Objective - GSA



Integrated Management Consulting Services Blanket Purchase AgreementStatement of Work*Note that this sample has been revised from the source document on the Government Point of Entry as necessary to align formatting and applicable FAR procedures.* TOC \h \u \z BackgroundManagement consulting/professional support firms are frequently engaged by the U.S. Food and Drug Administration (FDA) to complete complex, strategic, and time-sensitive initiatives. FDA has a need to ensure that our contract management processes have sufficient control measures in place to ensure FDA offices are leveraging internal resources appropriately, accessing the right firms for the desired tasks/deliverables, minimizing redundancy in scope and/or deliverables across contract awards, and enforcing consistent quality over contractor-produced deliverables.ObjectiveThe objective of this blanket purchase agreement (BPA) is for FDA to procure support under one contract vehicle to access management consulting/professional support services. The intent is to further reduce the administrative costs of acquiring professional support from the GSA Federal Supply Schedule (FSS) and other contracts. This BPA will address several inter-related needs that FDA is currently facing:Acquire appropriately-experienced professional services support: Based on previous acquisition of management consulting services support from a variety of vendors, FDA is more aware of the relevant expertise by task area delivered by certain vendors. While maintaining competition and small business award, FDA seeks to implement processes to ensure the Agency selects the most appropriate vendor for the area of need.Improve quality of contractor deliverables: Program standards exist to support the oversight of the contractor produced deliverables but without central coordination variance will continue to occur. FDA seeks to implement industry best practices to ensure the Agency is the recipient of high-quality contractor-produced deliverables. Minimize task redundancy: Historically, FDA Centers has independently procured management consulting services support for the same or similar task areas. FDA seeks to facilitate Center-to-Center collaboration to streamline the procurement of support resources and introduce more efficient, effective solutions that can be seamless implemented across the Agency. ScopeIndependently, and not as an agent of the Government, the Contractor shall provide the required personnel, materials, services, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described below.The Contractor shall provide Agency-wide technical and professional services to comprehensively support strategic initiatives that would benefit from external expertise. Specific task areas to be supported will include: Advisory Services; Business Process Improvement; Change Management; Communication; Implementation Framework, Organizational Assessments; Program Evaluation and Management; Project Management; Resources Capacity Planning Model Development; Quantitative/Qualitative Modeling, Analysis & Reporting; Risk Analysis and Management; Strategic Planning Subject; Matter Expertise.Executive Summary of Task AreasThe following tasks areas were identified to address the Agency’s requirements:Task AreasDefinitionAdvisory ServicesProvide expert advisory services on the implementation, governance, and management of projects/programs.Business Process ImprovementUtilize various methodologies to analyze procedures and identify areas for improved accuracy, consistency, effectiveness and/or efficiency and then, redesign those processes to realize the improvements.Change ManagementPrepare, support, and help individuals, teams, and the FDA organization in the implementation of processes to prepare and support organizational changeCommunicationsEnsure proper coordination and execution of communication strategies and functions using mutually understood?signs, symbols, and?semiotic?rules.Implementation FrameworkImprove the success of the deployment, adoption of tools/policies/processes, and ability of an activity to be replicated across other anizational AssessmentDevelop and execute an organizational assessment of FDA organization or sub-organization to understand current effectiveness and areas for improvementProgram EvaluationDevelop and execute a program evaluation to enable FDA to understand how the program is currently performing and how it could be improved going forwardProgram ManagementManage several related projects within a program portfolio to improve an organization's performance.Project ManagementInitiate, plan, execute, control, and close the?work?of a?project?to achieve specific goals and meet success criteria within the specified time frame.Resource Capacity Planning Model DevelopmentProvide technical services in the development of a resource capacity planning model that makes use of key operational data (e.g. workload, time reporting, human capital, financial, etc.) to gain insight into current and future resource demands. Quantitative/Qualitative Modeling, Analysis & ReportingUse mathematical and statistical modeling for measurement and research to represent a numerical value. Use subjective judgment based on non-quantifiable information (e.g., management expertise, industry cycles) to gain an understanding of underlying reasons, opinions, and motivation.Risk Analysis and ManagementIdentify, evaluate, and prioritize risks followed by a coordinated application of resources to minimize, monitor and control the impact or maximize the opportunity. Strategic PlanningProvide strategic planning services that support FDA’s efforts to craft near and long-term goals, objectives, and priorities, along with planning services that enhance the efficient utilization of resources, processes, and systems to achieve outcomes that advance the mission. Subject Matter ExpertiseIdentify resource(s) to serve as a definitive source of knowledge, technique, or expertise in a specific subject area to support FDA strategic goals and/or initiatives. Experts should have unique blend of administrative, regulatory, and scientific experience and knowledge with a strong understanding of the challenges facing FDA and related regulated industriesTask Areas & DeliverablesTask Area 1: Advisory ServicesThe Contractor shall provide expert advisory services on the implementation, governance, and management of internal projects/programsRepresentative activities may include:Advise on the development of business, functional, and data