VHA National Center for Patient Safety

Healthcare Failure Mode and Effect Analysis (HFMEA)

Healthcare Failure Mode and Effect Analysis (HFMEA) was designed by NCPS specifically for healthcare.

HFMEA streamlines the hazard analysis steps found in the traditional Failure Mode and Effect Analysis process by combining the detectability and criticality steps into an algorithm presented as a "Decision Tree."

It also replaces calculation of the risk priority number (RPN) with a hazard score that is read directly from the Hazard Matrix Table. This table was developed by NCPS specifically for this purpose.

The information below provides an overall undestanding of HFMEA:

• The Basics of Healthcare Failure Mode and Effect Analysis 
• HFMEA Guide Book - January 2021
• Simple Step-by-Step Guide to HFMEA - January 2021

Worksheets that focus on specific steps:

• HFMEA Worksheets, Steps 1 & 2  
• HFMEA Worksheet, Steps 4 & 5  

References

• DeRosier, J., Stalhandske, E., Bagian, J.P., & Nudell, T (2002). Using Health Care Failure Mode and Effect Analysis: The VA National Center for Patient Safety's Prospective Risk Analysis System(PDF).The Joint Commission Journal on Quality Improvement, Volume 27 Number 5:248-267, 2002. Posted with permission.
• Joint Commission Executive Briefings on the Patient Safety Standards: Designing Safer Health Care Systems (2001). Joint Commission Resources, pp 92-95.
• McDermott, R.E., Mikulak, R.J., & Beauregard, M.R. (1996). The Basics of FMEA. Portland, OR: Resources Engineering, Inc.
• Stamatis, D.H. (1995). Failure Mode and Effect Analysis: FMEA from Theory to Execution. Milwaukee, WI: ASQ Quality Press.
• Institute for Safe Medication Practices Sample Case for PCA Pump*†

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