LITMIR.BIZ

CHAPTER 11 Patient safety

       Katherine Evans1, Nandkishor Athavale1, Susannah Long2, and Charles Vincent2

      ¹ Department of Healthcare for Older People, Rotherham NHS Foundation Trust, Rotherham, UK

      ² Centre for Patient Safety and Service Quality, Imperial College London, London, UK

      Original chapter by Susannah Long and Charles Vincent; updated by Katherine Evans and Nandkishor Athavale.

Introduction

      History and evolution of the concept of patient safety

      The practice of medicine, aptly described by Samuel Johnson as ‘the greatest benefit to mankind’, has been and always will be associated with inherent risks.¹ This has been acknowledged for as long as medicine itself has existed: the ancient Greeks’ words for ‘kill’ and ‘cure’ were similar, and the Hippocratic Oath contains the promise ‘to abstain from doing harm’, later adapted by Thomas Sydenham into the famous phrase ‘primum non nocere’ or ‘first do no harm’.

      Perhaps surprisingly, it has only been relatively recently that these risks, their causes, and ways to ameliorate them have been subjected to rigorous academic study. One of the earliest specific observations of patient harm was made in the nineteenth century by Florence Nightingale regarding infection in hospitals, a new and devastating problem at the time. In the 1960s, more systematic studies of hospital‐associated harm began to be carried out, initially driven by the development of litigation. In more recent times, perhaps triggered by high‐profile events such as the Bristol heart inquiry and landmark international reports such as ‘An Organization with a Memory’² in the UK and To Err Is Human ³ in the USA, patient safety has become the focus of much attention. It is now recognized globally as one of the top priorities in healthcare; and as our understanding of healthcare‐related harm deepens, our ability to improve patient safety grows.

      In this chapter, we describe some of the current knowledge about patient safety and how it relates to the care of older people.

      Definitions

      Patient safety may be defined as ‘the prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare’.⁴ This definition encompasses not only the avoidance of individual error or harm and the high reliability of healthcare systems but also the appropriate management of healthcare‐associated harm in terms of appropriate immediate medical management as well as supporting staff, patients, and their families.

      Patient safety is just one aspect of high‐quality care. In the 2008 UK report High Quality Care for All,⁵ quality of care, defined from a patient’s point of view, encompasses safety, experience, and outcomes. In the US, ‘Crossing the quality chasm’ similarly described the elements of quality as safety, effectiveness, patient‐centeredness, timeliness, efficiency, and equitableness. Safety cannot be seen in isolation but should be viewed as part of the broader concept of quality healthcare. Safety has been described as ‘the dark side of quality’ because of its historical association with litigation and blame, but it is increasingly acknowledged that efforts to learn more about and improve safety are a feature of high‐quality healthcare organizations.¹

      Measurement – the scale of harm

There are several ways to measure or estimate the extent of errors or adverse events in healthcare, including analysis of administrative or reporting data, case record review, observations of patient care, and active clinical surveillance. Each of these methods has advantages and disadvantages in terms of availability of data, cost, reliability, observer bias, and clinical relevance. Clearly, the measurement of safety overlaps with the measurement of quality of care, described in other chapters. An adverse event is defined as an unintended injury caused by medical management rather than the disease process, which is sufficiently serious to lead to prolongation of hospitalization or temporary or permanent disability or death.⁴ This definition is important because it has been traditionally used in studies of the nature and scale of harm, described below. A critical incident or ‘near miss’ may be considered the next step down from this incident, which may have caused harm but did not actually do so.

Over the last 40 years, a number of international adverse event studies have been published in which retrospective case record review was used to identify adverse events and assess the nature and scale of harm in acute hospitals. A selection of these studies are shown in Table 11.1. Rates of adverse events in most recent studies lie between 8 and 12%, a range now accepted as typical of advanced healthcare systems. The rate per patient is always slightly higher, as some patients suffer more than one event, and about half of adverse events are generally judged to be preventable. Rates in the United States are much lower, and those in Australia appear to be much higher. The lower US rates might reflect better‐quality care but probably reflect the narrower focus on negligent injury rather than the broader quality improvement focus of most other studies.

      Studies of errors

A number of methods of studying errors and adverse events have evolved over time and been adapted to different contexts.¹⁹ Each method has particular advantages and disadvantages. Some methods are oriented toward detecting the incidence of errors and adverse events (Table 11.2), whereas others address the causes and contributory factors of those errors and adverse events (Table 11.3). There is no perfect way of estimating the incidence of adverse events or errors. For various reasons, all the approaches give a partial picture. Any retrospective review is vulnerable to hindsight or outcome bias, where knowledge that the outcome was bad leads to unjust simplification and criticism of preceding events. Record review is comprehensive and systematic but, by definition, is restricted to matters noted in the medical record. Reporting systems are strongly dependent on the willingness of staff to report and are a very imperfect reflection of the underlying rate of errors or adverse events. Michel, et al. compared three methods of estimating adverse events rates: cross‐sectional (data gathered in one day), prospective (data gathered during a hospital stay), and retrospective (review of medical records). The prospective and retrospective methods found similar numbers of cases; however, the former identified more preventable cases with high reliability and validity.²⁰ The cross‐sectional method showed a large number of false positives and did not pick up serious events.

      Why do adverse events occur?

      To obtain a true understanding of patient safety, it is not enough to assess the scale of healthcare‐associated harm: we have to look deeper to understand the processes that underlie it. As described later, attempts to understand the causes of adverse events are routinely made within individual organizations in several ways, such as through local morbidity and mortality meetings or the use of more structured approaches such as root cause analysis.

      Learning from other industries

      On a more general level, patient safety researchers have used

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