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Daily transcripts
Hearing summary
29th April 1999
Dr Norman Pryde Halliday ret., former Medical Secretary to the Supra Regional Services
Advisory Group gave evidence to the Inquiry today. He described the establishment of the
Supra-Regional Service (SRS) system and how it had eventually emerged in the 1980’s
as a response to the need to provide some specialised treatments outside Regional Health
Authority boundaries. He expressed the benefits of the SRS in terms of economic and
clinical advantages and described the method by which services were designated for SRS
status and how specific units were designated within an SRS. Dr Halliday said that the
medical Royal Colleges would advise the Supra-Regional Service Advisory Group (SRSAG) on
the units they considered appropriate, and these recommendations would be considered and
passed on from the SRSAG to the Secretary of State for final approval. Dr Halliday stated
that quality data as well as activity data were provided to the SRSAG, but quality data
was not considered unless a specific concern was raised. During conversations with
clinical colleagues and at visits to designated units, Dr Halliday said that no such
concerns regarding mortality rates at Bristol had been raised with him. He said that the
small number of referrals to the Bristol unit was recognised by the SRSAG early on but it
was hoped that these would increase over time. He concluded by explaining the decision to
de-designate the entire national neonatal and infant cardiac surgery service in 1992.
Professor Ian Kennedy, Inquiry Chairman, concluded today’s hearings by saying that
the Inquiry would next sit to hear oral evidence in Bristol on Monday 10th May
1999 at 10.30 a.m..
|
FULL TRANSCRIPT
1 Day 13, 29th April 1999
2 (9.30 am)
3 THE CHAIRMAN: Mr Langstaff, good morning.
4 MR LANGSTAFF: Good morning, sir, today we have the
5 privilege of hearing from Dr Norman Halliday, who was,
6 throughout the period with which we are principally
7 concerned, the Medical Secretary of the Supra Regional
8 Services Advisory Group.
9 He is represented, as was Mr Owen and
10 Mr Angilley.
11 Dr Halliday, would you like to come forward,
12 please?
13 DR NORMAN PRYDE HALLIDAY (Sworn):
14 Examined by MR LANGSTAFF:
15 Q. Dr Halliday, your full names are, I think, Dr Norman
16 Pryde Halliday?
17 A. Correct.
18 Q. Would you take a look on the screen in front of you at
19 what we have as WIT 49/1. That, I think, is the start
20 of a statement which you made for the purposes of this
21 Inquiry?
22 A. Yes.
23 Q. If we can turn through, please, to page 9, and look at
24 the end of it, that is your signature?
25 A. It is my signature.
0001
1 Q. The contents of that statement are true and accurate,
2 are they?
3 A. They are.
4 Q. Can I, before I start asking you questions about and
5 around it, for the purposes of the Inquiry, just say
6 this: that we appreciate that it has been quite
7 difficult to make arrangements for you to come here
8 today, and can I say how much it is appreciated that you
9 have made yourself available?
10 A. Thank you.
11 Q. You, I think, are unusual, possibly singular, in
12 combining, as I understand it, the medical
13 qualifications which you have with an interest in
14 business administration?
15 A. Yes.
16 Q. Do I take it that throughout, although your various
17 degrees in business administration have been in the
18 1990s, that throughout you have had an interest in
19 business administration, together with your natural
20 interest in medicine?
21 A. Yes.
22 Q. So when you came to be the Medical Secretary of the
23 Supra Regional Services Advisory Group, you were
24 qualified not only in medicine but also had an interest
25 in -- a significant interest in -- the way in which
0002
1 organisations were run?
2 A. An interest in, but no qualifications.
3 Q. Taking your statement as a whole, and taking an
4 overview, I want to ask you about a number of matters.
5 If one were to stand back, do I understand it that the
6 Supra Regional Services Advisory Group were dependent
7 upon the medical profession for any data which it had as
8 to surgical outcomes and surgical performance?
9 A. Yes.
10 Q. That depended upon what co-operation others in the
11 medical profession would give you?
12 A. Yes.
13 Q. What you say, I think, in your statement, is that you
14 were dependent upon the Medical Royal Colleges for the
15 assessment of any service before it was designated?
16 A. Yes.
17 Q. And you were dependent upon the Medical Royal Colleges
18 for the assessment of any unit in order to provide
19 a service before that was approved?
20 A. Yes.
21 Q. Again, as I understand what you say in your statement,
22 the Supra Regional Services Advisory Group were
23 dependent upon the Medical Royal Colleges for continuing
24 feedback as to whether or not units continued to meet
25 the criteria for designation?
0003
1 A. Formal feedback, yes, but the Advisory Group benefited
2 from our informal contacts with the profession.
3 Q. Again, that would depend upon what you, through your
4 contacts, and others no doubt, were able to glean from
5 members of the medical profession, what they were
6 prepared to say, if you like?
7 A. Yes, and management, of course.
8 Q. Questions might be asked, and have been raised in this
9 Inquiry, as to the way in which concerns about any
10 particular unit, if there were such concerns, would be
11 raised and would be dealt with.
12 Do I take it that so far as you were concerned,
13 you were dependent upon any formal or informal contacts
14 that you had in the medical profession?
15 A. And in management. I mean, we met doctors, nurses,
16 managers. It was not solely the medical profession,
17 no.
18 Q. Can I, against that background, break my questioning
19 down into five main areas? The first of those I want to
20 ask you about is the process of designation and
21 de-designation of both the service of neonatal and
22 infant cardiac surgery and the designation and
23 de-designation of Bristol as a unit providing that
24 service.
25 First of all, am I right in my understanding that
0004
1 when the service began, Bristol was there at the start?
2 A. Yes.
3 Q. And when it ended, Bristol was there at the end?
4 A. Yes.
5 Q. And it remained designated throughout?
6 A. Yes.
7 Q. The criteria -- because there were criteria, as there
8 have to be in business, against which a service is
9 measured. The criteria, as I understand it, are set out
10 in health note 36 of 1983. Can we have a look, please,
11 on the screen UBHT 62/242?
12 I will give you a moment to look at that. A deals
13 with the criteria of selecting services and B in the
14 annex, information to accompany proposals. Again,
15 I suspect it is common ground between us, but I would be
16 grateful for your confirmation, since you were there at
17 the start, the service was designated as from 1st April
18 1984?
19 A. Yes.
20 Q. How long before that was it that the idea germinated?
21 A. The idea being ...?
22 Q. A supra-regional service, in this particular field?
23 A. Of course, it was not set up to provide arrangements for
24 this particular field. The supra-regional services
25 arrangements were set up because developing medicine and
0005
1 complex services such as neonatal and infant cardiac
2 surgery did not fit with the NHS planning system which
3 was regionally based. So discussions about the
4 supra-regional services started in 1973.
5 Q. I think they may have had some impetus from a report
6 which we have seen. Again, I would be grateful for your
7 comment as to the significance or otherwise of it. We
8 have it at RCSE 3/17.
9 What you should have on the screen is the second
10 report of the Joint Cardiology Committee of the RCP and
11 the RCSE.
12 Am I right, first of all, in thinking in broad
13 terms that this report gave impetus to the development
14 of supra-regional services in this field?
15 A. Well, I think it might be useful if I explain how the
16 supra-regional services came about.
17 Q. Please.
18 A. In 1973, just before the reorganisation of the NHS in
19 1974, it became very clear that there were services that
20 did not fit within a regionally provided service, and in
21 1974, with the reorganisation of the NHS, we introduced
22 a regionally based planning system for the first time.
23 That highlighted the problem of many of the more
24 complex clinical services.
25 The Minister of Health of the day, David Owen,
0006
1 being a doctor himself, was particularly concerned about
2 this element and asked the officials in the Department
3 to make sure arrangements were included within the
4 planning system.
5 The best brains in the Department failed to come
6 up with anything that was workable.
7 Then Professor Brian Abel-Smith was asked to set
8 up a Working Group and he failed to come up with any
9 arrangements.
10 So it was generally accepted by the profession,
11 and indeed all the officials, that it really was not
12 going to be possible to provide any arrangements.
13 The real difficulty was that there are so many
14 complex clinical services within the NHS that to include
15 all these would have meant that the Department of Health
16 would have been running the NHS, which, of course, it
17 does not.
18 So it was generally accepted it would not be
19 possible, including myself.
20 The oil crisis in 1974/75 presented major problems
21 for the NHS because all the costs went up and there were
22 already concerns that some of the services were
23 under-funded so the Department was under constant
24 pressure from the medical profession to do something
25 about these very specialised services.
0007
1 In 1976 I was then head of one of the medical
2 divisions responsible for the policy for the acute
3 hospital sector in England, and I agreed that my
4 division would set up a Joint Working Party with the
5 medical profession to see if we could take this forward.
6 It became clear that it was very difficult, until
7 I had the idea of, rather than having inclusion
8 criteria, we should actually have exclusion criteria.
9 We then decided, and agreed with the profession, that
10 certain areas would be excluded. If, in particular,
11 they had alternative funding arrangements, for example,
12 if this was a research service, then we would not
13 include that within our considerations because there was
14 alternative funding for research.
15 If it was an educational matter, equally, that was
16 being funded through a different source.
17 If, in fact, the service we were considering was
18 a support service, such as pathology, radiology and so
19 on, we would not include those. So by going through
20 a series of exclusions, we then found we came up with
21 criteria that would allow us to identify some
22 specialised services which would be a manageable number.
23 Amongst the criteria we have, of course, there is
24 an important one here and that is that the cost of the
25 service had to be significant because there were still
0008
1 hundreds if not thousands of therapies which were
2 extremely complex, and poorly understood perhaps locally
3 because they were of national importance and had
4 difficulty with funding. But the costs of those
5 services were not particularly significant in national
6 terms, and may not even have been significant in
7 regional terms, so we excluded those as well.
8 So we were looking at services across the Board.
9 Against that background, my division was also
10 responsible for looking at policy within the various
11 specialties. The Department did not, as a matter of
12 principle, issue policies for all the clinical
13 services. If the services were functioning effectively,
14 there was no problem. My division was more concerned
15 with looking at those services where there were actual
16 problems or potential problems. If it was agreed by
17 ministers, we would issue policies in those areas.
18 Amongst services for which my division was
19 responsible was in fact neonatal and infant cardiac
20 surgery, although at that time it was just called
21 paediatric cardiac surgery.
22 One of the concerns that we had was that there
23 were allegations that many children were not being
24 diagnosed and treated and were actually dying without
25 such benefits.
0009
1 So there was a general concern, and indeed, the
2 Colleges do not set up joint working parties unless
3 there are problems.
4 So we were conscious of this.
5 The decision that had to be taken was, was this
6 a service that could benefit from the central funding
7 arrangements within the supra-regional services? So the
8 two were quite separate to begin with, but as it
9 emerged, it appeared that it was an ideal candidate for
10 the supra-regional services.
11 Q. If I can perhaps short-circuit the need to go through
12 a number of documents, I think the parameters were
13 these, were they -- tell me again if I have got it
14 wrong, and give any explanation that you feel would
15 help. Essentially, the service, as you say, could not
16 be so cheap that it was going to be performed out of the
17 regional budget without any difficulty?
18 A. Yes.
19 Q. It could not be so large that every region was going to
20 do it, because obviously the idea was supra-regional, so
21 one would be looking, I think in your statement you say
22 at a maximum of 400 operations per year. We have seen,
23 from what Mr Owen was able to tell us yesterday, that
24 that was a minimum, 400 to 1,000?
25 A. Well, I think in terms of numbers, the numbers were not
0010
1 included in the criteria.
2 Q. They were not?
3 A. They were not, no, but we quickly realised -- it took us
4 from 1976 to 1981 to agree these arrangements. It was
5 not an easy task at all. These arrangements, however,
6 having been established, are actually the envy of the
7 world. If you speak to clinicians in other countries,
8 they will say "I wish we could have some arrangement
9 like this", but their organisational arrangements do not
10 allow it. It was a very complex exercise.
11 Having worked for five years to introduce the
12 arrangements, they were issued a pilot study in 1981,
13 but the funding arrangements were not satisfactory, so
14 they were reissued again in 1983.
15 With hindsight, of course, we should have been
16 considering whether there should have been a particular
17 number of any treatment that would be included in the
18 criteria. But even then, it is very difficult. If you
19 look at some of the services that have been designated,
20 the numbers are exceedingly small. Most of those
21 excluded were where the numbers have been very large.
22 So the numbers to which we have been referring in many
23 documents were really crude rules of thumb which
24 assisted the Advisory Group, but they were not part of
25 the criteria.
0011
1 Q. I see. So when we see the range 400 to 1,000 in
2 documents, where we had that quoted to us by Mr Owen,
3 that really is a tool for working out whether or not
4 there may be an appropriate case for designation?
5 A. Yes.
6 Q. The purpose of designation, as I understand from your
7 statement, and again, tell me if I have got it wrong, or
8 put a gloss upon it, was two-fold: one was the idea that
9 if things remained as they were, spread across the
10 country on an ad hoc basis, no surgeon or unit would
11 gain sufficient expertise to do the job as well as they
12 ought to, or might. That is number 1, I think.
13 Number 2 was the need, therefore, to control
14 a proliferation of centres, to concentrate in a few
15 centres rather than many, and number 3, thereby to cut
16 the cost overall of the service while actually improving
17 and maintaining clinical quality.
18 Have I got it broadly right?
19 A. No, I would disagree, actually. The reason for setting
20 up the supra-regional service and the reason for
21 selecting any particular service was principally
22 funding. They had problems in funding the service. But
23 of course from the Department's point of view, we
24 recognised that there was also a benefit in that. There
25 was a benefit in that we could control the development
0012
1 of the services, which would be beneficial in terms of
2 cost, but also beneficial in terms of benefits to the
3 patients, because the experience worldwide was that the
4 more a doctor does a particular form of treatment, the
5 better are his results.
6 So by controlling the development of these
7 services, we would be giving benefits to the patients.
8 There was another point I wanted to make, but it
9 has gone at the moment.
10 Q. It will come back. If I can just go to your statement,
11 the top of page 3, WIT 49/3, you deal there, in the
12 opening words of paragraph 3, with the reasons as you
13 have just explained them.
14 A. Yes.
15 Q. You say at the top of the page:
16 "The joint Working Party agreed a system and it
17 proved to be a complete success."
18 The system you are talking about there is the
19 supra-regional services system, is it?
20 A. Yes.
21 Q. When you say "proved to be a complete success", that is
22 a bold claim to make for a service?
23 A. Well, it has lasted since 1983, unchanged. It has
24 survived the NHS reforms. It still provides a way of
25 Central Funding for these very specialised services.
0013
1 There is no other country in the world that has a system
2 that equals the supra-regional services arrangements.
3 If one can implement the arrangements effectively, you
4 should have the services concentrated in a few centres.
5 If you view the health services in any other country in
6 the world, you will find that there are complex clinical
7 services and the best money makers are in fact spread
8 all over the country, and there is no control in terms
9 of these specialised services.
10 So the benefits to the patients of this system are
11 significant.
12 Q. So far as neonatal and infant cardiac services are
13 concerned, can we look on the screen at DOH 2/243?
14 This is a document, so that you can see the origin
15 of it -- it is not very well reproduced there. If one
16 goes back to page 240, just look at the top, you will
17 see this is paper SRS(88)2.
18 Can we return to 243? It is talking about the
19 neonatal and infant cardiac services, paragraph 16,
20 abandonment:
21 "If the principles governing supra-regional
22 designation are strictly applied, then this is the only
23 option. Designation has been singularly unsuccessful in
24 containing the provision of the service to the existing
25 nine centres."
0014
1 Just pausing there, that is something which comes
2 out of the Supra Regional Services Advisory Group
3 itself?
4 A. Yes.
5 Q. So if one describes the service generally as a complete
6 success, it would appear that the Advisory Group in 1988
7 regarded the success as less than complete so far as
8 this particular part of the service was concerned.
9 A. Yes. With regard to this service. When we designated
10 the service originally, we were aware that there were,
11 in fact, more centres than the professional advice from
12 the various colleges suggested that we needed on
13 epidemiological evidence.
14 Q. Can I stop you there? I am going to go on to that. By
15 all means, we can amplify what you have to say in
16 a moment.
17 A. I do not think that this suggests that the
18 supra-regional services were not a success. I believe
19 they are a success; I believe, however, that there are
20 many other factors other than the arrangements by which
21 the supra-regional services worked which determine
22 whether a service will co-operate with these
23 arrangements, and therefore --
24 Q. I think what I was focusing on was the expression
25 "complete success" and the description given in
0015
1 paragraph 3 of the reasons for the service, to control
2 the development, you say, and equally important reason
3 for the service, to control the development of the
4 services; plainly in neonatal and infant cardiac
5 services it did not work for various reasons, which we
6 will go on to explore. I gather from what you are
7 saying, that was really by way of exception to the
8 general rule?
9 A. Yes. The supra-regional service arrangements were not
10 set up to control the development of any service; they
11 were set up to fund the services that were in dire need
12 of special funding, and as a quid pro quo, we obtained
13 a degree of control, but they were not actually set up
14 to control the provision of any service.
15 Q. Forgive me. If we go back to your statement, 49/3, the
16 second sentence of your paragraph 3, you dealt with one
17 reason for setting up Supra Regional Services Advisory
18 Group arrangements and you say:
19 "Another equally important reason was to control
20 the development of such specialised services."
21 Have I misunderstood what you meant by that?
22 A. You have not misunderstood, but the arrangements
23 themselves were not sufficient. I mean, clinical
24 medicine is not something that is easy to control, as we
25 see from every country in the world, so that a system
0016
1 like this required additional powers from other sources
2 before they could actually impose control. So we were
3 dependent on co-operation of the profits in making
4 arrangements for success.
