|
|
||
Hearing summary
14 July 1999
Today the Inquiry hearings concluded a two-day look at data sources and the relevance of statistical evidence to the Inquirys terms of reference. Mr Andrew Hooper, Health Records Manager, Bristol Royal Infirmary (BRI) and United Bristol Healthcare NHS Trust (UBHT); Ms Ann Harding, Acting Director, NHS Information Authority; and Dr David Spiegelhalter, Senior Scientist, Institute of Public Health, and a member of the Inquirys expert group of witnesses, discussed the introduction, quality and consistency of the data (administrative not clinical) recorded on the Patient Administration System (PAS) at the BRI. Ms Harding then went on to clarify some points arising from Mr Willmers evidence given yesterday relating to remuneration and training for clinical coders and incentives to promote accuracy of coding, which she said relied largely on personal motivation. Mr Spiegelhalter then reviewed the past two days, commenting on the usefulness to the Inquiry of the data sources discussed and concluded by explaining the next stages in the process of analysing the data.
The hearings were adjourned until Monday 19 July.
Full copies of the documents "Preliminary Critical Overview of Existing Data Sources Relevant to the Inquiry Remit" and "The Inquirys Approach to Making Use of Relevant Data Sources" are published the Inquiry website under Inquiry Procedures.
|
||
FULL TRANSCRIPT
1 Day 39, 14th July 1999 2 (10.00 am). 3 MR LANGSTAFF: Good morning, sir. Today the second part of 4 the preliminary overview, preliminary stage, in 5 examining the quality of the data before we approach the 6 analyses and draw the lessons that can be learned from 7 them, if any. We will be looking at the PAS (Patient 8 Administration System) which the hospitals in Bristol, 9 in particular the Trust, had during the years which are 10 relevant to us. 11 This morning we will hear first of all from 12 Mr Andrew Hooper; we will then hear from 13 Miss Ann Harding, our expert, who will pick up some of 14 the points which Mr Willmer made yesterday. She, of 15 course, while Mr Hooper is giving his evidence, will, 16 I hope, interact with him in the same way as we achieved 17 yesterday when we heard the evidence of Mr Willmer in 18 the afternoon. 19 Then Dr Spiegelhalter will finish the session with 20 examining the way forward that the Inquiry can take. 21 We begin with Mr Andrew Hooper. Will you come 22 forward, please? 23 Mr Hooper, would you mind standing for the oath? 24 MR ANDREW HOOPER (AFFIRMED): 25 Examined by MR LANGSTAFF: 0001 1 Q. Can we have on screen WIT 211/1? Is that the first 2 page of a statement which you made for the purposes of 3 this Inquiry about the Patient Administration System in 4 operation at the Bristol Royal Infirmary? 5 A. Yes. 6 Q. If we go to page 7, that is your signature? 7 A. Yes. 8 Q. And the contents of that statement are true and 9 accurate, are they? 10 A. Yes. 11 Q. You also have provided for us -- we find this at 12 INQ 1/24 -- comments on the published preliminary 13 overview of existing data sources, the paper produced by 14 the Inquiry Secretariat and published on the Internet, 15 and dated 13th July. It is one page and we can see if 16 we scroll down your signature at the bottom. 17 A. Yes. 18 Q. You have also provided us with a number of 19 appendices which show various diagrams and attach 20 a number of letters in relation to the Patient 21 Administration System. 22 A. Yes. 23 Q. Can I go back, then, to explore the nature of the 24 Patient Administration System? What we will do is, we 25 will take your statement as read and therefore I shall 0002 1 not ask you to go over everything which is in it and 2 just explore one or two aspects of it or that arise from 3 it. 4 You make the point that you have worked in 5 health records initially as a records clerk and then as 6 a records manager, and finally as the Health Records 7 Manager for the Trust over a number of years, and 8 certainly throughout the years with which this Inquiry 9 is concerned. 10 Since 1988 you have worked in the Bristol 11 hospitals? 12 A. Yes, I was based at the Trust in 1988, based at the 13 Bristol Royal Infirmary but with Trust responsibilities. 14 Q. You told us that in April 1988, when you became the 15 Trust PAS manager, you began to introduce a PAS system 16 to the Trust, having had familiarity with it earlier in 17 your post in Southmead? 18 A. Yes. 19 Q. Am I right in thinking that the inpatient part of 20 the PAS system was operative from 1st April 1988? 21 A. What I actually did, when I came back to Bristol 22 & Weston Health Authority, I had a three and four year 23 plan at that stage which was to implement a master 24 patient index, an inpatient module, an outpatient module 25 and a waiting list module. That was my remit when I was 0003 1 re-employed back there in 1988. The first thing I did 2 was to set up the index and because we did not want to 3 be in a situation where we had a manual and a computer 4 system, we actually took on all the retrospective, all 5 the historical index right back until 1948. 6 Historically, the patients' demographic information had 7 always been kept on 5 x 3 index cards so the first part 8 of the process was to convert the old manual system 9 across to the new Patient Administration System, which 10 at that time was a system being supported by the South 11 West Regional Health Authority. 12 So that was the first task, to achieve that index. 13 Q. Can I ask you to pause there for a moment? The reason 14 for that is that you are speaking naturally quite fast. 15 We have stenographers who need to keep up with you. 16 They are taking a note of every word you speak. If you 17 do not mind either speaking a little more slowly, or if 18 that is unnatural, I will ask you to pause for a few 19 moments. 20 I stopped you in mid-flow. 21 A. The first part was to set up the index. Once that had 22 been achieved, there was a local system that had been 23 developed in-house at Bristol at that stage. In 24 essence, all that was, it was a way of forming a very 25 brief index of the patients that had attended. They 0004 1 used to be called data admission and data discharge, and 2 they also used it as a diary mechanism for outpatients. 3 They used to use it for producing clinic lists and 4 patients' labels, no more, no less. It had no links to 5 information systems at all at that time. 6 Because they had that system in place, when I set 7 up the inpatient module on the new system, which would 8 have been some time probably in late 1989, we loaded 9 back retrospectively the inpatient episodal information 10 to 1st April 1988 and some of that information was 11 lifted from the locally developed system -- not very 12 much -- and then from a date which I cannot remember, as 13 I say, it was in 1989, we started entering real-time all 14 the admission, the transfer and the discharge data. 15 Q. So from 1st April 1988 up until a date in 1989, the data 16 is derived from historical records and loaded into the 17 computerised PAS system? 18 A. Yes. 19 Q. And from that time onwards, the information is recorded 20 in real-time? 21 A. Yes. What we actually did, we got rid of the old manual 22 bed statements and replaced it with real-time entry of 23 the data. That was the carrot we dropped in front of 24 the nurses and the ward staff to get the information put 25 on to the system. We wanted to try and encourage them 0005 1 to put in the data real-time. 2 Q. Did it work? 3 A. Yes. 4 Q. So effectively, if we look at it as a system -- first of 5 all, I want to explore with you, really, what it 6 recorded. Its purpose was administrative as you point 7 out. You point that out more than once in answer or 8 response to the invitation to comment on the critical 9 overview that was published? 10 A. Yes. 11 Q. Although it was administrative, it would record the 12 demographic information about the patient, date of 13 birth, postcode, date of admission, if admitted? 14 A. Yes. 15 Q. Date of outpatient attendance. You deal with 16 outpatients as well as inpatients, presumably? 17 A. Because it was supported by the regional computer 18 centre, as it was then, the system has always complied 19 with mandatory requirements so any mandatory information 20 that was required locally or nationally, it could always 21 be collected through the system. So, for instance, for 22 inpatients, it would collect all the patient's 23 demographic information, name, date of birth, address, 24 GP, and you would go on through that process to put on 25 the information required related to the date of 0006 1 admission, where they were referred from and so on and 2 so forth, the referring person, and then any internal 3 movements within that episode, whether it would be the 4 consultant transfer or a ward transfer, that was also 5 put on to the system in real-time, and then obviously 6 once the patient was discharged home, that should be 7 done the moment the person walks out of the door or is 8 taken out of the ward. 9 So the system has always complied with national 10 statistical requirements. 11 Q. And it would include, would it, a description of the 12 diagnosis? 13 A. No, not at all. Not at that stage. The diagnostic 14 information would have been put on after the patient had 15 been discharged through a diagnostic coding routine that 16 was linked in to the inpatient module. 17 Q. So if one looks at the PAD, the patient administration 18 database, one will find, will one, the diagnostic 19 information, even though it was not put on in real-time 20 as you described? 21 A. Yes. Once the diagnostic information has been input on 22 to the PAS, it would then move across to any other 23 systems that required that information. 24 Q. So if one goes back to the PAS now, one will find on 25 it diagnostic information and information as to any 0007 1 operative procedure which was carried out? 2 A. Back to 1st April 1988, yes. 3 Q. The system will record, will it, the death, if death 4 has happened, of the patient? 5 A. If the patient dies in hospital, then obviously, when 6 they are discharged from the ward, the disposal is put 7 on as "deceased". That will immediately update the rest 8 of the system and any outstanding outpatient 9 appointments, waiting list entries, will automatically 10 be cancelled off the system. 11 Similarly, when the patient's discharge summary is 12 produced, it should say "deceased" on the discharge 13 summary. That information will then go back to the GP. 14 There will obviously be the death notification as well. 15 Where we do have a bit of a problem is sometimes getting 16 the information back for the patients that have died 17 outside of the hospital. The information we get is only 18 as good as the information given to us by the GP's 19 surgery or the relatives. 20 Q. One of the differences, I think, that we have been told 21 of, I have been told of, comment on it if you can, 22 between HES and the information available from the PAS 23 system, is that HES takes, as it were, a snapshot 24 because it asks for data at intervals from regions and 25 hospitals, and so information that it has as to death 0008 1 will be the status as then revealed by the PAS records. 2 But the database which you have, the Patient 3 Administration System will be dynamic in the sense that 4 it will record deaths whenever they are notified to the 5 hospital, presumably? 6 A. That is correct, yes. 7 Q. So one will expect the PAS system to show greater 8 mortality rates than the HES system? 9 A. I would agree with that statement, yes. 10 Q. Can I, perhaps with the help of Ann Harding, or 11 Dr Spiegelhalter, explore the accuracy of the death 12 information that gets on to your system here in Bristol 13 and indeed for that matter, any comparative system 14 elsewhere. 15 Ann, would you wish to ask -- 16 MISS HARDING: I think there are a couple of important 17 issues here. A death associated with a particular 18 episode of care and a death that is associated only as 19 the subject of a record as part of the administrative 20 system: I just wonder if you could comment how, in your 21 PAS, you handled that, whether it was possible to handle 22 that within the PAS system or whether it was not 23 possible to handle it within the PAS system? 24 A. I am sorry, could you just repeat the question? I am 25 not sure of the first bit. 0009 1 Q. A death associated with a particular episode of care 2 which would be recorded on the HES database associated 3 with that episode: were you able, within your Patient 4 Administration System, to associate a death that did not 5 happen immediately with an episode of care if it 6 happened later and could be associated with that episode 7 of care? 8 A. No, unfortunately not, because if somebody had been in 9 hospital and then perhaps died at home a month later, 10 what you would do, you would notify the death to the 11 system. The only information, because it is an 12 administrative system, the information that goes on is 13 date of death, place of death, if known, and we would 14 normally make some sort of comment as to who had 15 notified us just in case there was a problem at a later 16 date. But it really is not linked back to any episode 17 of care as such. 18 Q. That would be, at that particular time for Patient 19 Administration Systems, the mechanisms that were used? 20 A. Yes. 21 Q. I was just wondering if there was any attempt made to 22 map them back. That would have been the standard 23 process at the time: the Patient Administration System 24 would not have linked the death to the episode? 25 MR LANGSTAFF: When you say "at the time", so we can have 0010 1 clarity here, we are looking at 1984 to 1995. 2 MISS HARDING: Yes. I think it is only in the last four or 3 five years that Patient Administration Systems, and 4 other systems, have been capable of making these more 5 sophisticated connections about being able to link 6 a death to a particular episode in a way that made it 7 clear that it was related to that episode, or that it 8 was not related to that episode but was related to some 9 other episode of care, or even not to any episode of 10 care that happened in the hospital. It is only recently 11 we have been able to do that. Would you agree? 12 A. I think so. I think now some of the systems are 13 becoming more sophisticated and you are getting into the 14 realms of patient's electronic records, then it has more 15 ability to link in the deaths with particular diagnostic 16 information, perhaps, in episodes of care. Because we 17 are talking about purely an administration system, it 18 had no links at all with diagnosis in any real 19 particular episode of care. 20 MISS HARDING: That is what I would have expected. 