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Clinical Incident InvestigationSafety I vs Safety II – why it is time to change
Dr Clare SkinnerDirector of Emergency Medicine
Hornsby Ku-ring-gai Hospital
Chair – Emergency Medicine Network NSLHD14 June 2019
How we ‘do’ safety in hospitals
• Root cause analysis (RCA)• Incident reporting• (Standard-based accreditation)
Just how effective are they?Is there any evidence?
NSW Health
• RCA first used 2002• Clinical Excellence Commission established 2004• Formal incident monitoring system (IIMS) implemented 2005• RCA mandated for all Clinical SAC 1 incidents and ‘sentinel events’
• Report to be submitted within 70 days of notification• Healthcare incident data publicly reported• Statewide programs developed in response to common incidents
• ‘Sepsis kills’• ‘Between the flags’• ‘Time out’
• http://www.cec.health.nsw.gov.au/clinical-incident-management
RCA – history and context
• Arose in manufacturing• Examination of industrial accidents
• Promoted by Sakichi Toyoda – ‘The 5 Whys’• Spread into other high risk industries
• Aviation• Nuclear power
• First used in hospitals in 1990s – Veterans Affairs USA• Mandated by The Joint Commission USA 1997• ‘To Err is Human’ Institute of Medicine 2000
‘The goal is to learn from adverse events and near misses, and to implement proactive change in order to reduce future similar events that might compromise patient safety’Hettinger et al 2013
RCA – What’s the evidence?
• Kellogg et al, BMJ Qual Saf, 2017• Review of 302 RCAs from USA teaching hospital 2001-2008• Incidents - procedural complication, cardiac arrest, neurological deficit,
retained foreign body• Settings - Surgical (52.6%), Medical (13.9%), O&G (7.6%), Imaging (6.3%)
• NB – ED ranked 7 with 4%• Solutions - 731 proposed, more like when incident involved patient death
• Training (20%), process change (19.6%), policy reinforcement (15.2%)• Multiple repeat events occurred during the study period despite RCAs
‘Many times, the RCA does not identify meaningful aspects of the event, but simply observes that humans are imperfect.’
RCA – What’s the evidence?
• Hettinger et al, J Health Risk Manag, 2013• Review of 302 RCAs from USA teaching hospital 2001-2008• Interviews with frontline staff• Modelled effectiveness and sustainability of recommendations
• Most effective – institutional change, IT solutions, physical environment• Least effective – training, policy, compliance checks, disciplinary action• Vague – reminders, questions
‘It is often best to focus on several smaller but more effective and sustainable solutions than to try to fix the entire system at once.’
RCA – What’s the evidence?
• Nicolini et al, J Health Serv Res Policy, 2011• Ethnographic tracking of ten incident investigations NHS UK• Challenges of RCA:
• Forming the team and gathering evidence• Conducting analysis and identifying root cause/s• Formulating and implementing change
‘Anxiety, fear and shame significantly affect the RCA process and its outcomes.’
‘Risk managers … were totally unprepared to address the challenges of turning recommendations into sustainable changes. They saw themselves as friendly and collaborative investigators. Change was someone else’s responsibility.’
RCA – What’s the evidence?
• Iedema et al, J Health Org, 2008• Interviews with senior clinical governance managers post implementation of
IIMS system NSW 2006• Burden of RCA process – especially in time frame• Quality of RCA recommendations – ‘motherhood statements’• Senior management scrutiny of RCA recommendations – ethics of editing• Impact of RCA recommendations on performance – scope restricted
There’s nothing I’ve really come across that I don’t think we wouldn’t have found by other means.’
RCA – What’s the evidence?
• Wu et al, JAMA, 2008 (Review)
‘The RCA process is designed to answer 3 basic questions: what happened, why did it happen, and what can be done to prevent it from happening again. What is missing in medicine is a fourth question: has the risk of recurrence actually been reduced?’
