Annex A > Chapter 18 - Medical and Clinical Audit > Audit at district and unit level > The BRI and the BRHSC after 1991
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The BRI and the BRHSC after 1991
The involvement of management in audit
273 In April 1991 the creation of the UBHT and the separation of the functions of purchaser and provider meant that the Trust as provider had primary responsibility for the development and implementation of an audit programme within its hospitals. This responsibility was imposed as a term of the `contracts' with the purchasers. [330] It was also a product of the need to account for the use of `ring-fenced' funds that, until 1994/95, were allocated by the DoH and distributed locally specifically for the purpose of carrying out audit. [331]
274 The organisation and development of audit within the UBHT differed from that of the other trusts within the region, which were smaller. Consistent with the Trust's policy of decentralisation, the budget for audit and the responsibility for the employment of audit assistants was devolved to directorate level and from there to the specialties. The Trust adopted the philosophy that medical audit should be the responsibility of specialty divisions, or departments, and not necessarily the responsibility of individual directorates. [332]
275 Dr Thomas told the Inquiry that this approach was adopted following considerable debate:
`From my memory I think that all shades of opinion were voiced. People were, I think, worried or concerned about the prospect of audit being undertaken in a way which did not allow them to guide it or to be the owner, if you wish, of the process and the information.
`We looked at the Regional Health Authority's pronouncements and the Working Paper 6 for guidance and it seemed to us that if we were to reassure colleagues and actually persuade them to pursue audit and gain the benefits from it, that we had to actually allow them to build their own audit process within their specialty. That, we felt, would assuage their concerns quite considerably, but there is no question in my mind that concerns continued for the whole of my time as the Chairman of the Audit Committee, and there was a constant need to reassure people [individual clinicians] that confidentiality would be protected ...' [333]
276 The NHS Working Paper No 6 had stated that:
`The [audit] system should be medically led, with the local medical audit advisory committee chaired by a senior clinician. The overall form of audit should be agreed locally between the profession and management ...'. [334]
277 The Working Paper envisaged that management should be aware of audit results:
`... the general results of [medical audit] need to be made available to local management so that they may be able to satisfy themselves that appropriate remedial action is taken when audit results reveal problems'. [335]
278 There was neither definition nor further explanation of what the phrase `general results' meant.
279 The Working Paper also envisaged that management had a role in ensuring that effective systems of audit were in place:
`While the practice of medical audit is essentially a professional matter, management too has significant responsibility for seeing that resources are used in the most effective way, and will therefore need to ensure that an effective system of medical audit is in place.' [336]
280 Furthermore, the draft Health Circular `Medical Audit and the Hospital and Community Health Services' [337] suggested that there was an obligation on the Audit Committee from the outset to provide regular reports to management as well as medical staff on the results of any audit being carried out:
`These may, for example, include:- a broad outline of the aggregate result, together with any national, regional or other comparisons available.' [338]
281 The NHS Management Executive's later report entitled `Clinical Audit' also described the Government's expectations of managers. On the one hand, the Government encouraged managers to be involved in audit and, on the other, they recognised that parts of audit were best left to the professions. The document stated:
`Managers need ... to be actively involved in the audit process, this being particularly important as deficiencies revealed by audit relate more often to the running of the organisation than to poor quality professional practice. The more managers are involved in the audit process and its organisation the more likely they will be committed to securing the necessary improvements in care.
`For their part managers must recognise that some aspects of audit are best carried out in complete confidence by the professions concerned, thus ensuring that more sensitive issues are not avoided.' [339]
282 In relation to the role of the chief executives of trusts the report continued:
`The Chief Executives of provider units have overall responsibility for the quality of care provided for patients and must therefore have confidence in the local audit programme.' [340]
283 However, no evidence was put before the Inquiry of any formal indication as to what information was to be circulated to management. It was primarily for the clinicians to determine what information was passed up the chain in order to support a case for particular changes to be made within a hospital. [341]
284 Dr Morgan stated that it was fair to say that there were no clear guidelines about which audit results could be passed on to management within trusts and health authorities. He reported that in the early 1990s the clinicians were, in effect, in a position to choose what was reported to management and the health authorities. He stated in his written evidence to the Inquiry that this began to change later in the 1990s `and is still evolving'. [342]
285 Mr Graham Nix [343] also agreed that it was a matter for the clinicians involved in a particular area to keep abreast of their relative performance. He told the Inquiry that the senior management within the Trust kept abreast of relative performance for things such as waiting times and the outcomes of the Trust's services compared with others, but that there was no information on outcomes and no other `top management' mechanism for monitoring relative performance of any particular specialty in the Trust. [344] Had there been such a mechanism, Mr Nix indicated that it would have fallen within the jurisdiction of the Deputy Chief Executive for clinical issues (Mr Wisheart), [345] since he (Mr Nix) was concerned only with financial and administrative matters. [346]
286 Dr Roylance stated that regular reports were made to the RHA for the purpose of demonstrating that audit was taking place, which subjects were being reviewed and what, if any, action was being taken to improve the quality of care. However, he went on, detailed results of audit were not communicated to the District or the RHA, because to have done so might have threatened the process and co-operation of clinicians. [347]
287 With respect to the role of management, he stated:
`... the primary responsibility of management was to ensure that audit was being introduced and conducted and that the requisite resources were made available. It was clear from both Regional and national guidance that managers were not to be directly involved in audit and that the actual audit figures were to remain confidential to those providing the service, i.e. the clinicians. Indeed, it was thought that any attempt by the management to become directly involved in audit or the results of audit would seriously inhibit the development of the audit process. Instead, those conducting audit were responsible for identifying any areas which needed management intervention and then for informing management of what intervention was required. Implementation of the process of audit was overseen and monitored by a Trust Audit Committee which reported through the HMC to the District [Regional] Medical Officer.' [348]
288 Sir Barry Jackson told the Inquiry that the attitude within many hospitals, in the late 1980s and early 1990s, was that management should not be a party to audit. He said that there was widespread opinion that audit was a confidential matter between the clinicians concerned. [349]
Devolution of responsibility
289 Dr Roylance had a policy of devolving responsibilities for audit to the specialty level. This devolution was a consequence of the Trust's philosophy of decentralisation generally. [350] He stated:
`Audit took place on a specialty basis, with each specialty committee or division taking responsibility for deciding how audit was to be arranged and the resources required in terms of clinical time, clerical and secretarial support, information technology and training and education.' [351]
290 Referring to medical audit, which was subsequently superseded by clinical audit, Dr Roylance explained that it was controlled professionally rather than managerially:
`... medical audit was introduced on the professional network from the Regional Medical Officer [RMO] and his Regional Hospital Medical Advisory Committee to the consultants within the staff, through the Medical Committee and their divisions; it was not through the management process; it did not come from the Regional General Managers.' [352]
291 This meant that audit was introduced directly to the consultants by the RMO, and it stayed at divisional level within the directorate when the clinical directorate structure was introduced and stabilised in the UBHT, and when medical audit was being changed to clinical audit. [353]
Views expressed on the devolutionary approach
292 Dr Thomas expressed the view that the devolutionary model worked well. It was, he told the Inquiry:
`... a very logical way to proceed. It maintained the contact between like clinicians who had similar problems and could therefore explore them. One of the problems of audit was always how does a single-handed practitioner audit, and that was always difficult to do and had to be done on a cross-district or cross-region or whatever basis. So if you bring people together with a common area of interest, then that is perceived as concentrating your skills into a group that can improve its practice, can identify problems and so on and so forth.' [354]
293 Dr Baker referred to what he saw as both the strengths and weaknesses in the UBHT's approach:
`I suppose the counter-weakness ... was that where one wanted co-ordination of competition for limited resources for audit assistants, some perhaps prioritisation of areas for audit, then there was not a ready mechanism for that taking place.
