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

Abstract

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.

Publication History

Received: 09 May 2023

Accepted after revision: 18 September 2023

Accepted Manuscript online:
18 September 2023

Article published online:
07 November 2023

• References

• 1 Joint Advisory Group for Gastrointestinal Endoscopy. JAG accreditation: Global rating scale (GRS) for UK services. Accessed September 19, 2023 at: https://www.thejag.org.uk/Downloads/JAG/Accreditation%20-%20Global%20Rating%20Scale%20(GRS)/Guidance%20-%20GRS%20standards%20UK%202023.pdf
• 2 Valori R, Cortas G, de Lange T. et al. Performance measures for endoscopy services: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2018; 50: 1186-1204 DOI: 10.1177/2050640618810242. (PMID: 30788114)
• 3 Ben-Menachem T, Decker GA, Early DS. et al. Adverse events of upper GI endoscopy. Gastrointest Endosc 2012; 76: 707-718 DOI: 10.1016/j.gie.2012.03.252. (PMID: 22985638)
• 4 Kothari ST, Huang RJ, Shaukat A. et al. ASGE review of adverse events in colonoscopy. Gastrointest Endosc 2019; 90: 863-876 e833 DOI: 10.1016/j.gie.2019.07.033. (PMID: 31563271)
• 5 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149 DOI: 10.1055/a-1075-4080. (PMID: 31863440)
• 6 Minoli G, Borsato P, Colombo E. et al. Errors and near misses in digestive endoscopy units. Dig Liver Dis 2012; 44: 914-918 DOI: 10.1016/j.dld.2012.06.009. (PMID: 22809959)
• 7 Matharoo M, Haycock A, Sevdalis N. et al. A prospective study of patient safety incidents in gastrointestinal endoscopy. Endosc Int Open 2017; 5: E83-E89 DOI: 10.1055/s-0042-117219. (PMID: 28191498)
• 8 Correa CSM, Bagatini A, Prates CG. et al. Patient safety in an endoscopy unit: an observational retrospective analysis of reported incidents. Braz J Anesthesiol 2021; 71: 137-141 DOI: 10.1016/j.bjane.2021.02.023. (PMID: 33894857)
• 9 NHS England. Report a patient safety incident. Accessed September 19, 2023 at: https://www.england.nhs.uk/patient-safety/report-patient-safety-incident/
• 10 Chartered Institute of Ergonomics and Human Factors. Learning from Adverse Events White Paper. Accessed September 19, 2023 at: https://ergonomics.org.uk/resource/learning-from-adverse-events.html
• 11 Diller T, Helmrich G, Dunning S. et al. The Human Factors Analysis Classification System (HFACS) applied to health care. Am J Med Qual 2013; 29: 181-190 DOI: 10.1177/1062860613491623. (PMID: 23814026)
• 12 O'Connor T, Papanikolaou V, Keogh I. Safe surgery, the human factors approach. Surgeon 2010; 8: 93-95 DOI: 10.1016/j.surge.2009.10.004. (PMID: 20303890)
• 13 Joint Advisory Group on Gastrointestinal Endoscopy. Improving Safety and Reducing Error in Endoscopy (ISREE) Implementation strategy. Accessed September 19, 2023 at: www.thejag.org.uk/Downloads/JAG/General/Improving%20Safety%20and%20Reducing%20Error%20in%20Endoscopy%20(ISREE)%20Implementation%20strategy%20v1.0.pdf
• 14 Carson-Stevens A, Hibbert P, Williams H. et al. Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice. Health Services and Delivery Research 2016; 27 DOI: 10.3310/hsdr04270.
• 15 Williams H, Donaldson SL, Noble S. et al. Quality improvement priorities for safer out-of-hours palliative care: Lessons from a mixed-methods analysis of a national incident-reporting database. Palliat Med 2019; 33: 346-356
• 16 Carson-Stevens A, Hibbert P, Avery A. et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open 2015; 5: e009079
• 17 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454 DOI: 10.1016/j.gie.2009.10.027. (PMID: 20189503)
• 18 NHS Improvement. Never Events list 2018. Updated 2021. Accessed September 19, 2023 at: https://www.england.nhs.uk/wp-content/uploads/2020/11/2018-Never-Events-List-updated-February-2021.pdf
