A period of reflection is always needed in professional endeavours. We need to ensure that what we are doing is still relevant and effective. Reflecting on professional reforms keeps our practice vibrant and healthy, avoiding stagnation. Emerging problems can be identified and strategies for prevention discussed along with any necessary recalibration and fine-tuning. The NHS has been no sloth when it comes to health regulatory, governance and patient safety reforms. Over the years, official inquiries and investigations into tragic patient safety crises in hospitals and elsewhere have spawned several reforms (Sirrs, 2023), and these span decades. The result is that we have a complex system of NHS healthcare regulation and governance that is confusing for both patients and staff:
‘Patients struggle to navigate the complaints system and it may take some time to find the correct organisation to complain to.’
An already confused, overlapping, and fragmented landscape
The Care Quality Commission (CQC) stated in Opening the Door to Change (CQC, 2013) that trusts face several challenges and that the landscape of health regulation and governance is confused and complex. This makes it difficult to see how it is organised and which organisation is responsible for what area. This makes it ‘difficult for trusts to prioritise what needs to be done and when’ (CQC, 2013: 6).
There have been other reports pointing to the overlapping, complex and confusing health regulatory and governance landscape, which can hinder the development of an effective NHS patient safety culture. The Professional Standards Authority (PSA) discussed the flaws in the patient safety framework:
‘Structural flaws in the safety framework: the patient and service user safety landscape is fragmented and complex. Concerns raised often fall between organisations or are left unaddressed due to jurisdiction issues or insufficient powers.’
These reports, and there are several others, convey the message that any proposed reforms to health regulation, governance and patient safety must be carefully considered.
The need to take care when considering reforms
NHS patient safety policies and practices operate within health and governance frameworks, and this is generally recognised as being a complex area and therefore great care must be taken in suggesting future reforms. Adding other regulatory agencies/remits and other reforms may well damage and destabilise what many would argue is an already fragile system. Reforms may have unintended, unforeseen consequences and may make things worse. The adage, ‘be careful what you wish for’, comes to mind here.
The Hughes report
The Patient Safety Commissioner (PSC), Henrietta Hughes, has put forward her views on redress options for those harmed by pelvic mesh and valproate (PSC, 2024). The report deals with the patient experience, key features of a redress scheme, operational issues and so on. Several key recommendations are made, which include the government setting up an ex-gratia redress scheme, which should provide financial and non-financial redress for those harmed by valproate and pelvic mesh. The report argues that the scheme should be based on the principles of restorative practice and be co-designed with harmed patients. Litigation progress for patients in England relating to valproate and pelvic mesh is discussed:
‘Since 2020, there has been little progress through litigation in relation to harm from valproate or pelvic mesh in England.’
PSC, 2024: 27
The NHS Resolution new claim pathways are discussed and whether these effectively support patients who wish to bring a clinical negligence claim in relation to valproate or pelvic mesh. The NHS Resolution Gateways also set out an alternative procedure for patients who do not want to pursue the litigation route. The conclusion drawn is that the Gateways are not beneficial to those claiming, nor do they make a substantial enough difference from normal legal proceedings. The report embarks on a discussion of some novel and interesting concepts relating to litigation. There is a discussion of restorative practice and how it differs from what is termed ‘adversarialism’. ‘Epistemic injustice’ is also discussed:
‘Epistemic injustice is fundamentally about power structures in which some people are more readily believed, some forms of knowledge are more frequently valued, and some people have a greater ability to explain their knowledge in a way that those in power are receptive to.’
PSC, 2024: 54
This is a well-crafted report and is a deep dive into key issues in the area. It remains to be seen whether the Government will accept the recommendations made and introduce the schemes.
A note of caution
A note of caution has been sounded by Paul Whiteing, chief executive of the charity Action against Medical Accidents (AvMA). One report he discusses is the PSC's and the trade-offs made for schemes that are advocated as alternatives to our traditional, adversarial, tort-based compensation system:
‘It seems to me, in all of these debates about redress schemes and No-Fault Compensation and moving away from an adversarial scheme – all of which I fully accept has its downsides – we do not acknowledge the trade-off that will be made. Any scheme created to replace court-based compensation will provide a lesser form of compensation to those harmed. That cannot be right.’
Once again, we should be wary of unintended consequences. Patients could be worse off financially under the schemes being advocated by the PSC and others. That downside may well be offset by easier patient access to the new schemes and the other benefits discussed in the PSC (2024) report. Change, however, may not always be a good thing unless it is fully explored and tested.
The vexed issue of Never Events
Never Events, unfortunately, continue to plague the NHS. Never Events data reports regularly reveal a depressing story of errors having the most profound of consequences on patients. Errors occur that should never happen in a modern-day NHS, but still do. Some NHS staff do not seem to learn from them. Ely (2023) captures well the issues and impact of Never Events in his analysis:
‘Shocking incidents uncovered include women getting parts of their reproductive anatomy cut out instead of an appendix, men getting unwanted circumcisions and laser procedures to the wrong eye … Brits have also been left with scalpels, surgical gloves and even part of a condom inside them after surgery or other medical procedures.’
NHS England (2024a) has produced Never Event data for those reported between 1 April and 31 December 2023.The report states that 268 serious incidents appeared to meet the definition of a Never Event. These included:
- Wrong site surgery: 139
- Retained foreign object post procedure: 50
- Wrong implant/prosthesis: 25.
Never Events framework consultation
NHS England is seeking views on whether to reform the existing Never Events framework and whether it can still be regarded as an effective mechanism in driving patient safety improvement. The consultation period closes on 5 May 2024.There is a consultation document (NHS England, 2024b) and an online survey form to complete. The CQC and Health Service Investigation Body (HSIB) have previously discussed weaknesses in Never Event controls (CQC; 2018; HSIB, 2021). These include that controls are not strong enough for some types and subtypes of Never Events. Therefore, they do not accord with the official definition of a Never Event, as stated in the revised Never Events policy and framework (NHS Improvement, 2018).
The consultation document (NHS England, 2024b) presents four options to discuss and provide feedback on:
- Option 1: no change; continue with the current framework
- Option 2: abolish the Never Events framework and list
- Option 3: revise the list of Never Events to include only those with current barriers that are ‘strong, systemic, protective’
- Option 4: revise the definition of and process for Never Events to create a new system that does not require all relevant incidents to be ‘wholly preventable’.
There is a discussion in the consultation document (NHS England, 2024b) of why change is being considered.
Our view would be Option 1: no change.
Challenges
Never Events present a huge challenge to the NHS, and they are stubbornly persistent. Some clinicians refer to some types of error as ‘common Never Events’. There are well recognised acute challenges that the NHS faces with Never Events, but that does not mean we have to move the goal posts. NHS staff know what Never Events are – as, we would suggest, do the public. They are events that should never happen – unforgivable lapses of care. When we start thinking about semantics, definitions, and the strengths of controls we begin to lose sight of the fundamental issues: that they should not be happening in the first place.
The words Never Events have a readily understandable meaning and power which should not be diluted by changes. Again, it is a question of the dangers of being careful of what you wish for and unintended consequences. If there is reform of the NHS Never Events Framework, then we might never get proper control of them. A preferred course may be to work with the system we have and to try harder to deal with the issues through more education and training.
Conclusion
We have hopefully shown through a discussion of reports by the PSC (2024) and NHS England (2024b) that change may work out to be counterproductive, and that we do need to be careful what we wish for. That should not, however, inhibit discussion, but we must always ensure that reform proposals are well detailed, research-based with supporting data, and needs for change clearly identified. Change may not always be a good thing unless it is fully explored and tested to manage and minimise negative consequences.