140D0421R0007 - NCI BITSDIS Draft IDIQ SOW_1.pdf

DRAFT STATEMENT OF WORK

National Cancer Institute (NCI)

Biomedical Information Technology, Software Development, and Informatics Support

(BITSDIS)

1.0 PURPOSE

The purpose of this Statement of Work (SOW) is to acquire professional Biomedical Consultation and Information Technology, Software Development, and Informatics Support (BITSDIS) services for the National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT). Support shall include the following:

• Contract, task order, project, and task management;

• Biomedical informatics and information technology support;

• Program and project planning, development, and tracking support;

• Enterprise architecture support;

• Application, system, and database definition, design, development, and maintenance;

• Semantics operations support;

• Biomedical subject matter expertise support, including informatics and IT consulting; and

• Website maintenance, content management and updates.

2.0 BACKGROUND

The National Cancer Institute (NCI), a major healthcare research institute within the National Institutes of Health (NIH), coordinates the nation’s research program on cancer prevention, detection, diagnosis, treatment, rehabilitation, survivorship and control. As a result of the 1971 National Cancer Act legislation, the NCI has built a research community that includes regional and community cancer centers, physicians who are cancer specialists, cooperative groups of clinical researchers, and volunteer and community outreach groups. NCI also has initiated cancer control programs to hasten the application of knowledge gained through cancer research.

NCI has developed research programs supported by an infrastructure for discovery composed of support mechanisms, organizations, and networks that link scientists, facilities, and information.

This infrastructure is the underpinning for activities that encompass all aspects of cancer prevention, detection, diagnosis, treatment, rehabilitation, survivorship, and control. In addition, the infrastructure supports basic, translational, and clinical cancer research, which culminates in a significant contribution of scientific advances in all areas of cancer research based on the efforts of thousands of scientists supported by the NCI.

NCI invests several hundred million dollars annually to sponsor and conduct clinical trials in the areas of cancer therapy, prevention, diagnosis, and epidemiology. Studies are conducted both at the NCI and at NCI-funded organizations nationwide. These organizations include the NCI-designated Cancer Centers; the NCI Clinical Trials Cooperative Groups; the Specialized Programs for Research Excellence (SPOREs) along with several smaller trial consortia. The major NCI Centers and Divisions sponsoring clinical trials include NCI Center for Cancer Research (CCR), Division of Cancer Prevention (DCP), Division of Cancer Epidemiology and Genetics (DCEG), Division of Cancer Control and Population Sciences (DCCPS), and Division of Cancer Treatment and Diagnosis (DCTD). These research activities, the institutions where these activities are performed, and the personnel conducting these activities, are collectively referred to as the NCI Clinical Research Enterprise.

In support of NCI’s basic research efforts and the NCI Clinical Research Enterprise, CBIIT is responsible for a range of biomedical informatics research, research support, data management and sharing policy and process implementation, and associated program and project management and administrative support. This support includes several general categories of program, project, and resource management, biomedical informatics, and biomedical research, clinical analyses or translation, and scientific program and policy implementation support. This includes but is not limited to providing subject matter expertise across the full range of activities: application, system, and database definition, design, development, documentation, testing, implementation, update and maintenance; program and project communications support; policy and process implementation, biomedical IT and biomedical informatics training, and other biomedical informatics, biomedical research, and data science management support services.

CBIIT also provides biomedical informatics support and integration capabilities to the cancer research community and the NCI and serves as a focal point for cancer research informatics planning worldwide and works with research organizations, biomedical informatics groups and standards bodies to facilitate the identification and adoption of information exchange standards, thus connecting research information sources wherever they may reside.

Major ongoing initiatives and programs include, but are not limited to, Childhood Cancer Data Initiative (CCDI), Cancer Research Data Commons (CRDC), a comprehensive Clinical Reporting and Research Informatics (CRRI) initiative that include elements of the Cancer Moonshot and Precision Medicine Initiative (PMI). CRRI will include Precision Medicine Activities, Correlative Study Management (CSMS), the Clinical Trials Reporting Program (CTRP) and CTRP’s Clinical Trials Reporting Office (CTRO), as well as ancillary support services. Specifics include:

• A Precision Medicine Analysis and Coordination Center (PMACC) that will support current and next generation NCI precision medicine trials. This center will serve existing trials and the three new major initiatives; each of which will be composed of an umbrella/basket screening platform and linked clinical trials. Each master protocol will require both a MATCHBox precision medicine trial platform to determine patient eligibility for specific therapies and associated precision diagnostic laboratories provided by the NCI/DCTD Molecular and Immunologic Diagnostics Network of Laboratories (MDNet). The PMACC will provide the treatment assignment decisions based on data obtained from MDNet, other qualified laboratories, and the trial groups. The MDNet will provide primary diagnostic screening for trial arms that require specialized laboratory testing for patient allocation.

• A Correlative Study Management System (CSMS) that will provide biospecimen tracking and management support for the Cancer Immune Monitoring and Analysis Centers (CIMAC) biomarker network. Samples will be tracked from either the enrolling site or study-associated biorepository to the target research or diagnostic laboratory where assays will be performed. The CSMS will integrate with data coordinating centers and biobanks while maintaining unique network-wide case identifiers. The system may also provide capabilities for other CRRI-supported initiatives, as applicable.