5 Q. I can understand the reasons. I think the point I am
6 making -- I will move on in a moment, but if one
7 measured the success of the system against the reasons
8 you give for setting up it in the first place, providing
9 it is in an environment where doctors can do their own
10 thing, so far as this was concerned there was a problem
11 because doctors exercised that freedom?
12 A. And because government departments took their own
13 decisions. It was not simply the medical profession.
14 Q. I am grateful. Again, I wonder if you can help me with
15 this: when the service began, the picture that I have --
16 it may be entirely wrong, which is why I would welcome
17 your input on it, is that surgery for congenital heart
18 disease in neonates and infants was performed at
19 a number of institutions up and down the country?
20 A. Yes.
21 Q. Many more than 9?
22 A. Yes.
23 Q. I do not know how many, but I suppose that is not the
24 point. The point was to reduce the numbers down to 9
25 for the reasons you have given?
0017
1 A. Yes.
2 Q. In order to decide what unit would provide the service,
3 no doubt the Advisory Group would look at the rival
4 claims of the various places that were actually doing
5 the work at the time?
6 A. Yes.
7 Q. What would they be looking for? Would they be looking
8 for a number of operations in the field?
9 A. Of course, I think you would have to ask the Royal
10 Colleges what they were looking for, but what we would
11 expect from the Royal Colleges is their expert opinion
12 as to the facilities available in the unit, the staffing
13 of the unit, the qualifications and experience of the
14 staff, and in their opinion, the ability of that unit to
15 provide that service.
16 Q. If one has a look at the numbers of operations which
17 were in fact being performed by Bristol, I think one
18 would discover that three operations were actually
19 performed during the year 1983 to 1984, which would be
20 the year that designation was decided upon.
21 Does that accord with your recollection? I will
22 find the figures in a moment.
23 A. I would have to see the numbers, I am sorry. It is
24 a long time ago.
25 Q. Let me find the numbers. My references for once have
0018
1 let me down, I apologise for that. I will find it in
2 just one moment.
3 MRS MACLEAN: Mr Langstaff, if it is helpful, I have with
4 me, my number for that is 4.
5 MR LANGSTAFF: No, there are two different figures,
6 Mrs McLean. It may be that it may be 4, it may be 3,
7 but there are two different figures which were quoted.
8 Can I have HAA 95/87? These are Bristol figures.
9 If we scroll down to neonatal and infant cardiac
10 surgery, one will see the figure for 1983 where it would
11 appear, if that is right, what the numbers of operations
12 were.
13 Perhaps if we look at DOH 4/28, and turn it
14 sideways, this is where the figure of 4 comes from, so
15 one sees the two different figures.
16 If you look across the top line, doctor, you will
17 see the figures for open heart surgery performed in
18 Bristol, as recorded by the Department of Health, and we
19 in this Inquiry are looking at those figures to see in
20 fact what the true position was, because one accepts,
21 I think, that there are all sorts of problems with the
22 data.
23 Looking at that, one would have a picture, would
24 one not, of really very low activity for the neonates
25 and infants in open heart surgery up until 1983, before
0019
1 designation took place?
2 A. Yes.
3 Q. So if one were looking for a centre that was actually
4 doing the work, there would seem, on the face of it, to
5 be little claim, would there, that Bristol would have to
6 do it?
7 A. Yes. I do not know whether you have covered how units
8 were designated, but the procedure was that the
9 Department each year would invite regional health
10 authorities to submit bids for any service that they
11 thought might warrant designation.
12 We got large numbers of bids for services.
13 In the case of neonatal and infant cardiac
14 surgery, as I mentioned, there was concern already
15 within the Department that this may be a service that
16 required some national input in terms of policy, and we
17 had before us the reports of the various professional
18 groups, so that was -- it was not expected that we had
19 a number of bids from various units.
20 These bids were all then submitted to the Royal
21 Colleges for their opinion, as to which of the units
22 should be selected. So Bristol was one of the units
23 which the Royal College thought was a suitable unit for
24 designation.
25 Q. The Supra Regional Services Advisory Group had to agree,
0020
1 of course?
2 A. Would have to agree?
3 Q. Well, they had to agree before there was any
4 designation?
5 A. Yes, of course.
6 Q. Because it was not the Royal Colleges' decision?
7 A. Of course not.
8 Q. It was the Secretary of State's ultimately and he would
9 do it on the Advisory Group's advice?
10 A. Yes.
11 Q. And the Advisory Group would take their input from the
12 Royal Colleges fed through you?
13 A. Yes.
14 Q. And contained on the Group were a number of doctors who
15 were there because they could lend the benefit of their
16 expertise to the whole supra-regional system?
17 A. Yes.
18 Q. Was there a difference between the process after the
19 system had got up and running in 1983/1984 and
20 thereafter, in terms of units putting in bids for
21 designation?
22 A. No. No, not that I am aware of, no.
23 Q. So one would expect, would one, to see somewhere
24 a written bid for designation, prepared by those
25 concerned with the administration of Bristol at the
0021
1 time?
2 A. I am sorry?
3 Q. Let me just repeat the question. After the service
4 began, dealing with a number of different fields --
5 A. You mean the supra-regional services, I am sorry,
6 I thought you were referring to this service.
7 Q. The supra-regional services began in 1983/84?
8 A. Yes.
9 Q. Presumably, when any unit wanted to apply for
10 designation, after the services as a whole began, there
11 would be a written bid?
12 A. Yes.
13 Q. And the written bid would condescend to detail?
14 A. Yes.
15 Q. It would have to?
16 A. It would have to.
17 Q. Because you, the Supra Regional Services Advisory Group,
18 would want to have some objective basis for designating
19 another unit?
20 A. Yes.
21 Q. Did that process of written bids, detailed information
22 on paper, happen first time round?
23 A. I am sure it did, but I cannot be certain. We are
24 talking about a long time ago.
25 Q. One of the reasons I ask as to that is that if one takes
0022
1 UBHT 278/577 -- this is dated 17th April 1984. It is
2 a letter you may not have seen, but I want to ask you
3 about the implications which may flow from it. It is
4 addressed to the regional administrator of the South
5 Western Regional Health Authority, who would have had
6 the administration of Bristol. It says:
7 "As you know, the Supra Regional Services Advisory
8 Group has designated neonatal and infant cardiac surgery
9 as a supra-regional service and has asked the Department
10 to initiate a study of the services provided in the
11 units designated for its provision and their costs. The
12 purpose of this letter, therefore, is to ask for up to
13 date information on activity and costs to enable the
14 Department to identify in regions' allocations for
15 1984/85 the expected expenditure on these services.
16 This will then form the basis for consideration of
17 funding protection in 1985/86."
18 Pausing there, the underlying premise one detects
19 in this letter is that there was no such information
20 held centrally by the Department of Health and Social
21 Security, otherwise they would not have been asking for
22 it?
23 A. Actually, it is quite helpful to see that letter. What
24 obviously has happened here, and it happened with some
25 of the supra-regional services, is that the case for
0023
1 designating this service is strong and the Advisory
2 Group may have considered that they would designate the
3 service, but they then had to go on and identify the
4 units who would provide those services.
5 Clearly, that is what we did in the case of
6 neonatal and infant cardiac surgery.
7 Q. Again, if I can just press the point, it would appear to
8 indicate that there was not the sort of information one
9 would expect from a detailed bid per unit in 1983/84, so
10 that the service was going to be designated and advice
11 was taken, no doubt, from the Royal Colleges on who
12 would provide the service, but the detailed information
13 came later?
14 A. No, they would not be designated without the detailed
15 information.
16 Q. Could you look at HAA 107/3. This is a letter, we can
17 scroll down to the bottom, from Mr Wisheart to
18 Dr Reynolds. Again, you will not have seen this letter
19 but I want to ask you about the implications which may
20 be thought to flow from it:
21 "Dear Martin,.
22 "As you can imagine, I was really delighted when
23 it was finally announced some months ago [this letter
24 was written in August 1984] that Bristol was to be
25 designated as one of the supra-regional centres for
0024
1 paediatric cardiology in infancy. This designation
2 obviously brings quite serious responsibilities to those
3 of us who are active in this field and, at the same
4 time, I believe it opens up certain possibilities. At
5 this stage, I can only speculate, but the possibilities
6 might extend into the areas of developing the work, both
7 medical and surgical, financing of the work and,
8 possibly, even into special manpower considerations.
9 Whether or not these speculations are correct ..."
10 It goes on and talks about the need to formulate
11 quite definite plans for the future of this work here in
12 Bristol.
13 One might think, reading that letter, that this
14 was written by somebody plainly centrally involved as
15 a cardiothoracic surgeon, who did not really have a very
16 clear idea what the implications would be, and had not
17 devised any sort of plan, business plan, plan for the
18 future, in relation to the service at Bristol.
19 That appears to be the implication of it.
20 The question for you that arises from this is,
21 would it be a fair inference from this that when the
22 service was first set up, discussions with units such as
23 Bristol were somewhat limited as to where the service
24 was going to go and what it was going to imply for the
25 future?
0025
1 A. It is useful seeing this letter, and I think had we seen
2 it earlier, we might have been able to prepare ourselves
3 to answer more helpfully.
4 In the case of the designation of the units, the
5 Royal College of Surgeons was given all the evidence we
6 had on all the units that were asking to be considered
7 for designation.
8 In the case of Bristol, the case was weak, but
9 there was an important point and that was the
10 geographical cover, because all the other units covered
11 the country well, but the South West was deprived in
12 terms of cardiac surgery, especially for neonatal and
13 infants. So the Advisory Group was concerned to see
14 that part was covered. Indeed, many of the professional
15 reports identified that there was a need for cover in
16 that area.
17 The weakness of the Bristol was case was a factor,
18 and I remember clearly that Terence English rang me and
19 spoke to me about this before the decision was taken,
20 and said -- at that time of course he was not President
21 of the College; I think he was actually President of the
22 Society of Cardiac Surgeons -- but he said if in fact
23 the Advisory Group designated Bristol, then through the
24 College they would endeavour to strengthen that unit.
25 Q. So that is what Sir Terence was saying?
0026
1 A. Yes.
2 Q. Can you help me with the whole question of geographical
3 considerations and weakness? Is what you are saying
4 that the track record in terms of numbers of operations
5 done was not really a justification for Bristol becoming
6 a supra-regional centre?
7 A. Well, it certainly did not perform anything like on
8 a par with the other units, no.
9 Q. It is very difficult to see how three open heart
10 operations would justify that?
11 A. Well, if you look at those figures again, you will see
12 it actually goes 10, 11, 3, and so on, so there might
13 have been a good reason, a management reason, for only
14 doing 3 that year.
15 Q. But if one took 10, which was the highest it had been
16 before 1984?
17 A. If you take 10, then you would have to look at
18 outstanding units such as Harefield, who only did about
19 10 in those years.
20 Q. What then did you mean by "weakness?"
21 A. It was a small unit. They were not doing many
22 operations. My division kept close contact with all the
23 professions within the various specialties, and
24 attending meetings of the Society and the College when
25 dealing with paediatric cardiac surgery and cardiology,
0027
1 Bristol did not actually shine as a star, whereas many
2 of the other units such as Birmingham, Harefield,
3 Brompton, Guy's, GOS, would stand out, so it did not
4 seem to be one of the leading lights in this area.
5 Q. "Shine as a star" in what sense?
6 A. In terms of clinical work that was going on there, in
7 terms of research, in terms of the results that they
8 were getting.
9 Q. So we have a unit which is doing a small number, and you
10 say it may well correspond with Harefield at 10, but
11 obviously not at 3, a unit where the view was -- I will
12 come back to the evidence for that in a moment -- that
13 it was not a star; and the basis that you are telling me
14 was decided by the Group to designate Bristol was
15 geography?
16 A. A main reason was the geography, yes.
17 Q. I want to explore with you precisely what one means by
18 "geography". We have heard evidence that in Wales
19 there were a number of outreach clinics, cardiology
20 clinics, which were operated from London and that these
21 outreach arrangements had been well established in the
22 1970s, and in consequence, children with congenital
23 heart disease were referred by the visiting clinicians
24 to the centres in London, the Heart Hospital,
25 Hammersmith, Great Ormond Street and so on.
0028
1 So plainly, they thought nothing wrong clinically
2 in putting a child into an ambulance or car and taking
3 the baby miles down the road to London.
4 One understands that geography may have a sense of
5 being near to the child rather than as remote and as
6 removed in London. Is that the sense?
7 A. Whilst clinically there is not usually a problem of
8 transferring patients hundreds of miles, the real
9 problem is that it means their relatives, the parents
10 and others then have to travel this distance and I think
11 in the case of children it is regrettable if a child has
12 to be treated in a hospital a long way away from the
13 parents who have great difficulty in visiting regularly.
14 So ideally, if one can, one should have units as
15 near the main populations as possible.
16 Q. Can you help at all: was there a political element in it
17 as well, to have a unit here so that the South West
18 feels it is being catered for, up in the North East so
19 it feels it is being catered for, that sort of thing?
20 A. No, that was not an element. My division would look at
21 many factors in looking at these services and there have
22 been many studies, including an important one in
23 Scotland, showing that after a certain distance the
24 visiting by parents and others dropped dramatically. So
25 one should really ideally have the units as close to the
0029
1 main conurbations as possible. There was evidence from
2 Canada and America to the same effect.
3 Q. Can you help at all why it would be, if that is the
4 case, that clinicians in Wales and for that matter in
5 the South West, would have referred to places such as
6 Birmingham, Southampton, London, rather than to Bristol
7 where the surgery, as we know, was actually being done,
8 albeit in small numbers, prior to 1984?
9 A. There would be many reasons, but if we are talking about
10 business reasons, they did not market their service
11 particularly well.
12 I am not at all surprised that there were a lot of
13 referrals to the Brompton, Hammersmith and others,
14 because they did in fact hold clinics in Cornwall and in
15 Wales and, I mean, it really is quite a privileged
16 situation, where you can afford to send your consultant
17 staff down to do clinics in other parts of the country.
18 There are many units who could not have afforded to have
19 done that. In terms of a marketing decision, I think
20 that was a wise one. I think it would be quite wrong if
21 we continued the service that patients in Cornwall had
22 to travel for treatment, unless of course they were
23 going to London because that was the best place for them
24 to be treated. If in fact it was possible for them to
25 have that kind of service in Bristol, or any other unit
0030
1 around that area, then that would be much better for the
2 patients.
3 Q. What you are factoring in there is provided the quality
4 was equal. Provided the quality in Bristol was equal,
5 it is better than far away?
6 A. Yes, the clinical outcome.
7 Q. The clinical outcome, as I understand it, depends to
8 some extent on the numbers performed?
9 A. Yes.
10 Q. You say more than once, I think, in your statement, that
11 there was evidence that the more operations a unit did,
12 the better they got at it?
13 A. Yes.
14 Q. I am putting it very crudely, but that is the essential
15 principle, is it not?
16 A. Yes.
17 Q. So one would expect the biggest centres to have better
18 results?
19 A. Yes.
20 Q. If one factors that into the equation, it makes a bit of
21 a difference in the geographical case, does it not? The
22 geographical case depends upon, does it not -- tell me
23 if I am wrong -- the results being equal in the two
24 centres being compared?
25 A. Yes, but if you are designating a service for the first
0031
1 time and you are endeavouring to cover the country, you
2 may well have to identify a unit which at that moment in
3 time is not performing as well as some of the other
4 centres which may have been established for many years,
5 but the intention is to develop that service, nurture
6 that service.
7 Q. Can we have a look at UBHT 62/32.
8 Again, just to put this document in context, we go
9 back to 62/28.
10 Let us see what the document is and the date of
11 it: 1984, "Paediatric cardiac supra-regional service
12 for infant cardiology and cardiac surgery".
13 Then the page I want to ask you about, which is
14 page UBHT 62/32, "Origin of patients undergoing cardiac
15 catheterisation."
16 We can look at the second paragraph. On average
17 only 20 per cent of the patients came from Bristol and
18 the west and 60 per cent from outside the region.
19 If we go down to the bottom: Plymouth sends most
20 of its cases to London or Southampton.
21 "(ii) non urgent cases from Wales are dealt with
22 in Cardiff or sent to London."
23 It might be suggested from this that although one
24 is looking here at catheterisation and referrals for
25 that purpose, that there are obviously established links
0032
1 from towns which might otherwise expect to send their
2 cases to Bristol, with units elsewhere, London,
3 Southampton, Cardiff, London.
4 The impression we were given on Monday by
5 Mr Gregory from the Welsh Office was that once you have
6 an existing arrangement, a referral arrangement,
7 a referral pattern, it is very difficult to change it
8 quickly?
9 A. Yes.
10 Q. It takes a long time.
11 A. Yes.
12 Q. So the natural expectation would be, would it, that
13 referral patterns are not going to change quickly as
14 a result of a new unit being established?
15 A. Yes.
16 Q. Would it follow from that that a unit such as Bristol,
17 doing the small numbers that it was in 1983/84, was
18 unlikely to grow very significantly over the next few
19 years?
20 A. If there was no other factors, but with assurances from
21 the Royal College that they were going to do what they
22 could to strengthen that unit, then there was every
23 prospect that there would be a change in the referral
24 pattern.
25 Q. So what you are saying is really, "Well, if the Advisory
0033
1 Group were looking at this as a matter of their own
2 experience and the criteria, Bristol would not qualify,
3 except on geography, and geography depends upon the
4 quality being maintained and improved; we are assured by
5 the Royal College of Surgeons that they are going to do
6 their best to make sure that happens".
7 Is that essentially it?
8 A. That is essentially it.
9 Q. Do you remember who in the Royal Colleges you spoke to
10 at the time?
11 A. Terence English, yes. Of course the discussion about
12 the units would be with the President at that time.
13 I cannot remember who it was that year.
14 Q. Was anything said by Sir Terence -- he was then,
15 I think, just Terence -- as to what precisely the Royal
16 Colleges proposed to do to encourage the change in
17 referral patterns?
