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Background: Ensuring effective identification and management of sepsis is a healthcare priority in many countries. Recommendations for sepsis management in primary care have been produced, but in complex healthcare systems, an in-depth understanding of current system interactions and functioning is often essential before improvement interventions can be successfully designed and implemented. A structured participatory design approach to model a primary care system was employed to hypothesise gaps between work as intended and work delivered to inform improvement and implementation priorities for sepsis management.Methods: In a Scottish regional health authority, multiple stakeholders were interviewed and the records of patients admitted from primary care to hospital with possible sepsis analysed. This identified the key work functions required to manage these patients successfully, the influence of system conditions (such as resource availability) and the resulting variability of function output. This information was used to model the system using the Functional Resonance Analysis Method (FRAM). The multiple stakeholder interviews also explored perspectives on system improvement needs which were subsequently themed. The FRAM model directed an expert group to reconcile improvement suggestions with current work systems and design an intervention to improve clinical management of sepsis.Results: Fourteen key system functions were identified, and a FRAM model was created. Variability was found in the output of all functions. The overall system purpose and improvement priorities were agreed. Improvement interventions were reconciled with the FRAM model of current work to understand how best to implement change, and a multi-component improvement intervention was designed.Conclusions: Traditional improvement approaches often focus on individual performance or a specific care process, rather than seeking to understand and improve overall performance in a complex system. The construction of the FRAM model facilitated an understanding of the complexity of interactions within the current system, how system conditions influence everyday sepsis management and how proposed interventions would work within the context of the current system. This directed the design of a multi-component improvement intervention that organisations could locally adapt and implement with the aim of improving overall system functioning and performance to improve sepsis management. [ABSTRACT FROM AUTHOR]

