Last week saw the publication of the report of the National Advisory Group, chaired by Professor Don Berwick, on improving the safety of patients in England (“the Report”). The Report was heralded as one of the centrepieces of the Government’s response to Robert Francis QC’s report into the Mid Staffs Inquiry in February; at the time of receiving that report David Cameron said he had asked Don Berwick “to make zero harm a reality in the NHS” stating that “bedsores and hospital infections… are unacceptable - end of story”.
Six months on, it appears the story has a different ending: the Report sensibly accepts that “hazards in care cannot be eliminated” altogether, but comments that “harms to patients can be and should be reduced continually, everywhere and forever”; rather than “zero harm”, the Report says the correct goal is “continual reduction”.
Concerns over the Report
The expectations set for the Report were, therefore, perhaps unrealistic. However, following publication, the reaction to the Report from many sources has been one of disappointment.
Lack of Practical Solutions
Although the Report endorses numerous themes arising from the Mid Staffs Inquiry, such as the need to prioritise patient safety and learning; encouraging openness and learning rather than blame; caution over the pursuit of quantitative targets; and the importance of transparency and patient and public involvement, it is extremely light on the practical steps by which these can be achieved. As Katherine Murphy, Chief Executive of the Patients Association, stated, the report is “heavy on platitudes but light on practical solutions”.
Lack of Co-ordination
Even where the Report makes some more concrete proposals, particularly around regulatory structures and enforcement, in many instances these clash with other initiatives already announced by other players in response to the Francis report. This is somewhat ironic given the Report’s own conclusions that there is a “very unhelpful complexity and lack of clarity and co-operation among regulatory agencies”. Indeed, one of the Report’s 10 formal recommendations is that “supervisory and regulatory systems should be simple and clear… all incentives should point in the same direction”. Whilst it was appreciated that the Report is “advice” to Government, Jeremy Hunt has indicated a willingness to act on its recommendations. There is concern, therefore, that, in some respects, this may simply add to the complexity rather than producing the “simple and clear” regulatory and supervisory system which all seem to desire.
Standards in Healthcare and Enforcement
It is in the area of standards in healthcare and enforcement that there appears to be a worrying lack of co-ordination in the response of the system as a whole to the Mid Staffs Inquiry. As each new report and consultation makes proposals for new standards and methods of enforcement, the risk of confusion, not only with existing legal safeguards, but between the new initiatives themselves, grows. There is a serious need for Government to take an overview and look at the 'fit' between these initiatives and those already on the statute books. Otherwise, not only might this lead to a confusing and potentially oppressive regulatory burden for providers, it might result in regulators failing to take action (on the basis of deferring to others to act) when serious failings do occur.
Duty of Candour
The Report states that the Advisory Committee does not subscribe to “an automatic 'duty of candour' where patients are told about every error or near miss”. However, it does call for patients or carers to be notified and supported whenever a "Serious Incident" (as defined by NHS England) occurs. This broadly concurs with the initial Government response to the Mid Staffs report to effect that there should be a statutory duty of candour in relation to incidents of serious harm or death. It should be remembered, however, that the contractual duty of candour, which has applied to all NHS services since 1 April 2013, sets the threshold for notification of patients/carers at “moderate” harm.
The Report endorses Robert Francis’ recommendation that CQC should develop a set of “fundamental standards” applicable to all care. CQC has now launched its consultation on these standards, which it calls 'fundamentals of care'. However, whereas Robert Francis recommended a simplified regulatory picture (with the regulator responsible only for monitoring compliance with fundamental standards and commissioners taking responsibility for higher, enhanced and developmental, standards), CQC’s consultation, in addition to the 'fundamentals', proposes a set of legally enforceable 'expected standards' and states it will take into account aspirational standards of 'high-quality care' in awarding its quality ratings. There is, therefore, a risk of a cluttering, rather than simplification, of the regulatory structure.
Breach of Fundamental Standards
There is also some discrepancy, between different parts of the system, in terms of what action the regulator should take upon breach of the fundamental standards. Robert Francis, in his report into the Mid Staffs Inquiry talked about there being “zero tolerance” of breaches of the fundamental standards. The CQC consultation 'A new start' states “there will be immediate, serious consequences for services where care falls below these levels, including possible prosecution”. However, the Report urges more caution and states that action in the event of breaches of fundamental standards should use “a pyramid of enforcement, ranging from persuasion through to punishment”. There is, therefore, a need for clarity as to precisely how 'fundamental' these standards are, and what zero tolerance will mean in terms of the nature of enforcement in the event of a breach.
