Section_C_Sentinel_Base_IDIQ.docx

SENTINEL INITIATIVE

SECTION C

SENTINEL INITIATIVE

IDIQ BASE CONTRACT STATEMENT OF WORK (SOW)

TABLE OF CONTENTS

C1. Background The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the Food and Drug Administration (FDA) to collaborate with public, academic, and private entities to develop methods for obtaining access to disparate data sources and to validate means of linking and analyzing safety data from multiple sources. FDAAA set goals that FDA’s new safety monitoring system must be able to access data from 25 million people by July 2010, and 100 million people by July 2012.[footnoteRef:2] [2: (Section 905(a) (3) (B) (i) – (ii) (II)).]

In 2008, the Secretary of Health and Human Services (HHS) and FDA’s Commissioner announced the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring FDA-regulated medical product safety in alignment with FDA’s mission to protect the public health. The Sentinel Initiative began with the Mini-Sentinel pilot in 2009, and by 2011 surpassed the FDAAA goal for access to 100 million patient lives. By 2012, Mini-Sentinel developed reusable programming tools for routine queries and completed the Mini-Sentinel Pilot in 2014.

In 2016, FDA officially announced the full-scale Sentinel System operations and formal embedding of Active Post-Market Risk Identification and Analysis (ARIA) system into the regulatory decision-making process.

C2. Introduction Sentinel Initiative’s decade of progress since 2009 sets the stage for the next five-year contract. From its developmental phase as the Mini-Sentinel Pilot, to the full-scale activated Sentinel System in 2016, the Sentinel Initiative has realized and exceeded all the goals set forth in its founding legislation. Its signature achievement was the creation of the Sentinel System, a nationwide privacy-protecting data network with electronic healthcare data on more than 290 million individuals for public health surveillance purposes. Operating under FDA’s public health authority, the ARIA system within the Sentinel System has transformed medical product safety surveillance by accelerating the speed of analysis through the development of an analytic platform of unprecedented scale. ARIA fulfils FDAAA’s mandate to modernize safety surveillance by capitalizing on electronic healthcare data and advanced epidemiological methods and expands the FDA’s capabilities of post-market surveillance for approved medical products. Indeed, pharmacoepidemiology studies that previously took as long as three to four years to complete can now be completed within months. Vital, rapid-response information on the rates and distribution of disease, and medical product use and prescribing patterns can be obtained within weeks using healthcare data representing millions of lives across the United States. Now an integrated part of FDA’s regulatory review process, ARIA can also provide complex, comparative, multi-site studies using analysis-ready, curated data and preprogrammed, parameterizable analysis tools that give investigators exquisite analytic flexibility. This analysis platform generates important health care evidence at a scale to inform regulatory decision-making and advance public health.

The Sentinel System and FDA-Catalyst are part of the broader agency-wide Sentinel Initiative. FDA Catalyst is a program that uses the Sentinel System’s infrastructure to expand FDA's ability to actively gather information about the performance of regulated medical products following FDA approval.

Sentinel Continuity, Expansion, and Future Goals This requirement for the Sentinel Initiative emphasizes continuity while directing the program to cross previously conceived boundaries with the expansion in the areas of enhancement, innovation and modernization of its foundational elements. FDA’s vision for the Sentinel System is to achieve a sustainable national resource to monitor the safety of marketed medical products and expand Real-World Data (RWD) sources. To realize this vision, FDA has identified five strategic aims.

1. Enhance the foundation of the Sentinel System (i.e. data, infrastructure, operations, technology).

2. Further enhance Sentinel System’s safety analysis capabilities.

3. Accelerate access to and broader use of RWD to generate RWE or evaluate medical product performance.

4. Create a national resource by broadening the Sentinel System user base.

5. Disseminate knowledge, and advance regulatory science to encourage innovation.

The Sentinel System 5-Year Strategy Report 2019-2023 can be found here: (https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm629326.htm).

In summary, this requirement seeks to preserve the foundation and accomplishments of the current Sentinel System, while asserting that it must embrace change to fulfill its promise to be a national resource for knowledge development about the safety and effectiveness of medical products. The core Distributed Data Network (DDN), Sentinel Common Data Model (SCDM), processes, and analysis tools represent an impressive achievement but must continue to evolve by adopting advanced analytics, become more effective at extracting information from electronic medical record data, and achieving higher efficiency through automation.

