Clinical risk management for anaesthetists
Astri MV Luoma MBChB FRCA
Sally R Wilson MBChB FRCA FFICM
Key points
Clinical errors are common.
Anaesthetists work in
environments where the
potential for serious harm is
high.
Clinical risk management is a
systematic process for
reducing and managing harm
to patients.
Astri MV Luoma MBChB FRCA
Consultant Neuroanaesthesia
National Hospital for Neurology and
Neurosurgery
Queen Square
London WC1N 3BG
UK
Sally R Wilson MBChB FRCA FFICM
Consultant Neuroanaesthesia and
Neurocritical Care
National Hospital for Neurology and
Neurosurgery
PO Box 56
Queen Square
London WC1N 3BG
UK
E-mail: sally.wilson@uclh.nhs.uk
(for correspondence)
14
Background
Clinical errors are common. They occur in at
least 10% of hospital admissions1 and result in
patients suffering through injury and worry.
Clinical errors prolong hospital stay, increase
costs, and lead to loss of confidence in the or-
ganization. For many cases, this will result in
complaints and litigation, particularly if the situ-
ation is not managed well. In the UK, there are
around 900 000 incidents or near misses every
year and 2000 patient deaths as a result.2
Causes include human error, poor organization,
lack of clear patient management plans, and
inadequate communication between clinical
teams. Medical errors have been highlighted
throughout history as a cause of harm to patients,
but came to prominence in 1999 after the
publication of To err is human: building a safer
health system by the US Institute for Medicine.
This was followed by the Department of
Health’s publication An Organisation with
Memory in 2000. Since then numerous systems
have been developed to minimize harm to
patients and improve the quality of care.
The 2010 publication by the Department of
Health, Equity and Excellence: Liberating the
NHS, highlights the need to focus on outcomes
and quality standards, not targets. The recent report
by Professor Berwick (https://www.gov.uk/
government/uploads/system/uploads/attachment_
data/file/226703/Berwick_Report.pdf ) and the
Francis Inquiry (http://www.midstaffspublic
inquiry.com/report) made numerous recommen-
dations focusing on providing high-quality care
to patients, in particular continuous learning
from errors, making patient safety and quality of
care a top priority, and the importance of patient
and public involvement. This will require a
variety of institutional and cultural changes,
including a contemporary audit process with
review of outcomes, engaging staff in the com-
plaints process, and also a high standard of
professional training. All these are integral to risk
management (https://www.gov.uk/government/
uploads/system/uploads/attachment_data/file/
doi:10.1093/bjaceaccp/mku003
Continuing Education in Anaesthesia, Critical Care & Pain | Volume 15 Number 1 2015
& The Author [2014]. Published by Oxford University Press on behalf of the British Journal of Anaesthesia.
All rights reserved. For Permissions, please email: journals.permissions@oup.com
Matrix reference 1I03, 3JOO
226703/Berwick_Report.pdf, http://www.midstaffs
publicinquiry.com/report).
A clinical error can be defined as a clinical
incident that has deviated from the intended
treatment, intervention, or diagnostic plan, which
may or may not result in an untoward outcome
(http://www.clinical-governance-toolbox.com/
risk-management). Clinical risk is the potential
for the error to occur and this requires both an
active error and contemporaneous conditions
that allow it to occur. Although risks are im-
possible to eliminate completely, they can be
reduced by minimizing error and improving
latent conditions (e.g. equipment). Clinical risk
management (CRM) provides a multidisciplin-
ary team system to identify, record, analyse, and
monitor clinical incidents, and reduce harm to
patients. Although serious incidents are rare in
anaesthesia and the theatre environment, both
areas have a relatively high risk of clinical
errors. A recent Quality and Safety update by the
Royal College of Anaesthetists reported 4057
anaesthesia-related incidents over 3 months, of
which 68.5% were near misses and 7.9% resulted
in moderate-to-severe harm or death (http://www.
rcoa.ac.uk/document-store/patient-safety-update-
october-december-2012). CRM therefore forms a
key aspect for anaesthetists in improving patient
safety and quality of care.