21 MR LANGSTAFF: One of the points you are making is that in 22 the system as it was operated in Bristol, the diagnostic 23 information was entered separately from the real-time 24 information which went on to the system? 25 A. Yes. 0011 1 Q. So how did the diagnostic information get on there? 2 A. The way that it works is obviously a patient comes into 3 hospital, they have their care, are discharged from the 4 hospital, and then the notes one would normally expect 5 to go back to the consultant's secretary to have 6 a summary dictated. 7 That summary should be dictated as quickly as 8 possible after the discharge, although some clinicians 9 are better than others at doing discharge summaries, so 10 the discharge summary would normally be a side of A4, 11 the top half would have the demographic information, the 12 middle portion would probably have the diagnostic 13 information written down, into a main and secondary 14 diagnosis. If they had an operation, there would be 15 a section for the operation details. At the bottom you 16 would have the text the medical staff dictated about the 17 patient's stay. 18 A copy of that discharge summary would obviously 19 go to the GP and any other interested parties. A copy 20 would be retained in the medical records. As soon as 21 that discharge summary has been dictated and typed, 22 those notes would then go off to the clinical coders for 23 that episode of care to be coded. That would be done as 24 quickly as the discharge summary was dictated. Most of 25 the coding clerks would code directly, all the coders 0012 1 would code from the diagnostic and operational 2 information that had been put on to that discharge 3 sheet. 4 MR LANGSTAFF: So the way it was done in Bristol was the 5 discharge summary was the basis of the diagnostic 6 coding? 7 A. Yes. 8 MR LANGSTAFF: Is this the way it is done generally or 9 not? 10 MISS HARDING: There are a number of different ways 11 it is done in different places. And some coders have 12 access to all of the case notes and do not have 13 a discharge summary and therefore would use all of the 14 information that was in the case notes rather than just 15 the discharge summary. In other places, coders just 16 have the discharge summary and do not have access to the 17 full set of case notes. In other places, coders code 18 from the discharge summary but being able to refer back 19 to the full set of case notes and any other information 20 they can use from the full case notes as part of their 21 process of making accurate diagnoses. So it works in 22 a number of different ways. 23 I would just like to ask a question, if I could, 24 about who did the discharge summaries? 25 A. Again, I could not say for sure, but it would be one of 0013 1 the consultant's medical team. I think normally one 2 would expect it probably to be the Registrar himself, 3 but that is not to say that the more junior staff did 4 not dictate summaries. I could not give you an accurate 5 answer on that. 6 What I was also going to say was that the 7 rationale for us giving the coders the notes was they 8 are very squirrel-like they take a big pride in their 9 work and, for instance, it is helpful if you have 10 a patient who contracts cancer to look back at the 11 histology report to input that data on to the cancer 12 screens. I am sure a lot of the coders have been around 13 a long while and will have the common sense to look at 14 appropriate sections of the notes to validate what they 15 are doing. 16 MR LANGSTAFF: Since you have raised it, can I explore 17 your perception of the quality of the coders here in 18 Bristol. First, really, we had some evidence yesterday 19 that there may be different types and qualities of 20 person interested in doing the work as a coder. 21 A. Yes. 22 Q. And we may have had an impression that coding perhaps 23 had not, at least in the 1980s and early 1990s, been 24 very highly valued, and for that reason, may not have 25 attracted the best quality of staff taken generally, 0014 1 although individuals may have been very good. 2 One indication of the quality of interest in the 3 job and the value people put on their own job may be the 4 length of time they actually stay in it and what sort of 5 staff turnaround you have. What was the picture at the 6 Bristol? 7 A. The frightening thing is, most of them have been around 8 as along as I have. As far as UBHT is concerned, most 9 of the coders that are in post now will have been in 10 post in the last 10, 15, 20, years. I cannot remember 11 the last time we had a coding vacancy within the Trust. 12 I think that is quite an important issue, because 13 they have not always been appreciated, in my view. 14 Their grades have been not abysmal, but they have not 15 been the best-paid staff within the Health Service. 16 I think they assumed a slightly higher profile perhaps 17 when contracts and GP funding came into the health 18 service where the information and diagnostic information 19 was used for charging purposes, and I think people then 20 started to sit up and say "The information the coders 21 are putting in is invaluable. We are basing our some of 22 costs on the coding", so they certainly assumed a higher 23 profile. 24 What we did as a Trust in the early 1990s, 25 I cannot be too precise about the date, the coding 0015 1 clerks were given to directorates in the Trust because 2 they were managing their own contracting. They were 3 centralised during the 1980s and very early 1990s but 4 they were given to the Directorate so they were made to 5 feel more part of the team they were working for. 6 Q. So in Bristol the person coding -- first of all, if I am 7 right in the thesis that I was advancing a moment or two 8 ago, suggesting that people would stay in a job if they 9 found some value in it -- there were people who, for 10 whatever reason, valued the work they were doing, and 11 secondly, so far as any specialty was concerned, they 12 were, as it were, specialist coders because you find 13 somebody in the cardiac surgery directorate, someone in 14 the children's services directorate, and so on? 15 A. Yes. From the time the staff were devolved to the 16 various directorates, it would have been the same two or 17 three coders coding the cardiac cases. 18 Q. So one would expect, if that is the case, a consistency 19 of coding approach? 20 A. Yes. Can I just say, prior to that they were in 21 a central office, and it was a sort of shared 22 responsibility, although what they tended to do when 23 they were in that central office, each one of them had 24 various responsibilities, so you may have one person who 25 was responsible for ophthalmology, somebody else was 0016 1 a bit of an expert in oncology, but at that time they 2 were managed, supervised, by a coding "expert" in 3 inverted commas, so she kept a very close eye on what 4 was happening in the section. 5 Q. It follows from that, as well, the next question I was 6 going to ask you, whether there was any moderation in 7 the sense of any checking to ensure consistency as 8 between coders and you did not get any great extent of 9 intercoder variation? 10 A. The audit of the coding has got better. Because the 11 coders were managed by the directorate, I have to say, 12 I do not think there was very much, if any, audit taking 13 place of what was being coded certainly in the early 14 1990s. 15 What we have done as a Trust in the last 16 18 months, we have actually appointed a Trust clinical 17 coding co-ordinator, because we wanted to ensure that 18 because the staff were diverse and being devolved to the 19 various directorates, some person is overseeing and 20 ensuring that all the national guidelines were being 21 implemented as and when required. 22 So audit coding I have to say probably was fairly 23 sparse in the 1980s and early 1990s. 24 Q. Is this the picture nationally? 25 MISS HARDING: I think to take a specific example of 0017 1 coders being associated with clinical directorates. 2 When clinical directorates were set up around the 3 management initiative, there was an incentive regionally 4 and nationally to make sure it was appropriate and more 5 timely. A number of different models were tried and 6 a model similar to the Bristol model, which was about 7 putting people where the specialists were, the theory 8 being they could talk more closely to the doctors about 9 the case notes, so bringing them away from the basement 10 to the garret, which is where traditionally they sat, 11 and actually making them more closely associated with 12 the directorates. 13 In some cases it worked very well. I think the 14 point you have just referred to, though, is that because 15 they were separated, sometimes the integrity and 16 reliability and the professionalism that you got from 17 having the coders working together actually was 18 sometimes lost. 19 I think the benefits of having them more 20 associated with the clinicians were actually the most 21 important thing, but supervision, co-ordination, 22 checking with each other, I think, was a bit lost by 23 that separation, but it was the model that was felt to 24 be most relevant at the time, and I think it will be the 25 model that we use about getting the clinical coders more 0018 1 closely involved with the case notes and the doctors who 2 were writing the information in the case notes. I think 3 that is fairly clear, that that was one of the things 4 that was beneficial. 5 If you have a large enough hospital as you have in 6 Bristol, there were two or three coders associated with 7 a particular directorate. Of course, that expertise 8 does build up with two or three very specific coders 9 becoming expert in those areas. 10 MR LANGSTAFF: Can I ask you to pause for a moment. We will 11 have your response first and then go back to 12 Ann Harding. 13 THE CHAIRMAN: Always remember that all of us, when we 14 get terribly interested in our topic, we sometimes tend 15 to speak slightly more quickly than normal. It is so 16 important that we do get a record. Can I urge you, 17 I realise there is an element of unnaturalness in it, 18 but if we could slow down just a bit, then we will not 19 lose anything. 20 MISS HARDING: I apologise. 21 A. I was going to say, when the staff were devolved to the 22 directorates, it depended to a degree on who their local 23 manager was as to what sort of supervision and help they 24 got with the coding. I think there were some cases 25 where they were very much left on their own and there 0019 1 were other people that were supervising the management 2 of those staff. They had an interest and knowledge of 3 the coding, and some of them through to successfully 4 coding, and I think you need to try and strike the right 5 note, really. 6 MR LANGSTAFF: You were going to go on? 7 MISS HARDING: I just wondered, given some of your coders 8 were working in very specialist areas, whether they were 9 able to talk to people, coding in those areas in other 10 hospitals. 11 A. I think that was probably one of our failures, that 12 they were given to the directorates. They were left 13 very much to those directorates to supervise and manage 14 them. It has only really been the last two, perhaps 15 three years, where we have tried to arrange regular 16 meetings with the coding staff so that it will give them 17 an opportunity to all get together. 18 Now we have a Trust clinical coding co-ordinator, 19 she has regular meetings with all the coders every 20 couple of months, to ensure that they all know who one 21 another are and that they are pulling and pushing in the 22 same way. 23 MR LANGSTAFF: Going back to the question of the quality 24 of the coders, what incentive did they have to get it 25 right? 0020 1 A. Their own personal satisfaction, I would suggest, no 2 more, no less. I think if you spoke to any of the 3 coders, not necessarily within Bristol but anywhere, and 4 Ann may very well support this statement, I have always 5 found coders to take a huge pride in what they do. 6 I have done it myself. I used to do coding quite 7 a number of years ago. I think if you look at the 8 discharge summary and you look at what the doctors put 9 on there, you can quite often get a feel as to whether 10 there is anything actually missing from that discharge 11 summary. 12 I can remember doing it myself. I used to ferret 13 through the notes and just see if I could pick up any 14 additional bits of information I felt to be appropriate 15 as perhaps a secondary diagnosis, like somebody with 16 diabetes. The medical staff quite often used to put on 17 the main diagnosis and forget about any other ailments 18 that the patient had which took them to hospital. 19 I think they take a pride in their work, they have been 20 around a long while and they are beginning to assume 21 a higher profile. I think people are beginning to 22 realise how important they are to the organisation. 23 MISS HARDING: I would support that. I think if 24 I could describe them, they are probably squirrels for 25 information. They do take enormous pride in trying to 0021 1 make sure that everything relevant does get put down. 2 I think the difficulty they have, although they 3 have become experts in their own area and require an 4 awful lot of clinical knowledge, I think the difficulty 5 they have is that the information that they have is all 6 that they can use. This is the point about them being 7 close enough to the clinical staff to be able to go and 8 ask them, "Is there something you have forgotten to 9 write down?" and "This does not seem to quite make 10 sense", but I think they are very professional in their 11 own right as clinical coders in the way that you have 12 described. I think it is amazing that there is a post 13 with no professional support, nothing that defines them 14 as a profession, that we have had such professional 15 support from in the particular group of experts. 16 I think the situation that is apparent from 17 Bristol would be mirrored across the entire country. 18 I do not think it would be substantially different 19 anywhere. 20 MR LANGSTAFF: So what you are saying is that despite 21 some of the reservations that were expressed yesterday, 22 you from your personal experience here, and you from 23 your experience and understanding of the national scene, 24 would actually think that coders on the whole do a good, 25 in terms of accurate and dedicated, job; they are not 0022 1 simply, as it were, filing clerks who wanted to get one 2 task out of the way? 3 A. No, I think they do not. They are dedicated staff. 