`The counter would be to say that in my experience of some audits with other Trusts, where the Audit Committee masterminded arrangements more so, at least from a purchaser point of view that could seem to be over-controlling and exclude to some extent our ability to make contact with clinicians to talk about audit areas.' [355]
294 Dr Walshe, as one of the Inquiry's Experts, told the Inquiry:
`... I think it might be helpful to refer to some of the research and evaluation that we did here. One of the things that we looked at in our survey of all Trusts in 1993 was whether Trusts had devolved the process to directorates and devolved the resource as well to directorates, or whether they had a central function. I think we found from memory about ten percent of Trusts had chosen to devolve the process wholly or largely to directorates. The great majority had established some kind of central audit function, quite often with a link then to directorates, so individual audit staff would serve particular directorates, for example. In that report ... we argued that the devolved model was not a good way to go, for a number of reasons: because it fragmented the resource across areas, it made it much more difficult to do anything across directorates; it was hard to monitor and there was some evidence from our survey that directorates did not necessarily use the resource for clinical audit as it was intended to be used, and it led to some very isolated audit and quality improvement staff. So we felt that a centrally led model, particularly in the early days of clinical audit, was much more appropriate.' [356]
295 Dr Walshe confirmed that Bristol was not one of the trusts involved in the research. However, he pointed out that:
`... we looked at some very large acute Trusts and also some smaller acute Trusts. We looked at community Trusts and combined Trusts that combined medical health and acute services.' [357]
296 Dr Walshe acknowledged that he was:
`... quite cautious about imposing a particular shape to the process on a Trust, because one of the things the research suggested was that it was very dependent on the local context; it was hard to prescribe that "this is the best way" of organising and auditing an organisation.' [358]
297 Mr McKinlay stated that although the structure kept the confidence of the consultants it also presented many opportunities for variations in procedures. [359]
298 Mr Hugh Ross, [360] currently the Chief Executive of the UBHT, told the Inquiry that a properly monitored institutionalised system of audit was lacking. [361]
299 Dr Jill Bullimore, Chair of the Clinical Audit Committee 1995/96, noted that the lack of central co-ordination also resulted in difficulty in obtaining information for audit reports. [362]
300 Mr Ross said that he recognised a problem in the lack of ownership for audit when he succeeded Dr Roylance in 1995. He said that no one was:
`... actually managing and gripping it [audit] in a way that I felt was necessary.' [363]
301 One consequence of devolution was that any money allocated by the Trust for audit activities was distributed to the directorates for their use. Consequently, the Audit Committee had no resources of its own. [364]
Audit committees
302 Dr Thomas informed the Inquiry that the existing District Audit Committee (DAC) became the UBHT's Medical Audit Committee (MAC) in 1991:
`I was ... the Chairman of the District Audit Committee of the Bristol & Weston Health Authority which was subsequently renamed the United Bristol Healthcare Trust Medical Audit Committee.' [365]
303 The membership of the MAC was identical to that of the DAC, save that Mr Dean Hart was replaced by Dr M Whitfield, a GP representative. Dr Thomas remained as the Chairman. [366] The constitution of the two committees was identical. [367] After the end of his formal three-year term of office, Dr Thomas remained the Acting Chairman until mid-1994. [368]
`It was a time of great concern and considerable controversy and new initiatives tended to be viewed with suspicion by both medical staff and management. To set up audit at this time was particularly difficult. It was essential to reassure consultant staff that they could "own" the audit process and the data which they accumulated.' [369]
305 Dr Thomas took the view that the MAC was there to `establish a formal audit function within the UBHT'. [370]
306 He also expressed the view that it was the role of the MAC to:
`ensure funding for audit was spent on audit, but not to scrutinise outcome figures or mortality statistics so as to be able to determine whether or not those were acceptable but rather whether the process of audit was being carried out.' [371]
307 Dr Roylance said that the MAC's purpose was: `...To facilitate and monitor development of an audit process.' [372] And to: `...obviously have a role in advising the Trust Board, probably via the Medical Director.' [373]
Its role, he said: `... would be a supportive one to Directorates' because in future, clinical audit will form an important part of contracts ...' because Dr Roylance `agreed that it was the Clinical Director's role to run the Directorate and the Audit Committee's role was to monitor audit.' [374]
He recognised that there was: `... a requirement for the development and nurturing of acceptable outcome measures ...' and accepted that: `It was clear that members had some concerns that the Committee had no specific resources and that its influence on the conduct of audit would necessarily be an indirect one.' [375]
`... the Chairman of the Audit Committee was clearly responsible for informing me as the Chief Executive, directly and urgently if necessary, if any management action was required for the introduction [of audit] ... and in theory, to deal with any adverse result of audit, although that was necessarily some time in the future.' [376]
309 Further, he told the Inquiry that he considered that it was the responsibility of the Chairman of the MAC to satisfy himself that the process of audit was being carried out:
`... it was very much divorced from me. This was a function that consultants were charged with pursuing, overseen and monitored by a committee which was a committee of consultants and at that time a subcommittee of the Medical committee. My role was to respond to any management action that arose thereby. It would have been quite counterproductive for me to monitor audit.' [377]
310 Dr Roylance said that if, for example, a Unit failed to carry out the process of audit, that would not be a management issue which would involve him:
`No, it would not and quite specifically not, but if the Chairman of the Audit Committee required my assistance, he was charged with asking for it and he did on a number of issues. You ... appear to be inviting me to jump into a position whereby management at that time had direct responsibility for audit. Curious as it may seem at this stage, it did not.' [378]
311 These issues were addressed in the Chairman's remarks in the 1993 MAC report itself:
`The devolutionary process which has lain at the heart of the Trust's operational philosophy has, in the past, made it quite difficult for the Audit Committee to influence and record audit activities. As the Regional Audit Team observed, the Audit Committee has no budget and is not made up of clinical directors. ... It seems likely that these parameters and limitations will also be a frame within which the new Clinical Audit Committee will work. The new Committee may well wish to establish a role in the co-ordination of audit projects across the Trust. It may also wish to play some part in the assessment of the quality and effect of audit projects. These objectives are highly desirable but will remain difficult to achieve unless some agreement can be made between senior management and the Clinical Audit Committee as to the future of audit in the UBHT'. [379]
312 Audit activities were organised at the clinical directorate level, and were monitored and co-ordinated by the MAC. The MAC prepared an annual report based on the returns from all the specialties, which was then submitted to the RHMAC and to the Chief Executive of the Trust. [380]
313 The MAC's terms of reference included the requirement that it `...notify the Steering Committee of the Hospital Medical Committee of any desirable or proposed changes in utilisation of practice.' [381] The Chairman of the MAC, or another representative in his absence, attended and reported to the Steering Committee meetings. In addition, the constitution of the MAC provided for its `ex officio' members to include the Chairman of the Hospital Medical Committee (HMC) or his/her deputy. [382]
`An Annual Report was prepared by the Committee, based on returns made from all the specialties, and submitted to the Regional Hospital Medical Advisory Committee. I was also sent a copy of the report and I considered it essential that I should see something of that nature that was going to be seen outside the Trust.' [383]
315 Dr Roylance, as Chief Executive, stated that he did not receive copies of minutes of audit meetings. He explained that this was because of the perception that management should be seen to be outside the audit process and because he was reassured by Dr Thomas, having talked with him a great deal `... about the implementation and development of audit within UBHT and beyond. He kept me informed of the problems that were being faced and overcome and I was satisfied that he would come to me if he needed my help.' [384]
316 It was not customary for the Trust Board, as distinct from the Chief Executive, to receive or to discuss MAC's Reports, as Mr McKinlay stated:
`In UBHT it was not the custom to circulate these reports to the Board or discuss them at Board Meetings. The only report which I saw [was] in the second quarter of 1995 ... I formed the conclusion that the audit process was in its infancy and the Board was not seen as being part of the monitoring process.' [385]
`Control of individual situations was in the hands of the clinical teams and the Trust executive management. A yearly audit report covering clinical performance was produced by the Medical Audit Committee under a senior consultant. In my time, it was not practice in UBHT for this report to be seen by the Board or the Board Committee.' [386]
317 Dr Roylance agreed with this recollection, although he noted that later the Reports did become available, from around October 1995. Dr Roylance said:
`The Audit Report was initially introduced along the provisional line from Region down to District and then became Trust. I was anxious that what was being reported outside the Trust should be made known to people responsible for the Trust, but I had to move very gently and delicately, because at this time the reassurance given to the staff is that it was nothing to do with management ... there certainly was a difficulty initially as to whom the audit report, which was a report about the process of audit and not of audit, should be made available and I think we have seen before, Dr Thomas' view that anything out of the Audit Committee could only go where he said.' [387]
318 The extent to which reports and information obtained by the audit process were made available was the subject of further examination by the Inquiry. Evidence was heard that purchasers requested information upon the work of the MAC, but that the Committee was reluctant to provide that information. In particular, Dr Thomas was referred by Counsel to the Inquiry to the MAC meeting of 10 June 1992 [388] where there was a discussion about purchasers' access to audit information:
`Q. You are minuted as referring to the constant pressure from the purchasers to have some access to audit information, but you were reluctant to accede to their request, particularly their suggestion that they should receive copies of the committee's annual report.
