1 Wednesday, 1 February 2012 - Vale of Leven 83 - … · Web viewIf one is dealing with a...

1 Wednesday, 1 February 2012

2 (10.00 am)

3 DR HUGH CARMICHAEL (continued)

4 Examination by MR MACAULAY

5 MR MACAULAY: Good morning, my Lord.

6 Good morning, Dr Carmichael.

7 A. Good morning.

8 Q. Yesterday, you gave us some information about your

9 commitments to the Vale of Leven Hospital. Can I just

10 explore one or two points with you in that connection.

11 So far as wards are concerned, were there particular

12 wards that you would be in attendance at?

13 A. The acute medical wards, as you know, were 3, 4 and 6,

14 so these would be the primary wards I would be involved

15 in.

16 Obviously, we often had boarders elsewhere,

17 particularly ward 5, the surgical ward, and

18 occasionally, of course, elsewhere.

19 Q. So if you focus on ward 6, for example, how frequently,

20 then, do you consider in a week you would be in

21 attendance in ward 6?

22 A. My routine ward rounds would be twice a week and, if

23 I was receiving at weekends, it would obviously be

24 another three days as well -- Friday, Saturday, Sunday.

25 Q. So far as your acute receiving duties were concerned,

1

1 would you attend ward 6 for that, or would you perhaps

2 attend MAU? How did it work in practice?

3 A. The MAU purely worked as a place where patients were

4 brought in by ambulance or came in on their own and were

5 assessed with a view to admission. We would not

6 normally go down there unless requested to do so by the

7 receiving middle grade staff, which sometimes happened.

8 Sometimes they were under a lot of pressure, and we went

9 down to help get through the numbers. As time went on,

10 that was becoming an increasingly frequent request, to

11 help them out.

12 Q. During the week, are you able to tell the Inquiry how

13 many medical staff would be based in the MAU?

14 A. Usually, there would be one, perhaps two, middle grade

15 and I think an FY1 would be helping out as well down

16 there during the daytime. There was a variation. But

17 during the weekdays, I think there could have been two

18 middle grade staff there at certain times, anyway.

19 Q. And at weekends?

20 A. At weekends, mostly one. There would be one middle

21 grade and one FY1 covering the hospital at weekends.

22 Q. Did you have any views on the adequacy of that cover for

23 the whole hospital?

24 A. We had concerns about that number. When things were not

25 busy, it was perfectly manageable, but when things got

2

1 busy, it proved difficult for relatively inexperienced

2 junior staff to cope, and that was a cause of concern.

3 We had attempted -- and I'm not sure of the timeframe of

4 this -- to get extra staff for the weekend, particularly

5 for the Saturday, when things were busier and an extra

6 pair of hands would have been very useful, for a number

7 of hours, anyway. But we were unable to get

8 accreditation for an extra junior member of staff.

9 Q. Can you just elaborate upon that: why was that? If you

10 needed the manpower, why did you not get it?

11 A. I suspect a number of reasons. In terms of

12 accreditation, it is looked on as whether there's

13 sufficient educational material to support an extra

14 post, and it was judged by those in charge of that that

15 that was not the case.

16 MR KINROY: My Lord, I wonder if I could ask if that was to

17 do with the deanery?

18 A. That's the deanery, yes. It's a deanery decision, that.

19 MR MACAULAY: I think you were responsible for the rota, and

20 I propose to ask you some questions about that.

21 A. The senior rota, yes, the consultant rota.

22 Q. That will perhaps put you in a position to give us some

23 indication as to medical staffing generally.

24 First of all, is it right to say that there were no

25 registrars or specialist registrars in the Vale of Leven

3

1 at the relevant time?

2 A. No, there were not. We had -- occasionally, had one or

3 two of them in the past, when staffing was a bit more --

4 there was more staffing available generally in the

5 deanery, but not for a number of years up to that point.

6 Q. Why was that the situation, then, Dr Carmichael?

7 A. Largely because there were fewer of the senior trainees

8 to go around anyway and, also, because of the departure

9 of the other specialties from the Vale, the Vale was

10 being regarded less and less as a potential source of

11 senior education.

12 Q. Did you have any views, from your perspective as

13 a consultant, on the fact that you didn't have this

14 middle grade level of medical expertise?

15 A. It would obviously have helped to have more experienced

16 middle grade staff in the hospital, yes, it would have,

17 and it did in the past. But as time went on, well, that

18 level of experience became less available.

19 Q. Would that have any impact on the training of the junior

20 doctors?

21 A. Not in the training of the junior doctors, just in how

22 things were managed, basically, the service was managed,

23 yes.

24 Q. Did you see this as an important gap in the medical

25 services at the Vale of Leven?

4

1 A. I think it would have been ideal to have had more senior

2 middle grade staff available, but we realised that was

3 just not going to happen.

4 Q. Did I understand from what you said a moment ago that

5 some of your patients would, in fact, be accommodated in

6 wards 14 and 15, as well as the acute wards?

7 A. It was not very common to be boarded out to 14 and 15.

8 Occasionally, if patients had to go there, they would

9 usually be those in whom we were expecting to transfer

10 them to care of the elderly anyway, at some stage, and

11 so a decision would be made to send them there, rather

12 than to, well, say, ward 5, but mostly they would go

13 through to the surgical ward.

14 Q. Are these patients who would be acutely ill and

15 otherwise would be accommodated in the acute medical

16 wards?

17 A. We would try to avoid sending patients with significant

18 ongoing acute problems to 14 and 15, largely because

19 of -- well, they were not really looked on as acute

20 wards. That was predominantly why. We tried to keep

21 the acute patients -- the ongoing issues within the

22 environment of the main hospital.

23 Q. But I think you just said you tried to do that, but did

24 it happen that patients --

25 A. I would imagine occasionally it did happen that patients

5

1 went to 14 and 15 that we would prefer not to, that we

2 would have preferred to have kept under a closer

3 scrutiny.

4 Q. That's the next point I was going to come to. Looking

5 to the experience of the staff in the different wards,

6 the staff in the rehabilitation wards, did you consider

7 that they were sufficiently experienced to deal with

8 patients who may be acutely ill and should have been in

9 another ward?

10 A. They were also used to dealing with elderly patients

11 with many comorbidities, and the answer to that would

12 be, yes, they did have these skills, but their staffing

13 was mainly geared to rehabilitation, of course, and not

14 to looking after acutely ill patients.

15 Q. We have heard evidence, Dr Carmichael, and you may have

16 seen this in the transcript yourself, that, at weekends,

17 indeed, as you said, you only really had two doctors

18 covering the whole hospital; is that correct?

19 A. At the weekends, yes, at any one time.

20 Q. I'm sorry?

21 A. At any one time, yes.

22 Q. Did you, yourself, consider whether this situation

23 compromised patient care?

24 A. Well, it's always been the situation at the Vale. It's

25 never been any different, really, so I suppose, if

6

1 I felt it did compromise patient care, I would feel it

2 was an untenable situation, so the answer to that must

3 be, no, I didn't feel it compromised it unduly.

4 Obviously, as time has gone on, as with most

5 other -- well, all other acute medical units throughout

6 the country, the pressure has increased inexorably over

7 the years. When I took up my post in '79, I think we

8 were roughly between 1,200 and 1,500 admissions per

9 annum and, when I retired -- I think we had peaked at

10 4,000 within the year or two before I retired. So that

11 is almost a threefold increase in admissions, and these

12 admissions were becoming more elderly, more complicated,

13 more comorbidities, more interventions had developed

14 over the years. So, all in all, the workload for

15 medical and nursing staff had steadily increased, and

16 I have to accept that the staffing, to some extent, had

17 not kept up with that increased need.

18 So the answer to your question must be, to some

19 extent, it would have been preferable if staffing levels

20 were higher than they were, but that's the reality we

21 have to live with, and certainly district hospitals

22 throughout the country, especially small ones, have

23 limited staffing.

24 Q. Could I just ask you to slow down a little bit, for the

25 benefit of the transcribers?

