PWS-_Strategy_and_Financial_Mgmt.pdf

Performance Work Statement

Strategy and Financial Management, and Analytical Services

Performance Work Statement – Strategic Planning, Financial and Analyst Services

PART 1

1.0 INTRODUCTION/OVERVIEW

Provide qualified and experienced personnel to support a full range of activities, including strategic and program planning, financial management and analysis, new and in-process project planning including program deployment and implementation, ongoing management, operations, administrative support, and any other activities necessary to the conduct of National Institute of Allergy and Infectious Diseases (NIAID)/Division of Clinical Research (DCR) business.

Functional areas include, strategic and program planning, advisory and assistance services, financial resource planning, performance assessment, management consulting, contract administration, and program management.

1.1 BACKGROUND

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats.

Toward this end, NIAID manages a complex and diverse research portfolio that aims to expand the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases; and develop flexible domestic and international research capabilities to appropriately respond to emerging and re- emerging disease threats at home and abroad.

The DCR is an organization within NIAID. The DCR’s vision is to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious diseases.

The DCR mission is to provide multi-disciplinary trans-NIAID services for facilitating clinical research and managing special projects as directed by NIAID leadership.

One of the primary objectives of the NIAID DCR is to provide an effective rapid response of clinical research activities in support of priorities as set forth by the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and other government agencies for these emerging and re-emerging diseases. These activities are known as Special Projects.

1.2 SCOPE

1.2.1

The types of services provided under this contract include providing qualified and experienced personnel to support a full range of activities, including strategic planning, new and in-process projects, program deployment and implementation, ongoing management and operations, administrative and financial management support, and any other activities necessary to the conduct of NIAID business. Functional areas include, strategic planning, performance assessment, finance and accounting, contract administration, and program management. The Contractor shall have the capabilities to provide subject matter expertise to perform the specific requirements as defined in the Performance Work Statement (PWS).

1.3 OBJECTIVES

The objective of this acquisition is to obtain contractor support for the following DCR purposes:

• Financial analysis and management

• Strategic and program planning management

• Operational and resource planning

• Administrative support

• Management consulting services

• Analyses and reporting on programs and initiatives

• Performance assessment functions, including recommendations for continuous improvement.

New and expanding Congressional mandates, changing policies and information technologies, expanding research programs, and NIAID’s leadership role in the global community has resulted in a critical requirement to obtain the services of a contractor capable of handling strategic and program planning, advisory and assistance service and all the afore mentioned functions. The contractor should also have experience in a clinical research setting.

1.4 REQUIREMENTS

1.4.1 TASKS

Independently, and not as an agent of the Government, the Contractor shall:

(1) Provide qualified and experienced personnel to support a full range of activities, including strategic and program planning, new and in-process project planning including program deployment and implementation, ongoing management, operations, administrative support, and any other activities necessary to the conduct of NIAID/DCR business. Functional areas include, strategic and program planning, advisory and assistance services, financial resource planning and analysis, performance assessment, management consulting, contract administration, and program management.

a. Services in support of strategy management and program planning include,

i. Development of an understanding of the current vision, mission, ongoing clinical research activities of the Division and the Institute

ii. Facilitation of meetings, retreats, or planning sessions that assist the Division, and its offices and branches, in the development and implementation of strategic plans and operational plans utilizing background and experience in the clinical research arena

iii. Guidance in strategic planning and evaluation in an international and domestic setting.

iv. Analysis of goals and objectives, as well as the business processes that support them

v. Guidance in the identification of key performance metrics

vi. Assessment of performance; analysis of key performance indicators

vii. Development of implementation plans, including resource plans, to support execution of strategic plans

viii. Assistance in execution and implementation of new programs and initiatives in an international and domestic setting.

ix. Preparing various management reports that provide analysis of performance against plan.

b. Services in support of new and in-process projects, program deployment and implementation include,

i. Providing market research and recommendations for new or existing Statement of Work (SOW), with recommendations regarding language to ensure program objectives and requirements are met

ii. Assisting with market research of cost estimates

iii. Developing management tools to assist DCR with contract management / project management

iv. Participating with DCR management in problem identification and resolution strategies

v. Preparing various management reports that provide analysis of performance against plan

vi. Preparing and/or delivering presentations related to program activities

vii. Developing cost estimates of clinical trials based on experience/background in clinical research in a domestic and international setting.

