Patient safety incidents in endoscopy: a human factors analysis of nonprocedural significant harm incidents from the National Reporting and Learning System (NRLS).

BACKGROUND: Despite advances in understanding and reducing the risk of endoscopic procedures, there is little consideration of the safety of the wider endoscopy service. Patient safety incidents (PSIs) still occur. We sought to identify nonprocedural PSIs (nPSIs) and their causative factors from a human factors perspective and generate ideas for safety improvement. METHODS: Endoscopy-specific PSI reports were extracted from the National Reporting and Learning System (NRLS). A retrospective, cross-sectional human factors analysis of data was performed. Two independent researchers coded data using a hybrid thematic analysis approach. The Human Factors Analysis and Classification System (HFACS) was used to code contributory factors. Analysis informed creation of driver diagrams and key recommendations for safety improvement in endoscopy. RESULTS: From 2017 to 2019, 1181 endoscopy-specific PSIs of significant harm were reported across England and Wales, with 539 (45.6%) being nPSIs. Five categories accounted for over 80% of all incidents, with "follow-up and surveillance" being the largest (23.4% of all nPSIs). From the free-text incident reports, 487 human factors codes were identified. Decision-based errors were the most common act prior to PSI occurrence. Other frequent preconditions to incidents were focused on environmental factors, particularly overwhelmed resources, patient factors, and ineffective team communication. Lack of staffing, standard operating procedures, effective systems, and clinical pathways were also contributory. Seven key recommendations for improving safety have been made in response to our findings. CONCLUSIONS: This was the first national-level human factors analysis of endoscopy-specific PSIs. This work will inform safety improvement strategies and should empower individual services to review their approach to safety.

Development of the "Teamwork in Endoscopy Assessment Module for Endoscopic Non-Technical Skills" (TEAM-ENTS) behavioral marker system.

BACKGROUND: Non-technical skills (NTS) are integral to team performance and subsequent quality and safety of care. Behavioral marker systems (BMSs) are now increasingly used in healthcare to support the training and assessment of team NTS. Within gastrointestinal endoscopy, this is an area of novel research. The aims of this study were to define the core relevant NTS for endoscopy teams and develop a preliminary framework for a team-based BMS known as TEAM-ENTS (Teamwork in Endoscopy Assessment Module for Endoscopic Non-Technical Skills). METHODS: This study was conducted in two phases. In phase 1, a literature review of team-based BMSs was performed to inform an interview study of core endoscopy team members. Cognitive task analysis was used to break down the NTS relevant to endoscopy teams. Framework analysis generated the structure for the preliminary TEAM-ENTS framework. In phase 2, a modified Delphi process was undertaken to refine the items of the framework. RESULTS: Seven consultant endoscopists and six nurses were interviewed. The final coding framework consisted of 88 codes grouped into five overarching categories. In total, 58 participants were recruited to the Delphi panel. In the first round, nine elements and 37 behavioral descriptors did not meet consensus. Following item adjustment, merging and deletion, all remaining items met consensus thresholds after the second round. The refined TEAM-ENTS BMS consists of five categories, 16 elements, and 47 behavioral descriptors. CONCLUSIONS: The refined TEAM-ENTS behavioral marker system was developed to reflect the core NTS relevant to endoscopy teams. Future studies will aim to fully validate this tool.

Novel classification for adverse events in GI endoscopy: the AGREE classification.