`Why was that a request that you were reluctant to accede to?
`A. I cannot answer your question. I do not know because the annual report had a very wide circulation and went across the Region. I suppose that I was responding to their wish as purchasers to have free access to information which the Audit Committee did not have and had it had that information, it might not have chosen to share it with the purchaser. A provider, fine, because that is within the envelope of the organisation the philosophy within the Health Service had changed quite markedly from a service to a business. Part of that change of culture involved a change of attitude towards many things, including information. Information then became commercially sensitive. This was one of the reasons why I, and I think the UBHT, were resistant to sharing processed information.
`It was, if you like "What is the recipe for Marmite, because if we know what it is, we might be able to make it cheaper". That is the commercial view. That was the sort of attitude that was beginning to creep into those discussions, and information was regarded as sensitive and not to be shared in a way that would make it accessible to competitors.' [389]
319 It was Dr Thomas' impression that purchasers were receiving mortality statistics for the whole of cardiac surgery, but he was not able to confirm whether they received them. Dr Baker told the Inquiry that they were never received. [390]
320 Dr Morgan stated that: `Trusts submitted annual reports to the Region which the purchaser Health Authorities were not shown at that time.' [391]
321 Mr McKinlay expected that concerns about standards of practice or care within the BRI would reach the Board through the Clinical Director, or the Medical Director, and the Chief Executive. Referring to concerns about paediatric cardiac surgical services, he said:
`I would have envisaged that the Clinical Director would go to where the source of the problem lay. We are talking here about consultant anaesthetists having concerns, so the Clinical Director in anaesthesia, in a very logical system, goes and talks to the Clinical Director in paediatric cardiac surgery. ... Then I think the logical next step is to the Medical Director ... The Chief Executive is the next step, possibly with the Chairman of the Hospital Medical Committee being somebody that might be consulted on the way. ... [the next step would be] From the Chief Executive to the Board.' [392]
322 Mr McKinlay stated in his written evidence to the Inquiry:
`... clinical outcomes and adverse events ... were fundamentally a matter for the audit meetings of the particular services involved ... were not as a matter of course reported to the Board.' [393]
323 The Clinical Audit Committee [394] (CAC) was responsible in succession to the MAC for encouraging and monitoring the introduction of the process of audit. It produced reports that were sent to Region to say how the development of audit was progressing. [395]
324 Dr Roylance was asked what use was made of the CAC and its deliberations within the Trust since the reports from the CAC, as with those of the MAC, did not go to the Board:
`... the report ... went to the Region and was ... processed with all the others ... If you say what function did the Audit Committee have, I think I told you: the Audit Committee was charged with encouraging and monitoring the introduction of the process of audit ... these were very early days and I cannot really discuss sensibly what we did with the outcome of audit because there was very little outcome of audit at that stage, it was only the process of audit we were concentrating on, but the Chairman of the Audit Committee was clearly responsible for informing me as the Chief Executive, directly and urgently if necessary, if any management action was required for the introduction ... of audit, and in theory, to deal with any adverse result of audit, although that was necessarily some time in the future.' [396]
Audit co-ordinators and audit assistants
325 Following the introduction of the Government's paper `Medical Audit Working Paper No 6', [397] medical audit co-ordinators were appointed for each service to co-ordinate and report to the MAC. Audit assistants were provided, although the use that was made of them differed widely at the outset, from specialty to specialty. [398] The audit co-ordinators reported to the Audit Committee through one of its members. [399]
326 The introduction of audit assistants went some way to rectify earlier problems in developing medical audit, summarised by Dr Stansbie, Vice Chairman, UBHT Medical Audit Committee (1990-1994), in his written evidence to the Inquiry as including:
`... a lack of secretarial and clerical support, a lack of an adequate audit database and a lack of time to prosecute audit, particularly in the case of single handed consultants in small specialties.'
`The provision of audit assistants with computers, who were trained to use word processing and spread sheet packages, went someway to dealing with these needs and were largely in place by 1992.' [400]
327 Ms Sheila Wilkins, Audit Assistant 1991-1993, set up a system whereby clinical information needed for the medical audit of services within the Directorate of Surgery could be recorded. The system used by the Directorate was the Medical Database Index (MDI) which was already in place in the South West Region:
`Part of my role was to train clinicians, including junior doctors, in the use of the system and identifying the importance of accurate data recording.
`As Audit Assistant within the Directorate of Surgery the specialties I supported were general surgery, urology, orthopaedics and Accident & Emergency. I understood that they submitted their data to the National Audit Registry. Paediatric services had their own audit assistant at the Bristol Children's Hospital. I did not know the input clerk of cardiac services. As well as preparing data for monthly audit meetings for the Directorate, my duties included instructing the house officers on rotation into the use of the MDI system used for audit purposes. ...
`Examples of the types of information that were entered onto the MDI system for the Directorate of Surgery were the bloods used; drugs given; procedures undertaken; the reason for death, (if it occurred and when); the length of stay in hospital, (pre and post operatively); if a catheter was inserted and for how long...
`My work included planning and implementing audit projects. Medical staff in the Directorate of Surgery would identify an audit subject and, if the data was not already captured, I would liaise with the Information Technology Department to ensure that that specific data was captured.
`Monthly meetings were held between Audit Co-ordinators and Assistants throughout UBHT. ... They were well attended by both the Audit Co-ordinators and Audit Assistants representatives of the various Directorates, for example from Surgery, from the Eye Hospital and Medicine and sometimes from the Children's Hospital.
`In addition to the monthly meetings, Audit Assistants often met with others doing the same sort of work, throughout the region in a group called SWAANS (South West Audit Assistants Network Services). Meetings took place once every 3 months. As many Audit Assistants from UBHT as possible would go to every meeting. The objective of these regional meetings of Audit Assistants was to obtain clear agreement, on a regional basis, on how the government guidelines on audit should be implemented. ... Representatives from Trusts in other areas in the region or elsewhere came to speak to the Group ... The purpose of the meetings was to discuss systems and statistics, not individual cases.' [401]
328 Ms Wilkins also commented that there was concern among audit assistants `... that they had no representatives on the [Audit] Committee' and `... no knowledge of what decisions the Committee was making on the implementation of audit. ...' [402]
329 Ms Wilkins described the experience of the audit co-ordinators and audit assistants:
`Audit Assistants throughout the Trust were using the MDI system in different ways. We nevertheless found it helpful to meet to discuss the problems we were encountering and the ways we were implementing the government guidelines. Meetings took place between ourselves and staff from the Information Technology Department. Although our use of systems within Directorates and specialties were different, many of the problems we encountered were the same and, in principle, solutions were similar... [403]
`... annual reports prepared by Audit Assistants and submitted to Clinical Co-ordinators were in standard format, so as to ease identification and comparison of material in the report. This was, I believe, a result of Dr Thomas's initiative. He sought to ensure that reports on the functioning of audit, from each Directorate, used the same format. I have already identified that the audit data itself was not in the same format, and that different systems were in place within each directorate, but yearly reports were to use the same layout.' [404]
Role of the clinical director [405]
330 The `Regional Audit Team Report' of 1994 [406] observed that the control of audit lay ultimately with the clinical directors.
