Learning from patient safety incidents involving acutely sick adults in hospital assessment units in England and Wales: a mixed methods analysis for quality improvement.

OBJECTIVE: Six per cent of hospital patients experience a patient safety incident, of which 12% result in severe/fatal outcomes. Acutely sick patients are at heightened risk. Our aim was to identify the most frequently reported incidents in acute medical units and their characteristics. DESIGN: Retrospective mixed methods methodology: (1) an a priori coding process, applying a multi-axial coding framework to incident reports; and, (2) a thematic interpretative analysis of reports. SETTING: Patient safety incident reports (10 years, 2005-2015) collected from the National Reporting and Learning System, which receives reports from hospitals and other care settings across England and Wales. PARTICIPANTS: Reports describing severe harm/death in acute medical unit were identified. MAIN OUTCOME MEASURES: Incident type, contributory factors, outcomes and level of harm were identified in the included reports. During thematic analysis, themes and metathemes were synthesised to inform priorities for quality improvement. RESULTS: A total of 377 reports of severe harm or death were confirmed. The most common incident types were diagnostic errors (n = 79), medication-related errors (n = 61), and failures monitoring patients (n = 57). Incidents commonly stemmed from lack of active decision-making during patient admissions and communication failures between teams. Patients were at heightened risk of unsafe care during handovers and transfers of care. Metathemes included the necessity of patient self-advocacy and a lack of care coordination. CONCLUSION: This 10-year national analysis of incident reports provides recommendations to improve patient safety including: introduction of electronic prescribing and monitoring systems; forcing checklists to reduce diagnostic errors; and increased senior presence overnight and at weekends.

The impact of general practitioners working in or alongside emergency departments: a rapid realist review.

OBJECTIVES: Worldwide, emergency healthcare systems are under intense pressure from ever-increasing demand and evidence is urgently needed to understand how this can be safely managed. An estimated 10%-43% of emergency department patients could be treated by primary care services. In England, this has led to a policy proposal and £100 million of funding (US$130 million), for emergency departments to stream appropriate patients to a co-located primary care facility so they are 'free to care for the sickest patients'. However, the research evidence to support this initiative is weak. DESIGN: Rapid realist literature review. SETTING: Emergency departments. INCLUSION CRITERIA: Articles describing general practitioners working in or alongside emergency departments. AIM: To develop context-specific theories that explain how and why general practitioners working in or alongside emergency departments affect: patient flow; patient experience; patient safety and the wider healthcare system. RESULTS: Ninety-six articles contributed data to theory development sourced from earlier systematic reviews, updated database searches (Medline, Embase, CINAHL, Cochrane DSR & CRCT, DARE, HTA Database, BSC, PsycINFO and SCOPUS) and citation tracking. We developed theories to explain: how staff interpret the streaming system; different roles general practitioners adopt in the emergency department setting (traditional, extended, gatekeeper or emergency clinician) and how these factors influence patient (experience and safety) and organisational (demand and cost-effectiveness) outcomes. CONCLUSIONS: Multiple factors influence the effectiveness of emergency department streaming to general practitioners; caution is needed in embedding the policy until further research and evaluation are available. Service models that encourage the traditional general practitioner approach may have shorter process times for non-urgent patients; however, there is little evidence that this frees up emergency department staff to care for the sickest patients. Distinct primary care services offering increased patient choice may result in provider-induced demand. Economic evaluation and safety requires further research. PROSPERO REGISTRATION NUMBER: CRD42017069741.

Agreeing on global research priorities for medication safety: an international prioritisation exercise.

