ARTICLE IN PRESS

Current Obstetrics & Gynaecology (2005) 15, 237–243

www.elsevier.com/locate/curobgyn

Risk management in obstetrics

Helen Scholefield

Liverpool Womens’ Hospital, Crown Street, Liverpool L8 7SS, UK

KEYWORDS Summary Clinical risk management is key to improving the safety of care that we
Risk management; provide. In obstetrics, it is particularly important as it is a high-risk speciality, and
Human error; the cost of mistakes is high, both financially and in human terms. Human error is
Risk assessment; inevitable, so there is a need to understand the theory of human error and the
In-service training; systems, rather than person-centred, approach to dealing with adverse events. Risk
Guidelines; management has many components, including organisational culture, risk assess-
Medical audit; ment, training, induction, guidelines, communication, audit, learning from adverse
Communication; incidents, claims and complaints. For the future, the aim should be to move from risk
Consent management to a safety culture.
& 2005 Elsevier Ltd. All rights reserved.

Introduction the reasons why they make mistakes, and of the

Patient safety is important for many reasons, and
clinical risk management is essential in achieving
this. It is known that 10.8% of hospital patients in
this country experience an adverse event. Half of
these are preventable, and a third lead to
moderate or greater disability or death. We work
within a safety paradox. Healthcare staff are highly
trained and motivated. They are committed to
their patients and use sophisticated technology,
errors are common, and patients are frequently
harmed. We are victims of our own success.
Medicine used to be simple, ineffective and
relatively safe. Now it is complex, effective and
potentially dangerous. Healthcare staff do not
intend to harm patients, and an understanding of
Tel.: +44 151 708 9988; fax: +44 151 702 4255.
E-mail address: helen.scholefield@lwh-tr.nhs.uk.
underlying contributory factors is important.
The costs to the NHS are huge, and it has been
estimated that adverse events cost about £1 billion
per year in increased hospital stay alone. Over £400
million is paid out in clinical negligence settle-
ments each year. Nearly half of this is in obstetrics,
the estimated value of obstetric claims in 2003
being £1.3 billion. In addition to claims, there are
28 000 written complaints about hospital treat-
ment.
There are also costs to our patients because of
the long-term effect on the quality of their lives.
The impact on staff should not be underestimated
too: 38% of doctors who are sued suffer from
clinical depression, and there is damage to their
morale and reputation. Staff can become so afraid
of making another mistake that they are unable to
continue working in the NHS and move to other jobs
where mistakes are unlikely to kill someone. There
is public and government pressure to provide a safe

0957-5847/$ - see front matter & 2005 Elsevier Ltd. All rights reserved.
doi:10.1016/j.curobgyn.2005.05.007
 ARTICLE IN PRESS
238 H. Scholefield

and effective service. Our professional bodies are more demanding and is concerned with the
also involved and can remove our right to work. implementation and integration into practice of
Clinical governance is a framework through policies. Level three requires an audit of the
which organisations are accountable for continually effectiveness of the clinical risk management sys-
improving their quality of service and safeguarding tems. The discounts are 10%, 20% and 30%, respec-
high standards by creating an environment in which tively. These represent huge savings as annual
excellence in clinical care will flourish. Clinical risk contributions are several million pounds a year.
management is central to this. The governance
arrangements in NHS trusts are subject to external
scrutiny, and this is reflected in their performance Principles of risk management
ratings.
A second safety paradox is that tackling errors The following need to be recognised when con-
creates the illusion that things are getting worse, sidering medical error:
and the time developing error-reducing procedures
and skills appears to detract from delivering  the uncertainty of clinical practice;
services. Other industries such as aviation and  the nature of clinical decisions;
petrochemicals have, however, been very success-  the benefits of hindsight;
ful in reducing risk and invest a much larger  the frequency of activity;
proportion of their resources in this as they have  the error-producing conditions under which we
found it to be cost-effective. work;
 the fact that people do not intend to commit
errors;
What is clinical risk management?  that accidents are rarely due to single errors but
are the product of multiple factors;
Clinical risk management can be defined as  that the psychological precursors of error are the
organisational systems or processes that aim to last and least manageable stages in the accident
improve the quality of health care and create and chain.
maintain safe systems of care. Risk management
addresses the various activities of an organisation
by identifying the risks that exist, assessing those Types of error
risks for potential, frequency and severity, and
eliminating those risks which can be eliminated. In There are different types of error, and they are
medicine, unfortunately, the only way of comple- categorised into whether they are intended or
tely eliminating the risks of a procedure such as a unintended actions (Fig. 1).
caesarean section completely is often not to do it
at all. Obviously, that is not an option as it
Slips and lapses
introduces a different set of risks for both patient
and organisation. Risk management must therefore
These are unintentional and occur where there is a
reduce the effect of those risks which cannot be
failure of:
eliminated and put in place financial mechanisms
to absorb the financial consequences when things
 recognition: e.g. the misinterpretation of a
do go wrong. The latter is rather like car insurance,
cardiotocograph (CTG);
and involves NHS trusts contributing to the National
Health Service Litigation Authority through the
Was there a prior
Clinical Negligence Scheme for Trusts (CNST) for intention to act?
clinical issues. Yes Recognition failures
The CNST set standards for risk management Did the actions
Unintentional action
Attentional failures
no
systems in trusts. There are separate standards for proceed as planned? SLIPS and
LAPSES Memory failures
maternity services because of the huge cost of
Yes
obstetric claims; these standards cover all of the Selection failures
Did the actions Intentional action
components of risk management described below. achieve their desired
no
MISTAKES Rule based
If the standards are achieved, trusts receive a end?

