Select Committee on Health Written Evidence


Memorandum by the Department of Health (PS 01)

PATIENT SAFETY

EXECUTIVE SUMMARY

  Patient safety is a challenge faced by healthcare systems all over the world. Modern healthcare brings many benefits but also increased risks to patients. Unsafe care is a significant source of preventable patient mortality and morbidity worldwide. One in ten patients admitted to hospitals will experience some sort of unintended harm, although not all of this is serious and not all of it is preventable.

  The most commonly reported incidents in England are patient falls, incidents associated with treatment and care and medicines related errors. Healthcare associated infections are also a significant safety issue.

  Safety is a fundamental element of quality and demands a system-wide effort. This requires a broad range of actions in organisational leadership, performance improvement, environmental safety, risk management and clinical engagement.

  Patient safety embraces all healthcare disciplines. No one professional group can solve this problem on their own. Action is needed to address risks to patient safety in individual services as well as broad long-term solutions for the NHS as a whole.

  Growing interest in the safety of patients among policy makers must be matched by sustained leadership and action. As exemplified by other high-risk industries, commitment is needed over the long term. Priority areas include:

    —  Embedding patient safety: Patient safety must be a high priority for standard setting, accountability, monitoring and review arrangements.

    —  Continue to strengthen reporting and learning systems. The most important knowledge in patient safety is how to prevent harm to patients during treatment and care. Local NHS organisations need to invest in robust risk management systems. National reporting has a vital role to play.

    —  Clear mandate and role for Boards within NHS organisations to assure the safety culture and performance of their organisation. Without strong and visible leadership from NHS Boards, senior managers and senior clinicians, patient care will not be safer.

INTRODUCTION

  1.  England was one of the first countries to give priority to tackling patient safety. The 2000 report, An Organisation with a Memory is still widely regarded as a seminal document.[1] It has galvanised action and commitment to patient safety both within the United Kingdom and internationally.

  2.  Improving the safety of patient care is a significant challenge for the NHS, as it is for many health services around the world. According to a Eurobarometer survey, 78% of European citizens consider medical errors to be an important issue.[2] No country can claim to have solved the problem of healthcare errors. In England, we are fortunate in many ways. Our healthcare system is affordable and accessible to all; it is staffed by skilled and dedicated professionals; and anybody who falls ill can reasonably expect a high standard of care. However, things can, and do, go wrong.

  3.  Modern healthcare relies on a range of complex interactions between people, technologies and drugs. Patients are sicker. Care is often delivered in pressurised and fast-moving environments, involving a vast array of equipment and, daily, many individual decisions and judgements by health-care staff. Sometimes unintentional harm comes to a patient during a clinical procedure or as a result, of a clinical decision. Errors in the process of care can also result in injury. Sometimes the harm that patients experience is serious and sometimes people die.

  4.  Errors in health care are usually provoked by weak or inadequate systems within and across health care organisations. These events are not random, one-off unconnected events. They often have common root causes relating to weakness, breakdown or dysfunction within an organisation's operational methods, processes or infrastructure.[3] Factors contributing to system failure are not always immediately apparent such as poor design of equipment or inadequate supervision of junior staff. Most unintended harm to patients is not the result of negligence or lack of training.

  5.  Countermeasures based on changes in the system are therefore more productive than those that only target individual practices or products, although both approaches are needed. For example, in 2007 the Medicines and Healthcare products Regulatory Authority (MHRA) received over 8,600 adverse incident reports relating to medical devices. Of these, 193 concerned patient deaths and 1,093 concerned serious injuries (although not all of these were caused by faulty devices).

  6.  Improving patient safety requires resilient organisational systems. Resilience is the degree to which an organisation continuously prevents, detects, mitigates or ameliorates hazards or incidents. Improving resilience encompasses the culture, processes and structures that prevent system failure and improve overall patient safety. Put simply, resilience refers to whether an organisation can stop small hazards becoming big risks.

  7.  A strong, open organisational safety culture is important ie "the way we do things around here—especially when no one is looking". A culture of blaming individuals and retribution can itself cause harm and prevent safety from flourishing.

  8.  Experience from other high-risk industries shows that an effective safety culture requires clarity about individual and organisational responsibilities. Patient safety requires well designed processes and structures of healthcare delivery. Competent, conscientious and risk aware health care providers are also essential at the "sharp end".

WHAT ARE THE RISKS TO PATIENT SAFETY AND ARE THEY AVOIDABLE?

  9.  The problem of adverse events in health care is not new. Research evidence stretching back 25 years points to unsafe care as a significant source of patient morbidity and mortality, but the subject remained largely neglected for many years. Further evidence emerged in the early 1990s with the publication of the Harvard Medical Practice Study.[4] Subsequent research in Australia, the United Kingdom and the USA and in particular the 1999 publication To err is human: building a safer health system by the Institute of Medicine, provided further data and brought patient safety to the forefront of the policy agenda and public debate worldwide.[5],[6] ,[7]

  10.  Today many more countries, including Canada, Denmark, Spain and New Zealand have published credible scientific studies on the prevalence of adverse events.[8],[9] ,[10] ,[11] Based on this research, it is estimated that one in ten patients admitted to hospitals will experience some form of unintended harm. Not all of this will be serious. Clinical review of patient records suggests that around 50% of these events could have been prevented given current knowledge and standards of practice.[12]

  11.  Much of the current evidence comes from hospitals, because the risks associated with hospital care are high. Many adverse events occur in other healthcare settings but there are fewer data on the extent of the problem outside hospitals.

