Attachment 2 - Task Order 1 SOW.pdf

CBER Biologics Effectiveness and Safety (BEST) Initiative: Data Sources for Surveillance of Biologics (BEST 3)

Solicitation Number: FDA-SOL-1224068

Task Order 1 Statement of Work (SOW) for Healthcare Patient Data

April 30, 2020

Table of Contents

1. Introduction

1.1 Background

1.2 Task Order 1 (TO1): Objectives and Scope

2. Tasks Description

2.1 Task 1: Data Network Requirements

2.1.1 Data Sources

2.1.2 Analytic Capabilities

Simple Queries Complex Queries Epidemiologic Studies

2.1.3 Medical Records

2.2 Task 2: Operations And Management

2.2.1 Management Plan

2.2.2 Monthly Progress Report (MPR) and Invoices

2.2.3 Establish Project-Specific Statement of Work and Procedures

2.2.4 Kick-Off Meeting

2.2.5 Administrative Requirements

2.3 Task 3: Communications And Outreach

2.3.1 Annual In-Person Meeting

2.3.2 Annual Public Workshop

2.3.3 Publications

2.3.4 Secure Portal

2.4 Task 4: Transition Services

2.4.1 Transition-In

3. Task Order Administration

3.1 Key Personnel

3.2 Period of performance

3.3 Place of Performance

3.4 Government Points of Contact (POCs)

1. INTRODUCTION

1.1 BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, tobacco products, the nation’s food and blood supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing public health through innovation to make medicines, devices, products, and foods more effective, safer, and more affordable.

The Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Epidemiology (OBE) conducts postmarket safety and effectiveness studies on biologic products. CBER collaborates with federal partners such as the Veterans Health Administration, Indian Health Services, and Center for Medicare and Medicaid Services (CMS) as well as contractors such as Harvard Pilgrim Health Care Institute (HPHC) and IQVIA. FDA uses these partnerships to help fulfill regulatory and public health responsibilities to conduct surveillance and to monitor the safety and effectiveness of biologics such as vaccines, blood and blood products, tissues and advanced therapeutics. These successful collaborations have contributed to FDA regulatory decision-making and resulted in a number of peer-reviewed publications. CBER’s Biologics Effectiveness and Safety (BEST) initiative commenced in 2017 as CBER active surveillance component of the Sentinel Initiative. BEST continues to expand CBER surveillance capabilities and to provide data sources, infrastructure, and analytics with the goal of providing deliverables in a more cost-effective, efficient, and timely manner. CBER is issuing this Task Order 1 (TO1) as part of its continuing effort to develop new capabilities and build additional capacity for conducting biologics safety surveillance. The proposed FDA work requirement may be conducted under a number of arrangements as indicated in Section 1.1 of the IDIQ Statement of Work (SOW).

1.2 TASK ORDER 1 (TO1): OBJECTIVES AND SCOPE

The purpose for this task order is to expand the BEST Initiative’s data network and have access to the full medical records of patients in the data network to monitor safety and effectiveness of biologics including, vaccines, blood, blood-derived products, human cells and tissue products, allergenics, gene therapies, and xenotransplantations. The core elements of the task order comprise of data sources, medical records, analytic capabilities, operations and management, and transition services.

The objectives of this task order are to:

1. Provide FDA with indirect access to large-scale de-identified United States (US) health care data of tens of millions of patients particularly adjudicated administrative claims data but also electronic health records (EHR) data sources (if available) using a distributed data network which may use a common data model (CDM). The data sources shall provide longitudinal health care data (particularly adjudicated administrative claims) for participating patients.

2. Provide access to full medical charts of patients, whose health care data (particularly adjudicated administrative claims) are available, for review, abstraction, and adjudication in the context of biologic products surveillance activities.

2. TASKS DESCRIPTION

2.1 TASK 1: DATA NETWORK REQUIREMENTS

Note: These tasks map to IDIQ SOW Section 2.1.,Task 1: Data sources and Medical Records

2.1.1 Data Sources

The primary goal of this task order is to provide FDA access to administrative claims data sources that cover millions of patients in the U.S., provide longitudinal health care data and access to full medical records of participating patients in the data network.

