Attachment_IV_Initial_FFP_Task_Order_PWS.docx

NAMRU-2 INITIAL FFP TASK ORDER (ITO) – PWS--R&D SUPPORT SERVICES

Project and Program Management Support

1. BACKGROUND

This acquisition will provide research program and administration of the NAMRU-2 human subject research program.

1.1 The purpose of this Initial Task Order (ITO) PWS is to supplement the PWS contained in the base contract and further define what is required for each of the positions being executed with the initial task order. The base 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 on this task order.

1.2 For the purposes of constructing the price proposal, the Government estimates the following costs that are required to provide the below mentioned services:

Travel: $27,000 Offerors shall use the amounts provided above in the construction of their Price proposal. All ODC and Travel costs are estimated amounts and are before contractor burdens. Contractor burdens must be applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

Travel shall be approved in advance and in writing by the COR.

1.3 The period of performance for this task order shall be 12 months from the date of award. The period of performance will be: 12 August 2018 to 11 August 2019.

1.4 Human use research is expected under this task order. A task order that contains research with human subjects may not be awarded unless the contractor (and all subcontractors) possess a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). Additionally, all research must be approved by an Institutional Review Board (IRB) named in the Assurance application before the research commences. A Human Research Protection Officer (HRPO) review must be in place before the task order is awarded.

1.5 This task order is considered a severable effort and is performance based.

1.6 This task order will be issued as Firm Fixed Price.

1.7 A Secret clearance is required for this task order.

1.8 This task order requires indemnification and medical liability insurance. The Federal Tort Claims Act does not apply.

1.9 The following positions are considered Key Personnel and require a resume to be provided with the offerors technical approach:

Biostatistician Epidemiologist Program Manager

GLOBAL REQUIREMENT

The Naval Medical Research Unit Two (NAMRU-2), based in Singapore, is at the forefront of the U.S. Department of Defense (DoD)’s infectious disease research and surveillance efforts in the US Pacific Command (PACOM) Area of Responsibility (AOR). Within the context of its ongoing infectious disease research and surveillance activities, the NAMRU-2 is well-positioned to evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise via training to detect and respond to emergent disease threats.

SPECIFIC REQUIREMENTS

This requirement is to put in place personnel and process infrastructure that will facilitate Navy Medicine’s mission to conduct Research & Development (R&D) across its enterprise, including commands that the Navy collaborates with, supports, and reports to (e.g., OASD-Health Affairs, Defense Health Agency, US Army). In addition to providing personnel, materials, equipment, and facilities (non-construction (bonded), non-Government spaces), this requirement addresses process infrastructure (such as basic research, vaccine development, clinical trials, or FDA IND application processing).

Navy Medicine provides high quality, economical health care to beneficiaries in wartime and in peacetime. Highly trained Navy Medicine personnel deploy with Sailors and Marines worldwide –providing critical mission support aboard ship, in the air, and on the battlefield. At the same time, Navy Medicine’s military and civilian health care professionals are providing care for uniformed services’ family members and retirees at military treatment facilities around the globe.

AREAS OF SUPPORT

The intent of this task order is provide support to Navy Medicine in the conduct of biomedical, epidemiological and clinical research efforts. Direct project and program mission support of the following:

1. Research Mission Support – Conduct analyses and develop solutions to provide medical decision support to command, medical logisticians, and research personnel

2. Behavioral Sciences & Epidemiology – Conduct research and development in the areas of epidemiology, predictive profiles, and interventions in recruit and active-duty populations; prevention, sub typing and viral resistance, and diagnostics.

3. Environmental Health Effects– Support Fleet operational readiness, protect the Warfighter, and provide the Department of the Navy, the Bureau of Medicine and Surgery, and other customers with timely solutions to current and anticipated operational problems through an integrated approach to innovative human effects toxicological research.

4. Environmental and Molecular Health Effects: This research can be divided into two main areas. One area is primarily involved in the evaluation of exposure to a variety of materials of interest to military personnel at the molecular (DNA, RNA, protein) level. The second area is involved in the development of improved methodology to assess the impact of operations on the overall health of the environment as it relates to the health of personnel exposed to a potentially contaminated area, as well as to activities occurring in the environment after it is vacated by the military. In addition, a focus of research is the development of biological sensors to protect personnel against a wide range of threats of chemical and biological nature.

5. Etiological Research – Conduct etiological research, which includes studies of emerging infectious enteric and pulmonary diseases and validation of methods for surveillance of such diseases; basic and applied research to support an understanding of the etiologic agents underlying such disease; development and testing of vaccines and therapeutics to address treatment of such diseases; and epidemiological investigations following outbreaks.