OBJECTIVES: Medication errors continue to contribute substantially to global morbidity and mortality. In the context of the recent launch of the World Health Organization's (WHO) Third Global Patient Safety Challenge: Medication Without Harm, we sought to establish agreement on research priorities for medication safety. METHODS: We undertook a consensus prioritisation exercise using an approach developed by the Child Health and Nutrition Research Initiative. Based on a combination of productivity and citations, we identified leading researchers in patient and medication safety and invited them to participate. We also extended the invitation to a further pool of experts from the WHO Global Patient Safety Network. All experts independently generated research ideas, which they then independently scored based on the criteria of: answerability, effectiveness, innovativeness, implementation, burden reduction and equity. An overall Research Priority Score and Average Expert Agreement were calculated for each research question. FINDINGS: 131 experts submitted 333 research ideas, and 42 experts then scored the proposed research questions. The top prioritised research areas were: (1) deploying and scaling technology to enhance medication safety; (2) developing guidelines and standard operating procedures for high-risk patients, medications and contexts; (3) score-based approaches to predicting high-risk patients and situations; (4) interventions to increase patient medication literacy; (5) focused training courses for health professionals; and (6) universally applicable pictograms to avoid medication-related harm. Whilst there was a focus on promoting patient education and involvement across resource settings, priorities identified in high-resource settings centred on the optimisation of existing systems through technology. In low- and middle-resource settings, priorities focused on identifying systemic issues contributing to high-risk situations. CONCLUSIONS: WHO now plans to work with global, regional and national research funding agencies to catalyse the investment needed to enable teams to pursue these research priorities in medication safety across high-, middle- and low-resource country settings.

Patient safety in palliative care: A mixed-methods study of reports to a national database of serious incidents.

BACKGROUND: Patients receiving palliative care are vulnerable to patient safety incidents but little is known about the extent of harm caused or the origins of unsafe care in this population. AIM: To quantify and qualitatively analyse serious incident reports in order to understand the causes and impact of unsafe care in a population receiving palliative care. DESIGN: A mixed-methods approach was used. Following quantification of type of incidents and their location, a qualitative analysis using a modified framework method was used to interpret themes in reports to examine the underlying causes and the nature of resultant harms. SETTING AND PARTICIPANTS: Reports to a national database of 'serious incidents requiring investigation' involving patients receiving palliative care in the National Health Service (NHS) in England during the 12-year period, April 2002 to March 2014. RESULTS: A total of 475 reports were identified: 266 related to pressure ulcers, 91 to medication errors, 46 to falls, 21 to healthcare-associated infections (HCAIs), 18 were other instances of disturbed dying, 14 were allegations against health professions, 8 transfer incidents, 6 suicides and 5 other concerns. The frequency of report types differed according to the care setting. Underlying causes included lack of palliative care experience, under-resourcing and poor service coordination. Resultant harms included worsened symptoms, disrupted dying, serious injury and hastened death. CONCLUSION: Unsafe care presents a risk of significant harm to patients receiving palliative care. Improvements in the coordination of care delivery alongside wider availability of specialist palliative care support may reduce this risk.

Patterns of regional variation of opioid prescribing in primary care in England: a retrospective observational study.

BACKGROUND: Opioids are a widely prescribed class of drug with potentially harmful short-term and long-term side effects. There are concerns about the amounts of these drugs being prescribed in England given that they are increasingly considered ineffective in the context of long-term non-cancer pain, which is one of the major reasons for their prescription. AIM: To assess the amount and type of opioids prescribed in primary care in England, and patterns of regional variation in prescribing. DESIGN AND SETTING: Retrospective observational study using publicly available government data from various sources pertaining to opioids prescribed in primary practice in England and Indices of Social Deprivation. METHOD: Official government data were analysed for opioid prescriptions from August 2010 to February 2014. The total amount of opioid prescribed was calculated and standardised to allow for geographical comparisons. RESULTS: The total amount of opioid prescribed, in equivalent milligrams of morphine, increased (r = 0.48) over the study period. More opioids were prescribed in the north than in the south of England (r = 0.66, P<0.0001), and more opioids were prescribed in areas of greater social deprivation (r = 0.56, P<0.0001). CONCLUSION: Long-term opioid prescribing is increasing despite poor efficacy for non-cancer pain, potential harm, and incompatibility with best practice. Questions of equality of care arise from higher prescription rates in the north of England and in areas of greater social deprivation. A national registry of patients with high opioid use would improve patient safety for this high-risk demographic, as well as provide more focused epidemiological data regarding patterns of prescribing.

Sources of unsafe primary care for older adults: a mixed-methods analysis of patient safety incident reports.