18 A. No.
19 Q. So really, it was left very vague?
20 A. Yes, but we were in a situation where the Advisory Group
21 was concerned to see the country covered. We had the
22 South West, which was not being provided for; we had
23 Wales which was not within the supra-regional service
24 arrangements, they were separate. We always provided
25 services through them. So ideally we would like to see
0034
1 that part of the country covered.
2 The professional advice was that Bristol was
3 a suitable unit. The Advisory Group could have decided,
4 "Well, we do not accept professional advice" and not
5 designated the unit, but given that there was a pressing
6 need, we have all these patients travelling all the way
7 to London, the Advisory Group, I think rightly at the
8 time, decided to designate Bristol.
9 Q. If we go back to the figures that we had a moment or two
10 ago, DOH 4/28, again, look at the number of open heart
11 operations which were performed.
12 We have gleaned, and I can show you if you want to
13 refresh your memory of it, that it was the advice of
14 Working Parties and the like to the effect that
15 a surgeon would need to do at least one operation per
16 week, 50 operations per year, if he was to benefit from
17 the throughput and maintain and indeed improve his
18 expertise?
19 A. Yes.
20 Q. We also gleaned from the documents that ideally a unit
21 should have at least two surgeons doing the work for
22 cover?
23 A. Yes.
24 Q. Even though one may not be full-time.
25 The number of open heart surgical operations
0035
1 performed throughout the period 1983 to 1984 to 1991,
2 never got to anything like that level in Bristol?
3 A. No.
4 Q. So it would follow that, whatever the assurances that
5 had been made to you by the Royal College of Surgeons on
6 this rather nebulous basis, nothing in fact was
7 happening very much to improve the throughput at
8 Bristol?
9 A. Well, it is increasing, but it is not significant.
10 Q. That must have been a matter of concern, then, to the
11 Group?
12 A. It was, yes.
13 Q. It would imply, because of the low numbers, that the
14 outcomes were unlikely to be as good as they would be in
15 one of the larger centres?
16 A. Well, as we have agreed, all the evidence suggests that
17 the more operations you do, the better you are. But of
18 course there are always exceptions to that and I can
19 give you many examples of people who have done only
20 a few operations, but their results are quite
21 outstanding: the cardiac surgeon in St Bartholomew's
22 Hospital, for example, who only did three heart
23 transplants but his success rate was 100 per cent. So
24 there are many factors that influence this.
25 The other thing I think you need to take into
0036
1 account is at the time Bristol were only doing 11, 14,
2 24. There were other units in the country doing 11, 13,
3 24, and were getting outstanding accounts.
4 All the evidence would suggest that it is a key
5 factor, but it is not the only factor.
6 Q. Can we have a look at WO 1/237? This is a comparison,
7 because you raise it, the position of Bristol with other
8 units, looking at the number of open and closed
9 operations from 1984 and 1985.
10 If one casts an eye down the left-hand column, and
11 for 1984 the open operations, it would appear that no
12 other unit, not even Leicester, which was not
13 designated, at the bottom of the table, was doing as few
14 open operations per year as Bristol?
15 A. I am not sure whether Leicester is 11 or 14.
16 Q. It is difficult to see, and I wonder if we can highlight
17 that in yellow, to see if that helps at all.
18 A. Then there is Guy's, which looks as if it might be 10 or
19 19.
20 Q. I think that is 19.
21 A. We are still talking about very small numbers. If in
22 a year you are talking about 11 cases in one unit and
23 19 in another, or 11 or 14, the difference is not
24 particularly significant.
25 Q. I think I can help you with whether it is 14 or 11. Our
0037
1 reading of the photocopy document appears to be 13, but
2 you are absolutely right, it does not come out very well
3 on the screen.
4 A. That would mean Leicester was only doing two more than
5 Bristol, and Guy's, which was one of the leading units,
6 was only doing 8 more.
7 Q. Guy's had a particular approach, I think, I do not know
8 when it developed, to use interventional catheterisation
9 rather than operations. Do you know when that
10 developed?
11 A. No, but most of the units performed this, although Guy's
12 was an elite, but that was not the designated service;
13 it was only the cardiac surgery that was designated.
14 Q. But it had an impact, obviously, on the numbers done?
15 A. Of course, but similarly, it would have an impact on the
16 numbers done in the other units. I am not sure how many
17 were treated by interventional cardiology in Bristol in
18 that year.
19 Q. In any event, I need not, I think, ask you any more
20 about the actual number, the throughput of operations.
21 As I understand it from the evidence which we had
22 from Mr Angilley, it was not until the change in the NHS
23 funding arrangements and contracts, the
24 purchaser/provider split, that it became part of the
25 obligation accepted by the provider of the service that
0038
1 they should provide data upon their mortality statistics
2 each year, and show the Department of Health or the
3 Supra Regional Services Advisory Group the returns which
4 they were making to the Register of Cardiothoracic
5 Surgery.
6 Am I right?
7 A. Not completely. I mean, the formal contracts in the
8 form that you discussed with Mr Angilley came in after
9 the NHS changes, but we were always endeavouring to
10 collect information on clinical outcome in the units.
11 One of the difficulties we had with cardiac
12 surgeons was that they had their own register, and they
13 jealously protected their register and were not keen to
14 provide data from that register for other purposes.
15 That, to an extent, was understandable, because medical
16 audit is a very sensitive issue. If in fact the
17 profession was in fact developing a system that might
18 well be very effective in medical audit, one would not
19 wish to threaten them in any way.
20 So it is true that it was not until the reforms
21 came in that they agreed to provide the same data, but
22 they were always providing data in some form in terms of
23 activity and mortality.
24 Q. Can I press you on that? You say in your statement,
25 paragraph 13 -- it is WIT 14/8:
0039
1 "In the absence of agreed medical audit
2 arrangements, we had to adopt alternative means of
3 monitoring the quality of the services being provided in
4 the designated units."
5 Pausing there, you are looking, I think, in that
6 part of your statement, at the period 1989/90, and
7 I accept that obviously the situation may differ from
8 the beginning of the period to the end.
9 Am I right in thinking that in the period 1984 to
10 1989, no figures as to outcomes were regularly produced
11 by any unit for consideration by the Supra Regional
12 Services Advisory Group?
13 A. I could not be sure on that. We are dealing with
14 a large number of services. Throughout our discussion
15 with all of the services, medical audit was always an
16 important issue. One of the difficulties we had with
17 regard to cardiac surgery as opposed to the other
18 services was that they had their own arrangements for
19 doing audit.
20 This was a matter of concern to me and although
21 I did not want to interfere with the way the Society was
22 providing its own medical audit, although we had many
23 discussions with them about the importance of their
24 audit and the relevance to our work, I actually arranged
25 a meeting with all the paediatric cardiologists with the
0040
1 objective of setting up a medical audit on the
2 cardiological front, as opposed to the cardiac surgical
3 front, and that meeting was convened by Professor Tynan
4 and Dr Richards and I presented a paper to that meeting
5 suggesting that we should in fact move forward and find
6 a way of carrying out an effective medical audit.
7 By "effective medical audit", I do not mean
8 simply the collection of data. If in fact you simply
9 collect data and you cannot use it, you find in time the
10 data becomes useless. Garbage in, garbage out. People
11 only provide effective data if it is being used, and to
12 be used I mean we had to have a system whereby the
13 experts in that field would look at the data and analyse
14 it for us, and tell us whether it was of value or not.
15 For the Department of Health to have collected
16 data in the absence of a system of analysing that data
17 would not have been particularly helpful.
18 Q. The question I was asking was whether there was any
19 systematic collection of data in relation to cardiac
20 surgery. Is the answer "No"?
21 A. We collected activity data. I cannot be absolutely
22 certain how much mortality data we got. We got activity
23 data.
24 Q. You are absolutely right to correct me and I am asking
25 about outcomes as opposed to activity. Activity figures
0041
1 you did get, and you got those regularly?
2 A. Yes.
3 Q. Every year, a return was made?
4 A. Yes.
5 Q. And the return was made as to the numbers of operations
6 performed in the different categories?
7 A. Yes.
8 Q. So you have no difficulty in keeping track of that, and
9 that was necessary, no doubt, to keep a check on whether
10 or not the service was effective and working in that
11 particular unit?
12 A. Yes.
13 Q. Because if the unit got too small, you would consider it
14 a de-designation, presumably?
15 A. Yes.
16 Q. And if it got too large and it was too large throughout
17 the country, it would no longer qualify as
18 a supra-regional service?
19 A. Correct.
20 Q. So you had to keep a track of the numbers?
21 A. Yes.
22 Q. But in terms of the numbers of deaths, mortality
23 outcomes, that did not feature in those returns, did it?
24 A. No. I do not think it did.
25 Q. So the question I am asking is, was there any systematic
0042
1 collection of such data?
2 A. There was systematic collection of that data by the
3 Society of cardiothoracic surgeons.
4 Q. But no systematic collection of that data by or on
5 behalf of the Supra Regional Services Advisory Group?
6 A. Not to my knowledge.
7 Q. The collection of data was one performed by the doctors
8 for their own purposes?
9 A. Yes.
10 Q. Outwith the control and checks of the Supra Regional
11 Services Advisory Group or the Department of Health?
12 A. I am sorry, when you said "the doctors", of course I was
13 thinking of my own doctors in the division. Yes, all
14 the clinical specialties, particularly those dealing
15 with complex procedures, routinely collected and present
16 that data at conferences -- regular conferences, both in
17 this country and internationally and in published
18 papers, so we had main sources of obtaining data
19 informally about the activities in the various fields.
20 Q. It may be a cynical comment, but the sort of data
21 presented at conferences subsequently is data to say
22 "Look how successful I have been at this particular
23 operation", or in the particular service?
24 A. Yes.
25 Q. It is rare, is it not, for any unit or service, or
0043
1 doctor, to say "Look how unsuccessful I have been"?
2 A. Yes, but many auditors are quite cynical and would
3 question the data and that discussion would be a very
4 useful source of information for us.
5 Q. What you are describing, I think, gives the answer
6 "Yes" to the question I asked five minutes ago, which
7 is whether there was any systematic collection of data
8 as to outcome by or on behalf of the Supra Regional
9 Services Advisory Group, and I think the answer which
10 you are implying by that last, is "No"?
11 A. "No", yes.
12 Q. The way in which the data came was, you are describing
13 the attendance at conferences by those on your staff?
14 A. And published papers and by meetings in units.
15 Q. So published papers, conferences, meetings at units?
16 A. In the units themselves, yes. I mean, we never had any
17 difficulty in obtaining the data from the units. If
18 I went to the unit and asked for the mortality data,
19 they would give me the mortality data. The problem
20 I had was who was going to analyse the data and make use
21 of it. In the absence of an expert group, which we had
22 not then agreed, we could not make use of it.
23 The collection of data is a costly activity. It
24 is also important that you get good reliable data, so
25 you have to take the people with you. It takes a long
0044
1 time to develop many of the arrangements that we need.
2 Q. Again, I appreciate we are looking at everything with
3 the hindsight of the 1990s. The system you are
4 describing is one where, if you had to evaluate the
5 quality in terms of outcome as opposed to in terms of
6 throughput of a service, you would do it on the basis of
7 talking to the unit, looking at the statistics and
8 making what you could of the information provided.
9 Is that fair?
10 A. Yes. It is not entirely a question of looking at this
11 in hindsight. We reviewed the evidence from all over
12 the world, and the country that was in the lead in terms
13 of formal medical audit was America. They collected
14 data regularly and in fact the PSRO system spent
15 $70 million a year collecting data. When President
16 Reagan had this reviewed, they discovered that this
17 $70 million spent every year collecting data made no
18 significant impact on the quality of the service. So
19 that you need to have a system which will make use of
20 the data in terms of analysing. That is why I prefer
21 a system such as CEPOD where you have a system of
22 analysis of individual patients.
23 Q. You were throughout, I think, aware that the
24 cardiothoracic surgeons had their register which would
25 hold data by virtue of which, if it were broadly
0045
1 reliable, a comparison might be made between one unit
2 and another's?
3 A. Yes. Unfortunately, it was anonymised. When I said
4 there was no systematic collection, a member of my staff
5 received their data each year, so we were able to
6 identify the trends in terms of mortality in all the
7 units, but we could not identify the units from their
8 report.
9 Q. So you would have, if you like, national figures, would
10 you?
11 A. National figures.
12 Q. So you would be able to say that in the field of open
13 heart surgery across the country, the broad mortality
14 rate was X per cent?
15 A. Yes. You would also see some units that were not
16 performing to that level.
17 Q. So the Advisory Group were in a position in the 1980s
18 to identify an under-performing unit?
19 A. Yes.
20 Q. Did they do so in respect of Bristol?
21 A. Bristol was always a worry. It was a particular worry
22 to me, but it was a worry in a sense that I could not
23 understand why referrals were not increasing, and I made
24 many visits to Bristol, to the Welsh Office, and met
25 many people in the South West, clinicians I mean mainly,
0046
1 but also managers, to try and identify what the problem
2 was. It never became clear.
3 As you are aware, the professions have analysed or
4 reviewed this many times and each time they have looked
5 at the "weak", in inverted commas, units such as
6 Newcastle, Harefield and Bristol, but in every single
7 report they have not raised any suggestion that the
8 units should be de-designated nor that they should not
9 continue. That is very reassuring to the officials in
10 the Department and to the Advisory Group, that the best
11 efforts in the field raised no concerns about Bristol.
12 Q. That is not quite what I was asking. I think I was
13 asking you in the light of the answers you have just
14 been giving me, to the effect that the Advisory Group
15 had, at its finger tips, the data provided by the
16 Society of Cardiothoracic Surgeons as to national
17 mortality, and there was no difficulty, you tell us,
18 about obtaining the data for units. You could see which
19 unit was under-performing, against that particular
20 standard.
21 Did it appear to you, looking at the crude
22 figures, that they needed interpretation by some medical
23 expert who might say, "Well, this is unacceptable", or
24 "This is entirely to be expected because it is the
25 nature of the beast", or whatever?
0047
1 A. Yes, and that is why I chose to meet with the paediatric
2 cardiologists to see if we could set up an audit in
3 medical cardiology as opposed to cardiac surgery.
4 Q. What I am asking, did it appear to you that there were
5 questions to be asked in respect of Bristol?
6 A. Questions to be asked in respect of Bristol?
7 Q. Because you were able to compare its performance with
8 the national, and the question is in two parts: did it
9 seem to you that the performance was less good than the
10 average, the first question, and the second question: if
11 so, what if any steps did you take about it?
12 A. The evidence did suggest that Bristol was not performing
13 as well as the other units, but of course, as you are
14 well aware, the appropriate Royal Colleges were
15 reviewing all of the services constantly as part of
16 their training and accreditation process, so that with
17 the Society's input to the College, together with the
18 College's responsibility to visit and approve units,
19 I mean, these were reassuring.
20 Q. So Bristol was not performing as well. You knew that,
21 it follows from your answer. The second part of my
22 question: knowing that, what did you do about it?
23 A. We kept Bristol constantly under review and of course,
24 we had also a problem that other units were continuing
25 to perform these operations when they should not be
0048
1 doing it, so the question of de-designating the whole
2 service was an issue that was constantly under
3 consideration.
4 Q. The answer you have given me, I think to the question
5 I was asking, which is what you do about the knowledge
6 that Bristol was under-performing, was that "we" kept
7 Bristol under review. The "we" in that is who?
8 A. My medical staff, the Advisory Group would be aware of
9 it; we had discussions with the College.
10 Q. So the Advisory Group knew, the medical staff considered
11 it, and you had discussions with the College. Broadly,
12 what was the nature of the review under which Bristol's
13 under-performance was kept?
14 A. If in fact you have only nine units in the country, one
15 of them has to be the top and one has to be the bottom.
16 So it did not necessarily follow that because it was not
17 performing as well as the other units it necessarily
18 was, in inverted commas, a "bad" unit. So we were
19 dependent on the profession's advice as to there really
20 was a problem with Bristol.
21 As I say, every single report we have had from
22 both cardiologists and cardiac surgeons, in all the
23 discussions we have had with the cardiologists and
24 cardiac surgeons, no-one ever said "Bristol is such
25 a weak unit it should be de-designated". No-one has
0049
1 ever said that.
2 Q. You may recall that in 1986 there was an issue as to
3 whether or not the Welsh Office would establish a centre
4 in Cardiff, which would not only perform paediatric
5 cardiac surgery, but such surgery upon the neonates and
6 infants, and therefore be, if you like, in direct
7 competition with Bristol.
8 You had close links, did you, with Dr Crompton?
9 A. Yes.
10 Q. And Dr Crompton would have spoken to you about the Welsh
11 plans?
12 A. Yes.
13 Q. Were you aware, in 1986, of concerns that had been
14 expressed by Professor Henderson in respect of the
15 service provided at Bristol?
16 A. It does not ring a bell, no. I mean, throughout all the
17 discussions with the Welsh Office and everyone in that
18 area, there were constant concerns about Bristol, but
19 they were vague concerns and they appeared to be about
20 the problems of referral.
21 We also had a situation of, quite properly,
22 clinicians in Cardiff wishing to establish their own
23 unit and if they were building that empire there, that
24 would threaten Bristol. So one reason for not referring
25 to Bristol may well have been to strengthen their own
0050
1 case. They would constantly send them to London whilst
2 they argued for a service within Cardiff.
3 So one had to balance these arguments very
4 carefully.
5 But no-one raised any concerns about the clinical
6 outcome in Bristol.
