CLINICAL FEATURE KEYWORDS Error, Patient safety, Migrations, Safety culture, Violations Provenance and Peer review: Invited contribution; Peer reviewed; Accepted for publication November 2013.

Violations and migrations in perioperative practice:

how organisational drift puts patients at risk by JH Reid Correspondence address: c/o AfPP, Daisy Ayris House, 42 Freemans Way, Harrogate, HG3 1 DH. Email: [email protected]

Background Short cuts and work-arounds are a feature of daily life, both domestically and professionally. They can include actions such as: failing to separate household waste for recycling, painting without rubbing down, wearing scrubs to the hospital canteen, or ignoring guidance and regulations for the control of substances hazardous to health (COSHH) (HMSO 2002) when handling toxic substances. Amalberti et al (2006) describe such acts as violations because they occur as deliberate digressions from standard practices and, in the case of our professional lives, deviations from established organisational procedures, processes and protocols. A violation can be justified as a creative way of managing a difficult situation. While this can sometimes be true, in the majority of cases violations are unconscious acts of deviance. They can be extremely seductive, because they ‘appear’ to be easier to execute and offer a range of perceived immediate benefits, including time savings.

Stop! Reflect! When was the last time you knowingly acted, or observed a colleague unconsciously acting, in a manner which was contrary to national/organisational guidance or procedure?

Blindingly beguiling The greatest risk for patients is that unconscious seduction increases our potential to normalise a deviant act/ behaviour, without having due regard to the consequences (associated risks/potential harms) (Vaughan 2004).

A common reaction in most organisations, when breaches in procedure or protocol (violations) are identified, is for management to reprimand those concerned and to re-emphasise the rules to be followed via memos, briefings and emails. Most of this has little or no impact, given the volume of information that staff receive, have to sift through and then prioritise on a daily basis. If the significance of a safety issue is buried in an email and the risks and potential harms are not obvious, we have to ask ourselves why any rational human being, ourselves included, would stop doing something that makes our working life easier? Unless the circumstances surrounding any and all deviations from desired practice are properly examined through a safety science lens (Emanuel et al 2008) the situation can rarely be rectified or improved upon, because the underlying reasons for the deviance are not properly identified and addressed. As Reason (1990) pointed out, patient harm is rarely due to bad people doing bad things. More often than not it is attributable to the contradictions and complexities of the systems in which people work that sometimes make it impossible to do the right thing. Improvement can only really occur when upstream defects in the system’s latent errors (organisation, management, training, and equipment) are designed and tackled synergistically (van Beuzekom et al 2010).

Violations: the perioperative paradox The irony in exploring this topic is that, although risky, many violations paradoxically support service efficiencies and productivity

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(at least in the short term), and enable perioperative staff to navigate known glitches in the system to keep the perioperative wheels on the ‘organisational bus’. Because violations often ‘help’ us to get things done, they become increasingly seductive and are very quickly relied upon, resulting in steady organisational drift to the boundaries of unacceptable risk and greater potential to harm. Particular behaviours, work-arounds and short cuts, become the accepted norm, the ‘modus operandi’... Simply ’the way things are done around here’. The paradox is compounded because on one level violations reflect worker flexibility so much so that staff are praised for the support and flexibility they provide. At the outset, adaptations are disregarded as violations and reframed as creative, indiscriminate ‘one-offs’. They are routinely justified as acceptable, because they are perceived as presenting negligible risk. The threat for patients and the service is that when minor violations are tolerated over time, particularly when they are depended on and encouraged by leaders and managers to help keep organisational ‘plates spinning’, they become the workplace norm and people are blinded to their inherent/associated risks. Take surgical capacity and demand pressures as an example, compounded by productivity and performance targets, such as the 18 week referral to treatment indicator. Routinely and in good faith, perioperative staff commit considerable energy to ensuring that patients undergo their procedure as planned, to avoid distressing cancellations during the day or week of surgery.

