When discussing patient safety and law initiatives it is always useful to ask what the rationale is or the driving force behind them. This provides much needed clarity, context, focus – and will help with implementation and discussion. It could well be that some initiatives are designed primarily to reduce or head off litigation and complaints.
Conversely, the aims may be much broader, designed to improve healthcare quality, patient outcomes, satisfaction and so on. In practice, there will often be several declared aims and outcomes. Avoiding clinical negligence litigation and complaints can often be one of them. Aims can be expressed formally in reports or implied.
A patient safety mindset
This discussion raises the issue of what is primarily driving the development of an NHS patient safety culture and how these aims could be seen negatively by nurses, doctors and other stakeholders. For example, a patient safety initiative could be targeted at litigation reduction, which may provoke negative perceptions. Nurses and doctors may feel that the legal profession is dictating clinical practice.
A better approach is to view these initiatives and developments more holistically as improving both patients' safety and care quality. This will hopefully have the attendant benefit of reducing the incidence of adverse outcomes, which could result in litigation and complaints. Clinical practice should not be led by lawyers.
History
It is hard to take litigation out of, or divorce it from, the debate surrounding patient safety and the quality of health care. When we talk about developing an NHS patient safety culture, litigation, clinical negligence costs etc always seem to feature somewhere in discussions.
The concepts of law and patient safety do seem to be embedded in each other. When we look at the history of patient safety in the NHS this link seems to be makes sense. Over the years, patient safety initiatives have often occurred in response to major NHS patient safety crises such as Mid Staffordshire (Francis, 2013) and, before that, Bristol (Kennedy, 2001). The frequency of patient safety crises such as Morecambe Bay (Kirkup, 2015), East Kent (Kirkup, 2022) and so on has helped create an inseparable link between healthcare quality, patient safety and litigation. There is a causal triangle of effect here, with one not being able to exist without the other.
Legal action – consulting lawyers and seeking compensation – occurs when patients have been harmed through clinical negligence. The courts resolve disputes and are the gatekeepers to awarding compensation if the parties cannot agree to settle out of court. It should be stated that most claims are settled out of court. The more patient safety crises we have, the more patients will consult lawyers. This impacts on NHS costs, patient rights, health regulatory and governance regimes and so on. This is widely reported in the media and in health regulatory and governance policy reports, and impacts on patient safety practice and culture development.
NHS Patient Safety Syllabus
The National Patient Safety Syllabus (Spurgeon et al, 2022) is an excellent tool to help develop an NHS patient safety culture. The law is mentioned specifically with reference to clinical negligence, and several other legal areas are covered:
‘6.4 Recognises the legal issues surrounding clinical negligence, compensation, and the accountability of individual practitioners.’
The key to the success of the syllabus will be its uptake and how it is subsequently put it into practice by NHS staff (it is due for review in early 2024, 3 years after v2.1 was agreed). It is good to see the topic of clinical negligence being covered in the syllabus. This is an area of acute concern in the NHS and, as discussed above, can be a major factor in patient safety policy development.
Curriculum guidance on the syllabus has been recently published, giving more details and help (Spurgeon et al, 2023). For example, clinical negligence litigation is covered in module 3.10 (Medico-legal and professional responsibilities). One of its learning outcome states: ‘Recognises the legal issues surrounding clinical negligence, gross negligence manslaughter, compensation, and the accountability of individual practitioners to provide safe care’ (Spurgeon et al, 2023:35). The module content covers the following:
- Explaining duty of care to patients from a healthcare staff, organisation and regulated health professional perspective
- Examples from different staff groups
- How duty of care applies to practice in health care and how it relates to patient safety
- Measures taken to ensure the duty of care is being met in practice.
This curriculum guidance is to be welcomed: there is excellent coverage of clinical negligence and of the link to patient safety. The syllabus and curriculum guidance documents clearly show the importance and intertwined nature of the topics of law and patient safety. Taken together, they provide excellent opportunities to explore the dynamics and interfaces of these critical issues. However, I would have liked to have seen more legal sources in the key literature section: more material could have been cited and I think students following this section will struggle to find up-to-date resources on clinical negligence, tort liability and the duty of care.