7 Q. May I have a look, please, at Welsh Office 1/266?
8 This page records a meeting of a Welsh party with
9 Bristol staff. Again, what I want to do is to discuss
10 with you the implications that arise from it and how far
11 it corresponds with your own experience:
12 "We did, however, raise the question of outcome
13 with Bristol staff. They put to us the accepted point
14 that outcome is influenced greatly by case mix. They
15 were quite open in quoting outcomes for some of the
16 commoner procedures they undertake. They see a gradual
17 improvement in these as expertise grows and specialist
18 equipment becomes available. For most of the more
19 commonly occurring conditions, their figures compare
20 well with other centres. They acknowledge, however,
21 that surgeons in different centres develop special
22 expertise in rarer conditions and that outcomes may
23 therefore vary greatly for these between centres."
24 One thing that one can take from that is that if
25 one spoke to the Bristol staff in, this would be 1986,
0051
1 they would be in effect saying, "Well, we have not done
2 desperately well but we are getting better", and they
3 will be, as one would expect of professionals, quite
4 prepared to say, "Well, our outcomes are not very good,
5 but there is a reason for it".
6 Was that the sort of conversation that you
7 yourself, or members of your staff, had with Bristol at
8 the time? Do you recall?
9 A. Yes. I think there would be an element of that, but the
10 real problem was the concern about referrals.
11 Can I say, I think it would be particularly
12 helpful if we had seen these documents in advance.
13 These are not documents we have seen before.
14 Q. I appreciate that, and what we shall endeavour to do,
15 Dr Halliday, as you know, we would be very much assisted
16 if, at leisure, you have further thoughts on some of the
17 documents that you have seen and if you would write to
18 us and tell us the conclusions that you have reached.
19 I appreciate that in your present position you no longer
20 have the easy access to some of the documents that you
21 once had.
22 A. And I do not have the leisure, as I mentioned to you.
23 Q. Perhaps I should not say "at leisure", but if you have
24 some time, we would be certainly very happy to hear
25 further from you.
0052
1 It really was not so much the document itself as
2 the implication that I draw from it, and I really want
3 the benefit of your recollection, as to the nature of
4 the discussions that took place at Bristol. I think
5 what you are telling me is, "Well, surgical outcome was
6 not an issue, it was referrals"?
7 A. Surgical outcome was an issue, but it was not a major
8 issue. If the referrals were to increase, the
9 likelihood was that the outcomes would improve. They
10 are not getting the throughput. There is no question
11 that Bristol was always a worrying unit from that point
12 of view, but there were many factors which would suggest
13 why referrals were not increasing in Bristol, other than
14 outcome.
15 Q. We have been going now for about an hour and a half and
16 I am sure you would welcome a break. I know that you,
17 Chairman, would normally take a break at this time?
18 THE CHAIRMAN: Yes. Shall we break for 15 minutes, and
19 therefore reconvene at 11.15?
20 (11.00 am)
21 (A short break)
22 (11.15 am)
23 MR LANGSTAFF: Dr Halliday, just following on from the
24 questions which I was asking before the break, could we
25 have a look on the screen at DOH 2/223? This is just to
0053
1 identify what we are looking at: the July 1989 interim
2 report of the Report on Neonatal and Infant
3 Supra-regional Cardiac Surgical Units.
4 That had a number of appendices. If we can have
5 a look, please, at page DOH 2/231, we can see there in
6 the form of bar charts the numbers of operations which
7 were performed in the different centres in the different
8 categories per year.
9 As you rightly point out, Bristol, which is the
10 second from the left, is small but by no means unique.
11 If one bears in mind -- this is the top chart --
12 that there are 29 operations performed by Bristol in
13 1988, and there is only one of the centres which is less
14 than that, and that is Newcastle, 19, if you would go
15 please on the screen to DOH 2/233, and turn it sideways,
16 one can identify, moving across from left to right,
17 which of the lines and spots is Bristol, can one not?
18 It is the second from the left, the one which will
19 correspond to 29 operations.
20 A. Yes, if that is correct. It is a long time since I read
21 the report, but I think at the time I read the report
22 I was not clear to which unit the mortality figures
23 related. If you are confident they relate to them, yes.
24 Q. I tell you the way I work it out. I am in no better
25 position other than obviously I have had longer with the
0054
1 documents than you have and I apologise for that.
2 The way I have done it is look at the bar chart.
3 I see there the figures for 19, 29 and 35, which are the
4 only ones under 50 -- there is 48. Guy's does not
5 appear in any of the charts so far as we can detect, so
6 it seems to us the position second on the left is
7 Bristol, a position which would correspond with 29,
8 halfway between 0 and 50. That is how we got there?
9 A. Yes, except Newcastle did only 19.
10 Q. That is to the left the first of the bar charts. This
11 may help to demonstrate one or two points you make in
12 your statement, that there appeared generally speaking,
13 and only generally speaking, a correlation between size
14 and performance. Is that fair?
15 A. Yes.
16 Q. You can tell us: when this report was discussed, it was
17 discussed at the Supra Regional Services Advisory Group,
18 I take it?
19 A. This was an interim report. I am not sure whether it
20 was or not. I cannot remember, honestly.
21 Q. Did you see it, the interim report, yourself?
22 A. Yes.
23 Q. You looked at the charts at the time?
24 A. Yes.
25 Q. Tell me, did you ask questions about the two outliers in
0055
1 terms of the statistics, the mortality statistics
2 demonstrated here in comparative terms?
3 A. Yes. Almost without exception, the professional reports
4 that we have been considering, I have had discussions
5 with the authors in the preparation of the reports,
6 because, you know, it is quite useful for them to
7 understand fully how the supra-regional services worked,
8 and for me to understand their thinking.
9 At no time during these discussions did anyone
10 ever say to me they were concerned about the clinical
11 outcome in Bristol. Indeed, in a report I was extremely
12 reassured to find, on the last page of the report, it
13 concluded by saying that really what we should be doing
14 is referring more patients to Bristol.
15 In the opinion of the experts in the field at that
16 day, that was very reassuring to me, that the problem
17 remained one of non-referral, rather than outcome.
18 Q. I think if we go back to page 228, we can pick it up in
19 the text, the bottom of the page, please: "tendency for
20 mortality to be higher in the units performing the
21 smallest number of cases."
22 That is the way it is described?
23 A. Yes.
24 Q. That was the way in which the advice that you had -- one
25 can read down to the rest of the paragraph. I am not
0056
1 going to take time to do it.
2 A. No, I am familiar with it.
3 Q. Broadly speaking, those figures -- what you are saying,
4 I think is that they did not excite alarm?
5 A. Naturally, as an ex-clinician, I was concerned, but if
6 you are reassured by the expert in the field, I was not
7 in a position to challenge that.
8 Q. I am not suggesting that you would have done. The
9 clinicians in the field: were they the authors of the
10 report?
11 A. Yes.
12 Q. Or were there others to whom you spoke?
13 A. And to the others to whom I spoke, yes. As I have said
14 earlier, I was dealing with a lot of specialties and
15 a lot of units, and neonatal and infant cardiac surgery
16 was not our main concern, so I was meeting professional
17 groups all the time. I know closely most of the people
18 involved in these activities. At no time did anyone
19 raise with me the question of the clinical outcome of
20 Bristol. They did, however, express concern that their
21 throughput was low, that their realities might well be
22 better if they could increase their throughput. This
23 report itself, although only an interim report, was in
24 fact quite reassuring in that context.
25 Q. The minute that follows from this, we have at
0057
1 DOH 2/214. Let us have a look at that for a moment.
2 Can we scroll down, please, to the bottom of the page?
3 Dr Halliday, this is you, reporting on the report, said:
4 "The Society's report endorsed the supra-regional
5 service arrangements; it did not provide guidance on the
6 number of units required, although it supported the need
7 to rationalise provision of this service."
8 Pausing there, there had been for some time, had
9 there, a view that there were too many units doing the
10 work?
11 A. There was a view before it was designated that there
12 were too many units doing this work, and one of the
13 benefits of designation was that we might well achieve
14 a rationalisation of the service.
15 The evidence from all over the world is that if
16 you leave individual hospitals, individual doctors and
17 managers to do their own thing, you have a proliferation
18 of the complex services all over and as a result, in
19 many units the results are very poor indeed.
20 So one of the benefits of designating the service
21 was that we hoped we might well rationalise the service.
22 This was a hope that was constantly supported by
23 all the professional reports in all the discussions we
24 had with the profession. The fact that it did not
25 materialise I think is disappointing, but
0058
1 understandable.
2 Q. We see in the second of the paragraphs here the
3 provision of services for infants was more than adequate
4 and members agreed that the number of designated units
5 should be reduced. This could be resolved by
6 de-designating the non-viable units."
7 Just pausing there, before we get on to the views
8 of the Medical Royal Colleges, the non-viable units, one
9 goes up to the first paragraph and I read the second
10 sentence there:
11 "The unit at Leeds did not provide information for
12 the survey, and those at Bristol, Newcastle and Guy's
13 Hospital were operating at sub-optimal levels. This had
14 previously been identified in the 1986 report.
15 Harefield and Brompton were not operating as a joint
16 unit."
17 Two or three questions arising out of that minute:
18 the non-viable units which are referred to in the second
19 paragraph, is that a reference back to Bristol,
20 Newcastle and Guy's, because they were operating at
21 sub-optimal levels?
22 A. Yes.
23 Q. So "sub-optimal" might refer to numbers; it might refer
24 to success rates, and the report itself makes the point
25 that the two tend to go together and the point you have
0059
1 just been emphasising?
2 A. Yes.
3 Q. So the idea was, was it, in the Group, "We really ought
4 to de-designate those units"?
5 A. That we ought to consider de-designating those units.
6 Q. You are absolutely right to correct me. That is why the
7 consideration in the longer term, it may be necessary to
8 seek the views of Medical Royal Colleges as to whether
9 the service would be suitable for regionalisation, it
10 looks as though the views of the colleges are going to
11 be sought as to whether the whole service should be
12 de-designated. That would be regionalisation, would it
13 not?
14 A. Regionalisation, yes.
15 Q. But in the short term, the idea is to get rid of the
16 small non-viable sub-optimal units?
17 A. Well, to consider the feasibility of getting rid of the
18 non-viable units.
19 Q. Again, you are absolutely right to correct me. Can you
20 clarify one thing. To go back to the passage in the
21 first paragraph, Harefield and Brompton were not
22 operating as a joint unit: is that "not" or is that
23 a misprint for "now"?
24 A. "Is not" is correct. What happened was that it was our
25 understanding that Harefield and Brompton would work as
0060
1 a joint unit. I am sure everyone knows that most of the
2 staff at Harefield or the leading staff at Harefield are
3 also on at the Brompton, so there was good reason to
4 believe that they would work together, but in every
5 profession there are always problems of such joint
6 working. It became increasingly clear that Harefield
7 and Brompton were not working as a joint unit, which
8 meant we were increasing the number of units.
9 The problem we had was that Magdi Yacoub had
10 actually brought about improvements in Harefield which
11 raised it to a standard of excellence both in terms of
12 facilities and clinical outcome that one could not
13 question its position as a unit. We nevertheless
14 encouraged them to work as a joint unit. I had many
15 visits to Harefield and Brompton to encourage them to do
16 just that. I have to admit, I did not succeed.
17 Q. Harefield and Brompton now operate as one?
18 A. I am sorry, I retired a number of years ago. I have not
19 kept tabs on this one.
20 Q. It is said in the minute you were going to visit Bristol
21 and Newcastle in order to look and discuss their future?
22 A. Yes.
23 Q. That is something which you did, I understand?
24 A. Yes.
25 Q. And can we have a look, please, at a report of your
0061
1 visit to Bristol? We will find that at 2/200.
2 We will just scroll down to paragraph 2, please.
3 "At present there are nine designated centres, one
4 of which is a centre formed from two units working
5 jointly", and I suppose we should read in from your last
6 comments, "not working jointly"?
7 A. From the Supra Regional Services Advisory Group's point
8 of view they were, but the fact that people were not
9 prepared to do that is a difficult one, but from our
10 point of view we had designated them as a joint unit.
11 The fact it was not working was a problem.
12 Q. The author mentions that "in addition there is
13 a functioning unit which has applied for designation and
14 the Advisory Group is presently considering that
15 application."
16 That a 1996 minute. That would be Leicester?
17 A. I think it was Leicester. We also had an obligation
18 from Oxford, but I think that one was Leicester.
19 Q. "3: of the designated centres, 3 were singled out in the
20 recent reports as requiring review. The centres in
21 question were Bristol, Newcastle and the Harefield part
22 of the joint Harefield Brompton centre. It says:
23 "Officials therefore set out to visit Bristol,
24 Newcastle, Harefield, Brompton and Guy's."
25 May we look and see what is said about Bristol?
0062
1 Scroll down to 4, please. When it says "officials
2 visited the Bristol unit", was that you?
3 A. That would be me, and either Alan or Steve. I cannot
4 remember who it was at that time. I think Dr Prophet
5 also joined us.
6 Q. What role did Dr Prophet have?
7 A. Dr Prophet was the Senior Medical Officer in my division
8 who actually had the policy responsibility for
9 paediatric cardiac surgery, which included neonatal
10 infant cardiac surgery.
11 Q. You describe there meeting with the staff, and
12 management. It then says this:
13 "The centre had had considerable difficulty in
14 getting the service started."
15 Can you add any flesh to that?
16 A. I mean, it was a number of factors. They worked a split
17 site which the College accepted was acceptable, but it
18 presented problems in terms of Intensive Care Unit and
19 so on. There was also the problem, as we referred to so
20 many times, the lack of referral. So it was these kind
21 of issues.
22 Q. You describe then the split:
23 "Considerable capital development in the wards at
24 the BRI and in the diagnostic facilities in the
25 cardiology department ... the referral of patients has
0063
1 increased and the centre appeared to be on a much
2 stronger base."
3 Those words, "much stronger base", that is
4 referring to the numbers of throughput of operations, is
5 it?
6 A. Yes, and referrals. Not all the referrals would
7 necessarily be operated on, but they would be seeing
8 more patients.
9 Q. Let me just again go back to the numbers that we had at
10 the beginning, and just see how the numbers were in fact
11 developing.
12 This elusive reference is surfacing again. I will
13 come back to that.
14 A much stronger base, a threat to Bristol, which
15 you note because of the decision by the Welsh Office --
16 just tell me a little bit about how you saw that? What
17 is minuted and what we saw earlier this week is that
18 when this report came for discussion in the Supra
19 Regional Services Advisory Group, Mr McGlinn from Wales
20 said, "Well, no, we have no intention of developing into
21 neonatal and infant cardiac surgery", and that was
22 repeated when a subsequent paper the same year, said
23 very much the same thing. But we also heard from
24 Mr Gregory on Monday that once the Welsh Office had
25 taken the decision to start a surgical unit, dealing
0064
1 with everything except the under 1s, then the process
2 was ineluctable, that was his word, towards the
3 under 1s?
4 A. Yes.
5 Q. So what was happening here with your saying or
6 describing the ineluctable process in this paragraph,
7 and Mr McGlinn saying "No, that is not our intention",
8 how did you see it?
9 A. Again, I was involved in discussions with the Welsh
10 Office and with the Royal College of Physicians. I met
11 fairly regularly with Professor Hoffenberg, who was then
12 the President, and we discussed this. I personally did
13 not feel from a policy point of view that there was
14 a case for neonatal infant cardiac surgery in Wales.
15 Wales has a population of about 2 million and it is all
16 around the edges. If you are in fact in the north part
17 of the country, it is easier for you to travel to
18 Liverpool, Manchester or Birmingham for your medical
19 treatments than it is to come down to Cardiff. That is
20 a fact. So with a population of 2 million, that is
21 barely a sufficient population to warrant such a unit in
22 the first place.
23 Given the travelling difficulties for
24 a significant part of the population, that weakened the
25 case further. I was personally arguing that Cardiff
0065
1 needed to consider very carefully whether they should be
2 moving into this area, because they were likely to have
3 a non-viable unit. They could only take from England;
4 there is nothing on the other side. Whereas Bristol
5 could at least take from Wales, if they co-operated.
6 So I did not feel that that was a sensible
7 option. I was conscious, however, as it is in all
8 clinical practice, that if you start up a service of
9 which there is a small part that you are told you should
10 not do, the likelihood is that it will do it, because
11 their experience enables them to do so.
12 So it was something of a disappointment to me to
13 find that the Welsh Office were in fact prepared to do
14 this work.
15 Q. Why did that not happen more generally with other
16 services? The designated service was for the under 1s,
17 so one takes it that there may have been a number of
18 centres in England and Wales which were providing
19 cardiac surgery for the over 1s?
20 A. Yes.
21 Q. And not a designated service funded regionally, no
22 reason why they should not do the work; perhaps every
23 reason why they should. Why did that not grow
24 ineluctably?
25 A. It did grow. In all the services which are not
0066
1 controlled in a central fashion, you will get
2 a proliferation of these units. That is the experience
3 in the United Kingdom and indeed every country. In
4 fact, in the early 1970s, we had a major problem in the
5 United Kingdom in the provision of cardiac surgery. We
6 had too many units in the country claiming to do cardiac
7 surgery, but in fact the numbers of cases they were
8 doing were exceedingly small and we managed by
9 persuasion to bring about a change.
10 We have, without exception, without doubt, the
11 most co-operative medical profession in the world. They
12 are very much, or were very much motivated towards the
13 National Health Service and would follow these
14 arguments, even though it meant they could not be
15 performing treatments they would like to perform. Such
16 co-operation does not exist elsewhere, in other
17 countries.
18 Q. Does it follow from what you are saying that even such
19 co-operation had its limits and for instance, you make
20 the point in your statement, that doctors would happily
21 fetter themselves and not do work they might want to do,
22 and enter into, as it were, voluntary contracts not to
23 do so?
24 A. Yes.
25 Q. But the reality is, in this area, at any rate, the
0067
1 problem was that despite that general approach, some
2 doctors did do what they wanted to do?
