Royal Society of Medicine Forum: Litigation, risk management and patient safety; a new approach to old problems.
This is a report of a meeting of the Forum on Maternity and the Newborn of the Royal Society of Medicine, held on Thursday 24th November 2005. The meeting was chaired by Dr Luke Zander.

This report is to be published in part in the Midwives Journal of the Royal College of Midwives. It is reproduced here with their consent and our thanks.

The meeting was preceded by the Annual Educational and Research Awards of the Iolanthe Midwifery Trust

The National Patient Safety Agency's contribution to maternity care.
Sue Osborn (SO), Chief Executive of the The National Patient Safety Agency (NPSA), London

I am becoming increasingly concerned at the lack of focus on quality in policy makers and the broader health service. Although there are many centres of excellence within the NHS providing outstanding care, there is unacceptable variation in service quality nationwide. The lack of progress in tackling this issue is due to the focus on the individual when something goes wrong, rather than recognising that in most cases system design or operation is actually at fault. Many drugs are not available in children's doses; staff are expected to undertake complicated mathematical calculations before administering a drug, for example in neonatal intensive care; this is an error trap waiting for staff to fall into, taking their patients with them.

The seminal work An Organisation with a Memory focused on four specific clinical areas, one of which was the aim of reducing by 25% the incidents of harm in obstetrics and gynaecology that result in litigation by 2005. Obstetric claims account for over 70% of all NHS litigation costs, and the average cost of settling cerebral palsy (CP) claims is approximately £1.5m (Vincent et al 2004). This represents a significant loss to front line services. We clearly need to focus on CP since it is the most common motor disability in childhood, with a prevalence of 2.45 per 1000 neonatal survivors (Colver et al 2000). There does appear to be a rising incidence due to the numbers of extreme preterm survivors, and although less than 20% of cases can be explained by hypoxic birth injury, these figures are significant.

The NPSA was established by Professor Sir Liam Donaldson to investigate the causes of things that go wrong in health care and to try to do something to reduce either the risk of recurrence or the resultant harm. This work cannot be undertaken successfully unless clinicians and patients and their families are supported.

The first programme we undertook was to establish a National Reporting and Learning System (NRLS), and we now have approximately 400,000 reports. Contrary to the case note reviews the numbers of deaths reported to us, currently 112, are significantly below the expected figures. The NRLS provides an unprecedented picture of mishaps in health care, and we are able to feed back the data in a number of ways to assist the NHS in understanding the risks they face. We can provide data by Trust on levels of severity and frequency of occurrence. When this is analysed issues that have been little researched are often recognised, and our colleague organisation, The Patient Safety Research Portfolio (PSRP) has commissioned research to fill the many gaps in knowledge that have emerged. We now know that there has been insufficient research in the maternity services on the risks faced by vulnerable groups of women such as teenagers, sufferers of domestic violence and refugees.

However, the NRLS gives just one perspective on the nature of error in health care services. We have supplemented this by the development of the NPSA's Patient Safety Observatory. The purpose of the observatory is to pull together information form a large variety of sources, such as the data from The National Health Litigation Authority and the reviews undertaken by the Care Quality Commission (formerly the Healthcare Commission)in order to get a more rounded picture of the risks faced by staff and patients. Most importantly the data we have is helpful in finding out root causes and contributory factors. The prevention of recurrence depends on true understanding of the causes of error.

Having obtained a better understanding of the scale and type of problems being faced by staff, we then turn to the development of solutions. It is not effective or valuable to tell staff to try harder. We need to design equipment and buildings in a way that helps to reduce the possibility of error, rather than always ascribing error to the failure of a member of staff. For example, we have received a number of reports regarding the failure to replenish cardiac arrest trolleys – there is no visual trigger that signals that the trolley is not ready for use. We are now working with design experts to develop a failsafe trolley.

From the research we have either undertaken or had commissioned we begin to see a common set of issues that need addressing in maternity services where standards and quality are variable if we are to make them safer.

