Written Evidence submitted by Action against Medical Accidents (CCF0023)
Introduction
Action against Medical Accidents (AvMA) is the UK charity for patient safety and justice. For over thirty years AvMA has championed the need to improve patient safety and the way patients and families are dealt with following a medical accident (patient safety incident). AvMA campaigned for and took an active role as a core participant in the Mid Staffordshire Public Inquiry. Most of AvMA’s suggestions were taken up in some form by Sir Robert Francis QC, including the statutory Duty of Candour, which AvMA had led the campaign for over two decades. AvMA’s priorities are informed by the daily contact we have with people who have been affected by patient safety incidents through our specialist helpline and casework service, including support for families at healthcare related inquests. We provide help and support to over 3,000 people a year. We also work in partnership with health professionals, the NHS, government departments, statutory and patients’ organisations for a safer and fairer health service.
Below, we address the questions you asked us to in your call for evidence. We would be happy to meet with members of the committee and / or secretariat or give verbal evidence if that would be helpful.
2.1 Our experience is that the NHS’s current approach to investigating untoward medical incidents / patient safety incidents is very inconsistent and often of unsatisfactory quality. We believe that the biggest reason for this is the lack of sufficient expertise and experience in conducting complex investigations available to NHS organisations. There are also circumstances when it is difficult to conduct an investigation objectively and effectively because of the seriousness of the issues. There is a danger in these circumstances of either deliberate or unintended defensiveness. Another common problem is the failure to engage fully with patients or patients families who have been affected by an incident from the outset. Whilst we also see some good practice, we have seen a number of examples where an investigation has been completed without the patient/family having known that an investigation was taking place, let alone having a meaningful opportunity to frame the terms of reference, provide evidence and contribute to the investigation itself in other ways. More common is for the communication with patients/families to be superficial.
2.2 Then proper involvement of patients/families from the beginning of an investigation not only improves the transparency and hence public confidence in the process, but is vital to avoid investigations going off on the wrong track and adding rigour and objectivity to the process. However, consideration also needs to be given to how patients can be supported to be more equal partners in what can be an unfamiliar and intimidating process. They should be provided with access to sources of independent specialist advice and support. By “specialist” we mean more than general advice and help to ‘navigate’ the NHS complaints procedure. In our experience, patients/families need help with understanding the clinical issues, and the legal or regulatory context and implications of the different investigations in order to play a meaningful role in them.
2.3 The committee will be aware that NHS England has been reviewing its Serious Incident Framework, which we understand is due to be published shortly. We believe that the draft version which we were consulted on is a big improvement on the last one, in that it stresses the need for patients/families to be involved meaningfully from the outset and also the need for independent investigations to be arranged in certain circumstances. Also, since November 2014 there has been a statutory requirement for NHS organisations to inform patients/their families when there has been an incident that is suspected to have caused or may lead to harm (the Duty of Candour). This should if properly implemented, prevent incident investigations from being kept from patients and give them more opportunity to be involved. We believe there needs to be a large investment in awareness raising, training and support to realise the full potential of this initiative.
3.1 In theory, lessons from incident investigations are shared within the organisation, and also regionally (via regional offices of NHS England) and nationally (to NHS England and also the Care Quality Commission (CQC), who should be notified about any serious incident that causes harm). CQC can use such information for its monitoring and regulation role. NHS England can use this information (and information it receives through the National Reporting and Learning System) to help identify risks and prioritise areas for risk reduction. The patient safety division of NHS England can then work on ‘solutions’ or risk reduction with the relevant experts and issue Patient Safety Alerts.
3.2 We say “in theory” because as mentioned above, NHS organisations often lack staff with sufficient expertise to conduct good investigations and because there is inconsistency about the sharing of investigations and their lessons. In addition, even when there has been a good investigation with sound conclusions and learning points or recommendations, there is the risk that organisations do not systematically implement the learning. There is inadequate external scrutiny to monitor organisations and ensure that they are actually implementing recommendations or, in the case of Patient Safety Alerts, even mandatory instructions. AvMA’s research into the implementation of patient safety alerts for example has found many examples of NHS organisations who have failed to implement Patient Safety Alerts, with no regulatory action resulting.
