Healthcare Failure Mode and Effect Analysis

Failure mode and effects analysis helps to anticipate what can go wrong with a high-risk health care process and to apply measures to prevent the error. Industries such as aviation, aerospace, and automotive manufacturing have long used failure mode and effects analysis to prevent accidents from occurring, but there is only one model specific to health care. That model, called Healthcare Failure Mode and Effects Analysis, was developed by the Department of Veterans Affairs (VA) National Center for Patient Safety and first put into practice in 2001.

The VA’s HFMEA™ model is a five-step process that involves selecting a topic for analysis, selecting a team to do the analysis, mapping a flow chart of the high-risk process, identifying failure modes within the process, and, if necessary, redesigning the process.

In its first application of HFMEA™ the VA asked its 163 medical centers to use HFMEA™ to analyze their contingency plans for their computerized, bar-code medication administration systems in the event of a power failure or other interruption to the system. The process was a valuable exercise, VA officials say, and revealed vulnerabilities to facilities’ contingency plans and prompted facilities to make changes to prevent problems from occurring.

For example, some facilities learned that they wrongly assumed that data backups of their computerized bar-code systems were performed more frequently than every 24 hours. In the event of a power failure, newly entered data such as a change in a patient’s medication may not have been included in the data backup, and the patient could be at risk of receiving an incorrect medication order. HFMEA™ teams recommended redesigning the process by requiring more frequent data backups of their facilities’ electronic medication records and providing a mechanism to let staff know when the backup is completed.

The HFMEA™ process helped the teams identify other gaps in the contingency plans by asking the following questions:

  • Do caregivers know how to access and use their contingency plans for the medication administration system?

  • Is a process in place to stop new referrals to a unit, if necessary, when the electronic medication administration system is unavailable?

  • Is there a procedure to request additional staff if necessary to help implement the contingency measures?

  • What process is in place to ensure that once the electronic system is restored, any information about a patient’s medications that is recorded manually during a power failure is available to caregivers?

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