One major patient safety metric that helps us judge the safety of a hospital or other healthcare facility is the number of Never Events that occur. In the NHS patient safety vocabulary, the term ‘Never Event’ has an officially ascribed meaning and there is a policy framework that helps unpack the concept (NHS Improvement, 2018). In this, the following definition is given:
‘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.’
However, later guidance has this definition:
‘Never Events are serious, largely preventable patient safety incidents that should not occur if healthcare providers have implemented existing national guidance or safety recommendations.’
NHS England/NHS Improvement, 2021:2
The phrase ‘largely preventable’ is used in this later publication, as opposed to ‘wholly’ preventable in the 2018 framework.
Never Events are events that should never have happened, such as operating on the wrong patient, on the wrong part of the body or failing to remove surgical instruments. They can be seen as unforgivable errors. The word ‘never’ is key here, and gives the term is essential power: it is a preeminent error among errors.
When Never Events are analysed, it is possible to see that many of them do reoccur, year after year. The incidence generally does not seem to be reducing as much as it should be. We now have the concept of ‘Common Never Events’ entering the NHS vocabulary. This issue remains a critical and a stubbornly persistent problem for the NHS to address and several reports have been produced on the topic:
‘As the numbers of reported Never Events did not dramatically reduce, especially the so called “surgical” Never Events (wrong site surgery, wrong implant or prosthesis, and retained foreign object post operation), a number of reports have been produced assessing the continued occurrence of Never Events.’
Healthcare Safety Investigation Branch (HSIB), 2020a:15
HSIB: misidentification at outpatient appointments
The HSIB has done some major work in this area. The HSIB's most recent Never Events report is based on a situation where 39-year-old women who attended a gynaecological clinic for a fertility treatment assessment received a colposcopy intended for another patient instead (HSIB, 2021a). This reference event triggered HSIB to embark on a national investigation into the risks involved in the correct identification of patients.
HSIB states that a better system of safety measures is needed to make sure patients are not mixed up and given the wrong invasive procedure during outpatient appointments. The report focused on looking at how effective existing risk controls were and then looked at the risk factors for error.
Several risk factors for patient misidentification were identified:
- Reliance on verbal communication
- The physical environment
- Clinical workload
- Design of the tools used to assist with patient identification
- Lack of integration of technology in outpatient departments
- Impact of patients moving around the department.
The report makes one safety recommendation (2021/131), that NHS England/NHS Improvement lead a review of risks relating to patient identification in outpatient settings.
HSIB: National learning report
At the beginning of 2021, HSIB published a national learning report analysing the findings of the Never Event investigations it carried out and gave three safety recommendations (HSIB, 2021b). The report is detailed and reflective, with much to inform policy development in the area. A key finding was:
‘The analysis of the 10 Never Events included in this report found barriers that were neither strong nor systemic. These events are therefore not wholly preventable and do not fit the current definition of Never Events.’
A key aspect of the definition of Never Events is the existence of strong systemic protective barriers. Barriers are described in the Never Events Framework as:
‘Strong systemic protective barriers are defined as barriers that must be successful, reliable and comprehensive safeguards or remedies—for example, a uniquely designed connector that stops a medicine being given by the wrong route.’
One of the three HSIB recommendations made was for a review and revision of the Never Event list in the light of the report and to remove events, such as those presented, that do not have strong and systemic safety barriers. NHS England/NHS Improvement has responded to the report agreeing that the systemic barriers for some Never Events are not as strong as others (HSIB, 2021c). It pointed out that following on from the seminal report, ‘Opening the Door to Change, (Care Quality Commission (CQC), 2018) a work programme was commenced to review the list of Never Events to identify which barriers are not as strong as originally thought. The review of the Never Events Framework and Never Events List is an ongoing process.
Problems of definition
In reviewing the national learning report (HSIB, 2021b) it is important to remember that it is the ideas behind the label that matter and not necessarily the label itself. The term Never Event is a powerful and valuable one. In CQC inspections it is an important quality precept. Healthcare staff also generally seem to recognise the importance of the term. It is possible to take a broader, more common, meaning of the term than is currently given by the NHS.
A foreign body being left in a person, wrong implant/prosthesis, or wrong site surgery is by common definition a Never Event, regardless of how the term is officially defined and whatever theoretical models have been used to reach that definitional conclusion. A major, highly significant error has occurred.
The national learning report is a well-reasoned and articulate discussion. There is a danger, however, that if we dispense with or alter too much the definition of Never Events and the list this might be seen by stakeholders and the public as being less transparent and accountable—obscuring key patient safety messages through what the public might regard as linguistic smoke and mirrors.
Yes, strong systemic barriers are important, but the nature of a Never Event speaks for itself. HSIB (2021b) identified several matters that contributed to the occurrence of Never Events. These included staff getting distracted in theatres, inattentional blindness, short staffing, inadequate training. Also, staff fatigue, interruptions, poor signage, poor working conditions, different values and norms between professional groups, workarounds, mental short cuts, and over familiarity with a task. It summarises the findings on risk factors:
‘The analysis of the HSIB Never Event investigations identified 17 work system themes that contributed to the occurrence of the Never Events. Common themes across the investigations related to: decision making, staff knowledge, team composition and roles, interruptions, variability in task performance, design of technology, design of workplaces, co-ordination and variability in organisational responses, and ineffective barriers to Never Events.’
The fact that these themes are found should not, in my view, mean that the label Never Event is removed from major adverse health events because the barriers to stop these things happening are not strong or effective. However, HSIB opines that:
‘It is difficult to see how many of these Never Events could ever have strong and systemic barriers.’
The type of lapses identified in the report are unforgivable by any measure. CQC reports of investigations show Never Event occurrences, and they are not uncommon.
NHS Resolution: Never Events
In March 2021, NHS Resolution published an important insight publication on Never Events. This useful resource states the headline costs of claims for incidents of retained foreign object post procedure, giving the clinical speciality where it occurred. Advice is given on what health professionals can do about the problem.
‘From 1st April 2015 to 31st March 2020, NHS Resolution received 800 claims for incidents of retained foreign object post procedure. Out of these 800 claims, 454 were settled with damages paid, 193 without merit and 153 remain open. This has cost the NHS £14, 546, 778.’
NHS Resolution, 2021a
This cost includes payments for claimant legal costs, NHS legal costs and damages.
Conclusion
We can see that the occurrence of Never Events represents a seemingly intractable problem in the NHS. There is no shortage of good advice from several sources on how to prevent them from happening. Unfortunately, the age-old problem of a failure to learn lessons reappears yet again. Worryingly, there is also the real possibility that we could dilute the meaning of the term Never Event in the NHS and elsewhere by redefining what are clearly catastrophic and unforgivable events on the basis that barriers to stop them are weak or have failed. There should be no excuse for a Never Event happening.
We can see that a significant amount of litigation has taken place on retained foreign objects with a significant cost to the NHS, notwithstanding the emotional and physical costs to the patients who have been injured. Courts and judges will always be the final arbiter on whether clinical negligence has taken place and the nature and gravity of the event in question. The courts are good at defining terms using common and literal meanings. It is a mainstay of professional legal practice. The NHS does need to be careful about tinkering around too much with terminology and linguistic definitions of Never Events and to focus much more on the ideas behind the label. There is a need to focus on a holistic, common and literal meaning of the term.