Adverse Event Reporting & Data Export Standards

Overview

This document establishes the standardized procedures for reporting, tracking, and analyzing adverse events across all 75 sessions of the WRH Master Curriculum. The framework ensures participant safety, institutional accountability, federal compliance, and continuous program improvement through systematic data collection and analysis.

1.0 Adverse Event Definition & Classification

An adverse event is any occurrence during or immediately following a WRH session that results in participant distress, dysregulation, or requires intervention beyond standard session protocol. Adverse events are classified into four categories:

Classification	Severity	Examples	Response Level
Level 1 (Minor)	Low	Mild participant anxiety, brief emotional response, self-corrected with RGP	Facilitator-managed, documented
Level 2 (Moderate)	Moderate	Significant dysregulation requiring extended RGP, participant requests session pause	Facilitator-managed, clinical staff notified, documented
Level 3 (Major)	High	Acute distress, indirect suicidal ideation, aggressive behavior, SPI handoff required	SPI Handoff Protocol activated, clinical staff assumes care, documented
Level 4 (Critical)	Critical	Direct suicidal ideation, active self-harm, threat to others, emergency services required	Immediate crisis response, emergency services contacted, documented

2.0 Reporting Procedure & Timeline

2.1 Immediate Notification (Within 1 Hour)

Upon occurrence of a Level 2, 3, or 4 adverse event, the facilitator must immediately notify the Program Coordinator and designated clinical support staff. Notification includes:

Session number and participant identifier (de-identified code).
Brief description of the event.
Current participant status (stabilized, in clinical care, etc.).
Any immediate actions taken.

2.2 Detailed Incident Report (Within 24 Hours)

A comprehensive incident report must be completed within 24 hours using the standardized Adverse Event Report Form (see Section 3.0). This report includes:

Complete S-Prefix Metrics (S-ACT, S-REG, S-INT, S-OUT).
Detailed description of the event and triggering factors.
Facilitator response and effectiveness.
Clinical intervention (if applicable).
Participant disposition and follow-up plan.

2.3 7-Day Follow-up Assessment

The Program Coordinator must conduct a follow-up assessment within 7 days of any Level 2, 3, or 4 adverse event. This assessment includes:

Direct contact with the participant (or clinical team, if handoff occurred).
Assessment of participant well-being and program impact.
Determination of whether additional clinical support is needed.
Documentation of follow-up findings and any recommendations.

3.0 Standardized Adverse Event Report Form

Field	Description	Required
Incident ID	Unique identifier (e.g., AER-2026-001)	Yes
Date & Time	Date and time of incident	Yes
Session Number	WRH session during which incident occurred	Yes
Delivery Tier	Tier 1 (Community), Tier 2 (Structured), or Tier 3 (Clinical)	Yes
Participant Code	De-identified participant identifier	Yes
Facilitator Name	Name of facilitator conducting session	Yes
Adverse Event Level	Level 1, 2, 3, or 4	Yes
Event Description	Detailed, de-identified description of what occurred	Yes
Triggering Factors	Content, participant state, or environmental factors that may have contributed	Yes
S-ACT (Activation Level)	1-5 scale of participant nervous system activation	Yes
S-REG (RGP Effectiveness)	Success, Partial Success, or Failure	Yes
S-INT (Intervention Type)	Verbal, RGP, SPI Handoff, or Other	Yes
S-OUT (Outcome)	Stabilized, Handoff to Clinical, Exit, or Other	Yes
Clinical Staff Involved	Names of clinical staff who assisted (if applicable)	Conditional
Emergency Services	Whether emergency services were contacted	Yes
Facilitator Reflection	Facilitator’s assessment of what could be improved	No
Follow-up Date	Date of 7-day follow-up assessment	Conditional
Follow-up Findings	Summary of follow-up assessment results	Conditional

4.0 De-Identified CSV Export Standards

4.1 Export Frequency & Timing

Adverse event data is compiled and exported weekly (every Monday) into a de-identified Comma Separated Values (CSV) format. Weekly exports allow for timely trend analysis and rapid identification of emerging safety concerns.

4.2 Data Fields for CSV Export

The following fields are included in the weekly CSV export:

Incident_ID, Date, Time, Session_Number, Delivery_Tier, S_ACT, S_REG, S_INT, S_OUT, 
Event_Level, Triggering_Factor_Category, Emergency_Services_Contacted, Follow_Up_Completed, 
Follow_Up_Status, Facilitator_Tier, Location_Code

4.3 Anonymization & Privacy Standards

All personally identifiable information (PII) is removed or aggregated prior to export:

Participant names, dates of birth, and contact information are replaced with de-identified codes.
Facilitator names are replaced with facilitator tier and location code.
Specific clinical diagnoses or sensitive personal details are summarized into categorical variables.
Geographic information is aggregated to facility/program level only.

4.4 Data Retention & Access Control

Retention Period: Adverse event data is retained for a minimum of 7 years to comply with federal contracting and healthcare regulations.
Access Control: CSV exports are stored in a secure, encrypted repository accessible only to authorized personnel (Program Coordinator, Clinical Director, Compliance Officer).
Audit Trail: All access to adverse event data is logged and audited quarterly.

5.0 Trend Analysis & Program Improvement

5.1 Monthly Trend Report

The Program Coordinator generates a monthly trend report analyzing the previous month’s adverse events. This report includes:

Total number of adverse events by level and session.
Identification of sessions or delivery tiers with elevated adverse event rates.
Analysis of common triggering factors.
Effectiveness of interventions (RGP success rates, SPI handoff outcomes).
Recommendations for facilitator training, script refinement, or protocol adjustment.

5.2 Continuous Improvement Process

Based on trend analysis, the program implements the following continuous improvement cycle:

Identify emerging safety concerns or patterns.
Analyze root causes and contributing factors.
Develop targeted interventions or protocol refinements.
Implement changes with facilitator training.
Monitor effectiveness of changes through subsequent adverse event data.

6.0 Compliance & Reporting to Federal Agencies

6.1 Quarterly Compliance Report

A quarterly compliance report is submitted to the contracting federal agency (e.g., VA, DoD) summarizing:

Total adverse events by level and session.
Serious adverse events (Level 3 or 4) with de-identified case summaries.
Program-level safety metrics and trends.
Any protocol changes or facilitator retraining conducted in response to adverse events.

6.2 Serious Adverse Event Notification

Any Level 4 (Critical) adverse event, or any Level 3 adverse event involving potential harm, must be reported to the contracting federal agency within 48 hours of occurrence, with a detailed follow-up report within 5 business days.