Final Report > Adequacy of Care

Adequacy of Care

Chapter 13: Introduction to Adequacy of Care

1 We are required by our Terms of Reference to reach conclusions on the adequacy of care provided at Bristol for those children undergoing paediatric cardiac surgery (PCS). We begin by drawing attention to some important points.

2 First, we concentrate on one particular aspect of the PCS service: care surrounding open-heart surgery on children under 1. It is this care which is the principal focus of concern about Bristol.

3 Secondly, while we may in what follows concentrate on aspects of the care which were less than adequate, because clearly Bristol did have a number of failings, we would not wish the impression to be gained that the PCS service at Bristol was always and in every regard of poor quality. While even now it is not possible to be absolutely certain about how many children received paediatric cardiac surgical care in Bristol between 1984 and 1995, the UBHT was able to identify at the Inquiry's request in 1999, the records of 1,827 children who had either open- or closed-heart surgery. The great majority of those children are alive today. We are anxious to record that, in a number of ways, the service was adequate or more than adequate.

4 The nursing staff, with few exceptions, were praised by witnesses for their dedication and caring attention. When this is set against a background of extremely constrained resources and a national shortage at the time of trained paediatric nurses, this is an achievement to be acknowledged.

5 Thirdly, we heard of the willingness to treat children whom other units seemed less inclined to treat. There is indirect support from the statistical evidence for this view in the case of children with Down's syndrome. [1]

6 Finally, we acknowledge the hard work, dedication and commitment of all those involved in the PCS service at Bristol.

7 In particular, we were sometimes amazed at how the paediatric cardiology service could have been maintained at all. The number of consultants was well below the recommended level [2] (indeed, for most of the period of our Terms of Reference, there was no paediatric cardiologist in the whole of Wales), they held clinics across a very large area, in the South West and South Wales, and they had no trainee posts to support them and provide cover.

8 Of course, dedication and commitment are sometimes not enough. This is one of the most important observations that we will make, such that it significantly informs what we say about the future in Section Two of our Report. As we have already said, this is not an account of bad people, nor of people who did not care. It is certainly not an account of people who wilfully harmed patients. Rather, it is an account of how people who were well motivated, failed to work together effectively for the interests of their patients, through lack of insight, poor leadership, and lack of teamwork. It is an account of a hospital where there was an imbalance of power, with too much control in the hands of a few individuals. It is an account of a service offering PCS which was split between two sites, had no dedicated PCS nurses, had no dedicated paediatric intensive care beds at the BRI, and had no full-time paediatric cardiac surgeon. And it is an account of a system of hospital care which was poorly organised and beset with uncertainty from top to bottom as to how to get things done, such that when concerns were raised, it took years for them to be taken seriously.

9 In keeping with our Terms of Reference, we separate our consideration of the adequacy of the PCS service at Bristol from the discussion of the concerns which were raised at the time about the care, and the responses to them. In the `concerns' section, we concentrated on the actions of those who formed the view that the service was not merely poor, or less than adequate, but unacceptable, such that something needed to be done. We also considered the responses to those actions. Here, however, we examine the extent to which the PCS service was adequate, or less than adequate, both as perceived at the time, and with the benefit of later analysis and hindsight.

10 In our consideration of adequacy, we focus on the care provided by the UBH/T to children over a period of 12 years. We are concerned with making findings about the overall pattern and quality of care, as provided at the BRI and the Children's Hospital, not to examine on an individual basis the care which each and every child received over time from the NHS.

11 We make no findings as to the care of individual children. We take account of particular cases, but as exemplars of patterns of conduct. This is how we approach the notion of adequacy, as we now explain in greater detail.

12 We turn now to what we mean by adequacy. The term `adequate' does not just refer to common practice. It is ultimately a judgmental term. Thus, it is not open to someone to say that a practice was adequate, as we use the term, simply because it conformed with what everyone else did. Otherwise, adequacy would lose any real meaning or force, since it could come to represent the lowest common denominator of practice. Equally, however, adequacy must not be confused with best practice. While all may strive to be best, by definition not all can be best.

13 To be adequate, therefore, a practice or service must meet some standard of quality, without necessarily being the best. To say that care, to be adequate, must meet some standard of quality invites the question, where does that standard come from? If there are standards set out by some body or group, the task is made much easier. A practice or service is adequate if it meets those standards, provided (and it is an important proviso) that the standards themselves are reasonable and not merely designed to serve the interests of the particular group. If there are no such agreed standards, the standard of quality comes from the input of two groups in particular: those providing the service and those receiving it. It represents an assessment of what, from their differing perspectives, they would regard as acceptable. Where technical skill is involved, it represents not what an individual professional may do or would have done, but what, in the view of professionals generally, they should do or should have done at the time. In reaching that view, they must take account not only of their own professional opinion but also of the opinion of the wider community. Where no technical skill is involved, the approach is different. No technical skill is required in, for example, treating people with respect. Yet it may be a crucial ingredient in the adequacy of a practice or service. Whether a service is adequate or not then depends on what parents, patients and the public are entitled to expect of those who serve them: not what they do expect.

