References

Care Quality Commission. CQC tells St George's Hospital to make immediate improvements to maternity care. 2023. https://tinyurl.com/yb24zz3p (accessed 13 September 2023)

Farrell AM, Dove ES. Mason and McCall Smith's Law and Medical Ethics, 12th edn. Oxford: Oxford University Press; 2023

Equipment left inside patient during prostate surgery. 2023. https://www.bbc.co.uk/news/uk-england-shropshire-66431424 (accessed 13 September 2023)

Healthcare Safety Investigation Branch. Never Events: analysis of HSIB's national investigations. 2021. https://tinyurl.com/ycyn24n7 (accessed 13 September 2023)

NHS England. Provisional publication of Never Events reported as occurring between 1 April and 30 June 2023. 2023. https://tinyurl.com/3wcauhc8 (accessed 13 September 2023)

Parliamentary and Health Service Ombudsman. Broken trust: making patient safety more than just a promise. 2023. https://tinyurl.com/35hhsd83 (accessed 13 September 2023)

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Determining what good looks like in patient safety

21 September 2023
Volume 32 · Issue 17

Abstract

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses several recently published patient safety reports

A key question that I often see when analysing and discussing patient safety and health quality reports is what ‘good’ looks like. Good is not a simple term. It may even be relative, with people agreeing to differ on what they consider good. Just saying that something is a good patient safety practice (or not) may not be enough to give the reader the full picture. The context in which the word is being used also requires discussion and understanding. There may also be other more technical, legal words used to describe care levels and any patient harm sustained. Saying good, mediocre, or poor care was given may not always be enough.

Clinical negligence cases

In a clinical negligence case, for example, the court must carefully unpack and analyse the level of care given to determine whether there was any negligence. Lawyers discuss with clinical experts the quality of care given and views on this can differ.

Negligence has a specific legal meaning, which past judicial precedents and cases illustrate and on which lawyers build arguments. There is a significant body of case law in clinical negligence law as to what various terms such as ‘the exercise of reasonable care and skill’ mean.

In relation to an allegation of negligent treatment, Farrell and Dove (2023: 381) stated:

‘… The most important distinction to be made is between medical mistake which the law regards as excusable and a mistake which would amount to negligence. In the former case, the court accepts that ordinary human fallibility precludes liability while, in the latter, the conduct of the defendant is considered to have strayed beyond the bounds of what is expected of the reasonably skilful or competent doctor.’

Labelling levels of care

In analysing patient safety reports we can see various levels of care being exercised, described by health professionals and regulators using differing labels For example, in inspection reports, the Care Quality Commission (CQC) (2023) uses such words as ‘exposed to risk’, ‘unsafe’ and ‘avoidable harm’. As a matter of common sense this must all translate into the exercise of poor care. If the risk manifests and harms the patient, then that might result in a finding of negligent care if the patient sues. However, before that determination is made the precise care context must be discussed. Some level of risk can be acceptable and would not necessarily translate into a finding of negligence.

What is good, mediocre, or bad in terms of healthcare delivery and practice must be seen as a professional value judgement supported by clinical guidelines, peer support, research-based evidence, practice and so on. However, reaching any consensus on this can prove difficult in practice.

What are the characteristics of good safety cultures?

The relativity of the meaning of the word good and its contentious nature is well illustrated by the RSM UK Consulting (2023) rapid literature review on safety culture for the CQC. The idea behind this report was to help the CQC incorporate safety culture into the single assessment framework. It discusses the surrounding literature, definitions and characteristics of good safety cultures. It is clear from reading the report that views do differ:

‘In interviews with safety culture experts, while some advocated measuring safety culture, others cautioned against this approach: “as soon as the tool or a measure gets produced, people will game it … If it's a staff survey then it will get circulated to the right staff to fill out rather than to all staff”.’

RSM UK Consulting, 2022:25

There are several instances that pinpoint differences of opinion. This excellent report also identifies areas of commonality, drawing together themes. These include

  • Key characteristics of good safety culture, how they develop and how they can be defined The report notes on this point a lack of agreement on an accepted definition and identifies five key features that are interrelated and linked with what a good safety culture should look like: behaviours and relationships of staff, open communication, psychological safety, organisation practices, and involvement of those who use services.
  • Enablers and barriers to developing and sustaining good safety culture
  • Looking for evidence of good practice of safety culture in health care, both nationally and internationally.

There is a lot of key information contained in this report, which will require careful reading to unpack.