4 MISS HARDING: I would agree. Obviously one cannot 5 generalise. The question you asked earlier on about 6 turnover of staff I think is very relevant here, that 7 staff do stay. The ones who do not enjoy it, do not see 8 it as valuable or find it very boring, go pretty 9 quickly. But we have this cohort of staff who have been 10 around for a long time and are very experienced. 11 THE CHAIRMAN: May I ask a question on that? Is it that 12 they stay because they are as you described them, or 13 because they have acquired a particular skill which is 14 not transferable to any other context? 15 MISS HARDING: I think it is true that the skill is not 16 transferable into another context. I think that is 17 absolutely true, but their general administrative skills 18 and general sort of I think organisational skills would 19 make those skills transferable into another area of 20 administration in a hospital, and given that they are 21 not very well paid, I think there would be an incentive 22 to move somewhere else for other pay, but that does not 23 happen terribly often. 24 MR LANGSTAFF: I suppose one answer to the point might 25 be, that would be a very valid point for someone 0023 1 starting off, who would think to themselves after 4, 5, 2 6, 8 weeks, "I do not want to do this for the rest of my 3 life and I will not be able to do anything else if 4 I stay, so I shall move on now". You are saying that 5 does happen, but not very often? 6 A. I think someone would know if they would be doing 7 coding for the next 10 or 15 years. It takes so long to 8 train somebody correctly and properly, it could take 9 anything up to 12, 18 months. You are always finding 10 new codes you are not quite sure what to do with. It is 11 important you have somebody you can ask what needs to be 12 done. I think because of the length of the training 13 period for coders, you would know very quickly if you 14 did not want to do that for the next few years. 15 MR LANGSTAFF: How does the system generally cope with 16 the learning curve of the coder? 17 A. What we have done now and what used to happen in the 18 past, if there is a new person appointed, they are now 19 linked to the clinical coding co-ordinator, so they will 20 spend as long as they need to be trained up to coding in 21 the areas they are responsible for, so she is like, 22 I suppose a nursemaid, if you like: she stays with them 23 or trains them thoroughly in the process of coding. 24 Some people pick them up quicker than others. I would 25 say it takes at least 6, 12 months to cope efficiently. 0024 1 MISS HARDING: I agree. Would it help if I talked about 2 the national picture around the support of clinical 3 coding and training? 4 THE CHAIRMAN: Mrs Maclean has a question. 5 MRS MACLEAN: Before we go on, I am very interested to 6 hear that with the new situation of the coders in the 7 directorates, they should have better access to query 8 matters they are unsure about with the clinicians. 9 I just wonder whether the queries came from the other 10 direction too: would a clinician ever query what a coder 11 was -- 12 A. I think they would possibly query it if they were 13 interested. For instance, if perhaps a clinician came 14 to look at some information and wanted a particular 15 code, for instance, or there were patients who had 16 a particular procedure carried out, he would get that 17 information back from the systems via the coding. When 18 they start to analyse that situation, I expect there 19 would be occasions when he would find it had been coded 20 incorrectly or not quite as he would have anticipated. 21 I think by analysing and looking back at the coding, 22 that is when those questions would most likely crop up. 23 I have to say, I cannot remember too many 24 occasions where clinicians have actually sat down and 25 looked at what has been coded. 0025 1 MRS MACLEAN: Thank you. 2 MISS HARDING: Could I just add something to that? 3 I think this is one of the problems that we have, the 4 data is collected for the purposes which clinicians 5 believe is managerial, and therefore not relevant to 6 them, and I have a great deal of sympathy for that, 7 because the level of detail at which a clinician would 8 want the information for the purposes of audit is not 9 readily encompassed within the levels of diagnosis and 10 operative coding that we currently have. 11 I also think that we have been quite lax in not 12 feeding back to clinicians the information that is being 13 submitted to the central returns about what it is they 14 are doing. 15 When we did give information back to clinicians, 16 they said "I do not do that operation, I do not have 17 that many patients with that diagnosis", and I think 18 therefore one of the things we must do is to find ways 19 of ensuring that the information does go back to them so 20 they in some ways validate it before it is used for 21 other purposes. 22 The period we are talking about, I think that was 23 done for specific audits, and in some places was done 24 quite consistently, but only on a very small scale, if 25 at all. I do not believe that Bristol is any different 0026 1 from other places in that. 2 But your point, when people are given it back, 3 they do have very specific and detailed comments to make 4 on it, which are very helpful in improving both the 5 quality and thereby the usefulness of the information. 6 MR LANGSTAFF: So if we are talking about feedback, as 7 I think we are, then the feedback comes in at least one 8 way which is from the consultant or -- for the 9 consultant's own purposes, somewhat imperfect from what 10 you are saying? 11 MISS HARDING: Yes. 12 MR LANGSTAFF: After the purchaser/provider split and 13 when contracting came in, was there rather greater 14 feedback, at least for contracting purposes, than there 15 had been before? 16 A. I think certainly from an administrative perspective, 17 there would have been a lot more interest in the 18 diagnostic information, the coding that had taken 19 place. I am still not totally convinced at that time 20 there was much more interest from the medical staff, but 21 I think because a lot of the contracting was based on 22 the diagnostic information that was input on to the 23 system, certainly from perhaps a finance and 24 administrative point of view, a lot more interest was 25 taken in the information going in and out of the system. 0027 1 Q. In the diagnostic or in the operative? One appreciates 2 that operative procedures may cost very different sums 3 and therefore may have a contracting implication in 4 a way that diagnosis may not? 5 A. I think in both -- I guess it depends on the various 6 specialties, but I think probably -- I am totally 7 convinced there was a bigger interest in the diagnostic 8 and the operative information when contracting came in. 9 MISS HARDING: I would agree. I think I also agree with 10 you that really did not go back into the clinical 11 arena. I think the difficulty we have is that the data 12 we collected was for administrative purposes and that 13 the new focus on clinical information for clinical 14 purposes, clinical governance, is the thing that will 15 drive the information going back to the clinician, but 16 I think that although that has happened, probably in 17 a small number of cases, I still do not think that is 18 the norm for data to be fed back to clinicians, even 19 resulting from the contracting process. 20 MR LANGSTAFF: But nonetheless, did the feedback from 21 the contracting process have an impact on the care or 22 the quality of the coding, do you think? 23 A. I think probably not. 24 Q. Because it was so good in the first place? 25 A. Absolutely. 0028 1 MISS HARDING: I think in some places where the standard 2 of coding was already quite good, there probably was not 3 such an incentive to improve it, but I think in other 4 places where the quality of the coding was not very 5 good, particularly in terms of operative procedures, 6 then I think there was much more attention paid to the 7 quality of the coding associated with contracting than 8 it ever had been before. 9 MR LANGSTAFF: One would otherwise find it very difficult 10 to explain what we were looking at yesterday, for 11 instance, when we came to looking at HES and the way it 12 appeared that coverage and particularly completeness of 13 data improved almost dramatically after 1991/92. 14 A. That would have been again for contracting purposes, 15 because obviously the information had to be put in 16 within a certain period of time, otherwise you were 17 potentially losing money. So I think you will find that 18 is why there was probably a more timely inputting of the 19 data. I think that the local managers would have moaned 20 to the clinicians if they were not getting the discharge 21 summary out in a timely fashion to allow the coding to 22 take place. 23 MR LANGSTAFF: So to some extent, we may actually be able 24 to achieve more from looking at PAS locally than one 25 could tell from taking the HES statistics in respect of 0029 1 Bristol, because, at some stage, PAS being dynamic in 2 the information, the diagnostic coding would have been 3 put on to it and it may not have been reflected in HES 4 because the discharge summary had not been produced, the 5 clinician had not yet tidied up his case notes a couple 6 of months before the discharge summary goes out, 7 whatever it may be. 8 MISS HARDING: I think it is quite difficult to quantify 9 how different PAS would be from HES. I mean, it should 10 not be different, but we know in different places that 11 we were able to submit further data to HES to update the 12 original submissions, but that did not always happen for 13 quite complicated reasons, that it is actually quite 14 difficult to update the structure of the database in 15 a way that allows it easily, and then extract that data 16 and load it back up to the HES data. 17 So I think that does differ from place to place 18 about how different the PAS data is to the HES data, and 19 I would be interested to know what your views about how 20 that would be in Bristol? 21 A. Again, it is difficult for me to say, I think. I think 22 you would need to speak to one of our information people 23 to clarify the situation with regard to that. It is 24 best if I do not comment, I do not think. 25 MR LANGSTAFF: We have looked, then, at the coders and the 0030 1 general satisfaction expressed as to coding and the 2 quality of coding particularly, I think, in the period 3 from 1990 onwards. We can draw from PAS probably quite 4 a lot of information about deaths, although I am not 5 sure we have explored how accurate that would 6 necessarily be. Obviously it depends on input which 7 comes in, you were saying, not only the hospital input, 8 if there is a death in hospital that is easy, but if 9 there is a death after, connected with the operation, 10 I think we have established that there is no link? 11 A. That is right. The problem we have, say someone came 12 from Cornwall, came to hospital, was discharged back 13 home and died six months later. 14 If the patient does not have to come back to the 15 hospital, there is not a lot of incentive for the 16 relative or GP's surgery to tell us that patient has 17 died. We are very dependent on outside agencies letting 18 us know if patients have deceased. It is only as 19 accurate as the last time the patient attended, to 20 a degree, with the caveat that the GP's surgery or 21 somebody else may have given us information. 22 MR LANGSTAFF: May I take this back in stages from where we 23 are now? Nowadays, with electronic systems, do we find 24 out electronically when people have died, so that the 25 database can be updated? 0031 1 MISS HARDING: Not yet. 2 MR LANGSTAFF: So that is coming? 3 MISS HARDING: That will come with the next stage of the 4 information strategy. 5 A. The links to the local health authorities and other 6 agencies that deal with health, those links are in the 7 foreseeable future. We are not any way from having 8 linked with the local Health Authority, we have been 9 having links with them in the last few months trying to 10 find a more seamless way of trying to make our data 11 similar, if not the same. 12 MR LANGSTAFF: So if someone were to die five years 13 after surgery, leaving aside whether there is any 14 connection or not, that may not be picked up unless 15 there is a continuing hospital attendance? 16 A. There will be a lot of patients on a Patient 17 Administration System who have had inpatient care that 18 will have died after they have been discharged and the 19 system will not know about it; there will a lot of those 20 patients. 21 Q. What about the patient in respect of whom there is some 22 follow-up? 23 MISS HARDING: I think there are some follow-ups that have 24 been done for audit processes. I think that has been 25 very useful with consultants, and again, the importance 0032 1 about the audit process is that it is clinical-led, so 2 there would be some carry-through from the audit process 3 with individual consultants wanting to follow patients 4 through, sometimes in conjunction with the general 5 practitioner as well. 6 There is one other source of data that can be used 7 to look at deaths, and those are the death registrations 8 and the analysis of that that is available through the 9 Office of National Statistics and a source of data 10 called the "death takes". That may be one of the things 11 that could be considered as following through individual 12 patients. But that is not something that is done 13 routinely. 14 A. No, and of course at the minute that information could 15 not be reconciled to the inpatient stays; our system 16 still cannot currently do that. 17 MR LANGSTAFF: For the patient who was still subject to 18 review in hospital at six-monthly or yearly intervals, 19 let us suppose, what systems were in place in the 1980s 20 and 1990s to prevent the hospital sending out an 21 outpatient attendance note, an appointment, to somebody 22 who had died and thereby perhaps unwittingly causing 23 offence to relatives? 24 A. It happens. I mean, I can give you a number of 25 occasions where patients have not turned up for an 0033 1 outpatient appointment and we have written to them 2 a polite letter saying "You had an appointment, you did 3 not attend, would you like to come on another date?" 4 offer them a date, and a distraught relative will say 5 "It is unfortunate my mother/son/daughter passed away 6 several weeks/months ago". That relates back to the 7 point I was making just now: the information is only as 8 good as the last time the patient attended or the last 9 time the GP or some other agency told us that a patient 10 was deceased. 