BACKGROUND AND AIMS: Standardized registration and evaluation of adverse events (AEs) are essential to assess the safety of endoscopic procedures. We propose a novel classification system, named adverse events in GI endoscopy (AGREE), adapted from a widely accepted surgical tool. METHODS: The Clavien-Dindo classification for surgical AEs was adapted for endoscopy. To validate the novel classification, we assessed if the severity of AEs, as perceived by 10 endoscopists, 10 endoscopy nurses, and 10 patients, corresponded with the severity grading used in the AGREE classification in 10 pairwise comparisons. We additionally assessed the correlation between the AGREE classification and the American Society for Gastrointestinal Endoscopy (ASGE) classification. The acceptability of the AGREE classification was evaluated through an international questionnaire. RESULTS: The perception of endoscopists, endoscopy nurses, and patients corresponded with the severity grading of the AGREE classification in 80% of cases (238/299). The AGREE classification significantly correlated with the ASGE classification (ρ = .760). Fifty-seven of 84 experts (68%) completed a questionnaire regarding the acceptability of the AGREE classification. The experts consulted considered the AGREE classification as simple (86%), reproducible (98%), logical (98%), and useful (96%). Most case presentations (84%) were correctly graded according to the AGREE classification. CONCLUSIONS: The AGREE classification provides a standardized and reproducible approach to the assessment of AEs in diagnostic and therapeutic GI endoscopy. Broad implementation of the AGREE classification may facilitate the evaluation of AEs across different endoscopists, disciplines, endoscopy services, and regions. This standardization of AE reporting will support improved quality assurance in GI endoscopy.

Teamworking in endoscopy: a human factors toolkit for the COVID-19 era.

BACKGROUND: Endoscopy services have had to rapidly adapt their working practices in response to COVID-19. As recovery of endoscopy services proceeds, our workforce faces numerous challenges that can impair effective teamworking. We designed and developed a novel toolkit to support teamworking in endoscopy during the pandemic. METHODS: A human factors model was developed to understand the impact of COVID-19 on endoscopy teams. From this, we identified a set of key teamworking goals, which informed the development of a toolkit to support several team processes. The toolkit was refined following expert input and refinement over a 6-week period. RESULTS: The toolkit consists of four cognitive aids that can be used to support team huddles, briefings, and debriefs, alongside techniques to optimize endoscopic nontechnical skills across the patient-procedure pathway. We describe the processes that local endoscopy units can employ to implement this toolkit. CONCLUSION: A toolkit of cognitive aids, based on human factors principles, may be useful in supporting teams, helping them adapt to working safely in the era of COVID-19.

Variability in cecal intubation rate by calculation method: a call for standardization of key performance indicators in endoscopy.

BACKGROUND AND AIMS: The cecal intubation rate (CIR) is a widely accepted key performance indicator (KPI) in colonoscopy but lacks a universal calculation method. We aimed to assess whether differences in CIR calculation methods could have an impact on perceived trainee outcomes. METHODS: A systematic review of CIR calculation methods was conducted on major societal guidelines (United Kingdom, European Society of Gastrointestinal Endoscopy [ESGE] and American Society for Gastrointestinal Endoscopy [ASGE]) and trainee-inclusive studies. Trainees awarded colonoscopy certification between June 2011 and 2016 were identified from the United Kingdom e-portfolio and selected as a validation cohort. For each trainee, both the crude and unassisted CIR were calculated for 50 post-certification procedures using definitions from the 3 international guidelines. The resulting CIRs, and the proportions of endoscopists failing to meet the minimum standard of CIR ≥90%, were then compared across these definitions. RESULTS: Across the 3 guidelines and 37 eligible studies identified, differences in CIR calculation methodology were demonstrated. These related to adjustment criteria (18 studies) and whether unassisted CIR was stipulated (18 studies). In the validation cohort of 733 trainees (36,650 procedures), the median crude CIR ranged from 96% (ESGE) to 98% (ASGE) (P < .001) and whether unassisted CIR was specified (ESGE, 94%; ASGE, 96%; P < .001). The proportion of trainees failing to achieve CIR ≥90% varied significantly across the different definitions, from 4.9% for the crude ASGE definition to 18.6% for the unassisted ESGE definition (P < .001). CONCLUSIONS: CIR calculation methods vary among guidelines and research studies; this has an impact on trainee performance measures. With CIR used as an example, this study highlights the need for standardized definitions and calculations of KPIs in endoscopy.

