A prospective study of patient safety incidents in gastrointestinal endoscopy

Abstract

Background and study aims Medical error occurs frequently with significant morbidity and mortality. This study aime to assess the frequency and type of endoscopy patient safety incidents (PSIs).

Patients and methods A prospective observational study of PSIs in routine diagnostic and therapeutic endoscopy was undertaken in a secondary and tertiary care center. Observations were undertaken within the endoscopy suite across pre-procedure, intra-procedure and post-procedure phases of care. Experienced (Consultant-level) and trainee endoscopists from medical, surgical, and nursing specialities were included. PSIs were defined as any safety issue that had the potential to or directly adversely affected patient care: PSIs included near misses, complications, adverse events and “never events”. PSIs were reviewed by an expert panel and categorized for severity and nature via expert consensus.

Results One hundred and forty procedures (92 diagnostic, 48 therapeutic) over 37 lists (experienced operators n = 25, trainees n = 12) were analyzed. One hundred forty PSIs were identified (median 1 per procedure, range 0 – 7). Eighty-six PSIs (61 %) occurred in 48 therapeutic procedures. Zero PSIs were detected in 13 diagnostic procedures. 21 (15 %) PSIs were categorized as severe and 12 (9 %) had the potential to be “never events,” including patient misidentification and wrong procedure. Forty PSIs (28 %) were of intermediate severity and 78 (56 %) were minor. Oxygen monitoring PSIs occurred most frequently.

Conclusion This is the first study documenting the range and frequency of PSIs in endoscopy. Although many errors are minor without immediate consequence, further work should identify whether prevention of such recurrent errors affects the incidence of severe errors, thus improving safety and quality.

• References

• 1 de Vries EN. Ramrattan MA. Smorenburg SM. et al. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care 2008; 17: 216-223
• 2 Leape L. The nature of adverse events in hospitalised patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377-384
• 3 Thomas E. Studdert D. Burstin H. et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000; 38: 261-271
• 4 Kohn L. Corrigan J. Donaldson M. To Err is Human: Building a Safer Healthcare System. Washington, DC: National Academy Press; 2000
• 5 Vincent C. Neale G. Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. BMJ 2001; 322: 517-519
• 6 Vincent C. Moorthy K. Sarker SK. et al. Systems Approaches to Surgical Quality and Safety. Ann Surg 2004; 239: 475-482
• 7 Reason JT. Human error: models and management. BMJ 2000; 320: 768-770
• 8 NHS England. Patient Safety Domain: Revised Never Events Policy and Framework. London: 2015
• 9 Jensen L. Merry A. Webster C. et al. Evidence-based strategies for preventing drug administration errors during anaesthesia. Anaesthesia 2004; 2004: 493-504
• 10 Pronovost P. Needham D. Berenholtz S. et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006; 355: 2725-2732
• 11 Gaba D. Anaesthesiology as a model for patient safety in health care. BMJ 2000; 320: 785-788
• 12 Catchpole K. Mishra A. Handa A. et al. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg 2008; 247: 699-706
• 13 Cotton PB. Advanced Digestive Endoscopy: Practice and Safety. Massachusetts: Wiley Blackwell; 2008
• 14 Rabeneck L. Paszat LF. Hilsden RJ. et al. Bleeding and perforation after outpatient colonoscopy and their risk factors in usual clinical practice. Gastroenterology 2008; 135: 1899-1906, 1906 e1891
• 15 Cullinane M. Gray A. Hargraves C. et al. National Confidential Enquiry into Patient Outcome and Death: Scoping our practice. 2004
• 16 Bowles CJA. Leicester R. Romaya C. et al. A prospective study of colonoscopy practice in the UK today: are we adequately prepared for national colorectal cancer screening tomorrow?. Gut 2004; 53: 277-283
• 17 Rex DK. Bond JH. Field AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol 2001; 96: 952-957
• 18 Richter JM. Kelsey PB. Campbell EJ. Adverse event and complication management in gastrointestinal endoscopy. Am J Gastroenterol 2016; 111: 348-352
• 19 Gavin DR. Valori RM. Anderson JT. et al. The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK. Gut 2013; 62: 242-249
• 20 Lee TJ. Rutter MD. Blanks RG. et al. Colonoscopy quality measures: experience from the NHS Bowel Cancer Screening Programme. Gut 2012; 61: 1050-1057
• 21 Sint Nicolaas J. de Jonge V. de Man RA. et al. The Global Rating Scale in clinical practice: a comprehensive quality assurance programme for endoscopy departments. Dig Liver Dis 2012; 44: 919-924
• 22 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
• 23 Barach P. Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 2000; 320: 759-763
• 24 The Patient Safety Policy Team. The “never events” list 2012/13. Department of Health; 2012
• 25 Lilford R. Mohammed M. Braunholtz D. et al. The measurement of active errors: methodological issues. Qual Saf Health Care 2003; 12: ii8-12
• 26 Catchpole KR. Giddings AE. Wilkinson M. et al. Improving patient safety by identifying latent failures in successful operations. Surgery 2007; 142: 102-110
• 27 Flin R. Patey R. Glavin R. et al. Anaesthetists' non-technical skills. Br J Anaesth 2010; 105: 38-44
• 28 BSG. Guidelines on Safety and Sedation During Endoscopic Procedures. 1991
• 29 Dumonceau JM. Riphaus A. Beilenhoff U. et al. European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Endoscopy 2013; 45: 496-504
• 30 Dumonceau JM. Riphaus A. Aparicio JR. et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy 2010; 42: 960-974
• 31 Matharoo M. Haycock A. Sevdalis N. et al. Endoscopic non-technical skills team training: The next step in quality assurance of endoscopy training. World J Gastroenterol 2014; 20: 17507-17515
• 32 Veitch A. Rutter M. Improving quality in endoscopy: are we nearly there yet?. Frontline Gastroenterology 2015;
• 33 Robertson DJ. Kaminski MF. Bretthauer M. Effectiveness, training and quality assurance of colonoscopy screening for colorectal cancer. Gut 2015; 64: 982-990
• 34 Howell AM. Burns EM. Hull L. et al. International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process. BMJ Qual Saf 2016;
• 35 Matharoo M. Thomas-Gibson S. Haycock A. et al. Implementation of an Endoscopy Safety Checklist. Frontline Gastroenterology 2014;
• 36 Vincent C. Framework for analysing risk and safety in clinical medicine. BMJ 1998; 316: 1154-1157
• 37 McCambridge J. Witton J. Elbourne D. Systematic review of the Hawthorne effect: New concepts are needed to study research participation effects. J Clin Epidemiol 2014; 67: 267-277
• 38 Runciman WB. Baker GR. Michel P. et al. Tracing the foundations of a conceptual framework for a patient safety ontology. Qual Saf Helath Care 2010; 19: e56