requirementsAdvise on leading practices in integrating systems, operations, and business planningAdvise on the development of strategic capabilities, including project management, financial management, resource management, and reporting and analysis as required to support the project/programAdvise on governance models, support models, organizational design, processes, materials, and roles and responsibilities to support the successful implementation and management of the project/program across impacted stakeholder groupsAdvise on how to scale the program/project including project plans and timelinesAssist in developing materials associated with requested services, such as, but not limited to, briefing decks, draft policies, standard operating procedures, business cases, cost estimates, and white papers.Representative Advisory Services deliverables may include:In-depth Analyses: shall research and summarize and make recommendations for integrating best practices in processes, systems, operations, and governancePresentations: shall develop compelling, visual representations of information to communicate to and be used by leadershipTask Area 2: Business Process ImprovementAs tasked, the Contractor shall develop new, innovative business processes for FDA. Processes could be required to support new User Fee Programs or Authorities, respond to increasing demands and limitations placed on operations, or advances in the regulated industry. Activities supporting this solution set shall include environmental scans, benchmarking/case studies, requirements analysis, and business process mapping.Representative activities include:Assess the current operating environment to identify drivers for new/improved business processes to include environmental scans to identify and assess major stakeholders and comparable organizations, analysis of regulatory requirements, and alignment with strategic goals and objectives.Facilitate the voice of the customer feedback from key stakeholders and customers to understand requirements for new models. Creating formal feedback mechanisms to provide feedback into new processesDocument current state business processes, including customers, organizational structures, and resource levels.Define the desired state and identifying gaps between the current environment and the desired outcome. Develop future state business processes, draft IT business requirements, conduct alternatives analysis for competing for IT solution options, assisting FDA evaluation of and decision‐making on various options, when appropriateRecommend communications, staff development/training, and other change management activities to support the implementation of business process improvementsRepresentative New Business Model Development deliverables may include:Environmental Analysis: shall present an assessment of the major stakeholders that will be directly involved in the new business model, their strengths and weaknesses, regulatory impacts and requirements, degree and scope of influence, risks for achieving the desired end state; shall identify any comparative organizations with a similar business model.Stakeholder Analysis: shall quantify the stakeholder(s) associated with the process and describe characteristics of the stakeholders to allow for a full understanding of business requirements. Process Maps: shall develop current and future state process maps using Business Process Modeling Notation (BPMN)Change Management Plan: shall develop a change management plan that describes activities needed to minimize the impact on the organization, staff, and technology (as appropriate)Task Area 3: Change ManagementThe Contractor shall assist FDA with the state-of-the-art change management procedures, tools, and techniques to support FDA’s management of people-side of change in furtherance of required FDA business outcomes. It shall incorporate organizational tools that can be used to help individuals make successful personal transitions (e.g., the Williams Bridges model), resulting in the adoption and realization of change, controlling change, and effecting change. Representative activities include:Apply a systematic, proactive approach to help individuals impacted by a change to be successful by building support, addressing resistance, and develop the required knowledge and ability to implement the change based on recognized leading practices like Prosci ADKAR or similar methodologyProvide a proactive, systematic, leadership-driven approach to identifying and dealing with risks associated with a major organization, operational, and leadership changesFacilitate leadership alignment sessions and providing leadership coaching related to change implementationConduct stakeholder issue-and-risk analyses (e.g., lack of leadership alignment, declining job performance, lower employee morale, and engagement) and developing mitigation strategies. Recommend communications, staff development/training, and other change management activities to support the implementation of business process improvementsRepresentative Change Management deliverables may include: Change Management Plan: shall develop a change management plan that describes activities needed to minimize the impact on the organization, staff, and technology (as appropriate) and increase adoption of the changeCommunications Plan: shall include the objective and a description of the communication, the medium to be used, the timing, the audience, and follow-up communication, if applicableStakeholder Engagement Strategy: shall develop a plan to engage, educate, and inform stakeholders of changesMessage Creation, Review, and Delivery: shall draft, review, and/or deliver messages that are clear, consistent, targeted, and timelyTask Area 4: CommunicationsThe Contractor shall support the management of business transformation project communication for the FDA to ensure proper coordination and execution of communication strategies and functions, as tasked.Representative activities may include: Enhance communications within the FDA and optimize communications channels by all available means.Provide review to ensure messages are clear, consistent, targeted, and timely.Sustain and reinforce the support, involvement, and commitment of customers and key stakeholders.Shape the expectations of the customers, stakeholders, and the workforce.Cultivate a culture of open dialogue between the FDA and its customers, stakeholders, and workforce.Facilitate input from customers back to FDA’s leadership and key stakeholders.Assist the