c. Services in support of ongoing management and operations include,

i. Reviewing and assessing ongoing management and operations practices, processes and systems within the Division and making recommendations to maximize operating efficiency and ultimate achievement of goals and objectives

ii. Performance assessment of goals and objectives

iii. Provide market analysis on trends in management and leadership

iv. Develop training in the areas of strategic planning and operational support in the area of national and international clinical research.

d. Services in support of administrative and financial management,

i. Liaising with other NIAID/NIH representatives in response and in support of program queries;

ii. Analysis and tracking of DCR funding allocation;

iii. Analysis and tracking of funding obligated under Division contracts and interagency agreements;

iv. Assist in developing funding strategies based on resource requirements;

v. Liaising with other NIAID offices, including but not limited to, Office of

Strategic Planning and Financial Management, (OSPFM) and Office of Workforce Effectiveness and Resources, (OWER);

vi. Liaising with other Institutes, including but not limited to, NIH Office of Research Facilities, (ORF) and National Cancer Institute (NCI)

vii. Draft and or deliver presentations as requested;

viii. Draft responses to data requests from DCR’s Office of Strategic Planning and

Assessment, Liaison Working Group;

ix. Formulation of budget and financial analysis of ongoing projects in an international setting, including liaising with international officials/partners to execute budget.

(2) Communicate findings, status, progress, issues, and other information to all appropriate levels of management, personnel, Project and Contracting Officers, and other designated NIAID representatives.

(3) Assist in maintaining professional best practices and knowledge of applicable Government, NIH, and NIAID regulations, policies, and standards.

(4) Draft and produce reports, briefings, and other deliverables required for performance with the Contract Officer Representative or other designated NIAID official.

1.4.2 MEETINGS AND REPORTS

The contractor shall participate in monthly status meetings with the Contracting Officer Representative (COR) and other DCR staff. The meetings will be scheduled within 10 days of the close of each month.

The contractor shall participate in ad hoc conference calls that may be scheduled to discuss potential concerns/issues directly related to the performance of activities associated with work covered under this PWS. Contractor shall produce reports as addressed in deliverables in 1.4.3.

Monthly Status Reports

The contractor shall provide monthly status reports. Specific task deliverables are defined in PWS. Deliverables will include financial information, status of strategy management, and status on any other performance projects. The COR will identify any issues that affect successful performance for discussion.

Quarterly Reports

The contractor shall provide quarterly reports. Specific task deliverables are defined in PWS.

Deliverables will include at a minimum, quarterly written reports to include identification of budget status.

Annual Reports

Specific task deliverables are defined in PWS. Deliverables will include at a minimum, yearly written reports to include identification of budget status at fiscal year- end.

Final Reports

Specific task deliverables are defined in PWS. Deliverables will include a written report to include identification of task activities completed; progress of ongoing activities; and any problems identified.

1.4.3 DELIVERABLES

The deliverables are the reports above and implementation plans and resource plans developed with the following DCR Branches/Offices:

Biostatistics Research Branch (BRB)

Collaborative Clinical Research Branch (CCRB)

Intramural Clinical Management and Operations Branch (ICMOB)

Program Planning and Analysis Branch (PPAB)

Office of Planning and Operations Support (OPOS)

Office of Clinical Research Policy and d Regulatory Operations (OCRPRO)

Office of the Chief Scientist, Integrated Research Facility (OCSIRF)

1.5.0 KEY PERSONNEL

Senior Operations Officer shall:

� Provide high-level guidance and expertise and contribute to organizational direction with senior level client leadership and team members;

� Provide highly specialized management and operations expertise to support senior client management in analyzing, planning, coordinating, and assessing the Division’s branches, offices, and initiatives, specifically utilizing clinical research experience

� Provide strategic planning and implementation expertise � Provide organization design, change management, business process solutions, and performance management solutions, � Make recommendations to resolve complex problems;

� Provide high level financial management expertise and meet with high level budget officials based on knowledge of clinical research paradigms;

� Prepare complex program and resource plans such as multi-site international clinical research network budget requirements;

� Prepare resource plans for a DCR that enables tracking of performance against plan;

� Identify key performance indicators.

� Provide guidance and contribute to budget analysis and projections;

� Provide organization design, and change management for management discussion and analysis (MD&As);

� Provide division representation at Leidos budget meetings;

� Provide financial management expertise for DCR and liaise with Office of Financial

Management (OFM) and institute budget office personnel;

� Provide market research on acquisition documents, Interagency Service Agreements

(ISA’s), contracts, and other legal agreements;

� Provide highly specialized operations expertise to support international clinical research initiatives;

� Provide translational services in Spanish and French for international clinical initiatives.

