5 An open, reporting and learning
NHS
99. As we have noted, the NHS has sought for a decade
to emulate other safety-critical industries by creating unified
mechanisms for reporting and analysing incidents, underpinned
by a "fair blame" culture that encourages staff to be
open about incidents and report them.
100. After a faltering start, the NHS has succeeded
in establishing an incident-reporting system (comprising both
local systems and the NRLS) that is unique in the world in its
scale and comprehensiveness. As Figure 1 shows, there have been
substantial increases in the number of incidents reported, and
of organisations reporting regularly, via the NRLS since it began
operating in October 2003. Over 850,000 incidents per year are
now reported in the NHS in England through the NRLS; and a total
of 3.3 million incidents have been reported since the NRLS was
set up. Of the 392 NHS organisations in England, 370 (94%) reported
at least once during the first quarter of 2009, with 55% of organisations
reporting at least once every month.[81]
Figure 1: NPSA chart showing numbers of incidents
reported and Trusts reporting by quarter, October 2003-March 2009
(England and Wales)[82]

101. The NPSA now publishes a substantial quantity
of statistical data and other forms of output, derived from the
NRLS and other sources, in order to assist NHS organisations in
making their services safer. (The various types of published output
produced by the NPSA since its inception are listed in Box 10.)Box
10: Types of NPSA published output
- NPSA Newsline (a monthly newsletter);
- Organisation Feedback Reports (confidential NRLS statistical reports, showing individual NHS organisations how their incident-reporting rates compare with a "benchmark" for a "cluster" of similar organisations);
- Organisation Patient Safety Incident Reports (public NRLS statistical reports, containing data broken down to the level of individual NHS organisations);
- Patient Safety Alerts (urgent information for immediate action); [83]
- Patient Safety Bulletin (a review of learning from incidents);
- Patient Safety Guidance (advice and information);
- Patient Safety Information (good practice guidance against which to review current practicegenerally reminders of existing guidance);
- Patient Safety Notices (good practice guidance, to be implemented over time);
- Quarterly Data Summaries (statistical breakdowns of NRLS data by care setting, incident type and degree of harm, for England and Wales);
- Rapid Response Reports (advice on patient safety issues that need immediate local attention);
- Reports, tools and resources (discussion documents; Patient Safety Observatory reports; toolkits and eLearning, for local education and training);
- Safer Practice Notices (guidance on patient safety issues).
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102. However, despite the great strides made in incident reporting,
its effectiveness is restricted by:
- the significant extent of under-reporting, which is caused
by several factors (particularly the continued absence of a "fair
blame" culture in much of the NHS);
- the lack of focus in the NRLS; and
- the inherent limitations of data from reporting
systems as a means of generating information about patient safety
issues and solutions.
These issues, and how they might be addressed, are
discussed in this chapter.
Under-reporting
103. Although many incidents are being reported through
local NHS systems and the NRLS, there is substantial under-reporting,
for several reasons.
THE EXTENT OF UNDER-REPORTING
104. Under-reporting is apparent as follows:
- Under-reporting in acute
care
According to an NAO survey, "Trusts estimated
that on average around 22% of incidents and 39% of near misses
go un-reported".[84]
The two hospital case note review studies conducted in England
suggest under-reporting is even greater than this. One of them
found that a local incident-reporting system had detected only
17% of all incidents detected by both the review and reportingand
just 5% of all identified incidents leading to harm.[85]
- Under-reporting in primary
care
General practice accounts for about 0.25% of reports
each year (around 2,000 incidents)yet up to 95% of NHS
patient contacts occur in primary care, most of them in general
practice, where there are some 750,000 consultations per day.
A large proportion of complaints in the NHS are about primary
care, particularly regarding delayed or inaccurate diagnosis in
general practice,[86]
which is the commonest cause of litigation against GPs.[87]
There are likely to be many more medication incidents in general
practice than are reported, as discussed below. NRLS data show
that reporting from other primary care settings (community pharmacy;
community and general dental services; and community optometry
/ optician services) is also extremely low.