Risk management is the systematic process by
which NHS boards are responsible for the manage-
ment and monitoring of risk within their organiza-
tion. These range from corporate to personal risk.
Risk management is covered by a wide range of
legislation and is a key component of Clinical
Governance. The process aims to identify risk and
to reduce incidence of injury, faults, errors, acci-
dents, and improve overall quality of patient care
(http://www.clinical-governance-toolbox.com/
risk-management, http://www.clinicalgovernance.
scot.nhs.uk/section3/riskmanaged.asp).
This article will review CRM in anaesthesia.
The definitions have been described in a previ-
ous article published in this journal and will not
be covered here.3
Advance Access publication 11 March, 2014

Analysing and identifying areas of risk
in healthcare
The Chief Executive of any NHS trust has overall statutory and oper-
ational responsibility for risk management, although a board
member is usually allocated to directly oversee health and safety
risk management. This includes identifying areas of risk, and also
organizing effective management strategies and policies. Trusts are
exposed to risk due to harm to patients, visitors, and staff, and also
through corporate strategy and policy affecting the organization.
Risk may be clinical, ethical, financial, or related to strategy. Every
trust must have effective risk management policies in place and a
register of potential risks.
Before developing a risk management strategy, it is important to
identify what can and may go wrong. To facilitate this, data are col-
lected through a number of systems including reports of incidents
and near misses, clinical audit, patient feedback, and the complaints
process.
Improving healthcare outcomes and patient safety is a key
element of NHS strategy and was highlighted in the publication
Equity and Excellence: Liberating the NHS (July 2010), and NHS
trusts are accountable for providing clinically credible and evidence-
based patient care.
Organizational risk in the NHS
To ensure that standards are met, a variety of national organizations
exist to review patient care across trusts, identify areas of potential
poor performance, and provide guidance to the trust to minimize
risk.
Care Quality Commission
The Care Quality Commission (CQC) (www.cqc.org.uk) is the inde-
pendent regulator of all healthcare and social services for England
and has been in existence since April 2009. The aim of the CQC is
to ensure that national standards on quality and safety are met. The
CQC publishes reports on NHS trusts and social services based on
inspections, incident reports, and direct online reporting of concerns
by the public or staff. Visits by the CQC are often unannounced and
will always result in a report containing guidance on areas for im-
provement. The organization must ensure that these are implemented
and the CQC can also issue fines and suspend services in failing
organizations.
Monitor
Monitor (www.monitor-nhsft.gov.uk) is responsible for assessing
NHS trusts for foundation trust status, and also ensuring that founda-
tion trusts have sound finances and are providing high-quality care
for patients.
Commissioning for quality and innovation
Commissioning for quality and innovation (CQUIN) was introduced
in the 2009/2010 financial year and provides a payment framework
Continuing Education in Anaesthesia, Critical Care & Pain j Volume 15 Number 1 2015
Clinical risk management for anaesthetists
that rewards excellence in the NHS. The income of trusts is linked
to achieving local quality improvement goals where a ‘bonus’ is
paid for reaching a target such as reducing the risk of venous
thrombo-embolism through risk assessment and appropriate pre-
scribing, or improving intraoperative fluid management by using
cardiac output monitoring for appropriate surgical patients. The
overall aim is to improve patient outcomes and experience through a
local culture of innovation.
NHS Operating Framework
The NHS Operating Framework aims to encourage NHS trusts to
provide a patient-centred service that focuses on improving quality
and outcomes while maintaining financial stability. It publishes
business and planning arrangements for each financial year to ensure
that a high-quality service and value-for-money service is being
delivered. National priorities, such as reducing healthcare-associated
infections and improving patient experience, are set along with the
steps that must be taken over the financial year to ensure that the
targets identified are achieved.
