Indications for Doing a Root Cause Analysis

What is RCA?

Variation in performance can produce unexpected and undesired adverse outcomes, including the occurrence of, or risk of, a sentinel event. Root cause analysis is a process for identifying the basic or causal factors that underlie such variation and focuses primarily on systems and processes, not individual performance. To be successful, it must not assign blame. Particular attention is paid to failed (and successful) defenses and recoveries for the patient, since adverse events require the formal instigation of defenses (for example, a medication is discontinued), whereas near misses involve built-in defenses (for example, automatic compensation through stand-by equipment). Improvements in the delivery of care are devised and implemented to prevent the adverse outcome from recurring, or at least to reduce the possibility of its recurrence and to ameliorate its consequences. The lessons learned are communicated to all hospital staff as a way to improve patient safety.

Unanswered Questions

• Where to draw the line when assessing the "risk" of an adverse event? If not careful, the entire database of incident reports could become inappropriately overweighted in incidents subjectively assessed as "severe" by managers with unequal training.
• If a near miss is rated as having the "risk of death", is it still a near miss, or should it be reclassified as SAC=type 1 because of its potential severity?
• TJCHA insists that their expert panel considers endotracheal dislodgement as a "moderate risk" in all cases. Is there no difference in risk for patients who need to be reintubated (clinical condition presumably poor if undergoing appropriate clinical care) and those who do not need to be reintubated (presumably because intubated for longer than necessary). Moreover, if those who are reintubated are at poor risk (many die), why does TJCHA only grade it as "moderate risk"?

Should we do an RCA for ALL adverse events?

It is not feasible to do an RCA for all individual adverse events and near misses, only a subset. Otherwise:

1. useless analyses will be carried out because there is no time to do them properly
2. effort will be devoted to performing analyses at the expense of testing and implementing real system changes that can reduce injury rates

Indications for RCA

The decision to carry out a root-cause analysis will normally be because of one of the following:

• Series (multiple occurrences of the same event): The likelihood of recurrence of similar adverse events — series of recurrences for which more detailed analyses were not carried out on individual incidents may lead to improvements in the delivery of care from aggregate analysis of the series as a whole, rather than one by one. This assessment is facilitated by access to a database of incident reports.
• Sentinel events (single event): require RCA by definition.
  1. Death
  2. Permanent disability
  3. Specific events designated as sentinel events
     1. Surgery events:
        • Procedures involving the wrong patient or body part
        • Retained instruments
        • Unintended material requiring surgical removal
     2. Hemolytic blood transfusion
     3. Infant abduction or discharge to wrong family
     4. The following are also in the ACHS list or specific events designated as sentinel events, but should already be classified as sentinel events by our system because of {a} death or {b} permanent disability:

        • Suicide
        • Intravascular gas embolism resulting in death {a} or neurologic damage {b}
        • Medication error leading to death {a}
        • Maternal death {a} or serious morbidity {b} associated with labor or delivery
  4. Risk (near miss) of any of the above {a~c}
• The severity of the adverse event — can be assessed by direct observation. A number of risk assessment indices have been developed to help in making the decision (e.g. Severity Assessment Code 1 and 2 are indications for RCA, even if not sentinel events).
• Whether the adverse event represents a previously unknown problem — a judgment call drawing on the collective expertise of the patient safety team and access to a database of incident reports.

Limiting Factors

• Whether a similar case has been investigated recently — full root-cause analysis will have only marginal usefulness.
• The resources available to carry out such analyses — a judgment call for the patient safety team.
• The potential for correction — depends on the expertise of the patient safety team.