Perhaps the strongest recommendation which the Report makes is that there should be a new offence of “wilful or reckless neglect or mistreatment” which could form the basis for prosecution of both organisations and individuals. In terms of individuals, such an offence may add something on a par to similar offences under the Mental Health and Mental Capacity Acts which only apply to those specific vulnerable groups.
However, for organisations, it is uncertain how this offence will fit the proposed ability of CQC to bring prosecutions for breaches of 'fundamentals of care' and the renewed emphasis on the HSE to pursue health and safety prosecutions in respect of criminally negligent practice. Further, in terms of sanctions for organisations, the Report suggests that financial sanctions should only be imposed “in extremis” and only where that will not compromise patient care; this appears to be extremely lenient, when one considers the offence relates to wilful or reckless acts, and inconsistent with the potential for prosecutions by CQC for breach of fundamental standards which, in the face of it, could result in severe financial penalties regardless of the perpetrator’s state of mind.
Withholding Relevant Information
The Report also recommends the creation of an offence of “withholding or obstructing the provision of relevant information to a commissioner, regulator, inspector, coroner or other person with a legitimate duty in relation to quality and safety of care”.
Such an offence would be similar to the offence set out at clause 84 of the Care Bill currently passing through Parliament which relates to the supply or publication of false and misleading information. However, again, the offence recommended by the Report appears to go further than the current Care Bill in terms of relating to withholding or obstructing the provision of information (as opposed to supplying false information). In relation to coroners, the proposed offence also raises questions as to precisely what is “relevant information” which there is a duty to provide to the coroner. This, in itself, is an issue which Robert Francis recommended for further clarification.
Interestingly, the Report makes reference to the difficulties of striking a balance between minimising risk and allocating resources and states “where scarcity of resources threatens to compromise safety, all… staff should raise concerns to their colleagues and superiors and be welcomed in so doing. This vigilance cannot come from regulation”.
Some of the Report’s more detailed conclusions relate to the issue of staffing levels. Whilst the Report endorses the Government’s proposed response to the Francis Inquiry to require providers to comply with evidence-based staffing levels, it goes somewhat further. The Report says that NICE should set evidence-based levels for “all types of NHS services” which not only set out nurse: patient ratios, but also skill mixes between registered and unregistered staff, and doctor: bed ratios.
The Report adds that pending the development of the NICE Guidance, providers should look to comply with existing research on proper staffing; it makes specific reference to the Safe Staffing Alliance’s findings (May 2013) that failure, on general medical-surgical wards to have, as a minimum, one registered nurse per eight patients, in addition to the nurse in charge, "may increase safety risks substantially".
Quality Measurement and Transparency
The Report continues the drive towards increasing transparency and comments that this should be “complete, timely and unequivocal”. Indeed, recommendation 7 states “All non-personal data on quality and safety, whether assembled by government, organisations, or professional societies, should be shared in a timely fashion with all parties who want it, including, in accessible form, with the public”.
The Report also states that “NHS Boards and chief executives should share all data on quality of care and patient safety that is collected with anyone who requests it… with due protection for individual patient confidentiality”.
However, the extent to which this level of transparency can be achieved in practice is difficult to predict, and organisations will have a difficult balancing act if this recommendation is accepted in view of potential inconsistencies with a number of the exemptions set out in the Freedom of Information Act 2000 ("FOIA"). For example the FOIA provides an exemption from disclosure where release of information would be likely to "inhibit the free and frank exchange of views". The purpose of this is to prevent a situation where staff are discouraged from expressing themselves openly and completely, which, in itself, may be an essential factor in learning from incidents and increasing patient safety. Organisations will have to strike a fine balance between the Report's recommendations (if adopted) of near unqualified transparency, and the potential for the effectiveness of internal investigations to be undermined if information is disclosed. Ultimately, however, the findings of the Report might arguably be seen in certain circumstances to shift the public interest balance away from maintaining the statutory exemptions and towards disclosure.
On quality measurement, the Report stresses the need for providers to carry out their own proactive assessments of quality and safety, rather than relying on reports from external agencies. As part of this, the Report backs Robert Francis’ recommendation for providers to make more use of peer review in order to facilitate learning.