Introduction: Healthcare is a highly complex adaptive system, requiring a systems approach to understand its behaviour better. We adapt the Systems Thinking for Everyday Work (STEW) cue cards, initially introduced as a systems approach tool in the UK, in a US healthcare system as part of a study investigating the feasibility of a systems thinking approach for front-line workers., Methods: The original STEW cards were adapted using consensus-building methods with front-line staff and safety leaders., Results: Each card was examined for relevance, applicability, language and aesthetics (colour, style, visual cues and size). Two sets of cards were created due to the recognition that systems thinking was relatively new in healthcare and that the successful use of the principles on the cards would need initial facilitation to ensure their effective application. Six principles were agreed on and are presented in the cards: Your System outlines the need to agree that problems belong to a system and that the system must be defined. Viewpoints ensure that multiple voices are heard within the discussion. Work Condition highlights the resources, constraints and barriers that exist in the system and contribute to the system's functions. Interactions ask participants to understand how parts of the system interact to perform the work. Performance guides users to understand how work can be performed daily. Finally, Understanding seeks to promote a just cultural environment of appreciating that people do what makes sense to them. The two final sets of cards were scored using a content validity survey, with a final score of 1., Conclusions: The cards provide an easy-to-use guide to help users understand the system being studied, learn from problems encountered and understand the everyday work involved in providing excellent care. The cards offer a practical 'systems approach' for use within complex healthcare systems., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The objective of this scoping review is to map methods used to study medication safety following electronic health record (EHR) implementation. Patterns and methodological gaps can provide insight for future research design., Materials and Methods: We used the Joanna Briggs Institute scoping review methodology and a custom data extraction table to summarize the following data: (1) study demographics (year, country, setting); (2) study design, study period, data sources, and measures; (3) analysis strategy; (4) identified limitations or recommendations; (5) quality appraisal; and (6) if a Safety-I or Safety-II perspective was employed., Results: We screened 5879 articles. One hundred and fifteen articles met our inclusion criteria and were assessed for eligibility by full-text review. Twenty-seven articles were eligible for extraction., Discussion and Conclusion: We found little consistency in how medication safety following EHR implementation was studied. Three study designs, 7 study settings, and 10 data sources were used across 27 articles. None of the articles shared the same combination of design, data sources, study periods, and research settings. Outcome measures were neither defined nor measured consistently. It may be difficult for researchers to aggregate and synthesize medication safety findings following EHR implementation research. All studies but one used a Safety-I perspective to study medication safety. We offer a conceptual model to support a more consistent approach to studying medication safety following EHR implementation., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context., Methods: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript., Results: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose., Conclusions: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Emergency departments (EDs) are dynamic, complex, and demanding environments. Introducing changes that lead to improvements in EDs can be challenging owing to the high staff turnover and mix, high patient volume with different needs, and being the front door to the hospital for the sickest patients. Quality improvement is a methodology applied routinely in EDs to instigate change to improve several outcomes such as waiting times, time to definitive treatment, and patient safety. Introducing the changes needed to transform the system in this way is seldom straightforward with the risk of "not seeing the forest for the trees" when attempting to change the system. In this article, we demonstrate how the functional resonance analysis method can be used to capture the experiences and perceptions of frontline staff to identify the key functions in the system (the trees), to understand the interactions and dependencies between them to make up the ED ecosystem ("the forest") and to support quality improvement planning, identifying priorities and patient safety risks., (Copyright © 2022 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Objective: To develop mid-range programme theory from perceptions and experiences of out-of-hours community palliative care, accounting for human factors design issues that might be influencing system performance for achieving desirable outcomes through quality improvement., Setting: Community providers and users of out-of-hours palliative care., Participants: 17 stakeholders participated in a workshop event., Design: In the UK, around 30% of people receiving palliative care have contact with out-of-hours services. Interactions between emotions, cognition, tasks, technology and behaviours must be considered to improve safety. After sharing experiences, participants were presented with analyses of 1072 National Reporting and Learning System incident reports. Discussion was orientated to consider priorities for change. Discussions were audio-recorded and transcribed verbatim by the study team. Event artefacts, for example, sticky notes, flip chart lists and participant notes, were retained for analysis. Two researchers independently identified context-mechanism-outcome configurations using realist approaches before studying the inter-relation of configurations to build a mid-range theory. This was critically appraised using an established human factors framework called Systems Engineering Initiative for Patient Safety (SEIPS)., Results: Complex interacting configurations explain relational human-mediated outcomes where cycles of thought and behaviour are refined and replicated according to prior experiences. Five such configurations were identified: (1) prioritisation; (2) emotional labour; (3) complicated/complex systems; (4a) system inadequacies and (4b) differential attention and weighing of risks by organisations; (5) learning. Underpinning all these configurations was a sixth: (6a) trust and access to expertise; and (6b) isolation at night. By developing a mid-range programme theory, we have created a framework with international relevance for guiding quality improvement work in similar modern health systems., Conclusions: Meta-cognition, emotional intelligence, and informal learning will either overcome system limitations or overwhelm system safeguards. Integration of human-centred co-design principles and informal learning theory into quality improvement may improve results., Competing Interests: Competing interests: AC-S was senior mentor to HW as recipient of a Royal College of General Practitioners Marie Curie Palliative Care Fellowship. No competing interests to declare for other authors., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The COVID-19 pandemic has resulted in the rapid reorganisation of health and social care services. Patients are already at significant risk of healthcare-associated harm and the wholesale disruption to service delivery during the pandemic stood to heighten those risks., Objectives: We explored the type and nature of patient safety incidents in French primary care settings during the COVID-19 first wave to make tentative recommendations for improvement., Methods: A national patient safety incident reporting survey was distributed to General Practitioners (GPs) in France on 28 April 2020. Reports were coded using a classification system aligned to the WHO International Classification for Patient Safety (incident types, contributing factors, incident outcomes and severity of harm). Analysis involved data coding, processing, iterative generation of data summaries using descriptive statistical analysis. Clinicaltrials.gov: NCT04346121., Results: Of 132 incidents, 58 (44%) related to delayed diagnosis, assessments and referrals. Cancellations of appointments, hospitalisations or procedures was reported in 22 (17%) of these incidents. Home confinement-related incidents accounted for 13 (10%) reports and inappropriate medication stopping for five (4%). Patients delayed attending or did not consult their general practitioner or other healthcare providers due to their fear of contracting COVID-19 infection at an in-person visit in 26 (10%) incidents or fear of burdening their GPs in eight (3%) incidents., Conclusion: Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents during non-COVID-19 care. Lessons from these incidents pinpoint where primary care services in France can focus resources to design safer systems for patients.

Human factors and ergonomics (HF/E) is concerned with the design of work and work systems. There is an increasing appreciation of the value that HF/E can bring to enhancing the quality and safety of care, but the professionalisation of HF/E in healthcare is still in its infancy. In this paper, we set out a vision for HF/E in healthcare based on the work of the Chartered Institute of Ergonomics and Human Factors (CIEHF), which is the professional body for HF/E in the UK. We consider the contribution of HF/E in design, in digital transformation, in organisational learning and during COVID-19., (© Royal College of Physicians 2021. All rights reserved.)

