Patient Safety - Health Committee Contents

2  Patient safety policy since 2000

13. Since 2000, there have been significant attempts to develop patient safety policy in the NHS. Those efforts are briefly summarised in this chapter and highlighted in Box 1.Box 1: Key patient safety policy documents and initiatives since 2000
2000 CMO's Expert Group, An Organisation with a memory—sets a new direction for patient safety in the NHS
April 2001DH, Building a Safer NHS for Patients: implementing An organisation with a memory—makes the NHS the first healthcare system in the world with a patient safety strategy
July 2001NPSA established
2004Health Foundation establishes Safer Patients Initiative in four UK hospitals, including Luton and Dunstable in England
2005-6Series of reports assessing progress:

NAO, A Safer Place for Patients

PAC, A Safer Place for Patients

DH, Safety First: A report for patients, clinicians and healthcare managers

2008Lord Darzi, High quality care for all: NHS Next Stage Review final report

14. In the late 1990s DH promised a fresh emphasis on the quality of NHS care, including patient safety, to be guaranteed by clinical governance.[6]

15. Subsequently, a more innovative approach to patient safety was developed in line with an international shift in thinking, definitively expressed in the American study To Err is Human: Building a Safer Health System (2000).[7] This argued that events causing or risking harm to patients were far more likely to result from systemic failure than the actions of individual healthcare workers.[8] Attempts to improve patient safety should not focus on punishing individuals for errors, but on removing "error-provoking" aspects of care-delivery systems. This entails moving away from a "blame culture", in which incidents are analysed to attribute blame to individuals. Such a culture encourages covering up incidents and fails to identify underlying causes and learn lessons that could prevent repetition of incidents. Instead, individuals should not fear being unfairly made to shoulder the blame for incidents (this has been termed a "fair blame culture").[9] Greater openness about, and reporting of, incidents, combined with determined searching for systemic faults, enables lessons to be learned and implemented with tangible improvements in safety. In this respect, healthcare needed to catch up with other safety-critical industries,[10] such as civil aviation, where this approach has become well established.

16. These ideas were readily accepted by an Expert Group on learning from adverse events in the NHS that was chaired by the CMO. The Group's report, An organisation with a memory (2000)[11] mirrored the approach of To Err is Human, and is similarly regarded as a pioneering document which has helped set the international agenda on patient safety. It highlighted the extent of avoidable harm to NHS patients and advocated both the fostering of an open, reporting and learning culture, and new systems for learning from failure.

17. The Expert Group's key practical recommendation was for the DH to introduce a mandatory reporting scheme for adverse events and specified "near misses".[12] This would allow reports of incidents to be collated nationally and used to identify lessons about how harm to patients could be avoided in future.Box 2: Key conclusions of An organisation with a memory (2000)[13]
[T]he NHS needs to develop:
  • unified mechanisms for reporting and analysis when things go wrong;
  • a more open culture, in which errors or service failures can be reported and discussed;
  • mechanisms for ensuring that, where lessons are identified, the necessary changes are put into practice;
  • a much wider appreciation of the value of the system approach in preventing, analysing and learning from errors.

18. In April 2001, the DH published Building a safer NHS for patients: Implementing 'An organisation with a memory', setting out how the Expert Group's recommendations were to be implemented. This would be done by means of a new national system for learning from error and adverse events, overseen by a new independent body, the National Patient Safety Agency (NPSA), and supported by "an open, no-blame reporting culture".

19. In July 2001, the NPSA was established as a Special Health Authority within the NHS.[14] The Agency began its work in 2003, with a remit covering the NHS in Wales as well as in England.

20. In February 2004 the NPSA published Seven steps to patient safety, setting out the steps that NHS organisations needed to take in order to ensure patient safety.[15]

21. A key task of the NPSA was to establish the National Reporting and Learning System (NRLS)[16] to receive reports from all NHS organisations of patient safety incidents. These were defined as "any unintended or unexpected incident [due to medical management, rather than the natural course of the patient's original illness or condition] which could have [led] or did lead to harm for one or more patients receiving NHS-funded healthcare".[17]

22. The NRLS was established in 2004 as a voluntary national reporting system, receiving reports from all local NHS reporting systems in England and Wales, as well as through a parallel, anonymous, electronic reporting system (allowing NHS staff to report incidents without going through their local system). A web-based Patient and Public Reporting e-form, to allow patients and the public to submit reports directly to the NRLS, was developed in 2005-6.