`Effectively they had the responsibility, they had the resource[s], and therefore it was their control that dictated what could or could not be done.' [407]
332 The role of the clinical director and the relative powerlessness [408] of the Audit Committee may have been a product of the uncertainty and change evident in 1991 when the Trust was set up. Mr McKinlay stated:
`... there was a strong suspicion in the Consultant group that this [the creation of the Trust] was the ultimate take-over by the administrators and that their freedom to make clinical decisions would be seriously curtailed. In order to combat this fear, the Trust was set up with 14 Clinical Directorates with a Consultant as the Clinical Director in each case.' [409]
333 The Report said that because the MAC was not constituted of clinical directors it was relatively powerless. It said:
`There was direct admission from a representative of the management team that issues for audit which they (the managers) feel need to be addressed or are asked to address by purchasers, tend to [be] implemented via the clinical directors rather than by any central overview from the Audit Committee.' [410]
334 Dr Roylance was asked about this view expressed in the report in the following exchange:
`Q. ...That would be consistent with your explanation, as I understand it, that it was for the Clinical Directors to run the directorate and the Audit Committee's role was not to control audit but to monitor it?
`A. Absolutely. I mean, people who, like, spin on it a direct admission, that always implies that they did not want to let it be known but eventually released it.
`Q. Leave aside the spin. What it indicates is that the author of this document from the region, the Regional Audit Team, envisaged audit in a very different way from the way in which it was in fact being delivered?
`A. No, that is quite wrong. That is quite wrong. He actually attended the Audit Committee, and he was reflecting the view of some of the Audit Committee. I talked to him directly. I talked to the audit group directly, from Region. I spent a lot of time ensuring that audit was set up.' [411]
335 Dr Walshe was of the view that putting clinical directors on the Audit Committee would not have made much difference:
`... I do not know, but I suspect that it would have made little difference ... Because I think that the directorates viewed the resource as theirs and at any meeting to discuss what audit was to be done, that would have coloured people's judgment ... given the devolved structure and the fact that the money was going to devolve anyway, I think having the Clinical Directors there would have made little difference to what was done.' [412]
336 Mr Wisheart expressed the view that the clinical director had a responsibility to see that audit was carried out within the directorate, a responsibility for the organisation of the clinical work and a responsibility if there had been any complaints of any sort, to deal with them. It was his opinion, however, that the clinical director was not responsible for the individual work of an individual clinician. [413] Mr Wisheart was asked about the 1990 application from the UBH for trust status which stated, in relation to quality of service, that:
`Within the Trust each contract will be the personal responsibility of a Clinical Director supported by a Manager. Quality of service will therefore be their responsibility.' [414]
337 Mr Wisheart did not regard this as meaning that the clinical director was directly responsible for the work of individual clinicians. He said that part of the issue turned on the definition of what `quality of service' meant:
`... One has to ask what the "quality of service" means. There are two broad areas under which it could be considered there. There is the area of quality in the sense of the management of the organisation, the waiting times, the promptness with which letters were sent out, the adequacy of the food and so forth and so on. Then secondly, there is the quality of the clinical service, which would be dealt with in a general way within the directorate, within additionally medical audit and later clinical audit.' [415]
The shift from medical to clinical audit
338 In early 1994, the MAC was reconstituted as the Clinical Audit Committee (the CAC). This change was consequent upon the introduction, in 1993, of the requirement by the Government that clinical audit be carried out. At a Committee meeting, Dr Thomas reported:
`... there was concern that medical audit will be marginalised under the pressure from clinical audit. The Chairman [Mr Wisheart] pointed out that we must be perceived to be carrying out the national guidance lest we lose audit monies. We must also maintain medical audit as a valuable educational and peer review activity.' [416]
339 When asked about the relationship between medical and clinical audit, Dr Thomas said:
`... the answer to your question is that the short history of medical audit set up a system which was being used as an educational system, and that the new form of audit, clinical audit, was going to be a much more widely-based type of audit; it was not going to be limited to educational purposes, and it was going to address problems of resource allocation, throughput and so on and so forth in a much wider sense and with a different emphasis.' [417]
340 In Dr Thomas' opinion there were indications that medical audit still had a role and should continue alongside clinical audit:
`I believed that ... there were indications - ... in I think both the government documents of the time that medical audit should indeed continue. I think that there were substantial reservations about the progress that had been made because - and I speculate here you understand - I believe that in Government circles they had anticipated that progress would be much more rapid than it was.' [418]
`... they also anticipated that medical audit would embrace the wider sphere of information-gathering, which I suspect was sought in the first place. I think that those anticipations of rapid progress were ill-founded and had the government chosen to listen to advice, it would have realised that setting up such a system as they had proposed in the White Paper was actually going to take a substantial amount of time, and not just a couple of years. It was not just a simple thing to put in place.
`There was, among most of the documents at the time, an emphasis on bringing non-medical paramedical, whatever you wish to call them, members of the hospital staff, the teams and so on, into the audit process. It is my memory that we had already done that to a limited extent in the directorates, not in the audit committee, but in the directorate. But that was a another aspect of clinical audit.' [419]
`Q. ... at a directorate level, some overlap had been taking place?
`Q. Some participation amongst non-medical staff in the audit process?
`A. Yes.' [420]
341 Dr Thomas was not able to say how widespread this participation was, except that:
`... the directorates that spring to my mind, as directorates where I was aware that that was happening, were medicine in general, although that was made out of separate subgroups, but general medicine, rheumatology and so on, ophthalmology and the dental services.' [421]
342 There was also a concern that by widening the parameters of medical audit to include other specialties, there would be a dilution of the effectiveness of audit. [422] Dr Thomas commented:
`It is not a question of letting other professional groups into the process, it is a question of how people perceive the time and the opportunity. So, for instance, I might, as I said this morning, wish to explore the complications of epidurals in pain relief. On the other hand, if you enlarge the group beyond me as a medical person and bring in somebody who may, perhaps, manage the resource of the Trust, they might be more interested in how I was going to use the money that they were prepared to let me have to buy kits or whatever.
`So the emphasis within the meetings was going to change and that might well have damaged educational processes, I thought.' [423]
343 However, Dr Thomas confirmed that by 1995 medical audit evolved into clinical audit. [424]
344 This move towards clinical audit resulted in the re-constitution in early 1994 of the MAC, which, as set out above, became the CAC. Dr Thomas stood down as Chairman of the Committee shortly before 22 June 1994. Mr Wisheart then chaired the Committee for six months. [425] Dr Thomas stated to the Inquiry that the transition from one form of audit to the other was completed by the end of 1994.
345 In January 1995, Dr Jill Bullimore, consultant clinical oncologist, took over as Chair of the CAC. [426]
346 Dr Roylance explained a change in reporting structures: the multidisciplinary CAC reported through the Patient Care Advisory Committee to the Trust Board. [427]
347 Dr Roylance described the change from medical to clinical audit:
`... before medical audit was up and running and in any sense robust, it was changed to clinical audit, and even with clinical audit, it was not expected to produce anything effective, anything that you could rely on as audit, for another five years.' [428]
348 Dr Joffe stated that with the change to clinical audit, the emphasis was placed on shared care of patients by a broad range of carers, including doctors, nurses and professions allied to medicine. Dr Joffe expressed the view that the shift to clinical audit appeared to make the sub-specialties even more marginalised. [429]
349 At about the same time, funding for audit was transferred from regional to district control. Dr Morgan stated that because: `...This change was signalled late during 1993/94 ... a contract between Bristol and District Health Authority and the Trusts (including the UBHT) was not agreed until November 1994.' [430]
Collation of audit material by the Audit Committee
350 There was no reference in the `Annual Audit Report' to audit activities in paediatric cardiac surgery or in paediatric cardiology in 1992 or 1993. [431] Dr Thomas confirmed that the MAC was aware of this omission. He said that he tried to persuade audit co-ordinators to file a report and sent reminders:
`... I think we probably sent out one, probably two reminders to audit co-ordinators that they had not yet filed their report with us.' [432]
351 However, Dr Thomas' only means of seeking to ensure that the reports were made were persuasion and exhortation:
`... I had no big stick with which to beat people into giving me a report.' [433]
352 Failure to provide a report to the Committee did not produce any adverse effect for the department concerned in terms of sanctions except for `embarrassment', as Professor John Farndon, the Audit Co-ordinator in Surgery in 1992, said:
`... I had to chase some groups more vigorously than others to get returns, and others found it difficult or impossible. The accident room, I think, found it particularly difficult because of staff shortages to initiate the process. Orthopaedics was gradually getting up to speed. And I would chase and encourage as much as I could, but it was as much as I could do to have responsibility for general surgery... There would be an embarrassment that there was no return from orthopaedic surgery, if that were the case, and it would appear in the Report.' [434]
353 The link between the Audit Committee and cardiac surgery was through the Audit
Co-ordinator in Surgery, as described by Dr Thomas:
`The route to cardiac surgery from the Committee would have been via the co-ordinator for surgery. That was Professor Farndon. The reason that that was the route was because we had a specific number of members of the Committee and to have divided the major specialties into their integral sub-specialty groups would have produced such a profusion of co-ordinators for the committee members to liaise with that it was not practicable.