NOTE: All italicized words are defined in the Glossary of Terms (See Attachment 1)

C3. Objectives This requirement seeks to strengthen the core capabilities of Sentinel and direct the program to meet the challenges during the period of performance. Specifically, the objectives are to:

Maintain current production-level analytic capabilities

1. Establish and provide the resources and support for an Operations Center (OC)

2. Establish and maintain a DDN with access to medical records

3. Establish and maintain routinely refreshed and curated analysis-ready data formatted in the SCDM

4. Maintain and enhance a rapid response analytic capability using a pre-programmed parameterizable and customizable toolkit Build enhanced capabilities and improve the data infrastructure

5. Establish and provide the resources and support for an Innovation Center (IC)

6. Establish and provide the resources and support for the Community Building and Outreach Center (CBOC)

7. Capitalize on new advanced analytics and innovative technologies, such as machine learning, natural language processing, and artificial intelligence

8. Increase the usage and adoption of EHRs, especially EHRs linked to administrative claims data sources

9. Access data sources beyond EHRs (e.g., rare disease registries, national and state registry linkages (National Death Index (NDI), Surveillance, Epidemiology, and End Results (SEER)))

10. Expand SCDM to accommodate new data types and interoperability with other common data models, both existing and emerging

11. Advance the development and adoption of RWD and RWE for evaluating efficacy within the Sentinel System and at FDA

12. Promote knowledge and use of SCDM and analytic tools with a broad group of stakeholders by building a community with strong scientific collaborations and by maintaining process transparency.

C4. IDIQ Scope of Work The Sentinel Initiative IDIQ contract supports the three task areas described below. Contractors may compete for any one or more of the task areas in this IDIQ. Contractors who are awarded any individual IDIQ task order shall collaborate, as necessary, to achieve the overall scientific, training, outreach and communication objectives described in all task orders. This collaboration shall include sharing knowledge, programming code, software, documentation, macros, toolkits, computable phenotypes, analytic results, and scientific algorithms developed as a result of any work product generated or directed within each of the three task areas below. The extent of collaboration shall be sufficient to ensure that the other Contractors can meet their own respective contract deliverables.

Task Area 1: Operations Center (OC) Task Area 2: Innovation Center (IC) Task Area 3: Community Building and Outreach Center (CBOC)

C5. Task Area 1: Operations Center

C5.1. Operations Center (OC)

C5.1.1. Establishment and Maintenance of the Operations Center The Contractor shall establish and operate an enterprise-level Executive Leadership Team to oversee all aspects of operations for the Operations Center (OC) and the Sentinel Data Partners Network (DPN).

C5.1.2. Platform for Communication with Stakeholders and Scientific Collaboration The Contractor shall develop and maintain a ‘Communications and Collaboration Plan’ including a platform to support communications with stakeholders and to promote scientific collaborations.

C5.2. Distributed Data Network Infrastructure

C5.2.1. Formation and Maintenance of Data Partners Network The Contractor shall establish and maintain business partnerships and Data Use Agreements (DUAs) to ascertain electronic healthcare data from at least 100 million patients.

C5.2.2. Data Sources The Contractor shall establish and maintain reliable and efficient DDN to access a variety of clinical data sources.

C5.2.3. Data Sources Management Plan The Contractor shall create a large, linked DDN to transforms raw source data into the SCDM format and quality checks the data to ensure that it is analysis-ready. The OC shall develop and maintain a Data Sources Management Plan.

C5.3. Medical Product Analyses The Contractor shall maintain the current Sentinel System suite of analysis tools including Summary Tables (ST), Level 1, 2, 3 tools, the Patient Episode Profile Retrieval Tool (PEPR) and TreeScan for the conduct of medical product assessments and a rapid analytics platform in the Sentinel System.

C5.4. Analytic Tools The Sentinel System currently possesses both descriptive and inferential analyses. The OC shall provide the requisite programming and data analysis experience to maintain and enhance these parameterizable analytic tools.

C5.5. Training The Contractor shall collaborate with the IC, and CBOC when necessary to meet all FDA training objectives, as described in each task order. The primary audience of this training program are those with an existing foundation in epidemiology and includes: a) FDA, b) FDA-regulated industry, c) other federal agencies, and d) international regulatory agencies.

C5.6. Medical Record Review The Contractor shall establish routine and standardized administrative, financial and scientific processes to ascertain medical records (electronic and/or paper).

C5.7. Methods Prioritization and Implementation The Contractor shall collaborate with the FDA, IC and CBOC to develop strategies to prioritize and establish novel methods to meet FDA’s methodologic needs. The Contractor shall develop advanced analytic methods to solve epidemiologic problems.

