Sol_140D0421R0007.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

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OFFEROR

D22

Suite 4000 381 Elden St Division 2/ Branch 2 Interior Business Center, AQD

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541690

SIZE STANDARD:

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RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

04/09/2021 1000 ED

03/23/2021

703 464 3600Russell Pfeiffer (No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

140D0421R0007

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 64 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

Herndon VA 20170

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Herndon VA 20170 Suite 4000 381 Elden St Division 2/ Branch 2

9. ISSUED BY

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EFFECTIVE DATE

$16.50

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

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DELIVERY FOR FOB DESTINA-

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MARKED

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SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

Interior Business Center, AQD

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ITEM NO.

This requirement is being issued by the United States Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), on behalf of the United States Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI). AQD will conduct this acquisition for Biomedical Information Technology, Software Development, and Informatics Support (BITSDIS) using part 12 and 15 of the of the FAR. See the attached RFP package for more

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

Nicole Beall

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

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ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

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ITEM NO.

information.

CO: Nicole Beall

Nicole_Beall@ibc.doi.gov

CS: Russell Pfeiffer

Russell_Pfeiffer@ibc.doi.gov

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

64 2 of

SECTION 1 Solicitation 140D0421R0007

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SECTION 1 – INTRODUCTION

1.1 Combined Synopsis/Solicitation for Commercial Items

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) Solicitation 140D0421R0007 is issued as a Request for Proposal (RFP) utilizing FAR Part

15, Contracting by Negotiation.

(iii) The Solicitation and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular 2021-05 (March 10, 2021).

(iv) This synopsis/solicitation is being issued as a full and open competition. The North

American Industry Classification System (NAICS) code is 541690 – Other Scientific and Technical Consulting Services, with a size standard of $16.5 Million. The Product Service Code (PSC) is DA01 – Business Application/Application Development Support Services (Labor).

(v) This RFP includes one (1) one-year base period and four (4) one-year option periods.

(vi) The objective of this requirement is to acquire contracted professional biomedical information technology, software development, and informatics support that will assist NCI in planning, developing, documenting, implementing, updating, and supporting biomedical research. The contracts 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.

(vii) Final inspection and acceptance of all work performed, reports and other deliverables will be performed at the place of performance by the Contracting Officer’s Representative

(COR).

(viii) The provision at FAR 52.212-1, Instructions to Offerors – Commercial (Jun 2020), applies to this acquisition and the RFP includes an addendum to the provision. See Section 4 of the RFP for more information.

(ix) The provision at FAR 52.212-2, Evaluation – Commercial Items (Oct 2014) applies to this acquisition and the RFP includes an addendum to the provision. See Section 5 of the RFP for more information

(x) Offerors shall submit the provision at FAR 52.212-3, Offeror Representations and

Certifications – Commercial Items (Feb 2021), with its offer. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations

1 - 2 and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision. See Attachment 4.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items, Alternate

1 (Oct 2018) applies to this acquisition and the RFP includes an addendum to the clause. See Section 3 of the RFP for more information.

(xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders – Commercial Items (Jan 2021) applies to this acquisition. See Section 3 of the RFP for more information.

(xiii) See Section 3 of the RFP for additional contract requirements and terms and conditions.

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this acquisition.

(xv) Proposals submitted in response to this RFP shall be received no later than 10:00 A.M.

current Eastern Time, April 09, 2021 for Phase I in order to be considered for award. See Section 4 for submission instructions.

(xvi) The Contracting Officer (CO) for this RFP is Nicole Beall (nicole_beall@ibc.doi.gov) and the Contract Specialist (CS) for this RFP is Russell Pfeiffer (russell_pfeiffer@ibc.doi.gov).

1.2 General

This requirement is being issued by the United States Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), on behalf of the United States Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI). AQD will conduct this acquisition for Biomedical Information Technology, Software Development, and Informatics Support (BITSDIS) using part 12 and 15 of the of the FAR.

1.3 Submission of Questions

Questions related to this RFP package must be submitted in Microsoft Excel format utilizing the template provided in Attachment 8 – Q&A Template. Questions must be submitted via email to nicole_beall@ibc.doi.gov and russell_pfeiffer@ibc.doi.gov no later than 10:00 A.M., current Eastern Time, March 29, 2021 for Phase I. The date for submission of Phase II questions will be sent with the advisory down select notice and must be submitted utilizing the Q&A template.

Any questions received after the specified cut-off date and time will not be accepted or answered. Please be advised that the Government reserves the right to transmit questions and answers of a common interest to all prospective offerors. All questions must be received in writing – No oral questions will be accepted. All e-mail inquiries must have “Questions – RFP # 140D0421R0007 – Name of your company” in the subject line. Questions with the Government’s responses will be provided to all contractors via solicitation amendment.

