References

Bar Council. Written evidence submitted to NHS Litigation Reform Inquiry (NLR0069). 2021. https://committees.parliament.uk/writtenevidence/40565/pdf/ (accessed 9 September 2022)

Hempsons Solicitors. Written evidence submitted to NHS Litigation Reform Inquiry (NLR0014). 2021. https://committees.parliament.uk/writtenevidence/40124/pdf/ (accessed 9 September 2022)

NHS Resolution. Did you know? Anti-infective medication errors. 2022a. https://resolution.nhs.uk/resources/anti-infective-medication-errors/ (accessed 9 September 2022)

NHS Resolution. Annual report and accounts 2021/22. 2022b. https://tinyurl.com/2p8rsjwt (accessed 31 August 2022)

World Health Organization. Implications of the COVID-19 pandemic for patient safety: a rapid review. 2022. https://tinyurl.com/4nhpmj33 (accessed 9 September 2022)

Patient safety and clinical negligence: the importance of reflection

22 September 2022
Volume 31 · Issue 17

Abstract

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses the need for careful consideration when looking to draw lessons from patient safety crises and clinical negligence claims

Hindsight is a wonderful thing, but it must be handled carefully. It is all too easy to say: if we would have done this and that, then the adverse healthcare event would never have happened. In the many cases that I have seen reported, there is often no simple, singular cause that explains all. I have discussed in previous columns the vexed issue of causation in clinical negligence and how it is often the most difficult of issues to resolve in a case. The same thinking applies equally to broader crises. Problems are often more complicated than they seem at first sight. It is important to look back to see what happened and to reflect on how things could possibly have worked out differently, to identify remedial steps, solutions, and any future problems.

In this column I will be discussing the recently published rapid review report from the World Health Organization (WHO) (2022) on the worldwide implications of the COVID-19 pandemic for patient safety. Meanwhile, NHS Resolution (2022a) has produced a report on clinical negligence claims relating to anti-infective medication.

COVID-19: patient safety impact

The COVID-19 pandemic is still with us as we have moved into the new normality of coping with the virus. There is now time for reflection on how events developed and progressed from a patient safety standpoint. WHO (2022) has recently published a rapid review paper on the implications of the COVID-19 pandemic for patient safety. The report focuses on two questions:

  • What impacts did the COVID-19 pandemic have on patient safety in terms of risks and avoidable harm, specifically in terms of diagnostic, treatment, and care management related issues?
  • What are the main patterns of these implications within the broader health system context?

It takes a global perspective on these issues and looks at several countries' approaches to the pandemic. Country data and responses are analysed, patient safety themes and implications drawn and discussed:

‘In Italy, the treatment of cancer patients was substantially impacted. Many cancer outpatient visits were replaced by telephone consultation, and routine therapy, tests, and procedures were deferred … A study from Spain observed a decline in new diagnoses across all diagnosis groups, suggesting the presence of a large number of untreated and undetected cases across many conditions …’

WHO, 2022:16

The report is a particularly interesting one because of this comparative approach, which includes the UK.

A view

I would argue that nurses and doctors in the UK will be acutely aware, as are most of the general population, of the care dilemmas and problems that COVID-19 brought for the NHS. Delays to treatment, capacity issues, staff brought back from retirement, equipment, PPE shortages and so on. Battleground healthcare conditions prevailed for a significant amount of time. Full diagnostic tests that would have been routinely done in more normal times may have been skipped, or reduced. Patients who required urgent testing and treatment faced delays. Chronic staff shortages caused immense problems. Staff were put in unfamiliar roles, some returning from retirement and having to adjust to new clinical areas.

I would also argue that over a sustained period working in this type of environment some healthcare staff became, out of necessity, more risk tolerant and that some could well remain so today, thereby posing a significant patient safety challenge. Only time will tell whether this is the case – hopefully it is not.

A perfect patient safety storm

The WHO (2022) report states that, based on the evidence that we have, a ‘perfect storm’ in patient safety was caused by the pandemic. There is a need to take stock of what happened so that we can handle future outbreaks and emergencies in a safer way. The report provides a summary of findings. It found that ‘risks and avoidable harm’ from the pandemic are highly prevalent, and many of these risks and harms are common across many countries.

Key observations include:

  • The COVID-19 pandemic revealed a range of safety gaps across all core components of health systems, at all levels
  • The risks and magnitude of avoidable harm from the COVID-19 pandemic still need to be understood
  • Disruptions to systems and processes of care affected previously known safety risks and sources of harm in health care and introduced new ones
  • Misinformation and disinformation have been prevalent during the pandemic. (WHO, 2022:27-28)

The report considers a full range of COVID-19 impacts on patient safety with the aim of helping to provide a deeper understanding of issues so that lessons can be learnt, and changes made.

