The year 2021 has not begun well, with the media full of reports of the difficulties and pressures that our hospitals are encountering with managing the COVID-19 pandemic. The NHS has once again risen to the challenge of COVID-19 and staff are making heroic efforts to cope. However, working in battlefront conditions brings with it patient safety challenges and quality-of-care issues.
Danger of normalising poor care
Lintern (2021) reported comments made to the Independent by Professor Ted Baker, Chief Inspector of Hospitals at the Care Quality Commission (CQC):
‘I know that staff are doing their utmost to deliver the best quality of care they can, but the challenges they face are enormous and the burden they are carrying is heavy.
‘The danger is that poor care becomes normalised due to Covid—and when incidents where staff haven't been able to deliver good care aren't reported, this normalisation moves closer.’
The demands and challenges brought by the COVID-19 pandemic are legion and the toll on patients and staff are generally well recognised. We are not living in normal times but at the same time the words of Professor Baker also need to fully resonate throughout the NHS—we do always have to guard against poor care being normalised.
The degree of risk tolerance
In a COVID-19 healthcare environment where care and treatment is being delivered in battlefield-type conditions, it is inevitable that health professionals can become more risk tolerant as they move from one crisis to another. The fundamental issue remains of the degree of risk tolerance permitted and its practical effect. There is no doubt in my mind that when the pandemic subsides the courts will be looking at cases brought by patients alleging clinical negligence in their treatment during the pandemic.
Some patients have already consulted solicitors on these issues. For example, Novum Law (2021), a firm of solicitors, says it has been contacted by people concerned about delays and cancellations of medical treatment. It remains to be seen how many cases progress to formal litigation and court judgements. English tort law has cases and judicial perspectives that can be applied to COVID-19 situations and the environment of NHS care. Any outcome will depend very much on the precise facts of each case, as highlighted by barrister Nigel Poole QC during the first wave:
‘Anecdotally solicitors have not told me of a rush of patients coming to their doors to complain about negligence arising out of the pandemic. Any assertions that the crisis will result in a glut of claims should be treated with extreme caution. Secondly, it will be harder to establish negligence because the courts will take into account the extreme circumstances that now prevail, including the call on scarce resources to tackle the pandemic. So, it is probable that fewer claims will be pursued than would otherwise have been the case because solicitors will be wary of taking on those claims under conditional fee agreements.’
A reasonable standard of care
The exercise of a reasonable standard of care within the precise situation and context of the pandemic will be crucial in determining claims. Mulholland (2020) discussed some practical legal issues involved in such claims. One matter will be evidencing the appropriate standard of care to be exercised:
‘Patients have a three-year limitation period within which to bring their claims. Lawyers and experts may well be faced with investigating a claim in, say, 2022 and will have to cast their minds back and reflect on what would have been a reasonable standard at the relevant time. Such an assessment will involve detailed factual evidence on how matters stood at the particular time in question: one can imagine defendants relying heavily on COVID policies which they might have implemented or referring to government guidance during the pandemic.’
Expecting the patient safety commissioner
This year we expect to see the formal establishment of the Patient Safety Commissioner (PSC) in England (Department of Health and Social Care (DHSC), 2021). The Government has amended the Medicines and Medical Devices Bill to establish a PSC for England and has produced a policy paper on the role (DHSC, 2021). This was the second recommendation of the Independent Medicines and Medical Devices Safety Review (Cumberlege report):
‘Recommendation 2: the appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users' perspectives in seeking improvements to patient safety around the use of medicines and medical devices.’
In discussing the role of the PSC it is instructive to contrast the Cumberlege report discussion of the expectations of the role with what the Government is now prepared to deliver. A discussion paper by Hughes (2020) is also useful on scoping the role. A key issue is the independence of the PSC:
‘Independence: the Patient Safety Commissioner must be independent of those funding and delivering healthcare and free to speak their mind without fear or favour. The Review suggests the Commissioner should be appointed by the Privy Council and funded by the Cabinet Office, maintaining a level of separation from the healthcare system …’
The policy paper (DHSC, 2021) does not follow this precise recommended path and some may challenge the PSC's independence. It states that the PSC will be an independent statutory office holder, funded by the DHSC and appointed by the Secretary of State. The Government expects the Secretary of State for Health and Social Care to work with the PSC to agree how their independence will be safeguarded. Annex A goes into the independence issue in more detail. Reference is made to the work of the Children's Commissioner, which is a role sponsored by the Department of Education, and the Victims' Commissioner, sponsored by the Department of Justice. The PSC role does maintain the potential to effectively enhance patient safety as discussed in the Cumberlege report and a lot will depend on the fine details of the post yet to be discussed and finalised. The post of PSC is a move in the right direction towards establishing an ingrained patient safety culture in the NHS, one which puts the patient first:
‘The Patient Safety Commissioner proposal will enhance the existing work we have done to improve patient safety in England. The commissioner will help us learn more about what we can do to improve patient safety in relation to medicines and medical devices and put patients at the forefront of what we do.’
Maternity service failures
Failures in NHS maternity services were a notable patient safety trend in 2020. At the end of 2020 the Ockenden Review published its first report on maternity services at Shrewsbury and Telford Hospital NHS Trust, following 250 clinical reviews. The report makes for difficult reading as some sad and tragic patient safety failings are revealed. Local and national recommendations for change and improvement are made. The report identified several midwifery and obstetric issues in the review of 250 cases at the Trust, with particular concern about ‘the reported lack of kindness and compassion from some members of the maternity team at the Trust’ including in some cases with tragic outcomes (Ockenden, 2020: 11). Other issues identified in the report include matters relating to escalation of concerns and bereavement care.
On 6 January 2021, the CQC published its inspection report of maternity services at the Royal Free Hospital in London (CQC, 2021). The report reveals several patient safety failings that can also be seen in other reports on NHS maternity service providers. Reasons why CQC inspectors rated the service as ‘inadequate’ included lack of a strategic vision.
‘Leaders could not give assurance that they understood and managed the priorities and challenges that the service faced [and there was concern that senior staff] did not show sufficient understanding of potential risks and issues.’
There was also a lack of effective processes to assess and improve care, or to manage risk, and poor systems to deal with safety incidents, so responses to serious incidents were sometimes delayed and ineffective. There was no written evidence of formal apologies when things went wrong.
Conclusion
Staff are making heroic efforts to cope with the challenges of COVID-19, but working in battlefront conditions does bring patient safety challenges. Quality of care issues could be grounds for subsequent litigation. The normalisation of poor care is a danger to be guarded against. The Patient Safety Commissioner (PSC) is a promising development and has the potential to significantly enhance patient safety in the NHS.
In my columns in 2020 I frequently discussed safety and care quality failures in maternity services across the NHS as they hit national media headlines. There were many common themes in these crises, a central one being failure to learn the lessons of past adverse events and to change practices accordingly. This has dogged many NHS services across many specialties for many years and continues to do so. It is hoped that in 2021 the message of improvement in maternity services in some quarters of the NHS will more fully permeate through. Also, that there will hopefully be an improvement generally when it comes to learning the lessons from past patient safety events.