Select Committee on Health Written Evidence

Memorandum by the Confidential Enquiry into Maternal and Child Health (CEMACH) (PS 19)




  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.


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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