‘The two most common recommendations in health care RCA (education and writing a policy) are weak and have a low probability of reducing risk.’
‘There are no studies in peer-reviewed literature on the effectiveness of RCA in reducing risk or improving safety, and there are no evaluations of the cost or cost-effectiveness of the procedure compared with other tools to mitigate hazards.’
RCA – What’s the evidence?
• Peerally et al, BMJ Qual Safe, 2016 (Review)• Searching for ‘the root cause’
• Reductionist and simplistic• Questionable quality
• Local non-expert teams, variable information• Political compromise
• Causes/solutions of mutual convenience• Poorly designed/implemented recommendations
• May do harm, implementation rates from 45-70%• Poor feedback loops
• To those who report, to those affected in the future• Analysis of single incidents/organisations
• Need to address the broader system conditions• Confusion about blame – the problem of many hands
Incident reporting – history and context
• Health care guided by other critical industries• Learning from incidents a key component of industrial safety systems• Implementation of large-scale health incident reporting systems in
the 2000s• Most common incidents NHS (2010-2012):
• Failure to act or recognise deterioration (23%)• Inpatient falls (10%)• Health-case associated infections (10%)• Unexpected peri-operative death (6%)• Poor or inadequate handover (5%)
Incident reporting – what happened?
• Mitchell et al, BMJ Qual Saf, 2016• Method – semi-structured interviews with leading international authorities
on patient safety (involved in IOM report and/or system implementation)• Inadequate report processes – large volume, insufficiently analysed and acted on• Lack of adequate medical engagement – reporting bias from nurses skews data• Insufficient action – attention on reporting but not feedback, resulting in under-
reporting of meaningful incidents• Inadequate funding and institutional support – delays in analysis, insufficient training,
poor accountability• Failure to capture health IT developments – poor linkage with EMRs and other
databases
‘Incident reports detect only a small percentage of relevant patient safety issues’
Incident reporting – how is health different?
• Macrae, BMJ Qual Saf, 2015 (Review)• Other industries:
• Report only serious, specific or surprising incidents• Use incident reports to prioritise significant or emerging risks• Expect reports to be inaccurate/incomplete – just a part of the picture• Apply pragmatic incident taxonomies• Ensure incidents are managed and coordinated by an independent group• Recognise that reporting is only one component of safety and risk management• Create regimes of mutual accountability for improvement
‘Problems can be traced to what was lost in translation when incident reporting was adapted from aviation and other safety-critical industries, with fundamental aspects of successful incident reporting systems misunderstood, misapplied or entirely missed in healthcare.’
Incident reporting – flawed thinking
• Sujan et al, Safety Sci, 2016• Healthcare tends to have high incident frequency with low severity• Many barriers to reporting – fear of blame, poor usability, perception that
reporting is a nursing task, lack of feedback, lack of visible improvement• Misperception that incident reporting is useful for monitoring incident
frequencies (NB some evidence that high reporting hospitals are safer)• Focus of learning too much on collecting and categorising data
‘The paper argues that health care organisations might improve their ability to learn from past experience by studying not only what goes wrong, but also by considering what goes right.’
A shift in thinking about safety
• Safety-I• Traditional safety engineering perspective• Safety defined by the absence of negative events
• Safety-II• Learning from what goes right• Analyse the everyday and the exceptional• Expect errors to happen• System resilience - dynamic trade-offs to adjust performance to deal with
disturbances and surprises• ‘A just culture’ – restorative not punitive
Human factors
Work as imaginedvs
Work as done
How can we do better?
• Broaden sources of information• ‘Hassle’ approach - ask staff to report things they find annoying or silly• Social media – reviews and ratings – eg ‘Trip Advisor’/Twitter feeds• Getting Rid of Stupid Stuff NEJM 2018• In situ simulation – to test planning and equipment
• Professionalise incident investigation• Specialist teams with high level training• Careful incident selection• Acknowledge/embrace uncertainty• Contextualised approach• Involve patients and families• Aggregate incidents – time and space
• Institutional learning and memory
I hope I have convinced you that this is our lane
Are you thinking what I’m thinking B2?
