For years, when an adverse event occurred, healthcare organizations engaged in root cause analysis (RCA) to determine what went wrong. The idea was that if you could determine the problem, you could avoid it in the future. But to prevent something bad from happening requires action, so the National Patient Safety Foundation (NPSF) published RCA2: Improving Root Cause Analyses and Actions to Prevent Harm, designed to emphasize not just the need to investigate how harm came about, but to implement changes so that it doesn’t happen again.
The NPSF released a document in June designed to explain the concept of RCA2 (RCA Squared). In it, they note that RCA alone has had “inconsistent success” in part because it has lacked the emphasis on acting on the findings such analyses uncover. Even with this new stress on action, the players involved have to be sure that actions delineated actually happen or the “entire RCA2 activity will be a waste of time and resources,” according to the paper.
“A root cause analysis project has always involved finding the problems and fixing them,” says Patrice Spath, Hospital Peer Review’s editorial advisor, and principal at Brown-Spath & Associates in Forest Grove, OR. “However, all too often the ‘fixing’ step received less attention.”
Spath says she thinks the guidelines and the weight they put on implementing action are good. “Studies have shown that actions recommended by RCA teams are often not fully implemented and even if implemented, not adequately evaluated for effectiveness. Without the action implementation and measurement piece, the cycle of performance improvement is incomplete and patient safety is still in jeopardy.”
An element of the paper that may be surprising calls for RCA2 team membership to exclude those who were involved in the event being studied. Rather, those people should be interviewed for information. Spath disagrees with this position and notes that organizations often routinely include people involved in a close call or sentinel event on the root cause team. “This often results in very successful investigations with strong actions that improve the systems of patient care,” she says. “It is unfortunate the NPSF group came out so strongly against this practice. I encourage facilities to include individuals involved in the event on the RCA team if this is working well for them. Merely interviewing people personally involved in the event prevents them from being actively involved in finding and fixing the system problems.”
When organizations discuss adverse events, they often talk about systemic issues and try to stress that people are usually not the problem. But sometimes they are, and the NPSF notes that when there are “blameworthy” events — often the result of criminal acts, substance abuse, or acts defined by the organization as being “intentionally or deliberately unsafe” — the authorities have to be notified according to local regulation. But that doesn’t mean that there is no further opportunity to learn from it or that no RCA2 should be done, says the NPSF report. It just means that other authorities have the primary responsibility for investigation and corrective action against a specific individual.
Spath thinks that RCA2 shouldn’t be different regardless of the type of event. “It is rare to find a totally blameless event, especially when there is a single point of failure,” she says. For example, the report tells the fictitious story of a COPD patient with an oxygen cylinder going for an MRI before knee surgery. The attendant asks him to remove his street clothes and put on a surgical gown, and be sure to take off all jewelry. The patient then follows the attendant to the exam room, pulling his O2 cylinder behind him. He is asked about metal objects on his person. They enter the magnet room, where the cylinder is pulled from the patient and goes flying, nearly missing the attendant. The machine is down for five days for repair.
“The technician was certainly to blame for allowing a metal device near the magnetic field of the MRI,” Spath says. “Should an RCA be done on this event? Definitely! Should the performance of the technician also be reviewed by his or her manager? Also definitely!”
The report also notes, though, that there was no signage about approaching the room about metal objects, and no metal detector at any point before the magnet room. Does that mean the technician was the only one at fault and should bear all the blame? That is for the RCA2 to determine.
“Referring supposed blameworthy events found during an RCA to another authority to review presumes that systems issues will be identified and resolved during this other review,” Spath continues. “This may not occur as such reviews historically focus on individual performance and the reviewers may not be familiar with system analysis techniques and human factors.”
If, when an RCA2 finds that individual performance might be an issue, then it can be referred to the appropriate authority, whether physician peer review, staff performance review, or legal authorities, she says.
