Memorandum by the Confidential Enquiry
into Maternal and Child Health (CEMACH) (PS 19)
PATIENT SAFETY
EXECUTIVE SUMMARY
Introduction
1. The national confidential enquiries are
part of the overall system for improving patient safety. The conclusions
of the evidence provided in this submission are:
— The role of national confidential
enquiries could be more closely integrated with the rest of the
system for improving patient safety.
— Specifically, they could be used
to independently assess whether the high standards of clinical
care promulgated in national clinical guidelines are applied locally.
— Further, higher priority should be
attached to the new national confidential enquiry into child health.
Role of National Confidential Enquiries
2. There are three national confidential
enquiries funded by the Department of Health and commissioned
by the National Patient Safety Agency (NPSA). These are the National
Confidential Enquiry into Patient Outcomes and Deaths (NCEPOD),
the National Confidential Inquiry into Suicides and Homicides
(NCISH) and the National Confidential Enquiry into Maternal and
Child Health (CEMACH). These organisations provide a blame-free
environment in which the quality of care provided to individual
patients with adverse outcomes is reviewed by independent clinicians.
The origins of national confidential enquiry go back to the 1950s.
They make a unique contribution to improving patient safety.
3. CEMACH identifies avoidable factors by
assessing against recognised standards the care provided to the
pregnant mother, the unborn and newborn baby, and children up
to the age of 18. Information is aggregated from many cases to
produce system-wide learning. The approach has achieved many improvements
in patient care over the years and is highly respected by practising
clinicians.
4. The standards used by CEMACH to assess
the quality of care provided come from authoritative bodies such
as the medical royal colleges. Increasingly the source of the
standards we use is the clinical guidance being issued by the
National Institute for Health and Clinical Excellence (NICE).
Scope for developing national enquiry role in
improvement of patient safety
5. Confidential enquiries could be more
closely integrated with the wider system for improving patient
safety. They are uniquely well placed to be used to provide an
independent assessment of the effectiveness—in terms of
influencing local clinical practice—of the national investment
in the growing body of clinical guidance, including that issued
by NICE.
6. The need for the development of such
a role is a natural extension of the reforms introduced in the
late 1990s. These reforms were intended to ensure consistently
high standards of health care provision. They included the establishment
of the Healthcare Commission (HCC), the NPSA and NICE. NICE fulfils
an important role in drawing up national clinical guidelines containing
standards for high quality care. The independent assessment of
whether these high standards are applied in practice is less well-developed.
National confidential enquiry could provide an efficient and effective
mechanism for filling this gap.
Greater priority for the national enquiry into
child health
7. Confidential enquiries into child health
are new, having started in 2004. In the first ever national confidential
enquiry report on children, published in May 2008, we found avoidable
factors in 26% of child deaths. The deaths often occurred in complex
circumstances involving both repeated individual clinician error
and systemic shortcomings. Current expenditure on the national
enquiry into child health is some £300,000 a year. This relatively
modest sum limits the amount of work that can be done in this
very important area.
8. We believe that within the overall national
confidential enquiry programme, higher priority should be given
to work on developing a greater understanding of avoidable factors
in adverse outcomes for children, including death. The confidential
enquiry approach could provide a cost effective way of improving
the safety of health care provided to children.
RESPONSE
1. Background
1.1 Confidential enquiries make a unique
contribution to improving patient safety. They provide a mechanism
whereby a panel of independent clinicians reviews the care provided
where there has been a death or other adverse outcome. Because
the full patient record is assessed after being anonymised, it
is possible for clinicians to do this without concern for the
medico-legal implications of their assessment. Panels can—and
do—make critical judgements about the quality of the care
provided to individual patients. These findings are then collated
by CEMACH into reports which support wider learning from the study
of individual tragedies.
1.2 Confidential enquiries originated in
the 1950s when the medical profession sought to establish a system
to share the lessons learned from a maternal death with colleagues
throughout the country, but in an environment that did not seek
to apportion blame. This first enquiry, the Confidential Enquiry
into Maternal Deaths (CEMD) was followed in 1992 by the Confidential
Enquiry into Stillbirths and Deaths in Infancy (CESDI). In 2003,
CEMD and CESDI were combined, whilst under the auspices of the
National Institute for Clinical Excellence (NICE), to create CEMACH.
The new organisation was given the additional remit of investigating
adverse outcomes, not just mortality, and to develop a new enquiry
into child health up to the age of 18. Additional funding was
not however provided for this expanded remit.
1.3 CEMACH now provides system-wide learning
from the review of care provided to individual mothers and children.
It operates across the UK. The work is funded by the health departments
of all 4 UK nations. Since 2005 the lead commissioning role has
been provided by the National Patient Safety Agency (NPSA) as
part of its overall remit for improving patient safety.
1.4 In addition to CEMACH, there are two
other national confidential enquiry organisations. These are the
National Confidential Enquiry into Patient Outcomes and Deaths
(NCEPOD) and the National Inquiry into Suicide and Homicide (NCISH).