11 It does happen. We have no seamless way of 12 updating the database with regards to death information. 13 Q. How good would you be at disclosing information? 14 MISS HARDING: At this particular stage, not terribly 15 good. There was no automatic way of doing it. Since 16 then we have had the development of an automatic way of 17 updating information into the master patient indexes in 18 hospitals and other places from the national 19 administrative database so that has improved things, but 20 at this period of time, it was not accurate and it was 21 not timely, and not complete. 22 A. One advantage we did have, which perhaps may not have 23 been appropriate at another Trust: because it was 24 a Trust system, if a patient has come into the BRI for 25 some sort of surgery but has also been attending the Eye 0034 1 Hospital or the Dental Hospital, if they had been 2 informed the patient had died, it would update the Trust 3 system. So that is one big advantage of having a Trust 4 system: it updates the system for the whole of the 5 Trust, it does not matter which hospital it is. So 6 I guess in a way, the fact we have more hospitals on the 7 system, we are slightly increasing our chances of 8 getting the information. 9 MR LANGSTAFF: So if one is to compare the PAS system 10 with one coming from HES or clinical records, one would 11 expect that PAS would have better information about 12 death, but it is still very patchy? 13 A. Yes, I think that is a good summarisation, yes. 14 Q. So looking at what use this Inquiry can make of the 15 information which is supplied by PAS in the way that you 16 have told us it was collected, one would expect the PAS 17 system to reflect the information available in the 18 clinical records, would you not? 19 A. Yes. I mean, as I say, the PAS is real-time. We have 20 a number of in-built checks to ensure that patients are 21 put on to the system and the appropriate transfer and 22 discharge information goes on as well. Therefore, 23 I would expect every patient who has come into the 24 hospital to be on the PAS system. 25 Q. So if clinical notes, for instance, for whatever reason, 0035 1 went missing, there would still be a record on the PAS 2 system? 3 A. Yes. I mean, the PAS system, things like registration 4 numbers, the patient's hospital registration number is 5 held on the PAS system. If you can find the notes, you 6 can search the system by name, date of birth. You can 7 at least find the patient you are looking for, find 8 their hospital number, although you may not be able to 9 find the notes. You could then dip into the summary of 10 the episodal information and get things like dates of 11 admission, dates of discharge, any other information you 12 wanted relating to that episode. 13 Q. So there is a cross-check available between the clinical 14 records and the PAS, and to the extent that the 15 cross-check shows that they reveal the same things, one 16 would have greater confidence in information derived 17 from either source? 18 MISS HARDING: Yes. I think that is right. I think that 19 one needs to be quite careful about chronology, because 20 the patient record itself would have a series of events 21 in it that would be within one episode. Depending on 22 the importance of those, some of those would then be 23 coded through to a diagnostic code and a operative code, 24 but I think with complicated interventions and long 25 episodes of care, then one would need to think through 0036 1 very carefully how much of that information would be 2 transferred not from PAS but from PAS to HES, I think. 3 That is one of the things one would need to look at. 4 A. We have already extracted from the PAS system a lot of 5 episodal type information for the Inquiry to look at 6 that has been requested over the period of the last few 7 months. 8 MR LANGSTAFF: Obviously there is a check as to the 9 completeness of the case records we have by 10 cross-checking with the PAS system. It also gives 11 information as to what the coders, the experienced 12 coders that you have described, classified the various 13 operations as being and one can cross-check that against 14 any in-house exercise to code the same records by other 15 coders. So there is a degree of cross-validation 16 available? 17 A. Yes. 18 MR LANGSTAFF: I do not know, Dr Spiegelhalter, whether 19 you want to comment at this stage? Whether there is any 20 question you wish to ask from your perspective? 21 DR SPIEGELHALTER: It builds on where the discussion had 22 got to, because PAS forms the intermediary link between 23 what is in the clinical records and what eventually gets 24 on to HES and in this Inquiry we are going to be 25 recoding the clinical records and looking at the HES 0037 1 data, so the strength of that link, the accuracy of 2 those links, would be looked at in detail for Bristol 3 and hopefully, from what you are saying, reasonably good 4 correspondence will be there, which will be very 5 encouraging. 6 For the other centres that we would like to 7 compare Bristol with, all we are going to have is the 8 HES data, and I suppose -- this is perhaps outside what 9 you would be willing to discuss, but may be Ann could 10 say something. If a good correspondence was found 11 between the records which one could think was the gold 12 standard in HES in Bristol, do you think that degree of 13 correspondence is likely to have occurred after 1991 in 14 other centres in the country? 15 A. I sit on various regional and national groups. I can 16 certainly speak for the South West region, which is 17 Cheltenham down to Cornwall, excluding Wiltshire as it 18 was then, because that was not part of the real South 19 West. All of those Trusts as they are now within the 20 South West region all have the same software. They are 21 all using the regional computer centre's PAS system. 22 I used to meet regularly with my colleagues from 23 around the region and I am reasonably confident that 24 most people, most hospitals, were using the system in 25 very similar way. 0038 1 The functionality was obviously identical. It was 2 the same system, so the functionality was absolutely 3 identical. At that time, there was no local deviation 4 from the regional system. You had the system and it was 5 agreed, regionally we used to meet regularly as a group 6 to enhance and change the system. We used to change the 7 system as a group, so I am totally confident everybody 8 was using the same system. 9 What I could not be totally sure of is where and 10 how people were inputting data to the system. I am 11 totally confident that most hospitals in the region were 12 inputting their admissions and discharges in real-time. 13 I could not make any comment about how they were doing 14 the coding, but most people were using it in a very 15 useful fashion in the South West. I cannot make comment 16 about outside the South West, because although I have 17 seen other systems and visited other hospitals, I have 18 never spent enough time there to comment on how they 19 were or were not using the systems. 20 MISS HARDING: I think Bristol at this time, and in the 21 South West, probably had a very good Patient 22 Administration System. The fact that everything was 23 being entered in real-time was certainly not standard in 24 other places. Although other people had Patient 25 Administration Systems which you could use in 0039 1 real-time -- 2 MR LANGSTAFF: Could I ask you to pause there and take the 3 microphone closer to you? 4 MISS HARDING: Although it was possible to use other 5 Patient Administration Systems in real-time, a number of 6 places actually tried it and decided that it did not 7 work effectively enough in the particular way they set 8 up their hospitals. One of the strengths Bristol had 9 was that it was used in real-time. 10 The other point is that there were not that many 11 Patient Administration Systems around. Their history 12 was coming from regional computer centres and being 13 owned by regional computer centres in the 1980s before 14 they were made commercial as part of the newer way of 15 working. 16 It would be possible to look at the way other 17 Patient Administration Systems were working to make 18 comparisons about (a) whether they were live systems; 19 and (b) whether that made any difference to the quality 20 of data that was put through from PAS into the HES 21 system. 22 That could be done because there were some 23 standard monitoring routines that we used to compare the 24 HES data and the PAS data in the 1980s and 1990s, and we 25 had something called a "metadata file" that it might be 0040 1 possible to look at. Again, I do not know, but there 2 were processes put in place to try and check between the 3 two sources, PAS data and HES data, sometimes on 4 a regional basis, depending where the PAS system was 5 owned, but at other times at health authority level as 6 well. It may be possible to look at that. 7 A. I think it was unusual to have a system that the users 8 were able to influence how it changed, along with local 9 and national guidelines. I think that was one of the 10 huge benefits of the system; it really was enhanced and 11 taken forward by the users. It was the way it was set 12 up within the region. I think also the way we 13 implemented the systems eventually within the UBHT, 14 I think our view was that we needed to implement the 15 systems gradually because it was a huge culture shock 16 and a change for most of the staff, and I think, I am 17 totally convinced when we implemented various aspects of 18 the system, we made sure that we could take the staff 19 along with us. I think that has been an important 20 ingredient in making sure that the quality of the data 21 is good. We could have done it in 6 months and ended up 22 with rubbish going in and rubbish coming out. We did it 23 slowly and gradually and took the users along with us. 24 MISS HARDING: I think that is a strength. I think the 25 reason other people who were trying to implement 0041 1 real-time Patient Administration Systems actually gave 2 up is because the culture and their organisational 3 issues were so great that they were not able to do that 4 at that particular time. 5 A. I think, you know, you kind of build up, you have to 6 take the users along with you. That is one of the 7 things we aimed to do right from the very beginning: 8 build up a core of expertise and enthusiasm, and then 9 you can take the staff along with you. I like to think 10 we have been fairly successful in achieving that. 11 MISS HARDING: My only comment would be that that was 12 for the administrative data rather than the clinical 13 data. We go back to the point that the purpose of the 14 PAS is an administrative system and not a clinical 15 system. 16 A. Yes. That is why the clinicians have not always seen 17 it as anything that can help them. They have seen it as 18 the administration of the hospital and the Trust and it 19 does not give them very much. I think that has been the 20 view of the system. 21 Q. And that would be mirrored elsewhere? 22 A. Yes. 23 DR SPIEGELHALTER: Going back to something Mr Willmer 24 said yesterday, recently the government has released 25 performance indicators derived from the HES data, which 0042 1 I wonder whether those will focus clinicians' attention 2 much more on the administrative systems, because the 3 variability between institutions was shown to be very 4 large, and probably a lot of that was due to faulty 5 information systems. 6 A. Hopefully it will help them to focus their minds on 7 some of these issues. 8 MISS HARDING: I think this is a very, very important 9 point, and some of the subsequent analysis to the 10 original analysis of the performance indicators that was 11 done in order to refine the accuracy of the original 12 tables of indicators has been very helpful. A number of 13 clinicians have been involved in looking at the data to 14 try and identify those issues where the data was just 15 wrong, and wrong in a sort of comprehensive way rather 16 than just incorrect, but wrong and wrongly used. 17 I think that has helped enormously in heightening the 18 understanding of (a) the performance indicators; but 19 (b) the need for good quality information that is owned 20 by clinicians rather than owned by an administrative 21 process. That has been very important already. 22 MR LANGSTAFF: In the course of analysis of the data 23 locally, would one expect, Dr Spiegelhalter, to throw up 24 any inaccuracies in the data, in the same way as was 25 described yesterday in respect of the HES system? 0043 1 DR SPIEGELHALTER: I think that the exercise that is going 2 on at the moment was the recoding of 1800 records and 3 the ability to compare those with the HES system and 4 temporary HES data will be an unprecedented opportunity 5 to see exactly how the system was worked in the past and 6 to judge the reliability of the way in which the HES 7 data has been derived through those stages of coding and 8 their derivation from the PAS system. 9 MR LANGSTAFF: Having heard what you have heard about the 10 way in which things were done in Bristol and got some 11 idea of how things might be done elsewhere, would the 12 fact of a general correspondence between the results of 13 the recoding of those clinical records in respect of 14 Bristol being similar to the results one would get from 15 looking at PAS and HES in respect of Bristol, give one 16 any confidence or additional confidence that one might 17 expect the same elsewhere when one comes to make 18 comparisons? 19 DR SPIEGELHALTER: That is really why I was asking whether, 20 if such correspondence occurs, is it because Bristol was 21 the only place in the country that was doing it 22 properly, or whether that is an extendable lesson and 23 something where we would have to ask some further 24 opinion? 25 I think even with Bristol, even if essentially the 0044 1 denominators are correct in terms of what cases were 2 being processed as accurately reflecting HES, I think 3 the problem with the HES that it will only contain 4 really the in-hospital mortality, will be a problem that 5 is unavoidable and will inevitably involve that HES will 6 miss some of the deaths, but we will know for Bristol 7 exactly the extent to which that is the case. 8 MR LANGSTAFF: There may be two respects in what you have 9 been saying in which the PAS system will provide better 10 quality information potentially than the recoding 11 exercise, and I put these out for comment: the first of 12 them is the fact that the coders were few in number, 13 specialists in their area and were able to talk in the 14 directorate structure to the clinicians means that they 15 had access to the clinicians in a way in which those 16 doing the recoding exercise have not had, and that 17 potentially may make a difference? 