While a person can be investigated by appropriate other authorities, an RCA team can still investigate systemic issues at play, Spath says. “For instance, why was an untrained individual assigned to the task? Why was someone with alcohol abuse problems allowed to continue to practice? Why was the individual’s error not caught and corrected before a patient was harmed? The RCA team is charged with strengthening the system so it does a better job of protecting patients from impaired or error-prone individuals and also from the simple mistakes that can be made by anyone.”
Spath says in her experience, it is better for leaders to “triage” events during the initial screening of reported events using a risk-based prioritization system or other criteria the organization may find useful.
Many organizations base their RCAs on harm as it occurs. The NPSF paper says a risk-stratified prioritization system is better. “A risk-based system prioritizes hazards and vulnerabilities that may not yet have caused harm so that these hazards and vulnerabilities can then be mitigated or eliminated before harm occurs,” the paper notes. “This thinking is consistent with successful practices in many high-reliability industries, such as aviation, as well as the recommended approaches of various healthcare accreditation organizations.”
The paper includes a how-to for a risk safety assessment and five examples of using its Safety Assessment Code Matrix in the first appendix. Culture is important for RCA2 to be successful, and the report suggests that every action recommended by a review team “should be approved or disapproved, preferably by the CEO or alternatively by another appropriate member of top management.” If disapproved, then the reason should be shared with the team so that it is understood. An alternative can be developed that can be used in the declined action’s place.
Spath says that having this kind of rejection from leadership can be disheartening, even if there is a logical rationale. “It can still dampen people’s enthusiasm for participating in another RCA,” she says. “It is far better for leadership to be kept informed throughout the RCA project with the project leader meeting regularly with relevant leaders and sharing pertinent details, such as possible action plans to be recommended.” In this way, the potential for a rejection is minimized because the leader will have pushed the project leader toward something he or she will be more likely to approve, and away from something more likely to be rejected.
While it is great to understand the main reason why something occurs, there is often more than one thing at play. Finding out contributing factors can be difficult, though. One tool the paper says can be helpful is The Five Whys — also known as the Five Rules of Causation — which was developed by the Department of Veterans Affairs. They are:
- Clearly show the “cause and effect” relationship.
- Use specific and accurate descriptors for what occurred, rather than negative and vague words. Avoid negative descriptors such as: Poor; Inadequate; Wrong; Bad; Failed.
- Human errors must have a preceding cause.
- Violations of procedure are not root causes, but must have a preceding cause.
- Failure to act is only causal when there is a pre-existing duty to act.
Spath says that the five rules are useful for identifying the root causes of an event at the frontlines, as are other tools such as the events and causal factor chart, which is also included in the paper. “But these tools are inadequate for identifying the latent system failures that contributed to the sharp end failures,” she says. “Latent system failures are underlying aspects of the organization, such as the way of doing business, that set people up for mistakes. These failures are identified by asking, “Why are the root causes allowed to exist?” For instance, why does the organization not conduct training and emergency drills in the MRI unit? The answer to this question might be an inadequate system of accountability, complacency — “It won’t happen to us” — failure of adequate supervision, or something else. Just finding and fixing the frontline failures at the sharp end of the system won’t resolve the underlying latent system failures. Unresolved latent failures smolder in the background and contribute to other types of events in other areas. It is important to dig deeper and find the latent failures so leaders can design actions to resolve these types of failures in addition to resolving sharp end failures.”
The NPSF Guidelines on Root Cause Analysis brings into focus an important element missing from too many RCAs, Spath says, including the need for implementing strong actions and measuring the effectiveness of these actions. “Whether this focus necessitates renaming the investigation project to RCA2 is debatable — most RCA models already include these steps.” The specific recommendations in the report should be viewed as considerations, though, and not hard, fast rules requiring compliance says Spath.
Indeed, Spath thinks that some important elements are missing and some of the recommendations may not be appropriate for all organizations. “There is no one right way of finding and resolving the root causes of patient safety events; various techniques can be used to accomplish this goal and the NPSF paper does not mention many of these successful techniques.”
The entire report can be downloaded at http://bit.ly/1J1KZq6.
For more information on this topic, contact Patrice Spath, Brown Spath Associates, Forest Grove, OR. Email: email@example.com.