• The Clinical Trial Reporting Program (CTRP) fulfills a recommendation made by the

NCI Clinical Trials Working Group (CTWG) to the National Cancer Advisory Board.

CTRP is designed to be a comprehensive database of regularly updated information, including accrual, on all NCI supported clinical trials. This comprehensive database of the entire NCI portfolio will help identify gaps in clinical research and duplicative studies, as well as facilitate effective clinical trial prioritization, trial search and trial matching.

• The Clinical Trial Reporting Office (CTRO) provides task management, data abstraction, coding, characterization quality assurance, user support and reporting in support of NCI’s Clinical Trials Reporting Program (CTRP). The CTRO manages CTRP content, including abstraction of submitted clinical trial protocols, updating and maintaining the content of the CTRP database, ensuring the accuracy of content through quality assurance procedures, managing the NCI’s ClinicalTrials.gov account, and responding to queries from stakeholder in a timely and accurate manner.

3.0 OBJECTIVE

The objective of this SOW is to acquire contracted professional biomedical information technology; system, application, and database design, development, implementation, and maintenance; data science; biomedical informatics; clinical and health science data sharing policy implementation, and biomedical IT and informatics subject matter expertise support and consulting services. The contract will assist CBIIT in planning, acquiring, developing, documenting, implementing, updating, and supporting biomedical research by focusing on developing and applying biomedical information technology (IT) support and informatics and their use. The contract and resulting IT and informatics tools and applications will assist researchers and the NCI to meet scientific objectives in clinical and translational research, cancer research and genomics, semantic infrastructure and interoperability, data science, discovery biology, and data sharing.

4.0 SCOPE

The NCI seeks a Contractor with experience in biomedical informatics and IT, clinical and health sciences data sharing, and cancer clinical trial abstraction who can provide several classes of biomedical information technology, software development, policy implementation and informatics support and consulting services to assist the CBIIT in the following classes of tasks:

• Contract, program, project, task, and activity management;

• Biomedical IT and informatics project management support including concept and business case development, cost and effort analysis, tracking, and reporting;

• Data semantics operations support;

• Technical and business requirements analysis, tracking, mapping to functionality, and prioritization;

• Design services, including business analysis, planning, requirements collection and analysis, data collection, modeling, and system, application, and database design;

• Software, application, database, system, and interface architecture, planning, development, testing, quality assurance, deficiency resolution tracking, reporting, documentation, and maintenance;

• Cloud Operations, Cloud General Security System, and Cybersecurity services;

• Enterprise Architecture support, including business process modeling, enterprise and information architecture design and development, and development of supporting artifacts;

• Implementation support services including evaluation and analysis of issues, development of recommendations for design, standards, and administration of systems, database management, data analysis, and reporting services;

• Biomedical IT and informatics program and project assessment and evaluation including recommendation of strategies and processes for evaluation, metrics for success, processes for go / no-go / cut-your- losses decisions, sustainability, and tracking and reporting;

• Program and project stakeholder requirements definition, coordination, and implementation communications support;

• Technical and functional consulting and provision of subject matter expertise across all areas outlined herein;

• Clinical and health science data policy implementation;

• Website maintenance, content management, and updates;

• Accurate and consistent abstraction, curation, and coding of clinical trial administrative and scientific data;

• Management of NCI’s ClinicalTrials.gov account; and

• User support, e.g., responding to incoming queries in a timely and accurate manner;

developing user training materials and presenting them to users, etc., These services shall include providing project and technical management, consulting, and technical support to CBIIT, including participating in CBIIT efforts supporting other NCI Divisions, Offices, and Centers, in biomedical informatics, biomedical information technology, and cancer research projects in all stages of their life cycle, in accordance with the tasks specified below. These services require interaction with the government Program Manager or Officer, senior business and IT managers, program stakeholders, and other contractors.

The Contractor shall report directly to the Contracting Officer’s Representative (COR) and shall not play any role in directing or managing work of any other project or support contractor staff.

Work products shall include data files, information models, software design artifacts, software source code and executables, IT capacity (provisioned information systems, storage arrays, etc.)

reports, recommendations, system and program requirements, analyses, management reports, and briefings.

5.0 TASKS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform task assignments at the direction of the COR in the Tasks specified below.

5.1 Task 1 – Contract Management

The Contractor shall provide the technical and functional activities necessary for the management of this SOW and work performed to meet SOW requirements.

The Contractor shall provide a Contract Management Plan outlining the tasks, sub tasks, and approaches to be used to provide the required services including the specific deliverable documents, analyses, and reports to be developed. When approved by the COR, this plan shall be used to monitor, control, and report progress, issues, and resource expenditure.

The Contractor shall participate in contract and project kickoff and management meetings and provide bi-weekly status updates and monthly status reports monitoring the performance and progress toward successful completion of this SOW.

Additionally, the Contractor shall provide and implement an approved Quality Assurance Plan outlining how assigned task work efforts will be controlled to ensure development and delivery of high quality services and products; provide insights into work processes; and provide positive guidance to improve work efficiency and acceptance of results.