3 A. Yes.
4 Q. That is the position, is it not?
5 A. The difficulty is that if a service is relatively new,
6 one's opportunity to bring about that degree of
7 co-operation is great. If, however, a service has been
8 long established, then it is very difficult to change
9 the culture. I mean, a good example of this is heart
10 transplantation and liver transplantation. In heart
11 transplantation, we only had 8 or 9 units in the United
12 Kingdom, whereas in America, with only four times the
13 population, they had 212 units. The results in many of
14 the units were disastrous. It was a waste of organs and
15 a waste of patients' lives because the results were so
16 poor. It took America many, many years to follow our
17 example and even there, it was not so successful.
18 In the case of a liver transplant, we had 8 units
19 in the country. In France with the same population,
20 they had 72 units, which became a major not only medical
21 but political embarrassment.
22 So if a service is relatively new, the
23 co-operation we have had within the United Kingdom has
24 been quite outstanding, and you do not find it anywhere
25 else in the world.
0068
1 However, as an established service, one can
2 understand it is very much more difficult to persuade
3 them to stop doing something they have been doing all
4 their lives.
5 Q. So was perhaps the, if I call it a problem it is perhaps
6 the wrong word, but is the difficulty the fact that when
7 the service was first designated, there was nothing
8 except age to distinguish the sort of operation done in
9 the under 1s from those over 1, and it was not
10 a discrete specialty, like a liver transplant or heart
11 transplant?
12 A. Yes. Even on the question of age there is a lot of
13 controversy. Many said the advice of the profession was
14 wrong, we should have widened it more. Yes, and some of
15 the children who have surgery later in life have had
16 previous surgery, which makes their surgery even more
17 complex. So whereas it was argued, and I think quite
18 rightly at that time, that some of the most complex and
19 difficult cases were the neonates and infants,
20 subsequently, there was an equally good argument that
21 some of the re-dos done later were equally complex.
22 Therefore we are talking about a whole spectrum of
23 a service and it is very much more difficult to
24 rationalise.
25 Q. And difficult to section off part of it and say, "Well,
0069
1 that only has to be done in 7 or 8 or 6 centres, or
2 whatever number one chooses?
3 A. Yes, especially when clinicians are under pressure. If
4 you have patients coming with their children to see you,
5 it is very difficult to say "Yes, I can do it, but I am
6 not allowed to".
7 Q. Just going back to the text of the report of your visit:
8 "When such unit is established [the Welsh unit] it
9 will reduce the number of patients referred to Bristol
10 from Wales. Further, a proportion of the patients who
11 could be referred to Bristol in fact go to the Brompton
12 Hospital and it is likely that this referral will
13 continue."
14 I wonder if you could expand a bit on why it is
15 likely that the referrals to the Brompton will continue,
16 despite the advantages of geographical proximity which
17 Bristol gave?
18 A. Because the hospitals in London such as the Brompton
19 actually had outpatient clinics in various parts of the
20 South West. As a result they were seeing patients, and
21 it clearly would not be acceptable to the parents of the
22 patients to say "Yes, this patient needs an operation,
23 you have built up a relationship with me but I cannot do
24 it; you have to go to Bristol and see a new clinician
25 that you have not met before". So most of the referrals
0070
1 still went to their own hospital.
2 Q. This is a practical example of how difficult it is to
3 alter referral patterns in an established service?
4 A. Yes, and particularly if you are in an internal market.
5 Q. It ties up with the point you were making a moment ago
6 about the fact that this was part of an established
7 service and therefore one would have, before it was
8 designated, established referral patterns?
9 A. Yes.
10 Q. Therefore, if one selects a centre which is only doing
11 a small quantity of the work, the chances of it growing
12 are really quite small?
13 A. Well, of course, looking at this in hindsight, you could
14 argue that. There are many examples of where, given the
15 profession the evidence that they needed to influence
16 their referral patterns, they did that. For example,
17 and Dr Lunn would be able to help on this, when CEPOD
18 looked at general surgery, and they looked at it many
19 times, on one occasion they looked and found that
20 ruptured aortic aneurysms were being treated all over
21 the country and the results were not very good. The way
22 that CEPOD looks at the management of each individual
23 case, it became clear that there were certain features
24 which suggested that these cases should not be treated
25 by a general surgeon but should be referred to
0071
1 a vascular surgeon.
2 I imagine general surgeons enjoy taking on such
3 challenges, but nevertheless the effect of that was that
4 patients suffering from ruptured aortic aneurysms were
5 being referred to vascular units. So given the evidence
6 I think our doctors in the United Kingdom will tend to
7 change the referral pattern if the evidence is
8 convincing.
9 Q. We go on, again, going back to the text here, which is
10 inspiring the questions I am asking you:
11 "Therefore, although officials found the Bristol
12 centre to be soundly based and giving every sign that
13 the centre would be a viable designated unit, and
14 despite the fact that geographical spread of the
15 designated centres is desirable, there remains
16 a question mark over the centre's long-term viability in
17 supra-regional terms."
18 A. Yes.
19 Q. The phrase "every sign that the centre would be a viable
20 designated unit" might suggest, if one was being
21 a purist, that it was not. Was that the intention of
22 the wording, or not?
23 A. The intention of the wording was to draw the attention
24 of the Advisory Group to the fact that there were still
25 weaknesses in Bristol. Although there was an apparent
0072
1 improvement in the referral pattern, there were
2 potential risks in the future from Wales and the
3 continued referral to Brompton, and indeed, to other
4 units.
5 Q. The numbers -- "soundly based" is a function of numbers,
6 is it, or was there something else behind it?
7 A. No, as we said in there, there had been significant
8 capital development. They had made significant changes
9 in terms of the wards, intensive care, and so on, so we
10 were quite impressed with the improvement in the
11 facilities available.
12 Q. So it was facilities?
13 A. It was a combination of all these factors.
14 Q. If we just have a look, now I have tracked it down, to
15 the number chart again, DOH 4/28. We are looking at
16 this position in 1990 and looking, therefore, back to
17 the figures for 1988 and before. There does appear to
18 be an increase in the number of open heart surgical
19 cases performed. If one looks down to the bottom of the
20 page, the total column, a modest increase between 1987
21 and 1991, not very great over 1986 in the total
22 numbers.
23 Those sorts of numbers, again, I welcome your
24 comment: was that the sort of increase which was going
25 to inspire confidence, or really rather confirm one's
0073
1 fears as to the long-term viability of the unit?
2 A. The most significant figures there are the open heart
3 surgery and of course, what we have there is a doubling
4 of the previous number of operations. I would suggest
5 that a doubling of activity is quite encouraging.
6 Q. How are you suggesting that Bristol should improve their
7 referral pattern?
8 A. There is no way the Department of Health can advise
9 clinicians to improve their referral pattern. Referral
10 patterns are established by many factors: doctors who
11 have gone to the same medical school as the individuals
12 in the same specialty or other specialties tend to have
13 a confidence because they know the people in terms of
14 referral. Brompton and other hospitals had a vested
15 interest in continuing to have patients referred to
16 their own hospital. Cardiff had a vested interest in
17 that they wanted the Welsh Office to set up their own
18 unit.
19 So there were many reasons why referrals were not
20 occurring to Bristol. There was really nothing the
21 Department of Health could do to interfere with that.
22 We could not tell the Brompton not to have its clinics
23 in the South West; we could not tell the Welsh Office
24 not to designate a unit in Cardiff. We could put
25 arguments to them that would suggest that we would not
0074
1 support such a thing, but it is their own decision.
2 Q. Can I just explore for a moment -- it is in the middle
3 of, I know, talking to you about the process of
4 designation and the history of it. Following from that
5 last answer, can I just explore with you the mechanisms
6 which were available to control centrally the
7 distribution of the work in England and Wales.
8 Essentially, as you say, supra-regional service
9 designation was a financial arrangement, an incentive to
10 do the work?
11 A. Yes.
12 Q. Was there any stick that might have been applied to
13 augment the carrot of the supra-regional funding?
14 A. Well, one stick there would be, and I have said it many
15 times to many clinicians, is that if they did not abide
16 by the accepted rules, then they were putting the
17 designation of their unit and the service at risk.
18 I had one good example of this where, as
19 I mentioned earlier, one cardiac surgeon in
20 St Bartholomew's was really quite outstanding and
21 I think he did 3 heart transplants. I went along to see
22 him and I put the case for the supra-regional service
23 arrangements, how that was benefiting not only the
24 service but the patients because it was a better use of
25 organs. No other country in the world had such control
0075
1 and were envious of our control. I simply put the
2 argument to him, and he agreed not to do any more. That
3 was quite remarkable. I know of no other professions
4 where someone so expert in a particular therapy or
5 whatever decides not to do it because it is in the
6 national interests.
7 So we used these arguments all along. Some did,
8 some did not.
9 Q. So persuasion obviously plays its part?
10 A. Yes.
11 Q. You are suggesting that the stick might be the implied
12 threat to one clinician that he is prejudicing the
13 service for everyone else?
14 A. Yes.
15 Q. That will obviously not help him or his unit and no
16 doubt it will bring a certain peer pressure to bear upon
17 him?
18 A. Yes.
19 Q. Was there any other form of stick that might have been
20 applied? I tell you why I ask. If we look on the
21 screen at DOH/2 211, and underneath the heading "Any
22 other business", this is a minute from 1990, I think the
23 first meeting of the Supra Regional Services Advisory
24 Group in 1990, and you are reporting at 8.1 on the need
25 for the units to participate in the National
0076
1 Confidential Enquiry in Peri-operative Deaths:
2 "The returns were lower than anticipated and it
3 was evident that 2 designated had not been providing the
4 required information. This had since been clarified
5 with one unit, but the other was refusing to
6 co-operate."
7 So things did not work with one unit at that
8 particular time.
9 "Members agreed that a tough line was necessary
10 and the unit should be informed that it must participate
11 in a national enquiry in order that its funds should not
12 be affected."
13 So the threat there is the withdrawal of
14 supra-regional funding?
15 A. Yes. In 1989 -- is that the date of the document?
16 Q. Yes. 1990, actually. It refers back to what obviously
17 was happening in 1989.
18 A. Yes. In 1989, the confidential enquiry into
19 peri-operative deaths looked at deaths in children. The
20 most common cause of deaths post-operatively in children
21 is cardiac surgery, where it accounts for about 60 per
22 cent of all the deaths. When CEPOD decided to take this
23 forward, we discovered that the cardiac surgeons
24 generally were not prepared to co-operate in it; that
25 they argued that since the Society had its own Registry,
0077
1 there was no need for them to co-operate in CEPOD.
2 I wrote to Sir Terence English, then President of
3 the Royal College of Surgeons, and I put two arguments.
4 The first was that it would not look good to the public
5 if cardiac surgeons opted out of the confidential
6 enquiry which was looking at deaths following operations
7 in children, when 60 per cent plus of all those deaths
8 would in fact be cardiac surgery.
9 So I said that that in itself would be a very
10 worrying factor to Ministers, and indeed the public.
11 The second part of my letter went on to say that
12 the Secretary of State would be more than concerned if
13 in fact it was the case that a national enquiry,
14 supported by the Secretary of State, the cardiac
15 surgeons were not prepared to participate, and
16 especially from units funded through the Central Funding
17 arrangements, and I said that they would be putting the
18 whole concept of the supra-regional service arrangements
19 in jeopardy. As a result of that letter, the cardiac
20 surgeons did in fact participate in CEPOD.
21 Q. So the threat of withdrawal of the funds, obviously,
22 works, or can work?
23 A. Yes.
24 Q. In fact that if it worked in that area, it might have
25 worked in others. Would there have been any way in
0078
1 which the threat or withdrawal of funding, or
2 withholding of funding, might have worked in preventing
3 the proliferation of units which were not designated?
4 A. Yes. Well, it should have done, in theory. We wrote --
5 I say "we", myself as the head of the division and also
6 administrative colleagues in comparable divisions --
7 many letters to units all over the United Kingdom,
8 saying, "You are carrying out work which is part of the
9 designated service". I meant, for instance,
10 endoprosthetic bone replacement or neonatal and infant
11 cardiac surgery. "The Secretary of State has made it
12 known that he does not wish such services to be funded
13 outside of the designated arrangements", so that
14 management were aware of the Secretary of State's wish
15 that no units be funded for these activities outside the
16 designated arrangements. The fact it went forward was
17 therefore a fault of local management and local
18 clinicians. That is where persuasion is not
19 sufficient. Even the threat of the Secretary of State's
20 concern about funding had no impact.
21 Q. The crude layman's approach might be to say, if you are
22 running a business and you have employees, and you find
23 out that an employee is insisting on spending an hour of
24 the day during the time in which he is paid by the
25 employer to do private business, to do work that he is
0079
1 not authorised to do, that the usual approach is to dock
2 an hour from the pay?
3 A. Yes.
4 Q. That generally works. Why should that analogy not apply
5 to the National Health Service?
6 A. Because we are not dealing with a business in that
7 sense. The Secretary of State is not responsible for
8 the way medicine is practiced. He has no duty to
9 Parliament for that. The responsibility of how clinical
10 medicine is practised is a matter for the General
11 Medical Council. The Secretary of State is obviously
12 concerned about the way that service is provided and he
13 looks to the Colleges and to the GMC to ensure that that
14 is the situation.
15 You could tell doctors to do -- I mean, for
16 example, if a doctor has a lot of patients waiting to
17 have hip replacements and he has identified that they
18 need hip replacements, there is nothing to stop the
19 manager saying "I would like you to do more hip
20 replacements on the patients you have decided to do hip
21 replacements". If however you are saying to a clinician
22 "You will carry out a switch operation on this patient"
23 and the clinician does not think it is necessary, there
24 is no way you can make him do it.
25 Q. It is rather the reverse: not that "you will", but "you
0080
1 will not"?
2 A. "You will not". As I said, the Secretary of State made
3 it known to all management in the country that they did
4 not wish these operations to be carried out in
5 non-designated units. If we were in a Sainsbury type
6 business, then you could tell them not to do it, but
7 clearly local managers found that to be impracticable.
8 Q. So the feature of the system which allows this to happen
9 is the local management imposed between the centre, the
10 funding source, and the work being done.
11 Again, we will have lots of views expressed on
12 this very topic to us, and I have no doubt that they
13 will vary quite greatly, which is why I will be grateful
14 for your views. You are saying really this is
15 a function of local management as opposed to local
16 clinicians, or are you saying it is a mixture of both,
17 or what?
18 A. If the Secretary of State says "This should not happen"
19 after agreement with the profession, because the
20 supra-regional arrangements were in fact agreed with the
21 profession, then the local management should implement
22 that, and the clinicians should abide by it.
23 Q. They did not, because they have the freedom to depart
24 from the generally expressed view of the profession and
25 the strongly expressed view of the Secretary of State?
0081
1 A. The difficulty we are having with neonatal and infant
2 cardiac surgery is that the supra-regional service
3 arrangements were set up for any service that fitted the
4 criteria. We took neonatal and infant cardiac surgery
5 into the arrangements knowing that there were more units
6 than we needed. We hoped we could bring about
7 a rationalisation. That was not achieved. That is not
8 a failure of the supra-regional service funding
9 arrangements, that is a failure of trying to change an
10 established service, which had been in existence for
11 decades, and in the absence of any formal powers that
12 will allow anyone to tell doctors what to do I do not
13 think it is in the interests of anyone to tell doctors
14 what to do.
15 Q. Let us look at DOH 2/168, please.
16 These are part of the record of the third meeting
17 of the Supra Regional Services Advisory Group in 1990.
18 If we scroll down, under 4, the second paragraph:
19 "Members agreed that the service should ideally be
20 concentrated in no more than 6 or 7 centres and that
21 proliferation occurred to the detriment of patients."
22 The members of the Group are not administrators,
23 they are largely medical?
24 A. No, it is a mixture.
25 Q. At any rate, the medical advice was all to that effect,
0082
1 was it not?
2 A. Yes.
3 Q. Here we have a general agreement between expert
4 clinicians and administrators, that proliferation is to
5 the detriment of pairs, and you were saying, a moment
6 ago, well, as it happened, you could not actually stop
7 somebody doing what he wanted to do, except that was the
8 position.
9 Were you going further to say it would be
10 undesirable to stop someone doing what they wanted to
11 do?
12 A. No. I was saying that a situation where clinical
13 practice is dictated by others -- those other than
14 clinicians, would be quite wrong. But if we are saying
15 that if you agree with the profession the way a service
16 should be provided, then I think that is the way it
17 should go.
18 The only difficulty is, I met with all the
19 clinicians involved in this, and every single clinician
20 I met in the designated units and the non-designated
21 units would endorse what is in the minute, that we only
22 need 6 or 7 units. It is the usual thing: "As long as
23 it is not my unit that is closed". So everyone I spoke
24 to endorsed our policy whole-heartedly: "As long as it
25 is not my unit". They did not say that, but that was
0083
1 the connotation.
2 Q. By the way that you say that, they did not say that on
3 the record. Did they say it off the record?
4 A. It does not have to be said. You only have to say,
5 amongst the units, "Which ones should it be?" and it is
6 never their unit. But of course, the supra-regional
7 arrangements were not set up to sort out all the
8 problems of the National Health Service, and this is
9 a factor of all the services within the National Health
10 Service. There are lots of services being provided
11 which the profession would not approve of, nor perhaps
12 even the Secretary of State, but how you stop it is
13 another matter.
14 Q. Moving on from that -- and I am very grateful for your
15 views on control and control mechanisms and how far they
16 exist or did not and the problems -- we were talking
17 about the process from designation of the service to
18 de-designation. A lot of the material we have been
19 through with Mr Angilley and Mr Owen, and I am not going
20 to trouble you with a lot of the detail. There are one
21 or two matters which I have to ask you about. If you
22 feel you cannot comment because you have not had long
23 enough to remind yourself of the documents, please say
24 so and by all means do so, if you ever have a spare
25 moment, in writing.
