Patient Safety, Law Policy and Practice

John Tingle, Pippa Bark

• Publisher: Routledge
• Year: 2011
• ISBN:
  9781136824395
• Edition: 1
• Topic: Law
• Subtopic: Law Theory & Practice
• Index: Law

Patient safety is an issue which in recent years has grown to prominence in a number of countries' political and health service agendas. The World Health Organisation has launched the World Alliance for Patient Safety. Millions of patients, according to the Alliance, endure prolonged ill-health, disability and death caused by unreliable practices, services, and poor health care environments. At any given time 1.4 million people worldwide are suffering from an infection acquired in a health facility.

Patient Safety, Law Policy and Practice explores the impact of legal systems on patient safety initiatives. It asks whether legal systems are being used in appropriate ways to support state and local managerial systems in developing patient safety procedures, and what alternative approaches can and should be utilized. The chapters in this collection explore the patient safety managerial structures that exist in countries where there is a developed patient safety infrastructure and culture. The legal structures of these countries are explored and related to major in-country patient safety issues such as consent to treatment protocols and guidelines, complaint handling, adverse incident reporting systems, and civil litigation systems, in order to draw comparisons and conclusions on patient safety.

1 Managing quality, safety and risk

Jo Samanta and Ash Samanta

Introduction

Quality, safety and risk are key components that underpin a health service of the highest rank. The need for successful management of these elements was emphasised in To Err Is Human¹ and An Organisation with a Memory.² Concern about safety, quality and risk is rooted in antiquity but the challenge remains as to how to ensure that a modern healthcare system is efficient, effective and safe.³ Despite major advancements in clinical care alongside technological innovation, the risk of iatrogenic harm to patients remains considerable.

Prior to 1999 the common law duty imposed upon healthcare providers in this jurisdiction was to exercise reasonable care and skill in the provision of services. The Health Act 1999, s18(1) stated that it was ‘the duty of each [NHS provider] to put and keep in place arrangements for the purpose of monitoring and improving the quality of healthcare which it provides for individuals’. This standard was revised by s45 of the Health and Social Care (Community Health and Standards) Act 2003, which states that it is the duty of each NHS body to ensure that arrangements are in place for the purpose of monitoring and improving the quality of healthcare provided by those organisations. The Department of Health labelled these arrangements a ‘framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’.⁴ The statutory duty of quality incorporates evaluation of organisational risk management and audit mechanisms as well as accountability.

Quality, safety and risk management of healthcare are inextricably intertwined, and in our view should be seamlessly pervasive throughout the layers of policy, provider organisations and their management, and practice resulting in good clinical care. This chapter focuses on the principal issues surrounding the management of these factors within the context of contemporary health service delivery in the UK.

Policy

The NHS constitution and legislative reform

In 2007 the Secretary of State for Health announced a wholesale review of the National Health Service. The NHS Next Stage Review ‘Our NHS, Our Future’, led by Lord Darzi, aimed to develop a 10-year strategy for health services following engagement with patients, staff and the public.⁵ The subsequent Interim Report set out a 10-year plan for the NHS to become fairer, more personalised, effective and safe. The Report puts the case for a Constitution to enshrine the values of the NHS, setting out the key rights and responsibilities of patients and staff. The NHS Next Stage Review Final Report High Quality Care for All (2008) advanced a conceptual strategy for health services with a clear focus on quality. The Health Act 2009 is the enabling statute that implements those aspects of the Next Stage Review that require primary legislation. Provisions include the NHS Constitution and Quality Accounts, and enables direct payments to be made in defined circumstances for healthcare services.

The sections of the Health Act 2009 that pertain to the NHS Constitution set out duties of these organisations involved with the provision, commissioning or regulation of care and those delivering NHS services under contracts or arrangements. The Constitution is subject to review by the Secretary of State for health at least every decade, following consultation with local authorities, staff and patients. The Constitution confers rights to service users, supported by redress and remedial mechanisms designed to put things right (as opposed to monetary compensation).

Strategic Health Authorities, NHS Foundation Trusts, Monitor and the Care Quality Commission have a statutory duty to have regard to the NHS Constitution when commissioning or providing services, when carrying out their functions as a regulator.⁶ Part 2 of the Act describes powers in respect of failing NHS organisations. Under its auspices Foundation Trusts are designed to be accountable to local communities, as opposed to the Secretary of State. They are authorised by the National Health Service Act 2006 and are subject to regulation by Monitor, the Independent Regulator of NHS Foundation Trusts. Monitor has authority to intervene in circumstances of failure and can remove directors under its legislative powers.⁷ If a Trust fails to comply the Secretary of State may make an order to dissolve the organisation or transfer its property or liabilities to another trust.⁸ However, these provisions do not give Monitor or the Secretary of State power to de-authorise a Foundation Trust or return it to ordinary trust status. The Health Act 2009 also provides powers of suspension. The outbreaks of Clostridium difficile at Maidstone and Tunbridge Wells NHS Trust highlighted the need to ensure that quick interventions could be made and that, if necessary, authority was available to suspend chairs and members of NHS boards. To this effect, the Health Act 2009 describes enhanced powers to suspend such role holders of NHS organisations.

