Root cause analysis (RCA), championed by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) since 1997 for sentinel-event investigation, identifies systemic factors contributing to failures. A sentinel event is an unanticipated adverse outcome involving death, serious physical or psychological injury, or the risk of such events (Table 1).¹ Sentinel events, unlike understandable negative patient care outcomes, never should occur during normal treatment.¹

Table 2 describes common settings, types, and outcomes for 3661 sentinel events reported to JCAHO as of March 31, 2006.²

As a problem-solving method, RCA presumes that faulty systems, not personal failures, are the root causes underlying sentinel events. Industrial psychology and human factors engineering sciences suggest that poor processes cause up to 95% of dire consequences.³ RCA leads to system modifications, preventing future occurrences.

Proximate and Latent Causes

To elucidate failures, RCA distinguishes proximate, apparent causes from latent, underlying system causes. In health care, proximate causes usually are care process deficiencies⁴: human error (eg, dose miscalculation), malfunctioning equipment, or failure to effect action. Latent causes are underlying organizational processes that galvanize proximate causes (eg, working mandatory overtime in an understaffed pharmacy). Identifying latent causes involves asking "Why?" repeatedly until organizational processes are revealed. (The sidebar describes a simplified RCA.)

Tips for Conducting a Credible RCA

Conducting an RCA takes days to weeks and should be completed without delay, or within 45 days of a sentinel event at JCAHO-accredited sites. These tips maximize efficiency and ensure creditability.

1. Team composition. The multidisciplinary RCA team, facilitated by a process expert, must be trained in RCA technique, preferably in advance, and must exclude staff members involved with the sentinel-event victim's care. Also, the team needs a recorder and a team leader (a subject matter expert who provides relevant technical information).⁵

2. Data collection establishes what happened. The most time-consuming part of the RCA, data collection must have a scope and depth sufficient to answer any question the team raises. Usually a quality improvement team or a risk manager gathers data, using blameless, open-ended questions when interviewing, refraining from value judgments.

3. Incident analysis follows. Team members review what happened during the incident and in the system and proceed to how it happened. Then the team must try to understand why it happened, without focusing on individual performance.⁶

4. Risk points are discrete points on the care continuum (involving care activities and associated staff members). Identifying risk points and their potential contribution assists with the analysis.³ The five "Rs" for medication—right drug, right dose, right route, right time, right patient—are risk points. The related physician, pharmacist, and medication nurse also are risk points.

Barrier analysis helps identify systemic faulty or nonexistent safeguards or unnecessary risks, pointing to potential corrective actions.⁵ The inability to select a patient record without verifying the entire name is a barrier.

5. Causal pathways are organized schematically, positioned from incidentspecific to organization-specific processes. In the example in the sidebar, specific causes involved nurse orientation and patient-identification procedures, but the broader organizational causes involved understaffing. Normally, multiple problem issues will cross various systems. Patient-identification procedures, for example, involve staffing, training, procedures, supervision, and technology use. RCAs identifying only a few systemic factors probably are flawed.

6. Corrective action plan. The team's corrective action recommendations should be unfettered by cost or complexity. Leadership will review proposed corrective actions thoroughly, make funding decisions, and ensure that correcting 1 root cause does not create another.⁷

7. Report. The team summarizes the RCA, beginning with summaries of what, how, and why the event occurred. Many organizations use a table highlighting contributing factors, corrective action recommendations, due dates, and staff members responsible for monitoring. Visuals also help. The fishbone-shaped diagram (Figure) effectively identifies causal pathways. The fish's head is the problem (result), and each bone represents a causal pathway. Major system factors (details), such as equipment, environment, or skills, are noted on the bones.

8. Know when to stop. RCA is theoretically endless, because there is always 1 more "why." Albeit a judgment call, the team can stop when the members concur that they have identified causal pathways that, if corrected, would minimize or prevent a future occurrence. They must limit systemic aspects to those that management can control. For example, the answer to "Why are pharmacy positions hard to fill?" (in the sidebar) also could have included "There is a national shortage." Although true, this situation is beyond management's control.

Never Events, Near Misses

Medication errors fall among the top 5 reported sentinel events. They were recently labeled as "never events" by the Centers for Medicare & Medicaid Services. Whereas many "near misses" are not classified as sentinel or never events, organizations should address them nonetheless. If patient medication allergies are missing from the record and pharmacists intercept several contraindicated orders, an internal RCA might uncover problems and improve information sharing, patient assessment, and on-line ordering pathways.

Final Thought

RCA is a qualitative technique, devoid of statistical attire. Although RCA teams cannot determine with total certainty whether the adverse outcome would have been avoided had the corrected systems been in place, doing nothing in response to unexpected events is not an option.

Dr. Zanni is a psychologist and health-systems consultant based in Alexandria,Va.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Rybovic, Pharmacy Times, Ascend Media Healthcare, 103 College Road East, Princeton, NJ 08540; or send an e-mail request to: arybovic@ascendmedia.com.