14 We have sought to ensure that our views are grounded in the conduct and the reality of the time covered by our Terms of Reference. We have asked ourselves whether, at that time and according to the standards of the time, from the perspective of clinicians, managers, parents and the public at large what was done in Bristol would have been regarded as acceptable. That things were done differently elsewhere, for the better or worse, while not conclusive, may help us reach a view.

15 A central question which arises in the case of the clinicians is how does an Inquiry, looking at the care offered by a hospital over a period of 12 years ending some six years before the publication of this Report, establish whether others at that time would have regarded what was done in Bristol as acceptable? If adequacy is, as we have said, a judgmental term, the judgment is that much more likely to be accepted if it is made against the background of a set of agreed national standards of care. Clearly, as regards matters of technical expertise, if all professionals had agreed on what was best practice, what was unacceptable, what was poor and, by implication, therefore, what was adequate, it would be easier to assess the adequacy of care at Bristol, at least from this point of view. But, during the whole of the period of our Terms of Reference, and even today as we write this report, no such standards exist as regards paediatric cardiac surgical services.

16 Professionals in the various specialties in Bristol, of course, have their views as to what constituted adequate care from the point of view of technical skills during the relevant period. Indeed, we have looked to some of them to advise us as our Experts. But, the absence of any agreed, established and monitored standards, meant that at that time any particular clinician had no real benchmark against which to judge technical skill and performance. There was very probably a sense of what amounted to good practice. And, there were, of course, approximations of such benchmarks in the form of reports based on the information held in local and national databases, and results presented at professional meetings and published in journals. But, these were universally regarded with some scepticism as not representing a true picture of performance. It was acknowledged that when a unit encountered poor results, these were rarely published. Moreover, not every unit submitted regular returns of its performance to the Register kept by the Society of Cardiothoracic Surgeons of Great Britain and Ireland.

17 One option open to us was to examine, for the purpose of comparison, paediatric cardiac surgical services as provided in hospitals in England at that time. We deliberately chose not to take that route. It would have been a very difficult undertaking: it would have involved taking evidence from those hospitals; it would not have been possible to complete such an examination within a reasonable timescale, and it would have been quite unjustifiable in terms of the burden of cost it would have placed on the respective hospitals. [3] We opted instead to draw extensively on the views and assessments of experts who were in practice at the relevant time in all parts of the country. In the absence of agreed standards of care in place at that time, we sought to try to create a notion of such standards through the experience and knowledge of a wide cross-section of experts who could reflect on practice at that time. In short, we have sought to bring a true sense of comparative judgment, by hearing the views of a wide range of experts as to what they think was acceptable during the time covered by the Terms of Reference. We accept, of course, that this is a poor substitute for having agreed standards. But, we repeat, none existed.

18 We need now to remind ourselves that adequacy is not concerned only with the exercise of professional skills and the existence of professional standards dealing with technical skills. It is also about common standards of behaviour. It is about how people behave and what parents, patients and the public experienced. These are of no less importance in guiding us to our conclusions. We need, therefore, to get a sense of what happened to the children and parents in Bristol and ask ourselves whether their experience was such as to brand the paediatric cardiac surgical (PCS) service less than adequate by the standards of the time. That parents may not have complained at the time is not conclusive on this question. What we need to ask is whether, according to the standards of the time they would have been entitled to do so. This discussion of what adequacy may mean makes it clear, as we recognised from the outset, there could be no single template against which the adequacy of the service at Bristol could readily be assessed. Equally, we recognised there was unlikely to be one source of evidence which on its own would produce an answer. So, we have had to build up a picture of adequacy based on evidence from a variety of sources: the clinicians involved and their professional bodies, the UBH/T, the Department of Health (DoH) and the health authorities, from the parents of children who died and children who survived, and from our Experts. At all times we have had to distinguish between that which was known (or knowable) at the time, and that which it has only been possible to see and understand with the benefit of hindsight. For example, we could come to the view that, with the benefit of hindsight, the PCS service in Bristol was poor and should never have been encouraged or developed. But coming to that view now is not the same as saying that it could have been reached at that time. We are concerned with how the PCS service was viewed during the time of our Terms of Reference and how it may be viewed now.

19 Some may say that we could reach a view on the adequacy of care at Bristol simply and conclusively by comparing statistically the outcomes, in terms of mortality rates, at Bristol with those of other centres. But this ignores the fact that, in relation to such data as were available at the time, there were no agreed standards against which to judge it. That another unit was at some point in time several percentage points better or worse than Bristol says little unless the data are properly comparable and there is some agreement as to what percentage outcome is unacceptable or poor.

20 We did commission our own statistical analyses and the Clinical Case Note Review. But these, of course, inform us from the perspective of hindsight. The conclusions were not known at the time. Thus, while they allow us to reach a clearer view of the adequacy of PCS services in Bristol at that time, they cannot, on their own, be the basis for criticism of what was done between 1984 and 1995.