Annual funding for the national confidential enquiry programme
is a little over £3m, of which £1.43m (on a recurrent
basis) is for CEMACH.
1.5 CEMACH assesses the quality of care
against evidence-based standards. This identifies avoidable factors
associated with adverse outcomes. Information on many cases is
then aggregated to provide system-wide learning. Where possible,
a case control approach is used to enhance the scientific robustness
of the findings.
1.6 The methodology thus builds on the approach
used in clinical audit—ie peer review of care against recognised
standards—to derive information on avoidable factors in
adverse outcomes.
1.7 The value of CEMACH's work is widely
recognised by practising clinicians, particularly obstetricians
and midwives, with many citations in the professional literature
and its findings are referred to in professional examinations.
The work of CEMACH and its predecessors is quoted as a source
for 23 of the criteria currently being piloted in the new maternity
risk management standards manual of the Clinical Negligence Scheme
for Trusts (CNST). In addition to having a local impact, the work,
particularly on the maternal death enquiry, has influenced DH
policy on maternity services, for example in the maternity module
of the National Service Framework for Children, Young People and
Maternity Services.
1.8 CEMACH's work on children is more recent
and has not had time to influence national policies and services
to the same extent as the well-established maternal and perinatal
enquiries. It is however described in more detail in this evidence
to illustrate its potential role.
2. Risks to patient safety and the extent
to which they are avoidable
Avoidable risk, human error, poor clinical judgement
and systems failures
2.1 In our recently published study of children's
deaths "Why Children Die: A Pilot Study" (May 2008),
we reported on "avoidable factors" associated with the
death of children aged between 28 days and 18 years. Our starting
point for identifying an "avoidable factor" is a failure
to meet established care standards, particularly those established
in authoritative guidelines published by the relevant royal colleges
or by NICE.
2.2 We found that the distinction frequently
drawn between poor individual judgement and systemic error is
often unhelpful and uninformative in the context of healthcare.
Poor judgement certainly occurs, but the solution may, nonetheless,
be found in improving the system. The circumstances of a death
are frequently complex, with multiple failures of individual judgement
allied to shortcomings in the system.
2.3 In our child death review, we found
that, of the 119 deaths we subjected to full enquiry, 26% involved
avoidable factors. In the published report, we have included vignettes
of a proportion of these deaths so that a proper appreciation
of the nature of the shortcomings we had identified could be gained.
We were particularly concerned about:
— failure to recognise serious illness
— lack of recognition of mental health
problems in children who commit suicide
— failure to follow up children who
do not attend outpatient appointments, which can even occur as
direct consequence of local policies on non-attendance.
2.4 Reproduced below is one of the many
vignettes from the report:
A teenager took a potentially lethal overdose.
When the overdose was discovered she was brought to A&E and
was seen by a senior house officer. She gave an honest history
in relation to the type and amount of drug ingested. The doctor
did not check that the dose involved was potentially lethal. She
was sent home without arrangements for follow up (contravening
NICE Guidelines on Self Harm (2004)). Her condition deteriorated
over the next two days. When she re-presented to A&E, there
was critical failure to recognise the severity of her symptoms
and a consequent significant delay in medical management. She
collapsed whilst waiting in the A&E and started to convulse.
She died later in intensive care.
This case highlights not only failure of individual
judgement but also systemic issues about the training of emergency
care staff and the practical implementation of NICE guidelines.
The requirement for there to be adequate training of clinical
staff who are not paediatricians but who nonetheless treat sick
children, in the particular needs of children, was a recurrent
theme in the avoidable factors we detected.
3. Ensuring patient safety: linking the centre
with local health care
3.1 National confidential enquiries can
provide a link between the centre and local health bodies. CEMACH
uses policies and standards of care promulgated centrally to assess
standards of care provided locally to individuals. We assess whether
national standards are being applied locally by looking at individual
cases and we can therefore identify the implications on outcomes
for patients when clinical standards are not met. As a result,
we have a particular insight into the relationship between clinical
standards set at a national level and their local implementation.
3.2 Clinical guidelines are essential for
patient safety. The critical question is whether the national
standards and guidelines underpinning safe clinical care are actually
implemented in practice. The volume and complexity of guidelines
can represent an obstacle. Dissemination, implementation and audit
of adherence to standards are as important for patient safety
as the initial production of the evidence-based guidelines. The
need to independently audit implementation will grow as the body
of clinical guidelines developed by NICE and other authoritative
bodies becomes more extensive and comprehensive.
3.4 Our contention is that, whilst there
are bodies providing essential links between the centre and local
providers, the independent evaluation of local implementation
of national clinical guidelines is less well developed. This could
be filled by using confidential enquiry methodology as an integral
part of the system.
3.5 In suggesting this, we fully recognise
the important role played by bodies which currently link the centre
and local providers. For example, the Clinical Negligence Scheme
for Trusts (CNST) run by the National Health Service Litigation
Authority (NHSLA) plays an important role. The premium paid by
health care providers to the NHSLA for participation in the Clinical
Negligence Scheme for Trusts (CNST) can be reduced by up to 30%
depending on how far they meet the NHSLA's risk management standards.
