Outline

Learning from experience is a core part of any risk management strategy. All NHS Trusts have untoward incident policies that call for the detailed investigation of the more serious events with the primary aim of ensuring that improvements can be made to prevent or limit the chances of a recurrence. The investigation itself will only be of benefit if it results in improvements on the ground that have a positive effect.

I offer a personal view of how an investigation needs to be undertaken in order to achieve the maximum benefit from what is a large investment in time and resource. I am not a clinician or manager within the NHS but I hope that my thoughts will assist those who undertake these investigations in practice.

Terms of reference

It is vital to work out what you are hoping to achieve by way of investigation. Are you simply looking at an isolated incident or are you looking at the wider circumstances? For example, are you investigating an error in drug administration on Ward X or drug administration within the Directorate or even within the Hospital? It is important not to be over ambitious, but at the same time it is important that you are not hindered by looking at local procedures that will have no relevance elsewhere in the organisation. Spending time scoping out the scale of the problem, perhaps by investigating whether there have been other similar incidents or near misses in the past in other areas of the organisation, will help you decide whether there are wider ramifications that need to be looked at.

Once you have scoped out what you are going to look at, you need to select the right person or persons to undertake the investigation. Within any healthcare setting a certain amount of knowledge can be helpful but it is not vital that the investigator is an expert in the area in question. Often someone who has some distance from the participants will be able to stand back and be a little more analytical of the problem and less prone to influence from any of the parallel agendas that may be pursued by the staff involved.

The investigators will need to have a clear mind as to the potential audience of the report. Any serious incident may well have external ramifications for the organisation. The documents produced may well be disclosed to external bodies such as the Healthcare Commission and SHA, as well as patients relatives and their legal advisors. In more serious cases, Professional bodies such as the NMC and GMC, and even the Coroner and the Police may have an interest in the report and its conclusions. Any documents produced may also need to be disclosed following Freedom of Information requests.

The report can be an extremely powerful document that can have positive and negative consequences for the organisation and individuals involved in the incident. Whilst I would in no way suggest that an investigation be sullied by attempts to achieve another purpose, I would encourage authors to look at and record the positive aspects of a case. Whilst things may have gone wrong I am sure that in every case some things have gone right. It is just as important to document those aspects of the system that worked as they were supposed to as it is to unpick those that did not. The spin off benefit is that it will alert external investigators to the good as well as the bad and mitigate some of their own concerns.

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Choose methodology

There are many different techniques for investigating the causes behind a particular incident. NHS Trusts are likely to have already chosen their preferred method and root cause analysis is by far the most common. Whatever methodology is used it is vital that the investigators have undergone training in the techniques and understand what it is they are doing.

There are limitations to any methodology and investigators should always remember to stand back and make sure that the terms of reference are being met. A heavy dollop of common sense usually helps.

One of the apparent weaknesses in root cause analysis based investigations is that they can often dilute the magnitude of individual failings closely related in time and place to the incident. The desire to foster the no blame culture and to keep looking deeper into underlying systemic causes can often result in serious problems being overlooked or given less importance. If an individual has made a significant error, yes it is important that the underlying organisation factors underlying that error are looked at, but that should not ignore the fact completely. If there is a real issue as to the competence of an individual it needs dealing with just as surely as any underlying root cause, perhaps more so. Organisational or cultural issues that contributed to that individual error are clearly mitigating features but any issue of competency or training also needs to be dealt with.

There will undoubtedly be cases where an individual action is so culpable that a disciplinary investigation is warranted. It would be a disservice to patients throughout the NHS if the desire to foster a no blame culture meant that unsafe practitioners were not brought up to standard before another incident arose. Any competency investigation should be carried out separately to the SUI investigation although much of the information may, in certain circumstances, be shared.

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Evidence

The investigators will need to gather all types of evidence and then consider what weight to attach to it before reaching any conclusions. Any conclusions reached should be based upon evidence they have gathered during their investigation but it will be a matter for themselves to determine what the facts of the incident are on the basis of their own analysis.

There will undoubtedly be conflicts in the evidence and it would be very suspicious if there was absolutely no deviation in accounts. The investigators may have to resolve some of those conflicts but, having regard to the terms of reference they may not need to deal with all of them. Where the objective is to improve performance, it may be that no definitive conclusion needs to be reached and the outcomes can be based on several different factual matrix. Make sure that you don’t give too much weight to rumour and speculation.