C5.8. FDA Catalyst The Contractor shall continue to advance the FDA Catalyst program to support effectiveness research and other key initiatives that require study designs that involve patient or provider interaction. FDA-Catalyst activities encompass a broad range of scientific activities that leverage the Sentinel System infrastructure, EHR data linked to administrative claims data, as well as the collection of real world data using various technologies, including the use of mobile technology apps and wearables.

C6. Task Area 2: Innovation Center (IC)

C6.1. Establishment and Maintenance of the Innovation Center The Contractor shall establish a network of scientific investigators who collaborate with the OC to identify methodological gaps and develop novel methods to improve the utility of Sentinel and support the creation of new analysis tools.

C6.2. Communication with Stakeholders and Scientific Collaboration The Contractor shall collaborate with the OC and CBOC to develop and maintain open communications with stakeholders and to promote scientific collaborations.

C6.3. Master Plan for Integration of Innovative Technologies The Contractor shall develop a master plan (i.e., blue print) for the development and incorporation of innovative technologies into the Sentinel System.

C6.4. IC Scientific Collaboration Activities The Contractor shall assemble, maintain, and coordinate a network of scientific collaborators to develop and test new methods that can operate within a distributed data network. The Contractor shall work collaboratively with FDA, the OC and CBOC to integrate the developed tools into the Sentinel production system and conduct training to ensure that the tools can be widely used by FDA and others.

C6.5. Innovation Projects The Contractor shall conduct scientific and methodological investigations to advance the development of new analytic tools and methods for the Sentinel System. The Contractor shall coordinate its network of investigators to meet the scientific objectives described in the Work Orders issued within the IC.

C7. Task Area 3: Community Building and Outreach Center (CBOC)

C7.1. Establishment and Maintenance of the Community Building and Outreach Center The Contractor shall create approaches, outreach materials and processes to promote and cultivate a broader Sentinel community with the goal of expanding the understanding and use of the Sentinel System’s infrastructure and tools and creating the opportunity for stakeholders to contribute to building the Sentinel System’s capabilities. The Contractor shall convene stakeholder meetings to seek expert input or explore priority areas, and share, publish or promote insights in topic areas of interest to FDA.

C7.2. Communication with Stakeholders and Scientific Collaboration The Contractor shall develop and promote scientific collaboration, develop training resources, and train interested members of the academic community, consumers, and the public about Sentinel tools and infrastructure. To spur innovation and focus talent towards a specific unmet Sentinel System need, the Contractor shall convene and coordinate challenges and other competition events.

C7.3. Master Plan for Support and Expansion of the Sentinel User Community The Contractor shall develop a master plan (i.e., blue print) for supporting and expanding the community of Sentinel System users to reach communities that do not routinely use pharmacoepidemiology tools and methods, including: a) computer science, informatics, or other academic disciplines, b) consumers and patients, c) the public. (This contrasts with the training objectives of the OC which will focus their training towards communities who have an existing foundation with pharmacoepidemiology tools and methods such as FDA-regulated industry, other federal agencies, and international regulators).

C8. Contractor Travel Travel costs in support of the activities in this contract shall be included in each offeror’s task order pricing as a separate line item and be in accordance with the FAR Section 31.205-46. The official travel costs include travel related to the Sentinel Initiative for training at FDA and the Sentinel Annual Meeting, community building efforts, FDA leadership meetings, and others. The contractor shall submit all travel requests to the Sentinel Contracting Officer Representative at least 10 days in advance. Travel and Per Diem authorized reimbursed under this contract shall not exceed the Government approved rates in effect (https://www.gsa.gov/portal/content/104877).

Description of travel plans to FDA headquarters in Silver Spring, Maryland for an annual meeting with FDA personnel to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed and quarterly 1-day visits to the FDA to collaborate on pending queries and to provide a two-hour presentation of system-level updates.

C9. Meetings and Training The contractor shall provide a complete list of all planned formal communications and interactions with FDA, Sentinel Centers (OC, IC, CBOC) and other Scientific Collaborators and its management approach for these. The contractor shall provide its plans for participation in the following meetings (include travel and other necessary arrangements to support its participation):

Operations Center (OC)

· Quarterly Program Updates and Strategic Planning Meetings: One (1) meeting will be held at the OC headquarters and the remaining three (3) will take place at FDA White Oak Campus.

· Annual Sentinel Centers Meeting at FDA White Oak Campus.

· Annual Sentinel Public Meeting at a location to be announced in the Washington, DC metropolitan area.

· Training-related meetings:

· Quarterly 1-day visits to the FDA White Oak Campus by OC epidemiologists and data analysts

· Ad hoc training. The OC shall provide budget estimates for at least two (2) ad hoc training sessions at FDA Headquarters at the White Oak Campus.

