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11.1 Reason’s Swiss cheese model.

Learning from high‐reliability organizations in other industries that achieve high levels of safety and performance in the face of considerable hazards and operational complexity is an ongoing challenge to improve safety in healthcare. Important characteristics of these organizations are their safety culture and leadership: there is evidence that these are related to some safety measures in healthcare.

Analyses of incidents usually reveal the causes to be a combination of all the factors described above. This can be summarized by ‘the seven‐level framework’,²⁵ which conceptualizes the patient, task and technology, staff, team, working environment, and organizational and institutional environmental factors that influence clinical practice. This is shown in Table 11.5.

Table 11.5 The seven‐level framework.

      Source: Adapted from Vincent, et al.²⁵

Factor types	Contributory influencing factor
Patient factors	Condition (complexity and seriousness) Language and communication Personality and social factors
Task and technology factors	Task design and clarity of structure Availability and use of protocols Availability and accuracy of test results Decision‐making aids
Individual (staff) factors	Knowledge and skills Competence Physical and mental health
Team factors	Verbal communication Written communication Supervision and seeking help Team leadership
Work environmental factors	Staffing levels and skills mix Workload and shift patterns Design, availability, and maintenance of equipment Administrative and managerial support Physical environment
Organizational and management factors	Financial resources and constraints Organizational structure Policy, standards and goals Safety culture and priorities
Institutional context factors	Economic and regulatory context National health service executive Links with external organizations

What happens after an adverse event?

      Reporting and learning

A variety of reporting systems are operating at different levels within healthcare systems across the world. Some operate primarily at the local level (risk management systems in hospitals), others at the regional or national level. Local systems are ideally used as part of an overall safety and quality improvement strategy but in practice may be dominated by managing claims and complaints. Many different clinical specialities, particularly anaesthesia, have established reporting systems to assist them in improving clinical practice. These systems are designed to provide information on specific clinical issues that can be shared within the professional group. The increasing attention paid to patient safety has led to the establishment of many new reporting and learning systems: most notably, in the UK, the Reporting and Learning System (RLS) established by the National Patient Safety Agency. Other national reporting systems include the wide‐ranging Veterans Affairs system in the US and the Australian Incident Monitoring System (AIMS).

      The primary purpose of reporting systems is to communicate information about patient safety issues so that learning and improvement of systems and practice can occur. A secondary benefit of these systems is that we can use them to assess the scale of harm and identify trends.

      There are inherent problems with all reporting systems in healthcare: most studies have found that reporting systems detect only 7–15% of adverse events²⁶ compared with other methods of detection such as case record review. Some of the common barriers to reporting include fear of embarrassment or punishment by oneself or others, fear of litigation, lack of feedback, and a belief that nothing will be done in response to reporting.

      Understanding why things go wrong

      The investigation and analysis of cases in which clinical incidents have occurred can be used to illustrate the process of clinical decision‐making, the weighing of treatment options and sometimes – particularly when errors are discussed – the personal impact of incidents and mishaps, and critically also includes reflection on the broader healthcare system. Several methods of investigation and analysis are used in healthcare, either retrospectively (for example, root cause analysis or systems analysis of events) or prospectively (for example, failure modes and effects analysis [FMEA]).

      Caring for patients after an adverse event

      Patients and relatives may suffer in two distinct ways from a medical‐induced injury: (1) from the injury itself and (2) from the way the incident is handled afterward. Many people harmed by their treatment suffer further trauma through the incident being insensitively and incompetently handled. Conversely, when staff come forward, acknowledge the damage, and take positive action, the support offered can ameliorate the impact in both the short and long terms. Injured patients and their families need open disclosure: an explanation, an apology, or to know that changes have been made to prevent future incidents, and they often also need practical and financial help.²⁷

      Supporting staff

      Making an error, particularly if a patient is harmed because of it, may have profound emotional or psychological consequences for the staff involved. This, in turn, can make future errors more likely and affect teamwork. Factors that may make this more likely include the severity of the error and the reactions of those involved, attitudes toward error, beliefs about control and the power of medicine, and the impact of litigation. Strategies to minimize the effects of adverse events on staff include wider acknowledgement of the potential for error, having an agreed policy on openness with injured patients, encouraging support from colleagues, education and training, and, if necessary, formal support and access to confidential counselling.

Patient safety and older people

      The incidence of adverse events in older people in the hospital

      Re‐analysis of international adverse event studies

      There is considerable evidence that older people suffer a higher incidence of adverse events than their younger counterparts in the hospital. The landmark, international, adverse event studies described in Table 11.1 investigated the incidence and types of adverse events in hospital inpatients of all ages. This was achieved by a two‐stage retrospective case record review in the majority of cases. Table 11.1 also shows that if the results of these large studies are re‐analysed to consider specifically the effects of age on patterns and frequencies of adverse events, they all show that age is a risk factor for adverse events. However, when this relationship is examined more closely, it emerges that comorbidity, rather than age alone, appears to be responsible for this association. In addition to experiencing more adverse events, older people also suffer more serious consequences of adverse events in the majority of studies in terms of morbidity and mortality, increased dependence, increased hospital stay, and a greater chance of institutionalization;²⁸ again, this seems to be related to their physical vulnerability in terms of frailty and diminished physiological reserve. A recent meta‐analysis confirmed that the incidences of adverse events in the elderly varied in different studies, increasing to 60% if geriatric

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