The Essentials of Patient Safety

The Essentials ofPatient Safety
Charles Vincent
Professor of Clinical Safety Research
Imperial Centre for Patient Safety and Service Quality
Department of Surgery and Cancer
Imperial College of Science, Technology & Medicine
London UK
c.vincent@imperial.ac.uk
www.cpssq.org
Adapted from Patient Safety 2nd Edition

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The Essentials of Patient Safety

Preface
Patient safety is the foundation of good patient care. When a member of your family
goes into hospital or receives other healthcare then above all you want them to besafe. There is something horrifying about being harmed, or indeed causing harm, in anenvironment of care and trust. I believe that safety is a touchstone and guide to thecare that is given to patients. The clinician or the organisation that keeps safety to thefore in the midst of many other often competing priorities achieves something
remarkable and provides the care that we would all want to receive.
As you will see however there is compelling evidence that, while healthcare
brings enormous benefits to us all, errors are common and patients are frequently
harmed. The nature and scale of this harm is hard to comprehend. It is made up,
world wide, of hundreds of thousands of individual tragedies every year in which
patients are traumatised, suffer unnecessary pain, are left disabled or die. Many more
people have their care interrupted or delayed by minor errors and problems; theseincidents are not as serious for patients but are a massive and relentless drain on
scarce healthcare resources.
Understanding how to make healthcare safer is hard and actually making caresafer is harder still. Healthcare is the largest industry in the world and extraordinarily
diverse in terms of the activities involved and the manner of its delivery. We are facedwith hugely intractable, multifaceted problems which are deeply embedded within ourhealthcare systems. Understanding and creating safety is a challenge equal tounderstanding the biological systems that medicine seeks to influence.
This short introduction is taken from my book Patient Safety (2nd edition,2010). My aim has been to make the essentials of patient safety available toeveryone. The topics addressed include the evolution of patient safety; the researchthat underpins the area, understanding how things go wrong, and the practical actionneeded to reduce error and harm and, when harm does occur, to help those involved.
The main book covers these topics in more depth and a number of additional topics
such as measurement, safety culture, design, safety campaigns and safe organisations.
If this introduction succeeds in its aims I hope you will be convinced thatpatient safety is critically important for both patients and healthcare staff in every
setting throughout the world. Hopefully you will be inspired to immerse yourself
more deeply in the subject and join the many other people working for safer
healthcare. Treating patients one at a time brings obvious and immediate benefits but
working to improve the safety of healthcare as a whole may ultimately benefit many
more.
Charles Vincent
London, August 20112

The Essentials of Patient Safety

Contents
Preface, ii
Chapter 1

The Evolution of Patient Safety, 1

Chapter 2

The Nature and Scale of Harm to Patients, 7

Chapter 3

Understanding How Things Go Wrong, 15

Chapter 4

Improving Healthcare Processes and Systems, 25

Chapter 5

People Create Safety, 33

Chapter 6

The Aftermath, 44

3The Essentials of Patient Safety

CHAPTER 1
The Evolution of Patient Safety

Medical error and patient harm have been described and studied for well over a
century. However, apart from a few isolated pioneers, the medical and nursing
professions did not appear to recognise the extent and seriousness of the problem or,if they did, were not prepared to acknowledge it. The great majority of clinical staff
have always been safety conscious in their personal practice. Patient safety however
is a broader endeavour that requires thinking beyond the individual patient to consider
the characteristics of the whole system of healthcare
One of the great achievements of the last ten years is that medical error andpatient harm are now acknowledged and discussed publicly by healthcare
professionals, politicians, and the general public. Before this medical error was
seldom acknowledged to patients, almost never mentioned in medical journals and noteven considered by governments. The fact that thousands, probably millions, ofpeople were being harmed unnecessarily and vast amounts of money being wasted
seemed to have escaped everyone’s attention. From our current understanding thisseems a curious state of affairs. It is as if an epidemic were raging across a country
without anybody noticing or troubling to investigate.
How then did patient safety evolve and emerge to assume its present
importance? This first chapter outlines some of the main influences and drivers ofpatient safety to show how it has become one of the defining features of practice andpolicy.
Defining patient safety
Achieving safe care is part of the broader quest to achieve high quality care on anumber of dimensions. The Institute of Medicine (1) sets out six dimensions (Box1.1), with safety leading the way as the dimension that is perhaps most critical topatients and families. Patient safety can, at its simplest, be defined as:‘The avoidance, prevention and amelioration of adverse outcomes or injuries
stemming from the process of healthcare’ (2)The definition also refers to the amelioration of adverse outcomes or injuries, whichbroadens the definition beyond traditional safety concerns towards an area that would,
in many industries, be called disaster management. In healthcare amelioration firstly
refers to the need for rapid medical intervention to deal with the immediate crisis, butalso to the need to care for injured patients and to support the staff involved.

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The Essentials of Patient Safety

Box 1.1 The dimensions of quality
Safe – avoiding injuries to patients from the care that is intended to help them
Effective – providing services based on scientific knowledge to all who could benefit
and refraining from providing services to those not likely to benefit (avoiding
underuse and overuse)
Patient-centred – providing care that is respectful of and responsive to individual
patient preferences, needs, and values and ensuring that patient values guide allclinical decisions
Timely – reducing waits and sometimes harmful delays for both those receive andthose who give care
Efficient – avoiding waste, in particular waste of equipment, supplies, ideas, energy
Equitable – providing care that does not vary in quality because of personal
characteristics such as gender, ethnicity, geographic location and socioeconomic
statusPatient safety – reducing harm or reducing error?
Patient safety is sometimes equated with preventing error (3). This seems innocent
enough, but is a potentially limiting assumption. There is no question that anunderstanding of error is fundamental to patient safety; however, there are differencesof view as to whether the focus of patient safety research and practice should be on
error or on harm (4). However, when we consider the overall aim of patient safety
there are a number of reasons for keeping harm in the forefront of our minds.


Harm is what patients care most about. We will all put up with errors in ourcare, to some extent at least, as long as we do not come to harm.



Not all harm is due to error. Consider all the myriad forms of harm that cancome from healthcare: complications of surgery, infection from unsafe
injections, infection from overcrowded hospitals, adverse drug reactions,
overdoses from badly designed infusion pumps and so on. If we equate patient
safety with error reduction we run the risk of not addressing any form of harm
which is either not due to error, or only partly due to error.



Many errors do not lead to harm and, indeed, may be necessary to the learningand maintenance of safety. Surgeons for instance, may make quite a numberof minor errors during a procedure none of which really compromise thesafety of the patient or the final outcome of the operation (5).

5The Essentials of Patient Safety

Tragedy and opportunities for change‘The knowledgeable health reporter for the Boston Globe, Betsy Lehman, diedfrom a drug overdose during chemotherapy. Willie King had the wrong leg
amputated. Ben Kolb was eight years old when he died during ‘minor’ surgery
during a drug mix up. These horrific cases that make of the headlines are justthe tip of the iceberg’.
(Opening paragraph of the Institute of Medicine report, To err is human (1))
Certain ‘celebrated’ cases attain particular prominence and evoke complicatedreactions. The public account of these stories is usually a gross over simplification ofwhat actually occurred and, as we shall see later, the causes of such events are often
complex. Such disastrous cases however come to symbolise fear of a morewidespread failure of the healthcare system, provoking more general concerns about
medical error (6). Perhaps it isn’t just a question of finding a good, reliable doctor.
Perhaps the system is unsafe? Such concerns are magnified a hundred fold when thereis hard evidence of longstanding problems in a service and a series of tragic losses.
This is well illustrated by the events that led to the UK Inquiry into infant cardiac
surgery at the Bristol Royal Infirmary (Box 1.2) which is still vividly remembered in
Britain (7). Many other countries have experienced similar high profile tragedies.

Box 1.2 Events leading up to the Bristol Inquiry
In the late 1980s some clinical staff at the Bristol Royal Infirmary began to raise
concerns about the quality of paediatrics cardiac surgery by two surgeons suggestingthat mortality was substantially higher than in comparable units. Between 1989 and1994 there was a continuing conflict at the hospital about the issue between surgeons,anaesthetists, cardiologists and managers. Agreement was eventually reached that a
specialist paediatric cardiac surgeon should be appointed and in the meantime that a
moratorium on certain procedures should be observed. In January 1995, before thesurgeon was appointed, a young child was scheduled for surgery against the advice ofanaesthetists, some surgeons and the Department of Health. He died and this led tofurther surgery being halted, an external inquiry being commissioned and to extensive
local and national media attention.
Parents of some of the children complained to the General Medical Council
which, in 1997 examined the cases of 53 children, 29 of whom had died and four ofwhom suffered severe brain damage. Three doctors were found guilty of serious
professional misconduct and two were struck off the medical register.
The Secretary of State for Health immediately established an Inquiry, costing£14 million, chaired by Professor Ian Kennedy. The Inquiry began in October 1998
and the report published in July 2001 made almost 200 recommendations.
(Adapted from Walshe and Offen 2001)

Error in medicine
Twenty years ago medical error was hardly mentioned in the medical literature letalone discussed publicly. In 1994 Lucian Leape, a surgeon from Harvard, published aprescient and seminal paper (8) which addressed the question of error in medicine
6The Essentials of Patient Safety

head on and brought some entirely new perspectives to bear. Leape began by notingthat a number of studies suggested that error rates in medicine were particularly high,that error was an emotionally fraught subject and that medicine had yet to seriously
address error in the way that other safety critical industries had. He went on to argue
that error prevention in medicine had characteristically followed what he called the‘perfectibility model’. If physicians and nurses were motivated and well trained thenthey should not make mistakes. If they did make mistakes then punishment in theform of disapproval or discipline was the most effect remedy and counter to future
mistakes. Leape summarised his argument by saying:‘The professional cultures of medicine and nursing typically use blame toencourage proper performance. Errors are caused by a lack of sufficientattention or, worse, lack of caring enough to make sure you are correct’(Leape 1994 p1852).
Leape, drawing on the psychology of error and human performance, rejected thisformulation on several counts.
Many errors are often beyond the individual’s conscious control; they are
precipitated by a wide range of factors, which are often also beyond theindividual’s control



Systems that rely on error-free performance are doomed to failureError prevention that relies exclusively on discipline and training is also
doomed to failure

Leape went on to argue that if physicians, nurses, pharmacists and administrators
were to succeed in reducing errors in hospital care, they would need to fundamentallychange the way they think about errors(8). He explicitly stated that the solutions to the
problem of medical error did not primarily lie within medicine, but in the disciplinesof psychology and human factors, and set out proposals for error reduction that
acknowledged human limitations and fallibility and relied more on changing theconditions of work than on training.
Professional and government reports: patient safety hits the headlines
In 1999 the US Institute of Medicine published a report called ‘To err is human’ (1),which bluntly set out the harm cause by healthcare in the United States and called foraction on patient safety at all levels of the health care system. Without doubt the
publication of this report was the single most important spur to the development ofpatient safety, catapulting it into public and political awareness and galvanising
political and professional will at the highest levels in the United States.
President Clinton ordered a government wide study of the feasibility of
implementing the report’s recommendations. However as Lucian Leape recalls one
particular statistic provided a focus and impetus for change:‘However, while the objective of the report, and the thrust of its
recommendations, was to stimulate a national effort to improve patient safety,
what initially grabbed public attention was the declaration that between
44,000 and 98,000 people die in US hospitals annually as a result of medical
errors’. (9)7The Essentials of Patient Safety‘To err is human’, the first of a series of reports on safety and quality from theInstitute, was far more wide ranging than the headline figures suggest. A large
number of studies of error and harm were reviewed including the causes of harm, thenature of safe and unsafe systems and the role of leadership and regulation. The
principal aim of the report was to establish patient safety as a major requirement andactivity of modern healthcare, by establishing national centres and programmes,
expanding and improving reporting systems and driving safety in clinical practicethrough the involvement of clinicians, purchasers of healthcare, regulatory agencies
and the public.
An organisation with a memory: learning from adverse events in the
NHS
Since the publication of the Institute of Medicine report many governments andprofessional organisations have released reports and official statements on patient
safety. The British equivalent of the Institute of Medicine report was prepared by agroup led by Professor Liam Donaldson, the UK’s Chief Medical Officer (10). Unlike
the Institute of Medicine report, it emanated from government and was bravely
authorised for release by the then Secretary of State for Health Alan Milburn.
The report’s primary emphasis was, as the title suggests, on learning.
Reviewing the systems of learning from errors in the NHS, the report identified
numerous weaknesses with the processes and contrasted this unfavourably with otherhigh-risk industries. Great stress was also laid on understanding the underlying causesof adverse events and on the potential parallels between healthcare and other high risk
industries. The report argued that all human beings who work in complex systems areprone to similar errors and subject to similar pressures. The themes and progress on
culture, teamwork, reporting, systems thinking highlighted in these reports will all be
examined in later chapters. But first we need to examine the studies of the nature andscale of harm. Can it really be true that healthcare kills tens of thousands of people
each year in the United States and, by implication, perhaps hundreds of thousands
across the world?

