As we start off a fresh new year in 2019 it's important to reflect on what has occurred in the previous one in terms of health quality and patient safety. Baselines and measures of improvement and deterioration need to be identified so that future challenges and opportunities can be fully met.
Improvements needed
The Care Quality Commission (CQC) annual report on the state of health care and adult social care in England for 2017/18 helps provide this overview and baseline assessment. The picture painted by the CQC (2018) is of an NHS creaking and groaning under major financial and capacity pressures while resiliently giving most people good care. It's important to remember that ever since the NHS was formed back in 1948 it has been short of money: there is infinite demand for its services with finite resources, and difficult choices must be made in trying to balance the budget. Add to the mix an increasingly elderly population presenting with complex, chronic or multiple conditions (diabetes, cancer, heart disease and dementia, to name a few) and we then approach a ‘perfect storm’ of challenges, as this report clearly articulates.
A central and persistent challenge seen in previous CQC state of care reports and in this one is the safety of patients:
‘The safety of people who use most health and social care services remains our main concern. The issues that affect the safety of people include poor safety systems and processes for managing medicines or determining staffing levels in adult social care, safety cultures in NHS acute hospitals that are not always effective and consistent, and concerns about the safety of ward environments in NHS mental health hospitals.’
Overall quality of care in the major health and care sectors has improved slightly but the fact that patient safety remains the CQC's main concern is worrying. It does raise the question of how effective NHS efforts are in developing an intrinsic patient safety culture that puts the patient first. There has over the years been a tremendous amount of effort put in by successive governments, NHS leaders and NHS staff in trying to make the NHS safer. We have had improvement but not enough to shift CQC concerns.
With constrained NHS resources and staffing capacity problems it seems likely that the same concerns will arise next year:
‘We are pleased that the majority of people in England continue to receive care that is good or outstanding. At the same time, it is clear that too many people received a quality of care that is not good enough. As at 31 July 2018, around one in six adult social care services and one in five NHS mental health core services needed to improve, and one in 100 was rated as inadequate. Almost a third of NHS acute core services was rated as requires improvement and three in 100 were rated as inadequate.’
Going forward in 2019
Next year, it will be interesting to see the shape of the NHS's new 10-year national patient safety strategy being led by the new NHS Patient Safety Director, Dr Aidan Fowler (National Health Executive, 2018). Hopefully the new policy will work to improve patient safety in the NHS.
Duty of candour: a key patient safety challenge
A key concern going into 2019 will be how well the CQC regulates the statutory duty of candour. A recent report by Negri (2018) on behalf of the patient safety and justice charity, Action against Medical Accidents (AvMA), shows some shortcomings along with some improvements in the way the CQC regulates the statutory duty of candour.
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20 is the relevant law here. It is designed to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in general in relation to care and treatment. The history of this fundamental healthcare standard helps explain its purpose. It came about as a direct response to recommendation 181 of the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust. The Francis report recommended that a statutory (legal) duty of candour be introduced for health and care providers and AvMA led the campaign for this.
‘Providers must promote a culture that encourages candour, openness and honesty at all levels. This should be an integral part of a culture of safety that supports organisational and personal learning. There should also be a commitment to being open and transparent at board level, or its equivalent such as a governing body.’
The CQC can and does prosecute for breach of Regulation 20 in accordance with its enforcement policy and can take other regulatory action.
AvMA's analysis on duty of candour
Negri (2018) says that the CQC can do better in how it regulates the statutory duty of candour. This poses important challenges for the future work of the CQC going into 2019 and beyond. The report clearly and fairly discusses statutory duty of candour issues, places them in context and makes commonsense, well-reasoned recommendations. The report should be read alongside an earlier AvMA report on the statutory duty of candour (Blythe, 2016)—Negri (2018) makes several comparisons of findings between both reports and measures improvement.
Both reports are based on an analysis of CQC inspection reports on hospital trusts. The sample size for Negri (2018) was 59 reports based on inspections carried out between 1 January and 31 December 2017. A freedom of information request was made to the CQC to try to determine what regulatory action, if any, has been taken with providers since the introduction of the duty of candour, and how many reports/allegations of non-compliance had been received from members of the public. Further discussions also took place with CQC staff.
Implementation and non-compliance
Since 2015, NHS trusts have improved how they implement the duty of candour provisions but there are still problems with compliance, and Negri (2018) makes several improvement recommendations.
To properly implement the statutory duty of candour, NHS trust staff must first be aware of the concept. Staff training is fundamental here. Staff knowledge and training in the duty of candour was not always evident from the inspection reports analysed. This issue was flagged up in the CQC inspections and trusts were called on to improve.
The triggering events for the duty of candour to come into effect are also discussed. These events can range from death to moderate harm or psychological harm. For the duty of candour system to work properly it is vital to understand what incidents should trigger the process. During inspections, CQC inspectors were not always assured that incidents were correctly categorised. Inspectors found varied application of the duty of candour within trusts.
Some good implementation practices were found. Most trusts have a duty of candour policy, and many trusts use electronic reporting systems to record and monitor duty of candour compliance. A common practice found was the use of governance teams or designated senior leaders to ensure compliance. All this goes towards showing an improvement in the ways trusts implement the duty of candour.
Inspections and monitoring
The quality of inspections and the detail of the analysis in the CQC inspectors' reports were found to vary. This highlights the need for a standard approach that CQC inspectors can use to gather evidence and complete their analyses:
‘Inspectors are still relying on the examples and data given by the provider. Only a few reports show evidence of independent analysis of random selection of incidents. Inspections and the degree of analysis have improved since 2015 but there needs to be a more detailed inspection guide for the duty of candour.’
The CQC found that many trusts lacked systems or, where they had them, they were inadequate to monitor the application of the duty of candour. Trusts did not always keep records of compliance with the duty and sometimes failed to keep the underpinning supporting evidence of action. During inspections the CQC assesses recorded compliance and if there is no record then it is difficult to ensure compliance.
Negri (2018) finds that the CQC has improved inspection and reporting on compliance with the duty of candour but raises an important issue:
‘Our analysis showed that, even where problems were found with trusts' compliance with the duty of candour and are mentioned in the inspection report or the evidence appendix, often this still was not leading to a recommendation to address it.’
CQC enforcement action
The report found that the CQC had used its statutory enforcement powers 108 times against providers who were not fully compliant with the duty of candour. The report notes that no examples were given at all for 2016. Negri (2018) says that the CQC has no idea as to how many individual allegations about organisational breaches of the duty of candour it receives. Also, there is no system in place to ensure that allegations indicating serious breaches are dealt with. The CQC is also weak on publicising that it is taking enforcement action regarding breach of the duty of candour. This represents a missed opportunity to send a clear message to providers and patients that the duty of candour is important, valued and is taken very seriously.
Recommendations
The report makes several recommendations to the CQC on how it can improve regulation (Negri, 2018: 17):
Conclusion
Clearly, the duty of candour is being taken seriously. There appears to have been significant improvement in the way the CQC regulates the statutory duty of candour. NHS trusts can also be seen to be improving on the application of the duty, but problems have been identified in several key areas and improvements must be made.