Development, validation, and results of a national endoscopy safety attitudes questionnaire (Endo-SAQ).

Background and study aims Safety attitudes are linked to patient outcomes. The Joint Advisory Group on Gastrointestinal Endoscopy (JAG) identifies the need to improve our understanding of safety culture in endoscopy. We describe the development and validation of the Endo-SAQ (endoscopy safety attitudes questionnaire) and the results of a national survey of staff attitudes. Methods Questions from the original SAQ were adapted to reflect endoscopy-specific content. This was refined by an expert group, followed by a pilot study to assess acceptability. The refined Endo-SAQ (comprising 35 questions across six domains) was disseminated to endoscopy staff across the UK and Ireland. Outcomes were domain scores and the percentage of positive responses (score ≥75/100) per domain. Descriptive and comparative analyses were performed. Binary logistic regression identified staff and service factors associated with positive scores. Validity and reliability of Endo-SAQ were assessed through psychometric analysis. Results After expert review, four questions in the preliminary Endo-SAQ were adjusted. Sixty-one participants undertook the pilot study with good acceptability. A total of 453 participants completed the refined Endo-SAQ. There were positive responses in teamwork, safety climate, job satisfaction, and working conditions domains. Endoscopists had significantly more positive responses to stress recognition and working conditions than nursing staff. JAG accreditation was associated with positive scores in safety climate and job satisfaction domains. Endo-SAQ met thresholds of construct validity and reliability. Conclusions Endoscopy staff had largely positive safety attitudes scores but there were significant differences across domains and staff. There is evidence for the validity and reliability of Endo-SAQ. Endo-SAQ could complement current measures of patient safety in endoscopy and be used in evaluation and research.

Joint Advisory Group on Gastrointestinal Endoscopy (JAG) framework for managing underperformance in gastrointestinal endoscopy.

Underperformance can be defined as performance which persistently falls below a desired minimum standard considered acceptable for patient care. Within gastrointestinal endoscopy, underperformance may be multifactorial, related to an individual's knowledge, skills, attitudes, health or external factors. If left unchecked, underperformance has the potential to impact on care and ultimately patient safety. Managing underperformance should be a key attribute of high-quality endoscopy service, as recognised in the Joint Advisory Group on Gastrointestinal Endoscopy (JAG) accreditation process. However, it is recognised that not all services have robust mechanisms to do this. This article provides the JAG position on managing underperformance in endoscopy, defined through a practical framework. This follows a stepwise process of detecting underperformance, verification, identification of additional causative factors, providing support and reassessment. Detection and verification of issues may require use of multiple evidence sources, including performance data, feedback and appraisal reports. Where technical underperformance is identified, this should be risk stratified by potential risk to patient safety. Support should be tailored to each individual case based on the type of underperformance detected, any causative factors with an action plan developed. Support may include coaching, mentoring, training and upskilling. Wider support from the medical director's office or external services may also be required. Monitoring and reassessment is a crucial part of the overall process.

National census of UK endoscopy services 2021.

Introduction: The Joint Advisory Group on Gastrointestinal (GI) Endoscopy (JAG) biennial census provides a unique view of UK endoscopy. The 2021 census was conducted to understand the impact of ongoing pressures, highlighted in the previous census, as well as COVID-19. Methods: The census was sent to all JAG-registered services in April 2021. Data were analysed across the domains of activity, waiting time targets, workforce, COVID-19, safety, GI bleeding, anaesthetic support, equipment and decontamination. Statistical methods were used to determine associations between domain-specific outcome variables and core demographic data. Results: 321 services completed the census (79.2% response rate). In the first 3 months of 2021, 57.9% of NHS services met urgent cancer waits, 17.9% met routine waits and 13.4% met surveillance waits. Workforce redeployment was the predominant reason cited for not meeting targets. There were significant regional differences in the proportion of patients waiting 6 or more weeks (p=0.001). During the pandemic, 64.8% of NHS services had staff redeployed and there was a mean sickness rate of 8.5%. Services were, on average, at 79.3% activity compared with 2 years ago. JAG-accredited services are more likely to meet urgent cancer waits, with a lower proportion of patient waiting 6 weeks or more (p=0.03). Over 10% of services stated that equipment shortage interfered with service delivery. Conclusions: Services are adapting to continued pressure and there are signs of a focused response to demand at a time of ongoing uncertainty. This census' findings will inform ongoing guidance from JAG and relevant stakeholders.