The Health and Social Care Act 2008 gives statutory force to the quality agenda by enhancing regulation of healthcare services. Part 1 of the Act establishes the Care Quality Commission, the body responsible for the registration, review and inspection of specific health and social care services in England. It replaces the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission.

The 2008 Act creates a system of registration for service providers, and enabling regulations will operate to identify the activities which a person will not be able to undertake unless that person is registered. The Commission has power to issue penalty notices for non-compliance and can also suspend registration.⁹ It also has jurisdiction over the professional regulatory bodies, whose role is to protect patients and the public in the execution of their statutory duties.¹⁰ The Act pertains to 12 of the regulatory bodies and operates to create an encompassing body corporate known as the Office of the Health Professions Adjudicator.¹¹ Its functions will be discharged by fitness to practise panels, and the standard of proof to be applied in such proceedings is that applicable to civil proceedings.¹² The Act renames the Council for Regulatory Excellence as the Council for Healthcare Regulatory Excellence and amends its constitution, functions and the way members are appointed.¹³

The Secretary of State may make regulations to require designated bodies in the United Kingdom to nominate or appoint ‘responsible officers’ for the regulation of doctors. Their role has been extended to cover clinical governance provisions such as the monitoring of conduct and performance of doctors. Information can be shared about concerns over the conduct and performance of healthcare workers to approve appropriate actions necessary to protect patients and the public.

National Health Service organisations have been subject to a statutory duty to ensure that arrangements are in place to monitor and improve the quality of care provided.¹⁴ Section 139 of the Health and Social Care Act 2008 amends section 23 of the National Health Service Act 2006 to impose a duty on Primary Care Trusts to ensure arrangements are in place to secure continual improvement in the quality of healthcare provided by or for them. Since April 2010 all NHS Trusts have been required to report to the National Patient Safety Agency (NPSA) every serious patient safety incident following which a patient is injured or dies whilst receiving care.¹⁵

National Service Frameworks

National Service Frameworks (NSFs) are policies set by the NHS to define standards of care and reduce variations in specific healthcare services. These quality initiatives were introduced in The New NHS, Modern, Dependable¹⁶ and set national healthcare standards to improve the quality of service provision and promote equitable access to healthcare. NSFs identify service models for specified care groups, alongside strategies for implementation and quality indicators against which progress within a timeframe can be assessed. They set clear quality requirements based upon best avail able evidence. One new framework is introduced each year as part of a rolling programme developed following input from an external reference group of service users, staff, health service managers and voluntary agencies. Topics are chosen because of their relevance to the government’s agenda for health improvement, healthcare inequalities and care quality indicators as well as areas of public concern on account of perceived shortfalls between acceptable and actual practice.

The NSFs receive considerable publicity and have raised legitimate expectations. As policy documents they operate at the level of guidance, and by themselves give no new legal rights to patients. Common law shows how notoriously difficult it is to challenge resource decisions and the courts remain reluctant to intervene in matters considered to be governed by policy. This reluctance was apparent in Sir Thomas Bingham’s explanation in R v Cambridge HA, ex p B (1995) that ‘[d]ifficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. That is not a judgment which the court can make’.¹⁷ Such judicial reluctance has since been tempered due to the need for healthcare organisations to provide reasons for decisions made.

Quality assurance

Quality assurance mechanisms such as the NSFs and nationally developed guidelines for practice rely upon local action to audit and maintain clinical standards. Davies¹⁸ suggests that doctors might neutralise the accountability mechanisms that apply to their colleagues during clinical audits by withholding adverse comments on a colleague’s performance out of concern about detrimental effects upon working relationships, or because of increased personal workloads if that colleague is suspended from duties. Whilst these effects might appear unlikely where patient safety is concerned, in pressured working environments they might interfere with a clinician’s professional judgement.

Doctors are involved in the process of drafting NSFs and guidelines, through professional collegiate bodies and as individually commissioned experts, a situation that might operate to deflect standard setting onto issues that are tangential to the central issues being regulated. By way of example Davies asserts that doctors’ involvement might encourage standards to be set according to process, rather than standards that require substantive clinical judgement. Opportunities are also available to ensure that audit methods are flexible and discretionary, to the extent that practitioners applying these check mechanisms are unlikely to encounter significant challenges to their working practices.

Potential safeguards have been incorporated to prevent neutralisation of audit and quality maintenance. The requirement for consultation with representatives of ...

Table of contents

• Cover
• Halftitle
• Title
• Copyright
• Contents
• Notes on contributors
• Table of cases
• Table of statutes
• Preface
• Introduction
• 1. Managing quality, safety and risk
• 2. Pre-trial clinical negligence issues
• 3. The tort of negligence and patient safety
• 4. Medical ethics and patient safety
• 5. Psychological aspects of patient safety
• 6. Blame free reporting
• 7. Economic aspects of patient safety
• 8. Patient safety in secondary care
• 9. Patient safety in mental health care
• 10. Regulating patient safety in the European Union
• 11. Patient safety and clinical risk management in Germany
• 12. Patient safety and the law in Canada
• 13. New developments in the US
• 14. Patient safety in American health care
• 15. Responding to patient harm
• Index