Background: older adults are frequent users of primary healthcare services, but are at increased risk of healthcare-related harm in this setting. Objectives: to describe the factors associated with actual or potential harm to patients aged 65 years and older, treated in primary care, to identify action to produce safer care. Design and Setting: a cross-sectional mixed-methods analysis of a national (England and Wales) database of patient safety incident reports from 2005 to 2013. Subjects: 1,591 primary care patient safety incident reports regarding patients aged 65 years and older. Methods: we developed a classification system for the analysis of patient safety incident reports to describe: the incident and preceding chain of incidents; other contributory factors; and patient harm outcome. We combined findings from exploratory descriptive and thematic analyses to identify key sources of unsafe care. Results: the main sources of unsafe care in our weighted sample were due to: medication-related incidents e.g. prescribing, dispensing and administering (n = 486, 31%; 15% serious patient harm); communication-related incidents e.g. incomplete or non-transfer of information across care boundaries (n = 390, 25%; 12% serious patient harm); and clinical decision-making incidents which led to the most serious patient harm outcomes (n = 203, 13%; 41% serious patient harm). Conclusion: priority areas for further research to determine the burden and preventability of unsafe primary care for older adults, include: the timely electronic tools for prescribing, dispensing and administering medication in the community; electronic transfer of information between healthcare settings; and, better clinical decision-making support and guidance.

Harms from discharge to primary care: mixed methods analysis of incident reports.

BACKGROUND: Discharge from hospital presents significant risks to patient safety, with up to one in five patients experiencing adverse events within 3 weeks of leaving hospital. AIM: To describe the frequency and types of patient safety incidents associated with discharge from secondary to primary care, and commonly described contributory factors to identify recommendations for practice. DESIGN AND SETTING: A mixed methods analysis of 598 patient safety incident reports in England and Wales related to 'Discharge' from the National Reporting and Learning System. METHOD: Detailed data coding (with 20% double-coding), data summaries generated using descriptive statistical analysis, and thematic analysis of special-case sample of reports. Incident type, contributory factors, type, and level of harm were described, informing recommendations for future practice. RESULTS: A total of 598 eligible reports were analysed. The four main themes were: errors in discharge communication (n = 151; 54% causing harm); errors in referrals to community care (n = 136; 73% causing harm); errors in medication (n = 97; 87% causing harm); and lack of provision of care adjuncts such as dressings (n = 62; 94% causing harm). Common contributory factors were staff factors (not following referral protocols); and organisational factors (lack of clear guidelines or inefficient processes). Improvement opportunities include developing and testing electronic discharge methods with agreed minimum information requirements and unified referrals systems to community care providers; and promoting a safety culture with 'safe discharge' checklists, discharge coordinators, and family involvement. CONCLUSION: Significant harm was evident due to deficits in the discharge process. Interventions in this area need to be evaluated and learning shared widely.

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

BACKGROUND: The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. METHODS: This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. FINDINGS: 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)]. CONCLUSION: The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.

Patient-safety-related hospital deaths in England: thematic analysis of incidents reported to a national database, 2010-2012.

BACKGROUND: Hospital mortality is increasingly being regarded as a key indicator of patient safety, yet methodologies for assessing mortality are frequently contested and seldom point directly to areas of risk and solutions. The aim of our study was to classify reports of deaths due to unsafe care into broad areas of systemic failure capable of being addressed by stronger policies, procedures, and practices. The deaths were reported to a patient safety incident reporting system after mandatory reporting of such incidents was introduced. METHODS AND FINDINGS: The UK National Health Service database was searched for incidents resulting in a reported death of an adult over the period of the study. The study population comprised 2,010 incidents involving patients aged 16 y and over in acute hospital settings. Each incident report was reviewed by two of the authors, and, by scrutinising the structured information together with the free text, a main reason for the harm was identified and recorded as one of 18 incident types. These incident types were then aggregated into six areas of apparent systemic failure: mismanagement of deterioration (35%), failure of prevention (26%), deficient checking and oversight (11%), dysfunctional patient flow (10%), equipment-related errors (6%), and other (12%). The most common incident types were failure to act on or recognise deterioration (23%), inpatient falls (10%), healthcare-associated infections (10%), unexpected per-operative death (6%), and poor or inadequate handover (5%). Analysis of these 2,010 fatal incidents reveals patterns of issues that point to actionable areas for improvement. CONCLUSIONS: Our approach demonstrates the potential utility of patient safety incident reports in identifying areas of service failure and highlights opportunities for corrective action to save lives.

Identifying systems failures in the pathway to a catastrophic event: an analysis of national incident report data relating to vinca alkaloids.