reduction in their contributions to the National Yes

Knowledge based
Intentional action
Health Service Litigation Authority. There are three Successful action Violations
levels. Level one represents the basic elements of a
clinical risk management framework. Level two is Figure 1 . Types of human error.
 ARTICLE IN PRESS
Risk management in obstetrics
 attention: interruptions and distractions from
the task;
 memory: something is forgotten;
 selection: the wrong medication is chosen from a
number of ampoules that look the same.
Mistakes
These are intentional and occur when a course of
action that is incorrect is selected, and therefore
does not have the desired result:
 Rule based: For example, syntometrine is given
for active management of the third stage in a
woman with hypertension and she subsequently
has a fit. A good rule is used in the wrong situation.
 Knowledge based: There is not a known pre-
planned course of action. A plan is worked out to
deal with this, but it does not have the desired
effect.
Violation
These are intentional deviation from safe practice:
 routine: cutting corners, e.g. not logging off the
computer;
 reasoned: the only option in the circumstances,
such as a trial of forceps for fetal bradycardia in
the delivery room as the theatre is busy;
 reckless: harm is foreseeable but not intended,
e.g. using multiple instruments in a trial of
instrumental delivery;
 malicious: such as the recently publicised case of
the GP Harold Shipman.
The systems approach
To be successful, there must be a systems rather
than an individual approach to error. As human
beings are fallible, errors are to be expected. The
focus should be on factors influencing errors and
actions aimed at conditions of work.
Active and latent failures need to be considered.
Active failures are the immediate causes of an
adverse event. They are the mistakes made by
frontline staff such as doctors and midwives. Latent
failures are the result decisions made higher up the
organisation. They create local conditions that
make errors more likely and may not become
apparent for a long time. Examples of latent
failures are understaffing and high workload. The
systems approach is different from the person-
centred view, in which there is individual respon-
239
sibility and blame, and action aimed at changing
individuals’ behaviour. There are often multiple
factors, and only dealing with these will result in
safer systems as dealing just with individuals will
not allow learning within the organisation and is
likely to result in the same mistake being made by
others in the future.
The following factors contribute to adverse
events and should be considered in the analysis of
adverse events.
 Patient factors: Age, general health, complexity
of the condition, language, social problems and
personality.
 Task factors: Task design, availability of proto-
cols, test results, etc.
 Individual factors: Training, physical and mental
health, and awareness.
 Team factors: Verbal communication, supervi-
sion, seeking help and team structure.
 Work environment: Staffing levels, skill mix,
shift patterns, equipment and administrative
support.
 Organisational and managerial factors: Financial
resources, policy standards, goals and the safety
culture.
Components of risk management
There are many components of risk management,
including organisational culture, learning from
adverse incidents, risk assessment, training, induc-
tion, guidelines, communication, audit, claims and
complaints.
Learning from adverse events
This is central to clinical risk management. The
most recent terminology refers to adverse clinical
events as patient safety incidents and defines these
as any unintended or unexpected incident(s) that
could have or did lead to harm for one or more
persons receiving health care. Adverse events
occur in about 7% of admissions in obstetrics and
gynaecology in the UK, and 71% are thought to be
preventable. There is a need to learn from these,
and Liam Donaldson, Chief Medical Officer, has said
in relation to this that ‘To err is Human. To cover up
is unforgivable. To fail to learn is inexcusable.’
Learning from adverse events involves incident-
reporting. It is important that all staff are aware of
how this takes place in their unit. Organisations
must make it clear that the purpose of this is for
the organisation to learn from its mistakes and
 ARTICLE IN PRESS
240
make changes that will reduce the risk of similar
events occurring in the future, and that it is not for
the punishment or disciplinary action of individuals
as described above. A fair-blame culture must be
developed; failure to achieve this will seriously
compromise the success of incident-reporting. Staff
also need to have feedback on what has been done
as a result of the investigation of reported incidents,
so that they can see the value of reporting. Other
important factors are support when this is required