- Under-reporting of medication
incidents
Around 80,000 incidents involving medication are
reported each year through the NRLS, the vast majority of them
from the acute hospital setting. Professor Thomson told us that
survey data "suggested that maybe as many as six in 100 [patients]
report that they have experienced some sort of error in medication
over the last two years".[88]
Less than 1% of reported medication incidents come directly from
general practice. Yet around 1.8 million prescriptions per day
are dispensed in that setting; and "about one in 25 patients
admitted to hospital in some studies are shown to have been admitted
because of a medication problem", implying significant problems
with medication safety in primary care.[89]
- Under-reporting of serious
incidents
The PAC found in 2006 that incidents leading to serious
harm were among the least likely to be reported.[90]
As we have noted, around 11,000 incident reports per year involve
serious harm or death;[91]
but extrapolations from the case note review studies indicate
that substantially more such incidents occur (one extrapolation,
by the NPSA in 2004, put the figure for deaths at 72,000 deaths
per year).[92]
- Under-reporting by doctors
The PAC found in 2006 that "Doctors are less
likely to report an incident than other staff groups".[93]
The NPSA recognises the need to get "doctors reporting as
much as we see nurses reporting";[94]
the NAO research undertaken for this inquiry found that "many
doctors simply do not report events";[95]
and the Royal College of Ophthalmologists told us "under
reporting by medical staff [
] is commonplace".[96]
- Under-reporting of "near
misses"
An organisation with a memory
(2000) stated that "systematic reporting of 'near misses'
(seen as an important early warning of serious problems) is almost
non-existent across the NHS".[97]
In 2004, the NPSA noted "research has shown that near misses
are rarely reported".[98]
And Dr Kreckler, one of our junior-doctor witnesses, told us:
"near misses, on the whole, are not reported as much as the
incidents themselves".[99]
REASONS FOR UNDER-REPORTING
105. The following reasons for under-reporting are
apparent:
- Persistence of the "blame
culture"
The PAC reported in 2006 that "the perception
amongst nursing and other non-medical staff is that they risk
suspicion if they report a serious incident"; and that "Trusts
said that fear of retribution undermines staff's willingness to
report".[100]
The NAO reported, following its research for this inquiry, that:
"Junior Doctors told us that they believed that the current
formal incident reporting systems were still focused on apportioning
blame and are not confidential."[101]
The Imperial College researchers found likewise that some interviewees
"thought that in principle reporting a patient safety incident
was worthwhile but in practice they were less likely to do so
because of fear of being blamed."[102]
We also heard from the Royal College of Nursing that:
The blame culture still exists in some environments
and this may contribute to under reporting of staff or patient
related incidents [
] Anecdotal evidence leads us to understand
that it is not uncommon for a trust to discipline staff following
incidents [
][103]
- Fear of litigation or prosecution
The Royal College of GPs told us that "Perceived
legal risk in [GPs] engaging in this process, that could result
in an adverse outcome" was a factor in lack of reporting.[104]
We also heard from an academic researcher that "there is
an increase in the rate of litigation against GPs so it might
be that they are becoming more reluctant to discuss their errors."[105]
Fear of criminal prosecution is a particular issue among pharmacists,
since they are criminally liable, under the Medicines Act 1968,
for any errors in the dispensing of medicines.[106]
- Lack of response to reports
The Imperial College researchers found that: "Some
individuals clearly felt that their voices would be unheard [
]
and some reported that they never had any feedback from reporting
and therefore it was pointless."[107]
Likewise, the Royal College of GPs referred to a "Perception
that reports are stored and not used".[108]
And Dr Kreckler, one of our junior-doctor witnesses, said that
"really there is very limited feedback that comes back down
the front line which also further reinforces to some extent the
pointlessness of incident reporting".[109]
- Lack of appropriate reporting
systems
Dr Aneez Esmail, Professor of General Practice at
Manchester University, told us his research indicated that GPs
were willing to report patient safety incidents; but systems could
not take the same form as they had done in the acute sector.[110]
The Royal College of GPs also referred to the fact that "Reporting
systems have not been adequately designed" as a reason for
low levels of reporting.[111]
Mr Fletcher informed us that the NPSA was working with the Royal
College to: build on the established tradition of Significant
Event Audit[112] in
general practice; develop an electronic reporting form for general
practice; and provide more feedback on reports for general practice.[113]
Similar work is being undertaken with the College of Anaesthetists
to design with a specialty reporting system for anaesthesia.[114]
The NPSA used to have Clinical Specialty Advisors, but these were
done away with in 2006, as the Royal College of Ophthalmologists
noted. They also told us that "More work could be done on
extracting specialty specific data from [the NRLS] if funding
was made available and if the quality of data on the NRLS was
improved upon by better reporting".[115]
- Lack of contractual incentive
The Royal College of GPs drew attention to "Lack
of a contractual incentive" for GPs to report incidents.[116]
This may be relevant to other independent practitioners, such
as dentists and pharmacists, who are contracted to provide NHS
services.