FDA in reviewing and disseminating communications materialsRepresentative Communication deliverables may include:Communication Plan: shall include the objective and a description of the communication, the medium to be used, the timing, the audience, and follow-up communications if applicable.Evaluation Plan: shall develop and execute a strategy to evaluate the effectiveness of communications strategies and tactical activities.Messaging: shall define key messages, communications tools, and channels (including satellite broadcasts), audiences, and the timing of communications releases. Task Area 5: Implementation FrameworkThe Contractor shall provide an implementation framework that defines program/process/initiative/technology execution, adoption, and sustainment. Representative activities may include:Design implementation framework for program/project informed by success in a high-performing organization in public and private sectors structure projectsDevelop the process to complete end-to-end rollout, including identification of critical milestones, inputs and outputs, and dependenciesDesign an organizational structure to establish appropriate and effective governanceEstablish a playbook (e.g. policy, process, and/or procedures) to ensure the process can be replicated across other programsRepresentative Implementation Framework deliverables may include:Framework: shall develop an implementation framework and approach for program/project executionGovernance: shall design governance organizationPlaybook: shall design/build, and execute the implementation playbook Task Area 6: Organizational Assessment As tasked, the Contractor shall develop and execute an organizational assessment of FDA organization or sub-organization to understand current effectiveness and areas for improvement. The goals of this assessment are to provide a holistic analysis of the organization's long-term effectiveness based not only on the ability to achieve mission-critical goals but also to continually evolve to meet new challenges. An organizational assessment provides a systematic approach for collecting and analyzing data to better understand the degree of organizational mission accomplishment, efficiency, governance, resource use, and future goals. Representative activities may include:Conduct a gap analysis to compare the current situation and the desired situation.Identify organizational priorities, strengths, and weaknessesIdentify the causes of performance problems and/or opportunities.Identify possible solutions and opportunities for growth.Review FDA strategy, authorizations, and growth plans, confirming that plans account for Office or Center mission support services and evaluating whether the Office/Center plans are aligned with overall organizational strategy and requirements.Conduct interviews and surveys, if necessary, with Office / Center leadership, agency and program leaders, other FDA and HHS staff, and stakeholders as necessary.Assess funding, organizational structures, and various project prioritization approaches for functions and stakeholder organizations based on risk to mission.Recommend governance models that support the prioritization and funding decisions.Assess opportunities for harmonization or centralization of support and resources to reduce costs and gain efficiencies.Evaluate current relationships with HHS and/or our state/federal partners to identify opportunities to reduce redundancy, promote reuse, and repurpose or streamline existing efforts.Conduct baseline analyses for selected Offices and Centers on information related to current operations, including strategy, structure, staffing, governance, funding, service level agreements, skills, tools and processes, and performance management.Assess a program’s overall readiness to meet current and future FDA mission program requirements.Identify future organizational requirements and disciplines as informed by benchmarks and implications of different models for the FDA.Propose organizational options and recommending the most effectual operational model(s) that address culture, strategy, structure, and efficient and effective processes and role clarity.Representative Organizational Assessment deliverables may include:Organizational Analysis: shall include the following elements at a minimum, unless otherwise specified: documented current organizational structure, work culture, communication process, employee skills evaluation, and key issues and anizational Strategic Plan: shall contain the following elements at a minimum, unless otherwise specified: Mission and vision statement, long term goals and yearly objectives, description of methods used to create the plan, and comprehensive action plans. Impact Assessment and Risk Assessment: shall include the following elements at a minimum, unless otherwise specified: TBD information on stakeholder willingness to adopt organizational change, direct and indirect impacts on the workforce, and type and severity of risks along with mitigation options. Reports: shall include a summary of findings, metrics measured and recommendationsTask Area 7: Program EvaluationAs tasked, the Contractor shall develop and execute a program evaluation to enable FDA to understand how the program is currently performing and how it could be improved going forward. The goals of a program evaluation are to provide a holistic analysis of program effectiveness against stated goals and objectives, efficiency, and its ability to meet new challenges. Program evaluation provides a systematic approach for designing evaluation metrics, collecting and analyzing data and developing future-state recommendations.Representative activities may include:Identify program goals and objectives.Define program processes, stakeholders and outputs.Define, collect and analyze quantitative and qualitative baseline program metrics.Define, collect and analyze quantitative and qualitative programmatic metrics and compare to baseline.Conduct focus groups, interviews and surveys, if necessary, with stakeholders as needed.Assess a program’s overall readiness to meet current and future program requirements.Assess program quality, effectiveness, and efficiency and make a recommendation for the future.Representative Program Assessment and Evaluation deliverables may include:Evaluation Workplan: shall include the following elements at a minimum, unless otherwise specified: documented program structure, evaluation architecture, evaluation metrics, data collection, and analysis plan.Internal Stakeholder