Background: There is limited engagement in healthcare with the kinds of proactive approaches to risk assessment used in other industries. Bowtie analysis (BTA) has previously been shown to have potential as a straightforward approach to proactively assessing risk in healthcare. The visual nature of BTA diagrams can aid communication of the essential elements of a complex risk management system. The aim of this small case report study was to investigate the training and support likely to be needed for existing healthcare professionals to conduct BTA in compliance with recognised industry best-practice., Method: Of 17 volunteers who attended training, 3 completed an analysis of significant healthcare risks in the study period: misadministration of gentamicin; unknown development of acute kidney injury and disposal of medical devices containing patient identifiable information (PII). Subjective assessments of the quality of the analyses were made against indicators of BTA best-practice., Results: Use of the BTA method led to a deeper understanding of the issues and a more thorough understanding of the risks and what was needed to control them than would have been the case if 'normal practice' had been followed. Classroom-based training supported by written guidance; however, do not appear adequate to support development of competence to carry out a quality BTA in a healthcare setting., Conclusions: BTA seems to have potential though further evaluation of its application and utility is necessary. The most cost-effective and productive approach is likely to be to train a small number of people to develop deeper skills and experience in BTA. In addition to training and user guidance, the opportunity to facilitate at least one analysis, with some specialist/trainer support, appears to be essential in developing BTA competence., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Why Is the Area Important?: A sub-group of rare but serious patient safety incidents, known as 'never events,' is judged to be 'avoidable.' There is growing interest in this concept in international care settings, including UK primary care. However, issues have been raised regarding the well-intentioned coupling of 'preventable harm' with zero tolerance 'never events,' especially around the lack of evidence for such harm ever being totally preventable., What Is Already Known and Gaps in Knowledge?: We consider whether the ideal of reducing preventable harm to 'never' is better for patient safety than, for example, the goal of managing risk materializing into harm to 'as low as reasonably practicable,' which is well-established in other complex socio-technical systems and is demonstrably achievable.We reflect on the 'never event' concept in the primary care context specifically, although the issues and the polarized opinion highlighted are widely applicable. Recent developments to validate primary care 'never event' lists are summarized and alternative safety management strategies considered, e.g. Safety-I and Safety-II., Future Areas for Advancing Research and Practice: Despite their rarity, if there is to be a policy focus on 'never events,' then specialist training for key workforce members is necessary to enable examination of the complex system interactions and design issues, which contribute to such events. The 'never event' term is well intentioned but largely aspirational-however, it is important to question prevailing assumptions about how patient safety can be understood and improved by offering alternative ways of thinking about related complexities., (© The Author(s) 2021. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Inadequate checking of safety-critical issues can compromise care quality in general practice (GP) work settings. Adopting a systemic, methodical approach may lead to improved standardisation of processes and reliability of task performance, strengthening the safety systems concerned. This study aimed to revise, modify and test the content and relevance of a previously validated safety checklist to the current GP context., Methods: A multimethod study was undertaken in Scottish GP involving: consensus building workshops with users and 'experts' to revise checklist content; regional testing of the modified checklist and follow-up usability evaluation survey of users. Quantitative data underwent descriptive statistical analyses and selected survey free-text comments are presented., Results: A redesigned checklist tool consisting of eight themes (eg, medication safety) and 61 items (eg, out-of-date stock is appropriately disposed) was agreed by 53 users/experts with items reclassified as: mandatory (n=25), essential (n=24) and advisory (n=12). Totally 42/55 GPs tested the tool and submitted checklist data (76.4%). The mean aggregated results demonstrated 92.0% compliance with all 61 checklist items (range: 83.0%-98.0%) and 25/42 GP managers responded to the survey (59.5%) and reported high mean levels of agreement on the usefulness of the checklist (77.0%), ease of use (89.0%), learnability (94.0%) and satisfaction (78.4%)., Conclusions: The checklist was comprehensively redesigned as a practical safety monitoring and improvement tool for potential implementation in Scottish GP. Testing and evaluation demonstrated high levels of checklist content compliance and strong usability feedback, but some variation was evident indicating room for improvement in current safety-critical checking processes. The checklist should be of interest in similar GP settings internationally and to other areas of primary care practice., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: This paper reports the results of the evaluation of the Scottish Quality and Safety Fellowship (SQSF)-a 10-month, lead-level international educational programme established in 2008 with the overarching aim of developing clinicians with advanced quality improvement knowledge, technical ability and essential leadership skills. The evaluation explores four levels of educational and practice outcomes associated with (1) the reaction of fellows to SQSF participation, (2) learning gained, (3) subsequent behaviour changes and (4) the overall impact on national and international level capability and capacity building., Methods: A theory-informed multi-method design was applied using (1) a search and review of the SQSF organisational database to tabulate personal, professional and demographic characteristics; (2) semi-structured telephone interviews with 16 participants using purposive and self-selected sampling; and (3) a cross-sectional online evaluation survey across all 10 cohorts involving 222 fellows RESULTS: SQSF was positively perceived as a high-quality learning experience containing a well-balanced mix of theory and practice, with a majority of respondents reporting career changing benefits. Most participants reported improved social, behavioural and emotional skills, knowledge and attitudes and, with sustained support of their host organisations, were able to apply and share learning in their workplace. The impact of the SQSF on a wider national and international level capability and capacity was both mediated and moderated by a wide range of interrelated contextual factors., Conclusions: This multi-method evaluation demonstrates that SQSF has achieved significant positive outcomes for the great majority of participants. Some tentative recommendations are provided with the aim of further enhancing fellowship content, delivery, transfer and future evaluations of wider impacts at regional, national and international health system levels., Competing Interests: Competing interests: MT, AB, NMG, DM and PB have no conflict of interest to declare. ST and LA are senior SQSF programme leaders and are responsible for its design and delivery., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: 'Systems thinking' is often recommended in healthcare to support quality and safety activities but a shared understanding of this concept and purposeful guidance on its application are limited. Healthcare systems have been described as complex where human adaptation to localised circumstances is often necessary to achieve success. Principles for managing and improving system safety developed by the European Organisation for the Safety of Air Navigation (EUROCONTROL; a European intergovernmental air navigation organisation) incorporate a 'Safety-II systems approach' to promote understanding of how safety may be achieved in complex work systems. We aimed to adapt and contextualise the core principles of this systems approach and demonstrate the application in a healthcare setting., Methods: The original EUROCONTROL principles were adapted using consensus-building methods with front-line staff and national safety leaders., Results: Six interrelated principles for healthcare were agreed. The foundation concept acknowledges that 'most healthcare problems and solutions belong to the system'. Principle 1 outlines the need to seek multiple perspectives to understand system safety. Principle 2 prompts us to consider the influence of prevailing work conditions-demand, capacity, resources and constraints. Principle 3 stresses the importance of analysing interactions and work flow within the system. Principle 4 encourages us to attempt to understand why professional decisions made sense at the time and principle 5 prompts us to explore everyday work including the adjustments made to achieve success in changing system conditions.A case study is used to demonstrate the application in an analysis of a system and in the subsequent improvement intervention design., Conclusions: Application of the adapted principles underpins, and is characteristic of, a holistic systems approach and may aid care team and organisational system understanding and improvement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Wrong-site/side surgical "never events" continue to cause considerable harm to patients, healthcare professionals, and organizations within the United Kingdom. Incidence has remained static despite the mandatory introduction of surgical checklists. Operating theater list errors have been identified as a regular contributor to these never events. The aims of the study were to identify and to learn from the incidence of wrong-site/side list errors in a single National Health Service board., Methods: The study was conducted in a single National Health Service board serving a population of approximately 300,000. All theater teams systematically recorded errors identified at the morning theater brief or checklist pause as part of a board-wide quality improvement project. Data were reviewed for a 2-year period from May 2013 to April 2015, and all episodes of wrong-site/side list errors were identified for analysis., Results: No episodes of wrong-site/side surgery were recorded for the study period. A total of 86 wrong-site/side list errors were identified in 29,480 cases (0.29%). There was considerable variation in incidence between surgical specialties with ophthalmology recording the largest proportion of errors per number of surgical cases performed (1 in 87 cases) and gynecology recording the smallest proportion (1 in 2671 cases). The commonest errors to occur were "wrong-side" list errors (62/86, 72.1%)., Discussion: This is the first study to identify incidence of wrong-site/site list errors in the United Kingdom. Reducing list errors should form part of a wider risk reduction strategy to reduce wrong-site/side never events. Human factors barrier management analysis may help identify the most effective checks and controls to reduce list errors incidence, whereas resilience engineering approaches should help develop understanding of how to best capture and neutralize errors.