Data from the National Reporting and Learning System

  12.  England and Wales are uniquely placed compared to other countries because there are national data on the size, scope and nature of unsafe patient care through reporting to the National Patient Safety Agency (NPSA) National Reporting and Learning System (NRLS). The NRLS is the most comprehensive national incident reporting system in the world. Every NHS staff member in every type of organisation—acute, primary care, mental health and ambulance—can report to the NRLS.

  13.  Significant progress has been made since the publication of Safety First to ensure that the NRLS provides actionable feedback to the NHS and the benefits of national reporting are realised. The NRLS has shown a steady increase in the volume and consistency of reporting (Figure One). More than 90% of Trusts now report regularly every quarter. Detailed data summaries from the NRLS are published quarterly.[13]


  Figure One: Number of incidents reported to the NRLS, Oct 2003 to June 2008 (England).

  14.  The most common types of reported incidents in the acute care sector are outlined in Figure Two. The main types are:

    —  Patient accidents mainly slips, trips and falls;

    —  Patient safety incidents associated with the delivery of treatment and/or clinical procedures;

    —  Medication related incidents usually associated with drug administration errors, for example, incorrect dose;

    —  Patient safety incidents associated with access/admission, transfer or discharge of patients. For example, delay in ambulance transportation for emergency transfer;

    —  Safety issues associated with healthcare infrastructure such as staffing, facilities and environment of care.



  Figure Two: Reported incident types in acute/general hospitals April 2007 to March 2008 (England).

  15.  The majority of incidents are reported as resulting in no harm to patients (around 66%—see Figure Three). Around 1% of incidents are reported as associated with severe harm or death. This is consistent with available international data. All reports of serious harm and patient deaths are reviewed by expert clinical reviewers at the NPSA to identify common contributing factors which may need action across the NHS. Rapid Response Reports are disseminated across the NHS for action. This work also draws on other sources such as Serious Untoward Incident Reports (SUIs) and reports from Coroners.


  Figure Three: Reported degree of harm to patients April 2007 to March 2008.

Other safety issues

  16.  Tackling healthcare associated infections has been a major focus for patient safety in the NHS. The latest Health Protection Agency data for April to June 2008 show significant progress across the NHS. The incidence of Methicillin resistant Staphylococcus aureus (MRSA) bloodstream infections has been reduced by 57% to 836 cases. In the first quarter of this year Clostridium difficile (C. difficile) infections have also shown a 32% decrease in the most vulnerable 65s and over group on the same quarter last year.[14]

  17.  The NHS is required to deliver a 30% reduction in the number of C.difficile infections by March 2011 and to sustain progress on reducing the number of MRSA bloodstream infections to 2010-11, keeping the number below half the 2003-04 level. Targets are not designed to limit the ambitions of organisations that wish to go further, faster. Rather, they emphasise the need to continuously strive for safe, high-quality care whenever patients come into contact with the NHS.

  18.  There is no single solution for reducing healthcare associated infections. The Clean, Safe Care strategy encompasses good hand hygiene, high standards of cleanliness, effective patient screening for MRSA and sensible use of antibiotics. These measures are backed by significant additional investment and all supports the legal requirement for NHS bodies to maintain proper infection control. The new regulator, the Care Quality Commission will have tough powers to investigate and intervene in ensuring the NHS meet the required standards. In the meantime, the Healthcare Commission will continue to inspect all acute trusts.

How much does unsafe care cost the NHS?

  19.  Unsafe care wastes scarce NHS resources. The economic benefits of improving safety are compelling. In the UK, the cost of consequent additional hospital stays alone is about £2 billion a year and paid litigation claims cost the NHS around £600 million annually, in addition to an estimated potential liability of £11,950 million for existing and expected claims.[15] The total national cost of preventable adverse medical events in the USA, including lost income, disability and medical expenses, has been estimated at between US$17,000 million and US$29,000 million annually. Added to these costs is the erosion of trust, confidence and satisfaction among the public and health-care providers.

  20.  In its review of patient safety, the National Audit Office (NAO) found that some NHS Trusts had estimated figures ranging from £88,000 to £400,000 per year for patient safety incidents. The cost of specific events has also been analysed. The NAO reported that a fractured neck of femur due to a fall in hospital costs £10,000, and inadequate patient information or clinical details on diagnostic requests costs approximately £1 million per year.[16] In a review of national incident reports associated with patient falls, the NPSA estimated that the immediate healthcare cost of treating falls is over £15 million for England and Wales per year.[17]

Can the NHS learn from the safety record of other high risk industries?