- Poor understanding of what
to report
In 2004, the NPSA cited research indicating that
prevented incidents ("near misses") are "rarely
reported because [NHS] staff do not understand what they are".[117]
There also appears to be a tendency not to report "No harm"
incidents (both completed incidents and near misses) in the mistaken
belief that, since no harm occurred, there is no point in reporting.
Dr Kreckler said there was an attitude that "'We've got away
with it this time' or 'No harm came, so why bother reporting it'".[118]
- Lack of knowledge about
how to report
The Imperial College researchers reported that:
We had mixed views on whether staff knew how
to fill in an incident report and what happens with them afterwards.
Those that had not reported an incident knew very little about
how to report one.[119]
The Royal College of GPs suggested that lack of reporting
could be due to clinical teams being "Unaware of the communication
channels".[120]
- Lengthy and complicated
reporting processes
The NAO reported:
Our survey responses suggested that the main
reason Junior Doctors did not report adverse events was due to
"lengthy and complicated reporting processes". This,
coupled with the heavy workloads of Junior Doctors, means that
many doctors simply do not report events [
][121]
Mr Fletcher acknowledged that reporting was less
likely "if it is hard for people to report", and one
of the NPSA's tasks was "making it simple" to report.[122]
One way of achieving this appears to be through Patient Safety
Direct, which "will build on the National Reporting and Learning
System and create a single portal nationally for reporting and
learning".[123]
- Fear of adverse publicity
Fear of hostile media coverage of patient safety
issues seems to be a factor discouraging openness and reporting.
Ms Dheansa, the Matron from whom we took evidence, told us "The
media can very much destroy morale on the ground floor [
]
when you are working extremely hard in the interests of the patient
and when it is spun round".[124]
Whilst the NHS itself sees increased reporting of patient safety
incidents as a positive thing, indicating a better safety culture,[125]
sections of the media assume that increased reporting must mean
that more incidents are actually occurring and services are becoming
less safe.[126] Such
coverage in the local media, referring to reporting data for particular
NHS organisations, could be particularly damaging, especially
if it influences patients' choice of service provider.
Lack of focus in the National
Reporting and Learning System
106. The NRLS has been set up as an overarching,
catch-all system that draws in summary data on all reported incidents,
whether they are common or uncommon in type; and regardless of
the extent of harm associated with them. Thus, it has accumulated
outline information on many incidents of common types that are
already well understood, such as slips, trips and falls by patients,
which account for around one-third of all reportsaround
280,000 per year.[127]
And it has similarly accumulated basic information on many less
serious ("No harm" and "Low harm") events,
of various types, to which 93% of reports relatearound
800,000 per year.[128]
107. It is a significant criticism of the NRLS that
its approach to data collection is "wide and shallow",
whereas it should be "narrow and deep". The latter approach,
would entail focusing on gathering in-depth analysis of reported
incidents that are less common in type and more serious in the
degree of actual or potential harm associated with them. Such
an approach is typical of safety-critical industries with well-established
safety cultures, such as civil aviation and of patient safety
reporting systems in other countries, such as New Zealand.[129]
In both cases, root-cause analysis[130]
is routinely deployed to provide in-depth analysis of serious
and sentinel events.[131]
The NRLS only gathers data on "contributory factors"
in incidents, and is not geared up to deal with the sort of detailed
information generated by root-cause analysis. The NPSA has been
actively promoting the use of root-cause analysis in the local
investigation of incidents in the NHS, but there are doubts about
how widely, and how well, it is used.
108. The apparent paucity of effective root-cause
analysis in the NHS, along with other potential drawbacks of self-investigation
by NHS organisations, raises the question of whether there ought
to be something akin to the Air Accident Investigation Branch
for healthcare. Mr Bromiley, the widower of a harmed patient who
works in the airline industry, made a good case for such a body:
Health care is technically very complex and it
requires proper investigation, for the sake of the clinicians
let alone the patients. A clinician needs to know and have peace
of mind that whatever they did there is no political influence
from their bosses, somebody independent who is an expert will
review their work and will look on it in a proper light and lessons
can be learned and an independent investigative process is the
best way forward.[132]
109. When we asked Lord Patel about this, he seemed
to stop short of endorsing the idea of a new independent investigation
body, but he did agree that "The principle of having an independent
inquiry for serious untoward incidents, particularly that might
lead to serious harm or death, is important". He pointed
out that 10,000 such incidents were reported each year and it
would require substantial resources to investigate them all. But
he suggested this might be got round by setting clear criteria
for in-depth investigation of incidentsfor instance, those
where there were likely to be particular lessons to learn and
those involving "a never eventthings that should not
happen". If necessary, those screening criteria could be
set aside to allow other cases to be independently investigated.