Women in gastroenterology: the UK trainee experience.

Introduction: Compared with other medical specialties, there are lower numbers of female trainees and lower rates of flexible working in gastroenterology. This study aims to examine the experience of male and female trainees to understand specialty demographics and the experience of training. Methods: Gastroenterology training data were obtained from the British Society of Gastroenterology (BSG) trainee surveys from 2014, 2018 and 2020, and from the Royal College of Physicians Medical Workforce unit between 2011 and 2019. Data on endoscopy measures from 2011 to 2021 were obtained from the Joint Advisory Group (JAG) on gastrointestinal endoscopy, including the JAG Endoscopy training system and the National Endoscopy Database. Data were segregated and compared by gender. Results: The percentage of female gastroenterology trainees remains at around 40%, largely unchanged over the previous decade. From the BSG trainee survey, 29.5% of women have flexible working patterns compared with 2.6% of men (p<0.001), which is lower than other medical specialties. Less than half of female trainees felt confident about their job prospects once they qualify. A greater proportion of male than female trainees achieved provisional colonoscopy certification during training (55% vs 45%, p=0.005) and female trainees took longer to certify than male trainees (63 months vs 56 months, p=0.004). The total length of training time from primary medical qualification to consultancy was the same for men and women. Conclusion: Changes must be addressed from a national and institutional level to address equitable access to national training programmes and equality of outcome for male and female trainees.

Bowel cancer screening workforce survey: developing the endoscopy workforce for 2025 and beyond.

AIM: The demand for bowel cancer screening (BCS) is expected to increase significantly within the next decade. Little is known about the intentions of the workforce required to meet this demand. The Joint Advisory Group on Gastrointestinal Endoscopy (JAG), the British Society of Gastroenterology (BSG) and Association of Coloproctology of Great Britain and Ireland (ACPGBI) developed the first BCS workforce survey. The aim was to assess endoscopist career intentions to aid in future workforce planning to meet the anticipated increase in BCS colonoscopy. METHODS: A survey was developed by JAG, BSG and ACPGBI and disseminated to consultant, clinical and trainee endoscopists between February and April 2020. Descriptive and comparative analyses were undertaken, supported with BCS data. RESULTS: There were 578 respondents. Screening consultants have a median of one programmed activity (PA) per week for screening, accounting for 40% of their current endoscopy workload. 38% of current screening consultants are considering giving up colonoscopy in the next 2-5 years. Retirement (58%) and pension issues (23%) are the principle reasons for this. Consultants would increase their screening PAs by 70% if able to do so. The top three activities that endoscopists would relinquish to further support screening were outpatient clinics, acute medical/surgical on call and ward cover. An extra 155 colonoscopists would be needed to fulfil increased demand and planned retirement at current PAs. CONCLUSION: This survey has identified a serious potential shortfall in screening colonoscopists in the next 5-10 years due to an ageing workforce and job plan pressures of aspirant BCS colonoscopists. We have outlined potential mitigations including reviewing job plans, improving workforce resources and supporting accreditation and training.

JAG consensus statements for training and certification in oesophagogastroduodenoscopy.