0084
1 Where I think we would go to is DOH 2/36, please.
2 We had better identify the start of that document so
3 that you know what we are looking at. It is the first
4 meeting in 1992. We see that at 2/33: minutes of the
5 meeting of February 4th 1992.
6 Back to 2/36. We are looking at neonatal and
7 infant cardiac surgery.
8 "4.2.2: Sir Terence English said that most
9 recently reports concluded that keeping 90/95 per cent
10 of neonatal and infant cardiac surgery work concentrated
11 in 6 or 8 centres was most beneficial to patient care."
12 That had been the theme throughout?
13 A. Yes.
14 Q. He suggested three options for the service and he sets
15 them out and offered to set up a Working Party to
16 consider looking into the suitability of each option and
17 to make recommendations to the Group.
18 I am right in thinking that that is in fact what
19 happened?
20 A. Yes.
21 Q. If we go then to 2/99, this is an extract from the
22 second meeting, and again, perhaps, we ought to go back
23 just to identify for yourself and for the wider audience
24 where it starts. It starts at 97. We can see it is the
25 second meeting of the Supra Regional Services Advisory
0085
1 Group, 28th July 1992.
2 Page 99 then again.
3 "Members noted the Royal College of Surgeons
4 Working Group report which recommended that the service
5 should continue to be designated and the number of
6 designated units should be reduced from the current 10
7 to 9."
8 So the Group has asked for it to go down,
9 effectively, from 10 to 6 or 8 and the Working Party has
10 come up with the most modest reduction possible, to 9?
11 A. No, that is not my recollection. My recollection is in
12 fact that the Royal College of Surgeons' report
13 recommended there should be 9 units, despite the fact
14 that it had previously argued that there should be 6, 7
15 or 8 units.
16 Q. "All the existing designated units except Harefield and
17 Guy's should remain designated ... The unit at Leicester
18 should be designated."
19 Then this:
20 "Dr Halliday reported that since receiving the
21 Royal College of Surgeons' report, he had been
22 approached by Sir Terence English, who indicated that
23 since submitting the report he now had reservations
24 about the continued designation of the Bristol unit."
25 We see, at 4.1.3 -- you might want to read that
0086
1 through before I ask you questions about it. (Pause).
2 Do you recollect now the content of the
3 discussions that you had with Sir Terence?
4 A. Yes.
5 Q. What was he saying?
6 A. I was not sure -- was this the -- I thought today we
7 were going to talk about the general arrangements.
8 Q. If you would rather deal with it in writing, let us do
9 it later and in writing.
10 A. I think we will be dealing with it later. I am quite
11 happy to deal with this now. Sir Terence was at the
12 February meeting but he could not be at the July
13 meeting.
14 Q. That is right.
15 A. So he rang me either the night before the meeting or on
16 the morning of the meeting, and I am confident of that
17 because we left the briefing of the Chairman to the very
18 last minute, so that anything that arose that was
19 relevant to the Group's discussion would be in his
20 briefing. So that was normally completed about 24 hours
21 before the meeting.
22 Sir Terence said he could not be at the meeting,
23 and I put it to him that he would not be particularly
24 happy with the outcome, because it was my expectation
25 that the Advisory Group would not accept the
0087
1 recommendations of the College, and that really we had
2 very little alternative but to de-designate the service.
3 Sir Terence asked me to make it known to the
4 Advisory Group that since the report had gone in, he now
5 had reservations about Bristol. He was not specific,
6 and I assumed he was referring to the ongoing problems
7 that we have discussed so much and that was all.
8 So at the Advisory Group I did report that
9 Sir Terence had spoken to me; that I had told him what
10 was likely to happen to date and he had said he wanted
11 his reservations about Bristol to be noted.
12 Q. Could I, in that light, have on the screen, please, RCSE
13 2/197. If we go down to the bottom of the page, and
14 over, it is a letter from David Hamilton, back please to
15 the first page, to Sir Terence English. It makes
16 reference to you in the body of the text.
17 Again, please, if you want time to consider the
18 questions and the circumstances, then by all means you
19 will have it. It is not a question of having to give an
20 immediate answer.
21 If we look through, we can see the date:
22 3rd August 1992, so it is after the meeting in July:
23 "Following our telephone conversations [says
24 Mr Hamilton] of Thursday evening 23rd and Friday
25 afternoon the 24th, I was not entirely happy about the
0088
1 agreement to take Presidential and Chairman's action
2 over the Working Party's report."
3 That I think is a reference to recommending that
4 Bristol be de-designated.
5 "On reflection, I realised a possible and specific
6 source of breach in confidentiality which could arise,
7 and a further feeling that the de-designation of one of
8 the units would probably leak out in the course of
9 time. Also the members of the Working Party were
10 unanimous in their findings and gave considerable
11 thought to their recommendations. Like you, I was
12 unable to contact Keith Ross but did so early on Monday
13 morning July 27th, and after he had returned home from
14 holiday. He was equally concerned that we had changed
15 the report and suggested on reflection that we should
16 speak with Norman Halliday to reverse the decision and
17 the instructions that you had given him."
18 He says the report is an advisory document.
19 "This appealed to me as a far safer course of
20 action. Keith rang Halliday and put this suggestion to
21 him. Halliday then phoned me on Monday morning and
22 appeared much relieved as he was unhappy that rapport
23 and trust between the Department of Health and College
24 could have been compromised by the previous suggestion."
25 It is very much second-hand hearsay. Can you help
0089
1 as to what happened and who said what?
2 A. Of course, I have not seen this letter and I would
3 have --
4 THE CHAIRMAN: Dr Halliday, may I interrupt and say that
5 some things may arise during questioning, and if you
6 feel you would like to reflect further, as counsel has
7 already said, you should please do so. Only answer now
8 if you feel confident that you are able to help us,
9 because that is, after all, the purpose of the exercise,
10 to help us.
11 DR HALLIDAY: My objective is to be helpful.
12 THE CHAIRMAN: That is absolutely right.
13 DR HALLIDAY: This letter changes the whole context. My
14 discussion with Sir Terence, or at least his discussion
15 with me about his concerns about Bristol simply meant
16 that he had reservations about Bristol and therefore he
17 was not entirely happy with the report from the College.
18 This letter would suggest that there appears to be
19 more to it than that, and I cannot comment on that.
20 MR LANGSTAFF: That is fine. If on reflection anything else
21 occurs to you, please let us know. The very last thing
22 we want to do is to spring something on you which you
23 are not able to answer here and now.
24 A. If I could have a copy of the letter, I would like to
25 reflect on what Keith Ross had said, because it may come
0090
1 back to me, because I had a very close relationship with
2 the individuals named here, and I have no recollection
3 of what is implied from that letter.
4 Q. Can I simply ask that before you leave here today, if
5 you make sure you have a copy of the letter, we will
6 make sure that you get one.
7 A. Thank you.
8 Q. Can I then turn away from that to ask you to pick up
9 a number of perhaps lesser points. The first, really,
10 arises from your own statement at WIT 49/8.
11 You describe in paragraph 12 the meeting that you
12 had with all the paediatric cardiologists by and large
13 in the country, and present a paper to introduce
14 arrangements by which they could audit the management of
15 their patients.
16 You were looking for a way to get audit data, were
17 you?
18 A. No. Getting data was not a problem. It never was
19 a problem. What I wanted was to get the data and
20 a mechanism by which we could analyse the data by
21 experts, so that we had sound opinion on it. Having
22 data is not a problem. All units would have given us
23 whatever data we requested, but if we could not use it,
24 there was no point in having the data. What I wanted
25 was having a mechanism by which a group of
0091
1 cardiologists, selected by their peers, would look at
2 this in a frank and honest way about the management of
3 individual patients.
4 Q. In the light of that answer, I wonder if you would just
5 look for a moment at DOH 2/243?
6 It is paragraph 17. This is 1988, a Supra
7 Regional Services Advisory Group document. (88)2 is the
8 paper. I will read it to you, since it is not
9 desperately clear on the screen.
10 A. Can you help me, was this attached to a letter?
11 Q. I will show you how it begins, because it begins at
12 page, I think it is at page 240. It appears to be
13 a paper, "Confidential, not for publication", so it
14 obviously was not sent out. It was, I think, for
15 discussion at the first meeting of the Supra Regional
16 Services Advisory Group in 1988.
17 A. Thank you.
18 Q. If we can turn over, then, back to page 243, at 17,
19 item (i) I think we covered before the break:
20 "History and geography have been used as arguments
21 to designate centres that would otherwise not have been
22 considered. Although the workload was low, the quality
23 was in keeping with the major units and the geographical
24 location was such that long journeys for parents to
25 larger centres would be avoided.
0092
1 "(ii) at this time there is no evidence available
2 centrally that would allow any evaluation of quality."
3 Can you help me, because the author here appears
4 to be saying, at least on one interpretation of it, two
5 contradictory things. He is saying that the quality of
6 the low workload centres was in keeping with the major
7 units, and in the second breath, almost, he appears to
8 be saying, "but there is no evidence that allows us to
9 establish that"?
10 A. Yes. I have great difficulty with the term "quality".
11 It is now the flavour of the month, and of course it is
12 very important. And in many areas it has been clearly
13 defined. It was only in 1985 that quality in business
14 management was defined by Duran and Crosby in 1984. So
15 really, at the time they were talking about quality, it
16 was only beginning to be defined in industry, where
17 measurement of activity was easy, just in time and so
18 on.
19 In health, I do not think even now we have
20 a clearly defined definition of "quality". So I always
21 had reservations in putting the term "quality" in any of
22 the documents we used, I preferred "clinical outcome"
23 but the word "quality" slipped in, and like all jargon
24 terms, we knew what we were talking about. It does not
25 follow that later reading them you necessarily
0093
1 understood. So, really, I do not think even today we
2 have measures for evaluating quality in all aspects of
3 health. You can select areas of health services which
4 can be clearly defined in terms of the quality one
5 expects. If, however, you are dealing with a switch
6 operation, what parameters do you use to measure
7 quality? I think even today we do not have the measures
8 for evaluating quality, but I think the earlier
9 reference to "quality" meant that in terms of clinical
10 outcome it was comparable to the other units.
11 Q. The second reference to quality, "this time there is no
12 evidence available centrally that would allow any
13 evaluation of quality": is quality being used in the
14 same sense?
15 A. I think it is being use in more general terms and
16 I think it is a term now used more widely, although it
17 is not well-defined in health. There are no reliable
18 definitions of quality in health services which will
19 cover all activities, and certainly very few which would
20 cover clinical medicine.
21 The problem is, if you are measuring quality, you
22 really need to have something scientific about it to
23 study the variations and so on. These are the things
24 that determine whether you have got good quality or not.
25 Medicine, although there is increasingly
0094
1 a scientific input, remains an art, and it is very
2 difficult to measure the variation in an art.
3 Q. Would someone at the Supra Regional Services Advisory
4 Group have read "quality", underneath (ii), in the same
5 sense as "quality" in (i), and if not, in what different
6 sense would he have read it?
7 A. I would have thought that the members of the Advisory
8 Group would have interpreted this as I have suggested,
9 that the first "quality" would have referred to clinical
10 outcome; the second "quality" would have been referring
11 to the standard of provision including facilities and
12 clinical outcome.
13 Q. Again, help me, it may not be your authorship, it may be
14 difficult, but under (ii), the author has said:
15 "At this time there is no evidence ... that would
16 allow any evaluation of quality."
17 It is really quite stark. It appears to be saying
18 that taking quality even in the sense that you give it
19 as a mixture of facilities and performance and outcomes,
20 that we simply not have anything, we cannot start
21 anywhere to evaluate this?
22 A. I accept I must have had an input to this, if I was not
23 the author. What I am saying, or what was being said
24 there, is that in terms of the evaluation of the quality
25 of the management of patients, the collection of data,
0095
1 whatever it was, was not sufficient to achieve that
2 goal. What we had to do was to establish arrangements
3 within each of the specialties, so that they could
4 evaluate the services as provided, and to that end,
5 I was having discussions with almost all the specialties
6 that I had, not only within the supra-regional services
7 but outside the supra-regional services. Indeed, I was
8 involved in the setting up of the confidential enquiry
9 into peri-operative deaths, because medical audit was
10 a very important subject to me. So I was constantly
11 endeavouring to bring about ways in which we could,
12 centrally, monitor quality, and CEPOD was one
13 contribution to that end, but at the time in
14 supra-regional services we had no central mechanism and
15 still have no central mechanism for evaluating quality
16 in totality.
17 Q. You go on -- we will go back to your statement -- at
18 WIT 49/8. You speak in paragraph 13 about the absence
19 of agreed medical audit arrangements.
20 "We had to adopt alternative means of monitoring
21 the quality of the services being provided in the
22 designated units."
23 In which sense are you using the word "quality"
24 there?
25 A. I am using the word "quality" there in terms of clinical
0096
1 outcome.
2 Q. So in order to establish what the clinical outcomes
3 were, you were using alternative means, other than any
4 agreed medical audit arrangements, because there were
5 none?
6 A. And endeavouring to establish medical audits.
7 Q. Can I look at the means that you describe in the
8 statement? What I think you are describing is
9 a two-fold process, and we can just read through from
10 "within my division" to the bottom of the page.
11 (Pause).
12 Just pausing there: you are describing first of
13 all the fact that doctors with specific policy
14 responsibility such as Dr Prophet, no doubt, in your
15 division, were members by invitation of the Medical
16 Committee of that specialty in the appropriate Medical
17 Royal College, so they would be a party to the
18 discussions that took place there?
19 A. And the Associations and Societies.
20 Q. And in terms of Dr Prophet, which ones would he have
21 belonged to?
22 A. Dr Prophet would have been on committees on the Society
23 of Cardiothoracic Surgeons. I cannot remember now which
24 committees he was on in the Royal College of Surgeons,
25 but it was a regular thing that they would like our
0097
1 doctors to be observers on their committees. I was on
2 a number of their committees.
3 Q. Obviously you would pick up information there in the
4 usual way one does on a committee?
5 A. And we developed a relationship with the clinicians.
6 Most of the clinicians in the field were known to us and
7 we were on informal terms. They knew that they could
8 contact us at any time.
9 Q. The second way in which information was obtained to
10 monitor the quality, you say:
11 "In addition to being present at formal
12 discussions of various developments and advances in the
13 specialty", the conference papers you were talking about
14 earlier today?
15 A. Yes.
16 Q. "They were also present at the very important informal
17 discussions at these conferences and committees. By
18 this approach, staff were able to keep up to date with
19 developments in the units and to be alerted to
20 developments which caused concern."
21 So can I be clear as to what has been described
22 there? The very important informal discussions at the
23 conferences and committees are not something we would
24 find a minute of, presumably?
25 A. They may have a minute, but it is not something that
0098
1 I would have, no.
2 Q. The nature of an informal discussion is that you do not?
3 A. The informal discussions there would not be, no.
4 Q. Let me paint a picture, and tell me how far it
5 corresponds or does not. At the conference where
6 a number of papers are being presented by a prestigious
7 speaker, obviously there are a lot of clinicians
8 listening and in attendance?
9 A. Yes.
10 Q. They will break for coffee for 15 minutes and they will
11 chat. They will have lunch together and they will chat
12 at lunch with whoever happens to be sitting next to
13 them. They will break for tea and if it is
14 a residential conference, there may be a chat
15 overnight. Are those the sort of informal discussions
16 to which you are referring?
17 A. Yes.
18 Q. So it is the chat around the place that alerts someone
19 to problems?
20 A. Yes. In addition -- I mean, the difficulty is at the
21 time I made this statement, I was rather constrained in
22 terms of time. There are many other avenues by which we
23 got feedback. I had what I call "mini reviews". Of the
24 43 medical specialties that my division was responsible
25 for, I had mini reviews with the consultant adviser in
0099
1 each of these specialties, and sometimes with others, on
2 an annual basis. In the case of cardiac surgery, we had
3 a formal cardiac liaison committee which had
4 representatives of the College, the Society of both
5 cardiac surgeons and cardiologists. So we met in that
6 form as well each year to review the specialty and to
7 identify any problems.
8 Q. There are two questions. One is the specialty itself
9 and the other is the unit.
10 A. Yes.
11 Q. No doubt, talking to the liaison committee, you get the
12 benefit of their own private discussions, if you like,
13 the whispers in corridors, and so on?
14 A. Yes.
15 Q. Which they have been party to. Am I right in thinking
16 the medical profession is one in which, just as it is in
17 the bar, there is quite a lot of gossip?
18 A. Of course, and useful gossip.
19 Q. That may set alarm bells ringing or not, depending on
20 what is said?
21 A. Exactly, yes.
22 Q. And if a matter of concern is raised, and obviously it
23 has been raised informally and there is no empirical
24 evidence for it, necessarily, that would be the trigger,
25 would it, for further steps, further questions?
0100
1 A. Yes.
2 Q. Getting the information through this process, as you
3 did, about all sorts of units through the gossip, the
4 "whispers in corridors" as I have called it, the coffee
5 break conversations, the chat around the place, how
6 often, in your recollection, was it that that actually
7 led to formal enquiries to get some empirical evidence
8 as to what might actually be happening?
9 A. It is very difficult. As I have said, I was dealing
10 with 43 medical specialties. The acute hospital sector
11 in England, it is quite a handful. It is very difficult
12 to recollect where something that was said, either to
13 myself or to the members of staff, actually led to
14 a significant development.
15 Anything that caused us concern, we would then
16 pursue with the appropriate body, usually informally to
17 begin with. You have to take gossip with a pinch of
18 salt. You cannot believe everything you are told. So
19 before we would take any formal action, we had to ensure
20 there was some substance to it, so we would go to the
21 profession to see if they supported what we had been
22 told. If they did not support it, then we would still
23 endeavour to pursue it through our own avenues,
24 management and so on, to see if there might be something
25 there.
