Attachment 1 Statement of Work.pdf

Statement of Work (SOW) VAERS Monitoring, Analytics, Reporting and Automation Enhancement

1. BACKGROUND AND OBJECTIVES

Ensuring vaccine safety is essential to maintaining public trust and supporting effective immunization programs across the Indian Health Service (IHS), Tribal, and Urban (I/T/U) health system. Timely identification, assessment, and communication of vaccine-related adverse events are critical components of maintaining a safe and effective immunization program.

The Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) serves as the national passive surveillance system for monitoring vaccine safety. While I/T/U facilities report vaccine adverse events through VAERS, there is currently limited staffing capacity to routinely aggregate, analyze, monitor, and communicate VAERS data specific to IHS and I/T/U systems of care.

The Indian Health Service seeks to establish an automated, sustainable, and efficient vaccine safety monitoring capability that leverages CDC VAERS data and the National Pharmacy and Therapeutics Committee (NPTC) Vaccine Sentinel Survey to improve situational awareness, support vaccine safety assessments, identify potential safety signals, and inform public health decision-making.

The purpose of this project is to design, develop, and implement an automated vaccine safety monitoring system that supports routine surveillance, trend analysis, signal detection, and dissemination of actionable vaccine safety information across the IHS and I/T/U health system using data from the CDC VAERS system and the NPTC vaccine sentinel survey.

2. SCOPE OF WORK

The Contractor shall provide project management, technical expertise, data analytics, subject-matter coordination, process mapping, system development, documentation, and other processes necessary to establish an automated vaccine safety monitoring and reporting capability for the IHS using CDC VAERS data and the NPTC vaccine sentinel survey.

The Contractor shall develop an automated, centralized analytical framework that routinely acquires, processes, analyzes, visualizes, and reports on vaccine adverse event data received from the CDC VAERS and data from the NPTC vaccine sentinel survey.

The resulting capability shall support:

Automated data ingestion, cleaning and processing Routine vaccine safety surveillance Signal detection and trend analysis Executive and programmatic reporting Data visualization and dashboard development using Power BI or Qlik Standardized guidance and reporting processes Reports Training modules and materials for providers

The enhancement shall be designed in coordination with the IHS Office of Information Technology (OIT), National Immunization Program, and National Pharmacy and Therapeutics Committee and will comply with all applicable IHS information technology, cybersecurity, and data governance requirements under which the current system operates.

Task 1: Project Planning and Requirements Development

The Contractor shall:

Conduct project kickoff meetings with IHS stakeholders Develop a detailed project work plan and timeline Gather and document functional and technical requirements Identify reporting, analytical, and visualization needs of key stakeholders Develop system specifications and design documentation Enhance and automate the vaccine sentinel survey data collection system and processes Coordinate requirements review and approval with IHS

Deliverables Project Management Plan Requirements and Design Documentation

Task 2: CDC VAERS / NPTC Vaccine Sentinel Survey Data Integration

The Contractor shall:

Assess the VAERS data extract from CDC and establish methods for determining historical and new data Develop extraction and integration of the vaccine sentinel survey data with VAERS data Design and implement automated data ingestion workflows Develop data validation and quality assurance processes Develop and automate cleaning process of the integrated data Create standardized data structures to support analysis and reporting

Deliverables Automated Data Ingestion and Integration Process Data Dictionary and Cleaning Methods

Task 3: Analytical Framework and Signal Detection Capability

Develop automated analytical processes to evaluate vaccine adverse events reported in the integrated data system Establish methodologies for identifying trends, patterns, clusters, and potential safety signals Develop statistical and epidemiologic monitoring approaches appropriate for passive surveillance data Create automated routine analyses to support quarterly and ad hoc reviews Establish thresholds and criteria to identify unusual reporting patterns that require further review Document analytical methodologies and assumptions Ensure analytics address metrics around vaccine allocation, distribution, utilization, and safety

Deliverables Signal Detection Methodology Analytical Framework Documentation Automated Analysis Scripts and Processes

Task 4: Dashboard Development and Reporting

Develop interactive dashboards and visualization tools to support metrics around vaccine allocation, distribution, utilization, and safety monitoring.

Create automated reporting capabilities Develop standardized reports for:

o IHS National Immunization Program o IHS leadership o Area Offices and facility levels o Other approved stakeholders

Design reports that summarize:

o Adverse event trends o Vaccine-specific reporting patterns o Serious adverse events o Emerging safety concerns o Vaccine allocation o Vaccine distribution o Vaccine utilization

Establish processes for routine report generation and dissemination Deliverables

Operational interactive dashboards and visualization tools Quarterly Reporting Templates Executive Summary Templates Reporting Standard Operating Procedures

Task 5: Guidance Development and User Support

Develop standardized guidance, training and educational materials to support frontline provider vaccine safety reporting and data interpretation Create Standardized Guidance on:

Best Practices for Reporting Vaccine-Related Adverse Events Reporting pathways and responsibilities (VAERS and NPTC Sentinel Survey) Reporting timelines and expectations Complete and accurate reporting Required and recommended data elements Documentation standards Quality assurance recommendations