KEY POINTS
Patient safety is the avoidance, prevention and amelioration of harm from healthcare
Tragedies and high profile cases have raised public awareness of patient safety
Some errors cause harm but many do not
Blame and discipline are an ineffective response to most safety problems
Government and professional reports brought patient safety into the mainstream

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The Essentials of Patient Safety

References
1.
Kohn L, Corrigan J, Donaldson ME. To err is human. Washington DC:
National Academy Press; 1999.
2.
Vincent C. Patient Safety, 2nd edn. Oxford: Wiley Blackwell; 2010.
3.
McNutt RA, Abrams R, Aron DC, for the Patient Safety C. Patient Safety
Efforts Should Focus on Medical Errors. Journal of the American Medical
Association, 2002; 287(15):1997-2001.
4.
Layde PM, Maas LA, Teret SP, Brasel KJ, Kuhn EM, Mercy JA, et al. Patient
Safety Efforts Should Focus on Medical Injuries. Journal of the American Medical
Association, 2002; 287(15):1993-7.
5.
Joice P, Hanna GB, Cuschieri A. Errors enacted during endoscopic surgery - ahuman realiability analysis. Applied Ergonomics, 1998;29(6):409-14.
6.
Cook RI, Woods DD, Miller CA. A tale of two stories: contrasting views ofpatient safety, US National Patient Safety Foundation 1998.
7.
Walshe K, Offen N. A very public failure: lessons for quality improvement inhealthcare organisations from the Bristol Royal Infirmary. Quality and Safety in
Health Care, 2001;10(4):250-6.
8.
Leape LL. Error in medicine. Journal of the American Medical Association,
1994;272(23):1851-7.
9.
Leape LL. Institute of Medicine medical error figures are not exaggerated.
Journal of the American Medical Association, 2000;284(1):95-7.
10.
Department of Health. An organisation with a memory: learning from adverse
events in the NHS. London: The Stationery Office; 2000.

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The Essentials of Patient Safety

CHAPTER 2
The Nature and Scale of Harm to Patients

How safe is healthcare? How often do errors occur? Are the high profile cases rareisolated accidents in an otherwise safe systems or are they, in the time honoured
phrase, just the tip of the iceberg? Defining and measuring error and harm is not as
simple as it might seem. We can however gain an understanding of the overall scaleof the problem and the challenges we face. As we shall see, while rates of error andharm vary in different settings, there is now substantial evidence of very high rates oferror in many contexts and considerable evidence of harm to patients.
Defining harm in healthcare
Safety in other domains is assessed by the incidence of accidents and injuries;
aviation accidents, road accidents, lost time injuries at work and other types of mishap
are counted and tabulated by various means. In healthcare we would ideally, we
would like to have a general index of safety, rather like rates of road or rail accidents,
so that we could track progress over time and ask more sophisticated questions about
the safety of different parts of the system and the factors that increased or degradedsafety. Defining harm however is a particularly difficult issue in healthcare for anumber of reasons:In other arenas establishing cause and effect between accident and injury isreasonably straightforward. In contrast, patients are generally, though notalways, sick and separating the harm due to healthcare from that due to illness
is often difficult.

Some treatments given in healthcare are necessarily ‘harmful’ to the patient;radiotherapy and chemotherapy are two obvious examples.

Harm from healthcare may not immediately be detected or may only gradually
become apparent. In fact, a cause celebre of medical error - the chemotherapy
overdose of Boston Globe reporter Betsy Lehman - was only discovered on aroutine review of research data(1).

Even if a patient is harmed this does not necessarily point to any deficiencies
in care. One patient may get pneumonia because of a major lapse in basic care;another may receive exemplary care but still succumb to pneumonia.

Once harm has been defined then once has to find ways of measuring it which can betricky, particularly if the events are rare or if the patient’s exposure to hazards is hardto assess. The principal have been well summarised by Peter Pronovost andcolleagues:
10

The Essentials of Patient Safety‘A prime challenge in measuring safety is clarifying indicators that can bevalidly measured as rates. Most safety parameters are difficult or impossible
to capture in the form of valid rates for several reasons: (1) events areuncommon (serious medication errors) or rare (wrong-site surgicalprocedure); (2) few have standardized definitions; (3) surveillance systems
generally rely on self-reporting; (4) denominators (the populations at risk) arelargely unknown; and (5) the time period for exposure (patient day or deviceday) is unspecified. All of these may introduce bias’ (2).
The concept of an adverse event
The most commonly used definition of harm in patient safety is the ‘adverse event’.
This concept has originally described by the authors of the Harvard Medical Practice
Study, described below, which set out to assess harm from healthcare in New YorkState in the mid 1980s. They defined an adverse event as:‘An unintended injury caused by medical management rather than by thedisease process and which is sufficiently serious to lead to prolongation of
hospitalisation or to temporary or permanent impairment or disability to thepatient at time of discharge or both’ (3).
Medical management includes acts of omission (for instance a failure to diagnose ortreat) and commission (giving an incorrect treatment). Injury therefore on this definition
may result either from harmful treatment or from failing to provide proper care. The
injury has to be unintended, since injury can occur deliberately and with good reason,such as a necessary amputation. Note especially that adverse events may or may not
be judged as being preventable. For instance a complication in surgery that was
judged to be almost inevitable because of the patient’s condition would be considered
as an adverse event, but an unpreventable one.
Studying adverse events using case record review
Retrospective reviews of medical records aim to assess the nature, incidence andeconomic impact of adverse events and to provide some information on their causes.
The classic, pioneering study in this area is the Harvard Medical Practice Study, still
hugely influential. The Harvard group developed the original process of review of
medical records to detect adverse events. The basic process is as follows. In phase I
nurses or experienced record clerks are trained to identify case records that satisfy one
or more of 18 well-defined screening criteria – such as death, transfer to a special careunit or re-admission to hospital within 12 months(4). These have been shown to be
associated with an increased likelihood of an adverse event(5). In phase II trained
doctors analyse positively screened records in detail to determine whether or not they
contain evidence of an adverse event using a standard set of questions.
Studies in many countries have followed this basic method and have come tobroadly similar conclusions (Table 2.1). Rates of adverse events in most recent studies
lie between 8% and 12%, a range now accepted as being typical of advanced
healthcare systems(6). Note however that only about half the adverse events detected
are thought to be preventable with current standards of care, though we might aim toeliminate many more as healthcare evolves. These findings suggest that healthcare
can actually be considered a public health risk:
11

The Essentials of Patient Safety‘Of the top 20 risk factors that account for nearly three quarters of all deaths
annually, adverse in-hospital events come in at number 11 above air pollution,
alcohol and drugs, violence and road traffic injury’ (7)Table 2.1 Adverse events in acute hospitals in ten countries
Study

Authors

Harvard Medical
Practice Study

Brennan et al, 1991;
Leape et al, 1991

1984

Number of
hospital
admissions
30195

Utah-Colorado Study Thomas et al, 2000

1992

14052

2.9

Quality in Australian
Health Care Study

Wilson et al, 1995

1992

14179

16.6

United Kingdom

Vincent et al, 2001

1999

1014

10.8

Denmark

Schioler et al, 2001

1998

1097

9.0

New ZealandDavis et al, 2002

1998

6579

11.2

CanadaBaker et al, 2004

2002

3745

7.5

FranceMichel et al, 2007

2004

8754

6.6% per 1000days admission

United Kingdom

Sari et al, 2007

2004

1006

8.7

Aranaz-Andre et al,
2008
Zegers et al, 2009

2005

5624

8.4

2006

7926

5.7

Soop et al, 2009

2006

1967

12.3

Spain
The Netherlands
SwedenDate ofadmissions

Adverse event
rate (%
admissions)
3.7

Types of adverse event
The most frequent adverse events in most studies are surgical complications,healthcare acquired infections and adverse drug events. In the UK complication rates
for some of the major operations are 20-25% with an acceptable mortality of 5-10%(8). However at least 30-50% of major complications occurring in patients undergoing
general surgical procedures are thought to be avoidable. Nosocomial infection, or
healthcare associated infection (HCAI), is the commonest complication affecting
hospitalised patients. Approximately 5-10% of patients admitted to hospital in Britain
and the United States acquire one of more infections; millions of people each year are
affected (9).

12The Essentials of Patient Safety

Many adverse drug events occur outside hospital, often then leading tohospital admission. For instance, in Boston Tejal Gandhi and colleagues reviewed 661
out patients on a variety of drug regimens (10). Incredibly, almost a quarter of thesepeople were assessed as suffering adverse drug reactions and about 6% of the patientswere suffering serious reactions. Serious adverse drug reactions included bradycardia,
hypotension and gastrointestinal bleeding, many of which were clearly preventable.
Other consequences were less serious, in that they did not present immediate threats
to life, but were certainly serious for the patient. For instance, one patient sufferedprolonged sexual dysfunction after his doctor failed to stop a selective serotonin
uptake inhibitor; another had continued sleep disturbance due to taking an antidepressant that his doctor was not aware of. Such reactions represent prolonged,
avoidable suffering over many months, to say nothing of the waste of time andresources.
The impact and cost of adverse events
The majority of adverse events, about 70% in most studies, do not have serious
consequences for the patient; the effects of minor events may be more economic, inthe sense of wasted time and resources, than clinical (6). Some, such as the reaction
to anaesthetic, are not serious for the patient but are classed as an adverse event
because there was an increased stay in hospital of one day; it was probably notpreventable in that it would have been hard to predict such an idiosyncratic reaction.
Others however, as the remaining examples show, cause considerable unnecessary
suffering and extended time in hospital.
In Britain the cost of preventable adverse events is £1 billion per annum in lostbed days alone as, on average, an adverse event leads to an extra week in hospital(11). The Institute of Medicine report (1999) was able to estimate that in the UnitedStates the total national costs associated with adverse events and preventable adverse
events represent approximately 4% and 2% respectively of national healthexpenditure (12). Costs of direct hospital care, essentially additional time in hospital,
have recently been estimated from the Dutch adverse events study finding that about
3% of all bed days and 1% of the total health budget could be attributed topreventable adverse events (13). The real overall costs are probably a good deal
higher, as these estimates do not include additional treatments and investigations or
any of the associated societal costs discussed above. Remember also that theseestimates are confined to the hospital sector; we have no idea of the additional costsof adverse events in primary care or mental health.
The human cost of adverse events is the greatest of all. Many patients suffer
increased pain and disability from serious adverse events. They often also suffer
psychological trauma and may experience failures in their treatment as a terrible betrayalof trust. Staff may experience shame, guilt and depression after making a mistake withlitigation and complaints imposing an additional burden (14). These profoundly
important aspects of patient safety, generally given far too little attention, are consideredlater.
Vulnerability to harm: the old and the frail
Curiously, relatively little attention has been paid to patient safety in older people
although they are particularly vulnerable to healthcare error and harm, as are the very
young (15). Most people in hospital are old. In Britain for instance patients over 65,
mostly with multiple long term conditions, account for about 60% of admissions and
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The Essentials of Patient Safety

70% of bed days; many of these people are also physically frail and may have somedegree of cognitive impairment (16). Dramatic, usually sudden deaths of younger
people, attract more attention than the slow decline of an elderly person fromdehydration, drug errors and neglect.
Although attitudes, culture and delivery of healthcare all influence the qualityof care provided, older people are also vulnerable to harm for solid physiologicalreasons. They are more likely to suffer from multiple conditions, receive multiple
treatments and to stay longer in hospital. A longer stay increases the risk of all thecomplications of hospitalisation. In addition, the frailty of older people means thatthey have a reduced physiological reserve and are more strongly affected by, say, an
adverse drug event than their younger counterparts and take much longer to recover.
Once weakened they become vulnerable to a downward spiral in which forexample a fall weakens them, an infection sets in, followed by delirium which makes
feeding difficult, in turn leading to malnutrition and increasing frailty; such a scenario
once entrenched is very hard to reverse (17). All too often, once the older patient has
recovered sufficiently to leave hospital, the combined effect of these geriatricsyndromes will have lead to (often irreversible) functional decline, loss of
independence and possibly institutionalisation. Conversely, active and effective
management of these conditions at an early stage can produce rapid improvement on
several fronts.
Detecting adverse events: reporting and learning systems
Systematic records reviews provide the most comprehensive assessment of the scaleof harm but they can be quite resource intensive. Many healthcare systems haverelied extensively on voluntary reporting of adverse events and related incidents as ameans of monitoring safety. Such safety reporting systems have drawn theirinspiration from similar systems in other industries, particularly aviation and thenuclear industry. Most industrial reporting systems have a broad remit in thatreporting of near misses, general safety issues and anything that worries the pilots oroperators is encouraged (18). All the reporting systems give feedback in the form of
regular reports on recent incidents and, crucially, actions taken to enhance safety; they
may also give feedback to individuals who make reports.
Reporting systems operate at different levels within the healthcare system.
Some operate primarily at local level others at regional or national level. Typicallythere is a standard incident form, asking for basic clinical details and a brief narrativedescribing the incident. Staff are asked to report any incident which concerns them ormight endanger a patient; in practice serious incidents are followed by an urgent
telephone call to the risk manager. In more sophisticated systems where staff within aunit may routinely monitor a designated list of incidents, although staff are free toreport other issues that do not fall into these categories.
Information from local reporting systems may be collated and analysed inmuch larger state wide or national systems. National and other large scale systems are
expensive to run and have the disadvantage of being primarily reliant on the written
reports, perhaps supplemented by telephone checking. On the positive side their sheer
scale gives a wealth of data, and their particular power is in picking up events that
may be rare at a local level with patterns of incident only appearing at national
level(19). For instance the United Kingdom Reporting and Learning System (RLS)
collects incident data from the British National Health Service in England and Wales.
Incidents collected in local risk management systems are forwarded to the NRLS and
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The Essentials of Patient Safety