Individual risk to patients, visitors, and staff
Clinical risk is not only the responsibility of the employer, but of
everybody working in healthcare. It is therefore essential that all
staff understand their role in the process of identifying and monitor-
ing current or potential areas of risk. There are a variety of methods
for collecting information about risk, including clinical incident
reports, patient feedback, complaints, and clinical audit. These may
be available at a local or national level.
Clinical audit
Although Florence Nightingale and Ernest Codman were pioneers of
clinical audit, it did not become integrated into professional clinical
practice in the NHS until the publication of the 1989 white paper
Working for patients. Clinical audit is a quality improvement
process in which a clinical system is evaluated against a recognized
standard to drive continuous improvement in quality and identify
areas of increased risk. Guidelines or standards are now developed
for most areas of healthcare and regular clinical audit against them
identifies the changes needed to improve care. Once these changes
are introduced, the system is re-audited, thus closing the audit cycle.
Clinical audit may also be initiated as a result of a critical incident or
feedback from patients, their relatives, or both.
Owing to the high-risk nature of both surgery and anaesthesia,
various national clinical audits have been established to analyse the
risks and benefits of treatment, encourage evidence-based care, iden-
tify areas of high risk, and improve the quality of care.
National Audit Projects (NAP)
The National Audit Projects (http://www.nationalauditprojects.org.
uk) were initially developed by the professional standards depart-
ment at the Royal College of Anaesthetists and are now run from the
15
Clinical risk management for anaesthetists
Health Services Research Centre. To date, four audits have been
published and data collection is in progress for a fifth. All anaesthetic
departments in the UK are encouraged to participate. The aim is to
quantify areas with significant morbidity and mortality in anaesthesia,
such as airway management or neuraxial block. The projects will
provide further information and recommendations to reduce risk to
patients.
Centre for Maternal and Child Enquiries
The Centre for Maternal and Child Enquiries (CMACE) organizes
the triennial national audit into maternal deaths (http://www.hqip.
org.uk/cmace-reports/). This began in 1952 and is the world’s
longest running audit. The most recent, Saving Mothers Lives, was
published in 2011. CMACE provides recommendations and guide-
lines for the multidisciplinary obstetric team and identifies risk
factors for maternal morbidity and mortality.
Other
Other national audit projects include the Intensive Care National
Audit and Research Centre and the Trauma and Audit Research
Network.
Incident reporting
Reporting of harm or near-incidents involving patients, staff, and
visitors may occur at local or national level. Some incidents, such as
Never Events (see below), must be reported to a national regulator,
either the National Reporting and Learning System (NRLS) (http://
www.nrls.npsa.nhs.uk/), a national database of patient safety inci-
dents, or the Medical and Healthcare Products Regulatory Agency
(MHRA) depending on their nature. The NRLS also provides the
Clinical Negligence Scheme for Trusts (CNST). Membership of this
scheme is voluntary, but requires payments which are discounted if
the trust meets specific risk management standards. CNST also
handles negligence claims against a trust.
National Patient Safety Agency
The National Patient Safety Agency (NPSA) (http://www.npsa.nhs.
uk/) was established in 2001 after the publication of reports from
several public inquiries into patient safety incidents, including those
at Bristol Royal Infirmary. Its main function is to identify patient
safety issues and provide solutions by providing information to health-
care workers and organizations. It includes the NRLS, to which
healthcare staff are encouraged to report incidents. The NRLS ana-
lyses the data submitted, identifies common risks, and publishes
patient safety alerts and guides (http://www.nrls.npsa.nhs.uk/
resources/?entryid45=65333&p=8). For anaesthesia-related incidents,
the NRLS utilizes the anaesthesia e-reporting system. The reported
incidents are reviewed by the Safe Anaesthesia Liaison Group at
the Royal College of Anaesthetists and the results published in a quar-
terly Patient Safety Update (http://www.rcoa.ac.uk/document-store/
patient-safety-update-october-december-2012). Recent examples in
16 Continuing Education in Anaesthesia, Critical Care & Pain j Volume 15 Number 1 2015
anaesthesia include alerts on the use of incompatible connectors for
epidurals and spinals, nasogastric tube placement, and the risk of
fires associated with skin preparation in the operating theatre.