The Contractor shall provide access to a:

• Network of large-scale distributed databases transformed into a common data model that include near real-time data with a quarterly refresh schedule (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary clinical data from administrative claims (and EHR data sources if available) in various care settings and cover among others vulnerable populations, such as children, elderly, pregnant women, immunocompromised patients, and others

• Data network to support surveillance of all biologic products, include data with linkage between mothers and infants, and storage capacity for different versions of databases

A common data model that can accommodate a distributed data network and uses a standardized vocabulary to ensure consistency and quality of data across the network

The contractor shall provide information about the data sources and the populations represented in these sources, within 3 months of task order award. Specifically, the contractor shall:

• Provide demographics of the patient population, type and geographic distribution of participating institutions, types of care settings, average length of follow-up for patients, number of current and historical enrollees in participating health plans

• Develop a data quality assessment plan for each database with respect to all coding systems used in the database such as ICD9, ICD10, HCPCS, CPT, and others.

• Develop a quarterly report to present the results of the data quality assessment plan for each database and develop an action plan to correct any deficiencies or missing data based on the quarterly report results

2.1.2 Analytic Capabilities

In collaboration with a coordinating center (if applicable), the contractor shall develop analytic capabilities to conduct simple and complex queries and studies to interrogate the databases. The queries can range from simple cohort identification or frequency distribution of events to complex assessment of association between exposures and outcomes adjusting for confounding.

The contractor shall provide the necessary personnel such as epidemiologists, experts on their databases, computer programmers, and project managers to maintain, update, and interrogate the databases, and run queries and studies. The contractor shall provide a roster of personnel and corresponding expertise and curriculum vitae within 10 days after the task order award date.

The contractor shall participate in conducting simple and complex queries and epidemiologic studies to evaluate the safety and effectiveness of biologic products and to address regulatory issues initiated by the

CBER staff. The contractor shall provide the capability and capacity in terms of data sources, scientific expertise, medical chart procurement, and operational management to run queries and studies.

The deliverables shall include access to data, participation in designing and implementing studies and preparing results. Deliverables must not exceed the agreed upon timeline between the contractor and the CBER staff.

To meet the requirements for performing queries and studies, the contractor shall:

• Collaborate with FDA to identify projects addressing specific products and adverse events associations to study and to establish and meet timelines to prepare query and study results. Timelines will be dependent on complexity of the query or study and shall be established in the management plan and agreed upon by the contractor and CBER staff.

• Provide a secure portal for communication and data transfer.

• Collaborate with FDA in the publication of study results in agreement and compliance with CBER policies and procedures.

• Prepare a running log of all queries and studies and their status (not feasible, in progress, and completed) on a monthly basis with the Monthly Progress Reports.The running log shall include title of query/study, objective, start and end dates, and status (not feasible with reason, in progress, or completed)

A workgroup comprised of CBER and contractor staff will be formed for designing and implementing each query and study. The contractor and CBER staff develop specifications and final reports for queries, and protocols and final reports for epidemiologic studies. The contractor prepares the results in the form of reports in text, graphical, and tabular formats. The contractor and CBER staff work together to post the results to a public website, or publish them in peer-reviewed journals, or publicly disseminate them in other ways. Queries and studies are divided into three categories:

Simple Queries Simple queries consist of frequency distribution, prevalence, or incidence of an event. The contractor shall provide capabilities to use data sources and analytics to conduct up to 40 simple queries per year that shall be the first step in descriptive or inferential epidemiologic studies to address regulatory questions of interest to CBER. A simple query shall be completed in no more than 7 business days after the specifications are confirmed by CBER. The specifications will be developed by CBER and contractor. The Contractor shall provide CBER the specifications, output, and results in a tabular and graphical format report as a deliverable for each simple query, and the deliverables shall be sent to CBER using a secure portal.

Complex Queries Complex queries consist of prevalence or incidence of multiple events within certain populations and in chronological relation to one another. The contractor shall provide capabilities to use data sources and analytics to conduct up to 20 complex queries per year that shall address regulatory questions of interest to CBER. A complex query shall be completed in no more than 14 business days after the specifications are confirmed by CBER. The specifications will be developed by CBER and contractor. The contractor shall provide CBER the specifications, output, and results in a tabular and graphical format report as a deliverable for each complex query, and the deliverables shall be sent to CBER using a secure portal.