`So Professor Farndon was our contact point with surgery. Certainly, he would have received the letters that went out asking for reports and he would have received the reminders. However, I would make two comments about cardiac surgery: I, as a Chairman of the Committee, and Mr Wisheart as committee member, had a conversation on a couple of occasions in which I pointed out that we had not yet received the report from cardiac surgery. In my memory, as I recall, he said "Well the quality of patient care is improving in cardiac surgery". I said "Well, in that case that makes it even more important that a report is received so that throughout the Region people will know that that is the case".
`However, we did not receive a report and I regretted the fact that they had been unable to produce one for us. There was some reassurance, I felt, in that we knew that cardiac surgery were carrying out basic audits on mortality outcomes as part of their contract with the purchaser and that they were returning figures to the Central Cardiac Surgery Registry, the national registry.
`So although I regretted the fact that they had not been able to produce a report, I was reassured that audit was in fact being done, and I believe that that is the case: it was being done.' [435]
354 In a letter dated 22 March 1993 to Dr David Stansbie, Professor Farndon wrote:
`The major problem with Cardiothoracic Surgery is that this is a highly specialist group working in isolation with no other similar group within the region. They, too, are establishing their own audit system which, I understand, will interface with other cardiothoracic units at national level.' [436]
355 Data concerning cardiac surgery did not reach Professor Farndon and was not included in his report to Dr Thomas:
`... I do not remember Dr Thomas wanting me to pursue this issue further. I think that I and the audit committee were happy that the cardiac unit were submitting to a national comparative audit. I felt that this was logical because of the highly specialised nature of cardiac surgery. It is a speciality[specialty] that does not compare easily to any other sub-speciality[specialty]. We knew that audit was taking place and at the time the focus was on getting audit carried out across the whole Directorate and in every sub-specialty of surgery.' [437]
356 As has been noted, Mr Wisheart's view was:
`... The actual figures that went to the register were never submitted to the Audit Committee, that was not part of the process as it existed ... So what I would have wanted to see ... were the appropriate reports that the meetings had taken place, which they had, and of course I knew they had taken place but the reports never reached the committee for those two years.' [438]
357 Professor Farndon stated that his understanding of cardiac surgical procedures in general and, in particular, paediatric cardiac surgery, and their associated morbidity and mortality, was very limited:
`... I would not have known the bench-marks that the cardiac surgeons should have been achieving. Few other surgical sub-specialties have mortality and morbidity to match that of cardiac surgery. It is a very technical, high risk, area with no comparisons to general surgery. I knew that the cardiac surgeons were submitting data to a national audit where comparisons with other units would be made. The process should have identified problems and corrections to allow closure of the audit loop. When reporting to the Medical Audit Committee I informed them that cardiac surgery were submitting externally. I felt that this national arena was the most appropriate way of dealing with cardiac surgery and provided a secure mechanism.' [439]
358 Professor Farndon agreed that the Committee received such information, through him, as people within the directorate chose to send and that his function was much like that of a `post box'. [440]
359 Professor Farndon told the Inquiry that he had heard of the external register to which the cardiac surgeons submitted their returns but he did not know any detail of it nor the nature and scope of the returns, nor did he ever see them. [441]
360 Dr Thomas confirmed that, as Chairman of the MAC, he thought that the cardiac surgery department was conducting adequate audit in 1991:
`We believed it to be so at the time: we knew that audit meetings were occurring and we knew we were assured that returns were being made to the National Registry.' [442]
361 Dr Thomas recalled that it might have been Mr Wisheart who reassured him that returns were being made. [443]
362 Professor Farndon told the Inquiry that he could not ever recall Dr Thomas ever seeking such reassurances from him, [444] although in his written statement to the Inquiry he stated that, when submitting his report to the MAC, he informed them that cardiac surgery were submitting data externally. [445]
363 Dr Thomas told the Inquiry that he could not recall any question as to the acceptability of results within the department of paediatric cardiac surgery ever being brought to the MAC's attention. [446] Dr Thomas said that he had no knowledge of the Bolsin-Black `audit' [447] nor did either of them raise concerns with the MAC at any time. [448] Dr Black was a member of the CAC from its inception in June 1994. [449]
Summary of annual Audit Committee reports
364 The MAC report for 1991 was published in March 1992. Specialties were required to report on a quarterly basis to the Audit Committee on a standard form. An annual precis was also requested from the specialty which was included in the report. The annual reports of the specialties were included in the report. [450]
365 In summary, the annual report for 1991 recorded the following:
- `Paediatric cardiology held five audit meetings in 1991. The annual audit of surgical intervention; the annual audit of non-surgical intervention; and multi-disciplinary meetings (morbidity and mortality) with cardiologists, surgeons, pathologists, radiologists, and anaesthetists were recorded. One new standard was reported as having been adopted: to operate more on patients under 1 year, in particular those with Atrio-Ventricular Septal Defect.
- `The audit co-ordinator was Dr Martin.
- `Cardiac Surgery held 12 meetings but attendance was not shown. The
co-ordinator was noted as being Mr Hutter. Much of the commentary related to adults.'
366 The Bristol & District Health Authority's (BDHA's) assessment of the MAC's 1991 report was that audit, in the sense of standard-setting, was not always being described. However, it noted that some changes in clinical practice had been introduced and that some of these were being audited. It was not clear whether others would be reviewed.
367 The report for 1992 [451] was more comprehensive. However, it was circulated to internal UBHT and Regional officers only, not to the DHAs. [452]
368 The Chairman's introduction stated:
`The main purchaser of health care from the UBHT is the Bristol and District Health Authority. A meeting was held between the Trust and the purchaser in order to review audit activities during 1992. During that meeting the responsibility of the Trust and its Medical Audit Committee for the process and prosecution of audit was restated unequivocally. It was agreed however that we would be able to act in concert with the purchaser in assessing some measures of outcome following treatment within the Trust. Audit Co-ordinators in a number of specialties responded most constructively to a request for suggestions of measurable and verifiable outcomes, six of which are being pursued by the Trust and the purchaser in partnership.' [453]
369 The introduction also noted that difficulties arose because of the low priority that was still accorded to audit by a minority of consultants.
370 The report contained a return from the Department of Anaesthesia but noted that the Department of Child Health did not submit its report in the correct form, so that nothing from that department was included. No report was submitted by cardiac surgery (or paediatric cardiac surgery) nor by paediatric cardiology.
371 The report for 1993 [454] reproduced the Regional Audit Team's report criticising the fact that power in relation to audit lay with the clinical directors, who were not members of the MAC. The MAC was by-passed, according to the report, when managers wished issues on audit to be addressed or were asked to address issues by purchasers. The report also noted the need to ensure that traditions of audit and audit methodology in other clinical fields were recognised by the (previously medical) Audit Committee.