  21.  An Organisation with a Memory highlighted other high-risk industries that have a much better safety record than healthcare. Much can be learned from this experience

  22.  The aviation industry has an impressive safety record, which is getting better all the time. Such results have been achieved through a systematic focus on safety as a core part of business strategy for many decades. The year 2004 was the safest ever for air travel: the number of airline fatalities worldwide was at the same level as in 1945. This was despite the fact that the number of passengers increased from 9 million to 1.8 billion per annum. This has been achieved by a constant search for better and safer ways of designing, constructing and flying aeroplanes. Indeed, in the United States alone, if the accident rate today had remained the same as when jet transportation was introduced in the 1950s, there would be around 300 major airline accidents every year. These are compelling statistics.[18]

  23.  At its heart, the success of aviation safety has several key elements:

    —  clear, measurable goal setting for safety improvements with strong leadership;

    —  data that are useful and used to understand the changes that need to occur;

    —  comprehensive and multifaceted approaches to risk management;

    —  building a strong safety culture that is owned by everyone in the organisation;

    —  comprehensive oversight and monitoring with clear accountabilities for action.

WHAT DO NHS ORGANISATIONS NEED TO DO?

  24.  The experience of other high-risk industries demonstrates that organisations with a strong culture of safety demonstrate certain characteristics. Applied to the NHS, this experience suggests that organisations which are serious about patient safety must have effective systems in place to prevent and detect harm to patients while receiving health care.

  25.  A central foundation for building well targeted safety initiatives is to better understand the nature of the hazards and risks faced in providing patient care. Safety cannot be improved without a range of valid reporting, analytical and investigative tools that identify sources and causes of risk in ways that lead to preventative action and organisation wide learning. While good progress has been made in many organisations more needs to be done.[19]

  26.  Strategies to ameliorate the effects of any such harm on patients, their families and healthcare providers are also vital. Consumers of health care are at the heart of patient safety. When things go wrong, they and their families suffer from any harm caused. Such harm is often made worse by the defensive and secretive way that many healthcare organisations respond.

  27.  This highlights the importance of being more open with patients and their families and support for frontline staff in making this possible. Around the world, health care organisations that are most successful in improving patient safety are those that encourage close cooperation with patients and their families. This is an area which requires continued focus.

  28.  At its heart, the test of whether an organisation is tackling the patient safety agenda will be reflected in the everyday experience of its patients and the practical ways in which frontline staff are supported to implement safer practices.

  29.  Patient safety is everyone's business and front line staff need to be strongly involved. Initiatives such as the National Patient Safety Campaign and educational initiatives are designed to strengthen frontline understanding, engagement and clinical leadership. There also needs to be a greater focus on strengthening team work in health care. Creating high performance teams is a key safety strategy in other high risk industries but not in health care so far.

WHAT HAS BEEN THE NATIONAL POLICY RESPONSE IN ENGLAND TO ACHIEVE THIS?

  30.  A number of reviews of patient safety have been conducted by government over the past 10 years focusing on ensuring that the NHS is able to learn from errors, through better reporting systems, skilful investigation of incidents and responsible sharing of data, and building greater skill and capacity to anticipate errors and address weaknesses in systems.

  31.   An Organisation with a Memory set out to review the scale and nature of serious failures in the NHS and the capacity for system-level learning to minimise the likelihood of these errors being repeated. The report concluded that if the NHS was to successfully learn from failures, four key areas had to be addressed:

    —  a unified mechanism for reporting and analysing when things went wrong;

    —  a more open culture in which errors could be reported and discussed;

    —  a method for ensuring that when a systemic error was identified it was rectified across the system;

    —  a wider appreciation of the system approach in preventing, analysing and learning from errors.

  32.   An Organisation with a Memory provides an enduring set of concepts to inform the patient safety programme in the NHS. Patient safety was subsequently incorporated into the NHS Plan and a blueprint, Building a Safer NHS for patients, was published in 2001 to implement the 10 recommendations in An Organisation with a Memory.[20] The overall policy objective was to provide an independent national system to record adverse events and near misses so that the NHS could minimise such incidents in the future. The NPSA was established to implement and operate the new NRLS in all sectors of the NHS. Key challenges have been the creation of a reporting culture and building local capability. This has been supported by the introduction of national core and developmental standards for safety.

  33.  Following a National Audit Office (NAO) report A Safer Place for Patients: Learning to improve patient safety in November 2005 examining the strategy for ensuring that the NHS was learning the lessons from patient safety incidents and the progress of that strategy, the Chief Medical Officer commissioned a review of the organisational arrangements to support patient safety in the NHS. The subsequent report, Safety First, published in December 2006 focussed on the role of the NPSA but also included other agencies and how the Department of Health supports the patient safety agenda.[21]

  34.  The review found that patient safety was now getting a significant national profile. However, it was not always given the same priority or status as other major issues such as reducing waiting times, implementing national service frameworks and achieving financial balance.

  35.  The review also found inconsistent evidence that data collected through the NRLS were effectively informing local, risk-reduction strategies. Opportunities for achieving "on the ground" improvements across the NHS had been missed. In many cases the environment needed to motivate clinical and non-clinical staff to insist that all care must be safe as possible had not been created.

  36.   Safety First made 14 recommendations to build on the progress that had been achieved and to refocus efforts to enable clinicians and healthcare organisations to deliver safe care and to harness the skills and expertise of the NPSA and all the other agencies to ensure the patient safety agenda is owned by clinicians at the front line and by the most senior policy makers in the NHS. Significant progress has been made to implement these recommendations. Appendix C sets out detailed progress for each of the recommendations.

