The evolution of quality assurance

Abstract

The evolution and maturity of quality assurance in healthcare remains largely unstudied and undocumented, in comparison to the literature about quality improvement. This article describes the development in thinking around quality assurance over the last four decades – from the first structured organisational framework that made boards accountable for quality, through the clinical governance system set up in the 1990s. Clinical governance brought together a range of disparate components into a coherent structure, which we would largely view as quality assurance today. As practice and learning about quality management has evolved in the subsequent decades, there is an appreciation of the need to balance quality assurance with other elements of quality management – improvement, control and planning. The article presents a detailed case study from East London NHS Foundation Trust which describes how modern quality assurance has become much more patient-led, informed by improvement science, and meaningful, through reducing burden and involving clinicians in quality assurance activities.

Introduction

Whilst much has been written about the development of structured and systematic approaches to quality improvement in healthcare over the last four decades, and the results that this has enabled, far less attention has been paid to the evolution of quality assurance. This article will describe the development in our understanding of quality assurance over this period – utilising the framework of Berwick’s three eras of medicine to articulate the growing maturity of thinking and practice in the field.¹

The article will describe how quality assurance has begun to move into the third era, as defined by Berwick, with examples from the author’s work at East London NHS Foundation Trust – a provider of mental health, community health and primary care serving two million people in England.

From era 1 to era 2 – the introduction of clinical governance

The concept of the ʻthree eras of medicine’ was articulated by Don Berwick in 2016 in his paper Era 3 for Medicine and Health Care, published in the JAMA.¹ Berwick used the framework to describe the evolution of how healthcare systems govern professional practice and manage quality. The first era, roughly spanning the mid-20th century until the late 1980s, was the era of professional autonomy. In this period, quality was assumed to be ensured primarily through the expertise, ethics, and self-regulation of clinicians. Oversight was limited, and variation in practice was largely accepted because clinical judgement was considered paramount.

However, research in the 1980s and 1990s demonstrating unwarranted variation, medical error, and inconsistent outcomes challenged this assumption.2, 3, 4 This led to the second era, emerging from the 1990s onwards, which introduced stronger external accountability and performance management. Governments, regulators, and commissioners/payers began using measurement, targets, guidelines, inspection, and public reporting to manage quality and safety.

In England, developments such as ʻA First Class Service: Quality in the New NHS’,⁵ the establishment of National Institute for Health and Care Excellence (set up in 1999 to reduce variation in healthcare and ensure consistent evidence-based treatment through the development of clinical guidelines and quality standards), and regulatory oversight by the Commission for Health Improvement (established in 2001, later replaced by the Healthcare Commission and then the Care Quality Commission⁶). reflect the second era.

Clinical governance was introduced in England in 1998–1999 as part of a major policy effort to improve the quality, safety, and accountability of healthcare within the National Health Service (NHS).⁷ The concept was formally set out in the UK government’s 1998 white paper ʻA First Class Service: Quality in the New NHS’.⁵ The concept and need for a clinical governance framework emerged in response to growing recognition that the NHS lacked systematic mechanisms for assuring and improving quality of care, highlighted by significant failures such as the Bristol Royal Infirmary scandal.⁸

Clinical governance was designed to create a statutory duty for NHS organisations to continuously improve the quality of services and safeguard high standards of care, making quality improvement a core responsibility of healthcare leadership and organisational management rather than solely the domain of individual clinicians.⁷ The framework of clinical governance brought together a set of interrelated components, including clinical audit, risk management, evidence-based practice, clinical effectiveness, continuing professional development, staff management and appraisal, patient and public involvement, and information management. It also established clearer accountability structures, with NHS boards responsible for the quality of care delivered by their organisations.

Alongside the introduction of a number of agencies aimed at developing guidelines, standards and regulating quality of care, clinical governance marked a shift toward a more systematic, organisation-wide approach to quality governance in English healthcare – albeit with a strong emphasis on implementing guidance and meeting standards that were defined far from the point of care.⁷

Development in quality management

Thinking and practice around how to manage quality has evolved substantially from the 1990s. Whilst the framework of clinical governance purported to support continuous quality improvement in healthcare, there is now much greater understanding of what quality improvement is, how to adopt this in complex health and care systems, and the different domains of quality management.⁹

Clinical governance largely restricted itself to what we would now describe as quality assurance. Quality assurance enables us to check that we are delivering the standards of care that people would expect – through occasional activities to inspect or check practice against standards. For example, clinical audit is a mechanism to define standards of care based on best available evidence, and check periodically that we are delivering the standards that patients and citizens would expect. Similarly, the approach to incident investigation, focused on a robust process to understand systemic and root causes, and then taking action, would be classified as a largely quality assurance function.

Today, we recognise that quality assurance is valued but only part of modern quality management – which also includes planning, improvement and control.9, 10 Proper quality improvement activity is focused on applying systematic methods to understand and tackle complex issues, involving the people closest to the issue in developing and testing ideas, using data to learn. Quality improvement is quite different with regard to pace, level of experimentation and ownership from what we now regard as quality assurance – where standards are often defined distant from the point of care, and assurance activities (for example, inspection) often carried out by teams and individuals who do not actually work within the service.