Updates: Prepare and present reports or presentations of findings to date to interested internal parties.Program Evaluation Report: summary of findings.Task Area 8: Program/Project ManagementThe Contractor shall provide project management support to ensure that the scope, schedule, and costs of a program/project are controlled and consistent with the contract. For each BPA Order, the Contractor shall prepare a Project Work Plan (PWP) describing the technical approach, organizational resources, and management controls to be employed to meet the cost, performance, and schedule requirements enough to manage concurrent tasks. Representative activities include:Provide leadership and creative solutions to program planning and problem-solvingDevelop and manage the scope of program/project (e.g. objectives, team, tasks, deliverables, timelines, and cost)Establish clear processes and identifies the objectives and measures for success necessary to achieve the desired outcomesPartner with other relevant stakeholders to initiate, coordinate, and ensure proactive and timely resolution of action itemsMonitor program/program quality and effectiveness; prepare reports to leadership and other relevant parties on status and resultsIdentify issues and problem promptly and manages them to resolution, elevating those that require leadership attentionSupport FDA management by developing resources for meetingsSupport ongoing knowledge-sharing effort with leadership and/process owners, written communications, individual discussions, as neededMaintain all documentation in a manner that allows for easy accessCreate and organize appropriate file structures on the SharePoint site(s)Representative Program/Project Management deliverables may include:Project Management Plan: shall develop and maintain a comprehensive plan to accomplish the scope of the BPA OrderProject Schedule: shall maintain and update schedule, as neededProgram/Project/Technical Status Reports: shall capture progress on all tasks and identify anticipated risks, as necessary Meeting Minutes: shall document meeting notes with key decisions, actions items, and next steps as appropriateTransition Plan: shall develop a transition plan and support migration of responsibilities to internal subject matter expert(s)Close-out Report: shall develop a close-out report that documents the approach/methodology, key outcomes, and best practices/lessons learnedTask Area 9: Resource Capacity Planning Model DevelopmentThe Contractor shall provide technical services in the development of a resource capacity planning model that makes use of key operational data (e.g., workload, time reporting, human capital, financial) and predictive algorithms to forecast resource needs. The model should be capable of producing analytical output that can be displayed in a dashboard and/or data visualization. Representative activities may include:Conduct interviews/focus groups with SMEs as needed to generate/validate/refine hypotheses and/or understand the relevant business context and other factorsScan and collect data from internal and external data sources relevant to the effortDefine model business and technical requirementsDevelop and validate resource capacity planning model designDevelop the prototype modeling including the data cleaning steps and input processes; develop the final resource capacity modelConduct user acceptance testing of the modelEvaluate the model including output validationDocument the model including but not limited to the design, code, data inputs, data dictionaryDevelop a user guide for the model Representative Resource Capacity Planning Model Development deliverables may includeReport: shall summarize relevant internal and external data sources required to run the modelInterviews/Focus Groups: shall summarize interviews/focus groups sessionsGap Analysis: shall describe gaps in data and relevancy to the model feasibility or improving the accuracy of the modelBusiness Requirements Document: shall document model business and technical requirementsData Quality Standard Operating Procedure: shall describe all data inputs, data collection steps, and cleaning processes requiredTest Plan: shall develop a user acceptance testing and evaluation planPrototype: shall develop a prototype resource capacity model including but not limited to the software and codeModel: shall provide a final resource capacity planning model including the design, code, data model, and description of code and methodsUser Guide: shall develop a resource capacity planning model draft and final user guideTask Area 10: Quantitative and Qualitative Modeling, Analysis & ReportingThe Contractor shall perform a wide range of quantitative and qualitative analytical methods drawn from decision science, risk analysis, social science, health outcomes research, health systems research, health economics, econometrics, data science, machine learning, artificial intelligence, and other analytical disciplines. These methods are applied in a variety of projects to develop algorithms in support of its public health mission and/or to enable FDA to use more comprehensive and rigorous methods of analysis, measures of effectiveness, measures of quality, and measures of value and other impacts on consumers, public health, healthcare, regulated industry and other stakeholders. Representative activities include:Provide technical assistance in identifying, developing, enhancing, applying and evaluating more formalized approaches to Center analysis and impact assessment.Develop a study design and plan, applying decision science, social science, risk analysis, economic, mathematical and statistical, or other methods of analysis as appropriate.Develop plans to identify and obtain data necessary to complete the specified analytic task and related evaluation.Conduct surveys, analysis of literature relevant to the identified dimension of benefit, risk, quality, effectiveness or other impact analysis.Conduct reviews and analysis of FDA-provided relevant primary data, including non-clinical/clinical data collected in studies.Identify and analyze potential advantages and disadvantages of existing and available methods to systematically evaluate benefit, risk, quality, effectiveness, uncertainty, or other dimensions of impact.Apply sophisticated modeling and analysis methods drawing from literature and current best practice in decision analysis, benefit-risk analysis, evaluation, economics, including pharmacoeconomic and medical outcomes researchDevelop new methods and models