BACKGROUND: Catastrophic errors in healthcare are rare, yet the consequences are so serious that where possible, special procedures are put in place to prevent them. As systems become safer, it becomes progressively more difficult to detect the remaining vulnerabilities. Using inadvertent intrathecal administration of vinca alkaloids as an example, we investigated whether analysis of incident report data describing low-harm events could bridge this gap. METHODS: We studied nine million patient safety incidents reported from England and Wales between November 2003 and May 2013. We searched for reports relating to administration of vinca alkaloids in patients also receiving intrathecal medication, and classified the failures identified against steps in the relevant national protocol. RESULTS: Of 38 reports that met our inclusion criteria, none resulted in actual harm. The stage of the medication process most commonly involved was 'supply, transport and storage' (15 cases). Seven cases related to dispensing, six to documentation, and four each to prescribing and administration. Defences most commonly breached related to separation of intravenous vinca alkaloids and intrathecal medication in timing (n=16) and location (n=8); potential for confusion due to inadequate separation of these drugs therefore remains. Problems involved in six cases did not align with the procedural defences in place, some of which represented major hazards. CONCLUSIONS: We identified areas of concern even within the context of a highly controlled standardised national process. If incident reporting systems include and encourage reports of no-harm incidents in addition to actual patient harm, they can facilitate monitoring the resilience of healthcare processes. Patient safety incidents that produce the most serious harm are often rare, and it is difficult to know whether patients are adequately protected. Our approach provides a potential solution.

Access to the NHS by telephone and Internet during an influenza pandemic: an observational study.

OBJECTIVES: To examine use of a novel telephone and Internet service-the National Pandemic Flu Service (NPFS)-by the population of England during the 2009-2010 influenza pandemic. SETTING: National telephone and Internet-based service. PARTICIPANTS: Service available to population of England (n=51.8 million). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: service use rate, by week. Numbers and age-specific and sex-specific rates of population who: accessed service; were authorised to collect antiviral medication; collected antiviral medication; were advised to seek further face-to-face assessment. Secondary: daily mean contacts by hour; proportion using service by telephone/Internet. RESULTS: The NPFS was activated on 23 July 2009, operated for 204 days and assessed 2.7 million patients (5200 consultations/100 000 population). This was six times the number of people who consulted their general practitioner with influenza-like illness during the same period (823 consultations/100 000 population, rate ratio (RR)=6.30, 95% CI 6.28 to 6.32). Women used the service more than men (52.6 vs 43.4 assessments/1000 population, RR1 21, 95% CI 1.21 to 1.22). Among adults, use of the service declined with age (16-29 years: 74.4 vs 65 years+: 9.9 assessments/1000 population (RR 7.46 95% CI 7.41 to 7.52). Almost three-quarters of those assessed met the criteria to receive antiviral medication (1 807 866/2 488 510; 72.6%). Most of the people subsequently collected this medication, although more than one-third did not (n=646 709; 35.8%). Just over one-third of those assessed were advised to seek further face-to-face assessment with a practitioner (951 332/2 488 504; 38.2%). CONCLUSIONS: This innovative healthcare service operated at large scale and achieved its aim of relieving considerable pressure from mainstream health services, while providing appropriate initial assessment and management for patients. This offers proof-of-concept for such a service that, with further refinement, England can use in future pandemics. Other countries may wish to adopt a similar system as part of their pandemic emergency planning.

Identification of poor performance in a national medical workforce over 11 years: an observational study.

BACKGROUND: Poorly performing doctors are a source of harm but do not commonly feature in discussions of patient safety. Few countries have national mechanisms to deal with these doctors; most opt for suspension and/or exclusion from clinical practice. This study reports on the 11-year experience of dealing with concerns about doctors' performance in the UK National Health Service (NHS). The aim of this study was to describe the frequency with which doctors were referred due to performance-related concerns, examine demographic and specialty differences, and identify the nature of the concerns prompting referral. METHODS: This observational study uses data collected by the National Clinical Assessment Service for each referral (n=6179 doctors) over an 11-year period (April 2001-March 2012) in England to examine the rate at which concerns about doctors' performance occur, understand differences in rates between practitioner groups, and changes over time. FINDINGS: The annual referral rate was five per 1000 doctors (95% CI 4.6 to 5.4). Doctors whose first medical qualification was gained outside the UK were more than twice as likely to be referred as UK-qualified doctors; male doctors were more than twice as likely to be referred as women doctors; and doctors in the late stages of their career were nearly six times as likely to be referred as early career doctors. DISCUSSION: The UK holds a consistently collected national dataset on performance concerns about doctors. This allows risk groups to be identified so that preventive action and early intervention can be targeted most effectively to reduce harm to patients. A feature of past handling of poor clinical performance has been late presentation and a lack of thematic study of causation.