Information saturation versus the need for debate

There is a clear need to thoroughly debate what is good and what is bad in terms of patient safety culture development and practice, and the need for further research into these issues. Patient safety is such a key issue for the health of the nation and it is sadly beset by acute recurrent problems. There is a considerable amount of patient safety information for busy NHS staff – who often work in challenging, resource-constrained environments – to keep up with.

When reading reports we also should be conscious of the possibility of information fatigue and overload for NHS staff who are often exposed to the same repeated messages about how to practise safely. Key messages might eventually be seen by NHS staff as just being well-meaning mantras.

There is no easy answer to the problem of saturation coverage of patient safety issues in the NHS and elsewhere. The frequency of patient safety investigation and other reports show no signs of abating as the issue is such an acute one nationally and internationally. The challenge is how to distil, manage and cascade the information into the NHS properly and effectively, bearing in mind the above difficulties and challenges.

The implementation gap

The problem of putting recommendations into practice was discussed by the charity, Patient Safety Learning (2022: 6):

‘We consider that a key reason for the persistence of avoidable harm is an “implementation gap” in patient safety in the UK, the difference between what we know improves patient safety and what is done in practice.’

More recently, the Parliamentary and Health Service Ombudsman (2023: 7) stated:

‘We may have a very sophisticated understanding of how to prevent patient safety incidents and avoid compounding harm for patients, families, and staff when things do go wrong. But our evidence suggests that, on the ground, this is regrettably not always implemented.’

We need to ask ourselves whether all these reports and recommendations make any discernible difference to practice. Hopefully they will. They should, at the very least, keep the patient safety debate alive and contribute to building an agenda for change. However, history has not served the NHS well in this regard. Acute patient safety failures stubbornly persist despite excellent patient safety report recommendations. Recommendations that in many cases have gone unheeded.

Never Events

A good illustration of the problems of definition and the use of terminology can be seen in Never Events. There is a detailed discussion of Never Event terminology and the recommendation that some current Never Events be re-defined in a national learning report from the Health Safety Investigation Branch (HSIB) (2021). There is a discussion about the lack of systemic barriers to prevent some Never Events from occurring and how this should lead to them being removed from the official list.

On the use of Never Event language, the HSIB controversially stated:

‘The discordant language between the use of the word ‘never’ and the fact that the available barriers are not effective enough to prevent all these events from occurring has implications for patients, staff, organisations, and others involved in these incidents and associated processes, such as coroners. The word ‘never’ can imply that someone has done something wrong and implies blame and liability.’

HSIB, 2021: 49

Again, we can see linguistic problems at issue. I would not agree with what the HSIB is saying here about revising Never Events. The word Never Event has a good, literal meaning, which has become widely known in the NHS. It has currency, value, and legitimacy. The HSIB makes some good points about available effective barriers, but we must not lose sight of the individual practitioner's personal accountability and responsibility for error. We cannot always blame the system. Some errors are so profound that they deserve the label of Never Event.

Never Events also continue to plague the NHS, and such errors are picked up and reported on widely in the public-facing media:

‘A piece of equipment was left inside a patient during surgery at a Shropshire hospital, a report has revealed. The patient was undergoing prostate surgery when the incident happened, a report to Shrewsbury and Telford Hospital NHS Trust (SaTH) said. The error went unnoticed as theatre staff failed to follow a theatre count policy and the patient was left suffering increased pain and anxiety.’

Gall and Trigg, 2023

NHS England Never Event data

The regular NHS England (2023) Never Event data release continually reminds us of the acute patient safety problems here. The latest report states that 83 Serious Incidents appeared to meet the official definition of a Never Event and had an incident date between 1 April and 31 June 2023. These included, among others:

  • Wrong site surgery – 39 Never Events
  • Retained foreign object post-procedure – 20 Never Events
  • Wrong implant/prosthesis - 7 Never Events.

Conclusion

What good looks like in patient safety terms can be a difficult question to answer. People can and do agree to differ on it. Labels are important, as are the ideas behind the term, and considering the surrounding context is paramount. There are many patient safety reports published and they all help enrich the field of literature and hopefully practice. We have, however, seen a veritable tidal wave of patient safety publications in recent years, often saying similar things. In my opinion this saturation of information could well lead to fatigue and staff switching off from key messages. The implementation gap is also to be noted – the degree to which the reports make a discernible difference to patient safety and health quality. The topic of Never Events showcases well the problems of definition and meaning.