and positive feedback when, despite the occurrence
of an adverse event, care has been good.
Reporting is usually by a form that contains
triggers lists of events that should be reported.
These lists vary between clinical areas. On the
delivery suite, e.g. such things as maternal death,
massive haemorrhage, third-degree tears and in-
trapartum stillbirth are included. On the obstetric
wards, wound infection, postnatal sepsis and
thromboembolism are to be noted, as are failure
to act on abnormal serum screening results in
antenatal clinics, miscarriage after invasive proce-
dures in the area of fetal medicine, and read-
mission of mother or baby and break down of
perineum in the community.
Near misses should also be included. These are
events that could potentially lead to a serious
adverse outcome but for some reason did not.
Learning from these is particularly beneficial as
they are less emotionally charged because no one
has been harmed and staff feel less threatened.
Identifying what prevented harm occurring can
allow changes to be implemented that will reduce
the chance of the near-miss event actually occur-
ring in the future.
Reports should be entered on to a suitable
database that will allow an analysis of the numbers
and types of events, and of any trends. Many events
will need to be recorded just to for the statistics,
but a number will need looking into further, and a
few will need a formal in-depth investigation to
find out exactly what happened and why. This
should be done for very serious incidents such as
maternal death, or for less serious but frequently
occurring ones.
Investigation involves collecting information
about what happened from the notes, people
involved and other sources. Information will also
be needed on workload, staffing, skill mix, training
records and equipment-checking records. Once it is
clear what happened, a root cause analysis is
carried out. A number of techniques are used to
find out which underlying contributory factors,
described above, were involved in the incident.
Action plans need to be developed to deal with
these root causes to allow the implementation of
H. Scholefield
any changes necessary to avoid future similar
events. Monitoring of the action plans is needed,
and audit of the implemented changes must take
place to ensure that they have been effective.
Learning should take place from adverse events
not only in the unit, but also elsewhere. The
National Patient Safety Authority has been set up to
allow learning across the whole NHS. A national
system for incident-reporting is being rolled out,
which should provide more information by facil-
itating the detection of issues that might not be
picked up locally because of a lack of numbers. This
system has so far resulted in a number of patient
safety alerts, including the use of potassium
chloride and, of particular relevance to obstetrics,
infusion devices.
Claims and complaints are other areas where
lessons can be learned. Common themes in ob-
stetrics include communication, delay, the cascade
of events, CTGs, perinatal asphyxia, abuse of
syntocinon, vaginal birth after caesarean section,
shoulder dystocia, anal sphincter injury, consent,
birth plans and the absence of midwives from the
delivery room. Record-keeping is consistently high-
lighted as an issue when investigating and defend-
ing these events.
Risk assessment
Unlike adverse event-reporting, risk assessment
aims to identify risks before adverse events occur
and put into place procedures, barriers and other
measures to reduce these risks. It involves a
systematic review of the unit. Risk assessments
should be multidisciplinary, and identified risks are
rated to enable prioritisation. Action plans are
developed to deal with the risks. Assessments may
include:
 personnel: staffing levels, skill mix and training;
 estate: a safe environment for staff and
patients;
 equipment: CTG machines, infusion pumps, etc.;
 practice: policies and procedures.
Training, induction and competence
Inexperience increases the risk of error four-fold,
so training is extremely important in risk manage-
ment. The generic requirements of all staff must be
identified. Training matrices are useful in this by
identifying what training is essential for each level
of staff. It is also important to tailor training needs
to individuals. This should form part of the
induction, assessment, appraisal and professional
 ARTICLE IN PRESS
Risk management in obstetrics
development process. Unfamiliarity increases the
risk of error by a factor of 17, so all new staff must
be familiarised with the unit and receive training as
discussed above. It is important that they are made
aware of guidelines, policies and procedures, and
how to access these.
The following are particularly important in
obstetrics, and should be included in induction
and should be regularly updated:
 CTGs: There are many ways this can be done,
