISK RELATED SCHEDULE

PERFORMANCE RATING

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Are the quarterly status reports complete, and are they compliant with various Government regulations?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent: Performance meets all contract timeliness requirements. Problems that are encountered are minor and resolved in a highly effective manner, having no impact on schedule, cost, and overall contractor performance.

Acceptable: Performance meets most timeliness requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance Unacceptable: Performance fails to meet many timeliness requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor committed to high customer satisfaction? How proactive is the contractor? Is the contractor providing positive value to the Government?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Periodic Inspection

What is the Governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.