6. Human Research Protection and Institutional Review Board Services – Conduct services in support of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB). Based on the Federal Common Rule established under Title 45 CFR Part 46, research institutions and sponsoring agencies follow policies set forth under their respective HRPP. The guiding body of the HRPP is the IRB, a supervisory panel formed in order to provide ongoing monitoring and periodical review of scientific, ethical, and regulatory compliance in Human Subject Research projects. IRBs are governed by Title 45 CFR Part 46 (Department of Health and Human Services – “Protection of Human Subjects”) and Title 21 CFR Part 56 (Food and Drug Administration – “Institutional Review Boards”)’ additionally, Title 21 CFR Part 312 (FDA –“Investigational New Drug (IND) Application”) outlines the protocol for IND research and clinical trial of new drugs and treatments for human use.

7. Developing technical reports, peer-review journal articles and conference presentations as well as any clerical needs required for the aforementioned projects.

PROCESS INFRASTRUCTURE

In addition to R&D support and services, a requirement to address the conventional process for maturation of research into the treatment facility via protocols, clinical trials, and FDA related applications such as those available via a Contract Research Organization. Recent trends show an increasing need to move research results more quickly to clinical settings. Clinical research is a vital component of progress toward improving America's health. Although clinical research helps assure that new treatments are safe and effective, it is a lengthy and sometimes inefficient process. The current system of clinical research must be re-engineered if it is to respond to these changing scientific and health care needs. Meeting these demands will require new and more efficient approaches to discovery and clinical validation of research results. The initiatives within this TO for Medical Research project management aim to contribute to accelerating and strengthening clinical research by adopting a systematic process infrastructure that will better serve the command, Navy Medicine and the warfighter in the evolving field of scientific discovery.

Travel will be required to fulfill the requirements of this contract and may be inside the Contiguous United States (CONUS) or outside of the Contiguous United States (OCONUS). The Contractor may be required to attend various meetings and reviews or to participate in Government projects.

The Contractor shall ensure that the requested travel costs will not exceed what the Government has pre-authorized. Contractor personnel must follow established Government travel requirements, complete all forms, and obtain the required signatures prior to any travel. The Contractor may be required to coordinate with other DOD and industry for travel. Trip reports may be required at the direction of the Government.

Reimbursements for travel will be in accordance with JTR and will in no case exceed those travel costs allowed by the JTR unless approved by the Government. The travel costs must be approved by the COR prior to the contractor incurring any costs.

The Contractor may be required to obtain materials/equipment to be used in performance of this contract. The COR must approve all purchases in advance and prior to the Contractor incurring any charges.

Project: Project Management and Research Support Services Location: Cambodia and Singapore

A. Project management

1. A project management office, abbreviated to PMO, is a group or department within a business, agency or enterprise that defines and maintains standards for project management within the organization. The PMO strives to standardize and introduce economies of repetition in the execution of projects.

There is an existing PMO Framework at the command. The contractor shall support staff to operationalize the PMO framework by optimizing return on investment through improved program administration and management, development of comprehensive project files, institution and training on command knowledge management systems. This is to ensure that the command provides a successful return on investment to stakeholders/funders. A holistic PMO support allows the NAMRU-2 Scientists to conduct their research in a manner that is fully compliant and harnesses acquisition best practices, thereby improving relationships with regional partners and increasing efficiencies (cost/schedule/scope/performance).

2. A major focus of this effort with be in support of project integration management

3. Primarily developed and led by home office staff

B. Provide in-country research support services outlined below:

Program Manager (1 FTE at 1,920 Hours per FTE)

a. Description: The Program Manager (PM) is responsible for providing overall administrative and management oversight in order to maximize the effective use of program resources. PM will coordinate corporate support for research program functions and activities with NAMRU-2 leadership and the in-country Project Manager(s). PM will also assist in defining and determining personnel, budgets, and facilitating the establishment of agreements with in-country collaborators and subcontractors to initiate foreign research projects.

b. Location: US-based

c. Qualifications: This position requires the equivalent of a college degree in Human Resources Management, Business Administration, or science-related field plus 4 to 6 years of experience supporting US military medical research programs. Equivalent of an advanced degree is preferred but not required.

Finance & Accounting Specialist (5 FTEs at 1,920 Hours per FTE)

a. Description: This position will prepare financial data for monthly reports, advise the Project Manager on cost issues, and provide overall cost data analysis for NAMRU-2 research program support.

b. Location: Located near or co-located at NAMRU-2 facilities in Cambodia and/or Singapore

c. Qualifications: Knowledge of government contracts, finances, invoice preparation, and general accounting tasks. Ability to interface with investigators, vendors, research staff, and USG finance personnel. A college degree in business administration, accounting, or related field plus 2-4 years of related experience is required. An advanced degree is preferred but not required.