including formal teaching sessions, CTG review
meetings and electronic training packages.
 Resuscitation: Both adult and neonate. Maternal
collapse is an uncommon but very serious
occurrence. Maternity units are often separate
from general wards, so it is imperative that all
maternity staff know how to deal with collapse
while awaiting the arrival of the crash team.
 Drills: Including those for shoulder dystocia,
vaginal breech delivery, cord prolapse, eclamp-
sia and massive haemorrhage. Staff may not
have been in these situations before and need to
have the necessary skills. These can be taught
using scenario-training with manikins in training
days and on recognised courses. Emergency ‘fire’
drills in the clinical areas are also useful to test
that the system is working properly.
 Equipment: Matrices are useful in identifying
which members of staff need training on
particular items of equipment; those who are
not trained must not use them.
 Supervised practice: This allows staff to develop
their skills and allows competencies to be
assessed while minimising the risk to patients.
 Risk management: The systems in place in the
organisation for patient safety and incident-
reporting, etc., and insight into human error, so
that they can understand why safety processes
are put in place to protect patients and
themselves. It is important to stress the systems
approach to give staff confidence in reporting
adverse events.
Guidelines
These are systematically developed statements to
assist practitioner and patient decisions about
appropriate health care for specific clinical circum-
stances and can improve quality of care by
supplying the knowledge that practitioners need
to put evidence-based medicine into practice. They
are important for all staff, particularly new ones.
In obstetrics, there are a number of national
guidelines produced by the National Institute of
241
Clinical Excellence on induction of labour, electro-
nic fetal monitoring, antenatal care and caesarean
section. These are recognised standards against
which care is judged, and it is important that all
units carefully consider how the standards are
implemented locally, which requires adapting them
to local needs. The Royal College of Obstetricians
and Gynaecologists also has a large number of
evidence-based ‘green top’ guidelines, and further
guidelines are available from the Scottish Inter-
collegiate Guidelines Network.
In addition to these national guidelines, CNST
require units to have guidelines on a large number
of topics. There is also a need to identify other
local clinical and administrative topics within the
unit. Guidelines are, however, helpful only if they
are effectively implemented, so the evaluation of
their effectiveness through audit and adverse
event-reporting is important. All guidelines need
reviewing at suitable intervals to incorporate new
evidence and issues identified through audit and
adverse event-reporting.
Communication
Communication is a big issue in risk management.
It is frequently a major factor in claims and
complaints.
Communication with the patient
Good communication skills are one of the most
important aspects of patient care, and it is
primarily these which our patients use to judge
the care they receive as they do not have the
knowledge to judge our competence. They are
much more likely to be satisfied with their care if
communication has been good. This is illustrated by
evidence showing that there is no difference in the
clinical competency of doctors who have been sued
frequently than those who have not been sued.
Patients who sued were more likely to feel that
they had not been listened to, or had had adequate
time spent with them, even though there was no
difference in the length of consultation between
the doctors who had and had not been sued.
Patients’ expectations are important. Patients
are likely to be dissatisfied with their care and
complain or claim if their expectations are not met.
Their expectations may not be realistic or may not
be what we think they are. It is important to check
what patients’ expectations are and address them,
explaining why they might be unrealistic.
Patient information is another key area. Informa-
tion can be an adequate verbal explanation, or
written information, and may be provided in other
 ARTICLE IN PRESS
242
formats, such as Braille and audiotapes. It may also
need to be provided in different languages. Patient
information leaflets are extremely useful but must
not be used as a replacement for adequate
explanation.
Consent is a specific area in which communica-
tion with the patient is important. Patients must be
given enough information about the procedure and
its risks, benefits and alternatives to make an
informed decision about it. Patients who are
mentally competent have the right to refuse
treatment even if that might result in harm to
themselves or the death of their baby. The issue of