7

1 A. Sorry, yes.

2 MR PEOPLES: My Lord, I wonder, before we go on about

3 weekend cover, I had understood Dr Carmichael yesterday

4 to say that he would attend on a Saturday and Sunday in

5 person. Would that be in addition to the two doctors

6 during the day?

7 A. When I --

8 MR PEOPLES: If so, for what purpose?

9 A. When I was receiving? On receiving duties?

10 MR PEOPLES: When you were on call for the weekends.

11 A. On call, yes, the consultant on call, we'd go in on

12 a Saturday and a Sunday morning as well.

13 MR MACAULAY: Would that be to respond to a call from the

14 doctor who was there to come and see a patient who was

15 ill?

16 A. No -- well, we would go in as a routine when we were on

17 call to see all the new patients that had arrived in

18 from the Friday to the Saturday and then from the

19 Saturday to the Sunday, so they had at least one

20 consultant assessment following admission.

21 Q. That's for new patients?

22 A. For new patients, and also any other patients flagged up

23 for us to see who were a cause of concern, either by the

24 junior staff, the junior medical staff, or by the

25 sisters in the various wards. We would go around all of

8

1 the medical wards and see what problems there were and

2 ask the sisters, or ask the nurse in charge, what issues

3 there were.

4 Q. Can I then ask you a little bit about the organisation

5 of the rota. When did you take on that responsibility,

6 Dr Carmichael?

7 A. Well, when I took up my post at the Vale, I was the only

8 full-time consultant. There was another part-timer.

9 So, really, from day one.

10 Q. Can you just give me some understanding as to what the

11 task involved, then? For example, when you were making

12 up the rotas, would you have a list of the days when the

13 consultants that were to participate in the rota would

14 have had ward rounds?

15 A. The rota was primarily based on days when the individual

16 consultants were best placed to undertake receiving. Of

17 course, that was not always possible. There were six

18 consultants to be accommodated, and the weekday rota was

19 from Monday to Thursday. That's four days. And the

20 oncall weekend rota was Friday, Saturday, Sunday. So

21 Friday, Saturday, Sunday was kept out of the weekday

22 rota.

23 To fill four days with six people does require

24 a fair degree of flexibility. Nonetheless, I tried to

25 maintain certain days for certain people.

9

1 Q. When you say four people, sorry, can you just remind

2 me -- not six people, then?

3 A. There were six people.

4 Q. Sorry, I thought --

5 A. Four days and six people.

6 Q. Four days and six people, yes.

7 A. Yes, six consultants. So on a Monday, that was my

8 preferred day; on a Tuesday, that was Dr Al-Shamma's

9 preferred day; I think in the early part of the period

10 in question Wednesday was Dr Forbat's preferred day; and

11 then, when he left, I think Dr McCruden preferred the

12 Wednesday -- I may be wrong about that. I'm not

13 100 per cent sure.

14 Thursday, the preference was for Dr Johnston and

15 I think Dr Akhter -- that's five, isn't it? Who have

16 I missed out?

17 DAME ELISH: My Lord, I wonder if my learned friend --

18 MR MACAULAY: Yourself, I think.

19 A. No, I was Monday. I think that more or less covers it,

20 in fact.

21 DAME ELISH: My Lord, I wonder if my learned friend could --

22 LORD MACLEAN: You were going to say?

23 A. Sorry.

24 DAME ELISH: I wonder if my learned friend could clarify,

25 when the doctor refers to composing a rota for six

10

1 people into four days, although there was normally six

2 people, was the reality that he had six people to

3 allocate or did leave, illness, training and committees

4 create a variable on the numbers available?

5 A. Obviously, colleagues would let me know when their

6 annual leave was and what other commitments they had

7 that would prevent them being on call certain days and

8 I would take that into account on making up the rota.

9 But, obviously, if a colleague was on holiday, one

10 would have to find somebody else to cover that

11 particular day, and, for example, when Dr Al-Shamma was

12 on holiday, that's the Tuesday that he would normally

13 cover, it was down to myself or Dr Akhter to cover the

14 Tuesday. That suited neither of us, because I was doing

15 all day endoscopies on a Tuesday and Dr Akhter I think

16 had a ward round on a Tuesday. So we would do it half

17 and half. I would probably do a number and he would do

18 a number. It was a compromise.

19 So I would, for example, if I was on call on the

20 Tuesday, start the ward rounds about 8 o'clock until,

21 say, 10.00, and then go to endoscopy and work straight

22 through until 4.30, working lunch, et cetera, and then

23 go back and do the afternoon ward rounds. Obviously,

24 any queries, the juniors would come up and find me in

25 endoscopy to ask me about. So that is not ideal, but

11

1 others had exactly the same problems to deal with in

2 these situations.

3 MR MACAULAY: We have heard from Dr Akhter on this subject.

4 He, I think, suggested that he, himself, had no real

5 control over what day or days he was to be allocated

6 oncall duties; is that correct?

7 A. As I said earlier, if colleagues felt they couldn't

8 undertake duties on certain days, I would try to

9 accommodate that. Obviously, if they were elsewhere,

10 I would have to accommodate that. Compromises had to be

11 made, as is the case, I'm sure, with many other such

12 rotas elsewhere.

13 LORD MACLEAN: Can I just be clear how many consultants

14 there were on the rota?

15 A. There were six consultants: that's the four general

16 physicians and the two care of the elderly physicians,

17 Dr Johnston and Dr Akhter.

18 LORD MACLEAN: Thank you.

19 MR MACAULAY: The other point that I think arose out of

20 Dr Akhter's evidence is that his oncall duties appeared

21 to clash with his ward round duties. I think you have

22 mentioned Tuesday and Thursday -- certainly Thursday

23 I think you said was Dr Akhter oncall --

24 A. Yes.

25 Q. -- which seemed to have been a day for his ward round.

12

1 How did you try to manage that sort of clash?

2 A. Well, as I said earlier, I tried to accommodate

3 colleagues' situations when asked to do so.

4 Q. Did you give consideration to a doctor's ward round

5 commitments when you were organising the rota?

6 A. As best I could. As best I could. Now, obviously, when

7 we were asked to -- required to undertake oncall duties

8 on a certain day when we had other fixed commitments, it

9 was our responsibility to try and manage these as best

10 we could, either by reallocating that fixed commitment

11 to another time or trying to accommodate it in that

12 oncall day as well.

13 As I said earlier, I would do that if I was covering

14 Dr Al-Shamma's Tuesdays, and certainly the case -- the

15 same is the case for other consultants.

16 Dr McCruden, for example, I think had commitments on

17 a Thursday and -- maybe not a Wednesday, but certainly

18 a Thursday, but he was often on call on a Thursday as

19 well.

20 Q. If someone like Dr Akhter, for example, was on call on

21 the Thursday and that was the day of his ward round,

22 what, then, were the options? I suppose he could, what,

23 get somebody to cover for the ward round?

24 A. Are we talking of Dr Akhter's ward rounds in care of

25 the elderly or ward F?

13

1 Q. One particular point that came out of his evidence

2 was -- I think it was in ward F where, for a period of

3 about a month, he didn't appear to have carried out

4 a ward round, and I think the explanation was that he

5 had oncall commitments.

6 A. Right.

7 MR WOOD: My Lord, I may be wrong, but I think this may

8 relate, in fact, to Mrs Pirog. Certainly his evidence

9 was it was a period of two months. It was the summer

10 months in 2007 when a number of ward rounds were missed,

11 and that would be in ward 15, because at that time, in

12 the summer of 2007, Dr Akhter was responsible for

13 ward 15, rather than ward 14, as I understand it, and he

14 became responsible for ward 14 in October/November 2007.

15 MR MACAULAY: I certainly had in my note that this may have

16 related to ward F.

17 MR WOOD: It may relate to ward F as well, but certainly,

18 when counsel mentioned a period of a month, I have

19 a clear recollection that we were looking at it in fact

20 yesterday in the context of Dr Herd. So it may be the

21 same point arises in respect both of ward 15 and ward F.

