1. INTRODUCTION:

Root cause analysis (RCA) is a structured method used to analyze serious adverse events. Initially developed to analyze industrial accidents, RCA is nowwidely deployed as an error analysis tool in health care. A central tenet of RCA is to identify underlying problems that increase the likelihood of errors while avoiding the trap of focusing on mistakes by individuals. RCA thus uses the systems approach to identify both active errors (errors occurring at the point of interface between humans and a complex system) and latent errors (the hidden problems within health care systems that contribute to adverse events). It is one of the most widely used retrospective methods for detecting safety hazards.

RCAs should generally follow a prespecified protocol that begins with data collection and reconstruction of the event in question through record review and participant interviews. A multidisciplinary team should then analyze the sequence of events leading to the error.

2. MEANING:

Root Cause Analysis (RCA) has been applied to the healthcare industry and has been found to be a highly effective tool to improve patient care and reduce healthcare costs from adverse events. RCA is a systematic and comprehensive methodology to identify the gaps in hospitals systems and processes of care that may not be immediately apparent and which may have contributed to the occurrence of the incident or near miss.

3. GOAL:

The goal of RCA is to find out ‘What happened? how the event occurred (through identification of active errors) and why the event occurred (through systematic identification and analysis of latent errors) What can be done to prevent it from happening again?’ The ultimate goal of RCA, of course, is to prevent future harm by eliminating the latent errors that so often underlie adverse events.

4. OBJECTIVES:

· To establish the facts i.e. what happened (effect), to whom, when, where, how and why?

· To establish whether failings occurred in care or treatment

· To look for improvements rather than to apportion blame

· To establish how recurrence may be reduced or eliminated

· To formulate recommendations and an action plan

· To provide a report and record of the investigation process & outcome

· To identify routes and provide a means of sharing learning from the incident

5. PURPOSE:

The RCA process is a critical feature of any safety management system because it enables answers to be found to the questions posed by high risk, high impact events—notably, what happened, why it occurred, and what can be done to prevent it from happening again.

It is believed that the frequency of clinical incidents is likely to be reduced by examining the settings in which they occur, and identifying system changes required, which may reduce the likelihood of similar occurrences in the future.

This approach focuses on the organisation of health care, rather than the assignment of individual blame, and is therefore likely to promote a serious approach to error reduction at the health service level and is in keeping with the principles of accountability.

6. CHARACTERISTICS:

· The review is interdisciplinary in nature with involvement of those closest to the process.

· The review should be undertaken by a small team (3- 5) who are familiar with the area in which the incident occurred but not involved in the incident.

· The analysis focuses primarily on systems and processes rather than individual performance

· The analysis identifies changes that could be made in systems and processes through either redesign or development of new processes or systems that would improve performance and reduce the risk of event or close call recurrence.

7. EVENTS MANDATING RCA:

The National quality forum (NQF) revised, most recently in 2011, and now consists of 29 events grouped into 6 categories:

· Surgical events (e.g., wrong-site surgery).

· Device events (e.g., air embolism).

· Care management events (e.g., death or disability due to medication errors).

· Patient protection events (e.g., patient suicide)

· Environmental events (e.g., fires).

· Radiologic events (death or significant injury of a patient associated with introduction of metallic object into the MRI area).

· Criminal events (eg., abduction of a patient, sexual abuse, death or significant injury of a patient or staff member resulting from physical assault).

Since the development and dissemination of this list, many states have mandated that health care facilities report all instances of these events. When such an event occurs, many institutions mandate performance of a root cause analysis.

8. STEPS:

Step One:

Construct a simple flowchart of the event.

Work out what you know and what you don’t know – ask ‘what, how and why?’

Any unanswered questions will form the basis of the questions that need to be asked and the information that team members need to collect. Gather as much information as possible about the event from a variety of sources (eg. Interview those involved and witnesses, review documentation) to determine the facts.

Who/what was involved?

Where/when did the incident happen?

What was the incident?

How did it happen?

Step Two:

Construct a detailed flowchart of events and identify where processes broke down (i.e. if an intervention was made at that point the sentinel event may not have occurred).

Construct a cause and effect diagram to identify the root causes. Analyse the factual information to determine the contributing factors and causes. There will always be a number of issues contributing to any event. Investigators should consider the following factors:

· Patient factors.

· Communication factors;

· Knowledge, skills and competence;

· Work environment and scheduling;

· Equipment factors;

· Policies, procedures and guidelines; and

· Safety mechanisms.

Step Three:

Make recommendations based on the contributing factors aimed at minimising the occurrence of similar incidents in the future. Recommendations must be feasible and within management’s control to fix. Investigators should ensure that each recommendation identifies the individual(s) who will be accountable for the implementation and ongoing monitoring of recommendations. The Area Chief Executive has ultimate responsibility for ensuring the recommendations are auctioned. Develop a report containing the contributing factors and the recommendations.

9. TECHNIQUES OF ROOTCAUSE ANALYSIS:

A root cause analysis should be performed as soon as possible after the error or variance occurs. Otherwise, important details may be missed. All of the personnel involved in the error must be involved in the analysis. Without all parties present, the discussion may lead to fictionalization or speculation that will dilute the facts. Asking for this level of involvement may cause staff to feel hostile, defensive, or apprehensive. Managers must explain that the purpose of the root cause analysis process is to focus on the setting of the error and the systems involved. Managers should also stress that the purpose of the analysis is not to assign blame. The comfort level with the technique increases with use, but the analysis will always be somewhat subjective. The most common techniques used are casual tree, decision table

9.1. CASUAL TREE:

In a causal tree, the worst thing that happened or almost happened is placed at the top. In near-miss situations, a recovery or prevention side is added to capture how an error was prevented. This step is important in identifying the safety nets that exist, such as a person or piece of equipment that checks processes. Having a written record of these safety nets can be important if the department is reorganized or the budget is cut. Proven safety measures should not be eliminated.

If the error did occur, the causal tree does not have a prevention or recovery side, as the event happened and was not prevented. In either the near-miss scenario or the full-blown event scenario, the team's next step is to provide the causes for the top event, followed by the causes for those secondary causes, and continuing on until the endpoints are reached. These endpoints are the root causes. The team may identify several root causes and will need to select the most important 2 or 3 for focused prevention efforts and possible corrective action.

9.2. DECISION TABLE:

The team can go one step further and use a decision table to determine how best to respond to the root causes that were uncovered. Use of this tool helps prevent the knee-jerk reaction: the memo or procedure change resulting from each error, regardless of its severity. Often, when errors occur, the only thing required is to monitor for reoccurrence. The decision table considers the severity levels of events: whether the event was potentially life threatening or involved a serious injury, had potential for minimal harm or temporary injury, or had no realistic potential for harm. The table also considers the probability of recurrence and the detectability of the event. For example, in a transfusion service, the key detectability issue is whether the error was detected prior to “release to the patient.” If the error is caught within the transfusion service, then the danger to the patient is lessened. However, if the error passes through the system and is released to the patient, the chance that the error will result in harm is increased. If the error progresses to “given to the patient,” then the error is full blown and has progressed to an undesirable endpoint.