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CLINICAL FEATURE

Violations and migrations in perioperative practice: how organisational drift puts patients at risk Continued

In the process, staff may flout rules and organisational procedures for advance listing; they may also juggle and accommodate multiple changes to operating lists hour by hour. Every perioperative professional knows that multiple list changes increase the risk of wrong patient/wrong procedure and should be avoided at all costs. Nevertheless, they are a feature of daily life in many theatre suites. It is generally regarded that list changes should always be tolerated by exception and should never become an accepted or routine practice. Demand and capacity pressures in every organisation need to be managed in a systemised way, supported through IT solutions that model flow, pressure points, resource and capacity (human, plant and equipment). The mitigation of risk of patient harm is further dependent on the discipline of all staff to comply with scheduling guidance that takes account of the complexity of case, estimated time of procedure, patient acuity, surgeon competence/experience, perioperative staffing levels, balance of elective/urgent/emergency demand and other extraneous factors.

Organisational tolerances and thresholds: a moveable feast Violations come in all guises and with varying degrees of risk/potential for harm. Regrettably for patients however, perioperative staff can sleep walk into accepting and perpetuating violations, unconsciously and far too easily. The most fertile ground to nurture deviance is when staff feel that they are stuck between a ‘rock and hard place’. In situations of tension, incredible challenge and perceived impossibility, quick fixes are beguiling and more easily tolerated. Common violations include: operating with unsafe staffing levels, re-use of single use devices, failure to double check IV medications, failure to engage with the WHO surgical safety checklist, and compromises on mandatory training/appraisal, to name but a few. Whilst each violation may not

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be perceived as particularly risky on a given day and may be something to be managed down the line, collectively and cumulatively they may create the ‘perfect storm’. Individual violations can drift to an unacceptable tolerance of mediocrity and poor standards and may increase the potential to cause actual and irreversible harm to patients. Because violations can be both positive and negative they will never be eliminated, but they do need attention and they need to be effectively managed.

Stop! Reflect! Do you know the routine violations in your work place? How many violations occur unconsciously and have simply become the way you do things?

Understanding deviance Perioperative professionals need to understand how deviance occurs, stabilises, regresses, or progresses and how it contributes to avoidable harm. Staff also need to recognise, how migration to the boundaries of safe practice, also referred to as organisational drift, increases risk to patients over time (Rasmussen 1997). Our perioperative reality is that violations are unavoidable because system dynamics and deviances are markers of adaptation. On a daily basis, staff adjust to the demands and pressures of their environment and work processes, striving as responsive professionals creatively and intuitively to tackle them to best effect. Violations cannot be eliminated in any organisation, even those which we might consider to be ‘ultra safe’, because it is about the human response. But the occurrence of violations can be managed by systems thinking and principles such as standardisation and simplification, by relaxing constraints that make it difficult to do the right thing, by incorporating forcing functions that make it easier to do the right thing, by increasing peer control and

by containing reckless, unprofessional behaviour (Emmanuel et al 2008).

Learning from others Many national and international disasters in healthcare and other industries, highlight how people deliberately deviate from workplace standards and rules, causing accidents and claiming lives. In 1987 for example, the ferry Herald of Free Enterprise left Zeebrugge’s inner harbour, took on water and sank. The consequences were devastating and many lives were lost because personnel, wishing to save time, had failed to close the back loading car ramp at the necessary time. In 2011 the Deep Water Horizon oil disaster off the Gulf of Mexico was attributed to the companies of BP, Transocean and Halliburton, violating US Federal safety regulations, in the interests of profit over safety. Neither accident was caused by intended errors, but they were due to deliberate deviation from process and by failure to comply with established company procedures which had been designed to mitigate risk. In both cases, accident analysis showed that the workers involved were engaged in behaviours that were symptomatic of a progressive and sustained drift in practice, so much so that violations had become the normal operating procedure. Of significance, the status quo, the ‘way things were done’ was universally known and accepted by those with corporate and management responsibility and accountability (Emmanuel et al 2008).