0101
1 Q. Pausing there for a moment, you may not be able to
2 comment on this, but I am just asking, how would the
3 profession know that there was a problem, except by the
4 same gossip route?
5 A. No, the Colleges inspected the units regularly. They
6 met with the people. They have a system of training for
7 their staff. They get to know. I mean, within the
8 specialties, the Colleges know each other very well and
9 they know exactly their strengths and weaknesses, so
10 that if in fact it was suggested to them that there was
11 a problem in a particular unit, that would ring bells
12 with them, but it would ring bells from an informed
13 position.
14 Q. So you would go to the representative body just to, if
15 you like, verify the gossip to see it was not just pure
16 malice, an unfounded rumour, something along those
17 lines?
18 A. Yes.
19 Q. How often was it that a unit was de-designated on the
20 grounds of poor clinical performance?
21 A. We have de-designated services, but I cannot recollect
22 us ever de-designating a particular unit. It is very
23 difficult to de-designate units, because although you
24 might find that the profession supported the decision,
25 there might be a reluctance, you know, a decision to
0102
1 de-designate the service, there might be a reluctance to
2 de-designate a particular unit. There are often very
3 good reasons for that. For example, Guy's was a unit
4 that was constantly being referred to as one that should
5 be de-designated, but it is very difficult, when you go
6 along to see the unit and you find in fact they are
7 leading the world in prenatal diagnosis, they are one of
8 the leading international units in interventional
9 catheterisation, and say, "De-designate this unit". It
10 is very difficult.
11 Q. In the light of those answers, I wonder if we could look
12 at DOH 2/44?
13 A. I should add, it is not difficult for me; it is
14 difficult for the Advisory Group. I did not make the
15 decisions.
16 Q. I am not suggesting for a moment that you did.
17 A. I think it is worth clarifying.
18 Q. Thank you, anyway, for that. Can we go down, please, to
19 paragraph 3:
20 "Members accepted the conclusions set out in the
21 paper SRS(90)15 that in general terms, all other factors
22 being equal, there is a strong case for Bristol and
23 Newcastle in terms of geographical spread. They agreed
24 that it would be difficult if not invidious to
25 de-designate the centres in question on the basis of
0103
1 surgical expertise, and doubted whether it was possible
2 to do so on the basis of referral pattern."
3 What was, as you recollect it, the substance of
4 the discussion that led to the expression "difficult if
5 not invidious to de-designate on the basis of surgical
6 expertise."
7 A. This refers to the point we discussed earlier. People
8 like John Dark in Newcastle did not simply do neonatal
9 and infant cardiac surgery; he did heart transplant,
10 lung transplant. These were experts in cardiac
11 surgery. So it is very difficult to say that they did
12 not have the cardiac expertise. It was very difficult
13 for the Advisory Group to say, because the Advisory
14 Group could not give an opinion on cardiac expertise; it
15 had to be the College's. Every report from the College
16 has supported these units and their continued
17 designation. In that situation, how could the Advisory
18 Group take upon themselves the decision to say, "We will
19 de-designate them on the basis of surgical expertise".
20 Q. Is there a distinction to be drawn between surgical
21 expertise on the one hand and surgical outcomes from
22 some procedures on the other?
23 A. This is why I think it is terribly important that we
24 simply do not collect data and simply analyse it,
25 because the outcomes are determined by the case mix. If
0104
1 you are dealing with extremely complex cases, then you
2 are going to have a higher mortality rate than units
3 that are not doing such complex cases.
4 It was suggested at one stage that Harefield
5 should be de-designated because its mortality was too
6 high. I went to see Magdi Yacoub and said I needed to
7 have all this data. He was quite happy and I had it.
8 Unfortunately, I said to him he had not provided the
9 data. He went to the Senior Registrar and said
10 "I thought I told you to let Dr Halliday have any
11 information he wants". "Yes, but we are too busy."
12 "You are not too busy, go and get the data." When it
13 was analysed, the mortality rate was comparable to many
14 other units, but what was very interesting is that they
15 were actually having referrals from other supra-regional
16 services and some of these referrals had already been
17 operated on. I am not a cardiac surgeon, but if you ask
18 any cardiac surgeon, one thing you do not want to do is
19 operate on somebody else's patient. Here was Magdi
20 Yacoub taking on patients from other units, some who had
21 one operation; some had two operations, yet his
22 mortality rates were as good as the others. On that
23 basis, you could not fault him.
24 Q. You would also hypothesise there had to be a reason for
25 other centres referring to Magdi Yacoub?
0105
1 A. Yes, they acknowledged his skill.
2 Q. The reason for that referral would be that they felt the
3 operation would be better done elsewhere?
4 A. Exactly.
5 Q. So that you give as a particular example; here, a more
6 general point is being made in 3, I think, the basis of
7 surgical expertise. Again, help me with the wording of
8 it. It may or may not be yours, but what was meant in
9 that paragraph: actually surgical expertise in the
10 general sense, or was it the outcomes of particular
11 procedures?
12 A. Well, I think the two go together. I think we were
13 talking about outcomes of particular procedures.
14 I think the difficulty we are in here is all the
15 documents that we considered this morning highlight that
16 almost from day 1 we were facing a situation where we
17 might have to de-designate this service, or units within
18 the service.
19 The problem was that however much we tried, and
20 however much advice we got from the various medical
21 organisations, no-one recommended de-designating
22 particular units, so we were faced with the situation
23 where the only option was to de-designate the service.
24 That is why we talk about the importance of geography,
25 the problems about de-designating on expertise, or
0106
1 referral problems. Unless someone could provide us with
2 the evidence which would allow us to take that decision,
3 we had no alternative but to de-designate the service.
4 Q. Can I put a hypothetical position to you, just to see
5 what your response is? I am interested to know from
6 your experience what you think the members of the Supra
7 Regional Services Advisory Group would have advised, and
8 therefore probably the minister would have done, in an
9 instance such as this.
10 Suppose that one had a unit which was not doing
11 very many operations; it was small in terms of
12 throughput. Suppose that one knew, through the best of
13 available sources, that the surgeon in the unit, or
14 surgeons in the unit, had a high reputation in the
15 general field with which the unit was concerned,
16 particularly for adult patients, let us suppose.
17 Suppose that year after year, over, let us say,
18 5, 6, 7 years, there were repeated statistics showing
19 that in a small number of operations, that for children,
20 these surgeons were performing badly in comparison with
21 other units.
22 The hypothesis is that they are experienced men,
23 professionally qualified with no professional block at
24 all; that they are recognised in the profession as being
25 very good, so having the necessary expertise; but the
0107
1 figures, as best they are, show that they are failing in
2 comparison with other centres.
3 Explanations are put forward in respect of the
4 case mix, particular difficulties, the fact that it is
5 a small series.
6 Given those features, and add in that this
7 particular small unit is small because it is not in
8 London, it is somewhere out in the provinces.
9 Would the Supra Regional Services Advisory Group
10 first of all consider, on the basis of the results that
11 I have described -- it is very hypothetical, as
12 I appreciate -- that this unit might be de-designated?
13 A. Yes, if the Advisory Group was presented with the
14 information you have just provided in a hypothetical
15 case, what would happen would be that the Secretariat,
16 myself and Steve Alan, would put a paper to the Advisory
17 Group expressing concern about a particular unit and
18 what had happened in that unit as far as we understood,
19 and we would be recommending to the Chairman that he
20 invite the President of the appropriate college to set
21 up a Working Group to review this situation.
22 Q. Suppose the Working Group reports and says, "Well, it is
23 not doing very well; on the other hand, it is not doing
24 desperately badly". What would the likely outcome be?
25 Would the service likely remain designated, or not? It
0108
1 is very hypothetical, I appreciate.
2 A. Yes, and if you have an equivocal answer to
3 a hypothetical situation, I think people would sweat
4 over midnight oil about what we should do, but the
5 difficulty would be, if that is the professional advice
6 that it should continue, how do you stop it?
7 Q. It all comes down to -- this started the question I was
8 asking you -- it depends on the professional input you
9 get in the Supra Regional Services Advisory Group from
10 the Royal Colleges?
11 A. I do not know who is better to judge the practice of
12 medicine than the doctors. I mean, if you are looking
13 at a question of law, I do not think you would be asking
14 the man on the Clapham bus.
15 Q. Only hypothetically. There are one or two other matters
16 I want to pick up with you, if I may --
17 A. Can I just add to what I have just said? If, in this
18 hypothetical situation, officials, the advising group
19 and the Secretary of State was still concerned, I think
20 we would contemplate referring the matter to the GMC, if
21 in your hypothetical situation, despite the advice of
22 the Colleges, the concern remained of that level. We
23 would certainly consider that.
24 Q. I think the essence of the answer you have given me is
25 that you would not rely upon what might seem to be the
0109
1 implications of the data available; you would defer to
2 the doctors' own professional bodies, because who better
3 to understand whether a doctor is failing or not than
4 the doctors?
5 A. And to interpret the data.
6 Q. Two or three other little questions, and a bit of
7 a ragbag; I apologise for that.
8 We have taken you through in the questions that
9 I have been asking the process of designation to
10 de-designation. In the middle of that paragraph there
11 were the great NHS reforms in the early 1990s.
12 The impact of those on the whole question of
13 supra-regional funding obviously was considered. We saw
14 the minute yesterday with Mr Owen, at the Supra Regional
15 Services Advisory Group.
16 We are looking for a broad view as to how those
17 reforms impacted upon the way in which supra-regional
18 services were viewed. Were they more of a flagship,
19 less of a flagship, before and after the reforms, or
20 what?
21 A. The supra-regional services arrangements were not really
22 formally considered in the review. Before the review
23 report was issued, I expressed concern that one of the
24 most effective arrangements we had in the National
25 Health Service had not been mentioned, so a sentence was
0110
1 included in the report. I cannot remember what it said,
2 but it was something to the effect that advice on the
3 supra-regional service would follow.
4 So as an afterthought, there was consideration of
5 how the supra-regional service would fit into the new
6 reformed NHS.
7 Q. The effect of the reforms: was that to raise the profile
8 of the supra-regional service, or lower it?
9 A. Given the earlier emphasis of the NHS reforms on
10 competition, and other features of business management,
11 clearly it should have increased the status of the Supra
12 Regional Services Advisory Group arrangements because
13 they were the leaders, and therefore, the others would
14 have to compete with them.
15 Q. Can we have on the screen, please -- I do not know if it
16 is possible to get the transcript up; it probably is
17 not. Let me read out to you what we have on the
18 transcript. I will have to read this out fairly
19 carefully, what was said on Day 10, page 95, line 13.
20 It comes from what Mr Gregory was telling us. He said:
21 "In addition, my understanding, although you need
22 to discuss this with him, is that Professor Crompton
23 took this up [and 'this up' was his concerns about
24 Bristol's performance in terms of outcomes] with his
25 opposite number in the Department of Health and was
0111
1 referred to Dr Norman Halliday as having, I think, the
2 best insight into the performance of the Bristol unit."
3 The question for you is: do you recollect any such
4 discussion with Dr Crompton?
5 A. I had many discussions with Dr Crompton. As I said
6 earlier, I met with the Welsh Office regularly and we
7 regularly discussed Bristol, but I do not remember any
8 discussion with any clinician or official where the
9 performance of Bristol was questioned. "Performance"
10 I am interpreting as meaning clinical outcome.
11 Q. The second question -- I told you it was something of
12 a ragbag -- is this: the regional bodies, the Regional
13 Health Authorities obviously had a role to play before
14 the NHS reforms. Part of that role was, was it, to
15 monitor and deliver quality?
16 A. The statutory duty for the provision of services rests
17 with the Health Authorities, and so they still retain
18 their statutory duties. The Supra Regional Services
19 Advisory Group did not alter the statutory
20 arrangements.
21 Q. What responsibility, as a practical matter, did you see
22 them as having in monitoring and delivering quality of
23 service before the 1991 reforms?
24 A. We are talking about supra-regional services now?
25 Q. Yes.
0112
1 A. None of the supra-regional services functioned in
2 isolation. They were almost invariably part of
3 a general hospital. So the management of the general
4 hospital would have to manage the unit which was
5 designated supra-regional. I would have expected them
6 to look after the provision of facilities and all
7 outcome measures that they would want to use in any
8 sphere, as they would with any other service.
9 Q. The third matter is this: that yesterday we were told by
10 Mr Owen that he visited Bristol in February 1992. When
11 he visited Bristol then, he was passed mortality figures
12 which did not mean lot to him, so he passed them on to
13 you.
14 First of all, do you recollect that?
15 A. Yes. I mean, I was getting data fairly regularly, yes.
16 Q. The second question: do you recollect what, if anything,
17 you did with those figures?
18 A. The difficulty is, as I have said, having figures in
19 isolation, without the machinery to analyse it, is of no
20 particular value. It would have been strange for me to
21 be given -- I mean, I was not given any figures with the
22 suggestion that there was a problem here. I was given
23 figures as I was on many visits. Sometimes my
24 administrative colleagues would visit the units with the
25 object of dealing with financial matters, and would be
0113
1 handed data. They would come back to me, or Dr Prophet,
2 and would hand us that data.
3 If, however, we were given the data and told that
4 there was a problem with that data, that would be
5 a different matter.
6 I have no recollection of any data being presented
7 to me from Bristol with the caveat that there was
8 a problem.
9 If there had been a problem, I would have clearly
10 gone to the College for advice, but to be given data
11 without the suggestion that there was a problem, would
12 not have given me the opportunity to raise this with the
13 College. I mean, it would be pointless me giving them
14 the data from one year and saying, "What do you think of
15 this?"
16 Q. Finally, we know as a matter of history that articles
17 appeared in the press; in particular, an article in
18 Private Eye?
19 A. I do not take Private Eye.
20 Q. I am not suggesting you did, but would such an article
21 have been drawn to your attention by anyone?
22 A. Are we talking hypothetically now?
23 Q. Hypothetically?
24 A. If there was something quite scandalous and it appeared
25 there was some substance to it, then it might come to my
0114
1 attention, but that would depend on -- well, there would
2 be many avenues. The Department had a unit which dealt
3 with press cuttings and they would look at what was
4 happening in the press relevant to health. If they took
5 Private Eye or any other journal and came across that,
6 we would see it.
7 Alternatively, somebody might send it to us. But
8 I have no recollection of ever seeing anything in
9 Private Eye.
10 Q. I am not suggesting you did for a moment. What I am
11 asking you really is about the system.
12 A. Yes.
13 Q. And the system, as you have described it, is that the
14 Department of Health monitor the national press?
15 A. Yes.
16 Q. Did they monitor the local press as well, do you know?
17 A. Really, you would have to ask the Press Office. My
18 concern, I mean, we had a big enough task as it was
19 monitoring the professional journals in all the spheres
20 in which we were responsible. I mean, I have spoken to
21 many clinicians specialising in particular fields who
22 find it impossible themselves to keep up with the
23 national and international data. And we had to do that
24 as non-clinicians, so that was a difficult enough task
25 without reading journals which do not really appeal to
0115
1 me in any case.
2 Q. I think lawyers have exactly the same problem with Law
3 Reports.
4 A. I am sure you do, so you will sympathise.
5 Q. I do indeed. Again, just coming back to the question of
6 the system, if the Department of Health Press Office had
7 come upon any item which related on the supra-regional
8 service, was it the pattern that they would cut it out
9 or photocopy it or make a note of it and pass it on to
10 you?
11 A. Yes.
12 Q. So if there was concern or comment in anything which
13 they monitored, it would find its way to you, or to
14 someone in your department who would deal with it?
15 A. Yes.
16 Q. If it was thought that it ought to have been taken
17 seriously, it would have been drawn to your attention.
18 I do not imagine you saw every press cutting that came
19 in, but someone will have drawn it to your attention, or
20 should have drawn it to your attention?
21 A. Yes.
22 MR LANGSTAFF: Dr Halliday, can I repeat what I said at the
23 outset? I know it has not administratively been easy
24 for you to make time to come and be with us today. Can
25 I for my part thank you very much indeed again for doing
0116
1 so, and say how helpful your evidence has been.
2 I am going to stop asking you questions now, save
3 for one: I have asked you lots of questions. It may
4 well be that there is something, nonetheless, which
5 I have overlooked which you would like to tell us about,
6 with a view to helping the Inquiry in its purposes.
7 If there is anything you would like to say or to
8 add, or to emphasize, now is your chance to do it.
9 DR HALLIDAY: Thank you. You have shown me documents today
10 I have never seen before. I will take the opportunity
11 of looking at these carefully and if there is
12 a follow-up, I will let you have something in writing.
13 I would, however, like to stress that if we are
14 viewing the supra-regional service arrangements, we have
15 to look at them in addition to the problems you are
16 facing in neonatal and infant cardiac surgery, because
17 the supra-regional service arrangements are the envy of
18 the world in terms of their ability to control the
19 development of specialised services. The fact we have
20 failed in neonatal and infant cardiac surgery I do not
21 think detracts from the success of the Advisory Group
22 arrangements, but it is just an example of an attempt to
23 control the development.
24 Q. That reminds me -- I am sorry for breaking my word by
25 saying it is the last question, but it reminds me of
0117
1 something which we have at DOH 2/2.
2 This, as I understand it, was the first report,
3 albeit it was 1992, of the Supra Regional Services
4 Advisory Group, the first annual report that was
5 produced.
6 A. The first annual report? May be, yes.
7 Q. The foreword -- it is misspelt on the top of the page --
8 written or attributed to Sir Michael Carlisle is: "The
9 provision of supra-regional services cost ..." and it
10 sets out the cost. The next paragraph:
11 "It is generally accepted that since their
12 creation in 1983, the supra-regional service
13 arrangements have led to continually improving levels of
14 patient care with outcomes which in many cases compare
15 favourably with those obtained elsewhere in the world."
