The reality is that we err. Having the unrealistic expectations developed in medical training of being perfect in all our actions perpetuates the blame cycle when the inevitable mistake occurs, and it prevents us from implementing solutions that prevent errors from ever occurring or catching them before they cause harm.
RCA and FMEA Help Us Create Solutions That Make a Difference
Briefly, Root Cause Analysis (RCA) is a retrospective investigation that is required by JCAHO after a sentinel event: “Root cause analysis is a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause is that most fundamental reason a problem―a situation where performance does not meet expectations―has occurred” (JCAHO 1998). An RCA looks back in time at an event and asks the question “What
happened?” The utility of this methodology lies in the fact that it not only asks what happened but also asks “Why did this happen” rather than focus on “Who is to blame?” Some hospitals use this methodology for cases that are not sentinel events, because the knowledge gained from these investigations often uncovers system issues previously not known and that negatively impact many departments, not just the departments involved in a particular case.
Failure Modes and Effects Analysis (FMEA) is a prospective investigation aimed at identifying vulnerabilities and preventing failures in the future. It looks forward and asks what could go wrong? Performance of an FMEA is also required yearly by JCAHO and focuses on improving risky processes such as blood transfusions, chemotherapy, and other high risk medications.
Approaching a clinical case clearly demonstrates the differences between RCA and FMEA. Imagine a 72-year-old patient admitted to your hospital with findings of an acute abdomen requiring surgery. The patient is a smoker, with Type 2 diabetes and an admission blood sugar of 465, but no evidence of DKA. She normally takes an oral hypoglycemic to control her diabetes and an ACE inhibitor for high blood pressure but no other medications. She is taken to the OR emergently, where surgery seems to go well, and post-operatively is admitted to the ICU. Subsequently, her blood glucose ranges from 260 to 370 and is “controlled” with sliding scale insulin. Unfortunately, within 18 hours of surgery she suffers an MI and develops a postoperative wound infection 4 days after surgery. She eventually dies from sepsis.
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An RCA of this case might reveal causal factors such as lack of use of a beta-blocker preoperatively and lack of use of IV insulin to lower her blood sugars to the 80–110 range. While possibly identifying the root cause of this adverse outcome, an RCA is limited by its hindsight bias and the labor-intensive nature of the investigation that may or may not have broad application, since it is an in-depth study of one case. However, RCA’s do have the salutary effects of building teamwork, identifying needed changes, and if carried out impartially without assigning blame can facilitate a culture of patient safety.
FMEA takes a different approach and proactively aims to prevent failure. It is a systematic method of identifying and preventing product and process failures before they occur. It does not require a specific case or adverse event. Rather, a high-risk process is chosen for study, and an interdisciplinary team asks the question “What can go wrong with this process and how can we prevent failures?” Considering the above case, imagine that before it ever occurred you as the hospitalist concerned with patient safety decided to conduct an FMEA on controlling blood sugar in the ICU or administering beta-blockers perioperatively to patients who are appropriate candidates.