By John Tingle, Associate Professor, Birmingham Law School, University of Birmingham
The importance of high-quality health regulation, governance, patient safety can never be overstated. Those that access the NHS need to be confident that they will be treated well and that patient safety problems will not occur. However, some degree of error is inevitable in health care treatment because of its fundamental nature. Health care services are delivered personally by human beings who are fallible. Health care treatment can involve complex equipment, drugs, care processes. The best we can hope to achieve is to successfully manage clinical risk. Our health regulatory and governance system helps achieve this. Good patient safety policies and practices are an intrinsic part of the NHS health regulatory and governance framework.
A crisis of confidence
The NHS health regulation and governance structure has recently come under the spotlight with the publication of the interim review report by Dr Penelope Dash on the Care Quality Commission (CQC) which is the independent regulator of health and social care in England. Major failings in the CQC’s functions and services have been found and substantial improvements are needed. A more detailed report will be published in autumn,2024 but initial findings from the report are:
“1. Poor operational performance.
2.Significant challenges with the provider portal and regulatory platform.
3.Considerable loss of credibility within the health and care sectors due to the loss of sector expertise and wider restructuring, resulting in lost opportunities for improvement.
4.Concerns around the SAF.
5.Lack of clarity regarding how ratings are calculated and concerning use of the outcome of previous inspections (often several years ago) to calculate a current rating.”
The government have responded to the report taking action to restore public confidence in the CQC.Steps include a review of the CQC assessment frameworks and increased government oversight of the CQC. The government have also asked Dr Dash to review the effectiveness of all patient safety organisations.
NHS poor at patient safety lesson learning
It is worrying to see that the regulator of health and social care in England is having significant performance issues. There have been significant NHS patient safety failings in hospitals and in in other health organisations reported in the past and there are current problems that include NHS maternity care. Recent patient safety investigation crisis reports include Morecambe Bay, Shrewsbury and Telford, East Kent, and Nottingham (which is in process) amongst others. The NHS is patently bad in some quarters of learning patient safety lessons from past investigation into care quality crises. The same or similar patient safety problems identified in investigation reports can often be seen to be repeated.
Review, rationalisation, and consolidation.
The Dash review will be most welcome as the system is complex, fragmentary, and overlapping and this has been noted in several past major reports.
The Professional Standards Authority (PSA) have stated:
“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. Large-scale failures of care still occur frequently… (p.10)”
There is an urgent need for review, rationalisation, and consolidation of NHS patient safety organisations.
NHS clinical negligence litigation reform
In looking at NHS health regulation, governance, and patient safety it is important to factor in clinical negligence litigation. These concepts are linked, adverse health care events can turn out to be negligently caused. The tort compensation system then becomes engaged with its adversarial, fault focus. Many patient safety commentators ask for a move away from tort, fault-based compensation to no fault schemes for clinical negligence. It is argued that the current tort-based system encourages defensive clinical practices, culture, under reporting of errors, lack of candour when mistakes occur and so on. The Patient Safety Commissioner (PSC) has stated:
“We will call for an overhaul of the complaints process and clinical negligence in the healthcare system, promoting restorative practice to support patients, families and healthcare workers “.
The Medical Defence Union (MDU) has recently called on the new government to consult on proposals to address the cost of clinical negligence. NHS Resolution has recently published its annual report and accounts, and the costs of clinical negligence claims are significant:
“The estimated ‘annual cost of harm’ for incidents in 2023/24 for the main clinical scheme, Clinical Negligence Scheme for Trusts (CNST) was over £4.7 billion.”
NHS Resolution’s future financial provision for claims liabilities is £58.5 billion.
Patient’s interests should not be compromised.
This is money that could well be spent funding front line NHS care but at the same time we must not forget the interests of the negligently injured patient. They need compensation to put them back in the position they were in before the negligence occurred. They have been injured by a system, person or persons that were meant to care for them. There are two sides, perspectives to the high cost of clinical negligence debate. It will be interesting to see what the new government does about clinical negligence litigation reform.
Conclusion
A lot has happened in recent months in terms of NHS health governance, regulation, and patient safety. The new government has taken steps to review the CQC and other NHS patient safety organisations and the outcome will be eagerly awaited. There is an urgent need to simplify, streamline the system to make it more effective and resource efficient. The clinical negligence system is also likely to be the subject of some review by the new government.