Patient Safety - Health Committee Contents


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 practice—generally 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).

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 reporting—and 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 reports—around 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 relate—around 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 incidents—for instance, those where there were likely to be particular lessons to learn and those involving "a never event—things 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 conceptual—you know, this is a public health approach and a way of thinking about data and information in a sensible way—part of it was about collaboration—it 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 issues—and 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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