1.4 Anticipated Award Type

https://www.sam.gov/ mailto:nicole_beall@ibc.doi.gov mailto:russell_pfeiffer@ibc.doi.gov mailto:nicole_beall@ibc.doi.gov mailto:russell_pfeiffer@ibc.doi.gov

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The Government anticipates awarding up to five (5) Indefinite-Delivery Indefinite-Quantity (IDIQ) contracts. However, the Government, at its discretion, reserves the right to adjust the number of IDIQ awards. The Government anticipates issuing Time-and-Materials (T&M) Task Orders (TOs) to IDIQ contract holders. Travel / Other Direct Costs (ODCs) are anticipated in performance of these orders.

SECTION 2 Solicitation 140D0421R0007

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SECTION 2 – IDIQ STATEMENT OF WORK

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 in support of the National Cancer Institute (NCI). 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.

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In support of NCI’s basic research efforts and the NCI Clinical Research Enterprise, the Center for Biomedical Informatics and Information Technology (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.

• The Clinical/Correlative Study Management System supports the NCI Cancer Immune

Monitoring and Analysis Centers (CIMAC) Biomarker Network and will directly support oncology studies/clinical trial operations including PMACC/PMI. The system must support tracking specimen from enrolling sites (e.g. via Medidata Rave), potentially from more than 20 biorepositories and multi-laboratory networks including, but not limited to CIMAC and MDnet laboratories performing a dispersed menu of assays. The current

2 - 3 solution should be maintained and enhanced to support study management dashboards, unique sample identifier generation, manifest and sample label generation, biospecimen tracking, document management and information management capabilities.

• 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, software development, and informatics support that will assist NCI in planning, developing, documenting, implementing, updating, and supporting biomedical research. The contracts 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 NCI 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;

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• 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 NCI, including participating in CBIIT efforts supporting other NCI Divisions, Offices, and Centers (DOCs), 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 multiple NCI DOCs, Government Program Manager(s), senior business and IT managers, program stakeholders, and other NCI 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

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5.1 Task 1 – Contract Management

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

The Contractor shall provide a Contract Management Plan for each Task Order 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 an IDIQ contract and Task Order kickoff and management meetings and provide bi-weekly status updates and monthly status reports monitoring the performance and progress toward successful completion of the Task Orders as applicable.

Additionally, the Contractor shall provide and implement an approved Quality Assurance Plan as specified in the Task Order 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 Task Order, 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.

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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, 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;

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• 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 NCI 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 (Attachment 13), the NCI CBIIT Cloud Computing Support Service Description (Attachment 14), and the NIH FISMA and FEDRAMP Information Security and/or Physical Access Security guidance (Attachment 15).

These services shall include, but not be limited to:

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• 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

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• 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 Application Program Interface (API)s 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 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)

2 - 10 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;

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• 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. The Contractor will work collaboratively with the CBIIT Communications Team to ensure that new web content properly integrates and aligns with CBIIT and NCI’s existing 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.

6.0 ESTIMATED IDIQ LABOR CATEGORIES

See Attachment 7 for a list of estimated IDIQ labor categories.

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/

SECTION 3 Solicitation 140D0421R0007

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SECTION 3 – GENERAL CONTRACT TERMS AND CONDITIONS

3.1 Period of Performance

The total period of performance for this IDIQ shall be for a base period of twelve months and four (4) twelve-month option periods. Total period of performance shall not exceed five years if all options are exercised. The IDIQ also includes Federal Acquisition Regulation (FAR) 52.217- 8, Option to Extend Services, which could extend the contract up to 6 months. Continued funding is contingent upon availability of funds and an acceptable level of performance.

3.2 Task Order Period of Performance

The terms for each Task Order placed under the IDIQ contract shall be specified in the individual Task Order. Under no circumstances may a new Task Order be placed under the IDIQ contract if the IDIQ contract is not in effect, has expired, has been cancelled, or has been terminated.

3.3 Place of Performance

Work under each resultant Task Order shall be performed at NCI facilities located in the Rockville, Maryland area and Non-Government facilities, to include the Contractor’s facility or the Contractor’s home. The Contractor is authorized to enable Contractor staff to telework when onsite presence is not required. The Contractor shall provide adequate oversight of work products to ensure contract adherence. Contractors shall have formal telework policies in place by their employer if telework is employed. Telework arrangements on individual orders shall be requested and approved by the COR and the Contractor’s Project Manager prior to beginning a telework assignment. All telework shall be billed as if working onsite at the Government facility. See the Telework During a Government Closure clause for more information on telework.

3.4 Hours of Work

NCI requires ready access to the Contractor’s personnel during normal Government business hours of 8:00 a.m. to 5:00 p.m. ET Monday through Friday, exclusive of Government holidays.

NCI’s core hours are 9:30 – 3:00 ET Monday through Thursday and 9:30 – 2:30 ET on Friday.

All employees must be available during those hours. Excess hours (>8 hours per day) must be requested in writing and approved by the COR at least 24 hours in advance, except in emergency situations.

3.5 Government Holidays

The following Government holidays are normally observed by Government personnel: New Year's Day, Martin Luther King’s Birthday, Presidential Inauguration Day (metropolitan DC area only), George Washington’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, Christmas Day, and any other day designated by Federal Statute, Executive Order, Presidential Proclamation, or any other kind of administrative leave such as acts of God (i.e., hurricanes, snowstorms, tornadoes, etc.), Presidential funerals, or any other unexpected Government closures.