• 19 Shale S, Woodier N. Human Factors Analysis and Classification System (HFACS): coding framework adapted for the NHS acute hospital setting v4.2. Accessed September 19, 2023 at: https://q.health.org.uk/document/human-factors-hfacs-acute-hospital-full-coding-system/
• 20 O’Connor C, Joffe H. Intercoder reliability in qualitative research: debates and practical guidelines. Int J Qual Methods 2020; DOI: 10.1177/1609406919899220.
• 21 Ravindran S, Thomas-Gibson S, Siau K. et al. Joint Advisory Group on Gastrointestinal Endoscopy (JAG) framework for managing underperformance in gastrointestinal endoscopy. Frontline Gastroenterol 2022; 13: 5-11 DOI: 10.1136/flgastro-2021-101830. (PMID: 34970427)
• 22 Oates B. Gastroenterology GIRFT Programme National Specialty Report. Accessed September 19, 2023 at: https://www.bsg.org.uk/wp-content/uploads/2021/10/Gastroenterology-Oct21v.pdf
• 23 Rees CJ, Koo S, Anderson J. et al. British Society of Gastroenterology Endoscopy Quality Improvement Programme (EQIP): overview and progress. Frontline Gastroenterol 2019; 10: 148-153 DOI: 10.1136/flgastro-2018-101073. (PMID: 31205655)
• 24 Thiels CA, Lal TM, Nienow JM. et al. Surgical never events and contributing human factors. Surgery 2015; 158: 515-521 DOI: 10.1016/j.surg.2015.03.053. (PMID: 26032826)
• 25 Bickley SJ, Torgler B. A systematic approach to public health – Novel application of the human factors analysis and classification system to public health and COVID-19. Saf Sci 2021; 140: 105312 DOI: 10.1016/j.ssci.2021.105312. (PMID: 33897105)
• 26 Gralnek IM, Bisschops R, Matharoo M. et al. Guidance for the implementation of a safety checklist for gastrointestinal endoscopic procedures: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement. Endoscopy 2022; 54: 206-210 DOI: 10.1055/a-1695-3244. (PMID: 34905797)
• 27 Sauro KM, Machan M, Whalen-Browne L. et al. Evolving factors in hospital safety: a systematic review and meta-analysis of hospital adverse events. J Patient Saf 2021; 17: e1285-e1295 DOI: 10.1097/PTS.0000000000000889. (PMID: 34469915)
• 28 Chukmaitov A, Siangphoe U, Dahman B. et al. Patient comorbidity and serious adverse events after outpatient colonoscopy: population-based study from three states, 2006 to 2009. Dis Colon Rectum 2016; 59: 677-687
• 29 Rees CJ, Trebble TM, Von Wagner C. et al. British Society of Gastroenterology position statement on patient experience of GI endoscopy. Gut 2020; DOI: 10.1136/gutjnl-2019-319207.
• 30 Valori R. How to improve your vetting processes and surveillance in COVID-19 era. Accessed September 19, 2023 at: https://www.thejag.org.uk/news/how-to-improve-your-vetting-processes-and-surveillance-in-covid19-era
• 31 Tillott S, Walsh K, Moxham L. Encouraging engagement at work to improve retention. Nurs Manag (Harrow) 2013; 19: 27-31 DOI: 10.7748/nm2013.03.19.10.27.e697. (PMID: 23577562)
• 32 Lentz CM, De Lind Van Wijngaarden RAF, Willeboordse F. et al. Dedicated teams to optimize quality and safety of surgery: A systematic review. Int J Qual Health Care 2022; 34: mzac078
• 33 Schmutz J, Manser T. Do team processes really have an effect on clinical performance? A systematic literature review. Br J Anaesth 2013; 110: 529-544 DOI: 10.1093/bja/aes513. (PMID: 23454826)
• 34 Ravindran S, Matharoo M, Coleman M. et al. Teamworking in endoscopy: a human factors toolkit for the COVID-19 era. Endoscopy 2020; 52: 879-883 DOI: 10.1055/a-1204-5212. (PMID: 32572861)
• 35 Ching H-L, Lau MS, Azmy IA. et al. Performance measures for the SACRED team-centered approach to advanced gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2022; 54: 712-722 DOI: 10.1055/a-1832-4232. (PMID: 35636453)
• 36 Holden RJ, Carayon P. SEIPS 101 and seven simple SEIPS tools. BMJ Qual Saf 2021; 30: 901-910 DOI: 10.1136/bmjqs-2020-012538. (PMID: 34039748)
• 37 Ravindran S, Matharoo M, Shaw T. et al. ‘Case of the month’: a novel way to learn from endoscopy-related patient safety incidents. Frontline Gastroenterol 2021; 12: 636-643