Key literature
NHS Litigation Inquiry
As a first step, I would recommend that staff, when following these legal sections of the syllabus and guidance, look at the documentation produced as part of the NHS Litigation Inquiry, chaired by Jeremy Hunt MP (Health and Social Care Committee (HSCC), 2022). The oral and written evidence and report provide excellent insights into the issues of clinical negligence, the advantages disadvantages of our present system, and suggestions for reform.
This material will need careful structuring by education and training teams running courses to avoid information overload. It should be possible to divide the materials in HSCC (2022) into discrete themes; the report's contents page can be used to select and structure topics for teaching purposes. Teaching sections could include:
- Clinical negligence: an introduction, duty, breach, damage, establishing and case, the litigation context in the NHS
- The issues surrounding NHS economics and patient rights
- Patient safety and the law: linkages and roles
- Towards patient safety culture change – reform?
It should be noted that the government is currently looking at clinical negligence litigation in the NHS and a consultation report is due. When published, it will also provide an excellent curriculum teaching resource.
NHS Resolution materials
NHS Resolution has a great deal of material that can be used as a resource to support the National Patient Safety Syllabus and NHS staff learning about clinical negligence. This resource provides a rich seam of information on topics in the area, and is a must-read.
NHS Resolution has several roles: it functions within the NHS as a special health authority and also serves as an arm's length body of the Department of Health and Social Care. Its remit includes patient safety and managing litigation claims made against health organisations in the NHS. The organisation's annual reports (NHS Resolution, 2022) provide key data on clinical negligence and other claims in the NHS. There are also case reports, litigation trend analysis against clinical specialities, costs and so on. Its annual reports and other publications provide real-time data and information on current claims against the NHS, both financially and in terms of developing a patient safety culture.
Recent publications
Through its legal claims management work over the years since its formation in 1995, NHS Resolution has collected a large array of clinical negligence claims information in its database. This rich repository of patient safety and clinical negligence claims is available is available from the NHS Resolution website (see NHS Resolution links below). The material can be used to inform study days on patient safety culture development and the National NHS Patient Safety Syllabus.
Some recent NHS patient safety and clinical negligence resources have been published by NHS Resolution (2023) on NHS medication errors. Claims figures, costs and themes are discussed:
‘From April 1, 2015, to 31 March 2020 NHS Resolution received 1,420 claims relating to errors in the medication process. Of those claims, 487 claims settled with damages paid, costing the NHS £35 million (excluding legal costs).’
NHS Resolution's learning from claims ‘Did you know’ series (see links below) covers many areas, including:
- Anti-infective medication errors
- Extravasation
- General practice medication errors
- Heparin and anticoagulants
- Paediatric medication errors.
The most common medications errors are related to anticoagulants, opioids, antimicrobials, antidepressants and anticonvulsants (NHS Resolution, 2023). Again, these show the close links between the law and patient safety, and the need to explore this relationship.
Conclusion
Law and patient safety are inextricably linked – you cannot have one without the other. This is important to remember for patient safety policy development, practice, education and training. Fundamentally, in efforts to develop an NHS patient safety culture there will always be a legal dimension. Laws underpin the healthcare regulatory governance environment, and dispute resolution mechanisms. This is recognised in the National NHS Patient Safety Syllabus and the accompanying curriculum guidance.
We can obtain learning points from past clinical negligence cases. The reports and publications of NHS Resolution (2022; see also NHS Resolution links below) can all help foster and further the development of an NHS patient safety culture.
We must, however, always remember that it is not the function of tort, clinical negligence law to bring about NHS systemic, system-wide patient safety change and improvement (Bar Council, 2021). This is beyond the remit of the litigation process, the aim of which is to resolve the dispute between the parties themselves to a claim within an adversarial setting. There are dangers in making clinical changes based solely on past cases without strong underpinning clinical research (Bar Council, 2021; Hempsons Solicitors, 2021).
There are several important resources that can enrich teaching on the topic of patient safety and the law. Although some of these have been discussed in this column, there are many others.