When is a rule not a rule? Deliberate deviations (violations) need to be understood, for they have been a feature of safety analyses in many other industries for some time. But the phenomenon continues to be poorly appreciated and studied in healthcare. Our collective challenge concerns the fact that defining non-compliance is complex and most definitely not black and white. The expected level of compliance in any operating theatre department, and the interpretation of non-compliance and violation, varies according to the format

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CLINICAL FEATURE

Violations come in all guises and with varying degrees of risk/potential for harm

and tone by which instructions are issued. The nature of the work and the social and organisational context in which staff are expected to follow rules also impacts the expected level of compliance. In some cases strict observance of rules is expected (e.g. management of radiation treatment and staff exposure), whereas in other cases a certain degree of flexibility is tolerated, or even expected (e.g. A&E patient trolley waits, incidence of list changes, engagement with the WHO surgical safety checklist). Often in healthcare the majority of information provided is considered as a guide to practice, not as an obligatory set of instructions to be followed. While serious violations of strict rules are likely to be severely penalised if discovered in any environment (e.g. staff abuse of controlled drugs) violations that are regarded as less serious or as necessary to get the job done are overlooked on a daily basis.

Stop! Reflect! What is regarded a serious rule in your department? Which rules are flexed according to the presenting situation/context? Which rules are routinely flouted and ignored? Which rules are consistently compromised with the knowing encouragement of management? Which rules compromise patient safety? What concerns you professionally, contractually and morally? If the position on rules is a moving feast, how do we expect staff to make a judgement? Who is ultimately accountable for tolerated and accepted violations that lead to organisational drift? What tolerances and thresholds does the board accept and endorse? What does all of this mean for personal and professional accountability, vicarious liability and corporate responsibility to patients and the public?

Understanding the violations that occur in any organisation is challenging because they are partially hidden or universally accepted and normalised, but we can be in no doubt that violations are the cause of patient harm. Failure to conduct the WHO checklist appropriately for example can be a precursor to a surgical never event (Reid 2011). Violations occur frequently, in all industries, even those with very good safety records. Healthcare is often compared to aviation, but in spite of aviation’s improving safety record the industry is not immune to violations. An extensive study of how air crews deviate from procedures showed that ’intentional non-compliance’ represented 55% of all errors and violations in 3500 flight segments, but only 3% of the noted violations affected the flight in an adverse way (Helmreich 2000). Pilots also showed poor compliance with checklists when they were introduced (Degani & Wiener 1993). Half of all checklists reviewed were incorrectly completed due to interruptions, distractions and complaints of poor design.

Complex phenomena In healthcare, particularly given the current financial climate, staff need to be attentive to violations that are justified on the grounds of economy. But they also need to ensure that any deviant act or behaviour has no adverse consequences for patients. Violations occur frequently because they can save time and bring benefits to both individuals and systems, so they are often tolerated by the wider clinical team and even actively encouraged by management, especially when there is pressure to increase workload and throughput of patients. Perioperative staff need to be sensitive to the fact that violations can also arise due to individual motivation such as a desire to go home on time, as well as due to wider social and organisational pressures (e.g. operating on all listed patients). Staff also need to recognise that extreme violations always put people and systems at risk.

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Violations: the potential for organisational drift How organisational drift occurs and how practices can creep to unacceptable margins of safety is explained through the studies of Rasmussen (1997) and Amalberti (2001). Their papers asserted that front line workers rarely follow procedures in a strict and logical manner, but try to follow the path that seems most useful and productive at the time. Rasmussen (1997) noted in particular, that workers operate within an envelope of possible actions that is influenced by wider organisational and social forces. Rasmussen also identified that, because workers in most industries have to adapt and react to organisational demands for increased performance and productivity, they are pressurised to migrate towards the boundaries of safe operations, which in turn erodes the margins of safety. If unchecked, violations become more frequent and more severe, so that the whole system drifts and hovers at the boundaries of safe practice, until an accident or near miss, forces review and realignment. Rasmussen (1997) argued that, in most organisations, in the absence of a ‘wake-up call’ such as a near miss, rules and recommendations are routinely and progressively ignored. This eventually increases the possibility of disaster, because the organisation becomes accustomed to operating at the margins. The Francis Report (Francis 2013) highlighted the shortcomings and failures in care at the Mid Staffordshire NHS Trust, and illustrated how migration to the limits of acceptability occurred, with tragic consequences. Building on Rasmussen’s work and studying violations in the aviation and rail industries, Amalberti (2001) proposed three phases of organisational safety migration and developed a model (Figure 1) to explain migration and transgression of practices: n Initial safe space of action n Creation of borderline tolerated conditions of use (BTCUs) n Normalisation of deviance and reckless individuals

