1. Adverse Events Consolidated User Story 1: Healthcare Provider Reporting User Story Names: Actors: Flow of Events: Pre-condition Post-condition Preferred Timing for Each Event Type EHR System, Incident Reporting System Public Health Agencys Information System Varies and is dependent upon an HCPs assessment that an event has occurred AHRQ PSO, AIRA Immunization Registry, and FDA Adverse Event Reporting Patient, Healthcare Provider (HCP), PSO, Immunization Registry, Public Health Agency 1)A patient receives healthcare services and an HCP determines that an adverse event has occurred based upon specific observations, diagnoses or event characteristics (e.g., device malfunction) 2)HCP enters relevant information about the event into the patients EHR 3)The EHR system renders a reporting form for HCP completion. Report information is unique to the appropriate jurisdictional or PH reporting program requirements 4)Appropriate patient information is auto-populated into the form, and the HCP enters additional information as specified by the jurisdictional or PH reporting program requirements 5)Report is saved to HCP local system (EHR or Incident Reporting System) 6)Local system sends report to the appropriate PH agency 7)PH agency sends ACK to HCP local system that report was received Definitions An HCP is broadly defined in this user story as: a healthcare practioner, hospital, or skilled nursing facility that provides healthcare services, and/or a specific person responsible for AE reporting functions Trigger: HCP recording of an adverse event into the patient EHR

2. Adverse Event Consolidated User Story 2: Automated Triggered Reporting User Story Names: Actors: Flow of Events: Pre-condition Post-condition Preferred Timing for Each Event Type Laboratory Information System, EHR System, Incident Reporting System Public Health Agencys Information System Varies depending upon jurisdictional or PH program requirements Automated Triggered Reporting Patient, *Healthcare Provider (HCP), Laboratory, PH Agency Trigger: Automated EHR triggers: lab and AEs 1)Automated surveillance triggers are programmed into an HCP EHR system based upon specific jurisdictional or PH program requirements (e.g., Liver function test or serious AE 2)A patient receives healthcare services and information is automatically uploaded to the HCP EHR (e.g., observations, lab results, etc.) via HCP PDA-device or other EHR data interface 3)When the automated trigger criteria is met, an adverse event report form is automatically rendered for HCP review 4)Report form is auto-populated with appropriate patient and event information based upon jurisdictional or PH program requirements 5)HCP validates completeness of report and makes adjustments as necessary, e.g., add reporters comments 6)HCP local system (EHR or Incident Reporting System) sends report to PH agency 7)PH agency send ACK to HCP local system that report was received Definitions An HCP is broadly defined in this user story as: a healthcare practioner, hospital, or skilled nursing facility that provides healthcare services, and/or a specific person responsible for AE reporting functions