18 A. Yes. I think perhaps it has to be said that, yes, they 19 were within the directorates. I am not too sure how 20 often the clinicians would have gone to the coders to 21 make comments about how they were going to code. 22 I suspect that the coders would only talk to a clinician 23 if there was something they thought was missing or 24 perhaps was fairly bizarre. I would not want you to get 25 the impression that the clinical staff were popping into 0045 1 the coding room every day or every other day. That 2 certainly is not the case. I think that needs to be 3 made quite clear. 4 MR LANGSTAFF: You have answered that one. The next is that 5 it is possible for a PAS system to show us rather more 6 records than we may have from the clinical records, 7 despite the best efforts of the Trust to give us all the 8 records. 9 The reason I put that as a possibility arises from 10 a letter I am going to show you on the screen now. It 11 is UBHT 154/190. It is a letter from you on 14th June 12 1993 to Mr Wisheart. 13 We can see your name at the bottom. If we just 14 read through it, you are explaining to Mr Wisheart that 15 the notes of patients who had open heart surgery are not 16 being destroyed as part of the BRI's destruction policy 17 for medical records. Then in the middle paragraph, you 18 mention that thousands of sets of notes which had been 19 filed in an old ward at Barrow Hospital got wet and 20 mouldy. 21 A. They became a health hazard, yes. 22 Q. And they had to be destroyed? 23 A. Yes. 24 Q. Do you know whether there were any records which might 25 relate to the period 1984 to 1995? 0046 1 A. I do not think there were. Obviously I have been in 2 constant discussion with the Inquiry team with regards 3 to the medical records that they required, and I think 4 it would be safe and fair to say that we have managed to 5 find a huge proportion of the notes that have been 6 filed. I think there are probably only a handful still 7 missing. 8 It was interesting when Mr Wisheart contacted me 9 about the destruction policy we had, it was a very, very 10 comprehensive policy and things like open heart surgery 11 were excluded from it. Again, I could not say with my 12 hand on my heart that among the notes at Barrow, there 13 were not one or two that related to the Inquiry. They 14 were significantly older records than the ones I think 15 you are interested in, and they were located in an old 16 ward out there where the roof had started to leak and 17 they were in a disgusting state. 18 Q. So essentially you are confident that perhaps bar one or 19 two, but only a minimal number, we have all the records? 20 A. I am confident that there were hardly any notes, if any 21 at all, in that old store you would be interested in. 22 In fact, a lot of them, we could read the names and the 23 numbers on, we have actually documented the names and 24 the numbers in case there have been any enquiries on 25 those, so most of them we managed to get a bit of paper 0047 1 with the patient's basic details on so we could document 2 what we were actually throwing away. 3 Q. So it follows, I think, from what I have been asking you 4 about, that one could use the PAS system to check on the 5 completeness of the clinical records that have been 6 provided to us? 7 A. Yes. 8 Q. And equally, to check on the completeness of the 9 surgeon's own personal logs of the operations they did, 10 and any other logs which there may be in-house? 11 A. Yes, because when we were pulling the medical records 12 for the Inquiry, our first target was the doctors' 13 logs. We went through Mr Dhasmana's and Mr Wisheart's 14 logbooks to get the patients' information, and they went 15 from 1984 to 1995, if my memory serves me correctly. 16 Our first pull of the medical records was from those 17 logbooks. 18 Subsequent to that, one of our information 19 officers then went through the Patient Administration 20 System to look for the patients who fell within the 21 deadlines and the right specialty. We did actually find 22 some that were not in the logbook. That has been 23 documented in a note I sent through John Gray back to 24 the Inquiry. 25 Q. Yes, and thank you for that. Is there anything else you 0048 1 would wish to ask, Dr Spiegelhalter, as to the utility 2 that the Inquiry can make of the PAS system as it has 3 been described today? 4 A. No. 5 Q. In which case, can I thank you very much for what you 6 have said thus far and for Miss Harding's contribution. 7 Is there anything you would like to add? Every witness 8 before has been given that opportunity and there is 9 absolutely no reason why you should not have it as 10 well. 11 A. No, I do not think so. Most of the things I wanted to 12 say I said in my statement originally, so there is 13 nothing I wish to add. 14 MR LANGSTAFF: There may be some questions from the Panel. 15 THE CHAIRMAN: Yes, there are. First, Mrs Maclean. 16 Examined by THE PANEL: 17 MRS MACLEAN: I am looking at your written statement, the 18 last page, paragraph 21, WIT 211/7. We may not need to 19 call it up. I can read it to you. It simply says: 20 "It is important to stress that until the early 21 1990s, very few people in the Trust were familiar with 22 computers and their uses in audit or maintenance of 23 administrative data and sharing information." 24 I wonder if you could elaborate a little on that, 25 perhaps in the context of other hospitals in the South 0049 1 West which you were familiar with? 2 A. As has already been stated, I came back to the Trust in 3 mid-1988 and my primary responsibility at that stage was 4 to implement the PAS system right across the Health 5 Authority as it was then. 6 I had a remit which spanned a period of three or 7 four years and that remit was to implement four aspects 8 of the system: the index, inpatient module, outpatients 9 and waiting lists, and I had to have a plan of campaign, 10 if you like, to make sure that I could achieve that 11 target. 12 But I soon realised that because I was coming back 13 to a Health Authority where most of the staff that would 14 be using the system initially had no real experience of 15 using a keyboard or a computer, so as I again said 16 a short while ago, we tried a "softly, softly, slowly, 17 slowly" approach to make sure we got everyone on board. 18 The implementation was gradual and the training of the 19 staff was gradual, so when, for instance, we set the 20 index up, there were only a small number of staff that 21 needed the facility to register and change patient 22 details. We then moved on from that to the inpatient 23 module and that brought on board another bundle of 24 staff, ward staff, admission staff, staff who were 25 responsible for the non-admission transfer discharge 0050 1 detail and we spent as along as we needed with them to 2 make sure (a) they could use the terminal, (b) they 3 understood what we were trying to do and (c) they 4 actually used the system efficiently in the manner we 5 wanted them to do. 6 The same applied to outpatients and waiting 7 lists. We gradually took everybody on board. One or 8 two people tried to run away from me, I caught up with 9 them all in the end, but the "proof of the pudding" is 10 in the staff. If you spoke to most of the staff in the 11 Trust, they would not go back to the way we used to 12 work. It is much more efficient than the manual systems 13 and certainly helps when we are trying to answer 14 patient-based enquiries. 15 MRS HOWARD: You made it clear that this was very much 16 an administrative system, and we have also heard about 17 what I would phrase the "lack of ownership" from 18 clinical staff with regards to that. Do you have any 19 comment about subsequent setting up of stand-alone 20 systems within the Trust to support the clinical staff 21 in the information that they wished to collect? That 22 would be the first part of the question. I would like 23 to explore that after your answer. 24 A. Certainly, as far as I am concerned, I have only ever 25 been involved in implementing the corporate systems. 0051 1 Again, I think probably the Trust philosophy has always 2 been, where possible, we would like to use those 3 corporate systems, but that is not to say that if 4 a clinician or a group of clinicians wanted to go and 5 purchase perhaps an audit system -- they should be able 6 to do that. 7 I think the problem with doing that is, if you are 8 inputting the data into two separate systems, it is 9 always going to be difficult reconciling the information 10 on the two systems. We are trying to move as a Trust 11 towards integrated systems. We have the ability already 12 for the PATS system, for instance, to extract some 13 information from our corporate systems. That sort of 14 information is currently in a minority within the Trust. 15 Q. That anticipates my second question, which was the idea 16 of integration. Were there any examples of that during 17 the period of our Inquiry, of attempts to integrate the 18 PAS data with clinical systems? 19 A. Could you repeat the middle bit of the question? 20 Q. During the period of the Inquiry, were there any 21 attempts or examples of attempts by clinical staff to 22 bring together the PAS system and stand-alone systems? 23 I am particularly interested obviously in the systems we 24 have heard about, such as METASA and PAS. 25 A. I cannot really comment, because if clinicians or other 0052 1 staff within the Trust were interested in the 2 information side of the system they would talk to our 3 information people rather than myself. If somebody had 4 asked me for some information, I would point them in the 5 direction of the appropriate person. That was not 6 really part of my remit. 7 Q. So information and medical records were separate and 8 distinct? 9 A. No, not medical records. I actually manage the Medical 10 Records Department at the Bristol Royal Infirmary. I am 11 also the adviser for the Trust. The information section 12 lives within the IM&T department, but it is a separate 13 section. 14 MRS HOWARD: Thank you. 15 THE CHAIRMAN: There are no further questions from the 16 Panel. Mr Chambers? 17 MR CHAMBERS: I have no questions. 18 THE CHAIRMAN: I am grateful. 19 Mr Langstaff, you have already said, I think (or 20 if you did not, I will say) to Mr Hooper, in addition to 21 our thanks, that if there are any other matters that you 22 wish to bring to our attention as time goes on, we will 23 always of course be anxious to hear from you. You have 24 been very helpful this morning. We are very grateful to 25 you, and equally to our two experts, Miss Harding and 0053 1 Dr Spiegelhalter, from whom we will hear after a break. 2 Thank you, both of you, also. What I suggest, 3 Mr Langstaff, is that we take a short break now, for let 4 us say 15 minutes, and reconvene, at which point I think 5 we are going to hear from Dr Spiegelhalter again? 6 MR LANGSTAFF: Yes. We will hear briefly first from 7 Ann Harding who wants to pick up a couple of matters 8 which were left over, if you remember, from yesterday by 9 Mr Willmer, and she is able to deal with those matters, 10 technically I think in evidence, so she will give 11 evidence briefly wearing, as it were, her "evidential" 12 hat rather than her "expert" hat. 13 THE CHAIRMAN: Forgive me, I anticipated you quite 14 wrongly. We will reconvene then in 15 minutes, thank 15 you. 16 (11.23 am) 17 (A short break) 18 (11.55 am) 19 MR LANGSTAFF: Sir, I had advertised in the brief commercial 20 for the second session this morning just before the 21 coffee break, two events. It is a correction of what 22 I said yesterday morning. If one looks back to the 23 transcript at page 10, line 21, I was talking about the 24 Trust PAS system. What I said was that the data was 25 generated by clinical coders using standard 0054 1 classification systems. I am told through the sources 2 available to us that when this was released on the 3 Internet and examined with the care with which our every 4 word obviously is, it was appreciated by a number who 5 read this that this was inaccurate because the word 6 "clinical" was not inserted before the word "data". 7 That of course is what I had in mind, and that is what 8 I should have said, and I failed in giving the 9 exposition at the beginning to indicate sufficiently 10 that the data I was talking about was of course clinical 11 data, because the data which goes onto the PAS system is 12 necessarily put on administratively, as we have heard in 13 the course of this morning. 14 I do not want there to be any confusion or 15 consternation about that. This shows the very valuable 16 way in which those who read our transcripts on the 17 Internet are actually able to feed back to us and to 18 identify, if there be errors, any errors. So it 19 actually demonstrates the validity of the public process 20 upon which we are engaged. 21 THE CHAIRMAN: Absolutely, Mr Langstaff, and I would 22 emphasise and re-emphasise that point. 23 MR LANGSTAFF: Miss Harding, would you stand to take 24 the oath, please? 25 MISS ANN HARDING (AFFIRMED): 0055 1 Examined by MR LANGSTAFF: 2 Q. We already know, Miss Harding, that you are Ann Harding, 3 the Acting Director of the NHS Information Authority? 4 A. Correct. 5 Q. You were here yesterday when Mr Willmer was giving his 6 evidence to us. There were a number of matters which he 7 felt he could not answer but others might. You are in 8 a position, I think, to give the answers? 9 A. Yes, I am. 10 Q. Would you like to do so? 11 A. Thank you very much indeed, I would. If I take the 12 questions as they were raised with Mr Willmer yesterday 13 and then provide an answer to them, some of the topics 14 that we discussed this morning have already covered some 15 of the questions that were asked yesterday, so I will 16 try not to cover that ground again. I think there were 17 one or two things maybe to add to what was said this 18 morning. 19 The first question was, is there an incentive, 20 motivation, to get coding right? We had some discussion 21 on that this morning. I think the biggest commitment is 22 the personal commitment of the coders, who see their 23 contribution to the provision of good quality 24 information as absolutely paramount in the work they 25 do. I think that is number 1 and very important. 0056 1 The second motivation I think is more recent than 2 in the 1990s, and that is through the resource 3 management initiative which is where the NHS started to 4 look at the costs and also subsequently the 5 effectiveness of treatments that were given and 6 therefore were more committed to understanding the need 7 and having good quality clinical information. 