372 Again, the 1993 report did not include a report in respect of paediatric cardiac surgery, nor did it explain its omission to do so.
373 The Regional Audit Team report stated that:
`This tight directorate structure and approach operates at all levels and for most issues and has, therefore, led to a confusion for the Audit Committee over its role.' [455]
374 Dr Thomas told the Inquiry that he rejected the idea that there was any confusion in this regard and indicated that the MAC had no incentives nor sanctions at its disposal:
`I do not think there was any confusion in our minds about what we might be able to achieve. We had ... no budget, no staff and therefore the only way in which we could influence people was by persuasion, by cajoling them into doing things which we thought were valuable. Sometimes they agreed with us, sometimes they did not. We knew that we would be able to influence people over such things as hardware, staffing and training, because the members of the Audit Committee had information which was not available easily to the Clinical Directors. So we could pass that information on to them and persuade them to take the steps that we thought were wise.
`There was, I suppose, the other element to the equation, and that was that they knew at the end of the year they would have to account for how they had expended their money. Certainly when things started the Audit Committee was required to put its seal on those items of accounting and say, "Yes, that is what happened."' [456]
375 The Regional Audit Team observed that the directorates were able to undertake effective audit in their own specialties, but that decentralised audit functions meant that they were less able than a central body to manage cross-specialty audit, to maintain consistent methodology, to disseminate lessons learned, or to develop and make best use of the audit staff who became isolated. [457]
376 In dealing with what it saw as the bypassing of the MAC, the Regional Audit Team report stated:
`The devolutionary process ... has made it quite difficult for the Audit Committee to influence and record audit activities ... the Audit Committee has no budget and is not made up of clinical directors. It seems likely that these parameters and limitations will also be a frame within which the new clinical Audit Committee will work. The new Committee may well wish to establish a role in the co-ordination of audit projects across the Trust. It may wish to play some part in the assessment of the quality and effect of audit projects. These objects are highly desirable but will remain difficult to achieve unless some agreement can be made between senior management and the Clinical Audit Committee as to the future of audit in the UBHT.' [458]
377 The report for 1994/95 [459] was the first report of the CAC. Again, it did not contain reports in respect of paediatric cardiac surgery or cardiology, nor did it explain the omission.
378 The annual reports of the Audit Committee were sent to the SWRHA. Dr Roylance commented on the RHA's use of these reports:
`They summated them [audit reports], had a look at them and they issued an encouraging document ... to say "Look what has been happening across the region and please, would other people like to do a similar thing", but it was a report on the introduction of the process of audit with a few encouraging notes to say, "and we have found something we can improve on"'. [460]
Nursing audit in Bristol
379 Until the introduction of clinical audit, nursing was audited separately from medical services.
380 Mrs Margaret Maisey, Director of Operations and Nurse Advisor at the UBHT, was responsible for the audit of nursing. She described her primary concern as being that:
`... nursing care was of the highest standard, that nurses were trained and had available to them all that they required to carry out their duties correctly and in accordance with our professional standards. I tried to ensure that proper records were kept and that nursing administration was efficient, so that nurses spent as much time with patients as possible, delivering high quality care and constantly looking for ways to improve what they were doing.' [461]
381 Mrs Maisey described her role as being:
`... to keep up with the standards of the day and ensure systems were in place so that nursing audit happened in UBHT.' [462]
382 She stated that she led the introduction of audit:
`... firstly as Chairman and later as facilitator on the District Nurse Advisory Committee. ... I led my colleagues in the introduction, consultations, discussions and eventual implementation of various nursing processes across the Trust as a whole. One of these processes was nursing audit.' [463]
383 Mrs Maisey stated that she had introduced the notion of nursing audit first through the Nursing Committee of the District, from 1989, then the Trust:
`... For example, I recall proposing that nurses should ensure that their staff were recording that they had checked on bedfast patients during their period on duty, to ensure that the patient was not left in soiled linen: an apparently minor point but essential to patient care and positive nursing attitudes. Nursing records are traditionally of a higher quality than medical notes. Accurate contemporaneous reports are recognised by all nurses as vital to their proper patient care. I was very concerned to maintain this principle from the time I arrived in Bristol and never failed to make this point at every appropriate opportunity.' [464]
384 Mrs Maisey stated that she ensured that appropriate structures were set up to report on audit measures:
`Within the Trust and the Trust Nursing Advisory Committee (TNAC), I worked to produce the forum in which nursing audit, nursing procedures, and policy advice in such matters from the centre, was discussed, adapted and implemented by those nurses with the relevant managerial and professional roles in the Trust. From TNAC, I took their views and decisions to the Regional Trust Nurses Group where such things were discussed and information given which might assist others and the centre as to what each Trust was doing.
`Similarly, within the TNAC, following the introduction of a contractual requirement by the Avon Purchasers, annual nursing audit reports were produced. I think I took these reports to the Trust Board or one of its Committees. Clearly, over time, these reports and procedures became far more sophisticated and wide-ranging, as we all learned more about the audit process as a consequence of carrying it out, but also as a result of receiving more and more information from the centre, other Trusts, and the clinical areas, including what other professions were doing.' [465]
385 At the meetings of the TNAC and District Nursing Advisory Committee (DNAC):
`... each senior clinical nurse reported back on their clinical area of responsibility. Issues raised were debated by the meeting and the greater experience of the group as a whole brought to bear. Subjects discussed at the DNAC/TNAC meetings included Department of Health circulars, UKCC consultative proposals, RHA and Regional Nursing Officer/RGM letters and similar documents, DHA matters, developments in nursing, nursing audit and nursing standards. Various aspects of nursing policy for the Health Authority/Trust as a whole were discussed and agreed upon at the meetings.' [466]
386 Annual nursing away-days were also organised to discuss issues in more depth and to consider standards, research and advanced nursing practice. [467]
387 Nursing audit was reported on a yearly basis:
`A Nursing Audit report was prepared annually and sent to the Avon purchasers and to the Trust. These reports were written by the Nurse Advisors for each part of the Trust. The reports evolved over time. They were designed to set standards, measure attainment against those standards, and lead to changes in nursing practice where changes were appropriate. The reports from the Children's Services written in 1995 for the Annual Report 1994/5 is typical of the period and reflects the confusion in the minds of many as to exactly what was expected of us in the matter of `audit'. To resolve this situation was one of the key tasks of the Trust Nurses'Advisory Committee. It must be understood that until very recently, "audit" was something that was medically driven and nurses were still feeling their way.' [468]
388 Mrs Maisey noted that with the commencement of trust status there was much change:
`... many ... relationships were changed; some of them disappeared altogether, while others became more at arm's length, while yet others followed the same patterns as previously but with different players. From being a general manager with general management responsibilities, I became a facilitator and enabler to the managers. As before, I continued to give ethical and professional guidance to the nurses and to give nursing advice to the Trust Board. The Nurse Advisory [TNAC] Committee continued to set standards. These were monitored and later reported as part of the nursing audit process.' [469]
389 Mrs Maisey commented on the evolution of audit in respect of her involvement with the MAC and CAC. She stated:
`At Bristol, I attended meetings of the Medical Audit Committee and its successor the Clinical Audit Committee. ... At the outset, the meetings of the Medical (later Clinical) Audit Committee which I attended dealt with funding, with the possible processes of recording audit events, the mechanical process by which the annual report would be generated ... . The meetings never discussed outcomes. They certainly did not discuss relationships between practitioners, or clinical performance in any way.
