This is the largest analysis of general practice patient safety incident reports undertaken. We have developed a method to derive learning from general practice patient safety incident reports to identify priority issues to guide future improvement efforts.
We will first discuss our main findings in relation to the methods development needed to undertake this study and observations about the completeness and accuracy of the incident reports reviewed. We will then consider the implications of the recommendations for research and development identified within, and between, the themes from each incident category.
Quality of National Reporting and Learning System reports
Development of a comprehensive classification system to characterise safety incident reports in general practice has permitted the description of events leading up to patient safety incidents, their reported contributory factors (human and system issues), and patient- and system-level outcomes. We propose that four independent classes (a description of the incident, its contributory factors and the type and level of harm) should provide sufficient minimal information for practising HCPs to identify learning for improvements in future practice from the reports.
The manual coding of reports was a resource-intensive process in terms of the application of codes and the development of the code book. Codes within each class were inductively added and amended throughout the study, with fewer iterations needed towards the end of the study. We consider that the regular team meetings we held to discuss such changes would need to be emulated by those responsible for the analysis of incident reports within health-care organisations.
Our methods of analysis (EDA and thematic analysis) were designed to permit future adoption in health-care organisations by HCPs with minimal training. Further work is now needed to develop and test the content and delivery of such training. Outcomes from analysis (e.g. clustered bar charts) were also chosen to provide a logical account of how priority issues for possible intervention were identified. In addition, clinical expertise supported interpretation of context and identification of the implications of the described safety incidents on patients and their families. Our findings are hypothesis generating, inductive in nature and require testing and development by further research and clinical practice improvement.
At best, around one-third of reports contained descriptions of contributory factors. This represents a major missed opportunity to learn from patient safety incidents. Descriptions of contributory factors, when considered in relation to the type of incident and context, can provide a steer on potential causes of patient safety incidents and inform the conceptual design of interventions to mitigate future harms. A total of 462 discrete NHS organisations uploaded at least one incident report, although over half of the reports originated from just 30 organisations (n = 7071, 51.6%). This implies that some organisations do not report general practice safety incidents to the NRLS, or do not have mechanisms for receiving reports from general practice in its organisation.
The number of reports excluded from the analysis suggests a misguided use of local reporting systems in terms of knowledge and understanding of its purpose.
Crosscutting issues for research and development
Our discussion of key findings from incident report analysis is focused on the themes informed by the most frequent and most harmful reports. Identifiable contributory factors, interpreted in terms of the incident type, the context in which they occurred and patient outcomes, support the basis of our recommendations. Our recommendations are exclusively focused on systems improvement since there was no apparent focus on human-specific recommendations from our analyses. When human error was described as an implicated contributing factor to the developing incident, the professional involved was usually working within a complex system with less than optimal work processes. However, we stress that the focus on systems does not negate the HCP’s duty to report a safety incident. We also recognise the need to enable practitioners to be provided with regular updates of learning from safety incidents that examine human factors.
We will focus our recommendations for research and development on four broad areas:
maximising opportunities to learn from patient safety incidents via mandatory data capture and a national, co-ordinated effort to support organisations to build the capacity and capability of their workforces to report data for learning
testing methods to identify and manage vulnerable patients at risk of deterioration, unscheduled hospital admission or readmission following discharge from hospital
building IT infrastructure to enable details of all health-care encounters to be recorded in one system, aid communication between professionals and services and support safer administrative practices (e.g. prescribing, referral and discharge communication)
activating the patient, parent and carer role in preventing patient safety incidents.
Improvement efforts to develop, test and implement solutions across these four broad areas of recommendation will address the prevention of the vast majority of safety incidents analysed within this study.