21 Finally, we must raise here one further aspect of our approach to adequacy. We have to decide whether care was adequate. As part of this process, we have to decide what were the elements or factors which made it more or less so. We have to identify what went wrong, since clearly there was something wrong. The traditional, widely held, but crude notion is that when something goes wrong, it does so because it is caused by and is the fault solely of the people directly involved. In our context, it would suggest that if a patient were to suffer harm while undergoing surgery, the surgeon would be the person at fault. In this traditional, `person-focused' approach, the response when something goes wrong is usually to seek to identify who can be blamed as causing the event, and then to apply a suitable sanction. The difficulty with this traditional approach is that it ignores the fact that individuals work within systems. Merely to adopt a simplistic approach to causation and, as a consequence, to sanction or remove an individual, without addressing the need to review and change the system, virtually guarantees that the error will be repeated. We have avoided this approach. Instead, we have been guided throughout by what has come to be known as the `human factors' approach, as a means of understanding how systems which are concerned with preventing harm in fact work and why they break down. The human factors approach has been defined as the study of the interrelationships between humans, the tools they use, and the environment in which they live and work. [4] It is more subtle, sophisticated and comprehensive than the `person-focused' approach. Human factors (or systems) analysis adopts an approach in which lapses in safety, in the form of errors and poor performance, are seen as the product of systems which are not performing well. Remedial action, therefore, lies in analysing the system and identifying all those factors which led to, or contributed to, the error. In other words, a much more comprehensive approach to causation is adopted. This does not mean to say that the performance of individuals is excused or overlooked. Rather it means that understanding all the factors which lead to an individual's performing in a particular way makes it more likely that the error will not be repeated. In our context, it means that we will obtain a more rounded and informed understanding of the extent to which the care in Bristol was not adequate and where the inadequacies lay.

22 When systems analysis is applied to any situation in which performance is poor, or where things go wrong, there are two elements which need to be considered: active failures and latent factors. Active failures are the more obvious events closely and directly connected to the error. They include slips, lapses and mistakes. An example is leaving a swab in a patient after an operation. This is traditionally what is regarded as `the error', and thus the sole cause of the problems that follow. But systems analysis suggests that behind the active failure sit what are known as latent factors, the systems and circumstances which, in our example, led to the swab being left behind. These factors, each of which plays a role in causation, may range from the working arrangements within the operating theatre, to communications between members of the team in the theatre, to the long hours worked by some or all of the staff, to the morale of the team. The thrust of the approach is that it is these systemic factors which must be understood and addressed. If they are not, the pattern of unsafe factors which led to the swab being left behind will continue to be repeated.

23 We endorse and adopt this approach for a number of reasons. We find it intellectually persuasive. We believe it is right to move away from an approach built exclusively around focusing on a single particular event and naming and blaming individuals. We say this not because we wish to shirk an unwholesome task but because such an approach does little to improve the safety and quality of care. Moreover, we regard systems analysis as offering critical insights both into understanding what happened in Bristol, and what we should learn from Bristol for the future.

24 Our approach to adequacy, therefore, is multi-factorial. There is a range of factors which, taken together, allow us to reach a view about the adequacy of care in Bristol. As we said during the Hearings, we liken our task to piecing together a jigsaw. Each factor is part of the jigsaw puzzle, but it is only when all the factors are put together that the full picture emerges.

25 To build up the picture of what happened in Bristol, we have divided the evidence which we received into a number of strands. Most of these strands relate to what was or could have been known contemporaneously during the period of our terms of reference. This evidence allows us to take a view on the extent to which those in Bristol at the time could form a view as to whether the service which was provided was adequate. Other strands of evidence reflect the perspective of hindsight. They include the comments of our Experts and the research commissioned by the Inquiry. They allow us to reach a view now about the adequacy of care in Bristol, but a view that was not known at the time. The evidence that we will examine relates to the following:

• the approach, nationally and locally, to the notion of clinical quality;
• the management of the UBH/T;
• the organisation of the PCS service in Bristol;
• the experience of parents;
• the views of the healthcare professionals in Bristol;
• reports and advice from the Inquiry's Group of Experts;
• the statistical analyses of clinical performance; and
• the Clinical Case Note Review.

26 We do not analyse each of these separately. That would be to produce a disjointed account which would obscure the interlocking nature of the various strands of evidence. Rather, in what follows, we group the evidence under a series of more general headings.

Footnotes

[1] Mr John McLorinan, father of Joseph, told the Inquiry that he moved back to the area as the BRI, unlike some other hospitals, was prepared to operate on his son, who had Down's syndrome. T2 p.2 and T2 p.160. See also Annex B. Papers 6b and 7c by Dr Aylin et al

[2] See the evidence of Drs Swanton and Godman, regarding recommended levels in the late 1980s and early 1990s. At Bristol, until Dr Martin began cardiology work in February 1989, Drs Joffe and Jordan carried the whole of the paediatric cardiology workload between them. T7 p.25 and T7 p.80

[3] See Annex B, 5e Inquiry paper `Note on supplementary analytical work - March 2000'

[4] Weinger MB, et al. `Incorporating Human Factors into the Design of Medical Devices'. `JAMA', 280(17); 1484, 1998