applying appropriate mathematical and statistical techniques to account for the features of specific health impact questions, issues and related needs for analysis and decision support.Analyze program parameters as appropriate using FDA data systems to assess the applicability and performance of formalized methods in the actual operational context of Center decision making processes.Document the model including but not limited to the design, code, data inputs, data dictionary.Representative Quantitative and Qualitative Modeling, Analysis, and Reporting deliverables may include:Study Protocol and Supporting Resources: shall describe every step of the study and answer relevant questions about tasks that will be addressedStudy Questions: shall identify questions to be answered, what?objectives?the study will achieve, how much?power?the study will have and what the?impact?of the findings will be.Progress Reports: shall include an update on the progress of the analysis with an outline of work to be accomplished during the next reporting period Scientific Reports: shall include the data, methods, analysis, findings/results, and recommendations relevant to the specific task.Algorithms: Shall provide algorithms developed and detailed documentation to explain the algorithm, the rational and the performance of results.Models: Shall provide models, the methodology used, detailed documentation and rationale for the methodology, input data and results.Task Area 11: Risk ManagementThe Contractor shall support, develop and assist FDA in implementing a risk management framework to facilitate effective identification, monitoring, and mitigation of risks across and integration with key decision-making and management process.Representative activities include:Evaluate and recommend options for the implementation of an FDA-wide enterprise risk management program. Recommendations should account for current practices and culture at FDA and reflect new guidance and best practices in federal-sector enterprise risk management.Review existing risk management processes, benchmark against best practices, propose new operating procedures and develop methodologies and tools for analytics in support of a strategic enterprise risk management program with clear links to strategic planning, performance management, and decision-making activities.Representative Risk Management deliverables may include:Risk Management Framework: shall develop a risk management framework and implementation strategy and schedule. The framework should include, at a minimum, roles and responsibilities, intersection with existing governance bodies, protocols for managing the risk register, communications plan, and implementation plan.Risk Assessment Plan: shall document foreseeable risks, anticipated impacts, and mitigation strategies associated with the project; should include risk assessment matrixRisk Registry: shall identify risks in a project or the organization to mitigate issues that may derail intended outcomesTask Area 12: Strategic PlanningFDA employs strategic planning, and develops strategic plans, at multiple levels and across numerous domains. For example, strategic plans are developed at the Center enterprise level to address the specific public health challenges and opportunities those programs face for their specific regulated products, industries, and stakeholders. As tasked, the Contractor shall provide strategic planning services that support FDA's efforts to efficiently utilize resources, processes, and systems to achieve outcomes that advance the mission to protect and promote public health. The Contractor shall identify strengths and weaknesses in the FDA's strategic planning processes. The Contractor shall work with the FDA to increase the use of data and analytics to more effectively address its strategic challenges, as well as identifying and developing plans for the most efficient pursuit of identified opportunities.Representative activities include:Become familiar with relevant FDA systems, data sources, product review areas, and stakeholdersEngage key stakeholders for a strategic plan, such as FDA senior leadership, staff, industry, state/federal partners, and/or consumers to understand stakeholder requirements. Document stakeholder’s current and future state needs and perceived performance gaps.Conduct assessments of the existing FDA strategic and operational plans, procedures, and practices to document and/or define the business processes, develop baseline measurements to assess the effectiveness of existing strategic plans.Assist with the prioritization of critical output, productivity and outcome measures.Analyze assessment information to identify and recommend strategic options that reflect and reinforce the FDA's mission, such as the restructuring of strategic plans, modifications to existing approaches, or new strategic goals, objectives, and report the findings. Outlining major strategic choices FDA can take to address isolated strategic gaps and identify and evaluate options to frame the path forward. Perform analytical modeling of potential consequences of strategic alternatives.Facilitate agency review of and debate around multiple strategic options, including validating and stress testing options or alternative approaches through stakeholder engagement and FDA governance processes.Develop revised and new strategic performance management plans, roadmaps, performance measures, and key performance indicators to determine their effectiveness.Benchmark core elements of FDA performance, structure and strategy against comparable federal agency groups (e.g., NIH, CDC, DOI) and leading public and private sector enterprises, and internationally if appropriate, to identify lessons learned and applicable approaches.Evaluate portfolio‐based approaches to strategic planning to effectively promote and integrate the long-term strategic objectives to the day‐to‐day operational execution of business transformation activities within the CenterDevelop a strategic performance management model to establish the governance, processes, and infrastructure required to manage business transformation activities throughout the lifecycle from concept through design and implementation.Representative Strategic Planning deliverables may include:Strategic Planning Stakeholder Engagement Report: shall include the following elements, at a minimum, unless otherwise specified: a description of the overall method for stakeholder engagement (e.g., interviews, survey, public meeting); stakeholders engaged (e.g., interviewee name; questions asked; summary of responses received, analysis of stakeholder themes; comparison of stakeholder findings to themes of benchmarked organizations where appropriate, and recommendations to address/mitigate concern(s).Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analysis: shall provide a current depiction of the organization and include a thorough analysis of the industry and shall consider it to comparative organizations; shall present case studies of similar organizations for contextGap Analysis: shall include the following elements, at a minimum, unless otherwise specified: description of current state for each applicable subarea; description of the desired state; identification whether gaps exist between the current state and future state; description of the gap; factors contributing to the gap; and specific potential actions to eliminate the gap; risk mitigation strategies to address risks that typically have impact on achieving the desired state. Strategic Plan: shall include the following elements, at a minimum, and unless otherwise specified is also to be aligned to appropriate standards (see ISO 17469‐1:2015 on Strategy Markup Language and OMB Circ. A‐11, HHS, and ANSI/ISO standards as applicable): mission statement; vision statement; guiding principles; long term strategic objectives; strategies; short term goals.Roadmap or Operational Plan: shall include the following, at a minimum, unless otherwise specified: a list of actionable initiatives, prioritization approaches (including recommendations for reductions when appropriate), change management plan, oversight structure and a method to track progress against the plan (scorecard, dashboard or the like) and communications plans.Task 13: Subject Matter ExpertiseThe Contractor shall identify resource(s) to serve as a definitive source of knowledge, technique, or expertise in a specific subject/technical area to support FDA strategic goals and/or initiatives. Experts should have a unique blend of administrative, regulatory, and scientific experience and knowledge with a strong understanding of the challenges facing FDA and related regulated industries. Representative activities may include: Leverage of public and private sector knowledge and experience to determine compare performance and expectationsResolve problems of high, strategic importance or identify new strategiesDevelop extremely high-quality resources within specialized niche expertiseRepresentative Subject Matter Expertise deliverables may include:Reports: shall benchmark core elements of strategy against comparable Federal Agency Group, private sector, etc. to identify lessons learned and applicable approaches.Reviews: shall review FDA initiatives to ensure plans are aligned with overall strategy and requirementsGovernance Structure: shall recommend governance models that support the prioritization of initiatives, funding discussions, etc. Task Area 14: Transition- In ActivitiesThe Contractor shall include a period of transition at the beginning of the BPA to ensure a high quality of services and deliverables associated with the BPA.Representative activities may include:Become familiar with strategy and transformation deployment.Become familiar with business process improvement.Become familiar with the training efforts Representative Transition-In Activities deliverables may include:Transition Plan: shall identify actions, plans, personnel procedures, deliverables, work products, and schedule to ensure a smooth transition from BPA start to full operational status by the Contractor. The transition plan shall include a description of parallel operations, personnel on-boarding process, tracking, and updating list of Contractor personnel with anticipated start dates and responsibilities.Work Plan: shall outline all tasks involved in a project, who is responsible for each task, and when the tasks should be completedTask Area 15: Transition- Out ActivitiesThe Contractor shall facilitate transition-out activities to the Federal Government or a successor contractor. Representative activities shall include:Deliver final versions of all code, data, models, end-user and developer guides, and other materials and documentation developed under this BPAReturn current inventory of any Government-owned assets used by the Contractor along with full support in the reconciliation of this inventory Shadow and conduct knowledge transfer meetings to facilitate the seamless transition of information, processes and data needed for FDA performed under this BPALabor CategoriesLabor categories and labor rates contained in the Contractor’s GSA contract are applicable under this BPA and corresponding BPA orders.The Government anticipates the following labor categories. However, the Contractor may propose other categories.The labor categories described below can be further subdivided by knowledge/skill level. The definitions of these levels are shown in the chart below.Labor CategoryDescriptionEntry-Level - 1Applies fundamental concepts, processes, practices, and procedures on technical assignments. Performs work that requires practical experience and training. Work is performed under supervision.Journeyman - 2Possesses and applies expertise on multiple complex work assignments. Assignments may be broad, requiring originality and innovation in determining how to accomplish tasks. Operates with appreciable latitude in developing methodology and presenting solutions to problems. Contributes to deliverables and performance metrics where applicable.Senior - 3Possesses and applies a comprehensive knowledge across key tasks and high impact assignments. Plans and leads major technology assignments. Evaluates performance results and recommends major changes affecting short-term project growth and success. Functions as a technical expert across multiple project assignments. May supervise others.Master - 4Provides technical/management leadership on major tasks or technology assignments. Establishes goals and plans that meet project objectives. Has a domain and expert technical knowledge. Directs and controls activities for a client, having overall responsibility for financial management, methods, and staffing to ensure that technical requirements are met. Interactions involve client negotiations and interfacing with senior management. Decision making and domain knowledge may have a critical impact on overall project implementation. May supervise others.The following section describes the work activities associated