  37.  In addition to the NPSA, a growing number of organisations and stakeholders, for example the Healthcare Commission, have played a significant role in patient safety at national level. This is a welcome development as no one body can address all of the requirements of a comprehensive patient safety agenda. The National Patient Safety Forum set up as a result of the recommendation of Safety First provides an important mechanism for information exchange among key national organisations. A summary of the key national stakeholders and their roles is outlined in Appendix C.

  38.  Lord Darzi's report High quality care for all sets out a vision for the NHS that has quality of care—personal, safe and effective—at its heart. Such a vision places a continued emphasis on patient safety as an integral component of quality health care. As a result, safety is proposed as a key part of the NHS Constitution currently under consultation. The report also announced an intention to streamline national reporting mechanisms and allowed the NPSA to further adopt initiatives from international best practice.[22]

HOW DOES ENGLAND FIT WITHIN THE WIDER INTERNATIONAL CONTEXT?

  39.  Action on patient safety in England forms part of a wider global effort on patient safety working closely with the World Health Organisation (WHO) World Alliance for Patient Safety. The World Alliance gives effect to a World Health Assembly Resolution (2002) urging WHO and Member States to pay the closest possible attention to patient safety.[23]

  40.  The Alliance raises awareness and political commitment to improve the safety of care and facilitates the development of patient safety policy and practice in all WHO Member States. Each year, the Alliance delivers a number of technical programmes to improve patient safety around the world. The World Alliance is chaired by Sir Liam Donaldson, Chief Medical Officer for England.

  41.  England makes significant expert contributions to technical work programmes largely through the NPSA. This includes reporting and learning systems, the development of an internationally agreed taxonomy for patient safety, work on safety solutions and close involvement in the Global Patient Safety Challenges on hand hygiene and safe surgery.

  42.  Close collaboration with the World Alliance brings international knowledge and experience to the patient safety agenda in England. There are many examples worldwide of organisations and best practices from which we can learn. Appendix C describes some of these organisations. There is also considerable interest internationally in patient safety developments here. England makes an important contribution to global knowledge and progress on patient safety.

  43.  The United Kingdom is also involved at the European level including the High Level Group on Health Services and Medical Care (the UK co-chairs its Patient Safety Working Group), and the European Network on Patient Safety (EUNetPas) which facilitates Member State collaboration on reporting and learning systems, education for patient safety, medication safety and safety cultures.[24]

WHAT SHOULD THE NHS DO REGARDING PATIENT SAFETY?

  44.  Growing interest in the safety of patients among policy makers and clinical leaders must also be matched by sustained leadership and action. As exemplified by other high-risk industries, commitment is needed over the long term. Three key priority areas are proposed:

  45.  Embedding patient safety: Assuring and improving patient safety must continue to be a high priority for standard setting, accountability, monitoring and review arrangements, with a particular focus on ensuring timely implementation of risk-reduction strategies and safety interventions. The same errors and system failures are often repeated. Action to reduce known risks is often too slow even where solid evidence exists.[25] The culture of safety culture of health care is not yet clearly focused or organised enough to rapidly reduce potentially fatal risks to patients. Organisations such as the NPSA and the new Care Quality Commission will play a leading role in identifying priority areas for action.

  46.  Continue to strengthen reporting and learning systems: The most important knowledge in patient safety is how to prevent harm to patients during treatment and care. Local NHS organisations need to invest in robust risk-management systems. National reporting has a vital role to play in helping to spot trends in patterns of risks which are not visible at a local level and to identifying new and emerging hazards. The NRLS is a unique knowledge resource for the NHS and continued effort is needed to build on it and improve it. For example, greater involvement of clinical specialties. An important focus for patient safety is the clinical specialty, each of which has its own hierarchy of risk and challenges to be addressed.

  47.  Ensure a clear mandate and role for Boards within NHS organisations: Without strong and visible leadership from NHS Boards, senior managers and senior clinicians, a strong organisational culture for patient safety will not be achieved. The Healthcare Commission investigation into failures in infection control at Maidstone and Tunbridge Wells NHS Trust demonstrates what can go wrong when organisational and clinical leadership is not sufficiently focused on patient safety.[26] Boards need to assure themselves that patient safety is a high priority within their organisation.

September 2008

Appendix A

WHICH ARE SOME OF THE KEY ORGANISATIONS NATIONALLY?