8 I think the use of the data that we have made in 9 the 1990s has made it much more important and therefore 10 the motivation for individual coders, but more 11 importantly I think their managers, to support good 12 quality coding has become much more relevant. 13 That was the answer to the first question. 14 The second point -- 15 Q. Would you wait for one moment there, because again, 16 you are naturally talking fairly quickly. 17 A. I am sorry. The second question was: what training, 18 pay, status, do these people have? I think the training 19 aspect is one that I need to put in perspective on 20 a national basis, that there has always been, originally 21 in Manchester but then more recently in Loughborough, an 22 organisation which is responsible for the quality and 23 training of clinical coders related to the whole process 24 of the development of coding and classification schemes 25 in conjunction with the World Health Organisation, for 0057 1 the ICD classification, and with the Office of 2 Population Censuses, now the ONS, in terms of procedure 3 classifications. 4 The responsibility of the trainers has been to 5 ensure that good quality clinical coding is available to 6 the NHS to support its managerial and epidemiological 7 processes through the HES data and those staff that have 8 been through the training programmes have had the 9 benefit of nationally trained and accredited trainers as 10 their mentors during their own particular training. 11 I think that is an important aspect of the 12 professionalism that is seen by the clinical coders and 13 also by those responsible for analysing and providing 14 information based on clinical coding. 15 So that is the issue about training: I think 16 a much more structured process than people probably 17 recognise. 18 In terms of pay, there was a discussion this 19 morning. My view is that clinical coders are paid on an 20 administrative and clerical grade of the Whitby Council, 21 and an inexperienced coder would now be at grade 3 22 level, probably between 12,000 and 15,000. 23 Experienced coders would probably be moving up to 24 grade 4s and managers now at grade 6. I am afraid I do 25 not have exactly the pay scales that relate to those 0058 1 grades, but I think you can see that from the level of 2 responsibility they have, those people are not very well 3 paid. 4 If you go back to what they would have been paid 5 at the beginning of the Inquiry period, I think they 6 would have been paid very, very substantially small 7 salaries in relation to other people. 8 I think valued, but not rewarded in terms of 9 remuneration. 10 They would have been comparable with medical 11 records staff and not seen as having expertise above 12 records clerks, and the skills needed as we have 13 discussed are substantially different. 14 As to status, I think again this has changed in 15 the 1990s, but I think the concept of a clinical coder 16 sitting remotely in either basement or in the garret is 17 one that actually describes very realistically how they 18 were placed. So I think not a high status. 19 The next question was, can differences occur in 20 coding the same procedures in different ways? We always 21 have issues about reliability and validity between 22 coders coding something once and then coding it a second 23 time subsequently in another set of case notes, but 24 there are very explicit rules and conventions set out 25 both within the International Classification of Diseases 0059 1 documents and the OPCS documents as well about 2 convention and rules for coding, and coders are trained 3 in using those and also trained to ask when they do not 4 understand what those rules mean. I think primary and 5 secondary diagnoses, we do have ways of looking at 6 primary and secondary diagnoses and trying to ensure 7 that there is consistency about how they are used and 8 some of the other coding conventions. 9 But of course, and I will come back to this 10 a little later, they are entirely dependent in their 11 ability to code on the evidence available to them from 12 the case notes and coding sheets. I would like to 13 address that in a bit more detail in a moment. 14 Q. Can I pause there? Are you perhaps saying that the 15 variability which there may be between coders which 16 implicitly you may be acknowledging is not their fault; 17 it is somebody else's fault? 18 A. I think that there are sometimes differences that are 19 their fault. That is probably about inexperience and 20 perhaps inadequate training at times, but the bigger 21 variability is not their fault, it is on the information 22 they get to code. 23 Q. But in terms of looking at the finished product, which 24 we have to do, you are, I think, accepting a degree of 25 variability from whichever source? 0060 1 A. Yes. The next question that was asked is: what feedback 2 do coders get as to the accuracy of their work? Again, 3 I think from the beginning of the Inquiry period to the 4 end of the Inquiry period, this has changed 5 substantially, for some of the reasons I have already 6 outlined. 7 In terms of some very practical things that one 8 could do, and still can do, the submissions from the 9 Patient Administration Systems that are used to feed the 10 HES data, there were high level reports back about 11 accuracy, the number of outliers, which, in places where 12 I have been, have always been used to feed back 13 information to coders about the accuracy of the 14 submissions that have gone through to HES. 15 Q. Can I again just pause you to clarify what is meant? 16 You have used the expression there "high level 17 reports". For our purposes, I would wish to understand 18 what is comprehended by the expression "high level". 19 A. The content of high level reports would be a summary of 20 the number of outliers which would be outside the 21 parameters that were acceptable by the HES data; so 22 parameters were set of what was unacceptable and I think 23 Richard Willmer's example of a male hysterectomy would 24 be one of them, but there are a number of others. The 25 number of those incidents of unacceptable data within 0061 1 the parameters set can be and were in places fed back to 2 the coders so that you had, as it were, a postmortem of 3 the data submission and were able to be aware of some 4 maybe consistent problems that were always coming up and 5 that would enable you to talk to perhaps a particular 6 coder or a particular group of coders about some 7 inaccuracies. But when I say "high level", they were at 8 that very high level and would not have been about 9 reliability of individual diagnosis for individual 10 patients. But there was information that was helpful 11 and that could be used and it was not used consistently 12 across the country, it varied depending on individual 13 hospitals, feelings of the usefulness and the time that 14 needed to be spent on using those reports. 15 More recently, the hospitals have commissioned 16 from either other hospitals or from external agencies 17 external audit of their data, and the accreditation 18 process that we have set up and supported from the 19 information management group in its old guise is one 20 that will now be taken up, but there is some evidence 21 already existing through those accreditation studies of 22 the sort of feedback the sort of improvement that has 23 been made as a result of accreditation. So work has 24 been done in those areas. 25 I think we will probably find some information 0062 1 about that and make it available to the Inquiry, if that 2 would be helpful? 3 MR LANGSTAFF: Yes, please. 4 A. The next question is what variability is there in the 5 information that is available for coding? We touched on 6 that this morning and I made the point that some people 7 code from a discharge summary; others have available to 8 them all of the case notes. I think, again, practice 9 differed in different places. I think I would not be 10 able to comment except to say that variability of coding 11 is very dependent on having access to all the 12 information that is included in the case notes and that 13 the discharge summaries cannot possibly hope to give the 14 level of detail that would be needed to code very 15 accurately, unless you have very, very good discharge 16 summaries. So, again, the quality of the discharge 17 summary is going to make the coding either very good or 18 very difficult. I think looking at quality of discharge 19 summaries is a very important aspect to get an accurate 20 coding and I think having access to the full sets of 21 information available in case notes is the only way in 22 which a coder could really be sure that they were coding 23 completely accurately. 24 The next question was how important is clinical 25 coding taken in local organisations, and that is very 0063 1 variable. It is variable because different 2 organisations use and process information in a number of 3 different ways and the history has been that the 4 information that has been available has not been used as 5 fully as we could have used it in a number of different 6 areas. 7 We also have to remember that the information that 8 was mainly available through the data sets that we have 9 currently been looking at is information that has been 10 managerial and epidemiological, rather than directly 11 about individual patients and the outcomes for 12 individual patients. 13 So I think depending on the organisation, 14 depending on the skills within the organisation, the use 15 of data has been very variable and therefore the balance 16 of resources that have been put into using and analysing 17 that data has been very variable as well. 18 The last question is, if there is judgment in 19 coding, can it ever be accurate? I think the point that 20 I would want to make there is that the data that is 21 going to be used and analysed has to be fit for 22 a purpose, and one of the problems that we have had, and 23 still continue to have, is that we need to understand 24 when we collect data and we use data for what purposes 25 it is going to be used, so we can be sure that the 0064 1 definitions are used in processing and collecting those 2 data are standardised. 3 A lot of work has been done through the central 4 committee for regulating information requirements in 5 defining data definitions, and that is a process that 6 has been in place I think since 1991, where there were 7 standard definitions and standard processes defined for 8 the collection of data within Patient Administration 9 Systems, and therefore in subsequent submissions to the 10 HES data. 11 So those data definitions have been defined in 12 terms of the purpose for which that data was going to be 13 collected, and that has been for the managerial and 14 administrative processes rather than the clinical 15 processes and for its subsequent analysis for 16 epidemiological purposes. 17 So when there are differences of opinion about 18 what information could be used, what codes should be 19 used, I think they will be different because people will 20 have different purposes. I think it is being clear 21 about what purpose the information is collected for; can 22 it then be used subsequently for other purposes? This 23 is one of the things that affects people's judgment 24 about the use of codes and classification systems. 25 Those are the comments that I had to make on 0065 1 questions that were asked of Mr Willmer that I picked up 2 from yesterday. 3 Q. Thank you very much. You have supplied answers he was 4 not able to. There is nothing, apart from those few 5 matters I have raised with you in the course of your 6 evidence, which I want to ask you about that, because 7 essentially you are answering other questions, but it 8 may be that the Panel themselves have some questions for 9 you. 10 THE CHAIRMAN: There is just one question from 11 Mrs Howard. 12 Examined by THE PANEL: 13 MRS HOWARD: It is purely for the facts and for the record, 14 really. You talked about the organisation in Manchester 15 that trains coders. It would be useful if we had a name 16 for that organisation? 17 A. Can I give you the name of the organisation, when it 18 changed, but the current organisation? I can do that 19 with the dates? 20 MRS HOWARD: Thank you very much. 21 MR LANGSTAFF: May I thank you in your dual function as 22 expert commentator, and as giving evidence to us. 23 A. Thank you very much indeed. 24 THE CHAIRMAN: May I join in that thanks from the Panel's 25 point of view. You have helped us in two roles and we 0066 1 are very grateful to you. 2 (The witness withdrew) 3 MR LANGSTAFF: Dr Spiegelhalter, would you come forward, 4 please? 5 DR DAVID SPIEGELHALTER (RECALLED): 6 Examined by MR LANGSTAFF: 7 MR LANGSTAFF: I wonder if we can have back our slide 8 SLD 1/1 and turn it round -- 9 THE CHAIRMAN: Mr Langstaff, for me and maybe others to 10 understand the capacity in which we are hearing 11 Dr Spiegelhalter, there is an oath to be administered or 12 not. Will you advise us, because others will be 13 interested in the answers. 14 MR LANGSTAFF: He gave evidence yesterday on oath. I think 15 you were sworn, were you not? 16 A. I affirmed. 17 Q. You affirmed when you first spoke to us. That will 18 cover anything that you have to say to us. You speak to 19 us as expert and adviser, and giving us the best of your 20 views as to the way forward now that we have, over the 21 past day and a half, had a public examination of some of 22 the evidence which bears upon the preliminary overview 23 of sources of data. 24 It will be appreciated by those who read this at 25 a distance that of course the oral evidence which we 0067 1 have heard is only part of the evidence which the 2 Inquiry has received, the rest of which was identified 3 yesterday evening and is in writing and which will 4 undoubtedly be supplemented by further written records 5 and evidence as and when they are received. 6 Indeed, if anyone has anything further which they 7 would wish to add, may I take this opportunity to 8 encourage them to give it to us at as early a stage as 9 possible so that you and other experts, and indeed the 10 Inquiry, can consider what they have to say. 11 We are now at the stage, really, of reviewing the 12 past day and a half and seeing whether we can move on 13 with any confidence at all, or at all, to Stages 2, 3 14 and 4 in the strategy which you mapped out for us 15 yesterday morning. Essentially, can we? 16 A. Perhaps if I could briefly review what we have covered 17 in Stage 1, the preliminary critical overview of sources 18 of data, we have heard about the HES system, the Cardiac 19 Register and the PAS system. 