22 MR MACAULAY: Whether it is F or not, if you had a period of

23 that length of time when the ward rounds were not being

24 carried out because of the oncall commitments, then I'm

25 just seeking to explore what the options might have been

14

1 for the doctor?

2 A. Well, I certainly have no recollection of Dr Akhter

3 raising these concerns with me when I made up the rota.

4 If his other duties were too onerous for him to carry

5 out, then that -- I would have thought he would have

6 discussed it with his colleagues to see what could be

7 done about it. I certainly don't remember him

8 discussing it with myself.

9 DAME ELISH: My Lord, I wonder if my learned friend could

10 clarify with the witness whether or not this rota had,

11 in any shape or form, built into it any resilience for

12 staffing or locums, where simply the allocation of

13 resources seemed to be too formidable?

14 A. By that I think you mean extra people brought in other

15 than the six consultants? No, it was simply the six

16 consultants and, if one or other of them were not there,

17 then we had to make up the difference, fill in the gaps.

18 MR MACAULAY: We heard some evidence that Dr Johnston was

19 off for a period of time.

20 A. That's right.

21 Q. How would you seek to accommodate that?

22 A. I can't remember whether we had a -- we had a locum,

23 I think, covering her post for a period of time, but --

24 was that Dr Yousif?

25 Q. Yes, there is certainly some reference to him.

15

1 A. Yes. Well, in that case he would have taken her place

2 in the rota, and he did so.

3 Q. If there was a clash, then, are you saying that it would

4 be for the doctor who had the clash in the first

5 instance, what, to come to you and raise it with you?

6 A. Yes, and they often did. They often did.

7 Q. Was it an option for the doctor to do both, to do the

8 rota and the ward round?

9 A. I would try to see what changes could be made to make it

10 function to their satisfaction, but that was not always

11 possible. So we had -- as I said earlier, we had to

12 compromise our other commitments with the oncall

13 commitments and, as I say, either reschedule these other

14 commitments or try to manage them within the constraints

15 of the oncall duties as well.

16 DAME ELISH: My Lord, on that particular point, I wonder if

17 my learned friend could clarify whether or not it was

18 likely, from the witness's experience, that the other

19 doctors would understand the challenges and difficulties

20 that Dr Carmichael would have in actually adjusting that

21 rota, if there wasn't an issue of additional resources?

22 LORD MACLEAN: You hope they did.

23 A. I would be more than willing if somebody else had taken

24 over the role of the rota. It was an onerous and

25 difficult juggling act at times. As I said, the door

16

1 was open to colleagues to come and speak to me if they

2 had any concerns and, as I say, it happened. I don't

3 remember Dr Akhter coming specifically and discussing

4 these concerns with me. I would have tried to

5 accommodate them, if he had.

6 MR KINROY: My Lord, may I ask a question, with

7 your Lordship's permission?

8 LORD MACLEAN: Yes.

9 MR KINROY: Which is this: does Dr Carmichael have any

10 reason to believe that Dr Akhter's oncall commitments

11 made it impossible for him to have a ward round in

12 a particular week so that the ward round just had to be

13 given up?

14 LORD MACLEAN: Do you?

15 A. I really don't know -- I realise Dr Akhter had

16 significant commitments in the care of the elderly.

17 I don't remember him discussing the difficulties he had

18 with that and accommodating oncall commitments. I have

19 read comments about how difficult it was for him, and

20 I would have thought that would have been discussed with

21 Dr Johnston, perhaps, and perhaps with Dr McCruden then

22 as well. But I don't remember any specific approach to

23 myself to see what could be done to change things.

24 MR MACAULAY: Would you have been concerned if you had been

25 told that one of the consultants had not been able to do

17

1 their ward rounds for a period of weeks?

2 A. I would have been concerned, yes, absolutely, and would

3 have wanted to discuss the matter with them to see what

4 we could do to change things.

5 LORD MACLEAN: How long did you carry out the duties of

6 fixing the rota?

7 A. Thirty-one years.

8 LORD MACLEAN: You did it right from the start?

9 A. Yes, right from the start, yes.

10 LORD MACLEAN: Gosh!

11 A. Nobody wanted to take it on.

12 MR MACAULAY: Was it a time-consuming exercise?

13 A. I would imagine I would spend an average of an hour

14 a week, maybe, just that kind of timeframe, just sorting

15 things, phoning people to see what suited. Because

16 I would have to phone around at times to see who could

17 do certain slots when people were on holiday or on leave

18 for other reasons. On average, I would think an hour

19 a week would cover it.

20 MR WOOD: My Lord, I wonder if I might have asked the

21 question, how far in advance of any given week was the

22 rota prepared: six weeks in advance; four weeks in

23 advance; the week before? How would the doctors

24 receiving the rota know to plan?

25 A. In my office on the wall, I had a rota that probably

18

1 stretched some months into the future, with some gaps

2 that I would fill in as time went on. To do it and

3 circulate it too far in advance was sometimes a mistake,

4 because often colleagues would come to me a week or two

5 before the rota and say, "Oh, by the way", et cetera.

6 So if people had any concerns, they could certainly

7 contact me and I would give them an idea of when they

8 were on next.

9 Weekends were the particular thing, and these were

10 usually -- it was clear to see who was on when, unless

11 holidays, et cetera, got in the way.

12 MR MACAULAY: Can I then leave that chapter aside and move

13 on to look at the issue of the prescription of

14 antibiotics?

15 Can I ask you, first of all, whether in the relevant

16 period there was a particular document or guideline that

17 you used to assist you in the prescription of

18 antibiotics?

19 A. The timeframe is the difficulty with me: what was where

20 when. I do recall there being several different types

21 of guidelines around over that year or two. Which one

22 was the formally accepted, current one, I'm not quite

23 sure at any one time.

24 Q. Can I see if I can identify any document that might

25 become familiar to you, then, Dr Carmichael? If we look

19

1 first at GGC21790001, we are looking at a document that

2 we understand to be the Argyll and Clyde drug formulary

3 for 2006, and just to give you a feel for what is in it,

4 if we turn to, for example, page 156, you will see here

5 that there is a list of conditions and recommended

6 treatment and alternative treatments.

7 Does this look at all familiar to you?

8 A. I think it probably does, yes.

9 Q. Was this formulary available then?

10 A. Well, it certainly was available at some point, but when

11 I'm not quite sure.

12 Q. The other document at the moment, if I can put it up on

13 the screen, is at GGC22180001. This is empirical

14 antibiotic therapy guidelines which I understand may

15 have been put in place perhaps in about 2007, into 2008.

16 Does this look familiar to you?

17 A. I certainly recognise it. I don't recall when it was

18 available. It might have been available during the

19 time, but I don't actually recall that.

20 Q. But, as a matter of practice, then, if you required to

21 consult some guidelines, are you able to say, looking at

22 the documents I have put on the screen, whether these

23 would be the documents or not?

24 A. This one certainly was the one I would have been using,

25 certainly by June 2008, and I think there was a version

20

1 before then, so I think the chances are I had that.

2 That was the one I would have pinned up on my wall in my

3 office and would be available.

4 Q. It is more accessible, it is one page.

5 A. It is a far more accessible one. The one we had

6 initially was from Stephanie Dancer, which was

7 a cardboard fold-in thing that fitted in your coat

8 pocket. At that time, we used to wear white coats.

9 I used to carry mine around with me all the time, but

10 I'm afraid, with overuse, it fell to pieces. I'm not

11 quite sure when that was no longer available. That is

12 what I used probably up until about 2005, but I don't

13 have a copy now. It has long since gone.

14 Q. Thereafter, post --

15 A. I imagine, after that, it was the Argyll and Clyde one

16 that was the one I was using, and then I think when we

17 amalgamated with Glasgow, their version became

18 available. But I don't think at any one time one was

19 officially the one and the other one was definitely no

20 longer regarded as being used. I don't remember any

21 clear guidance as to what we should be using when.

