RCA (root cause analysis) is a tool often used to provide an assessment after the occurrence of an adverse event or when investigating the safety of an environment. The idea behind this risk assessment is to uncover the overt and latent factors behind unsafe situations.  In non-medical industries this has proven to be an effective tool but in healthcare, the belief that this tool helps is variable. While many RCAs have uncovered surprising holes in healthcare safety systems, there are also concerns with its value.

In a 2008 interview with Robert Watcher, Albert Wu  said “Although we are living in an era of evidence-based medicine, root cause analysis was widely adopted by the medical community in the 1990s without the benefit of much evidence. Every institution now conducts root cause analysis. Thousands of health care workers devote many hours to conducting these analyses, yet root cause analysis has never really been evaluated.” (AHRQ, http://webmm.ahrq.gov/perspective.aspx?perspectiveID=61)

Some of the barriers to conducting root cause analysis:
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limited evidence for validly of the RCA approach

lack of training in using the tool

lack of tested solutions for the root causes discovered

failure to go deep enough into the problem  (eg. root cause=lack of training)

there is no national oversight agency examining all these local RCAs for patterns

lack of standard risk control action plans for root causes identified

More from WU(AHRQ, http://webmm.ahrq.gov/perspective.aspx?perspectiveID=61  “Here’s an example that we gave in our paper. The patient was receiving patient-controlled analgesia (PCA), which includes a local anesthetic and a narcotic. This is supposed to be given into the epidural space. Unfortunately, the nurse connected the tubing to an IV catheter. The patient did not succumb to this, but it could have been a lethal episode. The root cause analysis identified a number of problems, but what the team really wanted to do was to prevent tubing for an epidural infusion from being connected to an intravenous catheter. However, they felt that they couldn’t do that, so instead they reeducated their staff. They took some actions, but if you ask anyone in the institution if this was likely to be effective, they were not very secure that they had done anything worthwhile. In fact, a year later there was almost an identical incident at the same institution. And this happened after a lengthy root cause analysis, which took perhaps 100 hours to perform. A number of policies and changes were made, but things were not safer. What ideally would have been done was that someone at a higher level than the individual hospital would realize that this was a problem and perhaps make a recommendation to all the manufacturers of tubing for PCA and identify this as a problem that should be eradicated. This kind of solution has been achieved in aviation. But it has been achieved perhaps only a few times in medicine.”

Do RCAs result in safer patient care?

Not if the “root cause” is lack of staff training and the risk control plan is to train staff.

“Based on the 1,738 risk controls generated in the two largest studies, the authors found that risk controls based on training and education were negatively correlated with reports of improved outcomes that is, they made things worse. Actions focused on clinical changes and equipment/computers were found to be the most effective” (Card, Ward, & Clarkson, 2012).

This finding is consistent with the Hierachy of Intervention Effectiveness posted in an article by Caffazzo and St-Cyr, 2012)

Percapio, et al. (2008) summarized the RCA process as a far from a controlled study of an incident and described it as somewhat of an uncontrolled case study that may be hampered by hindsight bias, and stakeholder bias which cause one to wonder if the root cause is actually the true cause or one that fits the biases of the participants.

So how do we make RCAs useful?

In the absence of an NTSB-like agency for healthcare I think the best approach would be for hospitals, insurance companies and the government to fund an unlimited RCA plan. This service could offer unlimited RCAs conducted by participating PSOs (patient safety organizations) who could then create a national database of root causes and effective risk control action plans (as well as ineffective plans).

Imagine how quickly we could improve the national safety of patients if every medication safety issue were investigated by ISMP or every medical device malfunction were handled by ECRI.  This should be a reactive program, applying to all adverse events but also a proactive program where near misses and non-routine events are also examined.

The roots of medical error create imminent lethal, disabiling and financial threats to the citizens of the USA. It’s time we stop wasting hours and money on ineffective local RCAs and risk control plans and redirect these to figure out what works on a broader scale.

Decide for yourself:  Further Reading

Cafazzo, J.A & St-Cyr, O. (2012). From discovery to design: The evolution of human factors in health care. Healthcare Quality, 15(special issue), 24-29.

Card, A., Ward, J. & Clarkson, J. (2012). Successful risk assessment may not always lead to successful risk control: A systemic literature review of risk control after root cause analysis. Journal of Healthcare Risk Management, 31(3), 6-12.

Percarpio, K., Watts, V.,  & Weeks, W. (2008). The effectiveness of root cause analysis: What does the literature tell us? The Joint Commission Journal on Quality and Patient Safety, 34(7), 391-398.