Develop Supporting Materials Process maps and workflow diagrams Short YouTube Videos for providers Reporting guides Training materials Frequently Asked Questions (FAQ) Example reports and screenshots Standard operating procedures

Deliverables Vaccine Safety Reporting Guidance Training Materials Workflow Diagrams and Process Maps User Guide SOP Documentation

Task 6: Validation, Knowledge Transfer, and Final Deliverables

Demonstrate system functionality and reporting capabilities Incorporate stakeholder feedback into final products Provide knowledge transfer and system training Deliver final system documentation

Deliverables Final System Demonstration Final Report Knowledge Transfer Sessions Complete System Documentation necessary to effectuate complete transfer of system to be maintained by IHS

3. DELIVERABLES AND REPORTING SCHEDULE

1. Task 1 Deliverables Due: October 12, 2026

2. Task 2 Deliverables Due: Dec 31, 2026

3. Task 3 and 4 Deliverables Due: March 31, 2027

4. Task 5 and 6 Deliverables Due: June 30, 2027

5. Quarterly progress reports that include the items below Due: October 16, 2026 January 15, 2027 April 16, 2027 August 20, 2027

The Contractor shall also provide ad hoc updates upon request by the Program Manager or Contracting Officer Representative (COR).

The Contractor shall ensure:

Data analyses are accurate, reproducible, and documented Deliverables are complete, actionable, and submitted on schedule Dashboards and reports are user-friendly and operational Documentation is suitable for long-term maintenance and use Program staff feedback is incorporated into final products

All deliverables must be delivered electronically or in person, as applicable, to the Program Manager and Contracting Officer’s Representative (COR). Deliverables will be accepted upon review and approval by project stakeholders, with final approval resting with the COR.

Deliverables will be accepted upon:

Review and approval by the COR, upon input from designated project stakeholders

Demonstration of functional automated data processing and reporting capabilities Successful completion of dashboard and reporting requirements Demonstrated usability of reporting products and documentation Delivery of all required documentation and training materials

The period of performance will be from September 21, 2026 to July 31, 2027. The period of performance for all substantive work under this contract shall end no later than July 31, 2027. All technical, analytical, system development, implementation, training, and other performance activities shall be completed by that date. However, the contractor shall submit the final quarterly progress report no later than August 20, 2027.

Submission of the final quarterly report after July 31, 2027, shall be considered an administrative reporting requirement and shall not authorize or require additional substantive performance beyond the period of performance. The Contractor shall submit its final invoice within 60 calendar days after July 31, 2027.

4. PERIOD AND PLACE OF PERFORMANCE

Estimated Period of Performance: September 21, 2026 – July 31, 2027

The contract will be performed off-site, at contractor’s facility/place of work.

5. TRAVEL

No travel is required or included in this contract. Should travel become necessary, it shall be in accordance with Federal Travel Regulations and must be approved in advance by the Contracting Officer and COR before any costs are incurred.

6. GOVERNMENT FURNISHED INFORMATION/PROPERTY

The Government will provide:

Access to approved CDC VAERS datasets and documentation as available Access to IHS subject matter experts Access to immunization program stakeholders Existing guidance, policies, and educational materials Access to OIT resources necessary for system coordination and review

No Government-Furnished Property (GFP) will be provided under this contract.

7. SPECIAL CONSIDERATIONS

Coordination with CDC VAERS technical and program staff may be required Compliance with all IHS information security, PII protection, and data governance requirements is mandatory The system should maximize automation to reduce manual effort and support long-term sustainability Analytical methods should be transparent, reproducible, and adaptable to future vaccine safety monitoring needs The Government shall have unlimited rights in all data, documents, materials, software, source code, scripts, configurations, data models, dashboard source files, ETL workflows, documentation, and other deliverables first produced in the performance of this contract, subject to the applicable provisions and clauses of the contract. Nothing in this contract shall require the Contractor to transfer ownership of pre-existing intellectual property or third-party materials for which the Contractor does not possess ownership rights. Unlimited rights include the right to use, modify, reproduce, release, perform, display, or disclose the data, in whole or in part, in any manner and for any purpose whatsoever, and to authorize others to do so, including Government personnel and contractors acting on behalf of the Government for purposes of operating, maintaining, supporting, modifying, or enhancing the system.

The Contractor shall deliver all final products in formats that enable the Government to use, modify, distribute, operate, maintain, support, and enhance the deliverables independently of the Contractor.

This includes, but is not limited to, source code/scripts, configuration files, data models, dashboard source files, ETL workflows, system configuration and administrative instructions, and deployment/maintenance documentation.

The delivered materials and documentation shall be sufficient to permit the Government or a successor/support contractor, without assistance from the incumbent Contractor, to operate, administer, maintain, troubleshoot, modify, and enhance the delivered system.

The Contractor shall identify any pre-existing, proprietary, commercial, or third-party components incorporated into the solution and any associated license or use restrictions. Such components shall not be incorporated where their restrictions would prevent the Government or a contractor acting on behalf of the Government from independently operating, maintaining, supporting, or modifying the delivered system, unless specifically approved in writing by the Contracting Officer.