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The FDA monitors these adverse events. In the case of adverse events secondary to medical devices, the FDA recommends three levels of follow-up. This model might prove useful if applied in a hospital setting. The first level involves damage control — "correction." It refers to recognizing the error and providing an immediate intervention to prevent further harm. The second level involves finding a permanent solution so that the same event never happens again. This level is called the "corrective action." The third level is called "prevention action." This involves looking for system-wide solutions so that similar events never happen in other areas of the hospital. The FDA guideline makes sense in light of the Swiss cheese model.
The Swiss cheese model in healthcare facilities can be applied in numerous ways. We can constantly monitor symptoms and causes of latent hazards in all three levels, namely the conditions of the caregiver, unsafe supervision and causal factors at the organizational level, and mitigate them before any patient safety issue arises. Below are some examples.
Caregiver level factors:
- Failure to prioritize; lost focus and attention
- Omission of a step in a procedure
- Inadequate procedure
- Omission of a checklist item
- Inadvertent use of medical device controls
- Use of improper procedure
- Inadequate ability or training
- Wrong response to emergency
- Insufficient safeguards in delivery of medications
Unsafe supervision factors:
- Inadequate sanitization habits
- Occasional ignoring of the checklist
- Lack of availability of caregiver support
- Inadequate training of staff and inadequate supervision
- Insufficient enforcement of policies
- Time pressure prevents a junior caregiver from speaking up
- Inadequate use of lessons learned to prevent mishaps
- Insufficient focus on system thinking
- Insufficient training
Organization level factors:
- No ongoing senior management reviews of risks and mitigations
- Lack of documented procedure on risk assessment
- Lack of regular review of prevention of adverse events
- Lack of policy for prevention of adverse events
- No measure of policy effectiveness
- Poor cross-functional teams to prevent latent hazards
Conclusion
The Swiss cheese model offers a highly effective approach in understanding and preventing adverse events. It facilitates a multi-dimensional view of healthcare delivery, and offers preventive strategies and mitigation solutions in different levels.
References:
1. Reason, J. Human Error. Cambridge University Press, New York, 1990.
2. Woodall, Angela. "Woman who died at Alta Bates may be victim of medical error not medication mistake," Oakland Tribune, September 26, 2011.
3. Fireleadership.gov Website. Human Factors Analysis and Classification System, http://www.fireleadership.gov/toolbox/staffride/downloads/lsr12/lsr12_HFACS%20presentation.ppt.
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