Briefing in team sports has been shown to benefit both performance and confidence among team members. The neonatal resuscitation team shares similarities with sports teams, where task performance includes rapid decision-making skills within dynamic situations, alongside unpredictable circumstances., Aim: We aimed to determine the effect of a team sports briefing model on the neonatal resuscitation team. Method: We adapted and redesigned a team sports briefing and debriefing model and related protocol and tested them with a neonatal resuscitation team in a U.K. university teaching hospital., Results: The team's confidence and perceptions around these 2 aspects of resuscitation were studied along with frequency of task execution before and after a teaching intervention about the sports teams' approach to briefing and the introduction of a 7-point checklist. In 20 preintervention observations of 13 key tasks, areas for improvement in how neonatal intensive care unit (NICU) staff prepared for deliveries and potential resuscitations were found such as in "discussing potential deliveries that day" (n = 10, 50%), "identifying roles within the resus team that shift" (n = 5, 20%), and announcing when and where a debrief would occur (n = 0, 0%). Postintervention, the NICU team's mean task completion increased significantly from 9.23 (SD = 6.34) to 18.0 (SD = 1.83), a statistically meaningful difference of 8.77 (95% CI, 4.99-12.55; P < 0.001)., Conclusion: Together with increased levels of confidence and efficiency reported postintervention, this provides some evidence that a brief-debrief process based on how sports team's approach pregame situations could be potentially transferable and beneficial to NICU team performance., (Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Never events (NEs) are serious preventable patient safety incidents and are a component of formal quality and safety improvement (Q&SI) policies in the United Kingdom and elsewhere. A preliminary list of NEs for UK general practice has been developed, but the frequency of these events, or their acceptability to general practitioner (GPs) as a Q&SI approach, is currently unknown. The study aims to estimate (1) the frequency of 10 NEs occurring within GPs' own practices and (2) the extent to which the NE approach is perceived as acceptable for use., Methods: General practitioners were surveyed, and mixed-effects logistic regression models examined the relationship between GP opinions of NE, estimates of NE frequency, and the characteristics of the GPs and their practices., Results: Responses from 556 GPs in 412 practices were analyzed. Most participants (70%-88%, depending on the NE) agreed that the described incident should be designated as a NE. Three NEs were estimated to have occurred in less than 4% of practices in the last year; however, two NEs were estimated to have occurred in 45% to 61% of the practices. General practitioners reporting that a NE had occurred in their practice in the last year were significantly less likely to agree with the designation as a NE compared with GPs not reporting a NE (odds ratio, 0.42; 95% CI = 0.36-0.49)., Conclusions: The NE approach may have Q&SI potential for general practice, but further work to adapt the concept and content is required.