22 Q. If we look at the Greater Glasgow and Clyde formulary,

23 this is GGC18270001, is this what came into place after

24 the amalgamation?

25 A. I think so, but I'm not sure when. It says

21

1 "August 2007", but I think it was some time after that

2 before it was available. It might even have been

3 by May/June 2008. I'm not 100 per cent sure.

4 Q. To what extent would you, as an experienced

5 practitioner, require to consult a guideline to see what

6 antibiotics should be prescribed?

7 A. Well, it was always important to be clear what options

8 were being suggested, because guidelines are simply

9 that: they are suggestions for certain situations. It

10 is not always the case that the situation you are

11 dealing with is one of these situations. So the

12 guidelines are there to help you decide, is there

13 something that would be preferably used here or do you

14 have to make up your own mind?

15 Q. Would you expect the junior doctors to place greater

16 reliance on the guidelines?

17 A. Yes, I think so.

18 Q. Do you know what the junior doctors working under your

19 supervision used?

20 A. I think they had their own handbook, which I think had

21 some guidance in it as well, but also within the wards

22 they would have available the relevant guidelines at the

23 time.

24 Q. But in relation to prescription of antibiotics by junior

25 doctors, was it your practice to review what had been

22

1 prescribed by the junior doctors?

2 A. To view it, did you say?

3 Q. To review.

4 A. Review, yes. Yes.

5 Q. Would that be something you would do on a ward round,

6 when you came to doing your ward round?

7 A. Yes, we'd tend to go through the Kardex and check what

8 had been commenced and see what changes needed to be

9 made.

10 Q. Having a speciality in gastroenterology, Dr Carmichael,

11 I take it you would be familiar with the infection

12 C. difficile, even prior to the period we are looking at

13 here?

14 A. Yes.

15 Q. In relation to your own state of knowledge as to what

16 antibiotics may precipitate C. difficile, what was your

17 state of knowledge at that time?

18 A. Well, I was obviously aware of clindamycin, but that was

19 not a very frequently prescribed antibiotic, certainly

20 not in my practice. The cephalosporins were the biggest

21 bugbear. I abhorred cephalosporins. I thought they

22 were by far the biggest risk in terms of C. diff, and

23 I rarely would prescribe them without microbiological

24 advice or obvious guidance from guidelines. I would

25 tend to avoid the use of them, because I felt they were

23

1 the biggest risk.

2 Co-amoxiclav, which is coming in for a lot of stick,

3 shall we say, I saw that as an intermediate risk. It

4 wasn't nearly as risky, I felt, as the cephalosporins,

5 but perhaps not as clean as the narrow-spectrum

6 trimethoprim, et cetera. But I did see it as a very

7 useful drug. Its risk I saw as no different from

8 amoxicillin, and I saw it as a superior antibiotic to

9 amoxicillin, and used it probably more often for that

10 reason.

11 But the reason why amoxicillin was preferred in the

12 guidelines to co-amoxiclav, if possible, was nothing to

13 do with C. diff, really; it was really related to side

14 effects from the clavulanic acid, which was the

15 additional part added to the amoxicillin to make it

16 co-amoxiclav. That caused certain side effects

17 occasionally. I think one of them -- the relevant one

18 was a form of jaundice that could happen in some

19 patients. I don't think I ever saw that happening with

20 co-amoxiclav.

21 So it was a drug I was familiar with and I was

22 prepared to use under a range of circumstances.

23 Q. Before the period we are looking at, and this is

24 beginning in January 2007, what experience had you had

25 before that with C. difficile in the Vale of Leven

24

1 Hospital?

2 A. Well, if we go back to the time of Stephanie Dancer,

3 when she was at the Vale, MRSA was the thing then. That

4 was up to 2002, when she left. It was probably a year

5 or two after that that we started noticing a gradually

6 increasing frequency of C. diff being admitted, and that

7 was everywhere, that wasn't just the Vale, of course,

8 that was a general trend throughout the country,

9 throughout the western world, in fact. I think America

10 saw it first, but we were not far behind.

11 That rise was almost exponential over 2003 to --

12 well, now, for that matter. 2007, I think 2008, was

13 perhaps the peak incidence of C. diff, both in this

14 country and probably in most other western countries.

15 I think it's now starting to show signs of abating, but

16 that was the time it really peaked.

17 As I say, it was an exponential rise. I think my

18 recollection is -- I am sure I have got this wrong --

19 that the number of cases in England by 2007 had risen to

20 well over 50,000 per annum. Is that a figure that you

21 recognise?

22 Q. I will take that from you at the moment, Dr Carmichael.

23 In relation to the Vale of Leven, I think we did see

24 some figures that have been produced by, I think,

25 Mrs Murray, that in 2006 there were very few cases of

25

1 C. difficile in the Vale of Leven, as perhaps contrasted

2 to 2007/2008.

3 A. That's right. I think 2006 it was starting to rise more

4 rapidly, that's right. Before that, it had been much --

5 many fewer, and then, of course, 2007, it was a much

6 greater frequency.

7 Q. Were you, yourself, aware of the Stoke Mandeville and

8 Tunbridge Wells cases at this time that we are looking

9 at?

10 A. I've been trying to recollect when I became aware of

11 that, and it would probably be when the reports came

12 out, which I think were around about 2006/2007, 2007,

13 something like that.

14 Q. Yes.

15 A. Now, what detail I read at that time, I don't remember.

16 It would have appeared in the medical journals and

17 I would have looked at it, because of, obviously, my

18 interest in gastroenterology.

19 I had been aware of the outbreaks in Canada earlier

20 on, and I think these were 2003, reported probably 2005

21 or 2006, something like that. So I was aware that

22 things had been happening there and that the outbreaks

23 in Quebec, Canada, in particular, were the first

24 recordings of this new variance of C. diff that was

25 starting to make its presence felt.

26

1 Q. We went down this route by my asking you what your own

2 understanding was in relation to what antibiotics

3 precipitated C. diff, and you gave us some evidence on

4 that.

5 You have also mentioned that, up until 2002,

6 Dr Dancer was an onsite microbiologist, who I think you

7 said yesterday was quite hands-on in the ward; is that

8 right?

9 A. That's right.

10 Q. At that time, did she have any responsibility in

11 relation to seeing whether or not the antibiotic

12 treatment was appropriate?

13 A. Yes, she was very available to discuss issues with

14 regard to antibiotic, infection control, et cetera.

15 Q. What about the position after she left, then?

16 A. After she left, as I said yesterday, there was, I think,

17 an attempt to replace her locally, but that didn't work,

18 so thereafter we were reassured that there would be

19 a presence of a microbiologist at the Vale, and

20 certainly, to begin with, my recollection is that

21 Dr De Villiers came on a weekly basis for maybe six

22 months, roughly. I can't remember exactly how long it

23 went on for. But that stopped after a while.

24 I don't recall having seen any microbiologists at

25 the Vale with regard to coming to talk about clinical

27

1 issues on the wards. I don't recall that. That may

2 have happened, but I don't recall it.

3 Q. So if you are comparing the position before Dr Dancer

4 left and the position after that, then, can you make

5 a contrast in relation to, particularly, this area we

6 are looking at, the prescription of antibiotics?

7 A. The prescription of antibiotics? I certainly felt we

8 were vulnerable with not having a microbiologist onsite,

9 and I think I took the position that any significant

10 changes in treatment, particularly if it potentially

11 involved the likes of cephalosporins, had to be

12 discussed with a microbiologist first.

13 Now, that would not probably have happened before

14 when Stephanie was with us. I would have gone on to

15 a second line therapy with a more easy frame of mind, as

16 I said earlier, avoiding cephalosporins. I didn't use

17 them. But after she left, and after it was clear that

18 we had nobody regularly appearing on site, I felt

19 a regular contact between ourselves and the

20 microbiologists was required to authenticate, shall we

21 say, use of other antibiotics.