The following issues have emerged as factors contributory to error:

· Lack of clinical experience
· Labour ward culture and poor communication, including lack of interpreters
· Staff shortages and heavy workloads; time spent on non-clinical duties
· Unmet training needs
· Lack or failure of equipment
· Non-compliance with guidelines
· Poor or little risk assessment
· Errors in the interpretation of CTGs
· Risks contingent on changeover of staff and between staff groups

We need together to build alliances with all those responsible for and interested in maternity services to ensure that there is a will to tackle the problems. In particular there is growing evidence that adverse maternal health outcomes are more likely in a number of vulnerable, minority groups such as:

· Teenagers and their view that the structure of antenatal services does not met their needs.
· Problems of women with physical and sensory impairment. There appears to be a lack of knowledge of and negative attitudes to the ways in which pregnancy can affect such women.
· Women who suffer from domestic violence, and issues around fear of disclosure.
· Poor access for asylum seekers and minority ethnic groups to appropriate and sensitive services.

We are delighted that organisations and clinicians from every part of the service have been willing to work with us in this very important task.

References.

Colver AF, Gibson M, Hey EN, et al. Increasing rates of cerebral palsy across the severity spectrum in northeast England 1964–93. Arch Dis Child Fetal Neonatal Ed 2000;83:F7–12.

Vincent C, Davy C, Esmail A, Neale G, Elstein M, Firth-Cozens J, Walsh K (2004) Learning from litigation: an analysis of claims for clinical negligence. Manchester Centre for Healthcare Management, University of Manchester.

Benefits and problems of risk management activity.
Tim Draycott, Consultant Obstetrician, Bristol

The Joint Australia and New Zealand Standards Board's definition of risk management, recently adopted by our College of Obstetricians, is more of an obfuscation: “… the culture, processes and structures that are directed towards realizing potential opportunities whilst managing adverse effects”. It is significant that it refers to opportunities, where we see mistakes in practice. I fear that so-called risk management promotes the culture of blame; we focus on the prevention of litigation when a focus on the prevention of harm would reduce the litigation. The constant watch over performance paralyses action. Filling the many forms with data blinds us to the valuable information within that data; it is encouraging that the NPSA is beginning to face us with the nationwide information, since our tendency to react when mistakes happen has little point when, for example, a maternal death in a busy department like mine may occur once in 10 years. We must manage risk in a way which will reduce error. The eclampsia box prepared in our department with the over-helpful input of the anaesthetists was so full of equipment when the emergency arose that it proved useless. This was over reaction, a common tendency.

The information tells us that an error in drug administration occurs once in every 133 anaesthetics; "That means once a month in my practice", says one of our anaesthetists. We all make mistakes. It is unfortunate that the public are fed a mixture of information and misinformation, as in the television series "Bodies"; even in the clip which I am showing you it is clear that there is a serious system defect - a shortage of midwives, and blame is encouraged. I have a colleague who encountered an employer who explained that in their unit they practise "fair blame".

When looking for the benefit for mothers and babies which we so much desire we are faced with the complexity of systems, and the NPSA are to be thanked for showing us where to start. With the CNST standards The National Health Litigation Authority has defined for us what we must do first. Membership of CNST, the Authority’s Clinical Negligence Scheme for Trusts, is voluntary; providing cover for claims arising from clinical incidents occurring from April 1995. It assesses maternity and adult services in the UK against eight clinical risk standards, which, if in place, demonstrate that high quality and safe care for adults, mothers and babies is being provided and that the service has a ‘safety awareness culture’ embedded in its clinical practices. Using financial incentives these standards enable us to prioritise our activities, and the money generated by our CNST Level 2 activity has encouraged the Trust to put some modest funding into our department. It is confirmed by the CNST assessor that the achievement of Level 2 is a marker of safety, but building a safety culture into a department's work is no easy matter. Reporting can be promoted, for example, if staff feel safe enough to report; units which feel most insecure are the least likely to report. We all communicate - or do we? The NPSA's Incident Decision Tree is valuable in that it builds into the system the responsibility for directing disciplinary action where it is truly and fairly required.