As part of each assigned project or task, the Contractor shall provide the COR with a Work Plan for organizing, executing and monitoring the resource utilization, schedule, services and deliverables. This work plan when approved shall be incorporated into the Contract Management Plan.

The Contractor shall support the development, maintenance, and document control/tracking, of project plans, roadmaps, protocol documents, spreadsheets, financial statements, and contract deliverable documents. The Contractor shall keep all documents secured in a system that allows folder/document/workspace management allowing for access to be granted to the Contractor, NCI, NIH, HHS, and any 3rd party designated by the NCI.

Additionally, the Contractor shall collect and provide government requested metrics and data that provide insight into the efficiency of processes needed to support this SOW; and provide recommendations for changes that improve work, management effectiveness, and end-user satisfaction and reduce costs.

5.2 Task 2 – Program and Project Management Services

The contractor shall provide consulting and technical services for planning, definition, design, development, implementation, operation, and maintenance of services, applications, software, systems and infrastructures to support biomedical research, informatics, and care delivery. The Contractor shall apply expert level knowledge and best project management practices to ensure effective management of activities and achievement of project cost, schedule, and quality goals.

Services provided shall include, but not be limited to:

• Developing project and program Business Cases, work breakdown structures, management plans, effort and cost projections, and other required documentation;

• Examining alternatives for the potential projects and systems, non-compliant areas, risk areas related to project requirements and activities;

• Supporting project plan and business case updates, required cost analyses and cost tracking;

• Supporting project governance processes and reviews;

• Supporting data policy and process implementation for cancer research and clinical care initiatives;

• Technical and business requirements analysis and gathering / tracking, artifacts and process for mapping to functionality, prioritization;

• Program and Project Assessment and Evaluation such as strategies and process for evaluating progress and performance, development of metrics for success and processes for go-no-go decisions;

• Identifying and implementing project management tools to support project needs;

• Defining, distributing, and maintaining project schedules and project team task lists;

• Defining, documenting, and assisting with milestone reviews, project schedules, tasks and assumptions;

• Documenting and managing, project assumptions, risks, issues, and quality control;

• Providing consulting and training support to individual government project and task managers to help ensure successful, on-time, within budget project completion;

• Coordinating amongst teams and different CBIIT programs; and

• Developing and implementing communications strategies and mechanisms.

5.3 Task 3 – Enterprise Architecture Services

The Contractor shall provide consulting and technical services in support of the definition, design, development, implementation, operations, and management of an NCI wide Enterprise and Information Architecture. This architecture shall include NCI operations as well as activities supported by the NCI CBIIT, as outlined in this SOW. The Contractor shall apply expert level knowledge of Enterprise and Information Architecture, and business intelligence toolsets to support these efforts.

These services shall include, but not be limited to:

• Providing consulting services for NCI data repository, data architecture, and data warehousing initiatives;

• Providing support for the development of project and Enterprise Use Cases

• Providing Enterprise Architecture Modeling support;

• Providing business process modeling services to CBIIT for current and future processes that will drive the NCI’s investments in biomedical informatics and information technology;

• Providing program/project governance support;

• Providing expertise in the development and maintenance of the NCI’s Enterprise

Conformance and Compliance Framework (ECCF) and its support artifacts.

5.4 Task 4 – Definition and Design Services

The Contractor shall provide consulting and technical services in support of the definition and design of services, applications, and software systems used to support biomedical research, informatics, and care delivery. The contractor shall apply expert level knowledge in the areas of information system design, Service-oriented Architecture, Could-based Architecture, system modeling and design, and other best practices.

The services shall include, but not be limited to:

• Business process modeling;

• Requirements gathering;

• Systems analysis;

• Level of effort, cost, and schedule analysis and validation;

• Data collection, modeling and analysis;

• Information Modeling;

• System design;

• UI/UX design.

This task shall involve assisting CBIIT in creating designs that are compatible with NCI system design criteria and compatibility guidelines. The Enterprise Conformance and Compliance Framework (ECCF) is the current conformance and compliance model in use at CBIIT. The Contractor should be capable of adjusting the model based on other specified standards or frameworks in use for a specific effort.

5.5 Task 5 – Development Services

The contractor shall provide biomedical information technology services in support of the construction of software to enable biomedical research and care delivery in a manner that ensures understanding of applicable policy requirements. It is expected that a successful vendor shall provide staff with experience in the following technologies and processes: Agile (e.g., Kanban and Scrum), Cloud Infrastructure and Security, DevOps, Python, serverless computing including but not limited to AWS Lambda, Cloud Managed Services (e.g., QLDB, DynamoDB, Neptune, Aurora, RedShift), NoSQL, MongoDB, SAML, Java, Ruby, Oracle, Enterprise Architecture Modeling (e.g., BPMN, ArchiMate), FISMA Compliance, AWS S3, AWS CloudFront, AWS Shield, AWS API Gateway, and other AWS services.

The Contractor shall support CBIIT activities in a manner that aligns with the NCI Cloud Computing and Platform Management Approach, the NCI CBIIT Cloud Computing Support Service Description, and the NIH FISMA and FEDRAMP Information Security and/or Physical Access Security guidance.