Epidemiologic Studies Epidemiologic studies consist of evaluating the association between an exposure and an outcome while adjusting for confounding. The Contractor shall provide capabilities to use the data sources and analytics to conduct up to 2 epidemiologic studies per year that comprise of analyses to address complex regulatory questions of interest to CBER. CBER and the contractor shall generate a written statement of work (SOW) outlining project-specific activities, deliverables, workgroup members and timelines. These studies may require validation of exposure, outcome, or other components and therefore medical chart access and review. CBER and the contractor shall generate a written protocol describing the details of the study. If the protocol requires medical chart review, the contractor shall obtain the charts, provide experts to develop chart abstraction tools, perform medical record review, and adjudication. Once the protocol is finalized and the terms of the protocol, including the timeline, are mutually agreed upon between the contractor and CBER, the study shall comply with the agreed upon timeline. The Contractor shall obtain and meet all required review, approval, and standard processes to conduct studies such as Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA), data and information technology security, and any others. These procedures shall address at a minimum the following: data collection, ownership and security, management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

2.1.3 Medical Records

Some complex queries and epidemiologic studies may include a medical chart review component. This contract requires access to full medical chart of patients whose health care data are available in the databases. The contractor shall have the capability and capacity to obtain patients’ medical charts for certain queries and studies in a timely manner, to abstract the relevant data, and have clinicians adjudicate relevant exposures, outcomes, and covariates. FDA will not have direct access to the medical charts; the contractor shall provide the chart review results to FDA as part of query or study results in a de-identified and aggregate format. The timeline for obtaining and reviewing medical records will vary depending on the type of query and study and will be agreed upon by CBEr and the contractor on a query and study basis.

Table 1: Task 1 Deliverables/ Work Products

Task Deliverable/Work Product Title Due Date Quantity / Frequency Delivered To

Task 1

1. Provide documentation of access to administrative claims data

One month after task order award date Ongoing COR

Task 1

2. Provide documentation for available data and refresh schedule with a data lag less than 4 months

1st day of each Federal Government fiscal year quarter

Ongoing COR

Task 1

3. Provide a report describing the data sources and the populations represented in distributed data network (summary results of database characterization in tabular and graphical format)

3 months after task order award date Once COR

Task 1

4. Provide a report describing information about coding systems used in each data source such as ICD9, ICD10, CPT, HCPCS, ISBT-128

3 months after task order award date Once COR

Task 1 5. Simple queries

Each due no later than 7 business days after finalization of specifications by FDA

Up to 40 per year COR

2.2 TASK 2: OPERATIONS AND MANAGEMENT

Note: These tasks map to IDIQ 2.2 Section, TASK 2: Operations and Management

The Contractor’s Program Manager (PM) and the Principal Investigator (PI) along with their supporting staff shall provide Program Management for the BEST Initiative requirements. These program management responsibilities shall include what is necessary to plan, coordinate, manage, communicate, report, and steward all respective task orders and activities throughout the period of performance.

The contractor shall ensure efficient operations between data sources and FDA to safeguard optimal delivery of activities such as CDM ETL data transfer meetings, telecons, and study results.

The Contractor shall:

• Develop a management plan containing written processes and procedures for collaborating with CBER to provide health care data, obtain and review medical charts, and participate in running queries and studies. Details of the collaboration will be determined on a task order basis, by mutual decision of all collaborative parties. Collaboration includes sharing computer codes and summary and aggregate data, interpretation of findings, review of manuscripts, design of protocols, co-authorship of publications.

Additionally, the Contractor shall provide both program-level management services and task order-level project management services to establish control, management, monitoring, and notification mechanisms for the program requirements. Moreover, the Contactor shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR), and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met.

Representative activities include, but are not limited to:

• Administering the program

• Throughout the period of performance, developing, maintaining, modifying, and updating plans to include task order (TO) risk management plans, staffing plan, standard operating procedures (SOP)

• For each TO, preparing a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls throughout TO execution

Task 1 6. Complex queries

Each due no later than 14 business days after finalizing query specifications by FDA

Up to 20 per year COR

Task 1 7. Epidemiologic studies Time agreed upon between contractor and CBER

Up to 2 per year COR

Task 1

8. Roster of personnel and corresponding expertise and curriculum vitae

No later than 10 business days after the task order award date n/a COR

Task 1

9. Obtain medical charts and review them

Time agreed upon between contractor and CBER n/a COR

• Preparing and submitting monthly progress reports and invoices

• Following escalation procedures for problems, issues, and recommendations, as encountered

• Safeguarding information

• Managing Contractor staff and providing sub-contractor management, to include the proper on-boarding and exit procedures are followed when Contractor employees start and leave BPA contract and/or task orders;

• Coordinating tasks and working collaboratively with FDA CBER staff to carry out the work of the contract per Sections 2.1 to 2.4

• Attending quarterly face-to-face meetings, if needed, with FDA CBER staff at the FDA White Oak Campus

• Reporting, communicating, presenting, and publishing of all BEST project findings shall be done in coordination with and concurrence of the CBER staff and the FDA

COR

• Ensuring proper exit criteria are followed when contractor employees leave projects

• Providing risk mitigation plans and strategies per Section 2.2.4

• Conducting and participating in progress meetings, facility meetings, training meetings, performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, COR site visits, and post- requirements meetings as may be required for each individual task order

• Responding to ad-hoc data calls to refine or confirm project findings or address FDA questions or concerns concerning project findings

2.2.1 Management Plan

The Contractor shall deliver a Management Plan as specified in the Master Contract SOW Section 2.2.1.

including standard operating procedures and a master plan of procedures.