Alongside quality assurance and quality improvement, we recognise an important role for quality control in managing daily work – with the use of huddles, real-time data transparently available to the team, problem-solving and clear escalation routes when something cannot be resolved immediately by the team.¹¹

The final element of modern quality management is planning – the involvement of teams and departments (and often commissioners or payers) in a regular cycle of setting priorities, through deep understanding of population and patient need, and then defining the new service models and structures required to meet these priorities. This might occur on an annual basis, with alignment of priorities from point-of-care through to organisational strategy.

The balance across these four elements of quality management is absolutely key. In the 1990s and 2000s, the introduction of more structured approaches to clinical governance led to the dominance of quality assurance – with very limited development of quality control, improvement or planning. Over the following two decades, there has been greater understanding of the need for all four elements of the quality management system – with far greater need for quality control and quality improvement, leading to a reduction in quality assurance.

From era 2 to era 3 in quality assurance

While these mechanisms of oversight, measurement and scrutiny introduced during Era 2 improved transparency and standardisation, Berwick argued that they also created bureaucratic burden, compliance cultures, and sometimes undermined professional motivation. He therefore proposed a third era, centred on learning systems, intrinsic professional motivation, patient partnership, and continual improvement. In this model, healthcare organisations focus less on inspection and control and more on cultivating trust, improvement capability, transparency, teamwork, and co-production with patients, aligning closely with modern approaches to quality improvement, safety science, and system learning in healthcare.

Berwick proposed a number of changes required, in order to move from era 2 to era 3:

• ●Reduce mandatory measurement
• ●Stop complex individual incentives
• ●Shift the business strategy from revenue to quality
• ●Give up professional prerogative when it hurts the whole
• ●Use improvement science
• ●Ensure complete transparency
• ●Protect civility
• ●Hear the voices of the people served
• ●Reject greed

A case study in developing era 3 quality assurance

East London NHS Foundation Trust (ELFT) is a provider of mental health, community health and primary care services to a population of two million people in Bedfordshire, Luton and East London. The organisation has approximately 8,000 staff, and operates from around 150 sites. ELFT suffered a series of serious safety events in 2010–2011, forcing the organisation’s leadership to reconsider its approach to quality, which was largely quality assurance-based. This began a process of learning about quality improvement, and introducing this into the organisation in 2014.¹² Since 2011, there have been a number of changes made to way the organisation assures itself and its constituents about quality, that have contributed to the evolution into era 3.

Shifting the business strategy

Between 2011 and 2014, ELFT’s board undertook a series of development sessions and learning visits, in order to understand how to transform its approach to quality. This culminated in a formal business case and strategic partnership with the Institute for Healthcare Improvement, and its first strategy and mission statement – to provide the highest quality mental health and community care in England by 2020.

Reducing mandatory measurement

In preparation for the introduction of quality improvement in 2014, the organisation undertook a comprehensive review of all clinical audit activity, to ascertain whether the audit was internally mandated or externally imposed. For audits that were internally mandated, a steering group reviewed whether these were still necessary and why. Over a third of all clinical audits were stopped – in order to create time and space for clinical teams to begin to learn how to improve their service using the structured and systematic method of quality improvement.

National clinical audits are defined by national clinical leaders, to collect data on services across the country that enables an understanding of variation, and gaps in service provision. Participation in national clinical audit is mandated within the standard NHS contract. Each national clinical audit can have hundreds of standards to measure a service against, once a year, with a long lag in receiving the results back. From 2016 onwards, ELFT decided to reduce its participation in national clinical audit, as the effort involved in collecting the large volume of data was not appropriately balanced with the opportunity to act on the data. Clinical leads were invited to choose the particular standards in each national clinical audit that they felt were most meaningful and useful to audit, and the organisation only submitted data related to these standards – with more time focused on analysing the results and acting on the findings. This allowed ELFT to continue to participate in each national clinical audit, as mandated contractually, but reducing the number of standards that data was submitted against (by involving clinicians in determining the most meaningful areas to measure). There is a need to balance the national need for robust and complete data sets that enable a good understanding of variation across the country, with the demands placed on staff and organisations in collecting large volumes of data (often manually), which is then not available in a timely way to enable quality improvement.

During the covid-19 pandemic, all contract reporting of key performance indicators was temporarily paused. During this period, the organisation’s corporate performance team worked with all the commissioners to conduct a comprehensive review of all 6,000+ key performance indicators. All contractual key performance indicators were reviewed against jointly agreed principles for best practice measurement. Indicators needed to be:

• ●the minimum needed to provide assurance of service delivery
• ●meaningful for service users and staff
• ●balanced across outcome, structure and process
• ●removed if there was already a nationally reported indicator available

This process, which took over a year, led to a 50% reduction in contractual key performance indicators for the organisation and its staff.