analyses of different types of incidents undertaken, alongside a variety of othernational initiatives. The technical and analytic challenges of such a system areconsiderable, as it deals with simply staggering numbers of incidents; by early 2009
the database contained over 3 million incidents in total most of which, of necessity,
have not been subject to any formal analysis.
Reporting systems were established in response to the scale of harm revealed
by case record review studies. The studies had shown the underlying problem;
reporting systems were meant to provide information about adverse events on an
ongoing basis. However incident reporting systems are actually very poor at
detecting adverse events (20). For example Sari and colleagues (21) carried out aclassical case record review of 1000 records and compared the findings with locallyreported incidents. The reporting system detected only 5% of adverse events
discovered by reviewing records. This means that voluntary reporting systems are
pretty useless as a means of measuring harm. However, as we will see, they can bevaluable as a means of surfacing safety issues in order to learn about thevulnerabilities of the system.
Analysis, feedback and action from reporting systems
The real meaning and importance of incidents is apparent only in the narrative. To
make real sense of an incident you must have the story and, furthermore, the story
must be interpreted by someone who knows the work and knows the context. The
implication of this is that if healthcare incident reports are to be of real value theyneed to be reviewed by clinicians and, ideally, also by people who can tease out thehuman factors and organisational issues. One of the main problems that healthcare
faces is that the number of reported incidents is so vast in mature systems that only aminority of incidents can be reviewed by those with relevant expertise (20).
It is impossible to analyse all reports in detail and for common incidents
largely pointless; better to analyse a small number of reports in depth than carry out acursory analysis of a large number which often produces little more than a few bar
charts. Once analysis has been carried out though, there are various ways in which
action can be taken. Some issues are only of concern in a particular unit, faulty
equipment for instance or a system of handover within that unit. Others need action
across an organisation if, for instance, staffing levels are shown to be inadequate.
Feedback that is restricted to a local system or specialty is attractive because it can be
rapid and because it is being shared within a community of experts who understandthe significance of the incident and the lessons it conveys. However some safetyissues, such as the design of equipment or drug packaging, cannot easily be addressedby any single organisation and need action at a regional or national level.
Reporting will always be important, but has been overemphasised as a meansof enhancing safety. The fact that only a small proportion of incidents are reported isnot, in my view, critically important. As long as the system receives sufficient reports
to identify the main safety issues the absolute number of reports is not critical.
Reporting systems serve an important function in raising awareness and generating aculture of safety as well as providing data. However the results of reporting are often
misunderstood in that they are mistakenly held to be a true reflection of theunderlying rate of errors and adverse events. Incident reporting is crucial, but is only
one component of the whole safety process. Incident reports in themselves areprimarily flags and warnings of a problem area. Once collected however they must be
analysed and understood which is the subject of the next chapter.
15

The Essentials of Patient Safety

KEY POINTS
Adverse events are injuries that are due to healthcare management rather than to theunderlying disease
Adverse events may or may not be preventable
Studies of medical records in many countries suggest that 8-12% of hospitalised
patients suffer one or more adverse events
Older people are particularly vulnerable to harm from healthcare
Voluntary reporting systems are poor at measuring adverse events but useful forlearning about the vulnerabilities of healthcare systems

References
1.
Cook RI, Woods DD, Miller CA. A tale of two stories: contrasting views ofpatient safety, US National Patient Safety Foundation; 1998.
2.
Pronovost PJ, Miller MR, Wachter RM. Tracking progress in patient safety An elusive target. Journal of the American Medical Association, 2006;296(6):696-9.
3.
Brennan TA, Localio AR, Leape LL, Laird NM, Peterson L, Hiatt HH, et al.
Identification of adverse events occurring during hospitalization. A cross-sectional
study of litigation, quality assurance and medical records of two teaching hospitals.
Annals of Internal Medicine, 1990;112(3):221-6.
4.
Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al.
Incidence of adverse events and negligence in hospitalized patients; Results from theHarvard Medical Practice Study I. New England Journal of Medicine,
1991;324(6):370-6.
5.
Neale G, Woloshynowych M. Retrospective case record review: a blunt
instrument that needs sharpening. Quality and Safety in Health Care, 2003;12(1):2-3.
6.
de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA.
The incidence and nature of in-hospital adverse events: a systematic review. Quality
and Safety in Health Care, 2008;17(3):216-23.
7.
Davis P. Health care as a risk factor. Canadian Medical Association Journal,
2004;170(11):1688-9.
8.
Vincent C, Moorthy K, Sarker SK, Chang A, Darzi AW. Systems approaches
to surgical quality and safety: from concept to measurement. Annals of Surgery,2004;239(4):475-82.
9.
Burke JP. Infection Control – A Problem for Patient Safety. The New England
Journal of Medicine, 2003;348(7):651-6.

16

The Essentials of Patient Safety

10.
Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, et al.
Adverse drug events in ambulatory care. New England Journal of Medicine,
2003;348(16):1556-64.
11.
Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals:
preliminary retrospective record review. British Medical Journal,
2001;322(7285):517-9.
12.
Kohn L, Corrigan J, Donaldson ME. To err is human, Washington DC:
National Academy Press; 1999.
13.
Zegers M, de Bruijne MC, Wagner C, Hoonhout LH, Waaijman R, Smits M,
et al. Adverse events and potentially preventable deaths in Dutch hospitals: results ofa retrospective patient record review study. Quality and Safety in Health Care,2009;18(4):297-302.
14.
Vincent C. Understanding and responding to adverse events. New England
Journal of Medicine, 2003;348(11):1051-6.
15.
Tsilimingras D, Rosen AK, Berlowitz DR. Patient safety in geriatrics: A callfor action. Journals of Gerontology, 2003;58(9):813-9.
16.
Oliver D. 'Acopia' and 'social admission' are not diagnoses: why older people
deserve better. Journal of the Royal Society Medicine, 2008;101(4):168-74.
17.
Long S. Adverse events in the care of the elderly (Unpublished PhD thesis).
2010.
18.
Barach P, Small SD. Reporting and preventing mdeical mishaps: lessons from
non-medical near miss reporting systems. British Medical Journal, 2000;320(7237):759-63.
19.
Runciman WB, Williamson JAH, Deakin A, Benveniste KA, Bannon K,
Hibbert PD. An integrated framework for safety, quality and risk management: an
information and incident management system based on a universal patient safetyclassification. Quality and Safety in Health Care, 2006;15(suppl_1):i82-i90.
20.
Vincent C. Incident reporting and patient safety. British Medical Journal,
2007;334(7584):51.
21.
Sari AB-A, Sheldon TA, Cracknell A, Turnbull A. Sensitivity of routine
system for reporting patient safety incidents in an NHS hospital: retrospective patientcase note review. British Medical Journal, 2007;334(7584):79.

17

The Essentials of Patient Safety

CHAPTER 3
Understanding How Things Go Wrong

Human error is routinely blamed for accidents in the air, on the railways, in complex
surgery and in healthcare generally. Immediately after an incident people make quick
judgements and, all too often, blame the person most obviously associated with thedisaster. The pilot of the plane, the doctor who gives the injection or the train driver
who passes a red light are quickly singled out. However these quick judgements androutine assignment of blame prevent us uncovering the second story (1). This is thestory in its full richness and complexity, which only emerges after thoughtful andcareful inquiry. While a particular action or omission may be the immediate cause of
an incident, closer analysis usually reveals a series of events and departures from safe
practice, each influenced by the working environment and the wider organisational
context (2).
What is error?
In everyday life recognising error seems quite straightforward, though admitting it
may be harder. My own daily life is accompanied by a plethora of slips, lapses ofmemory and other ‘senior moments’, in the charming American phrase, that are often
the subject of critical comment from those around me. (How can you have forgotten
already?). Other errors may only be recognised long after they occur. You may only
realise you took a wrong turning some time later when it becomes clear that you are
irretrievably lost. Some errors, such as marrying the wrong person, may only become
apparent years later. An important common theme running through all these examples
is that an action is only recognised as an error after the event. Human error is a
judgement made in hindsight (3). There is no special class of things we do or don’t dothat we can designate as errors; it is just that some of the things we do turn out to have
undesirable or unwanted consequences. This does not mean that we cannot study error
or examine how our otherwise efficient brains lead us astray in some circumstances,
but it does suggest that there will not be specific cognitive mechanisms to explain
error that are different from those that explain other human thinking and behaviour.
The most precise definition of error, and most in accord with everyday usage,
is one that ties it to observable behaviours and actions. As a working definition, John
Senders and Neville Moray (4) proposed that an error means that something has been
done which:Was not desired by a set of rules or an external observer
Led the task or system outside acceptable limits
Was not intended by the actor

This definition of error, and other similar ones (5) imply a set of criteria for defining
an error. First, there must be a set of rules or standards, either explicitly defined or at
18

The Essentials of Patient Safety

least implied and accepted in that environment; second, there must be some kind of
failure or ‘performance shortfall’; third, the person involved did not intend this andmust, at least potentially, have been able to act in a different way. All three of thesecriteria can be challenged, or at least prove difficult to pin down in practice. Muchclinical medicine for instance is inherently uncertain and there are frequently no
guidelines or protocols to guide treatment. In addition the failure is not necessarily
easy to identify; it is certainly not always clear, at least at the time, when a diagnosis
is wrong or when at what point blood levels of a drug become dangerously high.
Finally, the notion of intention, and in theory at least being able to act differently, ischallenged by the fact that people’s behaviour is often influenced by factors, such as
fatigue or peer pressure, which they may not be aware of and have little control over.
So, while the working definition is reasonable, we should be aware of its limitations
and the difficulties of applying it in practice.
Types of error
In his analysis of different types of error James Reason (6)divides them into two
broad types: slips and lapses, which are errors of action, and mistakes which are,broadly speaking, errors of knowledge or planning.
Slips and lapses
Slips and lapses occur when a person knows what they want to do, but the action does
not turn out as they intended. Slips relate to observable actions and are associatedwith attentional failures (such as picking up the wrong syringe), whereas lapses areinternal events and associated with failures of memory (such as forgetting to give thedrug altogether).
Mistakes
Slips and lapses are errors of action; you intend to do something, but it does not go
according to plan. With mistakes, the actions may go entirely as planned but the plan
itself deviates from some adequate path towards its intended goal. Here the failure lies
at a higher level: with the mental processes involved in planning, formulating
intentions, judging, and problem solving(6). If a doctor treats someone with chest pain
as if they have a myocardial infarction, when in fact they do not, then this is a
mistake. The intention is clear, the action corresponds with the intention, but the plan
was wrong.
In daily life errors are frequently attributed to stupidity, carelessness,forgetfulness, recklessness and other personal defects. The implication is that theperson who makes an error has certain characteristics which produce the error and,furthermore, that these characteristics are under their control and they are therefore toblame for the errors they make. This is error seen from the individual perspective;
when applied to understanding accidents Reason refers to this as the ‘personmodel’(7). Efforts to reduce error are, from this perspective, targeted at individuals
and involve exhortations to ‘do better’, retraining, or adding new rules andprocedures. For errors with more serious consequences, more severe sanctions comeinto play such as naming and shaming, disciplinary action, suspension, media
condemnation and so on. However, while reckless behaviour may well deserve blameand sanction, we need to approach error rather more thoughtfully.

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The Essentials of Patient Safety

Error in context: the person and the system
James Reason and others have argued that that errors cannot be understood in
isolation, but only in relation to the context in which people are working. In
considering how people contribute to accidents therefore we have to distinguishbetween ‘active failures’ and ‘latent conditions’ (8).The active failures are errors andother types of unsafe act. These are committed by people at the ‘sharp end’ of thesystem who are actually operating it or working with a patient. The active failures arewrongly opening the bow door of a ferry, shutting down the wrong engine on anairliner, or misreading the anaesthetic monitor. These unsafe acts can, and often do,have immediate consequences.
However, other factors further back in the causal chain can also play a part in
the genesis of an accident. These ‘latent conditions’ as they are often termed lay thefoundations for accidents in the sense that they create the conditions in which errors
and failures can occur. This places the operators at the sharp end in an invidiousposition as James Reason eloquently explains:
Rather than being the instigators of an accident, operators tend to be theinheritors of system defects …their part is usually that of adding the final
garnish to a lethal brew whose ingredients have already been long in thecooking (6)Considering the wider influences of the healthcare systems does not mean simply
blaming everything on ‘the system’. Rather one needs to preserve individual
accountability but understand the interplay between the person, the technology andthe organisation. A strong sense of personal responsibility is fundamental to being agood clinician. People who deliberately behave recklessly and without regard to theirpatients’ welfare deserve to be blamed, whether or not they make errors. However
sometimes good people can, for complicated reasons, make simple mistakes with very
serious outcomes. Let us look at an example.
Understanding how things go wrong‘Mr David James…was prepared for an intrathecal (spinal) administration ofchemotherapy as part of his medical maintenance programme following
successful treatment of leukaemia. After carrying out a lumbar puncture andadministering the correct cytotoxic therapy (Cytosine) under the supervisionof the Specialist Registrar Dr Mitchell, Dr North, a Senior House Officer, waspassed a second drug by Dr Mitchell to administer to Mr James, which hesubsequently did. However, the second drug, Vincristine, should never beadministered by the intrathecal route because it is almost always fatal.
Unfortunately, whilst emergency treatment was provided very quickly in aneffort to rectify the error, Mr James died some days later’ (9)Professor Brian Toft was commissioned by the Chief Medical Officer of England to
conduct an inquiry into this death and to advise on the areas of vulnerability in theprocess of intrathecal injection of these drugs and ways in which fail-safes might bebuilt in (9). The orientation of the inquiry was therefore, from the outset, one oflearning and change. We will use this sad story, and Brian Toft’s thoughtful report, tointroduce the subject of analysing cases. Although the names of those involved weremade public I have changed them in the narrative as identifying the people again at
this distance serves no useful purpose. This case acts as an excellent, though tragic,
illustration of models of organisational accidents and systems thinking.
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The Essentials of Patient Safety