Some homework:• Sidney Dekker – Safety Differently
http://www.safetydifferently.com/author/sidneydekker/
• Suzette Woodward – Rethinking Patient Safetyhttps://suzettewoodward.org/
References:• Anderson, Kodate, Walters, Dodds, ‘Can incident reporting improve safety? Healthcare practitioners’ views of the effectiveness of incident reporting’, In J Quality in
Health Care, 2013; 1-10
• Donaldson , Panesar, Darzi, ‘Patient-Safety-Related Hospital Deaths in England: Thematic Analysis of Incidents Reported to a National Database, 2010-2012’, PLOS Medicine, 2014; 11(6) – accessed 19/2/2019
• Hettinger, Fairbanks, Hegde, Rackoff, Wreathall, Lewis, Bisantz, Wears, ‘An Evidenced-Based Toolkit for the Development of Effective and Sustainable Root Cause Analysis Safety Solutions’, J Health Risk Management, 2013; 33(2):11-20
• Iedema, Braithwaite, Jorm, ‘Managing the scope and impact of root causes analysis recommendations’, J Health Organisation and Management, 2008; 22(6):569-585
• Kellogg, Hettinger, Shah, Wears, Sellers, Squires, Fairbanks, ‘Our current approach to root cause analysis: is it contributing to our failure to improve patient safety?’, BMJ Quality and Safety, 2017; 26:381-387
• Leistikow, Mulder, Vesseur, Robben, ‘Learning from incidents in healthcare: the journey, not the arrival, matters’, BMJ Quality and Safety, 2017; 26:252-256
• Macrae, ‘The problem with incident reporting’, BMJ Quality and Safety, 2015; 0:1-5
• Mitchell, Schuster, Smith, Pronovost, Wu, ‘Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15 years after “To Err is Human”’, BMJ Quality and Safety, 2016; 25:92-99
• Nicolini, Waring, Mengis, ‘The challenges of undertaking root cause analysis in health care: a qualitative study’, J Health Services Research and Policy, 2011; 16(1):34-41
• Peerally, Carr, Waring, Dixon-Woods, ‘The problem with root cause analysis’, BMJ Quality and Safety, 2016; 0:1-6
• Polancich, Roussel, Patrician, ‘Best Practices for Conducting an RCA: Are There Any?’ Patient Safety and Quality, Oct 13 2014 – accessed 19/2/2019
• Rabol, Gaardboe, Hellebek, ‘Incident reporting must result in local action’, BMJ Quality and Safety, 2016; 0:1-2
• Sujan, ‘An organisation without a memory: a qualitative study of hospital staff perceptions on reporting and organisational learning for patient safety’, Reliability Engineering and System Safety, 2015; 144:45-52
• Sujan, Furniss, ‘Organisational reporting and learning systems: innovating inside and outside of the box’, Clinical Risk, 2015; 21(1):7-12
• Sujan, Huang, Braithwaite, ‘Learning from incidents in health care: Critique from a Safety-II perspective’, Safety Science, 2016;
• Trbovish, Shojana, ‘Root-cause analysis: swatting at mosquitoes versus draining the swamp’, BMJ Quality and Safety, 2017; 0:1-4
• Wears, ‘Learning from near misses in avaiation: so much more to it than you thought’, BMJ Qual and Safety, 2016; 0:1-2
• Westbrook, Li, Lehnbom, Baysari, Braithwaite, Burke, Conn, Day, ‘What are incident reports telling us? A comparative study at two Australian hospitals of medications errors identified at audit, detected by staff, and reported to an incident system’, Int J for Quality in Healthcare, 2015; 27(1):1-9
• Wu, Lipshutz, Pronovost, ‘Effectiveness and Efficiency of Root Cause Analysis in Medicine’, JAMA, 2008; 299(6):685-687
