In the world of lawyers and legal education statutory interpretation—the words used in statutes and cases and what they mean—is an important skill and practice area. Law students study this in their first year and they will need to hone that skill throughout their professional careers. Law can so often be about the meaning of words. We have seen this with the restrictions of movement around COVID-19—although there may be some ambiguity about what exactly is permitted regarding distance and purpose of travel from home, many say we should just follow the spirit of the rules in the absence of exactitude.
We can look at the literal meaning of the words used in the legislation, but language and words have limitations. There are a myriad number of events that can happen and we must apply those to the words in the legislation. The legislation may have been drafted many years before the events that we are concerned with. Times change, society and practices do not remain static. The written word has limitations and the hunt for meaning can be elusive.
‘Written words are not like conversation: there is no inflexion, no stress, no sense of irony, no opportunity to ask, ‘What do you mean?’. The lifeblood of everyday speech is missing. The reader therefore must give life to the words by interpreting what they mean and how they are meant to apply to situations. This is what is meant by statutory interpretation.’
This issue applies equally in nursing, medicine, and patient safety. Words can mean different things to different people. The key point to remember is that in defining any term, the label itself, the word, is arguably of secondary importance. It is the idea behind the word that matters. When we analyse and collect the ideas behind the word then we can begin to see the common accepted definition. This process in a legal setting may involve judges considering public policy, literal meanings, the intention of Parliament and so on. The process can also involve judicial value judgements. The key point to remember is that interpretation of words is not a straightforward process.
The HSIB and Never Events
I was recently reminded of the difficulties of language, words and interpretation. The Healthcare Safety Inspection Branch (HSIB) has just published a national learning report examining the findings of investigations carried out on incidents classed as ‘Never Events’ (HSIB, 2021). Investigations cover 7 of the 15 Never Events listed in the framework policy document (NHS Improvement, 2018). These account for more than 96% of the total Never Events recorded in 2018/19. They included implementation of wrong prostheses during joint replacement surgery, administering a wrong site nerve block, insertion of an incorrect intraocular lens, detection of retained vaginal swabs and tampons following birth, inadvertent administration of an oral liquid medicine into a vein, and wrong site surgery—wrong patient.
The report is a controversial one and I would argue can be challenged as not being in the spirit of advancing the patient safety agenda in the NHS in England. One recommendation made is that NHS England and NHS Improvement should revise the Never Events list to remove several that do not have strong and systemic safety barriers.
A note on terminology
In the latest provisional report, NHS England and NHS Improvement (2021: 2) defines Never Events as:
‘Never Events are serious, largely preventable patient safety incidents that should not occur if healthcare providers have implemented existing national guidance or safety recommendations.’
The framework document defines Never Events as follows:
‘Never Events are defined as Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers.’
There is an important distinction between events that are ‘largely preventable’ and those that are ‘wholly preventable’—and there is a discussion in the HSIB report on these differences (HSIB, 2021: 12). However, confusingly, ‘largely preventable’ references appear after 2018 in update reports.
The report
A structured qualitative approach is used to analyse HSIB Never Events investigations.
‘A qualitative, thematic analysis approach was taken to identify the work system factors that contributed to the occurrence of the Never Events investigated by HSIB. Thematic analysis was undertaken using the Systems Engineering Initiative for Patient Safety (SEIPS).’
The report identified 17 work system themes that contributed to the occurrence of the Never Events. Common themes were:
HSIB (2021) states that the work system themes reported reveal the challenges faced by health professionals when trying to ensure that Never Events never happen. There can be seen to be barriers or controls of different strengths relating to the different Never Events. It concludes that for many Never Events, including all those investigated for the report, there are no strong and systematic barriers to stop Never Events happening:
‘There is evidence presented that barriers involving human processes which exist with variable if any technical support are weak. This report also presents evidence that barriers which are thought to be more effective, such as some physical/technological barriers, are also unreliable. Some of these barriers can be worked around or do not function…’
The conclusion drawn is that all the Never Events included in the report do not have strong and systemic barriers and therefore do not qualify, under the exact words set out by NHS Improvement (2018), to be categorised as a Never Event. They do not meet the current definition and therefore should be removed from the list.
A wrong turning
HSIB (2021) seemingly falls into the definitional trap that I discussed above with regard to statutory interpretation. It is difficult to be absolute with language and words. We do need to look beyond the words to the ideas behind them. There is more to the Never Events framework than mere definitions and categorisations, we need to look for, and to, the spirit of the Never Events policy.
‘Learning from what goes wrong in healthcare is crucial to preventing future harm, but it requires a culture of openness and honesty to ensure staff, patients, families and carers feel supported to speak up in a constructive way. The revised Never Events policy and framework are designed to support the NHS to do that and are part of continuing efforts to build a learning culture and maximise opportunities to keep our patients safe.’
I would argue against the recommendation that a good chunk of the listed Never Events be removed because strong and systemic protective barriers don't exist. They do exist in some places and the fact remains that these types of incidents are termed ‘Never Events’ for a good reason. So termed, they can act as a valuable deterrent to poor practices and function as a valuable education mechanism.
When we look at some themes of the cases investigated, many do seem to imply a degree of personal health professional and system fault. The impact on the patient in many cases can also be catastrophic:
These themes are not good reasons to delist the relevant Never Events because of system weakness and to fully accord with the given definition. The HSIB goes into several consequences of Never Events:
‘The word ‘never’ can imply that someone has done something wrong and implies blame and liability. For patients this can suggest they may have been harmed by negligence. For staff it can lead to a feeling that they are to blame and can cause moral injury…’
It is important to remember that when a Never Event occurs it is not always followed by a clinical negligence action. There may be no legal action. Clinical negligence is a complex and hard matter to establish. In English tort law we have the maxim ‘res ipsa loquitur’ or ‘the thing speaks for itself’ which is a long-standing rule of evidence.
Rumley (2021) discussed the HSIB report, saying that it is unfortunate to see a body that is supposed to be at the forefront of patient safety learning effectively advocating patient safety avoidance:
‘In essence, HSIB are accepting that some ‘never events’ simply cannot be prevented, but surely that is defeatist? The types of events we are talking about … are absolutely preventable with basic adherence to the fundamental of clinical care to check what you are doing…’
Conclusion
I would agree with Rumley (2021) when he uses the terms ‘patient safety avoidance’, ‘defeatist’, and ‘fundamentally flawed argument’. We must look at HSIB (2021) within the context of patient safety in 2021 and against the backdrop of a long history of NHS patient safety crises. We must look behind the words ‘Never Events’ to ascertain the true meaning of the term. For the last 21 years the NHS has been and remains on a long and arduous journey to develop an ingrained patient safety culture which puts the patient first. The Never Events list as it stands has an important value in developing a safer NHS.