`Generally, these Committees were considering management matters related to clinical practice ... We would see summarised "audit"reports. We were aware that certain specialities [specialties] with common interests and concerns met to discuss specified topics, but we were not party to any of their debates, only to the agreed outcome of the debates and what future actions had been decided.' [470]
390 Fiona Thomas, a Sister at the UBHT, described the following difficulties in conducting nursing audit:
`... a level of expertise was required to undertake audit; diploma or degree nurses may have had these skills. Difficulties arose in conducting audit due to constraints of clinical work or other roles, which led to difficult decisions about what came first. Sometimes nursing staff were so busy caring for patients, it was difficult to find time or spare pairs of hands to carry out audit.' [471]
391 Ms Sarah Hoyle, Directorate General Manager for Women's and Children's Services (and, at one point, Mrs Maisey's assistant in Bristol), stated that:
`... nurses were always willing to support the development of clinical audit, involving all healthcare professionals.' [472]
Attitudes towards the formal introduction of audit 1990-1993
392 Mr David McCoy, Chairman of the RHMAC, stated that:
`The picture of audit at its inception was resented by some, and completely clouded by uncertainty of patient confidentiality, and the legal situation, with the risk of action for defamation as a result of published results.' [473]
`... there was much suspicion and a great deal of sensitivity from the professions....' [474]
394 Mrs Liz Jenkins, Assistant General Secretary, RCN, told the Inquiry:
`I can think of examples, not necessarily from my own organisation, but ... meetings that I went to ... across the country, where doctors would not even want medical students to take part in the clinical audit meetings in case the medical students actually really found out what the results were. I mean there was real fear and anxiety about it, and I have to say a lot of lip-service paid to it.' [475]
`... the profession were wary of the White Paper in general, and I suppose, therefore; any components of it. That was the sort of ambience within which we were working.' [476]
396 As has been seen, Mr McKinlay stated:
`... there was a strong suspicion in the Consultant group that this was the ultimate take-over by the administrators and that their freedom to make clinical decisions would be seriously curtailed. In order to combat this fear, the Trust was set up with 14 Clinical Directorates with a Consultant as the Clinical Director in each case.' [477]
397 Dr Roylance expressed this view:
`... a strong feeling within the medical profession that audit was going to be used as yet another management tool and I felt that its introduction to the formal structure of Bristol and Weston Health Authority, as it was at that time, and then the UBHT, needed to be handled very carefully in order to encourage doctors to participate. (This was a great change in the NHS generally and there were already strong feelings and a great deal of sensitivity about the increasing role of managers in healthcare.)' [478]
398 Dr Thomas told the Inquiry:
`... the profession was perhaps less enamoured, less convinced, than professional bodies and organisations. That is reflected in some of the papers recruited from individual clinicians, saying "Whilst we sign up to the aims of this, we are not sure it is really going to work and deliver improvement".' [479]
399 Dr Brian Williams, consultant anaesthetist at the BRI since 1977, stated:
`Senior management and most Associate Directorates of surgery were initially resistant to the idea of formal audit being conducted in our Directorate [anaesthesia] during in-service hours. They were of the opinion that the disadvantage of the inevitable interruption to elective surgery throughout the Trust would outweigh any possible advantages.' [480]
400 Dr Sally Masey, consultant anaesthetist and Anaesthetic Audit Convenor, explained that the use of clinical time to hold audit meetings was a problem:
`As it was considered to be a contractual requirement to be involved in audit the Department of Anaesthesia would ask for all routine operating to cease on those 8 half-days a year so as many anaesthetists could be involved as possible. An emergency anaesthetic service was maintained. Understandably, this met with considerable resistance from surgeons, and the Trust management was also not receptive to the cancellation of routine lists, despite it being clearly stated in the NHS [Management] Executive document "The Evolution of Clinical Audit" that adequate time had to be set aside for audit activities. However, we were able to establish this pattern of cancellation of routine working with moderate success by stressing the contractual obligation to audit.' [481]
401 These attitudes persisted after 1993. On 23 February 1994, the minutes of a meeting of the B&DHA recorded that Dr Morgan presented a paper on `Clinical Audit and Outcome Monitoring' which stated: `A significant problem was the feeling of clinical professions that clinical practice was not the concern of the Purchaser'. [482]
Views as to the relative responsibility for aspects of audit
402 Dr Roylance was recorded in the minutes of the clinical audit review meeting of the B&DHA on 11 November 1992 as commenting that: `... the way that care is carried out is the responsibility of the Trust, but the outcome is Bristol & District's domain ...' [483] He explained that in placing contracts with the UBHT or other trusts, the B&DHA could not disassociate itself from the benefits those contracts were achieving for patients, and that the District should be concerned with the value of the process to their patients, in terms of clinical outcome, and not just the process itself. [484]
403 Ms Evans stated that the District's view of responsibility for outcomes and clinical quality was that:
`... the primary responsibility for outcome and clinical quality of service lay with Trusts. That was one of their key roles, one of their main jobs, and they reported to the centre through the regional health authorities and later what was called the "regional outpost"of the NHS Executive about quality and about financial matters. So that was their province. I think, at the beginning of the period at any rate, audit was seen as being a professional activity. I think it was seen as being educative about learning and reviewing things, and I think it was seen, therefore, as not being the province of managers and not being the province of purchasers ... I think initially it was regarded as being purely professional and not something that Trust managers should be involved in the detail of, other than to know that it was happening. I think that changed over the period between 1991 and 1995.' [485]
404 She added that, in 1991, the role of the District was limited to satisfying itself that audit was taking place. [486] Further:
`It was the Trust's responsibility to make sure that it had appropriate frameworks and processes in place for quality assurance, both in terms of clinical audit and in terms of what perhaps might be described as "processes of care".
`In addition to that requirement, health authorities had specifically laid upon them certain national requirements, many of which came under the Patient's Charter, and these were requirements that we should monitor certain aspects of patient care processes, notably waiting times in Accident and Emergency departments, waiting times in outpatient clinics, between patient arrival and seeing a consultant, cancellation of operations, and, of course, waiting times for inpatient and outpatient appointment from GP referral.' [487]
In terms of monitoring the standards and outcomes of care:
`... the primary responsibility was laid on Trusts and their reporting was through the Region to the Centre. I think the Health Authority had a role, and I think a recognition of the Health Authority's role evolved over time, so that, by I think about 1995, it was recognised - and in that encouraged - by the Department of Health that health authorities should have the right to nominate certain audit topics that Trusts would undertake. But that was very much towards the end of the period and I think we saw our role as being to encourage the development of audit and to work with our Trusts, all of our Trusts, on specific audit topics, particularly those which, like the work we did on heart attacks, seemed to be important in terms of illness within our population, and health care for our population.' [488]
405 With regard to collecting data and conducting audit, Sir Graham Hart, Permanent Secretary at the DoH from March 1992 to November 1997, was clearly of the view that it was Region's responsibility after the introduction of trust status:
`I would certainly expect the contact with the UBHT to be from regional level.' [489]
He continued in the following exchange:
`Q. They should obviously have done the job and collected the data. On the assumption that they did not, as appears to be the case, they are part of the District and the District is part of the Region. What role or function would the District play in this?
`A. No, I do not think post-1991, I mean, this is a Trust now.'
406 If trusts were not collecting data or making it available, he went on, this was not something which districts could address:
`The District obviously has, or a number of Districts have a relationship with the Trust, but it is not such that you could really expect the District to put this right.' [490]
407 Overall responsibility for audit was separated from those who were expected to put it into effect. Ms Charlwood stated:
`... from 1990 right through to 1996, while the DHA was encouraging monitoring and audit, it was the SWRHA that was primarily responsible for monitoring clinical audit activity in the NHS Trusts in the South West. I have no evidence available to me showing that SWRHA raised with the DHA any issues which it required the DHA to pursue regarding monitoring of clinical audit. Actual implementation largely lay with the professionals in the NHS Trusts, who organised the clinical audit resource and arranged audit of specific clinical activity.' [491]
Audit of infant and neonatal cardiac surgical services: role and responsibility of the District [492]
408 From April 1984 to March 1994 paediatric cardiology and cardiac surgery for neonates and infants under 1 year old was designated a supra regional service. [493]
409 Ms Evans and Dr Baker told the Inquiry that, as a result, the District was not responsible for monitoring the performance of paediatric cardiac services for the under-1-year-olds.
410 Ms Evans expressed her view in the following exchange:
`Q. ... it is right, is it, that we must bear in mind that your detailed involvement was with services for the over-1s rather than the under-1s?