There is much more criticism among midwives than between obstetricians, and midwives respond to this with retraining, something which we doctors should copy. The Seven Steps to Patient Safety can be implemented by training, and by this I mean training to prevent future problems, not reactive to those from the past. Our trainers are midwives, with willing consultants in their audiences. We believe that by removing the threat of testing after training, and by working and training in teams, we promote the team ethos; it has been proved at great cost that this cannot be done with a lecture. We circulate information to the whole team about errors and problems by email, and all are required to attend one session on risk management annually. The staff responsible for risk management decisions must be familiar with the working environment and so must do clinical work. This is how we integrate risk management into real life.

The benefits of the CNST Level 2 style training for our department are clear: halving of low Apgar scores and hypoxic-ischaemic encephalopathy (HIE) rates; during the same period a 16% reduction in brachial plexus injuries due to mismanaged shoulder dystocia, and a 30% reduction in litigation. We might have expected a 20% increase in the midwife establishment to follow the 20% increase in births, but it has not happened; nonetheless with our easier way of doing things, we have a contented team.

Clinical, education and administrative implications for midwifery.
Sandra Reading, Director of Nursing and Midwifery, Newcross Hospital, Wolverhampton

Risk management should be recognised within the maternity services as an integral part of good clinical practice enabling it to become part of everyday culture. Clinical risk management should be integrated into a maternity training package to ensure that it is recognised appropriately in the unit's philosophy, practices and business plans allowing ongoing assessment and progress to be made. As cited in 'Building a safer NHS for patients', the key to learning is a meaningful review of patterns, trends and causal factors, with management systems in place to ensure the competence and appropriate training of all clinical staff. The clinical, education and administrative implications for midwifery practice range from ensuring that the programme of clinical education is imaginative and appropriate for current needs and that it is supported both multi-professionally and financially within the organisation.

At this time we have increasing litigation and defensive practice, yet we must improve outcomes and choice for women and somehow increase the quality of care while decreasing the costs of medical litigation. In 1998 NSFs set national standards and identified key interventions for a defined service or care group, put in place strategies to support implementation, established ways to ensure progress within an agreed time scale, and formed one of a range of measures to raise quality and decrease variations in service, all introduced in The New NHS and A First Class Service (1999).

The NHS Plan re-emphasised the role of National Service Frameworks (NSFs) as drivers in delivering the modernisation agenda. Now we have the National Institute of Clinical Evidence (NICE), the Healthcare Commission, the National Performance Framework, and responsibility for clinical governance, respectively improving safety for patients, providing modern professional regulation, supporting new roles and ways of working, and developing leadership. Guidance in these areas is assessed by CNSTs and CMACE.

All these should raise standards and drive down litigation costs, but still things can go wrong. At Wolverhampton we experienced an intrapartum fetal death and three neonatal deaths, all after 37 weeks gestation, in a three month period; public concern led to an investigation into the maternity unit's management and quality of care, and was extended to include ten other fetal losses. The subsequent confidential inquiry by the then Healthcare Commission identified 160 points of necessary improvement in practice in a unit which seemed to be no worse than any other in the UK; such events were occurring elsewhere, with sub-optimal care in many areas the identified cause. Defects in leadership and communication, including women not being listened to, were prominent, and a year later, although the unit had been under close scrutiny, immediate action had not been taken to remedy the problems. There were some suspensions among the medical and midwifery staff, and some supervised practice. Leadership became difficult, some teamwork issues were exposed, and there was a reactive rise in the caesarian section rate.