Biostatistician (1 FTE at 1,920 Hours per FTE)

a. Tasks: This position will provide statistical support for evaluation/research studies, including study design, sample size estimation, participant randomization, statistical analyses, and interpretation of data.

b. Location: NAMRU-2, Singapore

c. Qualifications: A Master’s degree in biostatistics, mathematics, or a related field, with knowledge of SAS programming is required.

Epidemiologist (1 FTE at 1,920 Hours per FTE)

a. Tasks: This position will work with NAMRU-2 researchers to conduct data analyses and interpret biosurveillance findings to assist in the development of conclusive research reports related to epidemiological studies. The epidemiologist may also advise on outbreak investigations and response plans in collaboration with in-country research partners.

b. Location: NAMRU-2, Singapore or Cambodia

c. Qualifications: Senior epidemiologist necessitates doctoral (M.D. and/or Ph.D.) degree in public health, epidemiology, or biostatistics and at least 6 years of experience in clinical and epidemiologic research, and experience in building national public health programs in developing countries. A minimum of 4 years of previous international work experience, the ability to work both independently and the ability to work on a team in an interdisciplinary environment are essential.

Database Administrator (1 FTE at 1,920 Hours per FTE)

a. Tasks: This position is responsible for evaluating and analyzing database systems used by NAMRU-2 to determine and develop solutions to better support researchers, especially in the area of data entry. The Database Specialist may also provide data entry support for NAMRU-2 researchers.

b. Location: NAMRU-2, Singapore or Cambodia

c. Qualifications: Bachelor’s degree in computer science or related field with knowledge of database management and data entry required.

Information Technology Specialist (1 FTE at 1,920 Hours per FTE)

a. Tasks: This position is responsible for supporting information systems under the guidance of NAMRU-2 information technology and systems administrators. The Information Technology Specialist will help trouble shoot problems and support NAMRU-2 researchers with NAMRU-2 information systems.

b. Location: NAMRU-2, Cambodia

c. Qualifications: Bachelor’s degree in computer science or related field with knowledge of information technology and support activities.

Computer Operator Assistant (2 FTEs at 1,920 Hours per FTE)

a. Tasks: Support NAMRU-2 computer system administrator maintain computer hardware and software systems.

b. Location: NAMRU-2, Cambodia

c. Qualifications: Associate’s degree in computer science or 2 years’ experience working in computer systems support.

Biosafety Technician (2 FTEs at 1,920 Hours per FTE)

a. Tasks: The Biosafety Technician supports NAMRU-2 programs for the disposal of biological materials, infectious agents and chemicals in compliance with US government and host national requirements. Assists with inspections and audits to ensure compliance with federal, host nation regulations, and institutional policies.

b. Location: NAMRU-2, Cambodia

c. Qualifications: Bachelor or Associate’s degree in laboratory or related sciences with knowledge of biosafety programs and regulations.

Laboratory Assurance Specialist (2 FTEs at 1,920 Hours per FTE)

a. Tasks: The Laboratory Assurance Specialist supports NAMRU-2’s laboratory manager, assure laboratory tests are conducted per standard procedures and that all relevant records are maintained for laboratory accreditations and intuitional quality assurance programs.

b. Location: NAMRU-2, Cambodia

c. Qualifications: Bachelor's degree in Medical Technology or equivalent or three to five years progressive responsibility in the specialty of Quality Assurance.

Document Control Specialist (4 FTEs at 1,920 Hours per FTE)

a. Tasks: The Document Control Specialists will support departments and manage documents while also ensuring their accuracy, quality and integrity. These specialists will help NAMRU-2 adhere to record retention policies, safeguard information and retrieve data more effectively.

b. Location: NAMRU-2, Cambodia (3) and Singapore (1)

c. Qualifications: Associate’s degree or 2 years’ experience working in an office administrator, office assistant, secretary or other position that required document generation, document editing and document archiving Deliverables:

1. Establish and operate an effective PMO. Develop materials and standardized PMO tools such as: scientific project planning schedule, project health dashboard, project management and integration plans, etc.

2. Assist and improve the administration and management of products required in research business cycle. (e.g. proposal review process, sustainment work-plan templates, Focus Area Roadmaps, request for proposals, detailed budget spreadsheets, annual reporting requirements and feedback, etc.)

3. Provide research support services in accordance with the QASP.

QASP:

TASK/

DELIVERABLE

PERFORMANCE

STANDARD

PERFORMANCE

INDICATOR/

ACCEPTABLE

LEVEL OF

PERFORMANCE

METHOD OF

SURVEILLANCE

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, 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 resolved in a satisfactory and timely manner.

Random inspection

Are study 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 were encountered were minor in nature, 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 resolved in a satisfactory and timely manner.

Random 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 encountered were minor in nature, as follows: does not cause a delay in schedule; does not cause increase costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling and feedback from client

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, as follows: does not cause a delay in schedule; does not cause increased costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling

What is the government’s 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.