Maximise opportunities to learn from patient safety incidents
Confront the blame culture
A culture of blame within NHS organisations is often described when a patient safety incident occurs.81–84 For over a decade, seminal patient safety policy documents and initiatives have highlighted that patient safety incidents are largely the result of poorly designed systems.85 Several public inquiries have highlighted the detrimental consequences of a workforce that practises in fear of reprimand and punitive action following a medical error.10,81,84,86
The UK policy document An Organisation with a Memory signalled the need to learn lessons from medical errors in order to prevent future, similar events.87 Patient safety incident reporting was heralded as an important mechanism to create learning, as part of an ongoing commitment to support a safe culture with a learning ethos, in which individuals acknowledge and learn from patient safety incidents.88,89 Reporting and learning systems rely on HCPs to report, and be open about, patient safety incidents that they witness or are involved in.90 Fear of blame, however, poses a significant barrier to staff fulfilling this duty and creates missed opportunities for system learning and improvement, often at a huge cost to the individual staff members.86,88,91–94
Previous studies have demonstrated that when HCPs report incidents, the narrative often reflects the fact that responsibility for the incident is placed on an individual through ‘person-blaming,’ rather than blaming the organisation or failings in the system.95 This is, however, contrary to the mantra encouraged by patient safety initiatives worldwide. It is well acknowledged that uncertainty about the implications of reporting, not least the personal shame about involvement in a medical error, fuels barriers to incident reporting.92,96 The ‘second victim’ concept describes the experience of HCPs who are involved in safety incidents and suffer psychological distress in the aftermath of a medical error. Loss of confidence, low self-esteem and self-doubt are well-documented issues.86
The term ‘whistleblowing’ has traditionally been coined to describe situations in which HCPs speak up about major system failures, malpractice, wrongdoing or fraud.8 The term often conjures negative professional connotations as a result of high-profile cases within medicine of clinicians who have been disgraced as a result of speaking up in the interests of patient safety.97,98 This has become evident in organisations where undue emphasis has been placed on the ‘active failure’ aspect of the incident in which an acute error has played a role in the event evolution, whereas the ‘latent system conditions,’ in which poor system defences act as predisposing weaknesses, receive less consideration. Although both of these components are important and frequently occur in combination, active errors are unduly emphasised, with blame, in the majority of cases, falling on individuals and teams.99 This is often apparent in media coverage of patient safety incidents.
Li et al.100 examined 64 news articles about medical errors printed in newspapers from six countries and concluded that the articles rarely accounted for system failures or approached the error without bias. Of the studied articles, 60% were reported from the viewpoint of a legal expert or patient with investment in the error, and often demonstrated a ‘person approach’ by blaming individuals, which was the case in 41% of the articles. The study also highlighted that 40% of news reports failed to signpost the importance of system failures in the evolution of the error.100 In the UK, 53% of articles discussed errors negatively, compared with 14% in the USA.101,102 These draw public attention to human failures and place blame on individual HCPs. These may all be well-intentioned attempts by health-care organisations to be seen to be acting on concerns raised by patients; however, this blame culture has the effect of reducing clinicians’ motivation to report patient safety incidents and preventing learning from incidents that may help to prevent future health care-related harm to patients.100
Shift focus from human to system failures
Diagnostic errors, for example, can be described as cognitive, system or ‘no-fault’ errors, and may be errors of commission or omission. Croskerry et al.103 describe a number of initiatives for mitigating specific cognitive errors in practice,104 in keeping with current literature around improving diagnosis and assessment by reducing dependence on flawless cognitive performance. Schiff et al.105 described the importance of adopting better multidisciplinary approaches, reducing pressure on clinicians to rely solely on their memory and clinical experience when making diagnoses, and instead supporting them by means of computerised and non-technological aids.106 This supports our findings, which demonstrate that lack of knowledge, oversights and mistakes were frequently described staff factors contributing to patient safety incidents. Cognitive errors, which are often unexpected active errors of commission, complicate the process of improving patient safety; however, focus on providing safe systems and safety-netting may help minimise patient harm when errors occur.106
Previous studies have highlighted the importance of streamlining systems for referral and discharge or follow-up, using electronic systems to unify patient records.107 Electronic systems are being developed to support a number of aspects of the diagnosis and assessment process. There is increasing support for the use of clinician decision support systems, to assist in managing consultations.108,109 For example, a system proposed by de Wit et al.110 supports the management of polypharmacy in the elderly patient population.
Vulnerable patients were described within the reports analysed. Elderly patients, patients with acute illness or disability have been associated with an increased risk of patient safety incidents.111 Such patients often experience multiple comorbidities and run the risk that new pathologies will be overlooked as clinicians focus on existing diagnoses which can undermine the presentation of new pathology.112–114 In addition, they may be incapable of raising concerns about their care or lack agency in decision-making. Guthrie et al.112 described polypharmacy and choice of acceptable care strategies as specific issues for patients with comorbidities yet to be addressed in policy. Limited resources exist to guide practitioners in managing this demographic. Involvement of patients in training HCPs, to improve management of the vulnerable, has been associated with improvements in patient satisfaction, with no clear detrimental effects.115,116 Cross-linking electronic guidelines for the management of related disorders, and to aid recognition of red flags to minimise diagnostic overshadowing, is a further proposal for practice-level improvement to mitigate human error.112
Build capacity and capability of information technology infrastructure
Building IT infrastructure and functionality capable of sharing data between health- and social-care providers could support identification of predictors of risk and inform interventions to prevent future incidents.117 In addition, efforts to transition existing written processes, and alignment of existing electronic processes, could support HCPs to have timely and reliable access to health-care data needed for safer consultations and permit continuity of care across different health- and social-care sectors.