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CLINICAL FEATURE

Violations and migrations in perioperative practice: how organisational drift puts patients at risk Continued

Figure 1 - A model to explain migration and transgression of practices (adapted to the context of surgery) Amalberti (2001)

severe pressure to increase output whilst containing or reducing the use of resources. This can often feel like: ‘we need you to do the same amount of work with less staff, equipment missing or out of order’. These demands transmit to the front line as pressure to act more quickly, sometimes resulting in the violation of even basic procedures. Once there has been one transgression, there is likely to be a second and even a third, and migration toward unsafe practice can snowball. Perioperative staff, pressured to increase performance by cutting corners, convince themselves that they are ’officially’ transgressing established rules and that their behaviour has, in some way, been sanctioned. The result is migration towards a ’normal illegal’ area of stabilised operations; ‘the way we do things around here’. Borderline tolerated conditions of use (BTCUs) are justified by management and individual staff as affording the organisation maximum benefit for the minimum and accepted probability of harm.

Initial safe space of action The first phase of Amalberti’s (2001) proposal corresponds with the initial design of a work process or procedure and the rules and procedures which are determined for following it. Amalberti highlighted that, in production lines or automated systems, many constraints and failsafe procedures are purposefully designed and built into processes to act as defences against human error and to constrain the potential of humans to violate. Examples in perioperative practice include: trays for surgical instruments that have indentations for each instrument so it is clear when a given instrument has not been returned before closure; swabs in packets of five to support swab control and accounting, and pre-packaged medication for epidural anaesthesia. Whilst fail safe design is a significant feature of total quality management in the manufacturing industry, many processes in healthcare evolve rather than being purposefully designed. There are some notable exceptions such as the Safer

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clinical systems programme invested in and led by The Health Foundation (2013). While there is often an informal understanding of the proper procedures across services and amongst healthcare staff, constraints are rarely built in or as strong as found in other industries. Amalberti (2001) suggests that borderline tolerated conditions of use (BTCUs) emerge as processes go live and have to adapt to human performance as well as social and technical demands. Migration toward the boundaries of safe operations develops through a combination of organisational demands for greater performance and the pressure that this generates, combined with the perceived advantages for individuals in getting things done. Rules are quickly bypassed given the pressures of real life.

Pressures of perioperative practice Reflecting on the current financial pressures of the NHS, it is fair to say that the majority of senior leaders and managers are under

Amalberti (2001) highlights that BTCUs have four features: 1) 2) 3) 4)

They are first seen as benefits and not as risks. They enhance performance of the system or provide advantage for the individual. They are tolerated by senior management and sometimes even required by it. They are associated with a variety of informal safety measures.

Consequently, safety behaviour, effective or not, is played out in a social context, independently of the rules and procedures envisaged by the original designers of the system, procedure or protocol, so that much of what emerges is a lottery. The third and last phase develops over time (Amalberti 2001). Unless challenged, the same violations are regularly repeated to the extent that they become routine and commonplace, invisible to both workers and managers. Subconsciously, deviance is simply normalised and accepted (Vaughan 1996).

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CLINICAL FEATURE

Conclusions to inform safety management in the operating room Violations are routine and pose challenges for regular management of patient and worker safety. In most settings violations are numerous, yet comparatively few lead to harm or real danger. They are therefore tolerated and even viewed as normal, exacerbating the potential to organisational drift. Perioperative staff need to learn much more from surgical near misses because violations contribute to their occurrence, and the understanding of their impact and potential is still relatively poor. However, despite limited knowledge, there are some important points to note: n Violations cannot be eliminated but they can be managed. n Proactive management of risk requires appreciation that systems are dynamic and are buffered by multiple factors and a range of forces, so much so that transformations need to be accepted and existing rules adapted. n Too often when thinking about safety we think of an ideal world, protected by absolute rules and procedures; our perioperative reality is that few of us ever work in situations that are ideal and the rules that we work with are rarely developed or tested in challenging situations. n We all need to understand the pattern of violations and system migrations in our places of work, for it is better to manage risk than to try to eliminate it.