3.6 Travel & Other Direct Costs

Travel and ODCs are anticipated for the resultant Task Orders under this IDIQ. All travel will require prior COR approval and must be billed in accordance with FAR 31.205-46 and other

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Government mandates and directives. Travel and ODCs will be reimbursed at cost; profit and general & administrative (G&A) expenses will not be allowed on travel or ODCs.

3.7 IDIQ Terms and Conditions Flow Down

All terms and conditions of the IDIQ contract flow down to individual Task Orders.

3.8 Ombudsman

In accordance with FAR 16.505(b)(8), an ombudsman will be designated at time of award to ensure all contractors are afforded a fair opportunity to be considered for award, consistent with procedures in the contract.

3.9 Ordering Procedures

In order to obtain services under this IDIQ the Contracting Officer (CO) will send a statement of work with a request for both a technical and price proposal. The Contractor will send the documentation directly to the Contracting Officer, who will forward the information to the program office for evaluation. The Contractor shall use the labor categories proposed for the IDIQ contract to prepare their Task Order proposals. Task Order labor rates cannot exceed the IDIQ labor rates, but additional discounts from the IDIQ rates are encouraged and can be provided at the Task Order level.

• Only an AQD CO can issue, negotiate, and obligated Task Orders against the IDIQ.

• Task Orders can be issued on behalf of any NCI Division, Office, or Center (DOC).

• No agreements by the Government to place future orders are stated or implied.

• Terms and conditions will be stated in each Task Order. The basic IDIQ contract also contains terms and conditions which flow down to the Task Orders. In the event of conflict, the terms and conditions of the IDIQ will have priority.

3.10 Fair Opportunity

All Task Orders must follow the Fair Opportunity procedures specified in FAR 16.505(b)(1) and the exceptions to Fair Opportunity in FAR 16.505(b)(2) when issuing a Task Order.

3.11 Order Duration

Order duration is not dependent upon exercising the IDIQ option. This means option periods on current Task Orders can be exercised even if the IDIQ is no longer available for new orders.

Task Orders may extend up to 5 years beyond the end of the last exercised IDIQ option period.

3.12 Maximum Contract Value

Pursuant to FAR 16.504(a), the total maximum quantity of all supplies and services under the multiple-award IDIQ shall not exceed $350 Million, including all Options. Each IDIQ will have a $350 Million ceiling.

3.13 Minimum Guarantee

The total minimum guarantee under the life of each IDIQ contract will be $1,000.00.

3.14 Payment for Unauthorized Work

No payments will be made for any unauthorized supplies or services, or for any unauthorized changes to the work specified herein. This includes any services performed by the Contractor of

3 - 3 their own volition or at the request of an individual other than a duly appointed Contracting Officer. Only a duly appointed Contracting Officer is authorized to change the specifications, terms, and conditions under this effort.

3.15 Quality Assurance

The COR will review, for completeness, preliminary or draft documentation that the Contractor submits, and may return it to the Contractor for correction. Absence of any comments by the COR will not relieve the Contractor of the responsibility for complying with the requirements of this work statement. Final approval and acceptance of documentation required herein shall be by letter of approval and acceptance by COR. The Contractor shall not construe any letter of acknowledgment of receipt material as a waiver of review, or as an acknowledgment that the material is in conformance with this work statement. Any approval given during preparation of the documentation, or approval for shipment shall not guarantee the final acceptance of the completed documentation.

3.16 Personnel Requirements

The Contractor is responsible for providing personnel with the necessary level of expertise to support the task activities and requirements in the resultant Task Order statements of work.

Contractor personnel shall be trained, qualified, and certified under the requirements specified in this contract, and be given full knowledge of the requirements of this contract before starting work.

3.16.1 Key Personnel

Certain skilled experienced professional or technical personnel are essential for accomplishing the work to be performed. These individuals are defined as "Key Personnel" and are those persons whose resumes were submitted and marked by the vendor as "Key Personnel". During the first ninety (90) days of performance, no substitutions shall be made of accepted key personnel except for sudden illness or death, or termination of employment. The Government shall accept substitutions only if in compliance with the “Substitution of Key Personnel" provision identified below.

3.16.2 Substitution of Key Personnel

In addition to the requirements in HHSAR clause 352.237-75 Key Personnel, all Contractor requests for approval of substitutions hereunder shall be submitted in writing to the COR and the Contracting Officer at least thirty (30) calendar days in advance of the effective date, whenever possible, and shall provide a detailed explanation of the circumstances necessitating the proposed substitution, a complete resume for the proposed substitute, and any other information requested by the Contracting Officer necessary to approve or disapprove the proposed substitution.

Proposed substitutes should have comparable qualifications to those of the person(s) being replaced. The COR and the Contracting Officer will evaluate such requests and promptly notify the Contractor of approval or disapproval in writing.

3.16.3 Key Personnel Designation

Key personnel will be determined at the Task Order level.

For each proposed key person, a resume is required.

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3.16.4 Program Manager

The Contracting Officer has…