It was particularly important to "have the right people with
the right skills carrying out these investigations".[133]
Inherent limitations of reporting
data
110. However good a reporting system is, it will
never on its own capture all the data needed to identify the full
range of patient safety issues and their solutions. Professor Thomson
told us:
It is clear that whatever source of identification
of patient safety incidents one uses, it is likely to provide
a different profile of incidents [
] Several studies have
demonstrated that the overlap between different sources is relatively
small [
] This emphasises the need for systems of surveillance
and monitoring that recognise the strengths and weaknesses of
different sources of data and brings them together to capture
a fuller picture of safety.[134]
111. The Patient Safety Observatory (PSO) was created
by the NPSA in 2004 as a "virtual observatory", to "draw
together information from different sources in new ways to quantify,
characterise and prioritise patient safety issues".[135]
Professor Thomson, who was one of the architects of the PSO, explained
to us that:
it had three components to it. Part of it was
conceptualyou know, this is a public health approach and
a way of thinking about data and information in a sensible waypart
of it was about collaborationit was bringing together people
across organisations that had information, so getting people from
the [Medicines and Healthcare products Regulatory Agency] and
other organisations around the table to discuss common issuesand
part of it was about a structure to deliver that. I think those
three components are important. From a public health perspective,
that is the way we should be taking it.[136]
112. There are numerous sources of data and intelligence
that need to be collated through the PSO to get as full a picture
as possible of patient safety issues and solutions. These sources
include the Yellow Card reporting scheme on adverse drug reactions,
the Serious Adverse Blood Reactions and Events reporting scheme,
the three national confidential enquiries, Hospital Episode Statistics,
litigation data and complaints data.
Conclusion
113. After the expenditure of much effort and
funding on the National Reporting and Learning System, clear progress
has been made in incident reporting; but we are concerned that
the NRLS is nevertheless still limited in its effectiveness.
114. We welcome the fact that the NRLS is now
collecting significant amounts of data, which are being used to
generate statistical and other output to help make services safer.
However, we are concerned that there remains significant under-reporting,
particularly in respect of incidents in primary care; medication
incidents; serious incidents; and reporting by doctors.
115. A major reason for under-reporting is the
persistent failure to eliminate the "blame culture"
in much of the NHS. Another important factor is fear of litigation
or prosecution, underlining the need for the Government to address
the medico-legal aspects of patient safety; we particularly recommend
the decriminalisation of dispensing errors on the part of pharmacists.
The "one size fits all" nature of reporting systems
is also a significant problem. We welcome the NPSA's recognition
of the need to address this by developing reporting systems that
are appropriate to different specialties (such as general practice
and anaesthesia). We recommend that work on this be treated as
a major priority by the Agency.
116. We believe that as much as possible of the
data collected by the NRLS on reported incidents should be published,
in the interests of openness and learning about patient safety.
We, therefore, welcome the decision to start publishing this data
broken down by individual NHS organisation.
117. While acknowledging the importance of incident
reporting for patient safety, we question whether the NRLS, as
presently constituted, is as useful and as cost-effective as it
should be. The System currently amasses a good deal of summary
data of doubtful usefulness, particularly on: common types of
incident that are already well understood, such as slips, trips
and falls; and less serious ("Low harm" and "No
harm") events, of various types. However, unlike reporting
systems in other safety-critical industries, and in other healthcare
systems, it does not systematically gather in-depth (root-cause
analysis) data on serious and sentinel events. We recommend that
consideration be given to rebalancing the NRLS accordingly. We
also recommend that root-cause analysis be undertaken much more
widely, and better, in the NHS in respect of serious and sentinel
events in general and less common types of these in particular.
We believe this might be facilitated by the establishment of a
body along the lines of the Department for Transport's Accident
Investigation Branches, which could undertake independent root-cause
analysis of serious and sentinel events in cases where there are
likely to be significant new lessons to learn. In cases involving
a patient's death, this could have the additional benefit of providing
their family with the full explanation that coroners do not seem
always to provide. We recommend that the DH look into the feasibility
of this.