`A. Yes. That is right, and that was because the service for the under-1s was purchased by the NHS Executive because it was designated as a supra regional service for part of the period until the service was de-designated.' [494]
411 Dr Baker explained, in the following exchange:
`Q. ... in terms of your overall planning function, did you have any responsibility to check that the service for either the under- or the over-1s was producing an acceptable outcome?
`A. Yes, certainly in terms of children over 1, they were part, obviously, of our overall planned or later commissioned services. Within the breadth of our responsibilities for understanding whether we were getting the services we wanted to, that would have been generally the case.
`Q. And in relation to the under-1s?
`A. Not in relation to the under-1s. My understanding always was that the supra regional service was supervised through their own arrangements.' [495]
412 When paediatric cardiac surgical services for the under-1s were de-designated with effect from April 1994, commissioning of the service became the responsibility of purchasing DHAs. There was no communication from the NHS Executive to these authorities on the nature or scope of any monitoring of quality that should be established for the service, despite the complexity or specialised services involved. [496]
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Footnotes
[330] HAA 0164 0023; circular HC (91) 2
[331] See above, para 68 onwards, for details of funding made available nationally
[332] UBHT 0273 0007; Medical Audit Committee report 1991. Dr Baker compared this devolved approach with that of other, smaller, local trusts: `There was a contrast around audit ... at UBHT ... audit had found its way down to the individual clinical directorates and the individual clinical directorates determined the course of the development of audit largely, with the Audit Committee being I think a fairly low-key committee.' T36 p.106 Dr Baker
[334] HOME 0003 0130; NHS Working Paper No 6
[335] HOME 0003 0130; NHS Working Paper No 6. See also the 1989 guidance from the Royal College of Surgeons, WIT 0048 0116 Sir Barry Jackson
[336] HOME 0003 0130; NHS working paper No 6
[337] UBHT 0058 0134; draft health circular
[339] UBHT 0271 0391; `Clinical Audit', NHS Management Executive, undated
[340] UBHT 0271 0391; `Clinical Audit', NHS Management Executive, undated
[341] T28 p.102 Sir Barry Jackson, President of the Royal College of Surgeons of England
[342] WIT 0307 0019 Dr Morgan
[343] T22 p.124 Mr Nix, Deputy Chief Executive and Director of Finance, UBHT, since 1993
[345] A post created in 1993, according to Mr Nix T23 p.97
[347] WIT 0108 0044 Dr Roylance
[348] WIT 0108 0019 Dr Roylance
[349] T28 p.92 Sir Barry Jackson
[351] WIT 0108 0044 Dr Roylance
[359] WIT 0102 0009 Mr McKinlay
[360] WIT 0128 0001 Mr Ross
[362] UBHT 0016 0006; notes of Patient Care Standards Committee, 7 November 1995
[364] UBHT 0030 0024; CAC Minutes 2 March 1994; T25 p.29-31 Dr Roylance; T41 p.102 Mr Wisheart
[365] WIT 0323 0003 Dr Thomas
[366] UBHT 0025 0156; constitution of the DAC and UBHT 0058 0149; constitution of the MAC
[367] UBHT 0025 0158; constitution of the DAC and UBHT 0058 0156; constitution of the MAC
[368] UBHT 0024 0076; report of the Regional Audit Team's visit to the UBHT 10 March 1994
[369] WIT 0323 0004 Dr Thomas
[370] WIT 0323 0004 Dr Thomas
[379] UBHT 0058 0309; MAC report 1993
[380] WIT 0108 0045 Dr Roylance
[381] UBHT 0058 0157 MAC constitution
[382] UBHT 0058 0156 MAC constitution
[383] WIT 0108 0045 Dr Roylance
[384] WIT 0108 0045 Dr Roylance
[385] WIT 0102 0023 - 0024 Mr McKinlay
[386] WIT 0102 0011 Mr McKinlay
[388] UBHT 0067 0083; MAC meeting
[391] WIT 0307 0004 Dr Morgan
[393] WIT 0102 0011 Mr McKinlay
[394] Which succeeded the MAC in 1994
[397] HOME 0003 0124; `Medical Audit Working Paper No 6'
[398] WIT 0108 0045 Dr Roylance
[400] WIT 0324 0002 Dr Stansbie
[401] WIT 0396 0002 - 0003 Ms Wilkins
[402] WIT 0396 0003 Ms Wilkins
[403] WIT 0396 0004 Ms Wilkins
[404] WIT 0396 0005 Ms Wilkins
[405] The role of the clinical director generally is dealt with in Chapter 8
[406] UBHT 0024 0076; `Regional Audit Team Report' 1994
[408] UBHT 0024 0076; `Regional Audit Team Report' 1994
[409] WIT 0102 0009 Mr McKinlay
[410] UBHT 0024 0077; `Regional Audit Team Report' 1994
[414] UBHT 0060 0041; `Application for NHS Trust Status'
[416] UBHT 0098 0013, 0017 ; meeting of the Steering Committee with Chairmen of Divisions, held on 5 January 1994
[422] WIT 0120 0405 Mr Wisheart
[424] T62 p.103 Dr Thomas; WIT 0323 0007 Dr Thomas
[425] UBHT 0024 0267; CAC minutes, 11 January 1995
[426] WIT 0108 0048 Dr Roylance
[427] WIT 0108 0019 Dr Roylance
[429] WIT 0097 0319 Dr Joffe
[430] WIT 0307 0004 Dr Morgan
[434] T69 p.84 Professor Farndon
[436] UBHT 0027 0282 ; letter to Dr Stansbie from Professor Farndon dated 22 March 1993
[437] WIT 0087 0003 Professor Farndon
[439] WIT 0087 0003 - 0004 Professor Farndon
[440] T69 p.84 Professor Farndon
[441] T69 p.74 Professor Farndon
[444] T69 p.81 Professor Farndon
[445] WIT 0087 0004 Professor Farndon
[449] UBHT 0024 0267; CAC meeting, 22 June 1994
[450] UBHT 0063 0336; `Annual MAC Report' 1991
[451] UBHT 0066 0107; `Annual MAC Report' 1992
[452] UBHT 0066 0106; `Annual MAC Report' 1992
[453] UBHT 0066 0111; `Annual MAC Report' 1992
[454] UBHT 0058 0301; `Medical Audit Report' 1993
[455] UBHT 0024 0076 `Regional Audit Team Report' 1994
[457] WIT 0437 0003 Dr Charles Shaw
[458] UBHT 0058 0309; `Annual MAC Report' 1993
[459] UBHT 0058 0217; `Clinical Audit Report' 1994/95
[461] WIT 0103 0078 - 0079 Mrs Maisey
[462] WIT 0103 0071 Mrs Maisey
[463] WIT 0103 0071 - 0072 Mrs Maisey
[464] WIT 0103 0073 - 0074 Mrs Maisey
[465] WIT 0103 0071 Mrs Maisey
[466] WIT 0103 0073 Mrs Maisey
[467] WIT 0103 0073 Mrs Maisey
[468] WIT 0103 0074 Mrs Maisey
[469] WIT 0103 0077 Mrs Maisey
[470] WIT 0103 0078 Mrs Maisey
[471] WIT 0114 0055 - 0056 Fiona Thomas
[472] WIT 0527 0007 Ms Hoyle
[473] WIT 0436 0002 Mr McCoy
[474] WIT 0307 0011 Dr Morgan
[477] WIT 0102 0009 Mr McKinlay
[478] WIT 0108 0043 Dr Roylance
[480] WIT 0352 0025 Dr Williams
[481] WIT 0270 0012 Dr Masey
[482] HAA 0145 0375; minutes of the meeting of the B&DHA, 23 February 1994
[484] T25 p.20 Dr Roylance (emphasis added)
[489] T52 p.85 Sir Graham Hart
[490] T52 p.85 Sir Graham Hart
[491] WIT 0038 0014 Ms Charlwood
[492] The role of the DoH, Supra Regional Services Advisory Group, Royal Colleges and others is examined in Chapter 7
[493] Designation as a supra regional service is considered in Chapter 7
[496] WIT 0159 0035 - 0036 Ms Evans