Introduction: Training and quality assurance in oesophagogastroduodenoscopy (OGD) is important to ensure competent practice. A national evidence-based review was undertaken to update and develop standards and recommendations for OGD training and certification. Methods: Under the oversight of the Joint Advisory Group (JAG), a modified Delphi process was conducted with stakeholder representation from British Society of Gastroenterology, Association of Upper Gastrointestinal Surgeons, trainees and trainers. Recommendations on OGD training and certification were formulated following literature review and appraised using Grading of Recommendations Assessment, Development and Evaluation. These were subjected to electronic voting to achieve consensus. Accepted statements were incorporated into the updated certification pathway. Results: In total, 32 recommendation statements were generated for the following domains: definition of competence (4 statements), acquisition of competence (12 statements), assessment of competence (10 statements) and post-certification support (6 statements). The consensus process led to following certification criteria: (1) performing ≥250 hands-on procedures; (2) attending a JAG-accredited basic skills course; (3) attainment of relevant minimal performance standards defined by British Society of Gastroenterology/Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, (4) achieving physically unassisted D2 intubation and J-manoeuvre in ≥95% of recent procedures, (5) satisfactory performance in formative and summative direct observation of procedural skills assessments. Conclusion: The JAG standards for diagnostic OGD have been updated following evidence-based consensus. These standards are intended to support training, improve competency assessment to uphold standards of practice and provide support to the newly-independent practitioner.

Development and impact of an endoscopic non-technical skills (ENTS) behavioural marker system.

Background: Non-technical skills (NTS) are crucial to effective team working in endoscopy. Training in NTS has been shown to improve team performance and patient outcomes. As such, NTS training and assessment are now considered essential components of the endoscopy quality assurance process. Across the literature, other specialties have achieved this through development of behavioural marker systems (BMS). BMS provide a framework for assessing, training and measuring the NTS relevant to healthcare individuals and team. This article describes the development and impact of a novel BMS for endoscopy: the endoscopic non-technical skills (ENTS) system. Methods: The initial NTS taxonomy for endoscopy was created through a combination of literature review, staff focus groups and semi-structured interviews, incorporating the critical decision method. Framework analysis was conducted with three individual coders and generated a skills list which formed the preliminary taxonomy. Video observation of Bowel Cancer Screening endoscopists was used to identify exemplar behaviours which were mapped to relevant skills in the NTS taxonomy. Behavioural descriptors, derived from video data, were added to form the basis of the ENTS system. Results: A taxonomy of 33 skills in 14 separate categories were identified through framework analysis. Following video analysis and behaviour mapping, 4 overarching categories and 13 behavioural elements were identified which formed the ENTS framework. The endoscopy (directly observed procedural skills) 4-point rating scale was added to create the final ENTS system. Since its development in 2010, the ENTS system has been validated in the assessment of endoscopy for trainees nationally. ENTS informs a number of training initiatives, including a national strategy to improve NTS for all endoscopists. Conclusions: The ENTS system is a clinically relevant tool, validated for use in trainee assessment. The use of ENTS will be important to the future of training and quality assurance in endoscopy.

Improving safety and reducing error in endoscopy (ISREE): a survey of UK services.

BACKGROUND: The Joint Advisory Group on Gastrointestinal Endoscopy (JAG) 'Improving Safety and Reducing Error in Endoscopy' (ISREE) strategy was developed in 2018. In line with the strategy, a survey was conducted within the JAG census in 2019 to gain further insights and understanding of key safety-related areas within UK endoscopy. METHODS: Questions were developed using the ISREE strategy as a guide and adapted by key JAG stakeholders. They were incorporated into the 2019 JAG census of UK endoscopy services. Quantitative and qualitative statistical methods were employed to analyse the results. RESULTS: There was a 68% response rate. There was regional variability in the provision of out-of-hours GIB services (p<0.001). Across 1 month, 1535 incidents were reported across all services. There was a significantly higher proportion of reported incidents in acute services compared with others (p<0.001). Technical and training incidents were likely to be reported significantly differently to all other incident types. 74% of services have an endoscopy-specific sedation policy and 42% have a named sedation or anaesthetic lead for endoscopy. Services highlighted a desire for more anaesthetic-supported lists. Only 66% of services stated they have an effective strategy for supporting upskilling of endoscopists. Across acute services, 56% have access to human factors and endoscopic non-technical skills (ENTS) training. Patient feedback is used in several ways to improve services, develop training and promote shared learning among endoscopy users. CONCLUSIONS: The census provides a benchmark for key safety-related characteristics of endoscopy services. These results have highlighted key areas to develop, guided by the ISREE strategy.