23. Following the Government's review of arm's-length bodies, the NPSA acquired several new responsibilities in 2005; these are reflected in its current form, shown in the Box 3 below.Box 3: Structure and responsibilities of the NPSA

The three NPSA divisions

·  National Reporting and Learning Service division

This aims to reduce risks to patients receiving NHS care, improving safety and care standards through: analysis of incidents that are reported via the NRLS; rapid responses to incidents; and the collaborative development of actions that can be implemented locally.

·  National Clinical Assessment Service division

This considers the performance of individual doctors, dentists or pharmacists in cases not serious enough to warrant referral to the relevant professional regulatory body (covers the UK and both the NHS and independent healthcare providers).

·  National Research Ethics Service division

This protects the rights, safety, dignity and well-being of research participants and facilitates ethical research that is of potential benefit to participants, science and society.

The national confidential enquiries

In addition, the NPSA is responsible for commissioning and monitoring the three national confidential enquiries, which are provided independently, often by academics. The enquiries examine fatal healthcare incidents in their respective areas of responsibility, collecting evidence on aspects of healthcare, identifying shortcomings in care and disseminating recommendations based on their findings.[18]

24. By the time it became fully operational, the NRLS was considerably behind schedule and over budget. Martin Fletcher, Chief Executive of the NPSA, told us that such teething troubles were down to the pioneering nature of the System:

    With hindsight there would be a recognition that an undertaking of this scale was a lot more complex than anybody had perhaps at first realised. You have to remember that when this system was set up five years ago it was the first of its type in the world.[19]

25. Following the delays there was an investigation by the NAO in 2005.[20] This underpinned the 2006 report by the House of Commons Public Accounts Committee (PAC), A Safer Place for Patients: Learning to improve patient safety.[21] The Committee criticised the lack of progress and concluded that "there is a question mark over the value for money being achieved by the National Patient Safety Agency". [22] A change of leadership subsequently took place at the NPSA.

26. In December 2006, a report, Safety First, which had been commissioned by the CMO, was published.[23] This report:

  • found that, while patient safety was gaining a significant national profile, 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".
  • found scant evidence that data collected through the NRLS were "effectively informing patient safety at the local NHS level". Although the system was now collecting a high volume of reports, too few of these resulted in "actionable learning for local NHS organisations". Also, "In many cases, an environment has not been created that motivates and inspires clinical and non-clinical staff working at the front line to insist that all care must be as safe as possible."
  • set out 14 recommendations intended to accelerate the pace of change in the NHS in England. These measures, which set a new agenda for the NPSA following its change of leadership, are discussed in the next chapter.

27. It is important to recognise that there have been a number of non-Government projects to improve patient safety over the last decade, including the Safer Patients Initiative (SPI), which was established by the Health Foundation[24] on a UK basis in 2004. The first phase of the SPI involved piloting by four NHS acute organisations (one in each of the countries of the UK) during 2004-6. In England, Luton and Dunstable Hospital took part in the SPI to test ways of improving safety on an organisation-wide basis. The Initiative worked on three levels:

  • addressing five clinical areas, each containing multiple interventions that have an established and accepted evidence base in the UK (such as better management of patients in intensive care, infection control, preventative antibiotics for surgery and medicines safety);
  • teaching methods for quality and safety improvement; and
  • establishing a specific role for the Chief Executives and senior executive teams.

28. In 2006, the initiative was expanded to another 20 hospitals (11 of them in England). These hospitals in the second phase aimed to reduce their mortality rates by at least 15% and to reduce adverse events by at least 30% over a two year period. There is evidence of impressive achievements in some areas but it is not clear whether the wider objective of a sustained reduction in harm has been achieved.[25]

29. In 2007, Lord Darzi, Parliamentary Under Secretary of State at the DH, published his interim review of the NHS which was followed by his final report, The Next Stage Review. This was probably the most important Government initiative in patient safety since An organisation with a memory. Lord Darzi's report was a long term vision for the NHS which stressed that the quality of services, including patient safety, should be the top priority for the NHS.