These services shall include, but not be limited to:

• Software development;

• Database design, implementation, and administration;

• Software and data quality assurance and Independent Verification and Validation (IV&V) services;

• DevOps;

• Technical writing; and

• Development of training.

5.6 Task 6 – Validation, Testing, and Quality Assurance Services

The Contractor shall provide technical and consulting services to provide validation, testing, and quality assurance of software, applications, databases, web sites, and systems to meet NCI and other federal, state and local authority requirements. These services shall include but not be limited to:

• Development and implementation of formal software validation, testing, and quality assurance processes and the underlying Software Development Lifecycle (SDLC) processes required to implement validation processes;

• Development, implementation, and operation of validation processes and procedures to be used to assess compliance with compatibility guidelines, testing, and quality assurance requirements;

• Validation against the requirements of federal laws governing electronic information systems and protection of human subjects, including HIPAA, 21 C.F.R. Part 11, and 45 C.F.R. 46 (usually referred to as “the Common Rule”);

• Testing and quality assurance of products including mapping functions to requirements, conducting testing activities, reporting test results, issues, and risks, and recommending mediation and/or resolution of problems identified;

• Support for submissions to external validation and certification bodies; and

• Development of supporting validation, testing, and quality assurance documentation required by developers, stakeholders, and user communities.

5.7 Task 7 – Implementation Management and Support Services

The contractor shall provide services to support the implementation management of NCI biomedical research, and NCI business systems.

These services include, but are not limited to:

• Support for the planning, management, tracking, and reporting on deployment of information systems at NCI, CBIIT leased, and NCI supported sites; as well as in the cloud;

• Database management services including planning, evaluation, risk and issue analysis and management support;

• Cloud Operations, Cloud General Security System, and Cybersecurity services; and

• Data analysis and reporting services including utilization, effectiveness, acceptance, performance, risks, issues, etc.

5.8 Task 8 – Semantics Support Services

The contractor shall provide technical and consulting support for management of semantic operations that are a major component of CBIIT software development processes. These services shall include, but are not limited to assistance in the management and implementation of the following:

• Creation, deployment, and maintenance of Enterprise Vocabulary Services, including controlled terminologies, metadata, vocabularies, and ontologies for the support of NCI operations and software development activities;

• Creation, deployment, and maintenance of Common Data Elements for the support of NCI operations and software development activities in the NCI’s cancer Data Standards Repository (caDSR) and any successor systems;

• Creation, deployment, and maintenance of additional semantic services as required by NCI, including APIs to semantic services.

5.9 Task 9 – Clinical Trials Reporting Office (CTRO) Support Services

The Contractor shall provide project management, data management, and reporting services; e.g., data abstraction, quality assurance, user support and reporting in support of NCI Clinical Trials Reporting Program (CTRP); The contractor shall provide services that include, but not be limited to the following:

• Provide accurate and consistent abstraction, curation and coding of clinical trial administrative and scientific data;

• Abstract new trial and amendment submissions; implement changes in trial status and participating sites;

• Manage updates to submissions; ensure automated solicitations are scheduled and sent to receive trial updates twice a year;

• Manage the reporting of clinical trial accrual into CTRP, ensuring the timeliness of reporting and compliance with accrual data reporting guidelines;

• Develop and implement a continuous quality assurance plan to assure accuracy and consistency of data entered and maintained in CTRP;

• Implement, maintain, and update Standing Operating Procedures (SOPs); identify departures from SOPs; recommend and implement appropriate changes in a timely manner;

• Maintain a list of operational issues; seek guidance from the Contracting Officer’s Representative (COR), Government lead, and/or designee on how to prioritize the resolution of operational issues; work with the COR, Government lead, and/or designee to develop a timeline to resolve operational issues;

• Meet with staff in NCI’s Coordinating Center for Clinical Trials (CCCT), other contractor staff, and internal and/or external NCI stakeholders upon request, to discuss topics, such as operational issues, technical issues and/or other related concerns;

• Manage the NCI’s ClinicalTrials.gov Protocol Registration and Results System (PRS) account for NCI Sponsored trials registered in CTRP;

• Manage compliance with results reporting for NCI sponsored trials and other trials directly funded by NCI, e.g., trials managed by NCI’s Cancer Therapy Evaluation

Program (CTEP);

• Provide user support, e.g., responding to incoming queries, sending messages regarding

CTRP as directed to listservs, developing training materials regarding CTRP and providing information webinars and/or presentations upon request;

• Manage the accuracy and curation of persons and organizations associated with clinical trials;

• Provide workload, status, performance, data quality, and other reports upon request from the COR, Government lead, and/or designee;

• Develop training and documentation materials, e.g., PowerPoint presentations, website content, etc., .and updates for CTRO related activities.

5.10 Task 10 – Technical and Policy Consulting and Expertise

The Contractor shall provide subject matter expertise and support services in the task areas delineated in the scope section of this SOW as requested by CBIIT to support required activities, tasks, projects, and initiatives. The expertise and support provided shall assist Federal staff to plan, implement, control, and manage on-going and new work to achieve approved NCI and CBIIT plans, goals, and objectives.

