In this section of the report, we build on existing knowledge to develop the themes from our casework. We then make our call to action for a range of organisations in our ‘learning points’ and in our recommendations.
Complaints to the Ombudsman are not necessarily representative of usual care – they are selected particularly by outcomes that are poor (or at least worse than expected), and dissatisfaction with the service. These case stories do not represent the overall standard of care in the NHS. We acknowledge that clinical teams cannot enjoy the benefit of foresight when they manage these very challenging cases. But a number of themes emerge from these stories that resonate with what is known about how things go wrong in the care of dangerously ill patients.
While selection bias may have influenced our analysis of the failings in these cases, the following recurring shortcomings are of particular note and concern:
- lack of timely history and examination (including adequate nurse triage) on presentation
- lack of necessary investigations
- failure to recognise the severity of the illness
- inadequate first-line treatment with fluids and antibiotics
- delays in administering first-line treatment
- inadequate physiological monitoring of vital signs
- delay in source control of infection
- delay in senior medical input, and
- the lack of timely referral to critical care.
These shortcomings can be summed up as inadequacy of initial assessment, failure to recognise critical illness, and consequent delay in emergency treatment.
What is already known
The learning points from these cases are not new. For example, in 2007 the National Patient Safety Agency published an analysis of acutely ill patients reported to them as having died following shortcomings in medical care. They concluded that staff can take too long to recognise that patients are deteriorating and do not always act to address this once identified; and that the right staff are not always available. In the same year, the National Confidential Enquiry into Patient Outcome and Death reported a review of emergency hospital admissions: 35% did not receive care consistent with good practice; in 7% the initial assessment was poor or unacceptable; 49% had not been seen by a consultant within 12 hours; and 8% did not receive observations appropriate for their condition. The lack of improvement resulting from these previous initiatives is disappointing.
These aspects of NHS performance must be improved, and systemic attention is required. Quite apart from the lives that can be saved and the improved experiences of patients and their families, there are substantial potential savings in healthcare costs. The UK Sepsis Trust estimates that there are some 100,000 hospital admissions for sepsis each year, with an average cost of about £20,000 each. Just following the ‘sepsis six’ principles (Appendix 1) could save some £4,000 per episode; the potential total saving, even after taking account of the increased costs related to improved survival, amounts to £196 million a year.
The findings in this report raise questions about why standards are not being met. This is not to do with ‘bad people’. Workplace challenges faced by doctors and nurses are likely to be relevant. So too is the issue of delay in senior clinical input. The skills necessary for early identification of patients at risk of severe sepsis are high level, and develop with long experience. Some senior consultants are concerned that the very processes that have been put in place by the NHS to improve quality and consistency may have had unforeseen consequences. For example, protocols and care pathways which seek to (and certainly do) reduce omissions and improve documentation of care may lead to a ‘tick-box mentality’, and the loss of critical thinking skills and clinical acumen. There are real problems of access to the many guidelines and policies, and some clinicians find it difficult to keep up-to-date.
The key learning point to be drawn from this report is the pressing need to address these shortcomings in a systemic way. Importantly, that is about the attitudes and values individuals bring to their work, the way that they interact with their colleagues, and how they behave – their working culture.
While much of the emphasis is on what happens in emergency departments, these clinical challenges also present to primary care, the ambulance service, and on hospital wards. Action is necessary to ensure compliance with standards throughout the healthcare system in a way that joins up its various parts. These are set out in our learning points on page 49 following this discussion. The UK Sepsis Trust and the College of Emergency Medicine have given detailed consideration to this and their evidence is included at page 60.
Standards are set nationally but implemented locally. Actions need to be taken at many levels. These include the NHS Commissioning Board, regulators of healthcare, the Royal Colleges responsible for professional education and training, NHS trusts, local commissioning groups and individual clinical teams. Leaders in the NHS should consider how services can be organised more effectively, staff supported better, how that can be overseen by NHS trust boards, and how healthcare regulatory organisations can be charged with addressing these issues during service reviews.
Organisations need to be aware of the pitfalls of unintended consequences when making illness-specific changes. More general changes should improve the care of other acute situations as well. Robust systems should include ‘safety net’ arrangements. In the following paragraphs, we break down some of the individual issues we have identified.
The initial assessment
The first interaction between someone coming to an emergency department and the service is the nurse triage – the immediate assessment by a nurse of the patient’s problem and condition.
Problems encountered include this being undertaken poorly, perhaps with no track and trigger early warning score being calculated, or necessary action not being taken. The cases of Mr F and Mr E (pages 12 and 25) particularly illustrate these issues. This leads to delay that is potentially disastrous in the care of the critically ill. The standards that apply are set out in general terms by the Nursing and Midwifery Council’s Code of Conduct (NMC’s Code of Conduct), and specifically in guidance on the management of the acutely unwell patient.
Emergency departments are busy, and sometimes chaotic, places. Staff must often prioritise in difficult circumstances, and decide which of several important and urgent tasks they should do next. The same issues apply to acute medical units and clinical decision units, where many such patients are managed. Assessment is not always straightforward. For example, some patients, particularly the elderly and those with neutropenia (as in the case of Mr C, page 32), may have severe infection without raised temperature. The features can be relatively nonspecific – patients can be sicker than they look – so the urgency of the situation is less obvious than in those with trauma or other medical emergencies. The real difficulties in picking out the relatively small proportion of patients with infection who are progressing to critical illness should not be underestimated. Improved clinical process should lead to a greater appreciation of the potential risks for patients with apparently uncomplicated infection.
Delay in implementing treatment plans, particularly fluid and antibiotic administration, are a concern as well. In the urgent situation, the prescriber has a responsibility to ensure timely administration.