Objective: The Scottish Patient Safety Programme - Pharmacy in Primary Care collaborative is a quality improvement initiative adopting the Institute of Healthcare Improvement Breakthrough Series collaborative approach. The programme developed and piloted High Risk Medicine (HRM) Care Bundles (CB), focused on warfarin and non-steroidal anti-inflammatories (NSAIDs), within 27 community pharmacies over 4 NHS Regions. Each CB involves clinical assessment and patient education, although the CB content varies between regions. To support national implementation, this study aims to understand how the pilot pharmacies integrated the HRM CBs into routine practice to inform the development of a generic HRM CB process map., Methods: Regional process maps were developed in 4 pharmacies through simulation of the CB process, staff interviews and documentation of resources. Commonalities were collated to develop a process map for each HRM, which were used to explore variation at a national event. A single, generic process map was developed which underwent validation by case study testing., Results: The findings allowed development of a generic process map applicable to warfarin and NSAID CB implementation. Five steps were identified as required for successful CB delivery: patient identification; clinical assessment; pharmacy CB prompt; CB delivery; and documentation. The generic HRM CB process map encompasses the staff and patients' journey and the CB's integration into routine community pharmacy practice. Pharmacist involvement was required only for clinical assessment, indicating suitability for whole-team involvement., Conclusions: Understanding CB integration into routine practice has positive implications for successful implementation. The generic process map can be used to develop targeted resources, and/or be disseminated to facilitate CB delivery and foster whole team involvement. Similar methods could be utilised within other settings, to allow those developing novel services to distil the key processes and consider their integration within routine workflows to effect maximal, efficient implementation and benefit to patient care., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Exploring frontline staff perceptions of patient safety is important, because they largely determine how improvement interventions are understood and implemented. However, research evidence in this area is very limited. This study therefore: explores participants' understanding of patient safety as a concept; describes the factors thought to contribute to patient safety incidents (PSIs); and identifies existing improvement actions and potential opportunities for future interventions to help mitigate risks., Methods: A total of 34 semi-structured interviews were conducted with 11 general practitioners, 12 practice nurses and 11 practice managers in the West of Scotland. The data were thematically analysed., Results: Patient safety was considered an important and integral part of routine practice. Participants perceived a proportion of PSIs as being inevitable and therefore not preventable. However, there was consensus that most factors contributing to PSIs are amenable to improvement efforts and acknolwedgement that the potential exists for further enhancements in care procedures and systems. Most were aware of, or already using, a wide range of safety improvement tools for this purpose. While the vast majority was able to identify specific, safety-critical areas requiring further action, this was counter-balanced by the reality that additional resources were a decisive requirment., Conclusion: The perceptions of participants in this study are comparable with the international patient safety literature: frontline staff and clinicians are aware of and potentially able to address a wide range of safety threats. However, they require additional resources and support to do so.