with the Labor Categories that will be needed for this BPA.AnalystTypically, Analysts hold a bachelor’s degree or higher or have equivalent work experience. Additionally, an Analyst shall provide a combination of the following: Assist with the review of an analysis of customer requirements or challenges and the development of solution proposalsAssist Analysts and Consultants in developing detailed documentation and specificationsPerform quantitative and/or qualitative analyses to assist in the identification of customer issues and the development of customer-specific solutionsAssist other Analysts and Consults in the design and structure of presentations that are appropriate to the characteristics or needs of the audienceDevelop knowledge of consulting engagements and participate in formal and informal learning opportunitiesBusiness AnalystTypically, Business Analysts hold a bachelor’s degree or have equivalent work experience. Additionally, a Business Analyst will typically provide a combination of the following:Provides technical and administrative direct support for personnel performing software development tasks including the review of work product for correctness, adherence to the design concept and user standards, and for progress following schedules.Provides support in the areas of analysis, design, development, and implementation of systems and technologies.Demonstrated experience supporting project tasks.Undertakes studies and analyses to identify areas for productivity improvements.Change Management AnalystTypically, Change Management Analysts hold a bachelor’s degree or have equivalent work experience. Additionally, a Change Management Analyst will typically provide a combination of the following:Responsible for analyzing the impact of changes to systems and business processesCollaborates heavily across the organization footprint to support enterprise-wide stakeholders at all levels of the organization, develops and follows a structured approach to change management.Able to communicate, persuade and/or influence internal and/or external customers at a high level such as senior leadership on matters of a technical and/or complex nature.Advanced knowledge of various software applications to create documents, reports and/or graphics. Strong technology acumen with the ability to determine the impacts of systems change requests, enhancements, etc. on business processes. Communications SpecialistTypically, Communications Specialists hold a bachelor’s degree or have equivalent work experience. Additionally, a Senior Communications Specialist will typically provide a combination of the following:Ensure effective communication of the organization's goals and initiatives to internal and external stakeholders.Support and participate in the development and implementation of internal and external communications programs and initiatives. Manage a variety of internal, external communications tasks to support leadership, including preparation of a range of communications publications, talking points, presentations, and other materials. Develop a strong working relationship with other organizations as needed, to implement outreach programs.Strong analytical skills; excellent organizational and presentation skills; proven ability to be innovative and creative.ConsultantTypically, Consultants hold a bachelor’s degree or have equivalent work experience. Additionally, a Consultant will typically provide a combination of the following:Demonstrated experience performing project tasks.Experience in one or more of the key project areas.Supports implementation of business operations improvements or project tasks.DirectorTypically, Directors hold a bachelor’s degree or have equivalent work experience. Additionally, Director, I will typically provide a combination of the following: Demonstrated ability to provide strategic guidance and direction in designing, implementing and managing business operations and process improvement. Manage multiple projects of high complexity. Recognized subject matter knowledge in one or more solution areas. Extensive experience in design, implementation and management of business operations, improvements or strategy projects. Interfaces with the client on strategic issues.Management AnalystTypically, Management Analysts has undergraduate degree have equivalent work experience. Additionally, a Management Analyst will typically provide a combination of the following:Undertakes studies and analyses to identify areas for productivity improvements. Makes use of tools, spreadsheets, and databases in performing job duties.ManagerTypically, Managers hold a bachelor’s degree or have equivalent work experience. Additionally, a Manager will typically provide a combination of the following:Demonstrated ability to provide guidance and direction at the project level. Manage complex projects.Significant subject matter knowledge in one or more solution areas. Implementation and management of business operations, improvements or strategy projects. Interfaces with the client on project issues.Managing DirectorTypically, Managing Directors hold a bachelor's degree or have equivalent work experience. Additionally, a Managing Director will typically provide a combination of the following:Demonstrated ability to provide strategic guidance and direction in designing, implementing and managing business operations and process improvement. Manage multiple projects of high complexity. Recognized subject matter knowledge in one or more solution areas. Extensive experience in design, implementation and management of business operations, improvements or strategy projects. Interfaces with the client on strategic issues.PrincipalTypically, Principals hold a bachelor’s degree have equivalent work experience. Primary owner of customer engagements with ultimate responsibility for customer satisfaction and delivering high levels of quality/added value. Meets or exceed customer expectations by developing and delivering insightful, value-added solutions that address complex customer issues. Additionally, the Principal will typically provide a combination of the following:Manage customer interface and project team to achieve efficient and effective project deliveryApply consultative problem-solving skills Identify issues of importance and work with the project team to develop tangible effective solutionsMaintain in-depth and extremely current knowledge of customer’s strategies, business issues, and relationship from senior management on downRemain current on