Box 3.1 The death of David James
Mr James arrived on the ward at about 4.00pm; he was late for his chemotherapy, but
staff tried to accommodate him. The pharmacist for the ward had made an earlier
request that the cytosine should be sent up and that the Vincristine should be ‘sent
separately’ the following day. The pharmacy made up the drugs correctly and they
were put on separate shelves in the pharmacy refrigerator. During the afternoon theward day case coordinator went to the pharmacy and was given a clear bag containing
two smaller bags each containing a syringe – one vincristine and one Cytosine. She
did not know they should not be in the same bag.
Dr Mitchell was informed and approached by Dr North to supervise theprocedure, as demanded by the protocol. The staff nurse went to the ward refrigerator
and removed the transparent plastic bag containing two separate transparent packets
each one containing a syringe. She noted that the name ‘David James’ was printed oneach of the syringe labels, delivered it and went to carry on her work.
Dr Mitchell looked at the prescription chart noting that the patient’s name,drugs and dosages corresponded with the information on the labels attached to thesyringes. He did not, however, notice that the administration of Vincristine wasplanned for the following day or that its route of administration was intravenous. Dr
Mitchell, anticipating a cytotoxic drugs system similar to the one at his previous placeof work had presumed that, as both drugs had come up to the ward together, bothwere planned for intrathecal use. He had previously administered two types ofchemotherapy intrathecally and it did not therefore seem unusual.
A lumbar puncture was carried out successfully and samples of cerebro-spinal
fluid taken for analysis. Dr Mitchell then read out aloud the name of the patient, thedrug and the dose from the label on the first syringe and then handed it to Dr North.
Dr Mitchell did not, however, read out the route of administration. Dr North, having
received the syringe, now asked if the drug was ‘Cytosine’ which Dr Mitchellconfirmed. Dr North then removed the cap at the bottom of the syringe and screwed it
onto the spinal needle after which he injected the contents of the syringe.
Having put down the first syringe, Dr Mitchell handed the second syringe
containing Vincristine to Dr North, again reading out aloud the name of the patient,the drug and dosage. Once again, he did not read out the route of administration. Dr
North was surprised when he was passed a second syringe, because on the only otheroccasion that he had performed a supervised intrathecal injection only one syringe had
been used. However, he assumed that that ‘...the patient was either at a different stage
in his treatment or was on a different treatment regime than the other patient.’
Dr North, with the second syringe in his hand, said to Dr Mitchell‘Vincristine?’ Dr Mitchell replied in the affirmative. Dr North then said ‘intrathecal
Vincristine?’ Dr Mitchell again replied in the affirmative. After which Dr North
removed the cap at the bottom of the syringe and screwed it onto the spinal needle. He
then administered the contents of the syringe to Mr James with ultimately fatal results.
Adapted from Toft 2001

21

The Essentials of Patient Safety

Background to the incident
Provided Vincristine is administered intravenously (IV), it is a powerful and useful
drug in the fight against leukaemia. The dangers of inadvertent intrathecal
administration of Vincristine are well known: there are product warnings to that
effect, a literature that stresses the dangers and well publicized previous cases. In this
hospital there was a standard written protocol which, at the request of hospital staff,
had been changed so that Cytosine and Vincristine would be administered on differentdays to avoid any potentially fatal confusion. Drugs for intravenous and for
intrathecal use were also supplied separately to the wards, again to reduce the chancesof mixing up the different types of drug.
Defences, discussed further below, are the means by which systems ensure
safety. Sometimes the term is used to encompass almost any safety measure, but it
more usually refers to particular administrative, physical or other barriers that protect
or warn against deviations from normal practice. Administering Cytosine andVincristine on separate days, for instance, is clearly intended to be a defence against
incorrect administration. The separation of the two drugs in pharmacy and theseparate delivery to the ward are other examples of defences against error. Having
two doctors present checking labels and doses is another check, another barrier
against potential disaster. Sometimes however, as in this case, a series of defences andbarriers are all by breached at once. This is brilliantly captured in James Reason’s
Swiss Cheese (7) metaphor of the trajectory of an accident which gives us the sense ofhazard being ever present and occasionally breaking through when all the holes in the
Swiss Cheese line up.

Figure 3.1 Swiss Cheese: vulnerabilities in the system (after Reason, 1997).
Death from spinal injection: a window on the system
From the chronology one can see the classic ‘chain of events’ leading toward thetragedy. Dr Mitchell was quite new to the ward, unfamiliar with the chemotherapy
regime and did not know the patient. The pharmacy somehow, although separating the22The Essentials of Patient Safety

two drugs, placed them in a single bag. Although the doctors involved can be held
responsible for their specific actions and omissions, one can also see thatcircumstances conspired against them. However, the case also illustrates some much
more general themes, issues that pervade healthcare and indeed other organisations,and which are right now as you read this putting patients at risk. We will consider
three recurring safety issues.
Assumption that the system was reliable
The unit where David James died had used these drugs for many years without amajor incident. After an event of this kind, and a subsequent analysis, we can see thatthe systems, while reasonably robust, nevertheless had many vulnerabilities. Hugereliance was placed on custom and practice and on people simply knowing what they
were doing. With experienced staff who know the unit’s procedures, this works
reasonably well, but when new staff join a unit without clear induction and training
the system inevitably becomes unsafe. In fact, the unit where David James died seems
to have been a well run unit, where professionals respected each other’s work andthings went well on a day to day basis. Paradoxically, safety creates its own dangers
in that an uneventful routine lulls one into a false sense of security. The safer one
becomes the more necessary it is to remind oneself that the environment is inherently
unsafe. This is what James Reason means when he says that the price of safety ischronic unease (10).
The influence of hierarchy on communication
When asked why he did not challenge Dr Mitchell, Dr North said:‘First of all, I was not in a position to challenge on the basis of my limited
experience of this type of treatment. Second, I was an SHO (junior doctor) anddid what I was told to do by the Registrar. He was supervising me and I
assumed he had the knowledge to know what was being done. Dr Mitchell was
employed as a registrar … in a centre for excellence and I did not intend tochallenge him’. (9)Dr North was in a very difficult position. He assumed Dr Mitchell, as a registrar,
knew what he was doing and reasonably points out that he himself had limited
experience of the treatment. However he did know that Vincristine should not begiven intrathecally, but he failed to speak up and challenge a senior colleague.
Criticism might be made here of both Dr North, for not having the courage to request
further checks, and of the Dr Mitchell for not taking the junior doctor’s query more
seriously and at least halting the procedure while checks were made.
Physical appearance of syringes containing cytotoxic drugs
Syringes containing Vincristine were labelled ‘for intravenous injection’ and syringes
containing Cytosine ‘for intrathecal use’. You might think this is fairly clear cut, but
on a busy ward with numerous injections being given every day, the design andpackaging of drugs is an important determinant of the likelihood of error. In the final
few minutes leading up to the fatal injection, the doctors involved were not helped by
the similarity in appearance and packaging of the drugs. First, the labels were similar
and, while the bold type of the drug and dose stood out there were no other strong
visual cues to draw a reader's eye to the significance of the route of administration.
Second, the syringes used to administer the two drugs were of similar size; the size of23

The Essentials of Patient Safety

the syringe did not give any clues as to the route of administration to be used. Third,
both drugs were clear liquids administered in similar volumes; neither colour nor
volume gave any indication of the proper route of administration. Finally, the mostdangerous physical aspect of all, in Toft’s opinion, is ‘that a syringe containing
Vincristine can also be connected to the spinal needle that delivers intrathecal drugs topatients. Clearly, once such a connection has been made the patient's life is in danger
as there are no other safeguards in place to prevent the Vincristine from being
administered’ (9).
Syringes of drugs for intrathecal use could have their own specific, uniquefitting, colour and design and thankfully, years later, these are now being developed.
While this might not eliminate the possibility of injecting the correct drug, it does add
a powerful check to wrong administration. In the same way, fatalities in anaesthesia
that resulted from switching oxygen and nitrous oxide supplies were eliminated by thesimple expedient of making it impossible to connect the nitrous oxide line to theoxygen input. In daily life there are thousands of such checks and guides to behaviour.
When you fill your car with unleaded petrol you use a small nozzle; larger nozzles forleaded or diesel will simply not fit into the filling pipe. It is shameful that these designmodifications have still not been implemented ten years after this tragic death.
Seven levels of safety: ‘organisational’ accidents
Many of the accidents in both healthcare and other industries need to be viewed fromthis broad systems perspective if they are to be fully understood. The actions andfailures of individual people usually play a central role, but their thinking andbehaviour is strongly influenced and constrained by their immediate working
environment and by wider organisational processes. The organisational accident
model (8) describes the immediate errors and problems and the background latentconditions.

Fig 3.2 Organisational accident model (Adapted from Reason, 1997)24

The Essentials of Patient Safety

We have extended Reason’s model and adapted it for use in a healthcare setting,classifying the error producing conditions and organisational factors in a single broad
framework of factors affecting clinical practice (2). The ‘seven levels of safety’framework describes the contributory factors and influences on safety under sevenbroad headings:


Patient factors. The patient’s condition has the most direct influence onpractice and outcome. Other factors such as personality, language andpsychological problems may also be important as they can influencecommunication with staff.

Task factors. The design of the task, the availability and utility of protocols
and test results may influence the care process and affect the quality of care.



Individual factors. Individual staff factors include the knowledge, skills andexperience of each member of staff, which will obviously affect their clinicalpractice.

Team factors. Each staff member is part of a team within the inpatient orcommunity unit. The way an individual practises, and their impact on the patient,
is influenced by other members of the team and the way they communicate andsupport each other.



Working conditions. These include the physical environment, availability ofequipment and supplies and the light, heat, interruptions and distractions that
staff endure.



Organisational factors. The team is influenced in turn by management actions
and by decisions made at a higher level in the organisation. These include
policies for the use of locum or agency staff, continuing education, training andsupervision and the availability of equipment and supplies.



Institutional context. The organisation itself is affected by the institutional
context, including financial constraints, external regulatory bodies and thebroader economic and political climate.

The investigation and analysis of clinical incidents
Reason’s model and the framework described above provide the foundations of the‘London protocol’ a systematic method of analysing clinical incidents, one of anumber developed in healthcare (www.cpssq.org). The incident acts as a ‘window’ on
the healthcare system revealing both strengths and vulnerabilities of the system(11).
The London protocol aims to guide reflection on incidents in order to reveal theseweaknesses.
During an investigation information is gleaned from a variety of sources. Case
records, statements and any other relevant documentation are reviewed. Structured
interviews with key members of staff are then undertaken to establish the chronology
of events, the main care delivery problems and their respective contributory factors, as
perceived by each member of staff. The key questions are ‘What happened? (theoutcome and chronology); How did it happen? (the care delivery problems) and Why
25

The Essentials of Patient Safety

did it happen? (the contributory factors). The investigator needs to differentiate
between those contributory factors that are only relevant on that particular occasion
and those which are longstanding or permanent features of the unit. For instance there
may be a failure of communication between two midwives which might be an isolated
occurrence or might reflect a more general pattern of poor communication on the unit.
Ideally the patient, or a member of their family, should also be interviewed though as
yet this does not often happen.
From accident analysis to system design
We are now at a transitional point in the book between the understanding and analysis
of incidents and the coming chapters which discuss methods of prevention and quality
improvement. The seven levels framework has outlined the patient, task andtechnology, staff, team, working environment, organisational and institutional
environmental factors that are revealed in analyses of incidents. These same factors
also point to the means of intervention and different levels on which safety andquality must be addressed, which we will illustrate in the next two chapters.

KEY POINTS
An error is something realised only after the event
Slips and lapses are errors of action and memory
Mistakes are errors of knowledge and planning
Errors can only be properly understood in context
Patient, task, individual, team, environment, organisational and institutional context
factors may all influence incidents and accidents
Incidents may act as a ‘window’ on the healthcare system

References
1.
Cook RI, Woods DD, Miller CA. A tale of two stories: contrasting views ofpatient safety, US National Patient Safety Foundation 1998.
2.
Vincent C, Taylor-Adams S, Stanhope N. Framework for analysing risk andsafety in clinical medicine. British Medical Journal. 1998;316(7138):1154-7.
3.
Woods DD, Cook RI. Nine steps to move forward from error. Cognition
Technology and Work, 2002;4(2):137-44.
4.
Senders JW, Moray N. Human error: course, prediction and reduction.
Hillsdale, NJ: Lawrence Earlbaum Associates; 1991.
5.
Hollnagel E. Cognitive reliability and error analysis method. Oxford:
Elsevier; 1998.
26

The Essentials of Patient Safety

6.

Reason JT. Human error. New York: Cambridge University Press; 1990.

