A12 (18): Adverse Events

Article

Root Cause Analysis: Learning from Adverse Safety Events

Speciality

Practice Management

Approved for THREE (3) Clinical Continuing Educational Units (CEU’s)

Background

An adverse event is one that results in unintended harm to the patient by an act of commission or omission, rather than by the underlying disease or condition of the patient.

Despite the best efforts of individuals and organizations to prevent harm in medicine, serious adverse events still take place.

Examples of adverse events include a patient slipping / falling while walking from the reception area to a consultation / procedure room, a missed imaging finding or an essential element of patient history (such as an allergy) being missed leading to inappropriate treatment.

When these occur, the first priority of health care providers is to ensure that the patient’s condition is managed appropriately. Despite the initial response, it is essential that health care professionals, both individually and as part of a team / organisation, learn from such events and make appropriate changes to decrease the likelihood that such events will recur.

Learning objectives include:

Root cause analysis is a widely accepted structured process for accomplishing this goal. 

  • Describing the steps involved in conducting RCA of an error.
  • Listing the tools that can be used during the RCA process.
  • Identifying who should be included on a debriefing team and what the ground rules are that will allow a debriefing meeting to be most effective.

Components of an RCA

Serious adverse events continue to occur in clinical practice, despite our best preventive efforts. It is essential to learn from such events and to decrease the likelihood that such events will recur. Root cause analysis (RCA) is a widely accepted structured process for accomplishing this goal.

Is a process to iden­tify factors that underlie variation in performance or that predispose an event toward undesired outcomes and allow for develop­ment of effective strategies to decrease the likelihood of similar adverse events occurring in the future.

An RCA process should be performed within the environment of a culture of safety, focusing on underlying system contributors and, in a confidential manner.

An RCA consists of three fundamental components:

  1. Consideration and identification of factors most directly associated with the adverse event
  2. Analysis and prioritization of these factors to plan the introduction of effective strategies to prevent them from recur­ring.
  3. Introduction, management, and, wherever possible, dissemination of effective countermeasures that are shown to have a beneficial effect.

Definitions:

(These definitions are key to some of the questions)

Adverse event: Event is one that results in unintended harm to the patient by an act of commission or omission, rather than by the underlying disease or condition of the patient. The term adverse does not imply whether the event may have been preventable.

Serious event: Event is one that results in death, loss of a body part, disability, or loss of bodily func­tion that lasts more than 7 days or is still present at the time of discharge from an inpatient health care facility.

Sentinel event:  Event is an unexpected occurrence that involves death, serious physical or psychologi­cal injury, or the risk thereof, meaning any process variation for which a recurrence would carry a substantial chance of a serious adverse outcome.

Active error: Active error is one that occurs at the level of the frontline operator, the effect of which is felt immediately or almost immediately.

Definitions:

(These definitions are key to some of the questions)

Near missEvent or situation that did not produce patient harm, but only because of intervening factors, such as patient health or timely intervention.

Mitigation:  An action or circumstance that prevents or moderates the progression of an incident that would result in severe harm to a patient. The focus is less on preventing errors, per se, and more on preventing harm from errors. Examples include implementation of a patient transfer mechanism, establishment of an educational program for venous access evaluation, and enforcement of structured reporting use.

Patient safety practice: Patient safety practice refers to discrete and clearly recognizable evidence-based processes or manners of providing care that reduce the likelihood of harm due to the systems, processes, or environments of care . An example is the introduction of checklists, which have been shown to reduce perioperative morbidity and mortality.

Managing the Acute Event

Suggested sequential steps in managing an adverse event are discussed below.

However, if an injury has occurred to a patient, all immediate attention must be focused on managing the patient’s condition and limiting the extent of injury.

1. Detect the problem:

The first step is to recognize or anticipate a potential problem and to have systems and processes in place for detecting such problems before or as soon as they occur.

Effective communication processes should be in place to make the appropriate people aware that something bad has happened, which then triggers an appropriate and timely response.

  • It is essential to have appropriately trained personnel at the work site
  • Computed tomography (CT) technologists who can recognize and manage a severe allergic reaction or contrast agent extravasation
  • X-ray technologists who can recognize and handle patients who may be at risk for falls
  • Magnetic resonance (MR) imaging technologists trained to implement protocol changes on the basis of a patient’s renal function and metal pacemaker or implant status.
  • All physicians working in an imaging environment should know how to manage a severe contrast agent reaction
  • How to minimize dose exposure
  • When and how to activate and initiate a code response.
  • All physicians who administer moderate sedation must be Advanced Cardiac Life Support certified and maintain current credentials and training in moderate sedation.
  • All staff are encouraged to continuously be on the lookout for nearmiss events and situations and to report these so that they can be addressed.

2. Manage the patient’s condition and protect patient

  • Ensure that any precipitating causes are removed
  • Manage all signs and symptoms
  • Only after the patient is clinically stable should additional steps be taken, such as securing relevant records and, when necessary, medications and equipment.

3. Report and disclose event

  • To the patient
  • When appropriate, to family members and the responsible caregivers
  • Appropriate regulatory groups
  • The hospital health care quality division
  • For some sentinel events, both state medi­cal boards and the Joint Commission require that the event be reported within a specified time period, usually within 24 hours.

4. Provide support to all involved

  • Do not underestimate the emotional effects a serious adverse event can have on staff members, who in many instances represent a “second victim”.
  • Staff may need to be excused temporarily from clinical service and be assured that the event will be thoroughly and fairly investigated.
  • Nevertheless, consequences should be enforced in the rare cases of reckless behavior, even in the absence of an adverse outcome.

