VHA National Center for Patient Safety
Healthcare Failure Mode Effect Analysis (HFMEA)
Introduction
Making medical procedures safer was the key reason that the HFMEA process was designed by NCPS. It has a wide range of applications, from developing backup medication delivery systems, to improving the way laboratory specimens are drawn.
A five-step process is used by interdisciplinary teams to proactively evaluate a health care process. Specifically designed for use by health care professionals, the process offers users analytical tools such as flow diagramming, decision trees, and prioritized scoring systems. The tools enable the user to proactively identify vulnerabilities and deal with them effectively.
The process streamlines hazard analysis steps found in a traditional Failure Mode and Effect Analysis procedure — an analytical process often used by engineers to identify potential failures of individual components and subsystems.
HFMEA includes health care-specific definitions for severity, probability, and detectability. It is a systematic engineering-based approach used to identify system vulnerabilities and correct problems before they occur.
The Five-Step Process
Step 1: Define the HFMEA Topic
- When selecting the topic, be specific about the process or product to be studied, thus narrowing the scope of the analysis.
Step 2: Assemble a Multidisciplinary Team
- The team should include one or more subject-matter experts, as well as individuals who have no detailed knowledge of the process under review. When needed, others can be called in as consultants.
Step 3: Graphically Describe the Process
- Team members develop and verify a flow process diagram, not to be confused with a chronological diagram. Each step in the process under study is identified and numbered.
- If a process is complex, a specific area is identified to keep the effort manageable. Appropriate sub-processes are also identified and flow process diagrams developed.
Step 4: Conduct a Hazard Analysis
- Focusing on the sub-processes, team members list all potential failure modes to determine their severity and probability. Cognitive aids developed by NCPS to support teams at this step include a Scoring Matrix and a Decision Tree.
- The Scoring Matrix is used to determine the probability of an event’s reoccurrence and its severity; the Decision Tree is used to determine if corrective actions should be taken.
Step 5: Actions and Outcome Measures
- The team determines what best course of action to take. Outcome measures are identified to analyze and test redesigned processes.