Based on our findings, referral and discharge processes require attention. The receipt of poor-quality, and sometimes inappropriate, referrals received by district nursing teams is well described,118–122 and each unclear referral has been estimated to cause 5 hours of extra work for district nurse teams.123 To overcome variability in referral processes, the development and testing of a single, unified electronic referral process with an agreed baseline of minimal information should be agreed between professionals in primary and secondary care settings.
NHS England and other organisations have previously reported that failures in communication processes can account for up to 33% of discharge-related safety incidents.124,125 Electronic discharge documentation could prevent most paper-based administration failures,126–128 and, across the UK, a process is under way to support 24-hour electronic discharge.129–131 However, we believe that electronic discharge summaries should be based on accepted best practices, such as those developed by the Scottish Intercollegiate Guidelines Network,132 as well as consensus agreement by primary and secondary care professionals about the minimal essential information that should be included. In parallel, patient-held records could aid understanding about a recent hospital stay and follow-up plans.133–135
Identify patients at high risk of harm in the community
Reports describing failures of timely diagnosis and assessment, the availability of treatments and care equipment, and lack of continuity of care following discharge often involved patients with social or medical issues that compromised their ability to access GP services.
Exploring the accessibility of clinical services must be a priority for all health-care organisations, and general practices should determine whether or not their existing telephone call-handling processes meet the needs and expectations of their patient population. In 2015, a randomised controlled trial by Campbell et al.136 was not sufficiently powered to detect differences in safety outcomes (in terms of patient mortality, emergency hospital admissions, and accident and emergency attendance rates) between same-day consultations with GPs/telephone calls, nurse-led computer-supported services and usual care. However, the accompanying process evaluation recognised the importance of culture, capacity and involvement of all practice staff when introducing such major changes to access. The authors recommended examination of significant event audits to explore safety outcomes.137 We support this recommendation given the diversity of issues patients face while accessing clinical services, in particular the need to focus future improvement efforts on vulnerable patient populations.
In 2015, Warren et al.138 highlighted the need to explore the drivers of satisfaction among patients from ethnic minority groups. Our findings support this, and determining what constitutes patient satisfaction, particularly among those seeking urgent medical attention, will be an important informant of the design of future improvement projects that seek to develop an accessible system.139 How best to determine those estimates of patient satisfaction within general practice should be explored with priority patient groups (e.g. the socially deprived, the elderly or homeless people). Issues identified within incident reports could empirically inform those inquiries.
Patients recently discharged from hospital and those receiving end-of-life care in the community or requiring regular district nursing involvement frequently did not receive timely follow-up by community HCPs. Exploring options to intervene early, to manage patients at home and to mitigate avoidable deterioration through proactive intervention is needed. Different options that could achieve this are described in NHS England’s General Medical Services ‘enhanced service’ for vulnerable groups,140 which describes a complex intervention that includes same-day telephone consultations for patients at risk of unplanned hospital admission and timely follow-up by a HCP in the practice on discharge from hospital. Although we acknowledge the unclear benefits of standalone system changes such as telephone triage,136,137 a synergy might be evident from new models that combine same-day telephone triage and risk stratification (or other options).
Given the failures in care that we have identified, we agree with NHS England that new services are needed to support GPs to develop and test new models of care delivery for the ‘enhanced service’: (1) rapid response community nursing; (2) support from mental health service providers; (3) designated district nursing; (4) additional discharge co-ordinator services; (5) additional support for carers; and (6) targeted social-care services.136 Given the largely social nature of such interventions and the risk of outcome-based evaluation determining the net effect to be minimal, formative theory-driven evaluation options should be considered.141,142
Activate the patient role in safety
Cultivating conditions in which patients, parents and carers feel comfortable challenging HCPs is needed and could prevent safety incidents.143 Encouraging patients and HCPs to co-design new models of care delivery that inform local improvement initiatives should be encouraged; for example, improvement in the parent–provider relationship could increase child safety.144–146 Public health organisations and researchers must seek to establish what methods of communication work best for different patient and parent groups, and embrace the challenge of undertaking research with and for vulnerable patient populations.
Providing patients with access to their medical records could reduce documentation discrepancies and appointment-related incidents, as well as provide HCPs with a safety net.143 Such incidents could also be prevented by providing staff with better accessibility to unified records.147
As care models for different patient groups change, investment is required to maximise patient understanding and empowerment to use those services. There is also a broader need to continue efforts to educate the public on the role of each health-care provider (e.g. general practice, pharmacy, optician, clinical injuries unit), and what the expectations of those services can be, including when and how to access each service.