7.
Reason JT. Human error: models and management. British Medical Journal,
2000;320(7237):768-70.
8.
Reason JT. Managing the risks of organisational accidents. Aldershot:
Ashgate; 1997.
9.
Toft B. External inquiry into the adverse incident that occured at Queen's
Medical Centre, Nottingham. London: Department of Health, 2001.
10.
Reason JT. Understanding adverse events: the human factor. In: Vincent C,
editor. Clinical risk management: Enhancing patient safety. London: BMJ Books;
2001. p. 9-30.
11.
Vincent CA. Analysis of clinical incidents: a window on the system not asearch for root causes. Quality and Safety in Health Care, 2004;13(4):242-3.

27

The Essentials of Patient Safety

CHAPTER 4
Improving healthcare processes and systems

Guy Cohen was Director of Quality, Safety and Reliability at NASA until the mid1990s. Don Berwick, then working on improving the quality of health care in the
Harvard Community system, had asked how to improve healthcare faster and more
effectively; in their first five hour meeting Cohen had barely started telling him what
he had learned about quality and safety. Berwick recalls the response to his initialquestion:‘“How do you get good enough to go to the moon”? Guy Cohen had no oneliners to offer me. He didn’t say “report cards” or “market forces” or“incentive pay” or even “accountability”. In fact, as I recall, not one of thosewords came up in the time we spent together. His view of human nature,organisations, systems, and change would not permit one-line answers’ (1)In healthcare, we are coming to understand how difficult the safety problem is, incultural, technical, clinical, and psychological terms, not to mention its massive scaleand heterogeneity. We have seen, in the analysis of individual incidents, just how
many factors can contribute to the occurrence of an error or bad outcome and there
are correspondingly many possible solutions. We could try to improve the efficiency
and reliability of processes. We could rely on teamwork and leadership. Or we could
turn to automation and technology. There are multiple possibilities and lines ofattack. We can however distinguish two broad approaches to improving patient safety.
These two visions of safety are seldom explicitly articulated, but are ever present
themes in debates and discussions about patient safety.
Two visions of safety
One broad approach is to simplify, standardise and improve basic processes andreduce reliance on people by automating or at least offering as much support as
possible in those tasks for which people are necessary. Ideally, the humancontribution to the process of care is reduced to a minimum as in industrial production
or commercial aviation. Such approaches are rooted in a basic industrial model, in
which the solutions to errors and defects rest in an increasing standardisation usuallycoupled with a reliance on technology. Careful design of the basic processes of care
and appropriate use of technology overcomes human fallibility, vulnerability tofatigue and environmental influences. Examples of safety measures within this broad
framework would include: simplification and standardisation of clinical processes,
more fundamental re-design of equipment and processes, computerised medication
systems, electronic medical records and memory and decision support, whether
computerised or in the form of protocols, guidelines, checklists and aides memoires.

28

The Essentials of Patient Safety

The second, contrasting approach, which I have called `people create safety’argues for an alternative to the rigid, proceduralised, technocratic driven view ofsafety that more truly reflects the realities of clinical work (2). Proponents of thisview are rightly extremely impressed by how often outcomes are good in the face of
extreme complexity, conflicting demands, hazards and uncertainty. Making healthcaresafer depends, on this view, not on minimising the human contribution but onunderstanding how people, look ahead, overcome hazards and, in effect, create safety.
These approaches are discussed in the following chapter.
Quality improvement
Manufacturing industries have made huge gains in safety, efficiency and costeffectiveness by close attention to the design, maintenance and performance of theprocesses used in factories. Rather than inspect products afterwards to identify
defects, those concerned with quality control and management sought to build quality
in to the process (3). The report on the British NHS by Lord Darzi similarly puts
quality at the heart of the NHS does and makes it clear that everyone should play theirpart in promoting and driving higher quality care for patients (4). In healthcare thishas become as aspiration but not yet a reality.
Doctors, nurses and others often find it hard to understand that approaches
developed in manufacturing can have any relevance to healthcare. We deal withpatients as individuals, how can we learn anything from companies that make cars? Infact of course cars and computers can now be completely customised and matched toindividual needs and preferences. Healthcare is also full of processes, of varying
degrees of complexity, which are very akin to manufacturing processes: pharmacy,ordering test results, the blood service and so on. The methods of quality management
are well described in many books (3, 5). Quality methods are sometimes presented
simply as a set of tools and techniques, but properly conceived the various systems
aim at substantial and enduring organisational change based on principles and values
that each organisation must define for itself.
Simplifying and standardising the processes of healthcare
Compared with manufacturing industry healthcare has little standardisation,comparatively little monitoring of processes and outcome, and few safeguards against
error and other quality problems (6). Most healthcare processes were not designed,
but just evolved and adapted to circumstances. Many healthcare processes are long,complicated and unreliable. The process of prescribing, ordering and giving drugs is agood example of complexity and lack of standardisation. David Bates gives anexample of the problems that he observed in his own hospital before a sustained
attack on medication error and adverse drug reactions:‘Take for example the allergy detection process used in our hospital several
years ago, which was similar to that used in most hospitals at the time.
Physicians, medical students and nurses all asked patients what their allergies
were. This information was recorded at several sites in the medical record,
though there was no one central location. The information was also required tobe written at the top of every order sheet, although in practice this was rarely
done. The pharmacy recorded the information in its computerised database,but it found out about allergies only if the information was entered into theorders, and often it was not. Checking by physicians, pharmacy and nursing
29

The Essentials of Patient Safety

staff was all manual. This information was not retained between the inpatientand outpatient settings, or from admission to admission. Not surprisingly,
about one in three orders for drugs to which a patient had a known allergy
slipped through’ (7).
The system Bates describes has now been replaced by one in which all allergies arenoted in one place in the information system, drugs are mapped to “drug families”(for example penicillin) so that they can be checked more easily, information isretained over time and checking for allergies is routinely performed by computers,
rather than tired and fallible human beings. Many healthcare systems however havenot benefited from such an overhaul. Ordering and reading of X-rays, communicationof risk information about suicidal or homicidal patients, informing patients and theirfamily doctors about abnormal test results, booking patients in for emergency
operations, effective discharge planning; all these and many more are vital for safe
healthcare, yet day to day experience tells patients and staff that they are far fromerror free.
Reducing medication error
Designing and building simpler, standardised processes which rely less on humanvigilance is therefore a powerful way of making at least some parts of healthcaremuch safer, as well as cheaper and more efficient. The Institute for Healthcare
Improvement (www.ihi.org) has pioneered quality improvement in healthcare
drawing together ideas and practical experience from healthcare and many othersources. We will use their approach to reducing medication error as an overall
framework to illustrate the potential of process improvement, addressing theparticular role of technology in a later section.
There are three basic elements to improving the safety of a medication
process:Design the system to prevent errors occurring in the first place
Design the system to make errors more visible when they do occur
Design the system to limit the effects of errors so that they do not lead to harm

Preventing errors is, broadly speaking, achieved by reducing the complexity of
information that healthcare staff need, reducing the opportunity for mixing up
different medications and trying to limit errors that occur because staff are trying to
do too many things at once. Errors can be made more visible by using a variety ofadditional checks, both by people (staff and patients) and by computers. For instance,
having a pharmacist reviewing orders before dispensing, asking staff to repeat backverbal orders and careful use of laboratory monitoring systems are all means ofdetecting errors that may have occurred. Even with all these checks and system
improvements errors will sometimes occur, if only because of the enormous numbersof drugs given. The final protection is to always be ready to mitigate the effects of any
error, to assume in fact that errors will occur and to prepare for it. Anticipating error
is a sign of a safe, rather than unsafe system. In this case keeping antidotes for highrisk drugs on hand at the point of administration is a key defence against harm topatients. These then are the general principles derived in years of experimentation,
evaluation and practical application with many organisations. Let us see how thisworks in practice.
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The Essentials of Patient Safety

Table 4.1 Principles for reducing medication error
Reducing errors due toinformation complexity

Limit hospital formularies to essential drugs and doses
Pharmacists on ward rounds to monitor and advise
Briefing at handover and shift change on
circumstances that increase risk of error, such as anunfamiliar disease, new staff or unusual drug regimens

Reducing errors due tocomplex or dangerous
medication

Provide an information system that allows access topatient information for all staff and allows electronicprescribing
Remove high risk medications, such as concentrated
electrolyte solutions, from patient care areas
Label high risk drugs clearly to indicate their danger
Remove or clearly differentiate look alike or soundalike drugs

Reducing errors due tomultiple competing tasks

Wherever possible reallocate tasks such as calculating,drawing up and mixing doses to pharmacy or the
manufacturer
Establish standard drug administration times and avoid
interruptions at those times
Assign one person to necessary double checks whodoes not have other duties at that time; use double
checks sparingly and make them properly independentStandardise equipment and supplies, such as
intravenous pumps, across all units
Involve patients in active checks such as identifying
themselves, checking drugs and allergies

Adapted from Berwick 1998
Reducing medication errors and adverse drug events
St Joseph Medical Centre is a 165 bed hospital in the heart of Illinois, providing avariety of services including open heart surgery and trauma care. The hospital has
established a number of safety projects backed by a strong commitment to culturalchange and backing from senior executives (8).
In June 2001 a survey of records suggested an ADE (adverse drug event) rateof 5.8 per 1000. Flowcharting of the medication process showed that it wascomplicated and labour intensive. Multiple members of staff were involved from the31

The Essentials of Patient Safety

time the order was written to the point where the patient received the medication.
Common sources of errors included unavailable patient information, unavailable drug
information, miscommunication of medication orders, problems with labelling or
packaging, drug standardisation, storage, stocking and process flaws. By May 2003
ADEs were running at 0.50 per 1000, a tenfold reduction, and the process of
medication delivery had been hugely simplified and standardised. How was thisachieved?

Box 4.1 Reducing medication errors in St Joseph Medical Centre

Added an adverse drug event hotline leading to a 10-fold increase in reportingof adverse drug events and medication errorsMonthly reporting of medication data to hospital quality council

Developed pre-printed heparin orders

Developed a single form that could be used for reconciliation of medications
at both admission and discharge

Separated sound-alike and look-alike medications in the pharmacy and on thenursing units

Implemented daily rounds by a clinical pharmacist who compares medication
orders to lab valuesStandardised intravenous drip concentrations



Decreased the amount of stock medications kept on patient care unitsEliminated the use of high-risk abbreviations

Changed process for non-standard doses so that all are prepared and packaged
in pharmacy

Standardised epidural pumps and use yellow coloured tubing with thesepumps

From Haig et al 2004

Standardisation of processes was a major feature of this programme with particularattention paid to high-risk medications. For instance all adult intravenous medications
were standardised and a single, weight based, Heparin Nomogram was developed andused throughout the hospital. A particularly popular intervention was increasing theavailability of pharmacists on nursing units to review and enter medication orders.
This gave the pharmacist the opportunity to identify potential dosage errors and32

The Essentials of Patient Safety

drug interactions and saved nurse time. Finally, the patients themselves were engaged
in the process. Each patient admitted to the hospital is now given a Medication Safety
Brochure that provides advice for them and a form on which to list their current
medication. Patients are also actively encouraged to check with staff if they have been
given unfamiliar medication and a ‘medicines reconciliation’ process ensured thatpatients leaving hospital returned to the medication appropriate to their life at home.
Technological innovations, in the form of automated medication dispensing machines,
formed the next phase of the drive to further reduce errors.
Using information technology to reduce medication error
Information technology can reduce error in a number of different ways: improving
communication, making knowledge more readily accessible, prompting for key pieces
of information (such as the dose of a drug), assisting with calculations, monitoring
and checking in real time, and providing decision support(6). Many medication errors
occur because clinicians do not have the necessary information about either thepatient of the drug or because test results are not available. Hand writtenprescriptions, transcribing errors and calculation mistakes are also major problems.
Several medication technology systems have been developed to address these andother problems operating at various stages of the medication and delivery process.
They show great promise but, as David Bates warns, are not a panacea:‘Information technologies …. may make some things better and others worse;the net effect is not entirely predictable, and it is vital to study the impact ofthese technologies. They have their greatest impact in organizing and making
available information, in identifying links between pieces of information, andin doing boring repetitive tasks, including checks for problems. The best
medication processes will thus not replace people but will harness thestrengths of information technology and allow people to do the things best
done by people, such as making complex decisions and communicating witheach other’ (7).
The system that has probably had the largest impact on medication error iscomputerized physician order entry (CPOE), in which medication orders are written
online. This improves orders in several ways. First, they are structured, so they must
include a drug, dose and frequency; the computer, unlike a person, can refuse toaccept any order without this information. They are always legible, and the clinician
making the order can always be identified if there is a need to check back. Finally, allorders can be routinely and automatically checked for allergies, drug interactions,excessively high or low doses and whether the dosage is appropriate for the patient’s
liver and kidney function. Clinical staff may fear that these advantages may be offset
by the time lost in typing rather than writing orders, but in practice there is minimal
difference (9).
Bates and his colleagues (10) showed that the introduction of a computerisedorder entry system resulted in a 55% reduction in medication errors. This systemprovided clinicians with information about drugs, including appropriate constraints on
choices (dose, route, frequency) and assistance with calculations and monitoring.
With the addition of higher levels of decision support, in the form of morecomprehensive checking for allergies and drug interactions, there was an 83%
reduction in error. Other studies have shown improvement of prescribing of33

The Essentials of Patient Safety

anticoagulants, heparin and anti-infective agents and reductions in inappropriate doses
and frequency of drugs given to patients with renal insufficiency (11).
Evidence of the value of CPOE continues to accumulate. However, many of
the systems however remain ‘home-grown’ systems, and have only considered small
numbers of patients in specific settings. Much more research is needed to compare
different applications, identify key components, examine factors relating toacceptance and uptake and anticipate and monitor the problems that such systems may
induce. Looking further ahead it is possible to envisage the use of many othertechnologies in the process of medication delivery. Most of these are in the earlystages of development, are relatively untested and sometimes delayed by external
constraints. Bar coding for instance, widely used in supermarkets, could beenormously useful but cannot be implemented until drug manufacturers have agreed
common standards. Considerable advances have been made however in the reliability
and efficiency of blood sampling and blood transfusion.

