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
||CMO's Expert Group, An Organisation with a memorysets a new direction for patient safety in the NHS
|April 2001||DH, Building a Safer NHS for Patients: implementing An organisation with a memorymakes the NHS the first healthcare system in the world with a patient safety strategy
|July 2001||NPSA established
|2004||Health Foundation establishes Safer Patients Initiative in four UK hospitals, including Luton and Dunstable in England
|2005-6||Series 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
|2008||Lord 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
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).
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.
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").
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
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) 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
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".
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)
|[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.
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.
21. A key task of the NPSA was to establish the National
Reporting and Learning System (NRLS)
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
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
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.
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
25. Following the delays there was an investigation by the NAO
in 2005. This underpinned
the 2006 report by the House of Commons Public Accounts Committee
(PAC), A Safer Place for Patients: Learning to improve patient
safety. 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". 
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.
- 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
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;
- 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.
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" (www.dh.gov.uk/en/Publichealth/Patientsafety/Clinicalgovernance/index.htm). Back
Linda Kohn et al., To Err is Human: Building a Safer
Health System (Washington DC, 2000) Back
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
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
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
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
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
Ibid., para 20, p xi Back
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
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
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
Step 7 Implement solutions to prevent
harm: Embed lessons through changes to practice, processes
or systems Back
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
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
Q 825 Back
National Audit Office, A Safer Place for Patients: Learning
to improve patient safety, HC (2005-06) 456 Back
Committee of Public Accounts, Fifty-first Report of Session 2005-06,
A safer place for patients: Learning to improve patient safety,
HC 831 Back
Ibid., p 4 Back
Department of Health, Safety First-A report for patients, clinicians
and healthcare managers, December 2006 Back
The Health Foundation is a charity, established in 1998, that
works to improve the quality of healthcare. Back
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