Never events
These are reportable events that result in, or have the potential to
cause, avoidable severe harm or death of a patient. There is a clearly
defined national process for reporting never events, and protocols
are already in place to prevent their occurrence. Examples include
wrong-site surgery or infusion of an epidural anaesthetic mixture i.v.
The Department of Health publishes a list of never events, and cur-
rently, there are 25 (https://www.gov.uk/government/uploads/system/
uploads/attachment_data/file/213046/never-events-policy-framework-
update-to-policy.pdf). Never events relating to anaesthesia are shown
in Table 1.
Local incident reporting
Every hospital must have a system in place to review all critical inci-
dents and near misses. The majority of local incident reporting
systems are now computer-based. Hospitals must also develop strat-
egies to investigate incidents, act on risks identified, decrease the
chance of incidents occurring, and provide feedback to staff/depart-
ments, so that the organization can learn from them. Data from these
systems are also fed-back to the NRLS.
Morbidity and mortality review
Ernest Codman, a Boston surgeon, was one of the first physicians to
collect patient morbidity and mortality data, analyse it, and publish
the results to inform the public of the quality of care they received.4
Table 1 Never events directly or indirectly relating to anaesthesia
Wrong-site surgery
Wrong surgical implant or prosthesis
Retained foreign object postoperation
Maladministration of potassium-containing solution
Wrong route of administration of oral/enteral treatment
I.V. administration of epidural medication
Maladministration of insulin
Overdose of midazolam during conscious sedation
Opioid overdose of an opioid-naı̈ve patient
Transfusion of ABO-incompatible blood components
Misplaced orogastric or nasogastric tube
Wrong gas administered
Failure to monitor or respond to oxygen saturations
Air embolism during i.v. infusion or bolus
Misidentification of the patient
Maternal death due to post-partum haemorrhage after an elective Caesarean section
 Clinical risk management for anaesthetists

In this way, he linked errors to outcomes, and used this information
to make improvements.
All departments of anaesthesia should arrange regular multidis-
ciplinary morbidity and mortality meetings to ensure systematic
review and monitoring of patient outcomes. These benefit from
interdisciplinary input. In addition to establishing the cause for mor-
tality or morbidity, the process allows for professional learning and
review of clinical practice.
There are also national morbidity and mortality reporting
arrangements. The hospital standardized mortality ratio is the ratio
of the number of patients who die in an NHS trust compared with
that expected, and the summary hospital-level mortality indicator
(SHMI) is the ratio of the number of patients who die in a trust or
within 30 days of discharge compared with that expected in an NHS
hospital. NHS England has used the SHMI since 2011 as an indica-
tor of trust performance and it is used with other indicators to
measure the quality of care provided to patients. An outlying result
should trigger the need for further investigation of cause.
The Royal College of Surgeons is developing a system for report-
ing outcomes in 10 surgical specialities utilizing local reporting to
improve the quality of healthcare and increase public transparency.
The Society of Cardiothoracic Surgery has been collecting national
morbidity and mortality data since 1977 and this is now conducted
via the Adult Cardiac Surgery Audit. Data on named-surgeon and
hospital mortality rates have been published since 2005.
Databases
Databases, both local and national, allow collection of data and the
identification of trends in high-risk procedures which can be used to
improve patient care and educate clinicians. Examples include diffi-
cult intubation databases, the national hip fracture database, and the
emergency laparotomy network. The Association for Anaesthetists
of Great Britain and Ireland (AAGBI) collects data on anaesthetic
incidents such as anaphylaxis.
The National Confidential Enquiry into Patient Outcomes and
Death (http://www.ncepod.org.uk/) was established 25 yr ago to crit-
ically examine specific aspects of patient care. It publishes reports
with recommendations on patient management to improve the
quality of care and decrease the risk of harm. Recent reports include
those on perioperative care, paediatric anaesthesia, and anaesthesia
for the elderly.