22 Q. Then would you, yourself, be in regular contact with the

23 microbiologists?

24 A. Personally, I wouldn't, because to get in touch with the

25 microbiologists, you'd have to go through the

28

1 switchboard, et cetera, and if you are busy doing a ward

2 round -- and it was usually on the ward rounds that one

3 would wish to get their advice -- it would impede the

4 progress of the ward round.

5 So I would leave the middle grade doctor to contact

6 the microbiologist, the middle grade who was based in

7 that ward and who was available in that ward to discuss

8 the case with the microbiologist. They'd have the case

9 notes in front of them. And I would hear about the

10 outcome of that when I next visited the ward.

11 Q. Were you aware at the time as to whether or not

12 a particular microbiologist had been designated as the

13 infection control doctor for the Vale of Leven Hospital?

14 A. No, I don't recall that.

15 Q. Yesterday, you made a comment that, in relation to the

16 role played by Dr Dancer at the Vale of Leven, that if

17 she had been in the Vale of Leven at the time we have

18 been looking at, you may not have been here then -- that

19 was yesterday. What did you mean by that?

20 A. Sorry, I don't quite ...

21 Q. I think yesterday you made a comment where you said

22 that, if Dr Dancer had remained in the

23 Vale of Leven Hospital, we would not be here today.

24 A. Well, I think that's true. Dr Dancer, or some -- if we

25 had had a replacement, somebody with her experience and

29

1 commitment, I'm sure we would have been aware of

2 the situation we ended up in at a far earlier stage.

3 Q. Were you aware, in the course of the relevant time, that

4 there were cases in the wards of patients with

5 C. difficile?

6 A. I was aware that we were having more admissions with

7 C. diff and had been over a period of time, but,

8 equally, I didn't feel it was any different than was

9 happening in most other hospitals throughout the

10 country. We were aware of, as I said earlier, an

11 inexorable rise in the numbers of C. diff throughout the

12 country, and I didn't see our experience as being any

13 different from what I gather was happening elsewhere.

14 An outbreak, one tends to think of, suddenly, you

15 have a lot of cases in the ward, and of course that was

16 not the case with C. diff. It was a slow process over

17 a 6- to 12-month period, and so it was difficult to

18 recognise that anything was different than that which

19 was happening elsewhere.

20 LORD MACLEAN: But you did say you were aware that you were

21 having more admissions with C. diff, that's patients

22 coming in with C. diff?

23 A. I was aware of C. diff -- this is the difficulty: I was

24 aware of C. diff, yes, being diagnosed in admissions,

25 sometimes coming in with it and sometimes a period after

30

1 admission.

2 My own feeling about C. diff, and I realised there

3 was this 48-hour thing of before -- developing symptoms

4 of C. diff 48 hours after admission, suggested this was

5 acquired within hospital.

6 I didn't have that clear-cut, two-day divide. I was

7 aware that C. diff could be around for a lot longer, or

8 contact with could be -- it could be some greater time

9 had passed before it became symptomatic. I didn't have

10 this 30-day or 90-day figure in my head that has come

11 out since then. But I kind of looked on it as a matter

12 of maybe one, two weeks, contact one, two weeks before

13 symptoms would appear.

14 So the two-day rule that I think existed at that

15 time I felt was rather rigid.

16 All I'm trying to say is, I didn't see the cases of

17 C. diff as necessarily occurring within the ward and

18 being caused by infection within the hospital.

19 MR MACAULAY: You weren't focusing on the number of cases,

20 then, at a given time in a particular ward?

21 A. None of us, I think, had significant numbers at any one

22 time, and I think we were aware of -- occasionally aware

23 of other cases around, but I don't think any of us were

24 aware of what the totality of it was, until, of

25 course, May 2008.

31

1 Q. Did you, yourself, have any knowledge of the contents of

2 the infection control manual at the relevant time?

3 A. I was aware of it. I'd seen it. But if you'd asked me

4 to quote from it, obviously I would -- I couldn't do

5 that. I would have to see the document.

6 Q. If we look at some of the documents in it, it's at

7 GGC00780001. The first document I want to take you to

8 is at page 252.

9 This is the C. diff policy that was in the manual.

10 Did you ever consult this particular policy?

11 A. I don't remember consulting it. I remember it being

12 available at some point. I think, in fact, the version

13 I had available was an older version than this one.

14 I probably knew this -- oh, it's 2004, right. Maybe

15 that's the one I'm referring to. Maybe that's the one

16 I was aware of being around, yes.

17 Q. I think you said yesterday that you had been on the

18 infection control committee until about 2003?

19 A. About then.

20 Q. Was there an infection control manual in place at that

21 time with this sort of policy document in it?

22 A. Yes, yes.

23 Q. We see here this is described as being NHS

24 Greater Glasgow and Clyde, which suggests that, although

25 it is dated October 2004, it may have been part and

32

1 parcel of the amalgamation.

2 A. I think the one I'm thinking of probably was an earlier

3 version than this, in that case. I can't remember when

4 it came out. I don't think it's got a date on it -- or

5 had a date on it. So this must have been a follow-on,

6 an upgraded version.

7 Q. The next document, if you could look at this, page 258,

8 this is the loose stools policy that at least was in

9 place for part of the time we are concerned with. Were

10 you aware of this policy?

11 A. I was aware of a policy, yes.

12 Q. In relation to loose stools and isolation, if you had

13 a patient who was suffering from potentially infectious

14 diarrhoea, did you consider that such a patient should

15 be isolated?

16 A. I think, if there was a significant concern that that

17 was the case, then yes.

18 Q. If you had a patient who was diagnosed with

19 C. difficile, then you would expect such a patient to be

20 isolated?

21 A. Yes.

22 Q. The other policy I want you to look at is at page 145.

23 This is described as an outbreak policy. I think we see

24 this is from December 2007, although there was, I think,

25 a previous policy which was broadly in the same terms.

33

1 Were you aware of this particular document?

2 A. I possibly was.

3 Q. What was your understanding at the time, Dr Carmichael,

4 as to what constituted an outbreak?

5 A. Right. As I say, I was aware of it being available, but

6 I don't remember actually reading it, in any detail,

7 anyway.

8 My idea of an outbreak? I don't think I had a clear

9 idea of what a C. diff outbreak was defined as.

10 I expected to be told by the infection control team

11 about an outbreak if such a thing occurred. So I didn't

12 have a clear idea in my own mind as to what that

13 constituted.

14 Q. Just focusing on the infection control team for

15 a moment, I think you told me earlier that you did not

16 know if a microbiologist had been designated as an

17 infection control doctor for the Vale of Leven at the

18 relevant time?

19 A. I had assumed that they did it in rota, as we had no

20 specific name to put to that post.

21 Q. But in relation to the onsite position, there was an

22 infection control nurse, or nurses, on site?

23 A. Yes.

24 Q. Did you have any dealings with the nurses who were

25 infection control nurses at this relevant time?

34

1 A. Well, I was aware and would bump into Helen O'Neill from

2 time to time, and maybe occasionally have

3 a conversation, but her interaction was largely with the

4 ward nursing staff, and my interaction would be through

5 the nursing staff as well, probably. So I didn't have

6 many one-to-one contacts with Helen, in terms of

7 specific clinical issues.

8 Q. Mrs Murray has been mentioned, I think, also, as at

9 least being involved in the Vale of Leven for part of

10 this period. Was she somebody that you came across?

11 A. I was less aware of Jean Murray, but I was aware of her,

12 yes.

13 Q. In relation to education and training, had you,

14 yourself, had any particular education and training in

15 relation to C. difficile within the context, in

16 particular, of infection control?

17 A. No.

18 Q. Insofar as C. difficile is concerned, as a diagnosis in

19 its own right, did you see it as an important clinical

20 diagnosis?

21 A. Oh, very much so, and it was becoming increasingly so.

22 I think, to be fair, looking back, I think most of us --

23 gastroenterologists, at any rate -- saw the risk of

24 C. diff as something that was going to hit us down the

25 road at some point, in terms of profligate use of

35

1 antibiotics over many decades.

