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New Guidelines for Investigating Medical Errors

Experts aim to improve root-cause analyses and actions to prevent harm

In addition to understanding why a medical error occurred, health care organizations must take action through its root cause analysis (RCA) process to keep it from happening again, according to new guidelines released this week by the National Patient Safety Foundation (NPSF). In fact, the NPSF has come up with a new name for “RCA.”

“We’ve renamed the process RCA2 –– RCA squared –– with the second 'A' meaning action, because unless real actions are taken to improve things, the RCA effort is essentially a waste of everyone’s time,” said the guideline panel’s co-chair, James P. Bagian, MD. “A big goal of this project is to help RCA teams learn to identify and implement sustainable, systems-based actions to improve the safety of care.”

The new recommendations include the active involvement of leadership, such as the CEO and board of directors, in the RCA2 process. The guidelines urge leaders to:

  • Approve the investigation process.
  • Approve and periodically review the status of actions that result.
  • Understand what a thorough RCA2 report should include and act when reviews do not meet those requirements.
  • Review the RCA2 process for effectiveness at least once a year.

The guidelines further recommend that:

  • An RCA2 review should be started within 72 hours of recognizing that a review is needed.
  • RCA2 teams should be composed of four to six people. The team should include pro­cess experts as well as other individuals drawn from all levels of the organization, and the inclusion of a patient representative unrelated to the event should be consid­ered. Team membership should not include individuals who were involved in the event or close call that is being reviewed, but those individuals should be interviewed for information.
  • Time should be provided during the normal work shift for staff to serve on an RCA2 team, including attending meetings, researching, and conducting interviews.
  • RCA2 tools –– such as interviewing techniques, flow diagramming, cause-and-effect dia­gramming, the five rules of causation, an action hierarchy, and process/outcome measures –– should be used by teams to assist in the investigation process and in the identification of corrective actions.
  • Feedback should be provided to staff involved in the event as well as to patients and/or their family members regarding the findings of the RCA2 process.

RCA is commonly conducted after harm occurs. The new NPSF guidelines emphasize the need to prioritize hazards based on the risk they pose, even if harm has not occurred. Prioritizing hazards according to risk is consistent with the practice of other high-reliability industries, such as aviation, the group says.

The NPSF will discuss its new guidelines during an open webcast scheduled for July 15.

Sources: FierceHealthcare; June 18, 2015; NPSF; June 16, 2015; and RCA2; June 16, 2015.

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