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«Pathology Quality Assurance Review Chaired by Dr Ian Barnes January 2014 Contents Contents 3 Chair’s foreword 4 1. Introduction 6 Why the Review? 6 ...»

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Pathology Quality

Assurance Review

Chaired by Dr Ian Barnes

January 2014


Contents 3

Chair’s foreword 4

1. Introduction 6

Why the Review? 6

Our approach 7

2. Understanding the existing system: the current assurance framework 9 External quality assurance 11 Accreditation 12 Conclusion 12

3. The need for change 13 Clinical effectiveness 13 Looking ahead: the changing nature of pathology in the NHS 15 The patient view 15 Conclusion 16

4. The way forward 17 Expected outcomes 17 Training and development for quality 18 The external quality assurance framework 22 Governance 24 Error reporting and the sharing of learning 26 Informatics and standardisation 28 Accreditation 30 Commissioning 32 Oversight 34 Case Study 36 Commissioning 36 Membership of the Review Board 38 Thanks and acknowledgements 38 Chair’s foreword Dear Sir Bruce, You asked me to chair a Review to assess the current quality assurance frameworks and governance mechanisms for pathology services at a national level, making recommendations as to how any issues I uncovered could be remedied.

This request in late 2012 followed an incident at Sherwood Forest Hospitals NHS Foundation Trust, subsequently one of the hospitals studied in your mortality review last year, where problems with quality assurance and an inadequate governance process was reported to have negatively impacted upon the care of a number of women with breast cancer.

Your ambition for quality assurance in pathology was to make it a benchmark against which other services could measure their own success.

As I have taken forward this Review, I have engaged extensively and am pleased to report that I have found your ambition to be shared across the system, from Ministers to pathology staff on the front line. I have also found consensus on areas for improvement which has allowed me to move beyond just making recommendations, to being in a position to set out an agreed system-wide way forward.

Pathology contributes to an overwhelming percentage of patient pathways, and only a service that supports the rest of the system to make the best possible decisions about treatment can be acceptable to patients. In the light of Robert Francis’ Report of the Mid-Staffordshire NHS Foundation Trust public inquiry, this means a service with a relentless focus on improvement, which champions the patient as a user and operates in a reflective and open manner, so that it can improve not only its own performance, but share its learning to benefit the rest of the NHS. Pathology services should be reliable, robust and responsive, heeding your challenge to the NHS to “make quality our primary concern”1.

In the course of this Review, the Review team and I have heard from a wide range of organisations and individuals, including a strong patient and public voice, laying out what is expected from pathology – a service which fundamentally informs clinical decisions about diagnosis and treatment – in terms of visibility, transparency, experience, communication, professionalism, reliability, safety, utility and contribution to the wider aims of NHS care.

I have heard that, for the most part, NHS pathology services compare favourably with the rest of Europe, and have multiple measures in place to ensure that the results they produce and the advice that they give is of high quality. The NHS in England boasts a dedicated and highly skilled workforce, good internal quality assessment and quality management systems, and mature external assurance of its pathology services that overall provides a safe, reliable and effective service.

1Review into the quality of care and treatment provided by 14 hospital trusts in England: overview report, July 2013 Chair’s foreword However, gaps exist. Elements of the system have become outdated. Quality must be scrutinised and made transparent, skills must be updated, and roles and responsibilities must be formalised. Steps must be taken to ensure that patients are truly safeguarded, and a culture developed where any errors that do occur are made in an environment primed to detect and correct them, seeking constantly to improve clinical and working practices through continuous learning, sharing and innovation.

It is important to note that, while the remit for the Review was for England, some of the changes suggested will impact upon the devolved administrations. We have therefore engaged with colleagues from Northern Ireland, Scotland and Wales, throughout the development of this report.

With the energy, appetite and shared aspirations for pathology quality assurance I have come across throughout this Review, it is my hope that this report and the agreed actions it sets out will speak to the service, empowering individuals and organisations, both at the centre and at the front lines, to work together to make its ambition a reality.

Yours sincerely, Dr Ian Barnes PhD, FRCPath Chair, Pathology Quality Assurance Review

1. Introduction

1.1. Pathology lies at the heart of the NHS’s work. NHS pathology services in England employ around 33,000 people in over 150 organisations responding to approximately 200 million requests a year, representing involvement in around 80% of patient interactions with the NHS.

1.2. The service routinely offers hundreds of different tests and investigations to requesting clinicians. Demand for tests has risen consistently as the NHS has understood the contribution that pathology can make to better outcomes and longer lives and patients and clinicians have consistently high levels of confidence in the service provided.

1.3. This confidence is not without foundation: the UK has been at the forefront of quality assurance in pathology for the past 50 years, leading the way on external quality assurance. The UK was, along with Holland, the first European country to introduce a laboratory accreditation scheme for pathology.

1.4. However, the current system relies almost entirely on professionalism and goodwill. It was set up to provide assurance to laboratories. It was not designed to provide public assurance to patients, nor to assist boards and commissioners in fulfilling their statutory duties.

1.5. Moreover, the current system is focused on minimal acceptable standards, and it does nothing to identify, incentivise or reward those who are striving for excellence. Nor, it must be said, does it provide much in the way of sanctions or support when laboratories do fall below an acceptable standard of performance.