20 The HES system, the broad conclusions were that 21 data from 1991 onwards would seem of reasonable quality 22 to use. We would expect incomplete death notification, 23 due to it only containing deaths that occurred within 24 hospital, in general, and that of course there is 25 reliance on the accuracy of the coding. 0068 1 Perhaps the discussion this morning has encouraged 2 us as to the conscientiousness of the coding done in 3 Bristol in any way, for one example. 4 For the Cardiac Register, perhaps that has the 5 strong advantage of having clinical ownership of the 6 data, although it is non-validated and for both the HES 7 and Cardiac Register we have the problem that there is 8 no case mix available. However, those two sources of 9 data I think we should be quite encouraged about the 10 possibility of their use at least in the exploratory 11 stage to identify potential outliers. 12 In terms of the PAS, the clinical record system, 13 the PAS is useful both in informing us about the quality 14 of the HES data and as a source of information for 15 determining the clinical records in order to find out an 16 exact description of what has happened in Bristol over 17 the period of the Inquiry. 18 Of course, there are many other sources to find 19 the relevant clinical records and to cross-check these 20 that are listed in the documentation, for example 21 surgeons' logs and so on. 22 So from my personal perspective in Stage 1, what 23 we have heard in the last couple of days gives us some 24 good encouragement to carry on with the intended 25 analysis of the data that is available, with of course 0069 1 continual thought in our minds of the limitations of the 2 data -- the inevitable limitations of data, not being 3 collected for the purpose to which it is now being put. 4 None of this data was collected in order to allow this 5 type of examination. 6 So could I go on to the other stages? 7 Q. Yes, please. 8 A. The intention in Stage 2 is exploration. If we take 9 those three main sources of evidence, the HES data, the 10 Cardiac Register and the clinical records themselves, 11 then the intention is to analyse those three sources of 12 data independently and some of this has already started. 13 Q. That would be necessary because of the pressures of 14 time, that that should have begun? 15 A. Yes. 16 Q. Although obviously if the past day and a half had shown 17 we could not place any confidence in the process, it 18 would have to stop there? 19 A. Yes, but I think if there is any chance of getting this 20 completed, it would have to start as early as possible. 21 From the clinical records which are being recoded, 22 at least 1800 records over the period, that will provide 23 an accurate record and description of the experience of 24 the relevant procedures in Bristol over the period of 25 the Inquiry, which will be useful in order to determine 0070 1 exactly what happened in Bristol in terms of the 2 outcomes of the surgery. 3 Q. For those who may not have read the documents which are 4 on the Internet, records of each and every child who 5 underwent surgery in Bristol from 1984 to 1995, which is 6 presently available -- and we have heard this morning 7 that that is virtually all of them -- are being looked 8 at by a team of coders so that each and every case plays 9 a part in showing to us, independently of any other 10 source, what happened at Bristol. 11 A. Exactly, and that data, of course, can be presented in 12 various ways to look at aggregate mortality rates, for 13 example, over procedures and over certain periods of 14 time. That will provide us a very accurate description 15 of what actually went on. 16 The issue then becomes of comparing that with what 17 perhaps could be considered as standard practice, 18 standard performance in this country at that time for 19 the procedures under investigation. 20 So that is the use of the HES data and the Cardiac 21 Register. 22 The intention is that analyses of these will 23 proceed in parallel but independently, but as far as 24 possible -- and of course with the limitations -- to 25 a reasonably common protocol in that as far as possible 0071 1 to try to use common codes, as far as possible to use 2 a similar analysis and a similar presentation, in order 3 to help the eventual comparison of these sources. 4 Q. So to use the expression which I have used a couple of 5 times in questioning, to make sure that the data sources 6 are, for the purpose of comparison, "speaking the same 7 language"? 8 A. Yes, both in terms of the categorisations, but I think 9 it is also quite important that the presentations should 10 be similar as well, so it will enable someone looking at 11 the results to be able to reasonably rapidly compare 12 them. I think that is rather important. 13 Both of those sources take into account the 14 limitations of the data and inevitably involve some 15 pooling of the time. We should be able to examine what 16 was the overall standard according to those data sources 17 for these procedures at this period in this country, and 18 also -- this is I think very important -- to examine 19 between-unit variability in the outcomes. There is no 20 case mix adjustment in either of these sources so there 21 is inevitably going to be variability due to any number 22 of sources. It would be quite unreasonable to expect 23 all centres to be performing at exactly the same level, 24 even allowing for the chance fluctuations. 25 So to estimate that between-unit variability for 0072 1 the particular groupings of codes can be carried out; 2 and after doing that, and allowing for the chances due 3 to the low denominators inevitable in some of these rare 4 procedures, to identify, I will put it in quotes, 5 "outliers", centres who, for one reason or another, 6 appear to have a low or a high performance for the 7 conditions of interest and over the particular periods 8 being examined. 9 Q. If I can just stop you there, you mentioned the problem 10 with denominators and that is a function, I think, of 11 the small number of cases in respect of some 12 procedures. You mentioned earlier the need, I think, to 13 group. 14 In order to make sense of the data and what they 15 can show us, are we looking at the need to group 16 a number of procedures or conditions together if that 17 can appropriately be done? 18 A. It is a difficult problem. If you over-group, you can 19 lose the ability to identify what might be actually 20 rather important differences in some rather rare 21 interventions, but if you under-group, the denominators 22 are so low that variability can be largely explained by 23 chance alone. So there is an element of judgment there. 24 Q. So taking an extreme to illustrate the point: if all one 25 had to go on was looking at one particular record of one 0073 1 particular operation on the basis that every operation 2 on a human being is bound to be unique, because each 3 human being is unique to a greater or lesser extent, and 4 therefore if one looked at it at the level of the single 5 operation, one simply could not draw any conclusion, 6 positive or negative, as to the quality of surgery from 7 the fact of the outcome? 8 A. No, one operation could always be bad luck. 9 Q. Equally, if one takes an overall view, taking surgery as 10 a whole, if 10 or 12 per cent of people die, if that 11 were the case, that does not actually tell you anything 12 about particular procedures, particular disciplines, 13 particular approaches in particular units, so there has 14 to be some compromise between the individuality of every 15 operation and getting information which is actually 16 useful and tells you something you need to know on the 17 other hand. That is the point, is it? 18 A. Exactly. There are techniques for identifying outlying 19 institutions and in these two analyses carried out 20 independently, one should be able to then afterwards 21 compare whether they come up with broadly similar 22 conclusions, and if they do reinforce our confidence in 23 the conclusions or if they do not. There is an element 24 of judgment about which is perhaps the most reliable to 25 follow. Certainly yesterday we heard from Mr Keogh that 0074 1 from his professional perspective, he believed the 2 Cardiac Register more than the HES results. 3 In any case, the results that come out of there 4 can only be considered as exploratory at that stage 5 because of the inevitable limitations that we have 6 described. 7 Q. So at the end of that stage, we may have identified one 8 or more outliers, and you are were careful, I think, not 9 to say, "Well, we will identify whether Bristol is 10 different from other units", but "whether it is an 11 outlier". Perhaps you will give us some idea of how 12 different one has to be to be an outlier? 13 A. I think non-technically, to say somebody would be 14 considered quite a serious outlier if, taking into 15 account both the chance variability arising from the 16 small number of cases and taking into account the fact 17 that there is inevitably some between-unit variability 18 due to various unmeasured factors, they still had 19 performance that was extreme, taking into account those 20 two sources of variability, then they would label them 21 as a possible outlier for further investigation. 22 The next stage, then, really is trying to confirm 23 that "outlyingness" without actually still providing any 24 definitive explanations. 25 Q. Can I stop you there. Suppose that the exploratory 0075 1 stage shows no "outlyingness"? 2 A. There are still elements of the confirmation that should 3 take place, which I will come on to. But it would not 4 provide the perhaps focus of attention that is 5 essentially the purpose of that exploratory stage, the 6 point being that the exploratory stage, by throwing up 7 essentially hypotheses that one would like to go into in 8 more detail, permits the further analysis and further 9 investigation to focus on particular aspects. 10 So the next stage is to focus on what is thrown up 11 by Stage 2, and in particular the first thing would be 12 obviously to check Bristol's true experience, which the 13 clinical data will reveal in great detail, against what 14 has been reported or been analysed within the HES and 15 the Cardiac Register analysis. That enables us to 16 calibrate at least Bristol's contribution to those data 17 sources. 18 The problem comes, of course, in working out -- 19 let us assume, as the evidence is so far suggesting, 20 that Bristol's data being submitted to those sources was 21 probably rather good -- essentially, whether we can 22 expect the other centres to have the same degree of 23 calibration between the true data reflected in the 24 clinical records and that being reported in the database 25 system. 0076 1 That is a difficult judgment to make. At that 2 point, there may be a need to consider other sources in 3 order to confirm within the areas under more detailed 4 investigation, what was the standard in the country at 5 that period and what was the background variability 6 between this and that over that period. I hasten to 7 add, this is very tentative, what we may need to 8 consider is perhaps other databases that other centres 9 have within these specific areas. It would be 10 unreasonable I think, at this stage to start trying to 11 explore every source of information on every case. 12 Q. So that is something for future review, and to be 13 reviewed no doubt in terms of feasibility and what one 14 would learn from it, and so on, in the light of what one 15 has derived from Stages 1 and 2? 16 A. Exactly, and I think in the light of perhaps 17 contributions from others on what they feel are perhaps 18 limitations on those data sources, people who might know 19 somewhat more about the quality of information provided 20 by other centres as well, to know whether those are 21 a reasonable benchmark or not. It is the benchmark that 22 we are looking for. 23 Q. So if, for instance, we had, in respect of a couple of 24 data sources from elsewhere, information which suggested 25 they were as reliable as Bristol may appear to be, that 0077 1 would give one more confidence in comparing Bristol with 2 the results of those units? In a lay understanding, 3 that is the point, is it? 4 A. Exactly. The final stage was, if we feel that at that 5 stage there still is some stronger evidence that Bristol 6 is being considered an outlier with respect to the 7 benchmark provided by the centres, we would seek 8 explanation for that. One possibility is to look at 9 more statistical explanation in terms of whether the 10 case mix being treated in Bristol differed 11 systematically from those in other centres. That again 12 may need to consider in the specific areas that have 13 been identified, collecting additional data from other 14 centres on their cases and their case mix. 15 I think at this stage, without prejudging the 16 issue, I would imagine only a reasonably rudimentary 17 adjustment for case mix would be possible, due to the 18 fact, as has been mentioned before in this particular 19 area, unlike adult cardiac surgery the development of 20 risk adjustment procedures based on more subtle 21 stratification has not been established. 22 In seeking to explain any variability that has 23 been to the best of my knowledge confirmed, it depends 24 of course on the explanation suggested by those with 25 a substantial knowledge of the area, but one study is in 0078 1 the process of being organised now which might 2 contribute to that explanation and in a sense, in order 3 for the evidence to be available in time when the 4 confirmatory analyses were being carried out, that study 5 really has to start taking place now in order to prevent 6 the evidence arriving really too late. 7 That is what one might call an "adequacy of care" 8 study, in which a stratified random sample of the 1800 9 or so clinical records that have already been identified 10 are taken and a multidisciplinary expert group assesses 11 that sample in terms of the adequacy of care delivered 12 to those children. 13 The form of that sample -- 14 Q. Can I just stop you there. So you are saying that in 15 order to help look at the explanation, one needs to 16 have, from the 1800 or so cases that we have here in 17 Bristol, a lesser number drawn on, and you use the words 18 "randomised, stratified" -- I am sorry, I forget the 19 full words -- mix? 20 A. Stratified random sample. 21 Q. I was groping for the words, I am sorry. If you have 22 the stratified random sample, you will then be able to 23 make general conclusions from that sample? 