Innovation Center (IC)

Community Building and Outreach Center (CBOC)

C10. Principles and Polices Public Document The contractor shall develop an official, publicly available document that describes the principles and policies related to data use, data privacy, communications, confidentiality, conflicts of interest, intellectual property and other relevant topics. All processes described in the document shall be compliant with all relevant federal laws and regulations, including Health Insurance Portability and Accountability Act (HIPAA), Federal Information Security Management Act (FISMA), and any applicable state and local laws. Further, the contractor shall complete an annual review and refine the document as necessary.

[Applicable only to Task Order #1: Operations Center – The OC shall use the existing Sentinel Initiative Principles and Policies document (https://www.sentinelinitiative.org/principles-policies) for the Sentinel System and FDA-Catalyst as a starting point and adapt it as necessary.]

C11. Transitional Services The OC, IC, CBOC shall efficiently transition all work from an incumbent (prior) contractor, to a new contractor. This transition may occur at the start and/or end of the period of performance. The OC, IC, and CBOC shall provide a detailed Transition-In/Out Plan to ensure the continuity of data infrastructure operations, and analytic capabilities with minimal reduction or degradation in services. Any proposed transition period shall not exceed 12 months.

Transition-In representative tasks include:

· The Contractor shall facilitate transitional services for the turnover of responsibilities to a new Contractor lead contractor. During the transition period, estimated to be 12 months, the new Contractor shall gradually assume responsibility for all major functions from the incumbent contractor. To ensure smooth transfer and prevent any disruption in services, the new Contractor shall fully collaborate with the incumbent contractor (i.e., “shadow”) in all relevant activities, participate in trainings, adopt and translate existing practices, operating procedures, and templates, to carry out the transition plan.

Transition-Out representative tasks include:

· Transitional services may be required to transition-out leadership of the OC, IC, and the CBOC to a new contractor. The incumbent contractor shall support the turnover of knowledge and processes through dedicated trainings to the new contractor. The incumbent contractor shall develop a staged transition plan that includes trainings on major data infrastructure and tool operations, closure plans for ongoing projects, transfer operating procedures, practices and relevant business informatics databases to prevent any disruption in services. FDA owns and retains the rights to the regulatory and scientific content of the business informatics databases. FDA will oversee and approve the transition plan and reserves the right to modify it as necessary to ensure that deliverables are met. The OC, IC, and CBOC (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the OC, IC, and CBOC shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or FDA policies.

C12. General Process for Individual Task Orders See Section B3.

C13. General Process for Individual Work Group Opportunities (Work Orders) See Section B3.

C14. Option to Extend Services and Contract Term The government may extend the term of this contract by written notice to the Contractor if the government gives the Contractors preliminary written notice of its intent before the contract expires. The preliminary notice does not commit the government to an extension. Task orders made against this contract may extend beyond the base contract’s five-year duration, so long as it was awarded within the five-year duration of this contract.

The government may require continued performance of services within the limits and at the rates specified in the contract. The option provision may be exercised more than once, but the total extension of performance shall not exceed 6 months. The government may exercise this option by written notice to the Contractor at least 30 days before the end of the contract.

C15. Organizational Conflict of Interest The OC, IC, and CBOC shall establish an independent Conflict of Interest (COI) Committee to help oversee the implementation of the Sentinel Initiative COI policy (Reference Instructions to offerors and Section H4).

C16. Sentinel System Activities are Public Health Practice, Not Research The US Department of Health and Human Services’ Office of Human Research Protections (OHRP) has determined that all activities conducted within the Sentinel Initiative shall be considered public health surveillance and not under the purview of Institutional Review Boards (IRB).[footnoteRef:3] Activities involving interaction or intervention with patients under FDA Catalyst are subject to IRB review. [3: https://www.sentinelinitiative.org/Sentinel System Principles and Policies-Federal Policy for Protection of Human Subjects See Attachment 1 https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects ]

C17. Data Rights The Offeror shall provide as required by FAR clause 52.227-14 Data in Rights – General, Alternative IV a descriptive list of the data that is considered proprietary, confidential, of commercial value and/or trade secret information.

C18. Access to Non-Public Information All contactors in senior leadership positions, involved in epidemiologic analyses, or who otherwise have potential access to non-public information as a result of their collaboration with the FDA are required to sign the Contractor’s Commitment to Protect Non-Public Information Agreement (Form FDA 3398). To prevent disclosure of non-public information, the prime contractor is responsible for identifying all relevant employees and subcontractors with potential access to non-public information and ensuring that all forms are completed.