KEY POINTSStandardising and simplifying clinical processes is a powerful way of increasing
reliability
Reducing reliance on human beings with decision support and technology increases
reliability in standardised systems
Even in good systems people need to anticipate hazards and create safety moment tomomentMedication errors can be reduced by preventing error, by making errors more visible
and by planned limitation of harm from remaining errors
Computerised prescribing reduces medication error but is not a panacea

References
1.
Berwick DM. Escape Fire. Designs for the future of healthcare. San
Francisco: Jossey Bass; 2003.
2.
Woods DD, Cook RI. Nine steps to move forward from error. Cognition
Technology and Work, 2002;4(2):137-44.
3.
Langley GJ, Nolan KM, Nolan TW, Norman CL, Provost LP. The
Improvement Guide: A Practical Approach to Enhancing Organizational
Performance. San Francisco Jossey-Bass Publishers; 1996.
4.
Darzi A. High Quality Care for All. Department of Health, 2009.
5.
Nelson EC, Batalden P, Godfrey MM. Quality by design. A clinicalmicrosystems approach. San Francisco: Jossey Bass; 2007.
6.
Bates DW, Gawande AA. Improving Safety with Information Technology.
New England Journal of Medicine, 2003;348(25):2526-34.
34

The Essentials of Patient Safety

7.
Bates DW. Using information technology to reduce rates of medication errors
in hospitals. British Medical Journal, 2000;320(7237):788-91.
8.
Haig K, Wills L, Pedersen P, Patterson C, Novario M, Hoy R, et al.
Improvement Report: Reducing adverse drug events per 1,000 doses. IHI; 2004
[updated 2004/10/15/]; Available from:http://www.ihi.org/search/pages/results.aspx?k=haig%20ADE.
9.
Hollingworth W, Devine EB, Hansen RN, Lawless NM, Comstock BA,
Wilson-Norton JL, et al. The impact of e-prescribing on prescriber and staff time inambulatory care clinics: a time motion study. Journal American Medical Informatics
Association, 2007;14(6):722-30.
10.
Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM, et al.
Effect of computerized physician order entry and a team intervention on prevention ofserious medication errors. Journal of the American Medical Association.
1998;280(15):1311-6.
11.
Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order
entry and clinical decision support systems on medication safety: a systematic review.
Archives of Internal Medicine, 2003;163(12):1409-16.

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The Essentials of Patient Safety

CHAPTER 5
People create safety

Clinical staff in addition to simply doing their jobs well, actively create safety as theywork. At the coal face, minute by minute, safety may either be eroded by errors andcasual deviations from procedure or conversely created by skilful, safety conscious
professionals. People partly create safety by being conscientious, disciplined andfollowing rules. However the treatment of complex, fluctuating conditions also
requires thinking ahead and being prepared to adjust treatment as the patient’s
condition changes.
When thinking about safety however we are also calling on a broader vision inwhich the clinician is anticipating not only the disease, but the functioning of theorganisation in which they work, assessing the hazards emanating from both. Safety,
from this broader perspective, requires anticipation, awareness of hazards,
preparedness, resilience and flexibility, the qualities that those studying highreliability organisations have sought to capture and articulate. Patients too have toanticipate the course of their disease, the gaps in the healthcare system and they andtheir families play a critical role in ensuring their safety. In this chapter we consider
the skills needed by patients, by staff and by clinical teams as they jointly monitor andcreate safe healthcare.

Box 5.1 Being and feeling unsafe in hospital
Above all we needed safety; and yet Ann was unsafe. ….The errors were not rare;
they were the norm. During one admission, the neurologist told us in the morning,“By no means should you be getting anticholinergic agents”, and a medication withprofoundly anticholinergic side effects was given that afternoon. The attending
neurologist in another admission told us by phone that a crucial and potentially toxic
drug should be started immediately. He said “Time is of the essence”. That was on
Thursday morning at 10.00am. The first dose was given 60 hours later. Nothing I
could do, nothing I did, nothing I could think of made any difference. It nearly droveme mad. Colace was discontinued by a physician’s order on Day 1 and wasnonetheless brought by the nurse every single evening throughout a 14 day
admission….. I tell you from my personal observation: No day passed – not one –without a medication error. Most weren’t serious, but they scared us.
Adapted from Berwick 2003

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The Essentials of Patient Safety

Patient involvement in patient safety
Patients and their families have a critical, privileged perspective on many aspects ofhealthcare. The patient may not, of course, understand the technical and clinical issues
at stake, but they do observe and experience the kindnesses, the small humiliations,the inconsistencies in care, the errors and sometimes the disasters. In the case ofpeople with chronic illnesses they become experts not only on their own disease buton the frailties, limitations and unintentional cruelties of their healthcare system. The
trouble is when we are patients, while we have great insight into the frailties of thehealthcare system, we find it astonishingly difficult to make our voice heard,
particularly where errors and safety are concerned.
Even an experienced senior doctor can find it hard to make their voice heard
when dealing with hospital staff caring for themselves or their family. Don Berwick,currently head of Medicare in the United States, has movingly described his
experiences of being with his wife Ann during her treatment for a serious autoimmune
condition (1). In his account Don stresses the good will, kindness, generosity andcommitment of the healthcare staff but, even after two decades of grappling with thequality and safety of healthcare, he was appalled at the operation of the healthcare
systems.
Patients, whether they have a clinical background or not, can provide
important safety information. Saul Weingart and his colleagues at Dana Farber
Cancer Institute in Boston (2, 3) interviewed 229 patients in hospital, who were bothwilling and able to participate, asking them three general questions:Do you believe that there were any problems with your care during this
hospitalisation?
Do you believe that you were hurt or stayed in the hospital longer thannecessary because of problems with your care?
Do you believe that anyone made a mistake that affected your care during this
hospitalisation?

From these simple five minute interviews patients identified a host of process failures
such as problems with diagnosis, medication, procedures, clinical services (such asradiology, phlebotomy and laboratory) and service quality. In a second study theteam found that patients reported many serious untoward events that were not foundin the medical record; however record review also revealed incidents and adverse
events that were not reported in patient interviews. Both record review and patientreports are necessary to obtain a reasonably complete picture of the harm fromhealthcare.
Patients’ willingness to engage in safety practices
Patients are usually thought of as the passive victims of errors and safety failures, butthere is considerable scope for them to play an active part in ensuring their care iseffective, appropriate and safe. Instead of treating patients as passive recipients ofmedical care, it is much more appropriate to view them as partners or co-producers
with an active role (4). The degree to which patients can be involved will varyconsiderably depending on the nature and complexity of the treatment and the degreeof technical knowledge required to understand the treatment process. Most
importantly it will depend on the extent to which each person feels willing and able to37

The Essentials of Patient Safety

play a more active role and whether they are encouraged in this by those who arecaring for them (5).
To encourage patients to take a more active stance some organisations haveproduced leaflets setting out what patients can do to make their own care safer. The
United States Joint Commission on Accreditation of Healthcare Organisations for
instance has campaigned for patient to ‘speak up’ to prevent errors in their care(www.jcaho.org). Encouraging patients to ask questions about their medication to
make sure they understand, not to take medication unless they are clear about its
purpose and to be responsible for their own contribution to their treatment seemreasonable and useful precautions. Much more difficult is the suggestion that patientsmight actively challenge a health professional. Patients are meant to observe whether
their identify band has been checked, tell the staff if they think they might be being
confused with another patient and remind nurses and doctors to wash their hands.
Although well intentioned this is a considerable extension of the patient’s role and,arguably, an abdication of responsibility on the part of healthcare staff.
A small number of studies have assessed patients’ willingness to speak up andotherwise check on hospital procedures. Most people are prepared to ask about thereason for a procedure, but many fewer would consider refusing care, such as aradiograph or the taking of blood that they had not been told about. Fewer still say
they would be willing to remind doctors or nurses to wash their hands and only about
5% actually did so when the opportunity presented (5, 6). However some small
studies have shown patients are much more willing to remind staff to wash their hands
when staff and patients are equally involved, in hand hygiene initiatives. Suchprogrammes need to be backed by an educational campaign, prompting aids and a
specific request to routinely remind all staff and visitors about hand washing (7).
Establishing a proper and fruitful role for patients to play in patient safety is
not straightforward and there are many issues to be resolved. There are however
already some impressive examples of patients being actively involved in the
management of a hospital, entirely changing the nature and tone of the usual patient
clinician relationships. For example by involving patients the Dana Farber Cancer
Centre in Boston learnt that patients with neutropenia (a reduction in white blood cells
occurring in many diseases) often experienced long, wearying waits in emergency
departments, seriously delaying the start of treatment. Telephone screening and direct
admission to appropriate wards transformed this process and reduced the risk ofinfections and other complications. Patients are member of several important hospitalcommittees and regarded as an essential voice in the redesign or improvement ofservices.
Safety skills
Expert clinicians, indeed experts in many fields, learn to work confidently yet safely,
by anticipating and negotiating the hazards of their work. Junior staff learn these skills
by trial and error or, if they are lucky, by observing experts recover from dangerous
situations. In healthcare, unlike many other high risk industries, these skills are
seldom explicitly identified or formally trained.
To identify the key skills and attributes of the safe, but effective, clinicians
Sonal Arora and Susy Long (8) interviewed clinical staff who identified dozens of
relevant characteristics. These were then grouped into several broad categories ofsafety skills (Table 5.1). Reviewing the preliminary list shows that clinical staff

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The Essentials of Patient Safety

Table 5.1 Some critical safety skills
Category

Individual skills

Illustrative quotes

Anticipation and• Anticipation of organisational“One thing that I do on a daily

preparedness

problems

basis, and I would like my juniors• Being able to anticipate thedeteriorating patient• Contingency planning with clearly

to do as well, is to think, what could
go wrong today? And I try to coverfor that...”defined levels of care
Awareness of oneself• Not letting your emotions interferewith patient care

“Be aware of your own abilities –when events will affect your• Learning from previous mistakes

judgements and working ability.”• Recognising one’s own limitations• Know who, when and how to callfor help appropriately
Conscientiousness• Being thorough /paying attention to“If there is an unexplained clinicaldetailHumility

Vigilance• Checking and re checking

problem – keep thinking (and• Going out of your way to help

hunting).”• Taking criticism constructively“Doesn’t have a chip on his/ her• Willingness to listen/take advice

shoulder about taking advise from• Allowing others to take overnurses and juniors”• Alertness/ being ‘on the ball’“Through knowledge and• Pattern recognition and vigilanceexperience comes vigilance for any

for deviation from patterns

deviation from an expected course• Regularly re-reviewing thesituation

39

of events.”

The Essentials of Patient Safety

are very conscious of the importance of these attitudes, behaviours and skills. Noteespecially that people identified a large number of character traits such as humility,
honesty and conscientiousness; we perhaps cannot train these attributes, but we cancertainly foster them in the wider culture and ethos of the organisation. Some of theskills however are more tangible and we will briefly highlight two key attributes:
anticipation and vigilance.
Anticipation and vigilance
Anticipation is a key component of expertise in many areas. Essentially it involves
thinking ahead and envisioning possible problems and hazards. If you drive a car inheavy rain you need to constantly think about what might happen. Suppose the types
don’t grip? Suppose the car in front brakes suddenly? Thinking in this way is
explicitly taught in advanced driving courses as a necessary foundation for safe yet
confident driving.
Experts are constantly thinking ahead and looking to the future. For instance,
Cynthia Dominguez showed surgeons a video of an operation involving an 80 year
old woman with an infected gallbladder that needed to be removed. She used thevideo as a prompt to ask the surgeons how they prepared for such an operation andwhat they would be thinking at each stage. She found that experienced surgeons mademore predictions about likely problems than their junior colleagues. In particular they
predicted that they would have difficulty in dissecting and identifying the surrounding
structures, because the gallbladder and surrounding areas would be swollen andinflamed (9). With these predictions in mind they were therefore mentally prepared
for the hazards that lay ahead.
Anaesthesia is ideally a routine procedure but a life threatening emergency canoccur at any time; anaesthetists are trained in numerous emergency routines and inmaintaining a constant awareness of what might happen. Experienced anaesthetists
ensure that they have a supply of equipment for emergencies and drugs that will, forinstance, will correct a rapidly falling heart rate. This kind of preparation sounds
obvious and, in a sense it is, but it is difficult to constantly maintain this kind of`emergency awareness’ day after day especially if few emergencies actually occur.
Paradoxically, the safer a unit is the harder it is to believe that disaster may strike at
any time.
Maintaining such safety awareness means anticipating the disease but also thevagaries of the organisation and the possibility that others may not check asassiduously as you would wish. My colleague Ros Jacklin expresses this clearly in an
example that spans all the stages of situation awareness:‘I feel that one of the keys to being a safe practitioner comes down to vigilance- looking for problems before they happen, when they still are in the brewing
stage. For instance, if you are on call, find out who has been operated on thatday, and have a brief look at them before you go to bed, whether or notanyone specifically asks you to. If the patient looks dry, you might check that
there's nothing to suggest bleeding, and increase their fluids a little overnight.
Otherwise, no one notices that they are dry until their urine output has
dropped. If that were to happen, you can probably easily rectify the patient's
fluid status with IV fluids at this stage, but if for any reason there is a delay,
the patient may find themselves in established renal failure’ (Jacklin personalcommunication).

