Clinical governance – an introduction

In the first of a two-part series, principal consultant Peter Allanson explores the surprisingly recent concept of clinical governance

It would be reasonable to assume that the practice of clinical governance has been in place at least since the inception of the NHS. But like many an assumption, this would be incorrect. The spur for its codification and measurement was, as is so often the case, a scandal. In this instance, the high mortality rate for paediatric cardiac surgery in Bristol, exposed in 1995.

The NHS then acquired a statutory duty of care for quality, which led to clinical governance being defined as “a framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish”. Its aim was to improve standards of care, make responsibility and accountability transparent and promote a constant dynamic of improvement.

Clinical governance therefore brought together a range of distinct activities such as risk management, incident investigation, quality improvement and clinical audit in a more systematic way.

Over the last 25 years, it has expanded and intensified following inquiries into significant failures of clinical care such as the Kennedy inquiry into the Bristol Royal Infirmary (2001), the Smith inquiry into the Shipman case (2005), the Francis Inquiry into Mid Staffordshire NHS Foundation Organisation (2013) and the Ockenden review of maternity services at Shrewsbury and Telford Hospitals (2020).

It is important to say that clinical governance is something the NHS generally does well, and its approach is used as a model by other countries. NICE guidelines – its quality standards – are held in particularly high regard.

This article is the first of two covering clinical governance. This one will clarify what it is and what is involved, and the second will outline what a clinical governance system at organisation level might look like.

Regulation and guidance

You might expect that there would be a clear statement of what clinical governance is, enshrined in a central code of holy writ. Not at all – there is a smorgasbord of regulation in the NHS Constitution and CQC requirements and a lot of guidance.

The constitution, to which NHS bodies must have regard when performing their healthcare functions, sets out a principle that the ‘NHS aspires to the highest standards of excellence and professionalism’ by providing high-quality care that is safe, effective and focused on patient experience.

One of the NHS constitutional values is a commitment to quality of care. These are backed up by a (legally enforceable) right and a pledge. It is a patient’s right ‘…to expect NHS bodies to monitor and make efforts to improve continuously the quality of healthcare they commission or provide’ and a pledge (an ambition that goes beyond the rights and so is not legally enforceable) to ‘identify and share best practice in quality of care and treatments’.

The job of the Care Quality Commission is largely centred around the delivery of safe, effective and high-quality care and of course providers are subject to its assessments. Its regulation 17 defines a legal duty for registered entities to operate an effective clinical governance system and its well-led domain covers the quality of care and outcomes for patients. The new statement associated with this gives providers their starting point: ‘We have clear responsibilities, roles, systems of accountability and good governance to manage and deliver good quality, sustainable care, treatment and support’.

Beyond these is a bible of guidance for providers to embrace and regulators to use when assessing the effectiveness of the services provided.

Inevitably there have been reviews of the original aims, most notable, Ara Darzi’s review in 2008, High Quality Care For All. He defined quality as having three dimensions: patient safety (the patient does not suffer avoidable harm while in the care of the service), patient experience (the patient is satisfied with the care and treatment provided), and clinical effectiveness (the care follows evidence-based guidelines and has the best possible outcome).

The National Institute of Clinical Excellence has 198 quality standards comprising a statement, rationale, quality measures, structure, process and outcome alongside detailed clinical guidance providing a set of clinical expectations to inform clinical practice.

Among other documents, NHS England (almost as was) has Matron’s Handbook, which deals with governance, patient safety and governance from a nursing perspective, the Model Health System and its improvement guides including the GIRFT (get it right first time) guidance for trusts.

Components of a system of clinical governance

While there are any number of clinical governance frameworks to follow, the seven pillars of clinical governance are often cited as the most user friendly. A common mnemonic for remembering the seven pillars is "PIRATES":

• Patient and public involvement – engaging patients and the public in the planning, delivery, and evaluation of services, ensuring that their needs and preferences are taken into account.
• Information management – ensuring that information is accurate, accessible, and used effectively to support decision-making and improve care.
• Risk management – identifying, assessing, and managing risks to patients and staff, including implementing safety measures and learning from incidents.
• Clinical audit – a systematic review of care to identify areas for improvement and ensure that standards are being met.
• Training and education – providing staff with the necessary knowledge and skills to deliver high-quality care, including ongoing professional development.
• Clinical effectiveness – ensuring that care is delivered in a way that is both effective and efficient, based on the best available evidence.
• Staff management – ensuring that staff are appropriately trained, competent, and supported, and that their contributions are valued.

The key advantage of embracing the seven pillars is that they map readily against the CQC’s five quality domains of safe, effective, caring, responsive and well led.

However, in thinking about establishing an effective quality management system there must be a consistent and coordinated approach to managing quality that is applied from team through to board level. Any effective approach to improving and maintaining quality in a healthcare setting must also recognise the vital role played by interactions between people, not least the impact of leadership behaviours and organisational cultures. It is also important to understand the impact of co-production to acknowledge the different perspectives on what enables high quality of care. This includes patients (or service users), carers, and direct care staff.

The concept of a quality management system (Healthcare Improve Scotland 2022) is shown pictorially below.

But this needs to be set within a quality strategy that enables the detailed planning that is essential to building a high-functioning quality management system to take place. A strategy is a prerequisite but often missing. What you should expect to see in a quality strategy includes all domains of the quality management system, identifies what the ambitions are for each and how progress against the agreed activities will be measured. It must be clear about the role and function of each of any committees that make up the quality management system and about the scope and limits of their functions to enable each one to give sufficient attention to what is important.

Any effective approach to quality management must also recognise the vital element of leadership behaviours and organisational cultures (including embracing co-production and equity issues).

Quality control describes the processes that are in place to monitor performance in real time and the action taken if outcomes do not match agreed performance standards. Quality control processes should be owned by those directly providing the service and should include measures to meet the quality objectives built from team level to board level. They should be sensitive enough to identify areas where improvement needs to happen and thus drive the quality improvement programme. To avoid over-centralisation, they must be built from team to board and not imposed the other way round. Reports should identify key trends and triangulate data sets against one another. Some trusts have built data sets using the CQC domains and identifying key proxy measures for each of the CQC domains.

Quality improvement can be defined as ‘the discipline that concerns itself with improving the level of performance of a process’ (Joseph Juran). It should also identify and measure interactions between people as well as recognising the importance of experimentation and improvement. It goes without saying that the quality improvement programme must be visible at board level.

Finally, quality assurance is the discipline that ‘checks’ whether the other aspects of the quality system are working, including:

• Planning – are you working on the right things and have you given sufficient resource to achieve your aims?
• Quality control – are you measuring the right things at the right time?
• Improvement – are you improving the areas that are not working as you want them?
• Cultural issues – are leaders encouraging/allowing teams to improve and work on what matters most to staff and patients? Are patients, carers and direct care staff involved in identifying what needs to be worked on? And is sufficient attention being paid to equity issues?

Aside from straightforward, formal audit, assurance processes to validate this can include developing heat maps at ward and team level using any available data to look at team functioning and effectiveness taking a structured approach. Or a peer review system involving clinicians, patients/users, carers and other independent eyes and ears. Fresh eyes are the important thing here as is a structured, organised approach.

Inevitably, to deliver such a manifesto takes some organising and will inevitably include a set of committees. The next article will outline what such a system might look like and suggest how its progress can be assessed and measured.