University of Michigan Health System
Patient Safety Toolkit

Overview

Safety Culture

Safety Plan

Safety Curriculum

Adverse Events

Medication Safety

Infection Prevention Control

Disclosure

Adverse Events Chapter

• Introduction
• Key Issues
• Definitions
• External Requirements
• Accreditation Standards
• Regulatory Requirements
• Understanding Error Causation
• Human Factors
• Systems Theory - An Organizational Model
• Systems Complexity
• Proactive Approaches to Risk and Error
• Failure Mode and Effects Analysis (FMEA)
• Sentinel Event Alerts/National Patient Safety Goals
• Seeking Input on Matters of Patient Safety
• Patients and Families as Partners in Safety
• Reactive Approaches to Risk and Error
• Categorizing Incidents for Follow-up
• Determining Appropriate Course of Action
• Root Cause Analysis
• Assembling the RCA Team
• Setting the Tone
• Protecting Interests and Maintaining Objectivity
• Ensuring "Thorough and Credible" Root Cause Analysis
• Beginning the Investigative Process
• Scope of the Review
• The Analysis
• Action Planning
• Conclusion of the Root Cause Analysis
• Lessons Learned
• Informing the Family of the Results
• Challenges
• Is This a Systems Issue or a Performance Issue?
• When Outcomes Can't Be Adequately Measured
• Limitations of Root Cause Analysis
• Quality Assurance Protection under the Law
• Copyright
• References
• Primers - Recommended Reading
• Tools & Templates
• FMEA Prioritization System
• Blood Transfusion Process Flowchart
• Safe Medical Device Act Policy
• Flowchart for SMDA Incident Reporting Exhibit A
• Flowchart for SMDA Explant Devices Reporting Exhibit B
• TJC Sentinel Event Alert Publications: Recommendations and Summary of UMHHC Compliance and Implementation of Recommendations
• Flowchart for Review and Analysis of Patient Safety Reports
• University of Michigan Hospitals & Health Centers Root Cause Analysis Process:
• Root Cause Analysis "Keys to Success" presentation
• Sentinel Event Review Policy
• Flowchart for Sentinel Events -
  Exhibit A
• Guidelines for Adverse or Sentinel Events - Exhibit B
• Adverse Event - Initial Meeting Agenda
• PCA Event Macro Flowchart
• PCA Event PACsU Flowchart #2
• PCA Event General Care Flowchart #1
• Sentinel Event Executive Summary
• PCA Sentinal Event Root Cause Analysis Meeting: Pre-Meeting Materials
• PCA Sentinel Event Root Cause Analysis Meeting Agenda
• Orientation to Sentinel Event Process
• Root Cause Analysis: Tools For Adverse Events
• Root Cause Analysis: Sample Questions
• PCA Sentinel Event Review - Identified Issues
• Adverse/Sentinel Event Action Plan Matrix
• PCA Sentinel Event Action Plan Matrix
• Patient Safety Brochure

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