  In addition to the NPSA, a growing number of organisations and stakeholders have played a significant role in patient safety at national level. This is a welcome development as no one body can address all of the requirements of a comprehensive patient safety agenda. The National Patient Safety Forum, set up as a result of the recommendation of Safety First, provides an important mechanism for information exchange among key national organisations. A summary of the key national and international stakeholders and their roles is outlined below.
Stakeholders Role
National Stakeholders
National Patient Safety Agency (NPSA)The NPSA manages a national reporting system which receives confidential patient safety incident reports from staff working in all NHS settings in England and Wales. Working closely with clinicians and safety experts, these reports are analysed to identify common sources of risk and actions to improve patient safety. The NPSA develops and disseminates safety recommendations and advice and provides tools to help implement safer practices. It is one of the three partner organisations running the National Patient Safety Campaign.
Medicines and Healthcare products Regulatory Agency (MHRA) MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. It makes fact-based judgements about any new device to ensure that the benefits to patients and the public justify the risk of introducing it. The MHRA also maintains surveillance over medicines and devices, and takes any necessary action to protect the public promptly if there is a problem.
National Institute for Health and Clinical Excellence (NICE) NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. A key part of NICE guidance is clinical effectiveness of which safety is a central theme.
National Clinical Assessment Service (NCAS) The National Clinical Assessment Service (a separate business unit of the NPSA) promotes patient safety by providing confidential advice and support to the NHS in situations where the performance of doctors and dentists is giving cause for concern.
The Healthcare CommissionThe Healthcare Commission exists to promote improvements to the quality of healthcare and public health in England and Wales. In England it is responsible for assessing and reporting the performance of NHS Trusts and independent healthcare providers. The Healthcare Commission also has powers to inspect where a serious failing in safety is detected and impose remedial action.
The National Institute for Innovation and Improvement (NHS III) NHS III supports the NHS to transform healthcare for patients and the public by rapidly developing and spreading new ways of working, new technology and world class leadership. NHS III runs a priority programme designed to educate clinicians in skills to lead improvements in patient safety. It is one of the three partner organisations running the National Patient Safety Campaign.
General Medical Council (GMC)The GMC is the independent regulatory body for doctors. It publishes Good Medical Practice, the code of conduct all doctors are required to follow. Good Medical Practice contains a section on patient safety requiring doctors to take adequate action to address patient safety issues if they have good reason to believe it has been compromised. The GMC has the power to strike doctors from the medical register if their fitness to practice is deemed to be impaired by failing to comply with Good Medical Practice or if a doctor causes serious deliberate or negligent harm to patients.
The Nursing and Midwifery Council (NMC)
The NMC performs a similar function to the GMC however regulates nurses and midwifes rather than doctors.
The Health FoundationThe Health Foundation is a charity working to improve the quality of healthcare in the UK. They projects, research and evaluation studies to further this aim. One of their projects is the Safer Patients Initiative which provides funds to individual NHS Trusts to develop exemplar approaches to improving patient safety in their organisations. It is also one of three partner organisations running the National Patient Safety Campaign.
The Academy of Medical Royal CollegesThe Academy and individual Royal Colleges, as the professional bodies for the various specialties in medicine, take a close interest in the national patient safety agenda. Most of the Colleges have individual patient safety programmes or take an active part in national or international initiatives. The Royal College of Surgeons for example is key player in the World Alliance for Patient Safety's Safe Surgery programme.
The NHS Litigation Authority (NHS LA)The role of the NHS LA is to act on behalf of NHS bodies when claims of negligence are made against them. The NHS LA also has a `risk management' function under which it seeks to help NHS bodies avoid negligent or preventable accidents.
NHS ConfederationThe NHS Confederation is the only independent membership body for the full range of organisations that make up the NHS. It represents over 95% of NHS organisations as well as a growing number of independent healthcare providers. It aims to influence policy, implementation and the public debate, support leaders through networking, sharing information and learning promoting excellence in employment.
The National Audit Office (NAO)The NAO has taken an interest in patient safety due to the costs association with unsafe healthcare. It published a report in 2005 which made a number of recommendations to strengthen the patient safety arrangements at national level.
International Stakeholders
The Devolved AdministrationsEach of the Devolved Administrations has representatives on the National Patient Safety Forum to ensure close working and shared learning between the four countries.
The European Union Patient Safety Working Group The European Commission has a Patient Safety Working Group which aims to facilitate and support its Member States in their work and activities. The Working Group is currently co-chaired by the Chief Executive of the National Patient Safety Agency on behalf of the Chief Medical Officer for England.
The World Alliance for Patient SafetyThe Alliance raises awareness and political commitment to improve the safety of care and facilitates the development of patient safety policy and practice in all WHO Member States. Each year, the Alliance delivers a number of programmes covering systemic and technical aspects to improve patient safety around the world. England takes an active part in these programmes notably the Clean Care is Safer Care and Safe Surgery initiatives. England's Chief Medical Officer is also the Chair of the Alliance.
The Institute for Health Improvement (IHI) IHI is an independent not-for-profit organisation in the US helping to lead the improvement of health care throughout the world. It was the driving force behind the 100,000 Lives campaign in the US and has extensive experience in the patient safety field. IHI frequently assists UK-based initiatives.
Joint Commission for the Accreditation of Hospital Organisations The Joint Commission is the organisation which accredits hospitals in the US. Most US insurers will not pay for treatment unless it is accredited by the Joint Commission. Patient safety is one of their core criteria and they also operate in a number of countries around the round. They are one of the major advisers to WHO.


Appendix B

KEY DEFINITIONS

  Progress on patient safety in England and internationally has been compromised by the inconsistent use of language. Similar concepts may have different labels (such as near miss, close call) and certain terms are sometimes used to embrace several concepts. For example, an earlier survey, seventeen definitions for error were found and fourteen for "adverse event". Through the WHO World Alliance for Patient Safety, a comprehensive international classification is being developed with agreed concepts, definitions and terms. The National Patient Safety Agency is playing a leading role in this work.