Adoption of a recommendation or standard in the NHSLA risk management
manuals unquestionably enhances the likelihood of its implementation.
An example from the confidential enquiries is the recommendation
that providers of maternity care should provide staff with regular
training in cardiotocograph (CTG) interpretation, in which the
fetal heart rate and uterine contractions are electronically monitored.
The Enquiry had found that poor CTG interpretation was leading
to intrapartum deaths and other adverse outcomes for babies. This
was adopted as a criterion for evidence of managing risk in the
NHSLA's risk management standards and subsequently became a priority
for maternity providers.
3.6 The CNST scheme therefore enables conclusions
to be drawn about the adequacy of a provider's risk management
systems. However, the CNST scheme is based on a systems assessment
and is not designed to assess the care provided to individuals.
3.7 A further example is the Healthcare
Commission's (HCC) reviews of individual trusts. These certainly
focus attention on patient safety at a local level. In the review
of maternity services at Northwick Park, the HCC extensively reviewed
the care provided to individual patients. We noted that maternity
providers paid increased attention to monitoring of maternal deaths
and learning from local reviews in the aftermath of the HCC's
investigation of maternal deaths at Northwick Park. The HCC's
reviews clearly play an important role. On the other hand, they
provide an assessment of the extent to which clinical care standards
are being implemented for individual patients in a specific unit,
rather across the NHS as a whole.
3.8 Therefore, whilst the CNST scheme and
HCC investigations clearly fulfil important roles in respect of
the purpose for which they were designed, something different
is needed if an independent assessment is to be made about whether
the care standards contained in national clinical guidance are
being applied in the care of individual patients across the NHS
as a whole.
4. Suggestions for further action
Systematic and extended use of confidential enquiry
to independently assess adherence to national guidelines and standards
4.1 National confidential enquiry could
be further developed as an integral part of the system, being
used to assess whether and to what extent clinical standards are
being met in the care of individual patients. It could identify
the impact on patient outcomes of failure to meet national clinical
guidelines. This would show which standards are most important
for improving patient safety.
4.2 CEMACH already takes account of the
increasing body of established clinical guidance in its study
design. For example, in our forthcoming enquiry into the care
of children with head injury, we will, inter alia, be reviewing
whether the recent NICE guidance on this is being implemented
in practice. However, new investment in confidential enquiry would
be needed for this role to be developed on a systematic basis.
4.3 We sometimes encounter scepticism about
the helpfulness or validity of particular guidelines or standards.
The additional information provided by confidential enquiry about
the impact of adherence to identifiable standards on outcomes
could be persuasive in encouraging practising clinicians to implement
recognised care standards—or, indeed, evidence that a guideline
may require revision.
4.4 We therefore recommend that consideration
be given to developing the potential of national confidential
enquiry to provide an independent assessment of whether the growing
body of national clinical guidance is being applied in practice
and the implications for patient outcomes where it is not.
Higher priority given to national confidential
enquiry into child health
4.4 A higher priority should be attached
to the future development of the national confidential enquiry
into child health. As already stated, no additional funding was
provided in 2003 for CEMACH to take on this important new responsibility.
Indeed a substantial (40%) cost saving was required of the new
organisation on its initial establishment.
4.5 CEMACH has striven nonetheless to set
up the new enquiry into child health. Its source of funding for
this has been through improving the efficiency of its work for
mothers and babies. CEMACH now spends approximately £300,000
a year on child health, about 20% of its resource. The balance
remains committed for work on mothers and babies. There is a limit
on how far it would be wise to reduce the national investment
on enquiries into maternity care. Mothers should be able to approach
pregnancy with the utmost confidence in their quality of care.
Confidential enquiry has over the years played a critical role
in this. Some 60% of the amount paid by the NHS in clinical negligence
claims, approx £300m a year, relates to maternity care. The
current CEMACH maternity care programme covers important areas.
This includes ongoing work on maternal and perinatal deaths and
specific projects on the management of obesity in pregnancy and
intrapartum care/birth asphyxia.
4.6 Our aspiration is to make as much difference
to the health care of children as we achieve in maternity care.
The knowledge gained as a result of our work—and that of
our predecessors—in maternity services, is recognised throughout
the UK and internationally. Our pilot study on child deaths has
shown that confidential enquiry work on child health is both feasible
and worthwhile. We recommend a periodic national enquiry into
child mortality so that a substantial body of knowledge would
be developed about why children die and how their deaths could
be avoided. There should be, in addition, specific projects covering
the different health issues relevant to older and younger children,
with major national reports approximately every 18 months or so,
and regular short reports and peer review papers in the interim.
Whilst such a programme would require some additional investment,
the funding required would be modest.
4.7 We believe this could over time make
a major difference to the quality of health care received by children
in Britain.
September 2008
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