� Create and maintain complex spreadsheets;

� Track overall spending and prepare financial reports;

� Provide organization design, and change management for management discussion and analysis (MD&As);

� Provide advice/guidance on social mobilization (clinical research-human subjects) in an international setting and/or in another language;

� Provide clinical research strategy management in a domestic and international setting;

� Provide guidance, budget formulation, and financial analysis for a complicated mix of extramural and intramural funding;

� Provide expertise in strategy management and financial analysis with the military and in a

BSL4 facility.

Required skills and experience: minimum of 20 years of experience in strategic, operations, and financial planning and management, with minimum of 5 years of experience at NIH; demonstrated expertise in resource planning and management domestic and internationally; demonstrated expertise utilizing financial and strategy management in a clinical research setting.

The government expects that the Key Personnel for whom the resume is submitted with the Offertory’s proposal shall be committed to this order for the life of the order.

The Key Personnel for this requirement is the Senior Operations Officer with responsibilities referenced above.

The Senior Operations Officer or a designated alternate shall be available at all times during normal business hours. The name of this person and the alternate who shall act for the Contractor when the Senior Operations Officer is absent shall be designated in writing to the Contracting Officer. The Senior Operations Officer or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

The Contractor shall identify contract and or subcontractor Key Personnel by providing the COR with their curriculum vitae or resume. The Senior Operations Officer shall ensure staff continuity when making task assignments. If personnel changes are necessary, the Senior Operations Officer shall discuss staffing needs with the COR at the earliest opportunity. Following this discussion, the Senior Operations Officer shall provide the COR, for his/her approval, the credentials of proposed new staff assigned and update the staffing plan.

The personnel specified in this contract are considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance (2-4 weeks prior to diversion) and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program.

No changes of personnel shall be made without the review and approval of the COR.

Personnel Requirements

The Contractor shall provide a resume and/or curriculum vitae for each Key Personnel position identified in this PWS. The resumes and/or curriculum vitae are limited to 5 pages and provide selected references for publications relevant to the scope of the PWS. All Key Personnel must be identified as either employees of the Contractor, sub-contractors to the Contractor, or planned employees of the Contractor verified by a letter of commitment at time of proposal submission.

PART 2

GENERAL INFORMATION

2.0 SCHEDULE

PERIOD OF PERFORMANCE

The period of performance is a base year with four one year options. Total period of this order shall be 5 years.

Period of performance, place of performance, milestones, etc.

2.1 RECOGNIZED HOLIDAYS

The Contractor maybe required to perform services on Government recognized holidays when required within the individual task. Below are Government recognized holidays that may require contractor performance:

New Year’s Day Labor Day

Martin Luther King Jr.’s Birthday Columbus Day

President’s Day Veteran’s Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

2.2 HOURS OF OPERATION

The contractor is responsible for conducting business during normal operating hours specific to each area supported as directed in the individual tasks, Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor may be required to perform on days when the Government is closed for either a recognized holiday or due to a weather emergency as directed in the specific task. While work outside of normal Government business hours will not be typical, this may be required based on the nature of the task. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

2.3 PLACE OF PERFORMANCE

Tasks will be performed primarily at 5601 Fishers Lane, Rockville MD and, NIH offices located on the NIH campus and/or NIH offices and facilities in the Bethesda, and Frederick, Maryland. Place of performance will also include International sites.

2.4 TYPE OF CONTRACT

The government will award a Firm Fixed Price contract.

2.5 SECURITY REQUIREMENTS

2.5.1 PHYSICAL SECURITY

The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

2.6 IDENTIFICATION OF CONTRACTOR EMPLOYEES

All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Key Contractor personnel shall be required to obtain and wear badges in performance of this service.

2.7 CONTRACTOR TRAVEL

Individuals may be required to travel for specific task requirements. Possible travel could involve meeting attendance, visiting United States Government domestic (referred to as continental United States/ CONUS) and or international (referred to as outside continental United States /OCONUS) project sites Contractor will be authorized for travel expenses consistent with the substantive provisions of the Joint Travel Regulation (JTR) and the limitation of funds specified in this contract. All travel requires Government approval/authorization and notification to the COR. Travel will be billed under Other Direct Costs, (ODC).