2 So we saw it as a potential threat for the future.

3 Q. I think we know it can lead to serious complications

4 and, indeed, death.

5 A. Indeed. To be fair, the perception then was that these

6 risks were a good deal less than they have turned out to

7 be, and that was certainly the case before this outbreak

8 of 027.

9 DAME ELISH: My Lord, I wonder, before my friend leaves this

10 particular point, the Inquiry heard yesterday from

11 a witness regarding the programme known as

12 Surviving Sepsis and, given what this witness has just

13 said, I wonder whether or not this witness can assist us

14 with what relevance that had to their understanding of

15 the use of broad-spectrum antibiotics at that time?

16 LORD MACLEAN: Don't answer that question in the meantime.

17 Are you about to move on?

18 MR MACAULAY: I wasn't inclined to pursue this matter with

19 this witness.

20 LORD MACLEAN: Indeed.

21 MR MACAULAY: I'm not quite sure where this is going, to be

22 perfectly honest.

23 LORD MACLEAN: No, I am not either.

24 DAME ELISH: My Lord, perhaps I can explain. The witness

25 referred to profligate use of antibiotics in the medical

36

1 profession at that stage. My understanding is that

2 there was an international programme which exhorted

3 clinicians to tackle sepsis very early by the empirical

4 prescription of broad-spectrum antibiotics, which

5 clearly is at odds with the way in which C. diff had to

6 be approached.

7 LORD MACLEAN: Are you aware of this?

8 MR MACAULAY: I haven't looked into this matter, my Lord,

9 I must confess. If it is important, it is something

10 that no doubt we can look at and give consideration to

11 and ask the appropriate witness the appropriate

12 questions.

13 MR KINROY: My Lord, there was evidence from Dr McCruden

14 about it.

15 LORD MACLEAN: Did he answer it, though?

16 MR KINROY: I think, my Lord, I was unable to pursue it to

17 an extent, but I am certainly keen to know whether the

18 programme was a factor in --

19 LORD MACLEAN: I remember you both raising this, and my

20 saying no.

21 MR KINROY: Yes.

22 LORD MACLEAN: Isn't that right?

23 MR KINROY: My Lord, yes.

24 LORD MACLEAN: It may yet be, I don't know, I will have to

25 be persuaded, that this is a route down which we will

37

1 have to go, but I'm not quite convinced that we are

2 there and this is the right witness to speak to about

3 it.

4 DAME ELISH: The reason I raise it with this witness is,

5 while we might have an expert who could speak to the

6 nature of the programme, what I am trying to ascertain

7 through my learned friend, with your Lordship's

8 permission, is the state of mind of clinicians as

9 a result of the message that they were getting from one

10 very significant worldwide source, which was being --

11 they were being trained in at that stage, in contrast to

12 what might have been the appropriate approach to the

13 treatment of C. diff and the tensions that might have

14 existed because of those two apparently opposing

15 programmes.

16 LORD MACLEAN: Are you aware that there were such

17 programmes?

18 MR MACAULAY: Whether or not this is important, my Lord,

19 I just can't say at the moment, and relevant to the

20 Inquiry. But if it is, then it is clearly something

21 that I am quite happy to take on board and raise with

22 the appropriate witness, but I don't think this

23 particular witness is the appropriate witness.

24 LORD MACLEAN: Who do you think the appropriate witness is?

25 MR MACAULAY: Professor Duerden, who is coming to give

38

1 evidence in this whole area, if this is relevant, would

2 be the appropriate witness to deal with it.

3 LORD MACLEAN: I suppose you could ask this witness, in the

4 light of the exchange that we have had, if it means

5 anything to him.

6 MR MACAULAY: Yes, I'm more than happy to do that.

7 LORD MACLEAN: I don't know if it does.

8 MR MACAULAY: Dr Carmichael, can you help us?

9 A. Could you ask the question first?

10 Q. I think the question is in relation to the

11 Surviving Sepsis Programme and as to whether that

12 increased the prescription of broad-spectrum

13 antibiotics, in contrast to what the position should

14 have been in relation to general prescribing?

15 A. Right. I think -- obviously, this has come from my

16 rather loose use of language "profligate".

17 This was a kind of general comment as to how

18 antibiotics were being used increasingly over the '50s,

19 '60s, '70s, '80s, and so on. Having said that, these

20 antibiotics have saved innumerable lives and it is not

21 a surprise that they have been increasingly used over

22 these years as new ones have been developed. But the

23 result of that is why we are sitting here today, of

24 course, that resistant bugs do grow in due course, and

25 this is what has happened.

39

1 So there is this tension between -- and always has

2 been this tension between -- using antibiotics as

3 properly as one can, but yet protecting patients and

4 trying to prevent ill-health and death, of course.

5 The Surviving Sepsis Programme was really

6 encouraging the early use of antibiotics in these very

7 sick patients. My recollection of the package of care

8 that was recommended was that, in the first hour of

9 presentation, at, say, the accident and emergency

10 department, such a patient would be recognised as having

11 sepsis on the basis of hypotension, shock, and so on,

12 and evidence of infection.

13 In that first hour, I think, from my memory, the

14 remit was to get intravenous access, obviously, bloods

15 off to check the inflammatory, et cetera, to get fluid

16 going as quickly as possible, to do blood cultures and

17 to start intravenous antibiotics.

18 So that was the aim within the first hour of

19 presentation, and I think that is what is being referred

20 to here: the need to use these antibiotics very early on

21 before even a diagnosis is made.

22 So there is this tension between needing to use

23 antibiotics as quickly as possible and using

24 broad-spectrum antibiotics and the risks of so

25 engendering resistant bugs in that individual and, of

40

1 course, in the community at large by that policy of

2 using antibiotics perhaps in situations where one could

3 have done other things.

4 But in this particular group of patients, very sick,

5 septic patients, one has to intervene very quickly.

6 I think that is what is being referred to.

7 Q. That qualification you have made at the end, you are

8 dealing with very sick patients?

9 A. Yes.

10 Q. With sepsis, in fact.

11 DAME ELISH: I wonder, my Lord, on that particular point --

12 LORD MACLEAN: No, go ahead.

13 MR MACAULAY: If I could just finish my line of thought.

14 I think you have indicated that it was well known, at

15 the time we are concerned about, that broad-spectrum

16 antibiotics could precipitate an infection like

17 C. difficile?

18 A. It was well recognised that the increasing use of more

19 broad-spectrum antibiotics over the decades was running

20 the risk of increasing the likelihood of resistant

21 C. diff, yes.

22 Q. Was it well known that if you could use

23 a narrow-spectrum antibiotic, then that was the route to

24 take?

25 A. That was the perception, that by the use of

41

1 narrow-spectrum antibiotics, we would hopefully avoid

2 this scenario. But, of course, the very reason why we

3 end up with these large-spectrum antibiotics is because,

4 as time has gone on, these narrow-spectrum antibiotics

5 have become less and less useful, in some situations,

6 not all situations.

7 Q. Is the philosophy behind the formularies we have

8 actually looked upon today just that, that you seek to

9 find the narrowest-possible-spectrum antibiotic?

10 A. That is right.

11 Q. For example, if you have a patient who presents with

12 a urinary tract infection, then you begin with a drug

13 like trimethoprim; is that right?

14 A. If one is dealing with a straightforward urinary tract

15 infection without any other issues, then yes.

16 Q. If you don't, if you have a patient who has got signs of

17 infection, then there are perhaps a number of things you

18 can do: you can take blood samples, and so on, and see

19 if you can identify the source of the infection, and

20 then prescribe antibiotics on that basis; is that right?

21 A. In an ideal world, that would be exactly how one should

22 proceed: get a diagnosis first and then treat it. But

23 unfortunately, patients don't necessarily present that

24 way and allow you the time to do that, because that

25 could take some time, several days, to reach that

42

1 situation.