Use improvement science

Core concepts in improvement science are to give power to those closest to the work, and to use data in a way that helps understand variation. ELFT shifted ownership of quality assurance to clinical teams and clinical directorates – to be able to define the standards they wished to measure in clinical audit each year, and to choose which quality assurance workstreams to participate in. These put the onus on clinical teams to determine what added value for them, and to help quality assurance feel useful and meaningful again. Whilst the clinical audit standards were now defined by local clinical leads, the frequency of auditing was increased to four times a year, with greater emphasis placed on acting from the data and tracking progress. The presentation of data from clinical audits was amended, from snapshot data that showed only one point in time, to data over time that showed how the service was meeting a standard over the course of a year or longer.

Hear the voices of the people served

Over the decade from 2014 to 2024, the voice of service users was strengthened within the way the organisation conducted quality assurance. This was epitomised by the design and introduction of a brand new programme in 2019 – service user-led accreditation. The concept of this programme was for service users to define the standards they expected services to meet, and then to visit services to talk to staff and service users, review documentation and evidence, and for the service users to award the service a level of accreditation against their standards. This is likely to be the world’s first entirely service user designed, delivered and led programme of accreditation. The nature of this programme has meant that clinical and corporate services demonstrated a real desire to take part, and receive feedback and validation from service users about the quality of care being provided.

The standards covered elements from the environment, responsiveness, involvement of the service user and their carers, the use of quality improvement, staffing, provision of information and collaboration with partner agencies. There are 27 standards, of which eight have to be met in order to achieve accreditation. Service users are trained to assess services, with some service users taking on a lead assessor role. Over 50 service users are part of the trained pool of assessors, and over 100 services have taken part in the programme. Three levels of accreditation were developed: bronze, silver and gold. After three years, a further platinum level of accreditation was introduced, which could be achieved by attaining a further 6 exceptional standards of care, for those teams that had already achieved gold.

Summary

Over the 15 years from 2011 to 2026, ELFT brought together its assurance activities and owners into a single function, led by a single team. Through reducing mandatory participation, shifting ownership more locally to clinical teams, focusing less on collection of data and more on acting on the findings, and strengthening the role of service users and patients in leading and defining quality assurance, the organisation has evolved the way that it seeks and receives assurance on the quality of care being provided. In parallel, clinical teams have continued to find quality assurance activity meaningful, and have greater autonomy about what quality assurance activities to participate in, where they are adding value.

More broadly, this represented part of an intentional move towards developing a better balanced and integrated approach to quality – which included the introduction of systematic quality improvement approaches. It is difficult to definitely gauge the effectiveness of this large-scale organisational transformation, and whether the mission was truly met by 2020 of delivering the highest quality mental health and community health in England. However, staff experience scores improved rapidly – for four of the six years between 2014 and 2020, ELFT had the highest score across all English NHS Trust for staff feeling able to contribute to improvement, and was often top in the country during this period for overall staff engagement. Three comprehensive inspections by England’s quality regulator, the Care Quality Commission, rated ELFT as ʻOutstanding’ – ELFT being the first mental health/community health provider to achieve this.

Conclusion

As healthcare’s understanding and learning about best practices with regard to quality management have evolved and developed over the last four decades, the domain of quality assurance has also matured. From a predominant assurance focus to quality management and clinical governance in the 1990s and 2000s, there is a recognised need now to balance across the four domains of quality management – assurance, improvement, planning and control. The move towards greater patient and service user leadership of quality assurance, greater clinical ownership and involvement in quality assurance, and the reduction in assurance burden, all contribute towards quality assurance remaining relevant, meaningful and engaging for healthcare teams.

With this shift towards more local and clinical ownership of quality assurance, there is a need to actively balance the opportunities and trade-offs – for example, reducing the amount of data collected for national clinical audits may reduce burden of data collection, but also limits the potential for a full understanding of variation in care provision across the country. Involving local clinical leaders in defining the standards for clinical audit leads to greater team-level engagement in quality assurance, but reduces the opportunity for organisation-level standards of care that are standardised and measured against.

As healthcare involves people with lived experience in a deeper and more meaningful way in defining and measuring standards (and then supporting services to tackle gaps), there needs to be careful attention to ensuring diversity of input, properly supporting and valuing the contribution of people with lived experience to this process, creating consensus about what matters from the patient perspective and balancing this with the clinical evidence-base about effective care, and the resources that are available in the system.

As healthcare organisations move towards a more integrated approach to quality, one of the key considerations is about creating balance – balance across the four domains of planning, control, improvement and assurance, and also balance between the benefits and trade-offs. A clearer sense of priorities through a more rigorous planning process feeds into more structured quality improvement work that aligns with priorities and reduces effort on areas that are less strategically important. Better quality control mechanisms at the point of care reduces the need for escalation and problem-solving at leadership level. More clinical and lived experience involvement in quality assurance leads to greater engagement and more meaningful assurance processes, but needs to be balanced carefully with the needs of the organisation and wider system in setting standards and understanding variation.

Ethics approval and consent to participate

Not applicable.

CRediT authorship contribution statement

Amar Shah: Writing – review & editing, Writing – original draft.

Funding

This article did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.