2.2.2 Monthly Progress Report (MPR) and Invoices

The Contractor shall provide task order management to ensure that tasks stay on track and milestones, performance measures, deliverables, and work products are met. The Contractor shall deliver a monthly progress report (MPR) and the invoices for the previous month’s worth of work to the COR and CO on the 10st day of each month of the Federal Government fiscal year. At a minimum, the MPR shall contain the following information:

• The previous month’s progress

• Deviance from previous month’s planned progress (either positive or negative)

• The current month’s planned progress

• Status of deliverables

• Issues and recommendations

• Performance and Cost Report (P&CR): the P&CR shall include all recurring and non-recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month

• Program risks, risk mitigation plans, risk mitigation actions taken and resolution of risks

• Invoices for the previous month’s worth of work

Lastly, the Contractor shall ensure that all deliverables are sent in electronic format (i.e., Microsoft Office or Adobe PDF) for the COR’s inspection/acceptance.

2.2.3 Establish Project-Specific Statement of Work and Procedures The contractor shall work collaboratively with the FDA to develop and finalize the BEST projects statement of work (SOW) and a Management Plan (MP) and update them as needed to reflect the individual task order (ITO) activities. The Contractor shall work with the FDA to identify and meet all required review, approval and standard processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as Institutional Review Boards (IRB), data and information technology security such as Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA) and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security;

management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

Moreover, the contractor shall develop and implement secure and robust data use, data quality control, tracking, management, and, each analysis and for all analyses.

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/aboutthe-section-508-standards .

2.2.4 Kick-Off Meeting

The Contractor shall participate in a kick-off meeting at FDA White Oak Campus in Silver Spring, MD with the COR and Government staff within 1-2 weeks of task order award. The purpose of the kickoff meeting is to introduce the contractor staff to the Government and discuss the contractor’s approach to meeting the requirements of the SOW.

2.2.5 Administrative Requirements

The Contractor shall work collaboratively with FDA to ensure delivery of activities such as kick-off meetings, telecons, quarterly reports, and in-person meetings; and completion of queries, query reports, protocols, interim analyses, interim reports and final reports.

The Contractor shall:

• Participate in bi-weekly administrative meetings to manage task order operations.

• Participate in quarterly executive/leadership meetings for strategic planning.

http://www.access-board.gov/guidelines-and-standards/communications-and-it/aboutthe-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/aboutthe-section-508-standards

• Generate a Key Personnel Document providing information as to which key personnel (see Section 3.1 for Key Personnel) w i l l be used on each project and identifying the percentage of time and staff member effort and contribution to the program on a per-project basis no later than 1 month after the award date.

Table 2: Task 2 Meetings

Table 3: Task 2 Deliverables/ Work Products

2.3 TASK 3: COMMUNICATIONS AND OUTREACH

Note: These tasks map to the IDIQ SOW Section 2.3, Task 3: Communications and Outreach

2.3.1 Annual In-Person Meeting

The Contractor shall schedule and conduct an annual in-person meeting with FDA personnel at the FDA White Oak Campus in Silver Spring, MD to discuss Contractor’s performance under the task order; and provide a presentation of recently completed or in progress individual task order collaborative studies and plans for future projects.

2.3.2 Annual Public Workshop

The contractor shall participate in an annual public workshop and assist CBER to organize the workshop.

The purpose of the workshop will be to present the results from the BEST Initiative activities to the public and the scientific and regulatory community.

Task Meeting / Activity Title Location(s) Estimated Occurrences

Receiving Organization

Task 2 Kick-Off Meeting FDA Once: Within 1-2 weeks of task order award

COR

Task 2 Annual In-person Meeting FDA One per year COR

Task 2 Scientific Workgroup Meeting Teleconference Weekly COR, FDA Project Staff

Task 2 Administrative Meeting Teleconference Two per Month COR, FDA Project Staff

Task 2 Executive/Leadership Meeting Teleconference Quarterly

COR, OBE

Leadership

Task Deliverable/Work Product Title Due Date Quantity / Frequency Delivered To

Task 2 Management Plan Initially reviewed at Kick-Off Meeting

Ongoing COR

Task 2 Monthly Status Reports 10st day of month Monthly COR and CO

Task 2 Abstracts and Presentations 10 business days prior to submission or presentation

To Be Determined

COR

Task 2 Reports and Manuscripts 21 business days prior to the agreed date

To Be Determined

COR

Task 2 Key Personnel Document 1 month after task order award date

Once COR

2.3.3 Publications

The Contractor shall participate in preparing drafts of protocols, reports, presentation materials (e.g., presentation slides and posters), and manuscripts.