'Case of the month': a novel way to learn from endoscopy-related patient safety incidents.

Patient safety incidents (PSIs) are unintended or unexpected incidents which can or do lead to patient harm. The Joint Advisory Group on Gastrointestinal Endoscopy (JAG) acknowledges that PSIs should be reviewed by endoscopy services and learning shared among staff. It is recognised that more could be done to promote shared learning as outlined by the JAG 'Improving Safety and Reducing Error in Endoscopy' strategy. The 'Case of the month' series aims to provide a broad selection of cases and subsequent learning that can be shared among services and their workforce. This review focuses on five case vignettes that highlight a variety of PSIs in endoscopy. A structured approach, based on incident analysis methodology, is applied to each case to categorise PSIs and develop learning points. Learning is directed toward the individual, team and healthcare organisation. A selection of methods to disseminate learning at local, regional and national levels are also described.

National census of UK endoscopy services in 2019.

INTRODUCTION: The 2017 Joint Advisory Group on Gastrointestinal (GI) Endoscopy (JAG) census highlighted the pressure endoscopy services were under in meeting national targets and the factors behind this. In 2019, JAG conducted a further national census of endoscopy services to understand trends in activity, workforce and waiting time targets. METHODS: In April 2019, the census was sent to all eligible JAG-registered services. Collated data were analysed through various statistical methods. A further comparative dataset was created using available submissions from the 2017 census matched to services in the current census. RESULTS: There was a 68% response rate (322/471). There has been a 12%-15% increase in activity across all GI procedures with largest increases in bowel cancer screening. Fewer services are meeting waiting time targets compared with 2017, with endoscopist, nursing and physical capacity cited as the main reasons. Services are striving to improve capacity: 80% of services have an agreed business plan to meet capacity and the number using insourcing has increased from 13% to 20%. The workforce has increased, with endoscopist numbers increasing by 15%, nurses and allied health professionals by 14% and clerical staff by 30%. CONCLUSIONS: The 2019 JAG census is the most recent and extensive survey of UK endoscopy services. There is a clear trend of increasing activity with fewer services able to meet national waiting time targets than 2 years ago. Services have increased their workforce and improved planning to stem the tide but there remains a continued pressure to deliver high quality, safe endoscopy. In light of the COVID-19 pandemic, JAG recognises that these pressures will be severely exacerbated and waiting time targets for accreditation will need adjustment and tolerance during the evolution and recovery from the pandemic.

Improving safety and reducing error in endoscopy: simulation training in human factors.

Patient safety incidents occur throughout healthcare and early reports have exposed how deficiencies in 'human factors' have contributed to mortality in endoscopy. Recognising this, in the UK, the Joint Advisory Group for Gastrointestinal Endoscopy have implemented a number of initiatives including the 'Improving Safety and Reducing Error in Endoscopy' (ISREE) strategy. Within this, simulation training in human factors and Endoscopic Non-Technical Skills (ENTS) is being developed. Across healthcare, simulation training has been shown to improve team skills and patient outcomes. Although the literature is sparse, integrated and in situ simulation modalities have shown promise in endoscopy. Outcomes demonstrate improved individual and team performance and development of skills that aid clinical practice. Additionally, the use of simulation training to detect latent errors in the working environment is of significant value in reducing error and preventing harm. Implementation of simulation training at local and regional levels can be successfully achieved with collaboration between organisational, educational and clinical leads. Nationally, simulation strategies are a key aspect of the ISREE strategy to improve ENTS training. These may include integration of simulation into current training or development of novel simulation-based curricula. However used, it is evident that simulation training is an important tool in developing safer endoscopy.