Quality Tools: Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA)

For example, using FMEA methodology to study the process of intensive insulin therapy to achieve tight control of glucose in the ICU would identify potential barriers and failures preventing successful implementation. A significant risk encountered in achieving tight glucose control in the range of 80–110 includes hypoglycemia. Common pitfalls of insulin administration include administration and calculation errors that can result in 10-fold differences in doses of insulin. Other details of administration, such as type of IV tubing used and how the IV tubing is primed, can greatly affect the amount of insulin delivered to the patient and thus the glucose levels. If an inadequate amount of solution is flushed through to prime the tubing, the patient may receive saline rather than insulin for a few hours, resulting in higher-than-expected glucose levels and titration of insulin to higher doses. The result would then be an unexpectedly low glucose several hours later. Once failure modes such as these are identified, a fail-safe system can be designed so that failures are less likely to occur.

The advantages of FMEA include its focus on system design rather than on a single incident such as in RCA. By focusing on systems and processes, the learning and changes implemented are likely to impact a larger number of patients.

Summary and Discussion

To summarize, RCA is retrospective and dissects a case, while FMEA is prospective and dissects a process. It is important to remember that given the right set of circumstances, any physician can make a mistake. It makes sense to apply methodologies that probe into surrounding circumstances and contributing factors so that knowledge gained can be used to prevent the same mistakes from happening to different individuals and have broader impact on healthcare systems.

Resources

1. www.patientsafety.gov: VA National Center for Patient Safety. Excellent website with very helpful, practical tools.
2. www.ihi.org: Institute for Healthcare Improvement website. Has a nice FMEA toolkit.
3. www.jcaho.com: The Joint Commission for Accreditation of Healthcare Organizations website. Has information on sentinel events and use of RCA.

Bibliography

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2. Joint Commission on Accreditation of Healthcare Organizations. Sentinel events: evaluating cause and planning improvement. 1998. Library of congress catalog number 97-80531.
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