Problems with medical review – particularly delay, failing to consider all relevant available information, and inadequate investigation – were recurring features in these stories.(The differing ways in which clinical teams had difficulty with diagnosis are particularly illustrated by the cases of Mr C, Mr D, Mrs K, Child B and Mrs G.) The inevitable consequence was delay in constructing an optimum treatment plan. The applicable standards are set out in general terms by the GMC guidance on good medical practice. This aspect of the service can be improved by sufficient levels of staffing, more readily available senior medical staff, better support for junior staff, improved training, the use of protocols and care pathways, and regular service review and audit. The timely availability of senior staff is crucial both to good patient care and the supervision and support of trainee doctors. This is being addressed nationally by such initiatives as ‘the seven‑day hospital’.
The various and complex characteristics of good practice are brought together in the sepsis care bundles, and they should be applied universally. There are striking differences between hospitals in adherence to guidelines. In institutions where there is no sepsis care pathway, or where audits show non‑compliance with the College of Emergency Medicine standards, the increased risks should be reflected by an entry in the trust’s risk register.
After admission to hospital
Some of the case stories, particularly those of Mr C, Mrs A, Mrs K and Mrs G, illustrate the difficulties experienced when sepsis develops on hospital wards some time after admission. Important information becomes available at different times and from various staff in a way that is different to the focus in emergency departments. The care setting is less acute, and access to senior staff less immediately available. The UK Sepsis Trust has carefully considered how this might be addressed (Appendix 2).
‘Early warning scores are not an option – they are essential to identify the deteriorating patient.’
Royal College of Physicians
Before reaching hospital
Just as the similarities between the early stages of severe sepsis and other more common self-limiting conditions (for example, flu) make recognition difficult for health professionals, they also make it hard for patients to know when they may be in serious trouble. The UK Sepsis Group has suggested a helpful list of warning signs:
- Slurred speech;
- Extreme muscle pain;
- Passing no urine;
- Severe breathlessness;
- ‘I feel I might die’; and
- Skin mottled or discoloured.
To these might be added a feeling of faintness on sitting or standing. But these are not easy health education messages to get across.
Most of these case stories describe problems encountered in hospital. But that of Mr D (page 22) occurred in a general practice setting. There are questions about the adequacy of clinical assessment in primary care, and the recognition of severe sepsis and critical illness. Early warning scores are generally used only in hospital. GPs need to ensure that immediate lines of communication with appropriate specialists are open for advice.
While we have not received complaints about the management of severe sepsis by the ambulance service, there are opportunities for care to be improved before patients arrive at hospital. That becomes more important when journey times to hospital are longer. Assessment could be improved – most ambulances do not have facilities to measure temperature.
Early warning scores are not calculated out of hospital. It should be possible to develop protocols for the administration of large-volume fluids in pre-hospital care, and there is scope to extend the circumstances in which paramedics could give antibiotics.
Education, training and research
Ethical considerations have made it difficult to do prospective clinical research in critical illness, but there is an overwhelming specialist consensus that in severe sepsis, early fluid resuscitation and antibiotic treatment improve outcomes. The delays experienced in the stories described here are in large part a consequence of shortcomings by doctors and nurses, and are the major cause for concern. The specific standards applied by the Ombudsman are the Surviving Sepsis Campaign’s guidance on immediate care, which was previously accepted by NHS Evidence. Again, the service issues should be addressed by training, support and supervision of junior clinicians, the use of care pathways, and service review.
There are many valid research questions in improving understanding. Those particularly important at the moment include optimal fluid resuscitation; the development of clinical tools in and outside hospitals, which would be highly predictive of severe sepsis; the development of technology to allow patient testing for blood marker indicators of severe sepsis and causative germs at the bedside; and the reasons that clinical teams do not adhere to guidelines.
The immediate administration of antibiotics in severe sepsis is essential. Delay in giving antibiotics leads to worse outcomes in severe sepsis (a four-hour delay in administering antibiotics increases mortality from 15% to 45%). At the same time, the wider context of antibiotic use has to be taken into account. Indiscriminate overuse of antibiotics leads to an increase in antibiotic side-effects – some of which are serious, for example, Clostridium difficile diarrhoea (C.diff). There is international concern about the increased emergence of bacteria resistant to commonly used antibiotics, for example, methicillin resistant Staphyllococcus aureus (MRSA), which is particularly a feature of health systems where the use of antibiotics is less regulated. These factors are drivers to reduce antibiotic prescription, and must be reconciled with the equally important need for immediate antibiotic treatment for the seriously ill. Microbiology departments should inform appropriate antibiotic choices for their local care pathways. But sepsis is not only about hospital acquired infections – it is about the recognition of dangerous deterioration in patients whose infection was acquired in the community.
The examples of poor communication between doctors and other healthcare workers within a team raise questions about the organisation, functioning and working culture of these services. Good clinical records are essential for safe communication between the several clinical teams that will usually be involved in the care of critical illness – poor records are a risk for adverse events and reflect badly on the quality of the service. The relevant standards are those of the GMC and the NMC professional organisations.
The audit of clinical practice against clear, agreed standards, including the monitoring of clinical outcomes, is an important driver to improving care. The College of Emergency Medicine audit described in Appendix 2 is a good example. Death is easy to measure, but is influenced by very many factors apart from the quality of care. Better measures of clinical performance are the intervals leading up to key treatment interventions, for example the ‘door to needle time’ that transformed the care of heart attack a generation ago. In sepsis, the time intervals from arrival to the administration of large volumes of fluid and antibiotics are important measures and should be recorded routinely. Benefit from audit is greatest when it is conducted widely rather than locally, ideally with national collection of data.