Positive developments emanating from COVID-19 are noted in the report, such as transformational changes in leadership and culture, new communication channels and data exchanges. The report points to significant opportunities for countries to address risks and avoidable harm.

This report is carefully crafted, well researched, easy to follow and provides excellent guidance. However, it states what many nurses and doctors have experienced themselves and know already. The report's value is that it draws together key patient safety themes emanating from the pandemic together into one accessible place. In doing so it provides an important catalyst for future patient safety improvements and change.

NHS Resolution

Keeping with the theme of COVID-19, in the latest NHS Resolution (2022b) annual report and accounts there is some discussion of COVID-19 legal claims made against the NHS. It says there have only been a few claims so far, but it is too early to make a full prediction of the extent of claims, given that there is in general a 3-year time limit for bringing legal claims:

‘We continue to monitor the potential impact of future Covid-19 related claims associated with risks arising from delayed or missed treatments, and recovery in NHS activity rates, while adjusting future claims projections. In 2021/22, we received 22 claims related to Covid-19 under CNSC [Clinical Negligence Scheme for Coronavirus], an increase of just 15 from seven in the previous year, and it is therefore too early to draw conclusions about future trends related to these claims given their low volumes to date.’

NHS Resolution, 2022b: 36

Anti-infective medication errors

NHS Resolution has several titles in its ‘Did you know?’, series of papers where there is an analysis of closed legal claims in clinical areas, giving costs along with arising themes and best practice to follow. A recently published one covers anti-infective medication errors (NHS Resolution, 2022a).

NHS Resolution received 172 claims relating to anti-infective medications between 1 April 2015 and 31 March 2020 – this includes antibiotics, antivirals, and antifungals. Of these claims 68 were settled with a payment of damages, 51 claims were found to be without merit and 53 claims currently remain open. The total cost of closed claims in this clinical area is £2 612 667, made up of claimant's legal costs, NHS legal costs and damages. Key causes of claims were:

  • Failure to check allergy status
  • Failure to cross-check the ingredients of a medication against allergy status
  • Failure to adjust dose of medication to the patient's weight
  • Failure to adjust dose of medication according to renal function. (NHS Resolution, 2022a:4)

Advice on practising safely is given, which includes referring to the British National Formulary (BNF) for guidance on adjusting dosage, ensuring the weight of the patient is regularly checked, and reviewing local guidelines. Overall, this is an excellent guide, which clearly states the problems in this area that result in litigation.

Looking at what happened

Closed claims analysis of past clinical litigation and looking at past healthcare crises can be a useful patient safety learning exercise. I have said in previous columns that in learning from cases, it must always be remembered that each legal claim is unique. The lawyers acting for the injured patient, the claimant, and those defending the NHS are not purposively setting out to help the NHS learn lessons from a case. They are intending to deal with the precise circumstances of the case, acting in their clients' best interests. Broad system-wide patient safety learning from a case is a secondary outcome, which is beneficial but should not be seen as a guarantee or as a litigation aim. However, as many of NHS Resolution's publications show, looking at these broadly can provide some good learning.

The Bar Council (2021) in its written evidence to the NHS Litigation Reform Inquiry made this important point about the aims of clinical negligence litigation:

‘To put it another way the NHS is in law no different to any other tortfeasor. Litigation has never really been understood to encourage lesson learning and commitment to change and indeed to suggest the tort system should encourage this, as a principal aim, is to misunderstand the purpose of tort law which is to compensate the victim and not to punish or prevent recidivism by the tortfeasor.’

Bar Council, 2021

Hempsons Solicitors (2021), also in written evidence to the inquiry, made the point about the dangers to clinical practice of acting on case law without further extensive research taking place:

‘Until the 1970's epidural anaesthesia was rare and spinal anaesthesia did not become commonplace until the 1990's. This was largely due to the adverse impact of a generation attempting to learn the lessons of litigation when our cases are best seen as anecdotal illustrations of danger, rather than presenting a template for safe practice based on the sort of evidence that medicine now demands.’

Hempsons Solicitors, 2021

These two pieces of persuasive evidence do force us to consider carefully the value of using past clinical negligence cases as educational tools. There should always be a caveat placed on their value. They speak to generality and broad propositions can be made from them. Thorough research should always take place before definitive substantive changes are made to clinical practice because of litigation claims.

Conclusion

It is always good to look back and reflect on events and to see how we handled past crises, such as the rapid review by WHO. We can do the same when we look at past clinical negligence cases, and the NHS Resolution review highlights pitfalls to be avoided. It must be remembered that there are often no simple answers to what went on and the outcomes that occurred. We can learn general lessons, but we must look at matters in more detail. More research will be needed before we can draw firm conclusions and change practices. Change must always be based on credible research.