5.11 Task 11 – Website Development and Maintenance, Content Management, Updates and Information Security Requirements

The Contractor shall provide high-quality integrated digital services and product development expertise that enables CBIIT to meet its digital communications goals effectively and efficiently.

The Contractor shall provide staff with technical skills and expertise to assist CBIIT to maintain and update NCI and project web sites. This support shall include, but not be limited to the following:

• Provide support and subject matter expertise in the areas of digital market research, discovery through user interviews, voice of the customer surveys, A/B testing, usability testing, and other relevant approaches;

• Develop creative briefs/reports that outline the business goals, audience needs, problems that need to be solved, and a general approach for each major web project;

• Submit requests for project approvals through the NCI New Website/Web Application Process;

• Ensure that any new websites/web applications incorporate appropriate analytics codes to support web analytics Federal reporting requirements;

• Develop measurement plans and key performance indicators for products and projects, create campaigns and monitor and report progress toward accomplishing goals of the campaigns as specified in the measurement plans;

• Maintaining sites including updating technologies and links as required;

• Keeping site content current through loading updated content provided;

• Ensuring all digital assets align with NCI branding and identity and NIH Identity guidelines;

• Conduct and support audience research and the use of analytics to enhance the user experience with CBIIT websites, web applications, and social media platforms;

• Provide appropriate support to CBIIT to obtain OMB clearance where required; and

• Providing development and programming support as needed.

The Contractor shall provide expertise and services that enable CBIIT’s digital deliverables (websites, web applications, web content and graphics, presentations, social media, and the like) to comply with NCI’s digital strategy, which embraces the following guiding principles:

• Audience-focused

• Data-informed

• Collaborative

• Agile processes

To allow for the effective integration of web, social media, email, and multimedia and appropriate development of new digital dissemination and marketing approaches to ensure CBIIT’s information reaches its target audiences, the Contractor shall abide by:

1) NCI’s digital strategy approach as documented on the NCI intranet myNCI; and

2) CBIIT’s digital strategy approach by collaborating with CBIIT’s Communications Team.

The Contractor shall support CBIIT activities in a manner that meets the requirements of the 21st Century Integrated Digital Experience Act (IDEA), OMB regulations such as the Paperwork Reduction Act, and HHS policies and guidelines related to digital communications, and other federal and NIH requirements which include Section 508 of the Rehabilitation Act, the Digital Analytics Program, the Plain Writing Act, as well as security mandates.

The Contractor shall demonstrate a clear understanding of integrated digital strategy development, implementation, and management to communicate cancer data science and informatics information to multiple audiences and will effectively interact with CBIIT Communications Team so that new web properties properly interact and reflect CBIIT and NCI’s web presence.

5.12 Task 12 – Other Services Required to Support SOW Requirements

The Contractor shall provide other technical and systems services in support of CBIIT tasks and projects within the scope of this SOW as required and directed by the Government’s assigned COR. Examples include end-user support and help desk.

5.13 Task 13 – Transition Planning and Support

The Contractor shall demonstrate in their response experience, and expertise in successfully transitioning an in-process cancer research clinical trial, biomedical research, and care delivery information systems contract of similar size and scope as prime contractor or subcontractor.

The Contractor shall work with CBIIT and other NCI support contractors to ensure that working relationships are cordial, professional, that incoming managers and staff fully absorb methodologies, experiences, and lessons learned to ensure all work, management, and reporting tasks and efforts are conducted rapidly and smoothly.

https://digital.gov/resources/21st-century-integrated-digital-experience-act/ https://digital.gov/resources/21st-century-integrated-digital-experience-act/ https://pra.digital.gov/ https://pra.digital.gov/ https://www.section508.gov/manage/laws-and-policies https://digital.gov/guides/dap/ https://digital.gov/guides/dap/ https://www.plainlanguage.gov/law/

The Contractor shall ensure that proposed key personnel are available to begin work upon contract award and that all staff required to implement the Contractor’s proposed technical approach are available and onboard within 30 days of award.

5.13.1 Transition-In Planning and Support

The Offeror shall provide a Draft Staffing and Transition-In Plan as a part of its proposal outlining how it proposes to quickly and successfully provide qualified staff to implement the proposed technical approach, transition current and ongoing tasks and activities, and ensure effective knowledge transfer from any outgoing contractor(s). After contract award and receipt of government comments and suggested changes, this Draft Staffing and Transition-In Plan shall be finalized and implemented to ensure a timely and successful transition.

The Staffing and Transition-In Plan shall provide a logical strategy and process to mitigate risk to the Government. The plan shall include the following as a minimum:

• Overview of how transition shall be implemented and managed;

• Staffing plan and approach;

• Staffing plan implementation and management;

• Transition of key personnel and non-key personnel;

• Transition of Existing Efforts;

• Resources required for the transition;

• Roles and responsibilities;

• Timeline;

• Risks, issues, and associated implications; and

• Risk and issue mitigation processes and procedures.

Transition-in shall begin at contract award. The contractor shall complete all transition-in efforts in accordance with the approved transition plan (to include the Government’s validation of the Transition Plan, containing critical events, schedules and approach) and be prepared to begin performance immediately and to be completed no later than thirty (30) calendar days after award.