1.6. We believe there is an appetite to improve and move towards aspirational practices at every level of the quality assurance system in pathology. Taken individually, the changes suggested in this report are modest and achievable.

They simply make better use of the processes we already have in place. But taken

together, these measures should ensure that pathology services are:

• visible to patients

• accountable to boards and commissioners

• reliable, robust, and responsive

• rewarded when they make improvements in quality, patient safety, and in the contribution they make to patient experience

• held to account when they fail to offer the level of service patients expect

Why the Review?

1.7. The current pathology quality assurance framework lacks several key factors:

transparency, integration, scrutiny, oversight and effective triggers for reward and sanction, without which we cannot say the best interests of patients and healthcare generally are truly being served.

1.7.1. The broad assurance framework has a lack of key assurance indicators (KAIs) to evidence quality and safety of pathology services, and to

1. Introduction enable effective contract management both within organisations and by commissioners.

1.7.2. Pathology assurance and governance is not consistently embedded in provider governance and assurance frameworks.

1.7.3. Pathology is unable to provide evidence to the Care Quality Commission (CQC)/Hospital Inspectorate of the overall quality of pathology services.

1.7.4. Pathology needs to respond to changing and additional requirements from commissioners and the public for information and assurance around consistency of provision and reporting.

1.7.5. The impact of new technology and processes (genomics, point of care testing (POCT), digitalisation, molecular techniques, informatics) on delivering pathology services, and the impact on a rapidly changing workforce, require a strengthened quality assurance framework.

–  –  –

1.8. The current system was fit for the purpose for which it was designed, but it is not fit for the future, nor does it meet the emerging requirement for transparency and well-evidenced quality assurance. Therefore, the Review and the recommendations it makes will attempt to bring these features of the system into sharper focus, strengthening existing structures to ensure these gaps are filled.

Our approach

1.9. The work of the Review was broad, covering a great number of facets and levels of an already complex system. In order to best tackle this expansive area of investigation a secretariat and a Review Board was appointed (members listed at the back of this document), and the scope of work was divided into three tiered

workstreams, each with an expert lead. These workstreams looked at:

• Professional development, ie individual responsibilities

• Quality Assurance and Governance, ie provider and trust responsibilities

• The NHS national system, ie the responsibilities of national organisations

1.10. In addition, Subject Matter Experts (SMEs), both individuals and agencies, contributed knowledge and expertise to undertake specific pieces of research and provide detailed information and analysis of some of the technical and specialist areas within the scope of the Review.

1.11. This included a survey of governance and culture with regards to pathology Quality Assurance (QA), an investigation into representative error reporting practice and attitudes, a large scale survey of aspects of roles and training for

1. Introduction quality amongst pathology staff, a comprehensive stakeholder engagement and communications programme, and technical input on the progress with, and potential for, standardisation of pathology data. Industry colleagues provided their perspective on how manufacturers can work with services to improve quality and quality assurance, and a wide range of contributors from the profession, the professional bodies, the devolved administrations, the international community, statutory and third sector bodies and regulators have generously supported the Review with their time and expertise, allowing us to shape an holistic report that attempts to address as many stakeholders’ interests as possible.

1.12. In studying the current systems of pathology quality assurance, the Review found much that was good. The professionalism, goodwill and commitment of the staff involved in the management of quality assurance schemes should be commended, as should the involvement of industry in the development and rapid diffusion of new technologies and process innovation. The professional bodies play a vital role in the existing assurance framework, and provide strong leadership for the service. The work of the Chief Scientific Officer (CSO) and team, with their recognition that the role of Healthcare Scientists is changing, has been visionary, and the efforts of the National Clinical Director (NCD) for Pathology and the Pathology Programmes at the Department of Health (DH) and NHS England have created a solid foundation of physical and human resources from which to build a pathology service that bears comparison to the best in the world.

1.13. During our Review, we asked pathology services how they assured themselves and their host organisations that their pathology service was safe, of high quality, and staffed by competent individuals. We received many submissions from organisations involved in the quality assurance of the service. We asked patients and commissioners what assurance they required, and what evidence of compliance they wanted. We also met with CQC and considered how the assessment of the quality of pathology services might best be incorporated into the CQCs new hospital inspection programme.

1.14. We have arrived at a view that the current systems of quality assurance in pathology are no longer able to meet the needs of modern healthcare, and the demand for greater transparency. Much of what is currently done is good and the structures and organisations necessary to carry out the changes proposed already exist. However, a redefinition of their scope and function is required, as well as a number of initiatives to enhance the use of data and information already collected. These themes form the basis of the recommendations of the Review.

2. Understanding the existing system: the current assurance framework

2.1. Meaningful assurance has three main requirements. There must be a clear understanding of what the service should be achieving (specification, standards), there must be clear evidence of how assurance is being achieved (key indicators, measurement), and there must be clear consequences if assurance is not provided (corrective action, sanctions).

2.2. The UK has been recognised internationally as being at the forefront of QA in pathology for decades, creating and running schemes that assure the quality of individuals, processes and systems. These include External Quality Assurance (EQA) schemes (used by pathology services as a tool to test the competence of individuals and the reliability of tests and methods), and a national laboratory accreditation scheme. The professional bodies including The Royal College of Pathologists (RCPath), Institute of Biomedical Science (IBMS), Association for Clinical Biochemistry and Laboratory Medicine (ACB) have taken the lead in setting professional standards.

–  –  –

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