Complaints
All NHS trusts must have a complaints procedure and any complaint
should be investigated to identify potential areas for improvement in
patient care. In addition to local investigation, national bodies such
as the NHS Litigation Authority (http://www.nhsla.com) in the UK
and the ASA closed-claims analysis (http://www.asaclosedclaims.
org) in the USA hold databases of complaints and claims which can
be analysed to provide information and education on risks and pro-
fessional standards. The ASA closed-claims database has several
registries including postoperative visual loss and awareness. Both
groups share information with anaesthetists on areas of high risk or
patterns of injury, thereby improving patient safety.
Minimizing the risk to patients during
surgery and anaesthesia
There are a multitude of methods that have been developed locally,
nationally, and internationally to minimize risk to patients during
anaesthesia, including clinical guidelines, training courses, check-
lists, contingency planning, and simulator training.
Guidelines
The World Health Organization (WHO) defines guidelines as ‘sys-
tematically developed evidence-based statements which assist provi-
ders, recipients and other stakeholders to make decisions about
appropriate health interventions’.5 Clinical guidelines in anaesthe-
sia, published by a variety of national and international bodies,
should be evidence-based and facilitate best practise by providing
recommendations and streamlining procedures. The AAGBI regularly
publishes consensus statements from working parties on both clinical
and non-clinical issues such as management of anaphylaxis, malig-
nant hyperpyrexia, monitoring in anaesthesia, and blood transfusion
(http://www.aagbi.org/). The Royal College of Anaesthetists (http://
www.rcoa.ac.uk/) guidelines are related to standards of anaesthetic
practice and provision of anaesthetic services (Table 2).
The National Institute for Health and Care Excellence (NICE)
(http://www.nice.org.uk/) provides evidence-based guidance for clinical

Table 2 Examples of CRM systems in anaesthesia. *http://www.rcoa.ac.uk/system/files/CSQ-PS-10-wrong-site-block.pdf

System Effect

Drug syringe labelling Standardized drug syringe labelling was introduced in 2003. Anaesthetic drugs are labelled according to international
non-propriety names and in-line with Australian and New Zealand standards. The aim is to minimize wrong drug error and
hence patient harm, for example, through giving cefuroxime instead of thiopental and resulting awareness
Physical interlinking N2O and O2 rotameters All modern anaesthetic machines are CO2-free and have N2O and O2 physically interlinked to reduce the risk of a hypoxic
and removal of CO2 mixture being administered to the patient and hence harm occurring
‘Stop before you block’ The Safe Anaesthesia Liaison Group has developed a tool kit/system to prevent wrong-site nerve blocks. This was in response to
a trigger incident and subsequent data collection which identified 67 wrong-site blocks over a period of 15 months*
Electronic Patient Records This is a novel concept already in use in areas of healthcare in the UK, for example intensive care units. It ensures standardized
and clear documentation allowing for improved communication and hence patient care

Continuing Education in Anaesthesia, Critical Care & Pain j Volume 15 Number 1 2015 17
Clinical risk management for anaesthetists
practice in the UK. NICE has been a public body since April 2013
and is therefore independent of the government. The most recent
guideline relevant to anaesthesia was the publication of recommen-
dations for the use of depth of anaesthesia monitors in 2012
(http://guidance.nice.org.uk/DT/7).
Checklists
Checklists are commonly used to improve safety in high-risk indus-
tries such as aviation. They are designed to provide an aid for
common procedures which, if omitted, may result in serious harm.6
Industry checklists have been adapted for use in healthcare to
improve compliance with evidence-based practise and ensure con-
sistency. These include the AAGBI anaesthetic machine checklist
and WHO safe surgery surgical checklist.