Key messages n If a system is designed with only a limited sphere of safe operation, violations are very likely to occur under the conditions of actual performance. n Violations cannot be eliminated but they can be managed. n Borderline tolerated conditions of use (BTCUs) are understandable— although not necessarily desirable. n Regarding BTCUs as unacceptable, requiring disciplinary action is unhelpful. n Theatre teams need continually to monitor self and peer performance to identify both violations and system migrations at an early stage. n Dialogue between clinicians and managers is a key factor in establishing a shared safety culture in the operating theatre.



Degani A, Wiener E 1993 Cockpit checklists: concepts, design, and use Human Factors 35 (2) 345-59 Emanuel L, Berwick D, Conway J et al 2008 What exactly is patient safety? In: Advances in patient safety: new directions and alternative approaches Agency for Healthcare Research and Quality Available from: www.ahrq.gov/professionals/ quality-patient-safety/patient-safety-resources/ resources/advances-in-patient-safety-2/index.html [Accessed December 2013] Francis R 2013 The Mid Staffordshire NHS Foundation Trust public inquiry Available from: www.midstaffspublicinquiry.com/ [Accessed December 2013] Health Foundation 2013 Safer clinical systems Available from: www.health.org.uk/areas-of-work/ programmes/safer-clinical-systems/ [Accessed December 2013] Helmreich R 2000 On error management: lessons from aviation British Medical Journal 320 781-5 Her Majesty’s Stationary Office 2002 Guidance on the control of substances hazardous to health (COSHH) regulations Available from: www.hse.gov. uk/coshh/ [Accessed December 2013]

n Violations and potential system migration due organisational pressures must be discussed openly at all levels of the organisation, board to frontline, and acknowledged in the risk register.

Rasmussen J 1997 Risk management in a dynamic society: A modelling problem Safety Science 27 (2) 183-213

n Standards of safe practice and acceptable and unacceptable deviations should be regularly reviewed and procedures adjusted when a violation is found to be adaptive, safe and effective.

Vaughan D 2004 Organisational rituals of risk and error In: Hunter B, Power M (eds) Organisational encounters with risk Cambridge, Cambridge University Press

n In the absence of effective peer pressure, if individuals commit more extreme violations, appropriate remedial or disciplinary action needs to be taken.

Stop! Reflect! Are some violations acceptable if they do not lead to danger or harm? Are acceptable and unacceptable violations part of the same continuum? What are the criteria for organisational tolerances? Will tolerance of certain violations require different safety approaches?

van Beuzekom M, Boer F, Akerboom S, Hudson P 2010 Patient safety: latent risk factors British Journal of Anaesthesia 105 (1) 52-9

Reason J 1990 Human error Cambridge, Cambridge University Press Reid J 2011 Surgical never events should never happen... Journal of Perioperative Practice 21 (11) 373-9

About the author Jane Helen Reid RN, DPNS, BSc (Hons), PGCEA, MSc Researcher, Queen Mary University of London, Independent Advisor, NHS Non-Executive Director, Visiting Professor Bournemouth University, Former President AfPP No competing interests declared

References Amalberti R 2001 The paradoxes of almost totally safe transportation systems Safety Science 37 (2) 109-26 Amalberti R, Vincent C, Auroy Y, de Saint Maurice G 2006 Violations and migrations in healthcare: a framework for understanding and management Quality and Safety Health Care 15 (Suppl 1) i66-i71

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Disclaimer The views expressed in articles published by the Association for Perioperative Practice are those of the writers and do not necessarily reflect the policy, opinions or beliefs of AfPP. Manuscripts submitted to the editor for consideration must be the original work of the author(s). © 2014 The Association for Perioperative Practice All legal and moral rights reserved.

The Association for Perioperative Practice Daisy Ayris House 42 Freemans Way Harrogate HG3 1DH United Kingdom Email: [email protected] Telephone: 01423 881300 Fax: 01423 880997 www.afpp.org.uk

Violations and migrations perioperative practice: how organisational drift puts patients at risk.

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