Background: The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools., Methods: A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability)., Results: Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists., Conclusions: Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

What prevents the delivery of effective, high quality and safe health care in the National Health Service (NHS) in England? This paper presents 760 challenges which 330 NHS staff reported as preventing the delivery of effective, high quality and safe care. Some problems have been known for over 25 years (staff shortages, finance and patient complexity) but other challenges raise questions about the commitment of the NHS to patient and staff safety. For example, Organisational Culture leading to 'stifling bureaucracy', 'odds stacked against smooth […] working' and Workload resulting in 'firefighting daily' and 'perpetual crisis mode'. The role of Human Factors/Ergonomics professional input (engagement with safety scientists) is discussed in the context of success stories and examples of Human Factors Integration from other safety critical industries (Defence, Nuclear and Rail). Practitioner Summary: 760 challenges to the quality, effectiveness and safety of health care were identified at Human Factors/Ergonomics taster workshops in England. These are used to challenge health care providers to think about a Human Factors Integration (HFI systems) approach for safety, well-being and performance for all people involved in providing and receiving health care.

Objectives: To report the implementation of a trigger review method (TRM) in primary care, with a particular focus on its impact on patient safety-related findings., Design: Cross-sectional structured review of random samples (n=25) of electronic records of 'high-risk' patient groups conducted twice per year (each for a retrospective review period of 3 months)., Setting: 274 general practices in two regions of Scotland., Intervention: Contractual incentivisation of TRM implementation., Main Outcome Measures: Practice participation rate; characteristics of patient safety incidents (PSIs), for example, their prevalence, type, perceived severity and preventability; and actions or intended actions undertaken during and after trigger reviews., Results: 274 of 318 eligible practices (86.2%) returned 536 TRM Summary Reports, which outlined findings from reviews of 13 351 electronic patient records. 1887 (14.1%) PSIs were recorded, with a mean of 3.5 (536/1887) per Summary Report (SD±1.6). Of these, 830 (44.0%) were judged to have caused mild to moderate harm, with 262 (13.9%) cases resulting in more severe harm. A total of 852 PSIs (46.2%) were rated as preventable or potentially preventable. In 459 Summary Reports (85.6%), reviewers indicated implementing one or more improvement actions during the actual TRM process; and 2177 actions after completion of the TRM process (mean 4.1 (SD±3.3) actions per review)., Conclusions: The great majority of clinician reviewers 'successfully' applied the TRM, uncovering important but previously undetected PSIs, which prompted care teams to take action during and after the trigger reviews. The method and data generated have the potential to drive improvements in related care processes at the practice, regional and national health system level. TRM arguably increased 'ownership' of the safety challenge and clinician engagement in implementing their solutions to specific problems identified. Our results suggest that the TRM has potential as a feasible, pragmatic approach to improving primary care safety and quality., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Introduction: Significant event analysis (SEA) is well established in many primary care settings but can be poorly implemented. Reasons include the emotional impact on clinicians and limited knowledge of systems thinking in establishing why events happen and formulating improvements. To enhance SEA effectiveness, we developed and tested "guiding tools" based on human factors principles., Methods: Mixed-methods development of guiding tools (Personal Booklet-to help with emotional demands and apply a human factors analysis at the individual level; Desk Pad-to guide a team-based systems analysis; and a written Report Format) by a multiprofessional "expert" group and testing with Scottish primary care practitioners who submitted completed enhanced SEA reports. Evaluation data were collected through questionnaire, telephone interviews, and thematic analysis of SEA reports., Results: Overall, 149/240 care practitioners tested the guiding tools and submitted completed SEA reports (62.1%). Reported understanding of how to undertake SEA improved postintervention (P < .001), while most agreed that the Personal Booklet was practical (88/123, 71.5%) and relevant to dealing with related emotions (93/123, 75.6%). The Desk Pad tool helped focus the SEA on systems issues (85/123, 69.1%), while most found the Report Format clear (94/123, 76.4%) and would recommend it (88/123, 71.5%). Most SEA reports adopted a systems approach to analyses (125/149, 83.9%), care improvement (74/149, 49.7), or planned actions (42/149, 28.2%)., Discussion: Applying human factors principles to SEA potentially enables care teams to gain a systems-based understanding of why things go wrong, which may help with related emotional demands and with more effective learning and improvement., Competing Interests: The authors declare no conflict of interest. P. Bowie, E. McNaughton, and D. Bruce conceived the idea, acquired funding, and led the study which was project managed by D. Holly. The data collection and analysis process was undertaken by D. Holly, E. Forrest, S. Stirling, J. Ferguson, and J. Wakeling, with additional data interpretation by P. Bowie, J. McKay, E. McNaughton, and D. Bruce. P. Bowie drafted the initial manuscript, and all authors contributed to the study design, conceptual model, guiding tool developments, and critical review, drafting, and final approval of the manuscript. The study was funded by the Health Foundation (www.health.org.uk) as part of a 2012/13 SHINE Programme Award.