The WHO surgical checklist was developed to improve world-
wide standards of surgical care. After the introduction of the check-
list, there was a reduction in surgery-related death rates from 1.5% to
0.8% (P¼0.03) and inpatient complications from 11.0% to 7.0%
(P,0.001).7 The WHO surgical checklist has been further devel-
oped by the SURPASS Collaborative group to include the entire sur-
gical stay, and this safety system reduced the incidence of surgical
complications from 27.3% to 16.7% and of mortality from 1.5% to
0.8%.8
In the UK, the NPSA is currently leading a campaign utilizing
care-bundles to reduce central-venous catheter (CVC)-related
bloodstream infections known as Matching Michigan (http://
www.patientsafetyfirst.nhs.uk/Content.aspx?path/interventions/
relatedprogrammes/matchingmichigan/). The care-bundle is based
on a US model where CVC-related blood stream infections were
reduced by the adoption of simple evidence-based interventions, and
recently published data report a 60% reduction in CVC-related blood-
stream infections after the introduction of the bundle in England.9
Education, training, and competency
An essential part of clinical effectiveness and risk management is
ensuring that all staff have the appropriate knowledge and skills to
perform their role in the healthcare team. Anaesthesia training is cur-
rently competency based. The required knowledge, skills, and atti-
tudes are identified at each stage of training, and assessed to ensure
that minimum standards are met. It is also important for all grades
of anaesthetist to keep up-to-date through continuing professional
development, and to maintain a record of these activities. Medical
revalidation in the UK began in 2012 and must be completed on a
5 yearly cycle. Doctors are required to demonstrate to the GMC that
they are up-to-date and fit to practice in order to minimize the risk of
harm to patients and to reassure the public that a doctor’s practice is
compatible with current standards of medical care.
The development of medical simulation for teaching and learning
has provided the opportunity to improve non-technical skills and
train for rare anaesthetic emergencies such as anaphylaxis, malig-
nant hyperpyrexia, or failed intubation. The aim is to improve the
18 Continuing Education in Anaesthesia, Critical Care & Pain j Volume 15 Number 1 2015
quality and outcome of critical incident management, although there
is currently limited evidence to support this.10
Openness
The need for an open and transparent culture in the NHS to improve
the quality of healthcare and patient safety was highlighted in
the Francis Report (https://www.gov.uk/government/uploads/system/
uploads/attachment_data/file/226703/Berwick_Report.pdf). Openness
within the organization allows for concerns to be raised freely, and
transparency for honest information to be available for the public and
staff. The NPSA published its framework on Being Open in 2009.
This highlights the need to acknowledge, explain, and apologize to
patients when incidents occur to reduce the stress experienced and to
ensure that a thorough investigation is carried out and that any lessons
learnt are shared with patients and staff.
After action review
After action review is a structured debriefing process. It was devel-
oped for use in the military but is now commonly used by many
NHS organizations after an event.11 It allows the analysis of the
cause of an incident, and also education of those involved, by ana-
lysing the incident using four questions:
† What was planned to happen?
† What actually happened?
† Why did this happen?
† How can the process be improved next time?
Documentation
Maintaining clear, accurate, and legible medical records is essential.
These should provide documentation of patient contact and deci-
sions made to facilitate continuity of patient care. Record keeping
forms an essential part of Good Medical Practice (http://www.
gmc-uk.org/guidance/good_medical_practice/record_work.asp) and
is therefore part of medical revalidation. In addition to GMC guid-
ance, the Academy of Medical Royal Colleges also published guide-
lines in 2008, A Clinician’s Guide to Medical Record Standards, to
increase the consistency of medical record keeping. Poor quality
medical records result in poor communication between staff and the
potential for harm to patients. In addition, good documentation pro-
vides a clear record in the event of patient complaints or claims. It is
also essential to ensure that records are maintained in line with data
protection requirements.
Summary
CRM is a multidisciplinary, systematic process that aims to reduce
the incidence of harm to patients by identifying and analysing areas
of risk, developing risk management plans, and disseminating the in-
formation to others. All processes should be monitored regularly to
ensure efficiency and effectiveness. Anaesthesia is unique because
of the potential for serious harm to patients, and all departments

should ensure that they have systems in place to share lessons learnt
from critical incidents both at a local and national level.
Declaration of interest
None declared.
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Please see multiple choice questions 9–12.
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