3.3 Having said that, the current arrangements do have the potential to work well, provided that the quality and consistency of investigations are improved, the organisations have a learning culture, and the regulators actively monitor investigation reports and the implementation of recommendations and Patient Safety Alerts and take action if it is not happening. Some organisations already demonstrate good practice in these areas, but the challenge is to bring all organisations up to the same level.
3.4 There also needs to be more support to underpin learning for patient safety purposes. We do not think that the patient safety division of NHS England is an adequate replacement for the National Patient Safety Agency (NPSA) which was abolished as a result of the recent reforms. The NPSA had the advantage of being solely focused on patient safety. We would like to see the core functions of the NPSA explicitly recreated in a more powerful and distinct form than currently. This would be a massive resource to support this work.
3.5 We also believe there should be agreed standards and qualifications expected of staff conducting either incident or complaints investigations. This should be reflected in the seniority / pay-grade of staff with responsibility for investigating incidents or complaints and access to relevant training, including patient expert-led training. All too often these staff are undervalued given the seriousness and complexity of their role.
4.1 We strongly agree that the NHS needs more independent investigations of serious incidents and that the development of central expertise in incident investigations could be a great help to the NHS. This was the main thrust of our submission to the NHS England regarding their draft Serious Incident Framework. However, we believe that there are a number of issues that need to be considered carefully before we could support “a single clinical accident investigation branch of the Department of Health”.
4.2 We agree that in certain circumstances it would be extremely beneficial for incidents to be investigated independently rather than by the organisation which experienced the incident itself, or organisations that are too close to it. Some form of specialist central resource would be extremely helpful in that regard. However, care would need to be taken to ensure that in so doing local NHS organisations are not inadvertently disempowered in the art of incident investigation. In many cases the ideal situation is for the organisation itself to investigate provided it has the staff with the skills to do so competently and that it is carried out honestly. There should be more ownership of the findings of investigations that are carried out in this way.
4.3 It should be noted that the NHS has many more serious incidents than arise in some of the other industries it is compared with. A central investigation agency would have to be huge if it were to independently investigate every serious incident. Careful consideration therefore needs to be given to the criteria to be used to determine when the central agency should investigate.
4.4 There is also the question of whether a wholly new investigation agency should be created or if not, where this function would be best placed. We are not convinced that a branch of the Department of Health is necessarily the best option. A branch of NHS England is another option, though possibly not sufficiently distant from healthcare providers and commissioners. The CQC is another option, if the function is to be hosted in an existing organisation. There is a danger of confusion of roles and duplication of effort if too many different agencies have a role in investigating incidents. The committee will be aware that the Clwyd/Hart review of complaints last year did not favour the creation of a completely new agency.
4.5 Wherever the central resource were to be located, we think it could both conduct some investigations independently according to agreed criteria, and act as a resource to support organisations conducting ‘local’ investigations. Something that would be particularly useful is if it could maintain a list of clinicians suitably qualified and experienced to take part in incident investigations.
4.6 It should be borne in mind that investigating a complaint is quite different from investigating a patient safety incident, although both may be prompted by the same incident and there may be considerable overlap. We strongly believe that one should not take precedence over the other. If incidents are investigated thoroughly and well, they may obviate the need for a complaint, or at least make the complaint investigation easier.
4.7 If a central incident investigation resource is created then it may help local investigations by being able to recommend independent clinicians to provide input from a list it would build and maintain.
5.1 We have considerable experience of dealing with complaints to the PHSO over the years. However, we do not claim any great expertise in the PHSO’s current capacity to manage and investigate complaints, other than our knowledge that formally, the PHSO is now investigating many more complaints than it used to. We do worry that the quality of investigation, especially of complex clinical complaints, may be suffering as a result of prioritising greater volume. There is also reason to suspect that the PHSO is under pressure to turn down complaints for investigation on spurious grounds because of the pressure it is under. In our submission to the Public Administration Select Committee in December 2012 pointed to a number of problems we were experiencing with the PHSO, most of which still pertain today. In particular, we remain concerned that the PHSO is still wrongly turning down complaints for investigation where there is a potential or ongoing clinical negligence claim. The PHSO’s legislation does not require them to do this, as a negligence claim can not provide the substantive remedies that the complaint can. There has been a conscious policy at the PHSO of interpreting its legislation very selectively so has to be able to bat some of these complaints away. This is particularly ironic as the PHSO represents the final stage of the NHS Complaints procedure and the Department of Health has made clear that potential or actual clinical negligence claims should in no way limit or delay patients’ access to the NHS complaints procedure. Not only is this practice an injustice to the complainant, but it also forces people down the litigation route when they may not have wanted to take it, and it means that investigation of the most serious complaints about patient safety are denied an investigation or investigation is severely delayed.