The systems-based management of laboratory test ordering and results handling is a significant patient safety concern in primary care internationally. In this pilot study, we describe the testing of a method to systematically measure and monitor compliance with basic safe performance in this area in different European primary care settings. The findings show high overall compliance with the safe system measures developed although the data indicates performance variation within and between the different systems audited, which suggests that aspects of the reliability (and safety) of these systems could be improved by care teams. However, the overall utility of the method is still to be determined and this will require testing on a greater scale in more diverse practices with larger samples of patients and blood tests, and using different technology support systems.

Rationale and Aim: Evidence of the benefits of clinical audit to patient care is limited, despite its longevity. Additionally, numerous attitudinal, professional and organizational barriers impede its effectiveness. Yet, audit remains a favoured quality improvement (QI) policy lever. Growing interest in QI techniques suggest it is timely to re-examine audit. Clinical audit advisors assist health care teams, so hold unique cross-cutting perspectives on the strategic and practical application of audit in NHS organizations. We aimed to explore their views and experiences of their role in supporting health care teams in the audit process., Method: Qualitative study using semi-structured and focus group interviews. Participants were purposively sampled (n = 21) across health sectors in two large Scottish NHS Boards. Interviews were audio-taped, transcribed and a thematic analysis performed., Results: Work pressure and lack of protected time were cited as audit barriers, but these hide other reasons for non-engagement. Different professions experience varying opportunities to participate. Doctors have more opportunities and may dominate or frustrate the process. Audit is perceived as a time-consuming, additional chore and a managerially driven exercise with no associated professional rewards. Management failure to support and resource changes fuels low motivation and disillusionment. Audit is regarded as a 'political' tool stifled by inter-professional differences and contextual constraints., Conclusions: The findings echo previous studies. We found limited evidence that audit as presently defined and used is meeting policy makers' aspirations. The quality and safety improvement focus is shifting towards 'alternative' systems-based QI methods, but research to suggest that these will be any more impactful is also lacking. Additionally, identified professional, educational and organizational barriers still need to be overcome. A debate on how best to overcome the limitations of audit and its place alongside other approaches to QI is necessary., (© 2010 Blackwell Publishing Ltd.)

Minimising the risk of preventable harm to patients is a National Health Service (NHS) priority in the UK. In the past decade, a patient safety agenda has been established in many secondary care, but is only now migrating to primary care. Information about the epidemiology of error, contributory factors and the scale of preventable harm is limited in comparison to what is known in acute hospitals. We describe how to apply a recently developed trigger tool - a rapid audit method of screening electronic patient records to detect patient harm - as a feasible part of routine primary care practice. We promote the idea that the trigger tool approach will enable care teams and clinicians to refocus their learning and improvement efforts on one of the most serious issues facing the NHS or any modern healthcare system - how to minimise the risks of unintended but avoidable harm to patients.

Rationale, Aims and Objectives: Clinical audit informs general practitioner (GP) appraisal and will provide evidence of performance for revalidation in the UK. However, objective evidence is now required. An established peer assessment system may offer an educational solution for making objective judgements on clinical audit quality. National Health Service (NHS) clinical audit specialists could potentially support this system if their audit assessments were comparable with established medical peer assessors. The study aimed to quantify differences between clinical audit specialists and medical peer assessors in their assessments of clinical audit projects., Methods: A comparison study of the assessment outcomes of clinical audit reports by two groups using appropriate assessment instruments was conducted. Mean scores were compared and 95% confidence intervals (CIs) and limits of agreement calculated. A two-point mean difference would be relevant., Results: Twelve significant event analysis (SEA) reports and 12 criterion audit projects were assessed by 11 experienced GP assessors and 10 NHS audit specialist novice assessors. For SEA, the mean score difference between groups was <1.0. The 95% CI for bias was -0.1 to 0.5 (P = 0.14). Limits of agreement ranged from -0.7 to 1.2. For criterion audit, a mean score difference of