The Report stresses the need for boards to have granular information, in order to understand variations of quality within different services across their organisation, and states that quality accounts should include “data on fundamental standards and other reportable measures, as required by CQC, [for] each ward, clinical department (and health care professional, where appropriate)”.
The Report urges commissioners to increase funding for NHS organisations to analyse and effectively use safety and quality information; it states that “most health care organisations at present have very little capacity to analyse, monitor or learn from safety and quality information” which it states is a costly gap, which should be closed.
Leadership for Quality and Safety
Recommendation 2 concerns the need to put quality of care in general, and patient safety in particular, as a top priority for all leaders concerned with NHS healthcare.
- The Report builds on the Francis recommendations and states that “NHS England, through the NHS Leadership Academy, should designate a set of safety-leadership behaviours that can be used in leaders’ hiring, in appraisals, in leadership development, and in promotion” – the Report sets out, in Box 1, the leadership behaviours which should be encouraged to reduce risk and increase safety.
However, other proposed actions under this Recommendation impose requirements on provider organisations including:
- The need for providers to define their strategic aims in patient safety, and “regularly review data and actions on quality, patient safety and continual improvement at Board or leadership meetings”.
- The need to provide all staff with the environment, resources and time to acquire skills necessary to identify and reduce risks to safety in their own job, team and adjacent teams.
- The need to address poor practices of individuals in relation to patient safety “using approaches founded on learning, support, listening and continual improvement, as well as effective appraisals, retraining and, where appropriate, revalidation”.
The Report reinforces this in the recommendations dealing with training and capacity building setting out a programme for all healthcare professionals to receive initial and on-going training in patient safety, measurement of quality and patient safety, and skills for engaging with patients. The Report states that providers should have a properly resourced capability programme in place within 12 months.
Patient and Public Involvement
The Report suggests a number of actions for providers to enhance their patient involvement ranging from front-line practicalities on wards to the organisation’s governance structure. These include:
- Clear information about the identity of staff working on wards and who will be each patient’s primary nurse that day and night.
- Having a designated clinician, known to the patient, responsible for the co-ordination of care “for every patient at every phase of treatment regardless of setting”.
- Having patient/carer representation on safety and quality committees.
- Encouraging experimentation with “full patient and carer membership on governing boards and panels that hold boards to account”, with patients and carers being given appropriate support and training to meaningfully participate in these structures. Although NHS trusts may wish to formalise their approach to such patient and carer stakeholder committees, it is unclear what further action, if anything, the Report expect of foundation trusts in this respect.
Whilst noting the ongoing review, by Ann Clwyd, into the NHS complaints system, the Report says that it would encourage further consideration “of an independent national complaints management system… that would also highlight and promote better practice and improvements in the NHS”.
The Report recommends that, as part of becoming learning organisations, providers should focus on having in place fully functioning reporting systems for serious incidents and ensuring that appropriate action is taken in response to incidents, including provision of appropriate support to affected patients and carers. All providers would be advised to ensure the proper functioning of their incident reporting systems and this is likely to be an issue reviewed by the regulator at the time of inspection.
Patient Safety Alerts
The Report endorses Robert Francis’s recommendation (recommendation 41) regarding the importance of CQC holding NHS boards responsible for the implementation of Patient Safety Alerts.
The Report urges Government to continually review the extent of co-operation between the different regulatory structures. Further, the Report states that an in-depth independent review should be completed, by the end of 2017, to consider whether the system should be redesigned, including consideration of merging regulators.
Interestingly, in relation to public and community involvement structures, the Report also suggests that consideration should be given to whether HealthWatch and Health and Wellbeing Boards are operating effectively, and expressly suggests that consideration be given to the case for revisiting earlier models such as Community Health Councils.
As stated, although the Report has been much awaited, now it is published there is some concern that, in many instances, it does not go far enough in terms of setting out practical recommendations and, where it does, those recommendations clash with other initiatives being put in place. The concern is that, in some instances, this will merely add to confusion rather than bringing the much needed simplicity and clarity to supervisory and regulatory systems. Whilst there is much for providers to focus on arising from the Report, there is also still much for Government to do in terms of ensuring the requirements to be met, and implications of failure, are clear.