School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, SA, Australia
District Court of South Australia, Government of South Australia, Adelaide, SA, Australia
Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, L5 Eleanor Harrald Building, North Terrace, 5000 Adelaide, SA, Australia
Brendon J. Coventry
Humans work within systems in a particular setting or environment. As such, there are numerous factors governing performance, outcomes and risk, with the operational elements often termed ‘human factors’, ‘system factors’ and ‘environmental factors’. In this Chapter we concentrate on risk and its relationship with these principal factors, and the evaluation of these.
Evidence has accumulated to demonstrate that the relative risk of a legal claim being made against a medical practitioner is related to a range of factors including (1) communication failures, (2) continuing professional development, and (3) failures of the systems that are in place to support and assist the medical practitioner in their medical practice (Goodwin 2000). Conversely, research has demonstrated no significant difference in the relative risk of litigation between trauma surgery and elective surgery (Stewart et al. 2005). Together, these findings suggest that the risk of litigation is associated with Human Factors and System Safety issues, rather than the complexity or the urgency of the practitioner’s work. Moreover, if risk is not increased with urgent elective procedures, then patient perception and expectation may play an important role, because discussion and the depth of communication might be expected to be less for trauma and acute patients, compared with elective situations where time for explanation should theoretically be greater.
Practitioners and the insurance companies that cover medical practitioner indemnity insurance have become increasingly interested in methods of risk reduction in relation to these Human Factors and System Safety issues. This is related to both a professional interest in provision of a quality service and also the containment of costs associated with claims and the escalation of indemnity insurance premiums. This chapter explores strategies to mitigate the risk of adverse events.
“Acknowledging that risk is present is the most important first step. Without this, one remains ignorant of a potential problem, and dealing with it cannot occur.”
“It is hard to avoid disaster if one denies that it can even exist.”
“The first step in the risk management process is to acknowledge the reality of risk. Denial is a common tactic that substitutes deliberate ignorance for thoughtful planning.” – Charles Tremper, PhD and CIO of American Association of Homes and Services for the Aging in Washington, USA
A 2007 report released by the Australian Institute of Health and Welfare (AIHW) showed that just over 30 % of public and private sector medical indemnity claims made in 2004–2005 were for harm or loss that allegedly resulted from an error or negligence in a medical or surgical procedure (AIHW 2007).
Medical Insurance Group Australia (MIGA), an Australian medical defense organization, reported in their 2010 Annual Review that the key cause of loss for claims notified by their members back to 1999/2000 concerned procedural matters. The report showed that postoperative complications constituted 25 % of all notifications and for 22 % of incurred costs, whereas intraoperative injuries were 12 % of notifications and 22 % of costs incurred (MIGA 2010).
Surgery is a risky business.
However, risks need not be a barrier to delivering quality healthcare provided when they are identified, fully understood, and accepted by the clinician, patient, system, and community. With this understanding, preventative strategies can often be put in place to minimize the risks and with forewarning complications can be recognized and managed early to optimize patient outcomes.
In the past, the focus for managing risk was primarily on clinical competence by achieving and maintaining clinical skills and experience. In recent years, this has been augmented by an emphasis on patient safety supported by effective teamwork, improved systems design, and good doctor-patient communication.
An analysis of 10 years of negligence claims (1997–2008) has identified that the “direct clinical judgement” of a practitioner represented only some 20 % of all risk management issues recorded. Informed consent, communication, and documentation, however, accounted for over one-third of closed claims files (MIGA 2008).
The National Patient Safety Agency (NPSA) in the UK published the seven steps to patient safety (Table 9.1).
National patient safety agency (NPSA) UK seven steps to patient safety
1. Build a safety culture. Create a culture that is open and fair
2. Lead and support your staff. Establish a clear and strong focus on patient safety throughout your organization
3. Integrate your risk management activity. Develop systems and processes to manage your risks and identify and assess things that can go wrong
4. Promote reporting. Ensure that your staff can easily report incidents locally and nationally
5. Involve and communicate with patients and the public. Develop ways to communicate openly and listen to patients
6. Learn and share safety lessons. Encourage staff to use root cause analysis to learn how and why incidents happen
7. Implement solutions to prevent harm. Embed lessons through practices, processes or systems
The process of analyzing the strength of a practitioner’s practice and supporting systems and attempting to improve relevant factors to reduce risk is termed “Risk Management.” It is a business and safety concept. In the typically complex environment of a modern practice, a large number of risks may exist. Modern patient safety thinking has led us to the understanding that these risks extend far beyond the traditional concepts of risk being simply a product of patient factors and an individual practitioner’s skill (Vincent et al. 2004). Clinical judgement was the cause of only about 20 % of all claims made with the remaining 80 % of the underlying cause recorded against claims being related to factors other than clinical judgement (MIGA 2008). We often refer to the range of risks in terms of “latent conditions” within the system, and they present two kinds of problems. First, they create the conditions in which human error is more likely, and second, they create weaknesses in the systemic defenses we create to protect our practice from adverse events (Reason 2000).