Global research priorities to better understand the burden of iatrogenic harm in primary care: an international Delphi exercise.

Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts. Please see later in the article for the Editors' Summary.

Global implementation of WHO's multimodal strategy for improvement of hand hygiene: a quasi-experimental study.

BACKGROUND: Health-care-associated infections are a major threat to patient safety worldwide. Transmission is mainly via the hands of health-care workers, but compliance with recommendations is usually low and effective improvement strategies are needed. We assessed the effect of WHO's strategy for improvement of hand hygiene in five countries. METHODS: We did a quasi-experimental study between December, 2006, and December, 2008, at six pilot sites (55 departments in 43 hospitals) in Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia. A step-wise approach in four 3-6 month phases was used to implement WHO's strategy and we assessed the hand-hygiene compliance of health-care workers and their knowledge, by questionnaire, of microbial transmission and hand-hygiene principles. We expressed compliance as the proportion of predefined opportunities met by hand-hygiene actions (ie, handwashing or hand rubbing). We assessed long-term sustainability of core strategy activities in April, 2010. FINDINGS: We noted 21,884 hand-hygiene opportunities during 1423 sessions before the intervention and 23,746 opportunities during 1784 sessions after. Overall compliance increased from 51.0% before the intervention (95% CI 45.1-56.9) to 67.2% after (61.8-72.2). Compliance was independently associated with gross national income per head, with a greater effect of the intervention in low-income and middle-income countries (odds ratio [OR] 4.67, 95% CI 3.16-6.89; p<0.0001) than in high-income countries (2.19, 2.03-2.37; p<0.0001). Implementation had a major effect on compliance of health-care workers across all sites after adjustment for main confounders (OR 2.15, 1.99-2.32). Health-care-workers' knowledge improved at all sites with an increase in the average score from 18.7 (95% CI 17.8-19.7) to 24.7 (23.7-25.6) after educational sessions. 2 years after the intervention, all sites reported ongoing hand-hygiene activities with sustained or further improvement, including national scale-up. INTERPRETATION: Implementation of WHO's hand-hygiene strategy is feasible and sustainable across a range of settings in different countries and leads to significant compliance and knowledge improvement in health-care workers, supporting recommendation for use worldwide. FUNDING: WHO, University of Geneva Hospitals, the Swiss National Science Foundation, Swiss Society of Public Health Administration and Hospital Pharmacists.

Socio-economic disparities in mortality due to pandemic influenza in England.

OBJECTIVES: This study examines variations in mortality between socio-economic groups due to the pandemic Influenza (H1N1) 2009 virus in England. METHODS: We established a system to identify all deaths related to pandemic (H1N1) 2009 influenza. We collected the postcode of every individual who died, and through this determined the socio-economic deprivation, urban-rural characteristics and region of their residence. Across England, we were therefore able to examine how mortality rates varied by socio-economic group, between urban and rural areas, and between regions. RESULTS: People in the most deprived quintile of England's population had an age and sex-standardised mortality rate three times that experienced by the least deprived quintile (RR = 3.1, 95% CI 2.2-4.4). Mortality was also higher in urban areas than in rural areas (RR = 1.7, 95% CI 1.2-2.3). Mortality rates were similar between regions of the country. CONCLUSION: Tackling socio-economic health inequalities is a central concept within public health, but has not always been a part of emergency preparedness plans. These data demonstrate the opportunity to reduce the overall impact and narrow inequalities by considering socio-economic disparities in future pandemic planning.

Advancing the science of patient safety.

Despite a decade's worth of effort, patient safety has improved slowly, in part because of the limited evidence base for the development and widespread dissemination of successful patient safety practices. The Agency for Healthcare Research and Quality sponsored an international group of experts in patient safety and evaluation methods to develop criteria to improve the design, evaluation, and reporting of practice research in patient safety. This article reports the findings and recommendations of this group, which include greater use of theory and logic models, more detailed descriptions of interventions and their implementation, enhanced explanation of desired and unintended outcomes, and better description and measurement of context and of how context influences interventions. Using these criteria and measuring and reporting contexts will improve the science of patient safety.