industry, customer, and market trends and direction to anticipate and identify new business challenges and customer issuesContribute to the expert body of knowledge in the marketplaceStrengthen subject matter expertise through on the job experience, conference participation, and other forums for professional knowledge sharingMentor, coach, and share subject matter expertise with others to elevate capabilities to deliver high-quality solutionsSharePoint DeveloperTypically, SharePoint Developers hold a bachelor’s degree have equivalent work experience. Individuals have experience in current graphics design and .NET technologies to develop, modify, maintain SharePoint server portals. Design, develop, and manage site content and capabilities and provide daily onsite maintenance of the existing MOSS portals. Participates in the testing process through test review and analysis, test witnessing and certification of software. Familiar with US Digital standard concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Work with project stakeholders daily.Develops software solutions by studying requirements analysis and information needs; conferring with stakeholdersand IT Management; studying systems flow, data usage, and work processes; performs software design using software development fundamentals and processes, debug, test, and deploy software solutions.Design, develop and maintain key components of the software suite using classic ASP, Microsoft .Net and SharePoint Server 2007 and new 2013.Implementation of SharePoint-based workflows as well as the development of Business Intelligence dashboards.Documents and demonstrates solutions by developing the documentation, flowcharts, layouts, diagrams, charts, code comments, and clear code.Build proof of concept examples or graphical simulation software. Then maintain product test software and demos for training purposes.Protects operations by keeping the information confidential.Actively participate in product design reviews by providing creative and practical ideas and solutions in a teamwork environment. Systems AnalystTypically, Systems Analysts hold a bachelor’s degree or have equivalent work experience. Additionally, a Systems Analyst will typically provide a combination of the following:Provides technical and administrative direct support for personnel performing software development tasks including the review of work product for correctness, adherence to the design concept and user standards, and for progress following schedules.Provides support in the areas of analysis, design, development, and implementation of systems and technologies.Demonstrated experience supporting project tasks.Undertakes studies and analyses to identify areas for productivity improvements.DeliverablesThe FDA will delineate actual tasks and deliverables and their schedules with the issues of each BPA order. The following are illustrative examples of future anticipated task and deliverables for a BPA order:Kick-off MeetingWithin 10 business days of the effective date of a BPA order, the Contractor shall conduct a kick-off meeting with the COR and other appropriate FDA staff and within two business days after the kick-off meeting provide the COR with meeting notes, including a summary of discussions, action items, and due dates.Work PlanWithin 10 business days after the kick-off meeting, the Contractor shall provide draft work plan documents to the COR and provide revised work plans within 10 business days of the FDA providing feedback on the draft materials.Biweekly TeleconferencesThe Contractor shall conduct a teleconference with the COR and other appropriate FDA staff every two weeks and within two business days after each teleconference provide the OCR with meeting notes, including a summary of the discussion, action items, and due dates.Progress ReportsThe Contractor shall provide monthly status reports on all Orders documenting the monthly progress of the work. This document shall be submitted to the BPA Order Contracting Officer Representative (COR). Within the first 30 days after BPA Order award, the Government and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:Status and progress of tasksCost and schedule variancesSignificant risks to scheduled deliverables and plans to mitigate themProgress against work plansRecommendations for changes or additional activities to ensure that the tasks support progress In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems, and recommendations that should be addressed for the overall effective accomplishment of BPA Order goals. Recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.Analytical ReportsThe Contractor shall provide the COR a report on the order's data, findings, analysis, results as agreed upon in the work plan.Final ReportUpon completion of all components of the project, the Contractor shall submit a Final Report to close-out the project as described in each BPA order. The Final Report may include, but is not limited to the following documentation related to the Order:Project management documentationInformation gathering and data collection documentationProject/Study datasets, code, and documentation of analysis techniquesDocumentation of study methods and results A copy of all BPA order deliverables Government Furnished Information (GFI) / Government Furnished Equipment (GFE)Government Furnished Information (GFI) will be provided with each BPA Order. In general, the FDA will not provide Government Furnished Equipment (GFE) to the Contractor during the POP of this BPA.Contractor Key PersonnelPer HSSAR 352.242‐70, The key personnel specified in this BPA are essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, because of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this BPA. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.Key Personnel at the BPA level are: TBDAdditional Key Personnel positions may be identified and added at the BPA Order level.Period of PerformanceThe period of performance for this BPA shall commence from the effective date of award for an ordering period of five (5) years. The ordering periods shall commence as follows: DescriptionOrdering PeriodOrdering Period#1TBDOrdering Period#2TBDOrdering Period#3TBDOrdering Period#4TBDOrdering Period#5TBDPlace of PerformanceThe specific place of performance shall be designated at the BPA order level. The Government anticipates most of the requested training will be conducted onsite in the Washington, DC Metro Area. ................
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