Objective: To review the literature on the perceived benefits and disadvantages associated with significant event analysis (SEA) and identify reported barriers and facilitating factors., Method: A comprehensive search of electronic databases and peer reviewed journals was conducted during June 2006. Studies which explored or measured perceptions or attitudes in relation to SEA or assessed its impact on health care quality were included., Results: 27 studies were identified with most undertaken in UK general practice. Perceived benefits include: improved communication, enhanced team-working and awareness of others' contributions. SEA has a strong emotional resonance which may lead to a greater commitment to change. Multiple but unverifiable changes in practice and improvements in service quality were reported through participation. Disadvantages include concerns about litigation, reprisal, embarrassment and confidentiality. The reliability of SEA is questioned because it lacks a robust, standard structured method. Evidence of its impact on health care is severely limited. Barriers include a lack of training, poor team dynamics, failings in facilitation and leadership, selective topic choice and associated emotional demands. Facilitating factors include: effective practice in meetings; protected meeting time; a structured methodical approach; and strong team dynamics and leadership., Conclusion: A chasm exists between the high expectations for SEA and the lack of evidence of its impact. SEA may have some merit as a team-based educational tool. However, it may not be a reliable technique for investigating serious or complex safety issues in general practice. Policy makers need to be more explicit about the actual purpose of SEA.

Introduction: Clinical audit has failed to fully deliver the rewards initially envisaged. Contributory factors include: an ill-defined approach to audit; the assumption that health care professionals can intuitively apply audit methods; and the lack of a system to 'quality assure' the process. A method of criterion audit was defined and developed in conjunction with an instrument to facilitate trained General Practitioner (GP) assessors in the review of colleagues' audit projects. Given the potential for improving audit practice, this study aimed to define the methodological factors that contributed to 'unsatisfactory' audits as judged by peer assessors., Methods: West of Scotland GPs voluntarily submitted a criterion audit in a standard format for review by two trained colleagues using an assessment instrument. Audits judged unsatisfactory and associated educational feedback were subjected to content analysis., Results: Between 1999 and 2004, 336 audits were submitted, of which 132 (39%) were judged to be unsatisfactory. Of these, 118 audits (89%) had a methodological issue identified in the initial project design (e.g. defining criteria) that effectively invalidated the audit. 119 projects (90%) were also judged to have at least one deficiency in the data analysis or change management stages of the audit (e.g. implementing inadequate change)., Conclusion: A range of audit method issues was found. The proportion of unsatisfactory audits may point to a larger problem beyond this sample, which may have implications for health care quality. If audit practise is to be consistent and rigorous, consideration should be given to assessing the standard of this activity.

Introduction: Clinical audit has a central role in the NHS clinical governance agenda and the professional appraisal of medical practitioners in the UK. However, concerns have been raised about the poor design and impact of clinical audit studies and the ability of practitioners to apply audit methods. One method of making informed judgements on audit performance is by peer review. In the west of Scotland a voluntary peer review model has been open to general practitioners since 1999, while general practice trainees are compelled to participate as part of summative assessment. The study aimed to compare the outcomes of peer review for two methods of audit undertaken by different professional and academic groups of doctors., Methods: Participants submitted a criterion audit or significant event analysis in standard formats for review by two informed general practitioners (GPs) using appropriate instruments. Peer review outcome data and the professional status of doctors participating were generated by computer search. Differences in proportions of those gaining a satisfactory peer review for each group were calculated., Results: Of 1002 criterion audit submissions, 552 (55%) were judged to be satisfactory. GP registrars were significantly more likely than GP trainers (P < 0.001) and other established GP groups (P < 0.001) to gain a satisfactory peer review. GPs in non-training practices were less likely to achieve a satisfactory review than registrars (P < 0.001) and colleagues in training practices (P < 0.001). Of 883 SEA submissions, 541 (65%) were judged as satisfactory, with all groups gaining a similar proportion of satisfactory assessments, although GP registrars may have outperformed non-training practice GPs (P = 0.05)., Conclusion: A significant proportion of GPs may be unable to adequately apply audit methods, potentially raising serious questions about the effectiveness of clinical audit as a health care improvement policy in general medical practice.