  The following definitions are used within this submission:
Adverse eventAn incident which results in harm to a patient.
Patient safetyFreedom for a patient from unnecessary harm or potential harm associated with healthcare.
ErrorA failure to carry out a planned action as intended or application of an incorrect plan.
Patient Safety IncidentAn event or circumstance which could have resulted, or did result, in unnecessary harm to a patient.
System failureA fault, breakdown or dysfunction within an organisation's operational methods, processes or infrastructure.


  Source: Conceptual Framework for the International Classification for Patient Safetywww.who.int/patientsafety

Appendix C

  Report against each of the Safety First recommendations:

Recommendation Progress
1As the next round of national goals, priorities and targets are being established from the period from 2008, it is important that the NHS takes steps to ensure that patient safety is further deeply embedded as a core principle that underpins those priorities. Patient safety is at the heart of the Department of Health's national goals and priorities. The first goal within the Department's Strategic Objective, Better Care for All, is: `We will provide you with the safest possible healthcare'.

The Department's Health & Social Care Outcomes and Accountability Framework sets out objectives and performance indicators for Primary Care Trusts as commissioners of services for the period 2008-2011. Commissioners now have a key role in establishing and monitoring quality and safety requirements in the services they commission.

The revised NHS Standard Contract for Acute Services for 2008-09 identifies the requirement to meet nationally mandated quality and safety indicators.

From April 2010, a common registration system for health and adult social care providers will be introduced. It will bring in essential safety and quality registration requirements that will apply to providers within the scope of registration, including both public and independent providers.

The draft NHS Constitution pledges that the NHS will strive to ensure that services are provided in a clean and safe environment that is fit for purpose, based on national best practice. It also pledges that all staff will be empowered to put forward ways to deliver better and safer services for patients and their families.

Finally, the NHS Next Stage Review makes clear that continuously improving patient safety should be at the top of the healthcare agenda for the 21st century.

2The Department of Health should establish a National Patient Safety forum, jointly chaired by the Chief Executive of the NHS and the Chief Medical Officer, to harness the skills and expertise of a number of organisations, agencies and stakeholders which are making a significant contribution to patient safety. The National Patient Safety Forum was established in February 2007. Its membership includes representatives from the NHS, other stakeholder organisations and patients. It has played a key role in co-ordinating and supporting the National Patient Safety Campaign. It has general oversight of the implementation of the Safety First recommendations and receives regular progress reports.
3The National Patient Safety Forum should oversee the design and implementation of a national patient safety campaign-focused initiative. The objective of this initiative should be to engage, inform and motivate clinical staff and healthcare providers o address the challenge of providing safer healthcare. A two-year campaign was launched at the NHS Confederation Annual Conference on 19 June 2008. It is being led by the National Patient Safety Agency (NPSA) in conjunction with The Health Foundation and the NHS Institute for Innovation and Improvement. There are five interventions initially at the heart of this campaign, chosen because they relate to known major sources of harm in hospitals: leadership for safety—getting Boards on board (see Recommendation 8); reduction of harm to deteriorating patients in acute care; critical care bundles (central line and ventilator care; perioperative care, including prevention of surgical site infection and World Health Organisation's Safe Surgery Checklist; and reduction of harm from high-risk medications. The Campaign now has almost 200 Trusts signed up to its cause and aim. The Campaign team is in the process of developing resources to support implementation. These resources will be available from mid to end September.
4The role of the National Patient Safety Agency (NPSA) should be refocused on its core objective of collecting and analysing patient safety data to inform rapid patient safety learning, priority setting and coordinate activity across the NHS. A number of current functions, for example the development of technical solutions to improve patient safety, presently delivered by the organisation should in future be commissioned from other expert organisations with the requisite expertise. Reorganisation of the National Reporting and Learning System (NRLS) has refocused the NPSA's work. It is producing more timely advice for the NHS on strategies to reduce risks to patients and priorities for action. The NHS receives regular feedback of staff reports of patient safety incidents including national and trust level reports. Specialty based reporting has been introduced starting with a pilot for reporting and response for anaesthesia. The English Patient Safety Managers have been transferred to SHAs to form part of the Patient Safety Action Teams (PSATs). The Agency now decides on a case-by-case basis whether to develop solutions in house or commission externally. The NHS Institute for Innovation and Improvement is providing educational programs for leadership and patient safety improvements and the PSATs are helping to embed patient safety in the local management of the NHS.
5The core purpose of the National Reporting and Learning System (NRLS) should be to identify sources of risk and harm to patients which can be acted upon at local and national level. The present NRLS should be redesigned to make it more effective in this respect, including simplifying and encouraging reporting as well as including a new category of analysing risk prone situations and anticipating adverse events. PCTs should take account of the information and learning available locally from the NRLS in commissioning services. The NPSA has introduced a rapid reporting and urgent response function and it is developing speciality reporting in some areas. These activities are helping to ensure greater clinical involvement and a more targeted response to risk reduction and actionable learning. Scope for improving the core NRLS data set has been identified with expert advice and guidance from John Hopkins University School of Medicine in Baltimore, USA. Drawing on the outcome of this work, the updated NRLS strategy includes a number of additional steps for system improvement. The NPSA is working with the World Class Commissioning team at DH in developing indicators to improve safety through commissioning.
6The Patient Safety Management function currently delivered by the NPSA should be hosted by Strategic Health Authorities (SHAs), and recast as `Patient Safety Action Teams' (PSATs) to support the delivery of the national patient safety agenda by local NHS organisations. The team should consist of experts with skills in data analysis, incident investigation and solution development. PSATs have been established in the ten SHAs since 1 October 2007. They provide a local resource to NHS organisations. Network arrangements have been set up with NHS organisations, including NHS Trusts. The NPSA has worked with the SHAs to determine the long term arrangements and priorities which took effect t from 1 April 2008.
7Prime responsibility for incident investigation should reside with local NHS organisations. Every NHS organisation should have access to a specialist investigator based within the Patient Safety Action Team. All reports should be considered locally within 24 hours of being reported. The NPSA should be notified of events that involve serious patient harm and death within 36 hours of the initial report. In April 2007, a project team was set up by the NPSA to progress work on learning from patient safety investigations. Discussions were held with risk groups, a patient and public involvement group, and the Department of Health. Several resources have been developed by the NPSA as an outcome of the discussions. These include a best practice patient safety investigation report guidance and template. Additional work on training modules and other methods of improving understanding of error and patient safety among clinical staff and managers is under way. To help ensure the NPSA can be notified of events involving serious patient safety harm and death early, it has access to reports of Serious Untoward Incidents recorded by the NHS on the Strategic Executive Information System (STEIS).
8Accountability for patient safety rests with the Chair and Board of each NHS organisation. Each Board should therefore be expected to outline how it intends to discharge this responsibility. Importantly, each initiative should also make clear how it intents to ensure that patients and carers play an integral part in all initiatives to introduce a patient safety culture change within the NHS. The Healthcare Commission has also developed a new workstream looking at the governance of safety, focusing on boards' involvement in safety improvement.