Risk management attempts to uncover these latent conditions in the “system” of our work and put in place measures to either decrease the likelihood of the factors that contribute to adverse events or protect our practice against the consequences of those factors.
According to the Australian Standard AS 4360, risk management can be defined as a process that applies “a logical and systematic method of establishing the context, identifying, analysing, evaluating, treating, monitoring and communicating risks associated with any activity…in a way that will enable organisations to minimise losses and maximise gains” (Standards Australia 2004). As illustrated in Fig. 9.1 below, the basic risk management framework is a cyclic process of continual improvement.
Some of the basic principles of risk management have been dealt with in the chapter on safety and quality in healthcare. The purpose of this chapter is to explore in more detail some of the different types of risks in surgical practice from a Human Factors’ perspective and the techniques used to identify, evaluate, and mitigate these risks.
Identifying Risks: Human Factors Analysis
Human Factors is the term given to the science of humans at work and focuses on how humans interact with all other aspects of their work environment, from equipment through to other team members. The overarching goals of Human Factors relate to the improvement of safety and efficiency of practice (Chapanis 1996; Wickens et al. 1998)
In healthcare, “Human Factors Analysis” relates to the study of the way in which adverse events might occur and how these might be reduced. Adopting the “system view” of safety, this approach is particularly concerned with identifying weak defenses against inevitable human error as well as the error producing conditions in the work environment (Reason 2000). The outcomes of these forms of risk analysis might be the identification of such risks as poorly designed equipment in the operating room, an ambiguous user interface in a computerized radiology request system, vulnerable practices relating to clinical handover, or the need to develop a protocol for managing postoperative complications. All these Human Factors’ risks are aspects of the overall system of work, rather than simple factors relating to the patient’s condition or the clinician’s skill. As studies in this area improve through investigation of adverse events, or “near misses,” we are gradually learning techniques for better designing systems and environments for safer operation and higher quality performance. Many problems can be effectively “designed out” of systems to avoid or reduce risk of adverse events occurring.
Some Key Human Factors Contributing to Risk of Patient Harm
“Human Factors Engineering” is the term given to the study of how humans interact and are affected by the design of equipment, systems, and work and is in ways in which improvement in safety and operation may be improved. Human factors influence the effective implementation of any system or procedure. These include:
Communication between staff members has been identified as an absolutely critical factor in determining performance, safety, quality, staff satisfaction, risk of error, and outcome(s). As mentioned, this often determines risk of litigation, disruption to work practices, and efficiency. Recently, the term “nontechnical skills” has been used to describe the critical cognitive and interpersonal skills that complement a clinician’s technical abilities. Within the perioperative environment, communication is seen as a core nontechnical skill (Yule et al. 2006).
Team and Environment
The organization of the team and leadership together with the satisfaction of staff in the work environment frequently determines performance (Moorthy et al. 2005). The systems supporting the work environment are integral to the work performance and frequently also determine the degree of job satisfaction. There are many examples of where incidents could be avoided with greater adherence to systems and procedures. One critical example is where surgery is performed on the wrong site or on the wrong patient or using the wrong procedure. Analysis of these cases highlighted that a lack of protocols or failure to follow protocols may have contributed to the occurrence of these incidents. Protocols developed to ensure correct patient, correct site, correct procedure often encounter significant resistance by surgeons. The inertia is perhaps understandable. However, the time investment required for this process is minimal and has been shown to reduce the incidence of these events and subsequent legal action. The time taken “to get it right” must be weighed against the consequences of “getting it wrong.”
The team may also act to compensate for other factors such as fatigue or poor communication or for the poor performance of an individual. Detection of errors, or of fatigued or unwell colleagues, whether it be self- or system detection, can be vital in avoiding an adverse event. The very “key” asset of any healthcare system is its staff.
Alertness, Fatigue, and Illness
The degree of rest and sleep and the length of work shifts are integral in determining the alertness, reaction times, and consequent judgement of individuals who make decisions and perform tasks. Complex tasks, performed with limited information and without breaks, are at higher risk of error than when these do not exist. Fatigue can impact upon communication and many other factors, including completeness, memory, thoroughness, and ability. Illness of workers may go unnoticed, and the reason for working while unwell may be to spare other workers the extra workload, but adverse consequences may sometimes occur. There is an increasing body of evidence which demonstrates that long shifts and fatigue can reduce ability to perform certain tasks and can equate to reductions in performance levels and coordination, similar in nature to the effects of excessive alcohol levels in the blood or the effects of other sedative drugs. In healthcare, the hours of work are often associated with restricted sleep opportunity, and many working regimes have been identified as posing significant risk to patient safety and to staff health (Gaba and Howard 2002).
Adequate time to permit a task being performed is essential for allowing adequate time for checking and risk reduction. This is particularly true for complex tasks where risk of error use is often higher. Shortage of staffing and difficulty with operational systems are two key factors that not only lead to worker dissatisfaction, but also to increased risk of error and adverse events.