24 A. To what one might consider to be a quantifiable extent, 25 because the purpose of statistical theory is to say to 0079 1 what extent you can generalise from a random sample of 2 a certain size. 3 Q. You are going on to describe how the stratified random 4 sample would work? 5 A. The idea is that it would be impossible to go through 6 all 1800 case notes to this level of detail required. 7 A simple random sample, if one just took a group at 8 random from those 1800, would not really reflect 9 adequately the cases of major interest in this Inquiry. 10 So the random sample is stratified so that cases that 11 are young and more severe have more chance of appearing 12 in the sample than those perhaps of simpler cases that 13 are not of such interest. 14 So that stratification scheme is preset, about 15 what defining what is meant by the young and more severe 16 cases and also it is not just the deaths but the 17 survivors that are being sampled to an equal number. 18 This enables an example that reflects the cases of 19 interest but also a broad range of types of patient 20 without specifically picking out known patients. These 21 patients are chosen completely at random, but weighted 22 in this way. 23 The initial sample will be of the size 80, and the 24 case notes will be subject to "blind review", the 25 reviewers will not know the identity of the patient, in 0080 1 terms of the adequacy of care which will be defined in 2 terms of levels of adequacy, distinguishing adequacy of 3 care, possible limitations of adequacy that would 4 possibly have led to a different conclusion or would 5 probably not have led to a different conclusion. 6 These will be distributed among the review panels 7 with some repeats going to multiple panels in order to 8 check the reproducibility of the assessments. 9 Q. The Inquiry has already published the names of the 10 experts who will advise it, getting on for 40 experts, 11 and they will be looking at 80 cases in order to draw 12 conclusions as you have indicated for the purposes that 13 you have set out. 14 A. 80 in the first wave; there may be more required. 15 Q. And you have mentioned there that there is an element of 16 cross-checking by random examples being given to more 17 than one group of four experts? 18 A. Yes. 19 The other aspect that should be mentioned, 20 although again, it is something that may need to be 21 considered, is that whereas in the mortality data we are 22 trying to benchmark the outcomes in Bristol by comparing 23 them with perhaps national standards, in terms of the 24 adequacy of care, it is rather difficult to establish 25 the national standard for what perhaps might have been 0081 1 the adequacy of care over that period for these 2 conditions. So it might be reasonable to explore the 3 possibility of providing a benchmark by considering 4 a limited exercise using the notes from other centres as 5 well. 6 Q. I have, I think, set out there the way forward that you 7 would expect in addressing what we see on our slide as 8 the explanation stage, at the end of which the 9 statistics, the available statistics, will have told us 10 what they can and enable such conclusions as can be 11 drawn from them to be drawn. 12 A. I feel that stage will not be largely a matter of 13 statistics. 14 Q. It will be largely a matter of analysis and 15 interpretation? 16 A. Yes. 17 MR LANGSTAFF: Thank you, Dr Spiegelhalter. May I say, 18 before you leave the witness stand, that what you have 19 said will undoubtedly be looked at carefully by others. 20 One of the purposes that the Inquiry have had in having, 21 today and yesterday, the public arena, as it were, was 22 to invite comment and discussion as to the way forward, 23 as I have indicated in my opening remarks, so that the 24 process could be refined and improved if that is 25 possible. 0082 1 Can I say, on behalf of the Inquiry -- I know the 2 Chairman is likely to echo this -- that we would welcome 3 any input from anyone who feels that he or she has 4 anything useful to add, whether by way of information, 5 whether by way of questions such as, "Have you thought 6 of this ...?", or comment, and it may well be experts in 7 their own fields who will have comments. Any of those 8 comments are invited because they need to be considered, 9 and considered carefully and over time, and of course 10 time in one sense we have something of before we 11 re-commence hearings in September, although, looked at 12 from another perspective, no great amount of time for 13 the investigations which have to take place. 14 So I would invite anyone who has comment, or 15 commentary, or advice or encouragement to give, to give 16 it sooner rather later if it is to be of the greatest 17 utility to us. 18 THE CHAIRMAN: And just interrupting for a moment, if 19 I may, I think it is a case, Mr Langstaff, that we will 20 be publishing a paper for consultation which sets out in 21 particular detail the sampling exercise that 22 Dr Spiegelhalter was referring to at the end of his 23 evidence a moment ago. 24 MR LANGSTAFF: Dr Spiegelhalter, unless there is anything 25 you would wish to add, may I thank you very much for 0083 1 your contribution and for being with us over the last 2 day and a half. I have no doubt that we will see you 3 again. 4 THE CHAIRMAN: And I, on behalf of the Panel, echo that 5 thanks. It must be clear by now, I think to all, how 6 complex are the issues that we are dealing with. It is 7 equally clear, I hope, that the scale of the enterprise 8 involved in seeking to resolve that complexity is huge, 9 but from the Panel's point of view, we see it as our 10 duty to undertake this work if we are fairly to draw any 11 conclusions which our terms of reference demand of us. 12 So we can only thank our experts who will carry out the 13 work and in particular, Dr Spiegelhalter, you today and 14 yesterday have begun us on the trail, as it were. We 15 owe you a great debt of gratitude, you and your 16 colleagues, not only for today but for your future 17 advice. Thank you. 18 (The witness withdrew) 19 MR LANGSTAFF: RE TIMETABLE 20 MR LANGSTAFF: Sir, if I can just review next week, as 21 I normally do towards the end of the session, next week, 22 on Monday and Tuesday, we recommence with Mr Wisheart, 23 whose evidence will go at this stage -- and I emphasise, 24 as I have done already -- to the question of 25 management. We have looked at the local scene. His 0084 1 evidence at this stage is part of the evidence that we 2 have been taking as to the management of the care. It 3 will not therefore deal with the adequacy of the care. 4 So the questions which we will be advancing to him 5 will not deal with any individual case; they will not 6 deal with the concerns that were expressed in whatever 7 time they were expressed, particularly perhaps in the 8 1990s, and they will not be concerned with the results 9 of any audit which was or was not carried out, and what 10 it did or might have shown. 11 I say that so that there is no misunderstanding as 12 to the scope of the questioning which Mr Wisheart will 13 face when he comes to see us and give his evidence on 14 Monday and Tuesday of next week. 15 On Wednesday and Thursday, the last two days that 16 we have before a break in the summer, we will sit to 17 listen to Professor Green of the Royal College of 18 Pathologists. They have recently published 19 a consultation paper which deals with, of particular 20 interest to us, the question of consents for postmortem 21 and retention of tissue. Mr Clifford then, from the 22 Home Office Coroner's Unit. 23 On Thursday, Mr Burgess of the Coroners' Society 24 and Diane Kennington, the Patient Affairs Officer of the 25 UBHT. 0085 1 Those four witnesses will revisit the issue of the 2 retention of hearts which we began this week with, and 3 they will help, we hope, to set both the national and to 4 some extent the local background scene against which the 5 particular evidence of what happened particularly in 6 this case in September will then be viewed. As 7 I indicated at the start of this week, in September we 8 will hear from Professor Berry and Dr Ashworth, and of 9 course from parents and their reaction as to what 10 happened to them in respect of what had happened to 11 their children whilst under the care of the Bristol 12 hospitals. 13 Sir, on Monday we begin at 10.30. On each of the 14 other days next week, at 9.30. 15 Sir, that would normally conclude the business for 16 this week, but before we close, Mr Lissack has an 17 application to make. I think it relates to timetabling 18 for next week. 19 It is perhaps convenient if I give him my 20 microphone, given the way in which, because of the 21 exigencies of the evidence, the hearing chamber has been 22 configured. 23 MR LISSACK: RE TIMETABLE 24 MR LISSACK: Sir, as you are aware, it has been our practice 25 throughout the Inquiry to keep Mr Langstaff and, through 0086 1 him, you informed of any problems which we foresee which 2 may cause a dislocation of the programme that you have 3 set. 4 We hope that that early warning system and the 5 constantly open lines of communication that we have with 6 Mr Langstaff has assisted in the smooth running of the 7 Inquiry to date. 8 It is in that spirit that I was minded to make an 9 application to you today. Happily, the application that 10 I was envisaging having to make, I need not, because an 11 accommodation, the details of which I need not go into, 12 has been reached which I hope may provide that a formula 13 by consensus to ensure that the programme in the early 14 part of the autumn session is not disrupted, is reached. 15 However, the matter I do apply to you about is 16 this: it is an application for an application, really. 17 I have discussed this with my learned friend 18 Mr Langstaff and we have agreed this is an appropriate 19 way of presenting the issue. 20 Next week is congested. There is a lot of 21 important evidence to be heard. But we would invite 22 you, please, to allow, in the timetable, for the need 23 for us to apply to you for an order to compel a party or 24 parties to produce material. 25 Our concern is simply this: if the consensus 0087 1 approach which we are proposing to adopt with 2 Mr Langstaff's assistance -- I am grateful to him for 3 it -- does not work, then there is a real risk that if 4 the Inquiry breaks without more, that when we revisit 5 the issue of organ and tissue retention in September, we 6 will actually be little forward from where we are now. 7 That is highly undesirable for the Inquiry, we submit, 8 and it is the last thing we wish to happen. 9 So beyond that, I need not go. 10 Whilst I am here, may I please say two other 11 things, which it would be remiss of me to fail to 12 mention. 13 Firstly this: my clients, and if I may say so, 14 with them, myself and the others who act on behalf of 15 the BHCAG, are very grateful to the Inquiry for 16 dislocating your timetable, as we know you have, at this 17 difficult time in the scheduling. They would ask me to 18 thank you expressly not only for the rescheduling that 19 you have permitted, but also for the sensitivity that 20 the Inquiry has shown in the handling of the issue of 21 retention of tissue, both inside and outside the 22 chamber. 23 Secondly, I am instructed, and welcome the 24 opportunity to pay tribute to those responsible for the 25 collating and presentation of the statistical evidence. 0088 1 We immediately saw the importance of this material 2 and evidence which we have paid close attention to 3 during its presentation and in the reading of the 4 material beforehand, because we respectfully agree that 5 it is key to forming a proper conclusion and proper 6 evaluation in a fair and balanced way of how Bristol 7 performed, to understand how it performed in the context 8 of other similar units carrying out the same work. 9 We hope that the evidence that has been provided 10 to date and will be elaborated upon in due course, will 11 be of considerable assistance in weighing the 12 significance of Block 6 evidence which of course closely 13 concerns our lay clients, and ultimately will be of 14 considerable assistance to you in the shaping of your 15 recommendations as to how data may be handled in the 16 future, a matter upon which we will be making written 17 submissions in due course. 18 But for the way in which it has been marshalled 19 and presented, speaking for myself, it would have been 20 a case of the uncomprehending in pursuit of the 21 incomprehensible! 22 Thank you very much indeed. 23 THE CHAIRMAN: Mr Lissack, thank you very much. I could 24 not claim to adopt the last of those observations; it is 25 clearly wrong. But thank you first for the kind remarks 0089 1 you have addressed both to the Panel and to those who 2 have been assisting us. We are very grateful. It is 3 always nice to hear nice things said, because very often 4 in this position, not so nice things are said, so we are 5 grateful and we shall store it away against harsher 6 times! 7 Lastly, and on the substantive point you raise, 8 I am very grateful to you for having pursued, as I know 9 assiduously, a means whereby you can come to an 10 agreement with others, and I am pleased to hear that so 11 far, at least, some consensus appears, but you rightly 12 say, and I agree, that there ought to be a "Plan B", if 13 I can put it that way, so of course should it be 14 required, time will be made available to you, yes, I can 15 give you that assurance. 16 MR LISSACK: Thank you. 17 THE CHAIRMAN: I will go on to say, for the general public 18 and for you, although we will be sitting from Thursday 19 of next week onwards, I am of course available, as are 20 those who advise me, throughout the whole of the 21 summer. Should matters arise upon which you need my 22 intervention or the intervention of anyone else, I am at 23 your disposal and always will be. I give you that 24 assurance as regards time, should it arise. 25 MR LISSACK: Thank you very much indeed. 0090 1 THE CHAIRMAN: Mr Langstaff? 2 MR LANGSTAFF: Sir, that concludes today's, and indeed this 3 week's, open business. 4 THE CHAIRMAN: Thank you very much indeed, everyone. 5 Thank you, Mr Langstaff. 6 We reconvene on Monday next at 10.30. 7 (12.56 pm) 8 (Adjourned until Monday 19th July 1999 at 10.30 am) 9 10 11 12 I N D E X 13 14 15 MR ANDREW HOOPER (affirmed) 16 Examined by MR LANGSTAFF .......... 1 17 Examined by THE PANEL .......... 49 18 MISS ANN HARDING (affirmed) 19 Examined by MR LANGSTAFF .......... 56 20 Examined by THE PANEL .......... 66 21 DR DAVID SPIEGELHALTER (recalled) .......... 67 22 Examined by MR LANGSTAFF .......... 67 23 MR LANGSTAFF: RE TIMETABLE .......... 84 24 MR LISSACK: RE TIMETABLE .......... 86 25 0091