The NHS Institute for Innovation and Improvement is also running an educational module entitled Boards on board as part of the National Patient Safety Campaign (see recommendation 11).

The NPSA routinely holds patient safety sessions with all new Trust Non-executive Directors to ensure that they are aware of their responsibility in this regard.

Separately, the working group on Tackling Concerns Locally set up following on from the White Paper, Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century and Safeguarding Patients, has a subgroup focussing on Clinical Governance which will produce its final report shortly. The subgroup has been considering recommendations for best practice in identifying concerns, investigating and remediating them and includes a chapter focussing on involving public, patients and carers in clinical governance activities.

9The approach of the Healthcare Commission in monitoring progress in patient safety should be further developed into a high-profile programme which comprehensively monitors and assesses progress against national and local standards and indicators of performance. PCTs should be accountable for ensuring that all providers used by their patients have effective patient safety reporting systems and are implementing technical solutions satisfactorily. The Healthcare Commission reviewed its safety strategy in summer 2007 in conjunction with key stakeholders including the NPSA. In September 2007, it started work on a range of new products and approaches to address key risks to the safety of patients. The risks it has identified and is addressing include:

falls while in hospital;

medicine errors after discharge from hospital;

implementing safety alerts; errors in the use of medical devices due to lack of training or unsafe procurement;

healthcare associated infection outside the acute sector.

10A pilot should be established to examine the option of the National Institute for health and Clinical Excellence (NICE) developing technical patient safety solutions. The NPSA and NICE have worked collaboratively to take forward this recommendation. Two topics selected for the pilot were (a) interventions for medicines reconciliation at the point of admission and (b) prevention of ventilator-associated pneumonia (VAP). The first technical solution was launched in December 2007. The second is scheduled to be launched on 26 August 2008. Following the pilot, it was agreed that the NPSA would retain lead responsibility for the development of technical safety solutions, and that NICE would not be asked to establish a specific programme of work in this area. Where appropriate, the NPSA will commission solutions from relevant NHS or professional bodies. It will incorporate the lessons learned from the pilots into the ongoing development process.
11The NHS Institute for Innovation and Improvement should be asked to work with the medical Royal Colleges and other education providers to ensure that advances are made and training to support patient safety. The NHS Institute is taking forward a number of measures in response to this recommendation:

The Leading Improvement in Patient Safety (LIPS) is a comprehensive programme designed to help NHS trusts build the capacity and capability to eliminate harm to patients. Forty-two acute organisations have participated in the first two waves of the programme. The third wave is due to start in September 2008.

The LIPS programme is working closely with the National Patient Safety Campaign to offer the educational support that organisations might need once they have signed up to the campaign. An important element of this will be the new Boards on board programme to support the work being undertaken in response to recommendation 8.

The development of a Quality and Safety Improvement Faculty is well underway and has involved Royal Colleges in stakeholder events. Existing faculty of doctors, nurses and pharmacists now lead the teaching of the LIPS programme.

Twenty three universities now offer a module in safety improvement in undergraduate education across disciplines.