5.2 Accessing appropriate medical expert opinions in clinical complaints is vital, but there is a limited supply of clinicians willing and able to provide such assistance. We believe that it is vital that the PHSO is able to investigate clinical complaints where there is evidence that the investigation of the incident earlier in the process or the clinical advice obtained in connection with it may have been flawed. Obviously, the better that NHS organisations (or the new independent service, if there is one) become at investigating incidents and complaints, the less likelihood there is that the complaint reaches this stage of the NHS complaints procedure and requires investigation by the PHSO.
5.3 We do think that there should be more transparency in the process that the PHSO uses in obtaining clinical advice/input into its investigations. At present complainants are not told who the clinician or medical expert is. There is no way of verifying the expert’s credentials, the complainant putting their own questions to or challenging the expert. Medical experts can get things wrong as easily as anyone else and in AvMA’s experience, medical expert opinion can often vary about the same incident. It is wrong therefore that a complaint to the PHSO can stand or fall purely of the opinion of one expert, when the complainant has no say in who the expert should be, who they were, or what questions or evidence is put to them. The principle of fully involving the patient/complainant should apply equally to the PHSO as to other incident and complaints investigations.
6.1 We have insufficient knowledge to be able to answer this question.
7. How any such body within the healthcare sector would support the work of PHSO?
7.1 We believe that the PHSO should remain focused on its role in investigating complaints. We can see the PHSO benefitting from the work of such a body in two main ways. Firstly, the better local and national incident investigations become, the less call should be made on the PHSO, which is the final stage in the complaints procedure. Secondly, if the new service / agency built a suitable pool of suitable medical experts prepared to help with investigations this would be a valuable resource for the PHSO.
8.1 Failure to address clinical incidents or complaints properly results in lost opportunities about what is going wrong and learning lessons to improve patient safety in the NHS. This results in untold human misery as well as millions of pounds financially every year. Such failure is also deeply damaging to individual and public confidence in the NHS and makes people more likely to litigate than they otherwise would be.
8.2 We strongly disagree with the Vincent & Macrae article in relation to their view that incident investigations should be legally privileged/protected. This would be deeply unfair and would damage public confidence in the NHS. Patients or their families have a right to know the facts about what happened in incidents which have affected them and why. The Government have just re-enforced this by bringing in a statutory Duty of Candour. It would be wrong to say on the one hand you are entitled to the information but you are not allowed to do anything with it. It has always been accepted policy that if people have been harmed as a result of negligence, then they should be entitled to compensation. If this information were to be privileged then that creates another huge obstacle for injured patients a to access justice.
8.3 We think it is imperative that the current policy of the PHSO to avoid investigating some complaints if there is a potential or current clinical negligence claim should be changed. It is at odds with the rest of the NHS complaints procedure, where it is made clear that such claims or potential claims should not affect patients’ rights to have complaints investigated. There is no justification for the PHSO insisting would-be complainants pursue legal claims before considering their complaint, as the redress they are seeking from their complaint can not be delivered through a claim which deals only with compensation. The PHSO’s existing legislation does not preclude it from investigating in these circumstances.
8.4 We believe the time may now be right to reconsider a scheme such as that which is allowed for under the NHS Redress Act as an alternative to litigation, where patients have been injured as a result of negligence.
8.5 Whilst we agree that investigations should not seek to scapegoat anyone or apportion blame inappropriately, we would recommend avoiding notions of a so-called ‘no-blame’ approach. It is now widely accepted that accountability of organisations and where appropriate individuals is sometimes needed. The ‘decision tree’ developed by the NPSA remains a useful resource in explaining when different approaches are appropriate.
8.6 Please see our comments under section 5.1 above concerning the PHSO’s inappropriate turning down of complaint investigations where there may be a clinical negligence claim. Ironically this forces some people down the litigation route when they may not have wanted it.
January 2015