16 This is talking of course about all services?
17 A. Yes.
18 Q. Does it imply that there was empirical evidence of
19 outcomes, or is this dealing with the data analysed and
20 sifted by the Royal Colleges and the doctors as you have
21 described?
22 A. In some areas, for instance, liver transplant and heart
23 transplantation, there are evaluations both nationally
24 and internationally of the situation and the UK units
25 come out in glowing terms.
0118
1 In terms of liver transplant, there is in fact
2 a European register which I think is in Switzerland --
3 I have forgotten -- and they monitor outcome. So,
4 depending on which service we are talking about, there
5 will be different sources.
6 In terms of neonatal and infant cardiac surgery,
7 there are a number of firsts amongst the designated
8 units, things that have not been done elsewhere in the
9 world. I think to an extent these might only have been
10 possible because of the central funding and improved
11 facilities.
12 Q. If I can turn over, it is the same vein, really,
13 DOH 2/4, and again, it is talking about the services
14 generally, one must emphasise:
15 "Since their origin in 1983, the Supra Regional
16 Service arrangements have played a crucial role in the
17 provision and planning of a range of highly specialised
18 services. The arrangements ... have contributed to
19 patients receiving the very best of treatment available
20 and ensured that designated services have been provided
21 in and developed in a cost-effective way."
22 The words "very best", it is hyperbole: was it
23 justified by objective data?
24 A. It is a question of how you measure these things. If
25 you have referred to you patients from all over the
0119
1 world for operation on the heart, then I think one could
2 suggest that is the best available treatment. Our main
3 competition is America, so it is a question of, if your
4 patient instead of going to America came to Harefield or
5 Birmingham or Brompton, then that suggests that we are
6 probably the best available treatment, because it is not
7 only patient choice, it is the referring clinicians.
8 I think that is a good basis upon which to decide that
9 the services being provided within the supra-regional
10 service arrangements are the very best. In one
11 specialty, one of the Kings, no names, his position is
12 one of the designated units. So, in whose opinion is it
13 the very best?
14 Q. You have answered the question I am asking. I rather
15 interrupted what you might want to say. Is there
16 anything else you would wish to add?
17 A. No, I do not think so.
18 MR LANGSTAFF: There may be some questions from the members
19 of the Panel.
20 EXAMINED by the PANEL
21 MRS MACLEAN: Earlier on this morning you were describing to
22 us how, in the early days at Bristol, you were looking
23 to see the development of the service, and for referrals
24 to increase and so on. You suggested that you were
25 looking to the Royal Colleges for support in the
0120
1 development of Bristol.
2 I wonder if you could give me some examples of the
3 kinds of things you meant by that support?
4 A. Actually, I did not say I was looking to the Royal
5 College for support, I said that the Royal College had
6 offered their support. You see, the Colleges are
7 responsible -- one point perhaps I should have made
8 earlier is that we are very fortunate in the way that
9 our Royal Colleges assist us, because they are not
10 formally part of the National Health Service. They have
11 no responsibility for the provision of services. Their
12 role is educational and the training of doctors. Yet
13 despite that, they are only too happy to contribute
14 their time, and sometimes money, to look at the things
15 we want them to address.
16 So I think we are very lucky in that sense.
17 In the case of Bristol, we were in a situation
18 where the Advisory Group had decided, based on all the
19 evidence we had, that we should designate the neonatal
20 and infant cardiac surgery. If we did not have a centre
21 in the South West, a significant part of the population
22 would not be served. We had to take into account Wales
23 as well, although Wales was not part of the
24 supra-regional service arrangements.
25 When it was suggested that Bristol be designated,
0121
1 even then we had concerns, because it did not seem to
2 be, you know, as good as the other units in terms of
3 facilities, staffing and so on.
4 When the College offered, through Sir Terence, to
5 say that they would assist us in strengthening that
6 unit, my interpretation of that would be that the
7 College had "powers", in inverted commas, through their
8 visits to say whether the facilities were effective, and
9 if they were not effective, they could withdraw their
10 recognition of it being a training post. That is a very
11 powerful weapon for managers.
12 The second thing is that they can influence their
13 young consultants coming along, or Senior Registrars,
14 and suggest to them that if they would like to apply to
15 Bristol, it would be in their long-term interests. So
16 I expected them, both in terms of their visitations and
17 encouraging staff, good staff, to take posts in Bristol,
18 that they would strengthen the unit.
19 But it is not something I could actually interfere
20 with. The College has its own way of ensuring its
21 standards are met.
22 THE CHAIRMAN: Professor Jarman?
23 PROFESSOR JARMAN: Dr Halliday, a lot of discussions have
24 been about the difficulty of measuring clinical
25 outcomes, and you said that you never had any difficulty
0122
1 obtaining the data from the units, and if you went to
2 a unit they would give you the mortality data. The
3 problem was, who was going to analyse the data and make
4 use of it? In the absence of an expert group, which you
5 had not agreed then, you could not make use of it.
6 There had been some discussion about the quality
7 of services at Bristol among a number of clinicians you
8 know of. You actually yourself said that there was
9 always a worry about Bristol; you did not say about the
10 quality of the service, exactly.
11 In fact, you said:
12 "It was a particular worry because in a sense
13 I could not understand why the referrals were not
14 increasing."
15 A. Exactly.
16 Q. "I made visits to Bristol with the Welsh Office and
17 talked to many people, clinicians, and tried to identify
18 what the problem was. It never became clear."
19 A. Yes.
20 Q. But in light of the fact that there had been a lot of
21 discussion about the problems at Bristol, I just
22 wondered whether you, in trying to analyse it, ever
23 approached the Department of Public Health, who would
24 have had statisticians available to help you with that
25 type of thing?
0123
1 A. Obviously we disagree on this one.
2 Q. I do not know your reply yet.
3 A. No, but you can anticipate it. I believe, if you are
4 going to look at any clinical service, that it has to be
5 analysed by people in that clinical service.
6 Statistical analysis of data is valuable. It does not
7 answer the question, are the patients being managed
8 effectively? That can only be answered by clinicians in
9 the same specialty.
10 Indeed, one of the reasons why I do not have a lot
11 of confidence in what has been called "public health"
12 and then "community medicine", and now perhaps back to
13 "public health", which suggests they are not sure of
14 their own role, but I was 15 years the Head of the
15 Medical Policy Division and in looking at the
16 information we required, usually epidemiological, and of
17 course statistical information on changes in treatment,
18 almost without exception, the evidence that came to us
19 that was of value did not come from members of the
20 public health and community medicine, it came from
21 practising clinicians.
22 Q. I will not comment about whether we agree or not, in
23 public at least.
24 Just in light of what we have been saying, your
25 worry and the other discussions that there were, I just
0124
1 wondered if you had seen a document which I would like
2 to show. I do not want you necessarily to comment on
3 it, unless you want to -- you can comment later -- but
4 it is UBHT 55/68.
5 You can see that that is a report on paediatric
6 cardiology and cardiac surgery from the Bristol Royal
7 Infirmary in 1989/90.
8 If we could go to UBHT 55/81, the last page of the
9 report, if you can take the fifth line down, you are
10 looking at open heart surgery under one year, and
11 percentage deaths.
12 If you look under the 1989 thing, the figure for
13 Bristol is 37.5 and if you look on the far right-hand
14 side of that, the percentage of deaths in the UK for
15 1988, which you might have expected to be higher, is
16 18.8?
17 A. Yes.
18 Q. Obviously you cannot do it now, but if you do
19 a statistical test on this, these are significantly
20 different?
21 A. Without doing a statistical test, that is worrying.
22 But I am confident that that has never been seen
23 by anyone in the Department of Health. I certainly did
24 not see it, and I am quite sure it has not been received
25 by the Department of Health.
0125
1 Q. And there was no mechanism for that sort of thing being
2 seen?
3 A. Of course. My door was open. All my staff's door was
4 open. The administrative colleagues were the same.
5 Making an approach to us was the simplest thing in the
6 world: either telephone, fax or post. We made it
7 a point of being available to attend any meeting to
8 which we were invited, even though at times that was not
9 particularly convenient. But we were always available.
10 Q. To get on to the related thing, what you said just now
11 about the visits to the College, really, I think they
12 would agree with what you were implying: that their only
13 power really is on approving training?
14 A. Yes.
15 Q. We did have a report from Professor Alberti about
16 a visit they had made to Bristol, and they did express
17 considerable concerns, agreed it was medical, about the
18 lack of the availability of beds and so on.
19 What power did the College have to do anything
20 about the only area where they could actually express
21 and have an effect?
22 A. If you did not approve posts for training, then you
23 would not get doctors in the posts, or you would not get
24 doctors who saw their career in that speciality in the
25 posts, so they would not be able to provide an effective
0126
1 service.
2 Q. You can see the problem the College would have had: that
3 they would not want to stop the training by not
4 approving it, because that would have been disastrous
5 for the service.
6 On the other hand, they did draw attention to the
7 problems of the BRI, that they thought that there was
8 effectively overwork and not enough beds?
9 A. Again, you know, I have not seen those reports, but if
10 in fact they were in a situation where they were
11 genuinely concerned about Bristol and they wanted to
12 stop short of removing training, then there was nothing
13 to stop them, given it was a designated service, coming
14 to the Department and saying, "Look, Norman [because
15 I know most of them] we are in a difficult situation;
16 how can we take this forward?"
17 If in fact there were concerns expressed by
18 Bristol that we could meet, that we could actually use,
19 then we would have worked on it.
20 PROFESSOR JARMAN: Thank you very much.
21 THE CHAIRMAN: I have one question, Dr Halliday. Tell me if
22 you think it is an overstatement. It is an attempt to
23 distill, from what you were saying, an impression.
24 The impression I have is that as a service -- let
25 alone we are talking about any particular unit -- this
0127
1 particular service concerned with neonatal and infant
2 cardiac surgery, et cetera, was doomed from the start,
3 in that the very criterion of one year had an element of
4 arbitrariness in it. The criteria for supra-regional
5 services could not appear to ever be met, at least in
6 some of the units. There were either going to be too
7 many units or there was not enough throughput; there was
8 already an existing and established service; there was
9 therefore an inability to make dirigisme from the centre
10 actually work. There were no financial sticks, only
11 carrots. And there was always the issue of clinical
12 freedom, whatever that may mean, operating against the
13 interests.
14 Would that be a fair set of observations, or have
15 I got it completely wrong?
16 A. No, that is entirely fair, but the other element of that
17 is the situation where the Department was aware that
18 there were allegations by reputable experienced
19 clinicians that there were children who were not being
20 diagnosed and treated in this specialty. You cannot
21 ignore that.
22 We were aware that there were parts of the country
23 in which we were very poorly covered, and other parts of
24 the country which were over-generously provided, so
25 there had to be something done about the service.
0128
1 The supra-regional service advisory arrangements
2 appeared to offer that mechanism, and it has worked in
3 other services very effectively.
4 We then consulted with appropriate colleges and
5 their view was that it should be a designated service.
6 In fact, their view is to this day that it should be
7 a designated service, but I agree with you, it has not
8 worked. But we did try.
9 I think that is all one would expect a department
10 to do: to try to make the system work. If it is not
11 possible for a variety of reasons, and there are no
12 powers to ensure that it happens, then there is nothing
13 we can do.
14 Q. I am very grateful, that is a very helpful answer.
15 Supplementary might be that to separate what is policy
16 and what as it were is an area of clinical discretion,
17 the policy would be to choose the model or the method or
18 the mechanism of a supra-regional service and that would
19 ultimately be a departmental issue, I guess, rather than
20 for the clinical professionals. Ultimately it would
21 rest with the Department to choose that model, rather
22 than the other way of solving what you described as
23 a problem I think we have already seen, that in Wales,
24 for example, there is only one paediatric cardiologist,
25 and one therefore is made aware of the maldistribution
0129
1 of resources?
2 A. Yes.
3 Q. Perhaps I did not make my question clear. Is it the
4 case, therefore, that the choice of the model to go with
5 supra-regional services would ultimately be a matter of
6 policy within your division, within the Department
7 generally?
8 A. Are you referring to the overall process by which it
9 functions? I thought I had made it fairly clear that
10 this was extremely difficult to set up. The best brains
11 in the Department and the best brains outside the
12 Department failed to come up with any mechanism. We
13 started, the Medical Division, my medical division, and
14 the profession, took five years to establish this
15 mechanism.
16 Q. You will forgive me, it is my fault. I am only
17 responding to much more particular point.
18 Accepting the nature of the problem you have
19 described about maldistribution of resources and
20 service, the choice was to try this supra-regional
21 service mechanism. Whose decision was it to use this
22 mechanism? Is it not ultimately a departmental policy?
23 A. Now I understand. As I said earlier, it was not the
24 role, or indeed the objective, of the supra-regional
25 service arrangements to solve all the problems of the
0130
1 NHS. In fact, no-one raised the issue of neonatal and
2 infant cardiac surgery as a problem that had to be
3 addressed, and "let us try this method". What we had
4 was a situation where, in the papers that you have seen
5 which preceded the establishment of the supra-regional
6 services, they were using terms such as, "it is
7 a supra-regional service", which meant that they knew
8 that we were dealing with a service that did not fit
9 neatly with the regional pattern of the Health Service.
10 So an alternative arrangement had to be found.
11 When the supra-regional services was set up,
12 clearly all those in that specialty thought, "Now is our
13 chance". So in a sense, the thrust for it came from the
14 field, but we already had a mechanism and a concern
15 within the Department for that specialty.
16 THE CHAIRMAN: I am grateful. Thank you.
17 Let me ask Mr Pirani, is there any
18 re-examination?
19 MR PIRANI: Chairman, I have one very brief question, if
20 I may.
21 THE CHAIRMAN: Please come forward.
22 RE-EXAMINED by MR PIRANI:
23 Q. Dr Halliday, if I can take you back very briefly to this
24 question relating to the collection of information
25 relating to interpretation of data on clinical outcome,
0131
1 can I ask you what, if any, input did you have from
2 clinicians based in countries other than England and
3 Wales, on the units in this country, and to what extent
4 was that information considered?
5 A. Myself and my staff attended as many conferences as we
6 could, both in this country and internationally, and the
7 international conferences were a valuable source of
8 feedback, because not only would you have the reaction
9 of the clinicians to presentations from units in the
10 United Kingdom, but you would also have the discussions
11 and again the informal discussions over dinner and so
12 on, and they would often highlight the services and the
13 units that they recognised as being internationally
14 outstanding. So that was a valuable input.
15 Q. That was something you did in addition to obviously
16 attending conferences in these countries?
17 A. Yes.
18 MR PIRANI: Thank you Chairman.
19 THE CHAIRMAN: Thank you, I am grateful to you. Let me,
20 Dr Halliday, repeat what Mr Langstaff said, namely our
21 thanks. I am aware of the fact you have had to readjust
22 your travel arrangements and I echo the gratitude of the
23 Panel that you were able to make time for us.
24 Let me repeat also, there have been a couple of
25 occasions in which you have been referred to matters
0132
1 upon which we would be very grateful if, having had
2 proper reflection, you could come back with some further
3 elucidation or observation, yourself or through others.
4 We look forward, therefore, to hearing from you.
5 If there are other matters that you would want to bring
6 to our attention, in addition to what you have been able
7 to help us with today, feel free also to let us know
8 that. But for now, thank you very much indeed.
9 DR HALLIDAY: Thank you.
10 MR LANGSTAFF: Sir, that concludes this week.
11 THE CHAIRMAN: I thought for a moment you might be tempted
12 to tell us about next week.
13 MR LANGSTAFF: I would be. Next week, I think, Chairman,
14 you will recall you decided that the Inquiry will not be
15 sitting, although that does not mean to say from our
16 point of view that we cease work. It is not so much
17 a holiday, except on the Bank Holiday, we all hope, as
18 preparing for what then follows on the week beginning
19 10th May, when we expect to hear from Professor Strunin
20 of the Royal College of Anaesthetists, and perhaps
21 I should say that during that period we hope to continue
22 to receive witness statements from the very many people
23 who have been asked.
24 At the moment there has been some, I think, local
25 press concern that there may not have been quite the
0133
1 number of statements coming through from people who used
2 to work in the Bristol hospitals, and we, for our part,
3 remain keen to hear from anyone who thinks that they
4 have anything that may be of help. If they feel that
5 they might have, we would rather we heard that than that
6 they said to themselves, "Oh, the Inquiry does not want
7 to hear from someone like me." We do, and it is part of
8 the objective, as you will recall, I made clear in my
9 opening, that the Inquiry be as inclusive and as
10 comprehensive as possible.
11 That said, may I pay tribute on this occasion,
12 conscious that this will go out over the Internet and to
13 Community Health Centres with live links, to those very
14 many people who have already given us written statements
15 and whose written statements are promised, even although
16 the majority of them will never themselves sit in the
17 'hot seat' that Dr Halliday has been sitting in today,
18 nonetheless, their evidence is all part of the evidence
19 which we know you are considering.
20 THE CHAIRMAN: I am grateful to you for saying that, and
21 endorse everything that you have said.
22 So we adjourn now. We reconvene a week on Monday,
23 and as you have heard, we will hear witnesses from Royal
24 Colleges and other national institutions. Thank you,
25 Mr Langstaff.
0134
1 (1.22 pm)
2 (Adjourned until 10.30 am on Monday, 10th May 1999)
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5 I N D E X
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8 DR NORMAN PRYDE HALLIDAY (Sworn)
9
10 Examined by MR LANGSTAFF...................... 1
11 Examined by the PANEL ........................ 120
12 Re-examined by MR PIRANI...................... 131
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Published by the Bristol Royal Infirmary Inquiry, July 2001
© Crown Copyright 2001