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The Essentials of Patient Safety

Teams create safety
Healthcare is delivered by teams of people rather than by individuals. Even when apatient has a particular relationship with their family doctor, surgeon or nurse, that
person is supported by a network of people who are essential for the delivery of safe,
effective care. Teams, like individuals, may erode or create safety. A team that isworking poorly multiplies the possibility of error. Conversely teams, when working
well, have the possibility of being safer than any one individual. A team can create
additional defences against error, by monitoring, double checking and backing eachother up; when one is struggling, another assists; when one makes an error, anotherpicks it up.
If you work in a team, as we almost all do, you may not think much about how
it functions and what factors make a team work well. Some days, everything justseems to go smoothly and it’s a joy to work with your colleagues. On another day theteam is fragmented, every communication seems to be misunderstood, the work takes
twice as long as usual and you go home stressed and exhausted. It’s easy to blame
others for being difficult or obstructive, which people sometimes are. However, in
healthcare, if we look a little deeper we see that there is a fundamental underlying
problem; teams are not designed, teamwork processes are not specified and the wholesystem relies on goodwill and the native resilience and adaptability of healthcare staff.
Team interventions: briefing, checklisting and daily goals
Watching teams and teamwork quickly reveals that a group of well intentioned
individuals does not make a team and further, that teamwork has to be planned andorganised. In some studies of urology and general surgery up to a third of standard
team tasks of standard communication and the checking of equipment were notcompleted (10, 11). Improving team training is one possible response to suchproblems. However there are other, simpler, approaches which turn out to have quite
profound effects.
Clarity and communication: the adoption of daily goals
Recall the case of David James who died from a spinal injection of vincristine. Oneof the features of this case was that almost everyone involved made assumptions
about the knowledge and abilities of those around them. We assume, by default, that
other people have the same understanding of a situation as we do and, even worse,that we have correctly communicated our intentions and wishes. Many instructions
for patient care are given rapidly, in a hurry, often in a kind of clinical shorthand andwith many assumptions about the kind of basic care that will be provided. In a fixed
team that works together day in and day out, this generally works pretty well.
However few teams, especially ward teams, are like that; it’s a shifting population ofpeople on a variety of shift patterns, supported to varying degrees by temporary staff.
Peter Pronovost (12) posed two simple but critical questions to intensive caredoctors and nurses after the daily rounds: (1) How well do you understand the goalsof care for this patient today? And (2) How well do you understand what work needs
to be accomplished to get this patient to the next level of care? These questions seem
unnecessary, almost insulting. These people are caring for very sick patients; surely
they know what they are meant to be doing? A formal survey revealed however that
only 10% of nurses and doctors surveyed understood the goals of care for specificpatients.

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The Essentials of Patient Safety

Following some interviews and exploration the team introduced a daily goals
sheet that asked staff to state the tasks to be completed, care plan and communication
with patients and families. The daily goals sheet first forces explicit objectives to be
stipulated for each patient, which can be reviewed and monitored. Second, it ensuresthat everyone works from the same set of assumptions and to the same plan.
Box 5.2 Daily goals in intensive care
Room No

Date
Initial as goals are reviewed
07.00 – 15.00 15.00-23.00 23.00- 07.00

What needs to be done for the patient
to be discharged from the ICU?
What is the patient’s greatest safety
risk? How can we reduce that risk?
Pain management/sedation
Cardiac volume status
Pulmonary/ventilator (PP, elevate
HOB)
MobilisationID, cultures, drug levels
GI/Nutrition
Medication changes (can any bediscontinued?)
Tests/procedures
Review scheduled labs; morning labs
& CXR
Consultations
Communication with primary service
Family communication
Can catheters/tubes be removed?
Is this patient receiving DVT/PUD
prophylaxis
Mgt. management; PP, plateau pressure; HOB, head of bed; ID, infectious disease;GI, gastrointestinal; labs, laboratory tests; CXR, chest radiograph; DVT, deep veinthrombosis; PUD, peptic ulcer disease

The impact of this simple intervention was remarkable. Within eight weeks
the proportion of nurses and doctors who clearly understood the daily goals for thepatient increased from 10% to 95%. Staff found the short term goals sheet to be asimple tool for setting priorities and guiding the daily work of the team. Nurses now
felt that they were an active part of the team working in partnership with physicians.
Remarkably, following the introduction of the daily goals sheet, length of stay
reduced from 2.2 days to 1.1 days allowing an additional 670 patients each year toreceive intensive care, though the authors are cautious about attributing this changesolely to the goals sheet.

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The Essentials of Patient Safety

Briefing and checklisting in surgery
A number of studies have now been carried out which demonstrate the value ofchecklisting and briefing which, although sometimes described separately, in practiceusually occur together. The most influential study of surgical checklists has
undoubtedly been that led by Atul Gawande as part of the World Health Organisation(WHO) World Alliance for Patient Safety ‘Safe Surgery Saves Lives’ campaign (13).
The WHO surgical safety checklist ensures that the entire operating theatre
team understands the patient, the surgical procedure the equipment needed and that
evidence based interventions such as antibiotic prophylaxis or deep vein thrombosis
prophylaxis are reliably given. The 19 item checklist is completed in three stages—
before induction of anaesthesia (sign in), just before skin incision (time out), andbefore the patient leaves the operating theatre (sign out). Items on the checklist must
be verbally confirmed with the patient and other team members (14). The WHO Safe
Surgery Saves Lives Study Group introduced the checklist in eight countries
worldwide studying 3733 patients before and 3955 patients after the implementationof the checklist. After implementation, deaths were reduced from 1.5% to 0.8% andin-hospital complications by from 11% to 7.0%. In some sites the checklist prompted
the introduction of techniques that are now standard in developed countries; forinstance use of a pulse oximeter rose from 60% to over 90% in one study site over thecourse of the study.
Briefings and checklists are however not a panacea. According to how they
are used, can be either a positive or negative influence on team performance. A
surgeon, for instance, can ostensibly take part in the briefing but express theirsuperiority and detachment by not really listening and carrying out other tasks at thesame time. A checklist can be read out by a nurse in a clipped and dismissive way
which closes down all possibility of discussion within the team.
These two interventions are important examples of how teamwork and patientcare can be improved with relatively simple measures, though persuading clinicians to
use them and actually implement them may of course be monumentally difficult.
Daily goals, pre-operative and post-operative checklists seem mundane, and thispartly accounts for clinicians’ resistance to their use. However, a checklist is not apiece of paper or even a list; it is a team intervention which, used well, can affect thewider team functioning, the relationships across professions and hierarchies and eventhe values and safety culture of the team.
These interventions just touch on some aspects of teamwork and it isimportant not to think that safety just means using more checklists. The real impact ofthese approaches is to bring a shared understanding, to specify team leadership in
particular situations, to anticipate problems. These wider endeavours require a moresophisticated understanding of teamwork than we have at the moment and need to befostered in new types of training involving groups of healthcare professionals in novel
simulations and other environments.

43

Figure 5.1 Surgical Safety Checklist (from WHO, 2009) Reproduced with permission by WHO, World Health Organization 2009,WHO
Surgical Safety Checklist.

The Essentials of Patient Safety

KEY POINTS
Patients and families can provide critical safety information and play a part inmonitoring the safety of their own care
Expert clinicians learn to work confidently yet safely, by anticipating and negotiating
the hazards of both the disease and the organisation.
A team that is working poorly multiplies the possibility of error. Teams that work
well are safer than any one individual.
Explicit daily plans and goals can enormously increase reliability of care providing topatients
Using briefing and checklists in the operating theatre reduces surgical complications
and improves team performance

References
1.
Berwick DM. Escape Fire. Designs for the future of healthcare. San
Francisco: Jossey Bass; 2003.
2.
Weingart SS. What Can Hospitalized Patients Tell Us About Adverse Events?
Learning from Patient-Reported Incidents. Journal of General Internal Medicine,
2005;20(9):830.
3.
Weissman JS, Schneider EC, Weingart SN, Epstein AM, David-Kasdan J,
Feibelmann S, et al. Comparing Patient-Reported Hospital Adverse Events with
Medical Record Review: Do Patients Know Something That Hospitals Do Not?
Annals of Internal Medicine, 2008;149(2):100-8.
4.
Coulter A, Ellins J. Effectiveness of strategies for informing, educating, andinvolving patients. British Medical Journal, 2007;335(7609):24-7.
5.
Davis RE, Koutantji M, Vincent CA. How willing are patients to question
healthcare staff on issues related to the quality and safety of their healthcare? An
exploratory study. Quality and Safety in Health Care, 2008;17(2):90-6.
6.
Waterman AD, Gallagher TH, Garbutt J, Waterman BM, Fraser V, Burroughs
TE. Brief report: Hospitalized patients' attitudes about and participation in error
prevention. Journal General Internal Medicine, 2006;21(4):367-70.
7.
McGuckin M, Taylor A, Martin V, Porten L, Salcido R. Evaluation of apatient education model for increasing hand hygiene compliance in an inpatient
rehabilitation unit. American Journal Infection Control, 2004;32(4):235-8.
8.
Long S, Arora S, Moorthy K, Sevdalis N, Vincent C. Qualities and attributesof a safe practitioner: identification of safety skills in healthcare. BMJ Quality &Safety, 2011 (6):483-90.
9.
Dominguez C, Flach JM, McDermott PC, McKellar DM, Dunn M. The
conversion decision in laparoscopic surgery: Knowing your limits and limiting yourrisks. In: Smith K, Shanteau J, Johnson P, editors. Psychological investigations ofcompetence in decision making. Cambridge: Cambridge University Press; 2004. p. 739.
34

The Essentials of Patient Safety

10.
Undre S, Sevdalis N, Healey AN, Darzi A, Vincent CA. Observational
teamwork assessment for surgery (OTAS): refinement and application in urologicalsurgery. World Journal of Surgery. 2007;31(7):1373-81.
11.
Undre S, Sevdalis N, Healey AN, Darzi SA, Vincent CA. Teamwork in theoperating theatre: cohesion or confusion? Journal Evaluation in Clinical Practice,
2006;12(2):182-9.
12.
Pronovost P, Berenholtz S, Dorman T, Lipsett PA, Simmonds T, Haraden C.
Improving communication in the ICU using daily goals. Journal of Critical Care,
2003;18(2):71-5.
13.
Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, etal. A surgical safety checklist to reduce morbidity and mortality in a global
population. New England Journal of Medicine, 2009;360(5):491-9.
14.
Soar J, Peyton J, Leonard M, Pullyblank AM. Surgical safety checklists.
British Medical Journal, 2009;338(jan21_1):b220.

35

The Essentials of Patient Safety

CHAPTER 6
The Aftermath

Many patients experience errors during their treatment, whether they realise it or not, andsome are harmed by healthcare. The harm may be minor, involving only inconvenienceor discomfort, but can involve serious disability or death. Almost all bad outcomes will
have some psychological consequences for both patients and staff, ranging from minor
worry and distress through to depression and even despair. The experiences of thesepeople tend not to be fully appreciated, and yet understanding the impact of suchinjuries is a prerequisite of providing useful and effective help.
Injury from medical treatment is different from other injuries
Patients and relatives may suffer in two distinct ways from a medical induced injury.
First from the injury itself and secondly from the way the incident is handled afterwards.
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 theimpact both in the short and long term. Injured patients need an explanation, an apology,
to know that changes have been made to prevent future incidents, and often also needpractical and financial help (1). The problems arise when ordinary impulses to help areblunted by anxiety, shame or just not knowing what to say.
The emotional impact is particularly complex because a medical injury differsfrom most other accidents in some important respects. First, patients have been harmed,
unintentionally, by people in whom they placed considerable trust, and so their reaction
may be especially powerful and hard to cope with. Imagine the complex of emotions
you might experience if you were accidentally injured by a member of your own family.
Secondly they are often cared for by the same professions, and perhaps the same people,
as those involved in the original injury. As they may have been very frightened by what
has happened to them, and have a range of conflicting feelings about those involved.
This too can be very difficult, even when staff are sympathetic and supportive.
The full impact of some incidents only becomes apparent in the longer term. A
perforated bowel, for example, may require a series of further operations and time in
hospital. As with all injuries the effects and associated problems can multiply over time,
especially if recovery is only partial. Chronic pain for instance will affect a person’s
mood, ability to care for their children ability to work, their family and social
relationships and their sexual relationship.
As relationships deteriorate, the person may become more isolated, less engaged
and consequently more prone to depression; this in turn makes work, family life andchildcare more difficult (2). The whole scenario may be compounded by the financial
problems induced by not being able to work, and the anxiety about the future that thiscauses. Most of this is unseen by the healthcare organisation which caused the injury in
the first place (3).