2 Q. Indeed. The alternative, then, would be to start on

3 a broad-spectrum antibiotic and then, once you know what

4 you are dealing with, to narrow it down to the narrower

5 spectrum?

6 A. Again, it depends on the clinical situation. If the

7 patient is not unwell, then one would be tempted to use

8 a narrow-spectrum antibiotic, running the risk that that

9 might not cover it, but if the patient is sick, and

10 particularly if that patient is elderly, frail, other

11 comorbidities, one would be anxious to make sure one is

12 treating the infection as well as one can, and one would

13 tend, then, to perhaps go for a broader-spectrum

14 antibiotic, just to cover that situation.

15 Q. And investigate to see whether one could identify the

16 bug?

17 A. If one could, yes.

18 MR MACAULAY: I think I interrupted my learned friend.

19 LORD MACLEAN: I wanted to ask you, before anyone else does,

20 when you gave that, if I might say so, very interesting

21 answer about dealing with people in the first hour who

22 are seriously unwell with sepsis -- right?

23 A. Yes.

24 LORD MACLEAN: Could you put that into a time context for

25 me? What period were you talking about?

43

1 A. Well, these are the patients presenting usually at the

2 A&E department, but it might of course be in the wards,

3 a patient who has suddenly deteriorated, and the doctor

4 would assess the patient, of course, and if that

5 assessment reaches the diagnosis that the patient is

6 very likely to be septic from, say, a urinary source or

7 a chest or an intraabdominal -- whatever source, if the

8 impression is that that patient has the sepsis syndrome,

9 and that is a diagnosis based on a number of factors,

10 but the dominant factors are evidence of infection

11 somewhere and evidence of that effect, the effect of

12 the infection, leading to, usually, hypotension and

13 other metabolic abnormalities, some of which would be

14 evident in the results of blood tests taken at the time.

15 So that diagnosis of septic syndrome would probably

16 require the results of some blood tests as well as

17 a physiological assessment of the patient.

18 LORD MACLEAN: And be treated with?

19 A. And once you reach that diagnosis, as I said earlier,

20 you would want intravenous access, so you could give

21 fluids and intravenous antibiotics, and you would start

22 them on the appropriate antibiotics as soon as you

23 possibly could, once you've got that access.

24 LORD MACLEAN: "Appropriate" being broad spectrum?

25 A. Very likely broad spectrum, to cover a range of options,

44

1 because in that septic patient you are not entirely

2 clear, perhaps, what the source of infection is: is it

3 the chest, the urine, some other source? So we would

4 try and cover, as far as one could judge, what was most

5 likely to be causing that sepsis.

6 LORD MACLEAN: In what period of your practice as

7 a consultant were you doing this?

8 A. I think, strangely enough, the sepsis approach probably

9 arose around about the same time.

10 LORD MACLEAN: The same time as?

11 A. The same time as we are talking about. It was about

12 2005/2006, I think, the move towards treating the septic

13 patient in this way became more prominent, around about

14 that time, 2005/2006, I think. So roughly around about

15 the same time.

16 LORD MACLEAN: Was there a tension? A tension between

17 treating such a patient in this way and the likelihood

18 of causing other illnesses?

19 A. No more than has been the case for a good number of

20 years. We have been well aware that we have been using

21 broad-spectrum antibiotics in sick inpatients for

22 a number of years and running the risk of leading to

23 resistant organisms of different types, of course, and

24 that has been happening because, 30 years ago, an

25 elderly patient would come in with a chest infection and

45

1 probably very rapidly settle with a relatively

2 narrow-spectrum antibiotic.

3 Nowadays, that same patient coming in might require

4 two or even three courses of antibiotics at times to get

5 them settled down, because the organisms have become

6 partly resistant to the first-line drugs. So that is

7 a general trend: that it is becoming more difficult to

8 treat such patients.

9 LORD MACLEAN: Dame Elish?

10 DAME ELISH: I'm very grateful, my Lord. That has covered

11 much of what I wished to add. There is one small point

12 of clarification. My learned friend mentioned that,

13 assuming once the unknown sepsis was treated with

14 a broad spectrum, would the clinician then move on to

15 a narrower spectrum. Could I clarify with the witness

16 whether or not, if the patient was responding well to

17 the broad-spectrum antibiotic and becoming better, would

18 that influence the decision of the clinician whether or

19 not to then move on to a narrower spectrum?

20 A. The decision would be based on results of cultures,

21 basically. Now, if one got back a blood culture showing

22 a definite organism that fitted in with what one

23 suspected and you were given the choice of

24 a narrower-spectrum antibiotic at that point, then one

25 could change to that, and one would probably tend to do

46

1 that. That reality was infrequent when we'd normally

2 find it difficult to isolate a specific organism in such

3 patients, either from the chest or from the blood or

4 from the urine.

5 But, as I said, if you did come up with a definite

6 organism, then one would wish, if the situation allowed,

7 to change to a narrower-spectrum antibiotic.

8 MR MACAULAY: Just in looking to the response you made to

9 his Lordship and the use of broad-spectrum antibiotics,

10 did I understand you to say that broad-spectrum

11 antibiotic prescribing was in place before the

12 Surviving Sepsis?

13 A. Oh, yes, over the decades, the pharmaceutical industry

14 has come up with many -- mostly broad-spectrum

15 antibiotics, as time has gone on, to cover the

16 increasing issue of -- well, resistance; to be more

17 effective. But that has the downside of increasing

18 resistance again. So it is a situation that is

19 perpetuating itself, shall we say.

20 Q. Were you aware at the relevant time that an

21 antimicrobial team had been set up to look into

22 antibiotic prescribing generally in the Greater Glasgow

23 and Clyde area?

24 A. I was aware of initiatives like that, and I think it is

25 Scotland-wide as well. I think there were other

47

1 initiatives going on.

2 Q. Indeed. Indeed, after matters came to a head in the

3 Vale of Leven, in about May or June 2008, was there

4 a fairly swift change in the manner in which antibiotics

5 were to be prescribed?

6 A. Yes. I think that change had already been happening

7 elsewhere in Glasgow, and we were somewhere on the list

8 to -- for it to happen as well. I think that was the

9 case. So it happened very quickly because of that.

10 They already had prepared the case for change and were

11 rolling it out throughout the hospitals within

12 Greater Glasgow.

13 Q. But in relation to the Vale of Leven, was it the

14 Vale of Leven situation that was the catalyst for the

15 change where you were?

16 A. Yes.

17 Q. Broadly, then, the difference between the pre- and

18 post-June 2008 positions was what? What was the

19 difference, broadly, between the two positions?

20 A. Right. It was really a range of things. Obviously

21 cleanliness issues and the physical nature of

22 the ward --

23 Q. If we are focusing on prescribing antibiotics.

24 A. Prescribing. With regards to prescribing, yes,

25 a greater need to restrict certain groups of antibiotics

48

1 than had been the custom up until that point, because

2 although we were aware of the issues involved in

3 prescribing broader-spectrum antibiotics, I think there

4 had been no overwhelming consensus amongst the

5 clinicians at large to implement a much more restrictive

6 approach to antibiotic use. We knew what we should be

7 doing, but I don't think anybody had really bitten the

8 bullet and said, "This is what we all must do from now

9 on".

10 MR KINROY: My Lord, I think there may be an important

11 correction to be made to the transcript. I can't

12 confess I know what was actually said, but at page 48,

13 line 22 -- I'm not going to say what I think the answer

14 should be, but I think there may be a need to examine

15 whether there was or was not an overwhelming consensus.

16 I don't want to give evidence myself to suggest an

17 answer, but I suspect there's something that needs to be

18 corrected.

19 MR MACAULAY: I think what you said was there had been no --

20 LORD MACLEAN: Yes, it is "no overwhelming consensus", isn't

21 it?

22 MR KINROY: That's what I thought.

23 LORD MACLEAN: That's what I thought you said.

24 A. Yes, that is my understanding.

25 MR MACAULAY: It is just the transcript said "there was an

49

1 overwhelming" and it is a "no" that should be there.