118. No reporting system, however well it functions,
can capture all the information about patient safety issues and
solutions that is needed to help make services safer. Data must
be collated from as wide a range of sources as possible. We acknowledge
the work that the NPSA has already done in this regard, particularly
through the Patient Safety Observatory, and we recommend that
this should be made a major priority for the Agency.
81 National Reporting and Learning System quarterly
data, Issue 12, May 2009 Back
82
Ibid. Back
83
Patient Safety Alerts carry a deadline for implementation, at
which Trusts must report whether they are fully, partially or
not compliant. Alerts were distributed initially through the Safety
Alert Broadcast System and subsequently through the electronic
Central Alerting System, managed by the DH, to which every Trust
is connected. Back
84
Committee of Public Accounts, A safer place for patients,
p 5 Back
85
Q 119; Ali Baba-Akbari Sari et al., "Extent, nature
and consequences of adverse events: results of a retrospective
casenote review in a large NHS hospital", Quality and
Safety in Health Care, vol 16 (2007), pp 434-439 Back
86
Ev 205 Back
87
Ev 22-23; Q 623 [Dr Kostopoulou] Back
88
Q 102 Back
89
Ibid. Back
90
Committee of Public Accounts, A safer place for patients,
p 5 Back
91
Ev 5, 141 Back
92
Qq 15-19 Back
93
Committee of Public Accounts, A safer place for patients,
p 5 Back
94
Q 829 Back
95
National Audit Office, commissioned research Back
96
Ev 85. See also Ev 87. Back
97
Department of Health, An organisation with a memory, 2000,
para 15, p x Back
98
National Patient Safety Agency, Seven Steps to Patient Safety-Step
4: Promote reporting, August 2004, p 97 Back
99
Q 433 Back
100
Committee of Public Accounts, A safer place for patients,
p 5 Back
101
National Audit Office, commissioned research Back
102
Centre for Patient Safety and Service Quality, Imperial College,
commissioned research Back
103
Ev 169 Back
104
Ev 187 Back
105
Q 654 Back
106
PS 78A Back
107
Centre for Patient Safety and Service Quality, Imperial College,
commissioned research Back
108
Ev 187 Back
109
Q 433 Back
110
Q 537 Back
111
Ev 187 Back
112
Significant Event Audit is a process through which individual
episodes in which there has been a significant occurrence (either
beneficial or deleterious) are analysed in a systematic and detailed
way to ascertain what can be learnt about the overall quality
of care and to indicate changes that might lead to future improvements. Back
113
Qq 21, 828-829 Back
114
Q 827. See also Ev 246. Back
115
Ev 88 Back
116
Ev 187 Back
117
National Patient Safety Agency, Seven Steps to Patient Safety-Step
4: Promote reporting, August 2004, p 97 Back
118
Q 433 Back
119
Centre for Patient Safety and Service Quality, Imperial College,
commissioned research Back
120
Ev 187 Back
121
National Audit Office, commissioned research Back
122
Q 827 Back
123
Q 829. In his interim report for the NHS Next Stage Review,
Lord Darzi announced that the NPSA would be "establishing
a single point of access for frontline workers to report incidents:
Patient Safety Direct" (Department of Health, Our NHS,
our future: NHS Next Stage Review interim report, October
2007, para 4, p 7). Back
124
Qq 447, 448 Back
125
Q 822 Back
126
See, for instance: "Mothers at risk on NHS blunder wards:
'Substandard' care claim as safety incidents double", Daily
Mail, 8 October 2008; "Deaths from hospital blunders
soar 60% in two years as NHS staff 'abandon quality of care to
chase targets'", Daily Mail, 6 January 2009. Back
127
Learning on this subject is summarised in National Patient Safety
Agency, Slips, trips and falls in hospital: The third report
from the Patient Safety Observatory, February 2007. Back
128
National Reporting and Learning System quarterly data, Issue 12,
May 2009 Back
129
In New Zealand, we learned that the Ministry of Health's Quality
Improvement Committee has begun publishing, on an annual basis,
detailed information on all serious and sentinel events (with
details of patients and staff anonymised), broken down by local
District Health Board. Back
130
Root-cause analysis is an investigative method that seeks to identify
the underlying causes of an incident, with a view to preventing
repetition. Back
131
Sentinel events are defined as those incidents that signal the
need for immediate investigation and response, since they involve
death or other serious injury, or the risk thereof. Back
132
Q 184 Back
133
Q 815 Back
134
PS 80 Back
135
National Patient Safety Agency Fact Sheet-Patient Safety Observatory Back
136
Q 120 Back
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