36The Essentials of Patient Safety

Box 6.1 Perforation of the colon leading to chronic pain and depression
A woman underwent a ventrosuspension – the fixation of a displaced uterus to theabdominal wall. After the operation she awoke with a terrible pain in her lower
abdomen which became steadily worse over the next 4 days. She was very frightened
and repeatedly told both doctors and nurses but they dismissed it as ‘wind’.
On the fifth day the pain reached a crescendo and she felt a ‘ripping sensation’inside her abdomen. That evening the wound opened and the contents of her bowel
began to seep through the dressings. Even then, no one seemed concerned. Finally,
the surgeon realised that the bowel had been perforated and a temporary colostomy
was carried out.
The next operation, to reverse the colostomy, was ‘another fiasco’. After a few
days there was a discharge of faecal matter from the scar, the wound became infected,
and the pain was excruciating, especially after eating. She persistently asked if she
could be fed with a drip but the nursing staff insisted she should keep eating. For 2
weeks she was ‘crying with the pain, really panicking – I just couldn’t take it any
more’. She was finally transferred to another hospital where she was immediately put
on a liquid diet.
A final operation to repair the bowel was successful but left her exhausted anddepressed. She only began to recover her strength after a year of convalescence. Three
years later she was still constantly tired, irritable, low in spirits and ‘I don’t enjoy
anything anymore’. She no longer welcomes affection or comfort and feels that she isgoing downhill, becoming more gloomy and preoccupied.
Her scars are still uncomfortable and painful at the time of her periods. Her
stomach is ‘deformed’ and she feels much less confident and attractive as a result. As
her depression has deepened, she has become less interested in sex and more selfconscious about the scar. Three years later the trauma of her time in hospital is still
very much alive. She still has nightmares about her time in hospital and is unable totalk about it without breaking into tears. She feels very angry and bitter that no one
has ever apologised to her or admitted that a mistake has been made.
Adapted from Vincent (2001)

When a patient dies the trauma is obviously more severe still, and may beparticularly severe after a potentially avoidable death. Relatives of patients whose death
was sudden or unexpected may therefore find the loss particularly difficult to bear. If theloss was avoidable in the sense that poor treatment played a part in the death, theirrelatives may face an unusually traumatic and prolonged bereavement. They may
ruminate endlessly on the death and find it hard to deal with the loss.

What do injured patients need?
Imagine that you or your husband, mother or child has, inexplicably, suffers a medical
injury. What would you want? Well, I imagine you would want to know what
happened, you would want an apology, you would want to be looked after and, later on,
you might want steps to be taken to prevent such things happening again to anyone else.
If the injury led to you being off work or unable to care for your children, you would
37

The Essentials of Patient Safety

certainly appreciate some financial support to help you during the recovery period. If theperson concerned was not going to recover, then long term support would be needed. In
a study of the reasons for litigation my colleagues and I found exactly this. Injured
patients wanted:An explanation
An apology
For action to be taken to prevent similar injuries
Compensation, in some cases only

Most wanted the clinicians concerned to realise what they were experiencing; feeling
ignored or not heard was a particularly painful and intensely frustrating experience
which potentially delayed recovery and adjustment (1). As one patient said to me ‘If
only I had been told honestly I could have faced it so much better’.
Every injured patient has their own particular problems and needs. Some will
require a great deal of professional help, while others will prefer to rely on family andfriends. Some will primarily require remedial medical treatment, while in others thepsychological effects will be to the fore. In the short term, the two most importantprinciples are to believe the patient and to be as honest and open as possible whichmeans that the error or harm must be disclosed to the patient and their family.
Breaking the news about error and harm
The ethics of open disclosure of errors are crystal clear and expressed in a many clinicalcodes of ethics. Here is an example from the American Medical Association:‘Patients have a right to know their past and present medical status and to be
free of any mistaken beliefs concerning their conditions. Situations
occasionally occur in which a patient suffers significant medical
complications that may have resulted from the physician’s mistake or
judgement. In these situation the physician is ethically required to inform thepatient of the all the facts necessary to ensure understanding of what has
occurred’ (AMA 1999 www.ama.org)
When something has gone wrong, healthcare staff should take the initiative to seekout the patient and/or family and face the situation openly and honestly. Most patients,
whether or not they have experienced an error, are strongly of the view that they wanted
to be told about all harmful errors, and to know what happened, how it happened, how it
would be mitigated and what will be done to prevent recurrence (4). Avoiding ordelaying such a meeting unnecessarily will only suggest there is something to hide. A
senior member of staff needs to give a thorough and clear account of what exactly
happened. At the first interview, junior staff involved with the patient may also bepresent. The patient and their relatives need to have time to reflect on what was said andto be able to return and ask further questions. Remember that people may be numb withshock after an incident and be unable to cope with very much information. Several
meetings may be needed over the course of weeks or months. Telling patients or theirfamilies about disappointing results and dealing with their reactions is not easy.
Nevertheless, if done with care and compassion, such communication maintains trust
between the people involved and can greatly help the patient’s adjustment to what has
happened.
38

The Essentials of Patient Safety

Box 6.2 Communication after an error or adverse outcome










Give bad news in a private place where the patient and/or family may reactand you can respond appropriately.
Clearly deliver the message. The adverse outcome must be understood. ‘I’m
sorry to report that the procedure resulted in ….
Wait silently for a reaction. Give the patient/family time to consider what has
happened and formulate their questions.
Acknowledge and accept the initial reaction. The usual reaction to bad news is
a mixture of denial, anger, resignation and shock. Listen.
Resist the urge to blame or appear to blame other health professionals for theoutcome
Discuss transition support. Tell the patient/family what steps will be taken toprovide medical, social, or other forms of support.
Finish by reassuring them about your continued willingness to answer any
questions they might have. Discuss next steps.
Consider scheduling a follow-up meeting. Some patients will want to talk only
after the crisis has subsided
Afterwards, document a summary of the discussion. Ideally share this with thepatient and family

Adapted from Pichert, Hickson, Pinto, Vincent (2011)

In the longer term
When serious harm has been done, acknowledging and discussing the incident is justthe first stage. The longer term needs of patients, families and staff need to beconsidered.
A common theme in interviews with injured patients is that none of theprofessionals involved in their care appreciated the depth of their distress. I can recall
several patients left in severe pain who were deeply depressed and at times suicidal;
although great efforts were being made to deal with their physical problems, no one hadthought to ask about their mental state. Risk managers, clinicians and others involved
with these patients can ask basic questions without fear of ‘making things worse’. Someof the most crucial areas of enquiry are feelings of depression, anxiety, anger,
humiliation, betrayal and loss of trust - all frequently experienced by injured patients.
Injured patients may receive support, comfort and practical help from manysources. It may come from their spouse, family, friends, colleagues, doctors orcommunity organisations. An especially important source of support will be the doctors,
nurses and other health professionals who are involved in their treatment. It is vital that
staff continue to provide the same care and do not withdraw from the patient throughguilt or embarrassment. Many patients have derived comfort from the empathy andsadness of staff involved in tragic incidents describing, for instance, the warmth andsupport they found in the staff’s own sadness at the event.
39

The Essentials of Patient Safety

Supporting staff after serious incidents
Human beings make frequent errors and misjudgements in every sphere of activity, butsome environments are less forgiving of error than others. Errors in academia, law orarchitecture, for instance, can mostly be remedied with an apology or a cheque. Those in
medicine, in the air, or on an oil rig may have severe or even catastrophic consequences.
This is not to say that the errors of doctors, nurses or pilots are more reprehensible, onlythat they bear a greater burden because their errors have greater consequences. Making
an error, particularly if a patient is harmed because of it, may therefore have profoundconsequences for the staff involved, particularly if they are seen, rightly or wrongly, as
primarily responsible for the outcome. The typical reaction has been well expressed byAlbert Wu in his aptly titled paper ‘the second victim’.
‘Virtually every clinician knows the sickening feeling of making a bad mistake.
You feel singled out and exposed - seized by the instinct to see if anyone has
noticed. You agonize about what to do, whether to tell anyone, what to say.
Later, the event replays itself in your mind. You question your competence but
fear being discovered. You know you should confess, but dread the prospect ofpotential punishment and of the patient’s anger’ (5).
Junior doctors single out making mistakes, together with dealing with death and dying,
relationships with senior doctors and overwork, as the most stressful events they have todeal with (6). Medical students anticipate the mistakes they will make as doctors even
before entering medical school:‘I think one of the scariest things about becoming a doctor is realising how much
responsibility you have and that human error happens all the time. I thought
about it even before I decided that I definitely wanted to go to medical school’(7).
In a series of in depth interviews with senior doctors Christensen and colleagues (8)discussed a variety of serious mistakes, including four deaths. All the doctors wereaffected to some degree, but four clinicians described intense agony or anguish as thereality of the mistake had sunk in. The interviews identified a number of general themes:
the frequency of mistakes in clinical practice; the infrequency of self-disclosure about
mistakes to colleagues, friends and family; and the emotional impact on the physician,such that some mistakes were remembered in great detail even after several years. Afterthe initial shock the clinicians had a variety of reactions that had lasted from several days
to several months. Some of the feelings of fear, guilt, anger, embarrassment andhumiliation were unresolved at the time of the interview, even a year after the mistake.
Strategies for coping with error, harm and their aftermath
Many of the doctors interviewed in these various studies study had not discussed themistakes or their emotional impact with colleagues. Shame, fear of humiliation, fear ofpunishment all acted to deter open discussion and isolate people from their colleagues.
Hopefully, as patient safety evolves, healthcare staff will be able to be more open about
error and more open about their need for support when errors do occur. While there islittle formal guidance, and almost no research on this topic, the following suggestions
may be useful.

40

The Essentials of Patient Safety

Acknowledge error. The potential for error in medicine, as in other activities,
needs to be recognized and openly acknowledged. Education about the ubiquityof error, its causes and likely consequences, would promote a more realistic
attitude and constructive approach.

Openness about error. Open discussion of error, particularly by respected senior
figures, is very powerful because it provides a mandate for such discussions tooccur at other times. In effect, the junior nurse or doctor learns that it isacceptable to discuss errors openly because their seniors do it.

Open disclosure. An agreed policy on openness is a critical for staff as forpatients. Many staff are still torn between their own desire for a more open
stance and the more cautious approach that they perceive to be demanded, rightly
or wrongly by managers and colleagues.

Training in disclosure. Training in disclosing and explaining error is critical.
Facing a patient harmed by treatment, or their naturally distressed and angry
relatives, is a particularly difficult clinical situation for which little guidance ortraining is available. Both patients and staff will benefit if clinical staff havesome training in helping dissatisfied, distressed, or injured patients and theirrelatives.



Formal and informal support. Understanding and acceptance from colleagues isalways important but sometimes people need more than general support andexpressions of confidence. The range of potential support extends from a quiet
word in a corridor to the offer of extended psychotherapy. Sometimes a private
discussion with a colleague or a senior figure will be sufficient; some hospitals
employ recently retired senior doctors as mentors.

Few organisations however have put staff support service into practice in an organised
and effective way or fully understood the need for such a service. Brigham and
Women’s Hospital in Boston is an exception, the home of a remarkable experiment inboth patient and staff support that has its origins in a near disaster in 1999 in which
Linda Kenney, the founder of Medically Induced Trauma Support Services, experienced
a grand mal seizure during an operation. Linda Kenney and Frederick van Pelt, theanaesthetist involved, began in parallel to establish support services for patients and apeer support programme for clinical staff. The staff support programme aims torecruit credible, experienced clinical staff with personal understanding of the impactof error who are immediately available to provide confidential reflection and support.
In addition to an active commitment to disclosure and apology, Brigham and
Women’s Hospital has started to develop an Early Support Activation (ESA) withMITSS for patients and families in conjunction with the hospital’s departments ofsocial services and patient relations. The long-term strategy is to have acomprehensive emotional support response for patients, families and care providers
(9).

41

The Essentials of Patient Safety

KEY POINTS
Injured patients have been harmed by people they trusted so their reactions can beespecially intense
Injured patients may suffer a second trauma if the incident is badly handled
Providing an explanation, apology, financial and other support and acting to prevent
recurrence are critical to maintaining trust
Making an errors that harms a patient is one of the most stressful experiences in aclinical career
Open disclosure and support are critical for patients, families and staff

References
1.
Vincent C, Young M, Phillips A. Why do people sue doctors? A study ofpatients and relatives taking legal action. Lancet, 1994;343(8913):1609-13.
2.
Vincent CA, Pincus T, Scurr JH. Patients' experience of surgical accidents.
Quality in Health Care, 1993;2(2):77-82.
3.
Duclos CW, Eichler M, Taylor L, Quintela J, Main DS, Pace W, et al. Patientperspectives of patient-provider communication after adverse events. International
Journal for Quality in Health Care, 2005;17(6):479-86.
4.
Gallagher TH, Studdert D, Levinson W. Disclosing Harmful Medical Errors toPatients. New England Journal of Medicine, 2007;356(26):2713-9.
5.
Wu A. Medical error: the second victim. British Medical Journal,
2000;320(7237):726-7.
6.
Firth-Cozens J. Emotional distress in junior house officers. British Medical
Journal, 1987;295(6597):533-6.
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Fischer MA, Mazor KM, Baril J, Alper E, DeMarco D, Pugnaire M. Learningfrom mistakes. Factors that influence how students and residents learn from medical
errors. Journal General Internal Medicine, 2006;21(5):419-23.
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Christensen JF, Levinson W, Dunn PM. The heart of darkness: the impact ofperceived mistakes on physicians. Journal of General Internal Medicine,
1992;7(4):424-31.
9.
van Pelt F. Peer support: healthcare professionals supporting each other after
adverse medical events. Quality and Safety in Health Care, 2008;17(4):249-52.

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