The contractor shall discuss the transition-in period and operational activities with the COR beginning not later than the 5th calendar day following award. The discussion shall address, at a minimum, those items identified as being key to the success of the transition identified in the plan, status, and any risks or issues identified.

5.13.2 Transition-Out Planning and Support

In the final year of the Contract, or in the event the Government requirements necessitate a re-compete of the requirements of this SOW, and prior to completion of this Delivery Order’s period of performance, the Contractor shall develop and deliver a Transition-Out Plan not later than 90 days prior to contract expiration. The purpose of the Transition-Out Plan is to ensure an orderly and successful transition of contract functions should the incumbent Contractor not be selected during the re-competition of the Contract.

This Transition-Out Plan shall include processes, procedures, and activities the Contractor shall use, if not selected for a follow-on contract, to adequately educate and train the successful contractor’s employees and smoothly and effectively transition work activities to the new Contractor. When tasked, the Contractor shall implement the Transition Plan and assist the NCI to transition knowledge, processes, tasks, activities, etc. to the follow-on contractor.

The plan shall detail transition-out activities to assure continuity of operations and the execution of a smooth and timely transition. Transition-out activities shall be coordinated through the COR and/or other designated federal staff. The outgoing contractor shall discuss the status of transition-out activities with the COR on a weekly basis beginning the 5th working day following the award of a successor contract. In the event the follow-on contract is awarded to an entity other than the incumbent, the incumbent Contractor shall cooperate to the extent required to ensure an orderly changeover to the successor Contractor.

6.0 DELIVERABLES/DELIVERY SCHEDULE

All written deliverable products shall be submitted in draft format for review, comment and approval by the COR. Final copies of approved drafts shall be delivered to the COR within five

(5) business days after receipt of the COR’s comments.

All written draft deliverable products shall be submitted as three (3) draft printed copies and one electronic copy for review and comment. Final deliverable products shall be submitted as five

(5) final bound copies, one (1) unbound flat final copy suitable for reproduction, and an electronic copy. Other quantities and formats may be submitted after prior approval from the Project Officer or COR. Electronic copies shall be submitted in Microsoft Office format unless prior approval for another format has been obtained from the COR.

The delivery schedule of products is outlined in the delivery schedule table below. Other written and technical deliverables shall be submitted according to the schedules identified in the approved Contract Management Plan developed under this SOW. The Contractor shall deliver the following:

Contract Management Plan – The Contractor shall prepare draft and final versions of a Contract Management Plan specifying the tasks, sub tasks, and approaches to be used to provide the services and products specified including the deliverable documents, analyses, and reports necessary to fulfill the requirements of this SOW. This Plan shall be delivered in draft not later than one week following the award of the Contract.

Quality Assurance Plan – The Contractor shall prepare draft and final versions of a Quality Assurance Plan specifying the tasks, sub tasks, and approaches to be used to ensure adequate quality and integrity of data in the database. This Plan shall be delivered in draft not later than one week following the approval of the Contract Management Plan.

Bi-Weekly Status and Progress Report – The contractor shall prepare and submit a Bi- Weekly (every two week) status report in Microsoft Excel format containing accomplishments for the current reporting period, goals for the next reporting period, current risks and issues, and upcoming project milestones.

Monthly Contract Status and Progress Summary Report – The Contractor shall prepare and submit Monthly Contract Status and Progress Summary Reports. Reports shall be forwarded to the COR by the 15th calendar day of the month following the reporting period.

The delivered Report must be suitable for forwarding to NIH executive management.

The format and content of the Report shall include the following:

• Activities planned for the reporting period,

• Work and deliverables completed during reporting period,

• Status of ongoing activities,

• Activities planned for the next reporting period,

• Risks, problems or issues identified or projected,

• Alternatives and/or recommended solution(s) for identified or projected problems or issues,

• Known or projected resources (staff and funding) and schedule impacts, and

• Status of project funds including monthly and total expenditures and funds remaining.

• A table summarizing turnaround time including, but not limited to, the number of new trial submissions (complete and abbreviated) and amendments processed during the reporting period, including the average turnaround time for each category (complete and abbreviated trials and protocol amendments) (CTRO Specific).

• A summary of external stakeholder communications identifying significant issues, trends, and themes broken down into various categories, e.g. number of ServiceNow (SN) tickets by submitting organization, cancer centers, cooperative groups, intramural, and include any significant quantitative and/or qualitative issues noted by the submitters. A table should be included with the number of outstanding tickets and recommendations on how to resolve them. (CTRO Specific)

• A table summarizing: 1) all currently open projects, e.g. data clean-up tasks, with the initial estimated completion date as well as the current initial estimated completion date if this differs from the initial projection; , 2) completed projects; and 3) upcoming projects with an estimated start date to be reviewed by COR, government lead, and/or designee. (CTRO Specific)

Monthly Financial Management Status Report – The Contractor shall prepare and submit draft and final Monthly Financial Management Status Reports. Draft reports shall be forwarded to the COR by the 15th calendar day of the month following the reporting period. Reports shall be broken out by workspace for review by the appropriate NCI Workspace Facilitator. A final report shall be submitted five days after receipt of government comments.