Protocols, final reports, and final work products will be posted to a web-based resource library after clearance by FDA, the prime contractor, and subcontractors. The Parties agree this is a multi-site program and any publications as a result of studies shall be a multi-site publication coordinated by the prime contractor, subcontractors, FDA/CBER/OBE, and other involved parties. Authorship and other matters relating to publications shall be determined at the study level.

2.3.4 Secure Portal

The contractor shall create and utilize a secure data transfer capability to allow secure file sharing and document storage for the contractor, subcontractors, CBER staff, and other collaborators. All the data transfer and document storage related to all queries and studies, and other activities shall be carried using the secure portal. The contractor shall obtain and meet all required review, approval and standards processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as HHS Information Security Program, Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA), the National Institute of Standards and Technology, Section 508 compliant, and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security;

management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

The secure portal data security and privacy shall be in compliance with the HHS Information Security and Privacy Policy (IS2P). The security and privacy requirements to ensure federally-mandated security and privacy controls and standards shall be met according to FDA/CBER policies. Furthermore, the contractor shall deliver a user-friendly secure portal with graphical interface for conducting day-to-day executive.

Table 4: Task 3 Deliverables/Work Products

2.4 TASK 4: TRANSITION SERVICES

Note: These tasks map to IDIQ Section 2.4, Task 4: Transition Services

Transition planning shall detail activities and practices to ensure minimal disruption to services, and shall extend to both Transition-in (arrival of new contractor) and transition-out (departure of new contractor at end of performance).

2.4.1 Transition-In

As specified in each ITO, the Contractor shall transition-in and assume the responsibility for activities and duties from the prior (incumbent) Contractor in a manner that does not interrupt or negatively impact OAGS’ mission critical operations and activities. The purpose of the Transition-In requirement is to provide an orderly transition from the prior Contractor. For a period as specified by the ITO, the Contractor shall work with the incumbent contractor to affect a smooth transition of work.

Task Deliverable/Work Product Title

Due Date Quantity / Frequency

Delivered To

Task 3 Annual in-person meeting To be determined during the period of performance One per year COR

Task 3 Annual public workshop To be determined during the period of performance

One per year COR

Task 3 Secure portal 16 weeks after task order award date

One COR

Work activities include:

• Developing a Transition-In Plan to ensure full operating accountability and responsibility of the task orders.

• Familiarizing the incoming Contractor staff with FDA processes and requirements and work with the incumbent Contractor as related to transferring tasks and work activities being performed.

• Coordinating with assigned COR to obtain access to the required data, Government furnished equipment (GFE), systems / applications, and required training.

• Participating in Transition-in meetings and other technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the incumbent Contractor.

• Certifying that employees working on the contract have completed their review and understand Integrated Services requirements, documentation, processes, and technical environments prior to the completion of the Transition-in activities.

Verifying to the COR that all of the Transition-in documents are available.

Table 5: Task 4 Deliverables/Work Products

3. TASK ORDER ADMINISTRATION

3.1 KEY PERSONNEL

Per HHSAR 352.237-75, the key personnel specified in this task order are considered to be essential to work performance. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

Key Personnel for this Task Order are:

• Principal Investigator

• Project Manager

• Epidemiologist

• Computer programers

3.2 PERIOD OF PERFORMANCE

Task Order Performance Period: 12-month period of performance.

09/2020 – 09/2021

Task Deliverable/Work Product Title Due Date Quantity / Frequency Delivered To

Task 4 Transition-in Plan Within 1 week of task order award One COR

Task 4 GFE and GFI Inventory

120 calendar days prior to period of performance end date

One COR

3.3 PLACE OF PERFORMANCE

The Contractor shall perform specified duties at its own site. Swing space may be provided occasionally to staff members who may need to visit the FDA headquarters for certain meetings and activities.

3.4 GOVERNMENT POINTS OF CONTACT (POCS)

Task Order Contracting Officer’s Representative (COR):

• To be completed at time of award.

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