12All NHS organisations should develop and implement local initiatives to promote greater openness with patients and their families when things go wrong and provide required support. The Department of Health has undertaken a review of current legislative mechanisms and guidance such as the NHS Redress Scheme and the NPSA's Being Open and has identified a common approach and consistency of language applied to offering apology, expressing remorse, and providing explanations to patients, families and their carers. The next stage of the review was to consider what barriers in the NHS are preventing open communication with patients and how to overcome these in light of successful strategies used internationally. This has been carried out by Professor Albert Wu. He will be presenting his report about options for strengthening Being Open to the National Patient Safety Forum in October 2008.
13The active involvement of patients and their families should be promoted by establishing a national network of patient champions who will work in partnership with NHS organisations and other key players to improve patient safety; the network should also have strong links with WHO World Alliance for Patient Safety's `Patients for Patient Safety' initiative. A joint project has been established between the NPSA and Action Against Medical Accidents (AvMA) in concert with WHO's Patients for Patient Safety programme. A campaign launch took place in March 2008 and since then Patient Safety Champions have been recruited and held their first induction meeting on 20 and 21 May 2008. A training day was held on 14 July to discuss their work programme for this year. This will be promoting Being Open and infection control work and encouraging Patient and Public reporting. They will be working locally with Trusts, regionally with PSATs and nationally with the NPSA.
14The development of an overall project plan to ensure delivery of all key recommendations—this should be discussed at the first meeting of the National Patient Safety Forum.

An inaugural meeting of the National Patient Safety Forum in early 2007.

With expert input, redesigning of the National Reporting and Learning System in order to have a re-engineered system launched in 2007.

An early pilot to determine if NICE can effectively deliver technical solutions with a decision in early 2007.

Immediate action to establish Patient Safety Action Teams.

There is a need to clarify roles and responsibilities both within the Department and in the NHS for the delivery of the Patient Safety Agenda.

The imperative to improve patient safety will need to be taken into account as a central component of the Health Reform Agenda. It is therefore important that an ongoing dialogue takes place with the Healthcare Commission, Monitor and other regulators.

Recommendation 14 listed the priorities for implementation for the other recommendations in Safety First to ensure swift progress.








1  
Department of Health (2000) An Organisation with a Memory, London: The Stationery Office Back

2   Eurobarometer survey (January 2006) Back

3   Reason, James Human Error: Models and Management, BMJ 2000; 320; 768-770 Back

4   Brennan TA, Leape LL, Laird N et al. Incidence of adverse events and negligence in hospitalised patients: results of the Harvard Medical Practice Study. New England Journal of Medicine, 1991, 324 (6):370-7. Leape LL, Brennan TA, Laird N et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. New England Journal of Medicine, 1991, 324 (6):377-84. Back

5   Wilson RM, Runciman WB, Gibberd RW et al. The Quality in Australian Health Care Study. Medical Journal of Australia, 1995, 163:458-71. Back

6   Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. British Medical Journal, 2001, 322:517-9. Back

7   Kohn LT, Corrigan JM, Donaldson MS Eds. To err is human: Building a safer health system. 1999, Institute of Medicine, National Academy Press. Back

8   Baker GR, Norton PG, Flintolf V, et al. The Canadian Adverse events Study: the incidence of adverse events among hospital patients in Canada. Canadian Medical Association Journal, 2004, 179(11):1678-1686 Back

9   Schioler T, Lipezak H, Pedersen BL et al. Danish Adverse Event Study. Incidence of adverse events in hospitals. A retrospective study of medical records, Ugeskr laeger, 2001, 163 (39):5370-8. Back

10   ENEAS National Study on Hospitalisation-Related Adverse Events 2005. Available at www.msc.es/organizacion/sns/plancalidadSNS/docs/ENEAS_Eng.pdf Back

11   Davis P, Lay-Yee R, Briant R et al. Adverse events in New Zealand public hospitals I: occurrence and impact. New Zealand Medical Journal, 2002, 115 (1167):U271. Back

12   Wilson RM, Runciman WB, Gibberd RW et al. The Quality in Australian Health Care Study. Medical Journal of Australia, 1995, 163:458-71. Back

13   See www.npsa.nhs.uk/nrls/patient-safety-incident-data/quarterly-data-reports/ Back

14   Health Protection Agency Quarterly Reporting Results for MRSA bacteraemia, September 2008 and Quarterly Reporting Results for C. Difficile July 2008. Back

15   The NHS Litigation Authority Report and Accounts 2008, July 2008. Back

16   National Audit Office (2005) A Safer Place for Patients: Learning to Improve Patient Safety, London: The Stationery Office Back

17   National Patient Safety Agency (2007) The 3rd Report for the Patient Safety Observatory: Slips, trips and falls in hospitals, London. Back

18   Department of Health On the state of public health: Annual Report of the Chief Medical Officer 2005, London. Back

19   For examples of good practice in Safety Reporting see the joint NPSA/NHS Confederation Policy Briefing on High Reporting Trusts at www.npsa.nhs.uk/nrls Back

20   Department of Health (2001) Building a Safer NHS for Patients: Implementing An Organisation with a Memory, London: The Stationery Office Back

21   Department of Health (2006) Safety First A report for patients, clinicians and healthcare managers, London, The Stationery Office Back

22   Department of Health (2008) High Quality Care for All NHS Next Stage Review Final Report, London Back

23   See www.who.int/patientsafety Back

24   See www.eunetpas.eu Back

25   Department of Health On the state of public health: Annual Report of the Chief Medical Officer 2004, London Back

26   Healthcare Commission Investigation into outbreaks of Clostridium difficile at Maidstone and Tunbridge Wells MHS Trust October 2007 Back


 
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