The remedy was directed at strong leadership with inclusiveness, active communication, motivation and commitment, and it involved training, a review of education, team-building, and an ongoing shared plan with audit of the outcomes. The immediate action plan included the empowerment of senior staff, planning for the high risk team and a midwifery-led care team, an antenatal high risk care plan and a fetal medicine unit. The involvement of the Maternity Services Liaison Committee and the women of Wolverhampton was important to us. No additional money was allocated, so we were unable to employ more midwives. We had to address a CS rate which had risen to 32% and to follow the guidance in CNST levels 2 and 3; passing level 2 underpinned our success.

The new organisation, to which excellence in practice was the key, was well understood at all levels in the hospital trust; we had a commitment to improve care and reduce litigation, focussed on risk management and learning lessons. Practice in the unit had become excessively medicalised, and with midwifery led care we hope to improve normality and choice, reducing defensive practice and the rate of induction of labour and increasing continuity of carer. Better recruitment and retention of staff and cost-effectiveness are important aims.

Responding to public expectation in-service training became comprehensive, emphasising safety in teamwork, midwives and obstetricians understanding and respecting each other's roles. The training, adapting and revising the Southmead (Bristol) programme, is standardised and evidence-based, but has a changing theme; difficult though this may be, time must be dedicated for it. We have active birthing and water birth workshops and some parent education; a study day is held on public health issues including domestic violence, mental health, teenage pregnancy and vulnerability. Antenatal issues including case histories, fetal growth, and CTG interpretation are addressed.

I have calculated that the cost of in-house training is about £40,000 annually plus medical time; this compares with £210,000 for midwives attending externally run programmes for one-and-a-half days annually, which would not deliver a standardised education programme or achieve teamwork and professional respect, and is unlikely to be evidence based. The training is achieving its objectives, and midwives, by learning alternative skills, can work in different areas. We are getting clear explanations for unexpected poor outcomes using CEMACH criteria, and the culture has become blame free. Lessons are being learned, and confidence has improved. The past three years have seen reducing trends in babies which might not have died had care been different, and in surviving babies where the outcome might have been better with different management. Our CS rate has gradually reduced from 32% and is currently between 22-26%, and epidurals have fallen from 64% to 35% for first labours. With user involvement the service is being designed in line with local need, tackling inequality in health provision. Feedback from the MSLC confirms client satisfaction.

The cost of litigation is such that trust updating cannot be the solution; it must be better to reduce litigation costs by in-house training. However, national resources must be the key to advancing the aim of reducing perinatal mortality and improving the quality of maternity care.

Discussion.

Although hers is intended as a resource for midwives, the editor of MIDIRS reports numerous complaints from mothers that they are being given incomprehensible explanations which remain unclarified. "All we can do is advise them to return to the individual concerned to ask for clarification. I am pleased to learn that this issue is being addressed in some maternity units". It was suggested that only by a marked increase in the time that clinicians spend with mothers will information be properly conveyed; national resources are needed for this. In many instances leaflets will be the solution.

The adviser to the health service ombudsman for midwifery asked when Trusts would realise the importance of one-to-one care for mothers in labour. SR: Using Birthrate Plus (1997), a tailor-made workforce planning package for maternity services, we have identified at Wolverhampton that we are indeed short of staff to support this. SO: The NPSA has been assisting the NHS Litigation Authority with their review of the CNST standards. There is growing evidence that compliance with CNST standards can reduce risks and resultant harm. This will necessarily help to reduce the cost of litigation which takes resources away from front line services. In addition compliance with NPSA alerts, such as the recommendation to have a medical equipment store, has already saved the resources which can be reinvested in services. There is difficulty in getting a full dialogue with Chief Executives of Trusts as they have very clear targets which they have to meet, none of which at present relate to safety. Change of this nature is difficult and unfortunately the 'life' of an Acute Services Trust Chief Executive is about two and a half years which is insufficient time to make a difference in relation to issues of quality and safety.