The delivered Report must be suitable for forwarding to NCI executive management.

The format and content of the Report shall include the following as a minimum:

• Budgeted total and budgeted monthly hours by CBIIT workspace, project and/or task, and Delivery Order total.

• Actual hours expended for the reporting period by unit including breakdown by labor category and name for each CBIIT workspace, project and/or task, and the Delivery Order total.

• Actual hours expended to date by task including breakdown by labor category and name including task totals, CBIIT workspace, project and/or task totals, and Delivery Order total

• Actual costs to date and for the reporting period (based on actual hours) by CBIIT workspace, project and/or task, and Delivery Order total.

• Estimated Cost to Completion by CBIIT workspace, project and/or task, and Delivery Order total.

• Task and cost variance (for >10% variance include explanation/analysis) by CBIIT workspace, project and/or task, and Delivery Order total.

• ODC progress and costs by CBIIT workspace, project and/or task, and Delivery Order total.

Staffing and Transition-In Plan – The Contractor shall prepare and submit draft and final Staffing and Transition-In Plans as prescribed in Section 6-13 - Task Area 13. This Staffing and Transition-In Plan shall include detailed background information, workflow and processes, work plans and procedures, and specific activities the Contractor shall use and conduct to adequately and effectively provide required numbers of qualified staff, transfer roles and responsibilities, ensure required knowledge transfer is conducted, and smoothly and effectively transition work and ongoing activities from an outgoing contractor. The Draft Staffing and Transition-In Plan shall be submitted with the Offeror’s proposal and evaluated.

The Draft Staffing and Transition-In Plan shall provide a logical strategy and process to mitigate risk to the Government. The plan shall include the following as a minimum:

• Overview of how transition shall be implemented and managed;

• Staffing plan and approach;

• Staffing plan implementation and management;

• Transition of key personnel and non-key personnel;

• Transition of Existing Efforts;

• Resources required for the transition;

• Roles and responsibilities;

• Timeline;

• Risks, issues, and associated implications; and

• Risk and issue mitigation processes and procedures.

The Contractor shall ensure that proposed key personnel are available to begin work upon contract award and that all staff required to implement the Contractor’s proposed technical approach are available and onboard within 90 days of award.

Transition-Out Plan – The Contractor shall prepare and submit draft and final Transition- Out Plans as prescribed in Section 5-13 - Task Area 13. This Transition-Out Plan shall include detailed background information, workflow and processes, work plans and procedures, and specific activities the Contractor shall use and conduct, if not selected for a follow-on contract, to adequately educate and train the successful contractor’s employees and smoothly and effectively transition CTRP work activities to the incoming Contractor.

The plan shall detail transition-out activities to assure continuity of operations and the execution of a smooth and timely transition. Transition-out activities shall be coordinated through the COR and/or other designated federal staff. The outgoing contractor shall discuss the status of transition-out activities with the COR on a weekly basis beginning the 5th working day following the award of a successor contract. In the event the follow-on contract is awarded to an entity other than the incumbent, the incumbent Contractor shall cooperate to the extent required to ensure an orderly changeover to the successor Contractor.

Other Deliverable Products – The Contractor shall prepare other draft and final deliverable plans, analyses, evaluations, reviews, and reports necessary to fulfill the tasks specified in this SOW and assigned by the Government’ COR.

DELIVERY SCHEDULE

Task Area Deliverable Deliverable Due Date

1 Draft Contract Management Plan One week after Contract award 1 Final Contract Management Plan Five working days after receipt of

Government comments 1 Draft Quality Assurance Plan Five working days after approval of Final

Contract Management Plan 1 Final Quality Assurance Plan Five working days after receipt of

Government comments 1 Bi-Weekly Status and Progress Review Every two weeks beginning two weeks after

Contract award 1 Draft Monthly Status and Progress Report Monthly, NLT 15th calendar day or next business day 1 Monthly Status and Progress Report Five working days after receipt of

Government comments 1 Draft Monthly Financial Management

Status Report Monthly, NLT 15th calendar day or next business day

1 Final Monthly Financial Management Status Report

Five working days after receipt of Government comments

12 Draft Staffing and Transition-In Plan With Offeror’s proposal

12 Final Staffing and Transition-In Plan Five working days after receipt of Government comments

12 Draft Transition-Out Plan As specified in the Government-approved Contract Management Plan or as mutually agreed by the contractor and the COTR and/or Contracting Officer

12 Final Transition-Out Plan As specified in the Government-approved Contract Management Plan or as mutually agreed by the contractor and the COTR and/or Contracting Officer

1 – 12 Other Deliverables necessary to satisfy the requirements of this SOW

As specified in a Government-approved Contract Management Plan or as mutually agreed by the Contractor and the COR and/or Contracting Officer

7.0 CONTRACT TYPE

Time-and-Materials (T&M). Travel and Other Direct Costs (ODCs) are to be determine.

8.0 PLACE OF PERFORMANCE

The place of performance will be determined upon award. Due to ongoing operations as a result of COVID-19, the Contractor may be expected to telework until further guidance is available.

