Final Report > Chapter 1: Introduction > Background to this Inquiry

Background to this Inquiry

1 The Bristol Royal Infirmary (BRI) and the Bristol Royal Hospital for Sick Children (BRHSC) [9] were and are teaching hospitals associated with Bristol University's Medical School. They looked after patients with heart disease: adults, children and infants. In this Report we are concerned particularly with congenital heart disease: babies born with heart problems, and their subsequent treatment.

2 Many such babies are at the very edges of survival. About half of the babies born with congenital heart disease need intervention to help them survive: without treatment their outlook can be bleak. Some, tragically, are beyond help. Over the years treatment became possible; in particular, surgery. One form of surgery, and the one with which we are most concerned, is open-heart surgery. Whereas with closed-heart surgery the operation takes place whilst the heart continues to beat, with open-heart surgery the heart is stopped while the surgery takes place. The blood supply to the child's vital organs is supported by a heart-lung bypass machine.

3 Heart surgery at any age is a risky enterprise. In babies only months old, surgical techniques are at the frontiers of skill and care. The heart, after all, at that point, is barely the size of a walnut. It is not just the operation itself, but the whole process of care, from initial diagnosis to aftercare, which is challenging and complex. Without care, the baby may die or live a short and increasingly blighted life. With care, the baby may live to adulthood and enjoy a relatively normal life, notwithstanding that further operations may be needed.

4 Over the decades from the 1960s, the skills and techniques involved in caring for those born with congenital heart disease have developed such that the very difficult has become almost routine, and boundaries of the possible have been continually pushed out. This is a tribute to the extraordinary skills and dedication of those working in this area of care: the surgeons, the cardiologists, the anaesthetists, the nurses, and the various technical support staff. But open-heart surgery on babies is a risky enterprise. It can never be free of risks: the more difficult the problem, the greater the risk.

5 Bristol had a group of clinicians who brought these developments in open-heart surgery to patients living in the South West of England and South Wales. This area historically had been neglected in terms of its share of the resources of the NHS. This neglect was reflected in the resources available for cardiac surgical care. National shortages in such specialists as paediatric cardiologists or paediatric nurses were, therefore, experienced more keenly in the South West. Moreover, shortages of resources were not only reflected in the revenue available to employ staff, but also in the capital available for buildings and equipment. But this was the NHS at that time. All who worked in it sought to transcend these difficulties.

6 In the early 1980s, the then Department of Health and Social Security (DHSS) established a system whereby certain very specialised services should be funded centrally. The aim was to concentrate resources and expertise. The system, establishing what were called Supra Regional Services (SRS), was intended to control the proliferation of units. This, in turn, it was hoped, would avoid the risk of too many units expending large amounts of resources doing only a few procedures. It would also mean that the clinicians involved would encounter a sufficient number of what were rare cases to acquire the necessary experience and expertise. Paediatric cardiac surgery (PCS) was one of the services deemed suitable for categorisation as an SRS. The service was, somewhat arbitrarily, limited to paediatric cardiac surgery on new-born and infant children up to 1 year of age. Bristol in 1984 was made one of the nine designated centres. At the same time, Bristol also continued to carry out heart surgery on children over 1 year old.

7 In 1984, therefore, at the start of the period of the years of our Terms of Reference, there was a designated service for babies under 1 year old, which involved open-heart surgery at the BRI and closed-heart surgery at the BRHSC. There was also a service funded from local sources for children over 1 year old, similarly divided between the two hospitals.

8 One assumption in the process of designation was that a unit should undertake a certain volume of cases to ensure good results in this very exacting field. The reasoning is readily understandable, if not proven: the more you practise, the better you become and the more likely you are, over time, to meet the complete range of what are, in any event, rare conditions. Bristol at the time of designation performed very few open-heart operations on children under 1. Over the ten years as an SRS centre, Bristol never achieved the numbers deemed appropriate.

9 Adverse comments about aspects of Bristol's performance surfaced from time to time. It needs to be appreciated, however, that the word `performance' was understood in different ways over time. On one interpretation, performance was equated with throughput (the number of cases treated). This was relevant both because of the assumption of a relationship between the volume of cases treated and the development of professionals' skills, and also because funding was based on treating a targeted number of cases. Performance could also refer to the quality of care, not least the outcome, be it recovery, residual disability or death. This is the meaning which patients, parents and healthcare professionals were concerned with, although it may not have been the meaning ascribed by others concerned to measure other things.

10 It was recognised in Bristol and in the DHSS that the circumstances under which PCS was carried out in Bristol were capable of improvement. From the early 1980s plans were laid to consolidate the service on one site in the wholly paediatric-oriented environment at the BRHSC. This would avoid the need to carry out the open-heart surgery at the BRI in a context in which children were treated and cared for alongside (and to a degree in competition with) adults. It was also planned to appoint a paediatric cardiac surgeon, that is, a heart surgeon who would operate only on children, and not, as was the case with the cardiac surgeons in Bristol, also carry out operations on adults with acquired heart disease. These plans did not come to fruition until 1995.

11 Meanwhile, from the late 1980s onwards, doubts and concerns about aspects of the performance of the Bristol Unit were increasingly expressed in a variety of contexts. Some of these concerns were expressed by healthcare professionals working in the Bristol Unit. Others were expressed by individuals in a variety of contexts outside the Unit. Concerns also circulated in the form of rumour and some appeared in the form of unattributed reports in the media. An operation performed on Joshua Loveday on 12 January 1995 proved to be the catalyst for action. Joshua died on the operating table. An outside review was instituted. PCS was all but halted until the new surgeon who had already been appointed was in post.

12 Complaints were subsequently made to the General Medical Council (GMC) concerning the conduct of two cardiac surgeons, Mr James Wisheart and Mr Janardan Dhasmana, and of the Chief Executive of the Trust, Dr John Roylance. They were found guilty in 1998 of serious professional misconduct. Dr Roylance and Mr Wisheart were erased from the medical register. Mr Dhasmana's registration was made subject to a condition, valid for three years, that he did not operate on children. The GMC's hearing was limited, both in terms of only examining the role of those appearing before it, and also in terms of the number of cases considered. It examined the cases of only 53 children of whom 29 had died and focused particularly on the Switch operation.

13 A group of parents of children who had undergone cardiac surgery at the BRI organised themselves to provide mutual support. In June 1996 the group first called for a Public Inquiry into the PCS services at the BRI.

Footnotes

[9] The BRHSC was also referred to in evidence as the Bristol Children's Hospital (BCH)