If a patient goes to hospital to have their right kidney removed it follows that the left kidney shouldn't be taken out instead. What's more, removing the healthy kidney and leaving the diseased one is catastrophic for the patient. This type of patient safety incident (wrong site surgery) has a name; a 'never event'.
However, despite the MDU's chief executive noting in an editorial almost three years ago that the term 'never event' is a misnomer, and calling instead for a transparent culture in the NHS where mistakes are reported and learning is shared to improve patient safety, it appears little has changed.
One thing is certain; despite being uncommon, never events keep on happening. In a press release from February 2016, the Patients Association put it this way:
'It is a disgrace that incidents which are supposed 'never' to happen are still so prevalent. With all the systems and procedures that are in place within the NHS, how are such basic, avoidable mistakes still happening?'
The criticism highlights an important point. The term 'never event' implies that something does not, or should not, occur. And when it does it tends to engender emotions of disbelief and outrage, arguably serving as a distraction to on-going and necessary patient safety initiatives.
Paradoxically, the organisation credited with coining the expression never event (the National Quality Forum) does not use the term, preferring 'serious reportable events'. But Lembitz and Clark (2009) suggest that the preferred terminology is unlikely to prevail, 'given the prevalence of the viscerally moving term 'never event''.
The NHS' focus on never events can be traced back to Lord Darzi's report, 'High Quality Care for All'. Darzi's review noted that in some parts of the US, serious events that were largely preventable were designated never events, and he proposed that the then National Patient Safety Agency drew up its own list. He also noted that in parts of the US payment was withheld when these events occurred.
April 2009 saw the implementation of a never events policy and framework. A never event was defined as a 'serious, largely preventable patient safety incident that should not occur if the available preventative measures have been implemented by healthcare providers.'
The original list of eight defined never events included wrong site surgery, some in-patient suicides and intravenous administration of wrong-dose potassium chloride. The focus was on detection, investigation and action at a local level with reports shared with commissioners of care.
Just three years later the never events policy framework had expanded the number of reportable incidents to 25 and included the following policy objective: 'The aim of this policy is to reduce the incidence of never events to zero. They are intolerable and inexcusable.'
Also by 2012 the concept of financial penalty was linked to never events, with a procedure allowing the commissioner of care to recover the costs of the particular episode from the hospital provider.
Where are we now?
So, seven years on from the introduction of the original policy and framework, how close are we to achieving the goal of zero never events? If we just look at wrong site surgery, you may be forgiven for thinking we never will. As the graph below shows, based on data published by NHS England, rather than approaching zero the trend over the last four years is of a steady increase.
The focus on failure makes it easy to overlook success in patient safety initiatives, even in relation to never events. But there is some evidence that efforts to reduce certain never events in the US have had a measure of success. In its 2015 report on hospital-acquired conditions (HACs), which include a number of US-defined never events such as hospital-acquired infections, the Agency for Healthcare Research and Quality found that there was a 17% decline in HACs from 2010 to 2014.
This equated to a cumulative total of 2.1 million fewer incidents (if 2010 rates had persisted), 87,000 fewer patients dying in hospital and a saving of approximately $19.8 billion in healthcare costs. Separately, a study in California published in 2015i found that pressure ulcers in children, a never event, were reduced by 60% through improved awareness and prevention strategies.
However, there is also evidence of the ineffectiveness of interventions – particularly strategies in preventing wrong-site surgery. At best, the effectiveness of such interventions studied in recent systematic reviews could be described as limited (Hempel et al, 2015ii and Algie et al, 2015iii).
The focus on failure makes it easy to overlook success in patient safety initiatives
It's been suggested that the reason why incidents of never events seem to rise despite initiatives to prevent them may be due to deficiencies in the science of patient-safety measurement, rather than evidence of deteriorating clinical standards. In this article from the Harvard Business Review, the authors suggest that instead of focusing on never events there is greater benefit in looking beyond a list of these sentinel events. They advocate looking at a broader and more inclusive list of care outcomes and patient safety incidents and they achieved good results by doing so.
But they still encounter pressure ulcers, wrong-site surgery and other never events, and the main reason is that even where gross error is controlled, more subtle mistakes are not – such as operating on the wrong vertebral level because of abnormal anatomy or technical difficulties where the patient is obese.
It is fundamentally right that clinicians continue to do what they can to make patient care as safe as possible. But it is equally right to question whether the approaches that have been adopted are helping or hindering public perceptions of safe medical care.
There will be new opportunities to develop methodology that supports learning from medical errors, and when the Healthcare Safety Investigation Branch begins its work in 2017 hopefully it will do just that. Two of the early challenges will probably be how to develop an organisational culture across the NHS that promotes learning over blame, and deciding whether the focus on never events has been effective or if a different approach might work better.
Dr Michael Devlin
Head of professional standards and liaison
Mike was an MDU medico-legal adviser for 15 years, latterly as head of medico-legal services, before taking up the new role of head of professional standards and liaison. He sat on the FFLM’s academic committee and was previously treasurer, and an examiner for the MFFLM. He has published widely on medico-legal matters, and has significant experience in teaching and assessing knowledge in medico-legal subjects.
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