All telework must be in accordance with HHS/NIH telework policies. All telework shall be billed as if working onsite at the Government facility. The NCI requires ready access to the Contractor’s personnel during normal business hours (8:30 a.m. to 5:30 p.m. Monday through Friday, exclusive of Government holidays).

9.0 PERIOD OF PERFORMANCE

The period of performance of this Contract shall be for a 12-month Base Period from date of award, with four (4) successive 12-month Option Periods:

Base Period: Date of Award through _____________ Option Period 1: ______________through ______________ Option Period 2: ______________ through ______________ Option Period 3 ______________ through ______________ Option Period 4 ______________ through ______________

10.0 ESTIMATED LEVEL OF EFFORT AND LABOR CATEGORIES

The Contractor shall provide the following resources, labor categories and level of effort are estimated for the performance of this SOW:

10.1 Estimated Level of Effort

SOW Labor Categories

Base Option Option Option Option Total Period Period 1 Period 2 Period 3 Period 4 5 Years 1 Program Manager III 1,920 1,920 1,920 1,920 1,920 9,600 2 Project Manager III 1,920 1,920 1,920 1,920 1,920 9,600 3 Project Manager II 1,920 1,920 1,920 1,920 1,920 9,600 4 Subject Matter Expert IV 1,920 1,920 1,920 1,920 1,920 9,600 5 Subject Matter Expert III 1,920 1,920 1,920 1,920 1,920 9,600 6 Subject Matter Expert II 1,920 1,920 1,920 1,920 1,920 9,600 7 Subject Matter Expert I 1,920 1,920 1,920 1,920 1,920 9,600

8 Biomedical Informatics Specialist III 1,920 1,920 1,920 1,920 1,920 9,600

9 Biomedical Informatics Specialist II 1,920 1,920 1,920 1,920 1,920 9,600

10 Business Analyst III 1,299 1,299 1,299 1,299 1,299 6,495 11 Business Analyst II 1,920 1,920 1,920 1,920 1,920 9,600 12 Business Analyst I 7,974 7,974 7,974 7,974 7,974 39,870

13 Quality Assurance Analyst

III 1,920 1,920 1,920 1,920 1,920 9,600

14 Quality Assurance Analyst I 1,920 1,920 1,920 1,920 1,920 9,600 15 System Analyst 9,092 9,092 9,092 9,092 9,092 45,460 16 Systems Expert III 5,196 5,196 5,196 5,196 5,196 25,980 17 Systems Expert II 1,299 1,299 1,299 1,299 1,299 6,495 18 Bioinformatician III 1,920 1,920 1,920 1,920 1,920 9,600 19 Bioinformatician II 1,920 1,920 1,920 1,920 1,920 9,600 20 Reengineering Specialist 1,920 1,920 1,920 1,920 1,920 9,600 21 Technical Writer 1,920 1,920 1,920 1,920 1,920 9,600 22 Data Architect 5,433 5,433 5,433 5,433 5,433 27,165 23 Database Administrator III 5,196 5,196 5,196 5,196 5,196 25,980 24 Database Administrator II 3,897 3,897 3,897 3,897 3,897 19,485 25 Database Administrator I 1,299 1,299 1,299 1,299 1,299 6,495 26 Enterprise Architect III 12,989 12,989 12,989 12,989 12,989 64,945 27 Enterprise Architect II 10,391 10,391 10,391 10,391 10,391 51,955 28 Enterprise Architect I 33,771 33,771 33,771 33,771 33,771 168,855

29 IT Computational Biologist

III 1,299 1,299 1,299 1,299 1,299 6,495

30 IT Computational Biologist

II 2,598 2,598 2,598 2,598 2,598 12,990

High Performance Computing Specialist 7,793 7,793 7,793 7,793 7,793 38,965

32 Bioinformatics Analyst IV 1,920 1,920 1,920 1,920 1,920 9,600 33 Bioinformatics Analyst III 1,920 1,920 1,920 1,920 1,920 9,600 34 Bioinformatics Analyst II 1,920 1,920 1,920 1,920 1,920 9,600 35 Bioinformatics Analyst I 1,920 1,920 1,920 1,920 1,920 9,600 36 Bioinformatics Manager 1,920 1,920 1,920 1,920 1,920 9,600 37 Business Analyst III 1,920 1,920 1,920 1,920 1,920 9,600 38 Cloud Engineer III 1,920 1,920 1,920 1,920 1,920 9,600 39 Cloud Engineer II 1,920 1,920 1,920 1,920 1,920 9,600 40 Cloud Manager 1,920 1,920 1,920 1,920 1,920 9,600 41 Data Scientist III 1,920 1,920 1,920 1,920 1,920 9,600 42 Data Scientist II 1,920 1,920 1,920 1,920 1,920 9,600 43 Data Scientist I 1,920 1,920 1,920 1,920 1,920 9,600 44 Database Programmer III 1,920 1,920 1,920 1,920 1,920 9,600 45 Database Programmer II 1,920 1,920 1,920 1,920 1,920 9,600 46 Database Programmer I 1,920 1,920 1,920 1,920 1,920 9,600 47 Help Desk Manager 1,920 1,920 1,920 1,920 1,920 9,600

48 Information Security Analyst III 1,920…