Investigators should also be on their guard for bias in their own evaluations. When carrying out an investigation within your own organisation it can be very easy to have your own fixed views on certain individuals or areas and it is important that they are minimised as far as possible.

When undertaking interviews with staff ensure that you use open questions to allow them to tell the story. Allow pauses and listen for facts, feelings and agendas. Try to remain open on what you have been told and consider holding off any direct challenges to what is being said until you have gathered all the evidence. Try not to appear judgmental or jump in with challenging questions. Don’t assume anything or ignore the feelings of the interviewee. You will inevitably have to listen to what is being said and react accordingly – don’t blindly use checklists of questions that you have prepared in advance.

Don’t forget that patients themselves and their relatives may also have information that would assist your investigation.

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Analysis

Once you have completed your first pass of evidence gathering you will need to start making some sense of it. A helpful first step is to put together a chronology using the medical records as well as the oral testimony of the staff. This can be a useful way of testing out the accuracy of people’s recollections regarding the timing and sequence of events and it will help identify any major gaps. Be wary of shorthand in the notes. Check that it means what you think it means and consider what is not said as well as what is. Where there is conflict, consider grading the evidence to see which is likely to be the most accurate. Has it come from the actual member of staff who undertook a particular task, from someone who saw them, or via another source? Are there ways of verifying a particular piece of evidence through switchboard records, CCTV video, or test results? Of course many incidents will not have any major conflict at all.

It is important to make sure that your conclusions are supported by the evidence that you have collected. Whilst you are of course undertaking the investigation because there had been an incident, do make sure that you are positive and that you refer to the evidence of good practice as well as failures. Much damage can be done to morale by only picking out what went wrong. It will also help in external forums to set out the control measures that were in place to minimise the apparent gap between what was being done and what is now necessary.

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Risk assessment

An investigation into a serious untoward incident in a clinical setting is the perfect opportunity to undertake a risk assessment of the whole procedure or system being operated at the time. It will enable any recommendations to be based upon a proactive assessment of the risks that may arise; done with the clear knowledge of why any control measures in place failed. If that was not enough reason, the fact that the failure to have conducted any risk assessments is itself a criminal offence and that a failure to review it in light of the incident may be a further offence, should give further motivation.

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Recommendations

It is clearly necessary for recommendations to be made after an investigation. But try not to be too ambitious and remember to keep any recommendations specific and achievable. 34 recommendations, many of which requiring further ‘reviews’ themselves will struggle to actually be implemented.

Don’t be shy to seek help to make sense of all the information that you have. It will be obvious in some cases that specialist knowledge is required but in others it may not be quite so clear cut. On several occasions I have attended Inquests where evidence is required on the changes made to the systems in place. An investigation has identified an apparent cause or causes and a raft of recommendations were made and accepted by the Trust Board, eager to minimise adverse publicity. Unfortunately many of the recommendations themselves were simply not supported by the relevant staff and some even went against latest thinking. At that point it can be very difficult to explain away why recommendations were not actioned without it appearing that the report was simply not taken seriously.

One excellent way of getting the input of a number of experts is to consult the staff before the final report is published. This is an excellent opportunity to get buy-in to the conclusions and ensure that any changes are actually going to be implemented.

Regulation 3(3) of the Management of Health and Safety at Work Regulations 1999 - Any assessment shall be reviewed by if there is reason to suspect that it is no longer valid or there has been a significant change in the matters to which it relates.

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Action plan

Whatever the particular recommendations being made, a suggested action plan can be helpful. Not only will this minimise the risk of nothing actually happening as a result of the report, but it also acts as a further test of the practicality of the recommendations. If it is not immediately obvious what needs to be done and the timescales involved then it may be worth rethinking whether the recommendation is actually specific enough.

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Monitor and review

The most important step of all is to ensure that all systems and procedures, especially those subject to recent change, are monitored and reviewed appropriately. Any risk management strategy should ensure that those systems that have recently failed, causing harm or injury, are at the top of the list for close attention. New systems of work will be untried and unfamiliar to staff and it may take some time to ensure that the changes made are the right ones. It would be a shame if the need for them to be changed arose as a result of a new incident.

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