Wendy Savage lamented the poverty of attention given women by government, whose policies are determined by its subservience to big business. Vital services and precious NHS resources are being handed over to the private sector, including companies run for profit for shareholders here and overseas. Please go to the website Keep Our NHS Public set up by the NHS Consultants Association to oppose this disastrous trend. SO: It is very difficult to get maternity services onto the agenda of policy makers. I believe that part of the reason for this is a deep seated gender issue. A representative of the Royal College of Midwives made a plea for a women's Tsar, for which the time is ripe, since ministers are desperate for the women's vote. A midwife pointed to the huge savings that would be made by investment in normal birth for women.

An obstetrician again made the case for the ongoing sophisticated review of risk management and for the importance of in-service training with consultants present to team working. Training must incorporate the lessons learned from errors made in the particular unit. SO agreed that training programmes such as training in the management of shoulder dystocia being undertaken at Southmead Hospital in Bristol was critical to improved outcomes for babies and consequent reduced litigation costs.

TD: At the end of the year our labour ward secretary organises a sinners' round-up for members of staff who have failed to attend in-service training. SO: With the commitment of senior staff it is possible to reduce a unit's workload around training sessions - apart from emergencies. A midwife described the non-threatening "fire drills" with role-play held in her unit.

SO: The majority of reports that are received by the NPSA from NHS staff are through the local risk management systems. This is important as most action to rectify problems needs to happen locally. However the NPSA also has an e-form available for staff should they not feel able to report locally. Although reports of this sort that reach the NPSA are very small in number, they have a different profile with a much higher percentage of doctors reporting, indicating that doctors feel there is still a blame culture operating. The reporting system is confidential, and although we are able to identify the Trust generating a report we would never release that data except in extreme circumstances. We will be feeding information back to the Trusts and more broadly to the service and the public, but only in a form that would ensure that confidentiality is maintained. Counter-intuitively the higher the number of incidents reported, the safer the hospital. A nil return from a hospital would clearly indicate that staff were frightened or unwilling to report, which means that staff and management would be unaware of the risks they are facing, and so unable to address them. I would be unwilling to attend a hospital where there were no reports of patient safety incidents, and believe that the Chief Executive would urgently need to review and assess the situation in his organisation, for it probably signals an unhealthy bullying culture.

SO: Evidence worldwide from health and other safety-critical industries shows clearly that naming of staff who make mistakes drives error underground and brings the reporting of incidents to a full stop. The NPSA has never named everyone and the huge number of reports now being received would indicate a high level of trust in the organisation. Our job is to hold up a mirror to the service, not to blame individuals, which would be counter-productive. We are already seeing the value of this approach and are now able, following our alert on nasogastric tubes, to show a real impact on safety, with staff having the courage to report relevant errors.

SO: One of the issues that is emerging from the data is the failure to recognise general health issues of pregnant women in a timely way. A controversial question we need to ask ourselves is whether direct-entry midwifery has had an adverse effect on the quality of care, as necessarily these staff have different levels of training in general medical issues than those provided by the previous training pathway. This is not to criticise midwives, but a question for the service as to whether we are preparing them appropriately. Was this change risk-assessed when it was introduced, and if it was were appropriate mitigating actions put in place?

A consultant midwife, seconded to the DoH: Socially excluded women have the worst outcomes; they often fail to present to the services and our risk management seems to exclude them. The processes to focus the care where it is needed and the appropriate training are lacking; are there triggers for failed antenatal attendance, for unemployment, for multiple disadvantage - homelessness, a prison record, ignorance of the benefits system? Only if we are given the time to make relationships with women will the focus in the NHS move from hospital to women and families. SureStart provides good local examples, but this needs to be incorporated into the mainstream of practice. SR: I believe that the key will be the employment of specialist midwives to oversee this area of practice. Every unit should reflect on its CEMACH report and make necessary changes, particularly for care in the antenatal period. Unfortunately there is a lack of funding for this. SO: If targets are introduced it is important that appropriate resources are allocated to ensure their effective introduction. Failure to do this demoralises staff.

Reference.

Ball, J. & Washbrook, M. “Birthrate Plus. A framework for workplace planning and decision making for midwifery services.” 1997 London: Elsevier.