Managing the intermediate event – short term

Convene a debriefing meeting

Organize a multidisciplinary team

This may take place several days after the initial event, depending on the circumstances and their effect on personnel.

Team members should include:

  • Participating and responsible staff involved in the event
  • Personnel who may be “upstream” and even “downstream” from the event.
  • Individuals who were closest to the event
  • Those critical to implementation of recommendations
  • A respected and credible leader
  • Individuals with diverse clinical knowledge bases.
  • However, the meeting should not include too many people, or it will lose its effectiveness.

Manage the patient’s condition and protect patient

The debriefing process:

  • Requires assembling all involved staff and gathering information from all involved parties through a facilitated review process.
  • Sequentially walking though the expected practice, path, and outcomes of the event, each step in the process can be documented and applied to a timeline. In this way, any practice deviations are defined more easily.
  • “What factors are responsible?” rather than “Who is responsible?” helps to steer the conversation in the right direction.
  • Helping to focus the discussion on what steps can be put in place to prevent future occurrence of a similar event can make the meetings more effec­tive.
  • Confidentiality of the reporting and RCA processes must be maintained at all times.
  • Maintaining a just culture is based on the willingness of all participants to share their observations, knowledge, and thoughts about actual and potential errors, which depends on an environment that is free from blame.
  • In an environment of blame, individuals tend to adopt a “code of silence” to protect themselves from shame, reprimand, termination, or even prosecution.

Define the precise series of event

  • Should be succinct, relevant, and objective narrative
  • Pertinent answers to the questions of “who, what, when, where, and how.”
  • Team should recognize the profound effect of hindsight bias which is inherent in any event investigation and prevents an individual from objectively evaluating his or her past performance.
  • When the outcome is known beforehand, individuals are primed to look for evidence that supports the inevitability of the outcome and to discount evidence that contradicts it.
  • Bias artificially narrows the review of the available data and may cause reviewers to miss alternative or wider explanations.
  • Individuals tend to focus on specific people involved in the incident, rather than on the underlying processes or circumstances that allowed the incident to happen.
  • Complete sentences and professional language should be used.
  • Narrative should de-identify the authors and all individuals involved in the event.
  • Narrative should be free from emotion or judgment.
  • Portray the incident from the position of the person involved
  • Members of the organization need to understand why it made sense for people to do what they did

Identify root cause solution

  • Once the contributors have been identified, the focus turns to identifying solutions to address the root causes.
  • To identify mitigation solutions and develop corrective actions, the contributing factors are measured, ana­lyzed, and prioritized.
  • Common tools applied at this stage include team brainstorming techniques and Pareto charts which are visual representa­tions and rankings of data collected from a cause-and-effect, or Ishikawa, diagram.

Classify the contributing causes

Delve more deeply into factors that support the processes.

It is often helpful to create a flowchart of the sequence and timeline of events that includes the actual sequence, what the ideal sequence would have been, and the policies and protocols related to each step in the process

Affinity Diagram — assesses the potential causes of the event.

  • Which processes were involved or may have contributed to the outcome?
  • What are the expected steps in the process, and were there any deviations from them?
  • What is currently done to prevent failure at each point and, if not done, why not?

Error Taxonomy — Classification of contributors to an adverse event

  • The cause is divided into system errors and human errors.
  • The Eindhoven classification – applies a systems approach to classi­fying errors.
  • All errors are dis­tinguished as
  • Active (human): attributed to behavior related to skills, rules, or knowledge.
  • Latent (systems and processes): process and system errors (technical or organizational) that enable human errors to occur.

Use of Appropriate RCA Tools: Once the event has been defined clearly, a structured RCA is performed to consider both human (active) and system or process (latent) contributing factors.

“five whys” approach

  • Root cause contributors can be identified along with the ante­cedent events, and potential mitigation or prevention strategies can be suggested on the basis of the answers.

Cause-and-effect (Ishikawa diagram)

  • Creation of a visual repre­sentation of the event, encouraging participants to consider contributors from several domains.
  • Categories for consideration are often equipment, processes, people involved and their expertise, materials, environment, and management or cultural contributors.

Causal tree mapping

  • Define a hierarchy that starts with discovery of the event.
  • It then moves to possible latent and active anteced­ent or predisposing occurrences, defining root causes for each,
  • and finally provides a classifica­tion of the root causes.

Implement specific changes and corrective actions

  • Consider which solutions can be implemented immediately
  • Consider which solutions will require change in management.
  • Corrective actions are based on specific identified root causes, which help identify real­istic and implementable action items.

Managing change – long term

Feed change ideas into quality improvement process

  • An important part of the challenge is determining which processes to change and how to change them.
  • Obvious and smaller solutions should be implemented immediately.
  • Solutions that involve more substantial change to the organization, such as changes in procedures, policies, techniques, or electronic systems, often cannot be implemented hastily.

Monitor changed process

  • If the organization cannot provide resources for system changes, this issue should explicitly be identified as system vulner­ability, and feasible safeguards should be put in place to mitigate potential errors.
  • The ultimate purpose of the RCA is to improve the safe opera­tions of the organization, if it is not translated into improve­ment, then the extensive effort invested in the RCA is effectively a waste of time.

Sharing lessons learnt:

  • Health care practitioners do not work in isolation.
  • Consequently, it is important that experiences be shared and that individuals learn from others without having to experience the same adverse events.

Conclusion:

In conclusion, when an adverse event occurs, it is essential to perform an RCA to identify all possible contributors. Tools that can be used to perform the analysis include a timeline, the “five whys” approach for determining causation, cause-and-effect diagrams, causal tree mapping, affinity diagrams, and Pareto charts. On the basis of this analysis, strategies should be implemented to mitigate the future occurrence of similar adverse events.

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