consent in labour is difficult, but this must not be
used as an excuse not to explain things to the
patient. If a complication arises, failure to warn of
this is likely to result in a claim. For minor
procedures such as venepuncture or vaginal exam-
ination, verbal consent is adequate but should be
recorded. Consent for more invasive procedures
should be written with a note made of the
discussions with the patient and any information
leaflets given.
Communication between professionals
The care of a pregnant woman involves a large
number of professionals—it is vital that adequate
communication occurs between all of these. This
needs to encompass communication between the
hospital services and community and primary care.
All the relevant professionals must be kept in-
formed of the plan of care and any complications.
Adequate discharge information is essential.
The handover of care is increasingly important
with shift patterns of work and should be forma-
lised. As a minimum, all patients causing concern
and all new admissions should be discussed,
including, for each one, what the problem is, what
has been done, what results are awaited, when the
patient needs review, what needs doing and what
the current management plan is. When patients
move from one area to another, e.g. from the
delivery suite to the ward, this needs to be
repeated. Checklists can be very useful to make
sure that all the relevant information is handed over.
In addition to verbal communication, documen-
tation helps those caring for the patient after us to
be aware of what we have done. Documentation
must be legible, dated and signed. It should include
the discussions that have taken place with the
patient and a management plan, and key indivi-
duals should be identified. Inadequate documenta-
tion makes patient care more difficult and, in the
event of claims or complaints, makes it impossible
to defend ourselves.
H. Scholefield
Audit
Audit has been discussed in many of the above
sections. Locally, it must cover relevant topics
identified from adverse event-reporting, the effec-
tiveness and implementation of guidelines and
service delivery, e.g. decision-to-delivery intervals
for emergency caesarean section as well as other
topics of interest. The most important aspect of
audit closes the loop with implementation of the
action points and re-audit to make sure action
taken has had the desired effect. Regional audits
are useful in comparing perinatal data and in
benchmarking.
In obstetrics, there are a number of national
audits, the most important being the Confidential
Enquiry into Maternal and Child Health. Units must
use these as a source of learning and review their
service provision against the recommendations of
these reports.
Conclusion
Clinical risk management is key to improving the
safety of the care we provide. This is particularly
important in obstetrics as it is a high-risk speciality,
and the cost of mistakes is high in both financial and
human terms. There is a need to understand the
theory of human error as well as the systems
approach to dealing with mistakes. Risk manage-
ment has many components. For the future, the
aim should be to move from risk management to a
safety culture.
Practice points
 Adverse events are common, occurring in
10.8% of UK hospital admissions. They have
huge financial implications to the NHS and
human costs to patients, their families and
staff.
 Clinical risk management aims to improve
the quality of care by creating and main-
taining safe systems.
 All humans make mistakes. A systems
approach must be adopted to reduce the
risk of these inevitable mistakes causing
harm.
 There are many components of risk manage-
ment, including organisational culture, risk
assessment, training, induction, guidelines,
communication, audit, learning from ad-
verse incidents, claims and complaints.
 ARTICLE IN PRESS
Risk management in obstetrics
Further reading
1. Department of Health. An organisation with a memory.
London: HMSO; 2000.
2. Department of Health. Making amends. London: HMSO; 2003.
3. Lakasing L, Spencer JA. Care management problems on the
labour ward: 5 years’ experience of clinical risk management.
J Obstet Gynaecol 2002;22:470–6.
4. MPS Risk consulting. Mastering Patient Communication Work-
shop. Leeds, 2004.
5. Ransom SB, Studdert DM, Dombrowski MP, Mello M, Brennam
T. Reduced medicolegal risk by compliance with obstetric
243
clinical pathways: a case–control study. Obstet Gynecol
2003;10:751–5.
6. Reason J. Understanding adverse events. In: Vincent C,
editor. Clinical risk management. Enhancing patient safety.
2nd ed. London: BMJ Books; 2001. p. 9–30.
7. Stanhope N, Vincent C, Taylor-Adams SE. Applying human
factors to clinical risk management in obstetrics. Br J Obstet
Gynaecol 1997;104:1225–32.
8. Vincent C, Neale G, Woloshynowych M. Adverse events in
British hospitals. Br Med J 2001;322:517–9.