How to investigate and analyse clinical incidents: Clinical Risk Unit and Association of Litigation and Risk Management protocolBMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7237.777 (Published 18 March 2000) Cite this as: BMJ 2000;320:777
- Details of investigation process
Which incidents should be investigated?
Only a minority of incidents will need to be analysed in detail in clinical practice. In-depth analysis of a small number of incidents will bring greater dividends than a cursory examination of a large numbers of incidents. Broadly speaking, the incident will either be investigated because of its seriousness for the patient, and perhaps for the organisation, or because of its potential for learning about the functioning of the department or organisation. There is much to be said for investigating a "near miss" or a well handled incident, as these are less emotive and not generally open to external scrutiny. Such incidents may be just as fruitful in terms of "organisational learning."
Reviewing case records
Accounts of the incident may be taken from statements made by staff members, case notes, or interviews with staff. The analysis may be limited if only written statements and notes are considered since it may not be possible to explore the full range of conditions that allowed the event to occur. The protocol incorporates analyses from both interviews and records and assumes that much important material can be gained only from interviews.
The first task, from the information immediately available, is to record the initial summary of the event and identify the most obvious care management problems. In some instances there may only be one, but nearly always several problems conspire to create the event. The investigator should then make an initial summary of the principal events (an outline chronology), as recorded in the notes, before starting the interviews. The investigator then lists the key staff involved and decides who should be interviewed and in what order to see them.
Framing the problem
The investigator's next task is to decide which section of the process of care to examine. This is not always straightforward. It depends on when and where the problems first arose, something which may become apparent only during the investigation. For instance, a haemorrhage may have been badly managed leading ultimately to the patient’s death two weeks later. The chronology may summarise three weeks of care, most of which may be of high standard. However, the analysis will concentrate on those aspects where problems were apparent—for example, in the preparation for surgery, conduct of the surgery, and postoperative monitoring—in order that appropriate lessons may be learnt.
The interviews, analysis, and final report all follow the format outlined above and rest on the same conceptual foundations. The purpose of the interview is simply to find out what happened, and this should be explained at the outset. The style adopted should be supportive and understanding, not judgmental or confrontational. It is important to stress that the investigation is separate from disciplinary procedures. There are several distinct phases to the interview, and it will generally be more effective to move through these phases in order. Each interview should take 30-35 minutes. Ideally two interviewers are used, one leading the interview and the other taking notes and asking supplementary questions.
What happened?—establishing the chronology and outcome
First the investigator should establish the role of the member of staff in relation to the incident as a whole and record the limits of their involvement. The investigator then establishes the chronology of events as the member of staff saw them. The information is recorded and compared with what is known of the overall sequence.
How did it happen?—identifying the care management problems
In the second phase, the investigator should first explain the concept of a care management problem. The member of staff is then asked to identify the main care management problems as he or she sees them, without consideration of whether anyone is or is not to blame. Identify all important acts or omissions made by staff or other breakdowns in the clinical process that were (with hindsight) important points in the chain of events leading to the adverse outcome. Look for points in the sequence of events when care went outside acceptable limits.
Why did it happen?—identifying the contributory factors
In the third phase, the investigator goes back and asks separately about each of the care management problems that the member of staff may have information about or experience of. Questions should cover contributory factors at all levels of the framework (table 1[t1]). Each care management problem may be associated with several factors at different levels of the framework. Although the framework has higher level organisational factors at the top, it may be more natural in clinical terms to begin by asking about patient factors, then moving up the table through task factors, individual, team, and so on. The full protocol contains a much more detailed framework of factors that may be helpful at this stage when formulating questions.
Distinguishing specific and general contributory factors
When a member of staff identifies a clearly important contributory factor the investigator should be sure to ask a follow up question: was this factor specific to this occasion or would you regard this as a more general problem on the unit? The prevention of future incidents relies on identifying general, systemic problems rather than isolated difficulties that are unlikely to recur.
Analysis of case
The core of the analysis is to ask: what happened? how did it happen? why did it happen? what can we learn from this? and what changes should we make, if any? Here again the task is simply to follow the basic format, drawing together the material from the case records, interviews, and the investigator’s observations.
The first step in the analysis is simply to produce an agreed chronology of events, identifying any important areas of disagreement between accounts or between the case notes and the memories of the staff. The next stage is to identify the key care management problems. These may be provided by the staff or from the investigator’s clinical knowledge and expertise. The investigator should look back over the list and ensure that all the care management problems are specific actions or omissions on the part of staff, rather than more general observations on the quality of care, which should be recorded elsewhere. It is easy to note down "poor teamwork" as a care management problem, which may be a correct description of the team but should properly be recorded elsewhere as a contributory factor.
The next step is to attempt to specify the conditions associated with each care management problem using the framework as a guide and as a way of reflecting on the many factors that may affect the clinical process. Interviews with staff will already have provided lists of both specific and general contributory factors. When these conflict it may be necessary for the investigator to judge the most important causes of the events.
A separate analysis should be carried out for each care management problem, although the depth and detail of the contributory factors identified may vary. It is important to clearly distinguish specific contributory factors, which describe the reasons for the care management problem on that occasion, from general contributory factors, which the investigator judges to be more longstanding features of the individual, team, or working conditions. Factors that are specific to that occasion probably have no long term implications for the quality and safety of practice and usually do not require action or changes of any kind. The final list of general contributory factors for each care management problem is examined, and those that have implications for action are identified.
If the protocol is followed systematically and the interview and analysis conducted thoroughly, the report and implications of the incident should emerge from the analysis in a relatively straightforward fashion. When the composite is complete, there should be a clear summary of the problem and the circumstances which led up to it, and the flaws in the care process should be readily apparent. The final section of the report will consider what implications the incident has for the department or organisation and will make recommendations for remedial actions.
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