2.8 OTHER DIRECT COSTS

Costs will be reimbursable by the Government (directly or indirectly) are pre-approved by the COR and the Contracting Officer. Direct costs associated with this contract could include travel, training activities, meeting attendance, etc. The COR and the Contracting Office will approve materials, including specialized materials and equipment required in excess of $500.00 required for performance to complete the requirements of the individual tasks.

2.9 QUALITY ASSURANCE

The government shall evaluate the contractor’s performance under this contract with monthly status meetings and evaluation of quality of deliverables. These meetings are primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance work statement.

2.10 GOVERNMENT FURNISHED ITEMS

Facilities: The Government will provide any Government information that is necessary for performance under the contract; in addition computer equipment and office/cubicle space for contractor staff to accomplish duties outlined earlier in PWS.

2.11 GOVERNMENT INFORMATION

The Government will provide any relevant NIAID Policies and Procedures required to accomplish the PWS.

2.12 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES

General: The Contractor shall furnish all specialized furniture, equipment, supplies, such as ergonomic furniture and equipment, phone equipment, and services required to perform work under this contract that are not listed under Section 3 of this PWS.

2.13 POST AWARD CONFERENCE/PERIODIC PROGRESS MEETINGS

The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

The Contractor shall meet with the COR and other staff designated by the COR at NIAID at least once a month to discuss and review items of work to be assigned, already assigned, or work requiring revision. These meetings shall involve the selected Contractor staff as designated by the COR.

2.14 CONTRACTING OFFICER REPRESENTITIVE

The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting.

2.15 DATA RIGHTS

The Government has unlimited rights to all documents/material produced under this contract.

All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

2.16 CONFLICT OF INTEREST

Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

The Contractor shall clearly identify (disclose) all ongoing current and past (within last 12 months) work experiences, agreements, or arrangements with Government agencies and businesses who are conducting comparable or related work similar in size, scope, and complexity to that required in the task areas of the PWS.

2.17 PHASE IN/PHASE OUT PERIOD

After contract award, the Contractor shall provide personnel during the 30 day transition (phase-in) period to ensure continuity of services. During the phase in period, the Contractor shall become familiar with performance requirements, obtain security and identification badges, and exchange any required government information or equipment.

The contractor shall provide a phase out plan 30 days prior to the end of the contract period.

This plan shall include all activity for a smooth transition of services

PART 3

DEFINITIONS and ACRONYMS

3.0 DEFINITIONS AND ACRONYMS:

3.1. DEFINITIONS:

3.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

3.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government.

Note: The only individual who can legally bind the government.

3.1.3. CONTRACTING OFFICER'S REPRESENTATIVE. An employee of the U.S.

Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

3.1.4. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

3.1.5. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When Key Personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

3.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

3.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

3.1.9. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

3.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

3.1.11. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

3.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

3.2. ACRONYMS:

CO Contracting Officer

CONUS Continental United States (excludes Alaska and Hawaii)

COR Contracting Officer Representative

DCR Division of Clinical Research

FAR Federal Acquisition Regulation

HHS U.S. Department of Health and Human Services

MD&A Management Discussion and Analysis

NIAID National Institute of Allergy and Infectious Diseases

NCI National Cancer Institute

NIH National Institutes of Health

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

ORF Office of Research Facilities

OSPFM Office of Strategic Planning and Financial Management

OWER Office of Workforce Effectiveness and Resources

PIPO Phase In/Phase Out

POC Point of Contact

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Plan

PART 4

ATTACHMENT/TECHNICAL EXHIBIT LISTING

4.0 ATTACHMENT/TECHNICAL EXHIBIT LIST:

4.1. Attachment 1/Technical Exhibit 1 – Deliverables Schedule

TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverables Frequency # of Copies

Medium/Format Submit To

Monthly Status Reports

5 days after the close of the month and 2 days before the monthly status meeting

3 Spreadsheet/hardcopy /electronic

COR (to be distributed to Program Officials)

Quarterly Reports 5 days after the end of the quarter

3 Spreadsheet/hardcopy /electronic

COR (to be distributed to Program Officials)

Implementation and Resource Plans

According to program schedule (Annually – Every 3 years).Within 5 days of specified program schedule

Spreadsheet/hardcopy /electronic

COR (to be distributed to Program Officials)

Annual Reports Annually within 5 days of request

3 Spreadsheet/hardcopy /electronic

COR (to be distributed to Program Officials)

Final Report 10 days of closeout of contract

3 Spreadsheet/hardcopy /electronic

COR (to be distribute to Program Officials)