30. Since 2000, the Department of Health has sought to move the NHS away from a "blame culture", in which harm to patients is unfairly attributed to individual healthcare workers, to an open, reporting and learning culture, which can identify and address the systemic failings that are responsible for the vast majority of avoidable harm. At the same time, a mechanism (the National Reporting and Learning System) and an organisation (the National Patient Safety Agency) have been created to facilitate systematic reporting of, and learning from, patient safety incidents, and improvement of services. These measures mean the NHS has led the way for healthcare systems throughout the world in the development of patient safety policy and for this credit is due. In his reports in 2007 and 2008 Lord Darzi stressed the importance of safe care in the NHS as part of his Next Stage Review.

31. In addition, the Health Foundation has established the Safer Patients Initiative which seeks to encourage clinicians and other staff to look for the best ways of reducing the harm done to patients.

32. We are, however, concerned that Lord Darzi's emphasis on quality and safety is an indication that, for all the policy innovations of the past decade, insufficient progress has been made in making NHS services safer. We note that the report commissioned by the Chief Medical Officer in 2006, Safety First, concluded that patient safety was attaining a significant national profile, but 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". This concern is heightened by the recent cases of disastrously unsafe care that have come to light in a small number of Trusts.

33. Judging what effect policy to date has had on the safety of services across the NHS requires the examination of data regarding the extent, and cost, of harm that has been done to patients. We turn to this in the next chapter.

6   Clinical governance is defined as "the system 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 clinical excellence will flourish" ( Back

7   Linda Kohn et al., To Err is Human: Building a Safer Health System (Washington DC, 2000) Back

8   On this basis, terms such as "mistake" or "error" now tend to be avoided in discussing medical harm, as they are perceived to be associated with attributing harm mainly to the "proximal unsafe acts" of individuals, rather than latent "error-provoking" conditions present in the healthcare provider concerned. Back

9   The term "no blame culture" has been used in this context, but is now widely seen as inaccurate and unhelpful, since in cases of malicious or inept conduct it clearly is appropriate for blame to be attached to individuals. Back

10   Safety-critical industries are those in which failure can cause serious injury or death. They are also termed "high-reliability" and "high-risk" industries. Back

11   Department of Health, An organisation with a memory: Report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer, June 2000 Back

12   A "near miss" was defined as "A situation in which an event or omission, or a sequence of events or omissions, arising during clinical care fails to develop further, whether or not as the result of compensating action, thus preventing injury to a patient" (ibid., p xii). Back

13   Ibid., para 20, p xi Back

14   A Special Health Authority is a type of arm's-length body that is independent but can be subject to ministerial direction like other NHS bodies. Back

15   Step 1 Build a safety culture: Create a culture that is open and fair

Step 2 Lead and support your staff: Establish a clear and strong focus on patient safety throughout your organisation

Step 3 Integrate your risk management activity: Develop systems and processes to manage your risks and identify and assess things that could go wrong

Step 4 Promote reporting: Ensure your staff can easily report incidents locally and nationally

Step 5 Involve and communicate with patients and the public: Develop ways to communicate openly with and listen to patients

Step 6 Learn and share safety lessons: Encourage staff to use root cause analysis to learn how and why incidents happen

Step 7 Implement solutions to prevent harm: Embed lessons through changes to practice, processes or systems Back

16   The NPSA has recently begun using the acronym "RLS" to refer to the Reporting and Learning System, and "NRLS" to refer to the National Reporting and Learning Service division of the Agency. However, "NRLS" is still widely used to refer to the Reporting and Learning System, as it is throughout this report. Back

17 Back

18   The three national confidential enquiries are: the National Confidential Enquiry into Patient Outcome and Death; the Confidential Enquiry into Maternal and Child Health; and the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness. Back

19   Q 825 Back

20   National Audit Office, A Safer Place for Patients: Learning to improve patient safety, HC (2005-06) 456 Back

21   Committee of Public Accounts, Fifty-first Report of Session 2005-06, A safer place for patients: Learning to improve patient safety, HC 831 Back

22   Ibid., p 4 Back

23   Department of Health, Safety First-A report for patients, clinicians and healthcare managers, December 2006 Back

24   The Health Foundation is a charity, established in 1998, that works to improve the quality of healthcare. Back

25   In October 2008, the Health Foundation launched Safer Clinical Systems, a programme to test and demonstrate ways to improve healthcare systems or processes to systematically improve patient safety, which is intended to build on the SPI. Back

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