2 A. I beg your pardon.

3 LORD MACLEAN: "There was no overwhelming consensus".

4 The new policy certainly can put you in the right

5 direction?

6 A. I think that is now --

7 LORD MACLEAN: The bullet was bitten.

8 A. The bullet has been bitten, as they say. I think,

9 nationwide, the move certainly has been in the last few

10 years to try to be more restrictive in the use of these

11 particular broad-spectrum antibiotics.

12 MR MACAULAY: Coming back to the change in the

13 Vale of Leven, did that then result in guidance being

14 issued as to what antibiotics should be prescribed for

15 particular conditions?

16 A. Yes.

17 Q. If we look at the document, it is at GGC06380009. Can

18 we see this is another version of the empirical

19 antibiotic therapy guidelines, and do you recognise this

20 as something that came into force after June 2008?

21 A. Yes.

22 Q. We can see that it is attached to an email, if we turn

23 to page 1 of the document. We have an email from

24 Evelyn Forrest, dated 22 July 2008, addressed to

25 a number of people, making reference to a document that

50

1 summarises the actions and changes to guidance. If we

2 turn to the next page, page 2, I don't know if you saw

3 this at the time or not, but can you see that a number

4 of points are made, for example, point 1:

5 "The main modifications within GGC guidance are ..."

6 And in bold print:

7 "Stop and think before prescribing an antibiotic."

8 Was this seeking to change the culture of antibiotic

9 prescribing at this time?

10 A. Yes.

11 Q. So far as you could see, was this in response to the

12 Vale of Leven experience?

13 A. Well, yes, I think that was -- as I said earlier,

14 I think already such guidelines were being promulgated,

15 but I think the Vale's situation may have accelerated

16 that.

17 Q. You think, am I right in thinking, that such guidance

18 had already been promulgated to other hospitals in

19 Argyll and Clyde?

20 A. I may be mixing up two things, but I think that was my

21 understanding, that Dr Seaton was going around the

22 Glasgow hospitals and extolling the virtues of this

23 approach.

24 LORD MACLEAN: Could I ask you about the particular

25 document? Could you go back to the first page?

51

1 MR MACAULAY: Indeed, the first page, page 1.

2 LORD MACLEAN: Yes, that's right.

3 A. Can I perhaps add, my understanding was that this

4 approach had been stimulated by the perception of large

5 numbers of C. diff in some of the larger teaching

6 hospitals in Glasgow in the year or so preceding the

7 Vale's outbreak. I think there were large outbreaks in

8 the Western, Gartnavel, Stobhill, et cetera, so I think

9 perhaps that was a stimulus for this, and then, of

10 course, the Vale happened and that added extra impetus

11 to certainly produce it at the Vale. That is my

12 understanding.

13 LORD MACLEAN: It is the policy itself. I wanted to ask

14 you, is this the first time it has appeared in this

15 format, or is it another edition?

16 MR MACAULAY: It is another edition. I think, if we can put

17 on the screen beside it, if we can squeeze it on,

18 GGC22180001.

19 I think I had taken from you that the document on

20 the right may have been a document that was in place

21 certainly in 2008, before June 2008, as the empirical

22 guideline?

23 A. That's -- I think so. I think that's the one I --

24 LORD MACLEAN: The one you used, yes.

25 A. I think so.

52

1 MR MACAULAY: We can compare and contrast that version to

2 the version that appeared after June 2008, which is the

3 other version that we can now focus on.

4 LORD MACLEAN: Yes. Thank you very much. It is quite

5 considerably reviewed, isn't it? It must be. I'm not

6 in a position to make a comparison, but there were quite

7 major changes.

8 A. I'd have to go through it section by section, but there

9 were certainly significant changes.

10 LORD MACLEAN: Yes. Right.

11 MR MACAULAY: My Lord, that might be an appropriate time to

12 have a break.


14 (11.20 am)

15 (A short break)

16 (11.50 am)

17 MR MACAULAY: Before the break, Dr Carmichael, we had looked

18 at the change in antibiotic practice post June 2008. If

19 I could just go back to the document we had on the

20 screen, that's at GGC06380001. If you turn to page 2,

21 this is the message from Scott Bryson -- you see that on

22 the next page, page 3 of the document. If we go back to

23 page 2, the second paragraph is to the effect that:

24 "CDAD [that's C. difficile associated disease] is

25 increasing throughout Scotland with recent local

53

1 outbreaks highlighting the associated mortality and

2 morbidity. The role of broad-spectrum antibiotics in

3 increasing susceptibility to CDAD is, without question,

4 of fundamental importance."

5 It goes on:

6 "Antibiotics implicated include a number of commonly

7 used agents: cephalosporins; co-amoxiclav (Augmentin);

8 and fluoroquinolones ..."

9 And there is mention of ciprofloxacin.

10 I don't think you mentioned ciprofloxacin in your

11 evidence earlier, but were you aware that ciprofloxacin

12 did also impact upon patients and might make them more

13 susceptible to C. difficile, at the time?

14 A. Yes, I was.

15 Q. It goes on to say:

16 "The main modifications within GGC guidance are ..."

17 Then, particularly at 4, 5, 6 and 7, is there

18 information given in relation to the restriction on

19 certain antibiotics? Do you see that?

20 A. Yes.

21 Q. Had that guidance been in place during the period we are

22 concerned with, would that have made it less likely that

23 broad-spectrum antibiotics would have been prescribed in

24 certain circumstances?

25 A. As I said earlier, guidelines, as they were envisaged,

54

1 were simply that before, guidelines, and not as

2 restrictive as this has now become. It is more the

3 change of culture that is the difference. There is no

4 real difference in terms of what is being highlighted as

5 being desirable, it is a question of how rigidly it now

6 is going to be applied. I think that is the flavour of

7 this as compared to what happened before.

8 The language is stronger, certainly, in terms of

9 cephalosporins and clindamycin -- sorry, and

10 ciprofloxacin, but I think it is more the emphasis on

11 adherence that is the difference, as compared to what

12 existed before then, before 2007.

13 Q. Looking at the question I put, then, would it have been

14 less likely, then, that broad-spectrum antibiotics would

15 have been prescribed if this approach had been taken at

16 the relevant time?

17 A. I think if this had been sold to everybody by a presence

18 and somebody really saying, "This is what has been

19 agreed, this is what" -- and giving reasons, and so on,

20 explaining what had happened down south and just brought

21 everybody up to date with how things were, it might have

22 made a difference.

23 MR KINROY: My Lord, I wonder, with your Lordship's

24 permission, whether we could clarify, Dr Carmichael said

25 there was a change of culture which he, in many ways,

55

1 feels was more important than any substantive change to

2 what was allowed or what was recommended or not. Might

3 we explore or discover if he agrees if that change of

4 culture occurred, not just within the Vale of Leven, but

5 within other hospitals?

6 LORD MACLEAN: Would you know?

7 A. Well, that's certainly the message that was coming back,

8 that this was being applied nationwide and, as far as

9 I'm aware, was being adhered to more so than in the

10 past.

11 LORD MACLEAN: Elsewhere?

12 A. Elsewhere. In terms of the timeframe for that, we are

13 talking about this timeframe. When this was being

14 rolled out to the Vale was when I think it was happening

15 throughout Scotland, really, wasn't it? I think that's

16 the case.

17 MR MACAULAY: What was the position in the Vale of Leven in

18 relation to pharmacy input into the prescription of

19 antibiotics, and I'm focusing on the relevant time, and

20 I will also ask you about the period after this.

21 A. Right. As far as antibiotic prescribing is concerned,

22 I know they took a role in terms of the

23 intravenous-to-oral timeframe. We had a ruling that

24 intravenous antibiotics should be changed to oral as

25 soon as clinically indicated, and usually that was

56

1 within 24, perhaps 48, hours of starting IV antibiotics.

2 So they had a role there in trying to make sure the

3 junior doctors adhered to that.

4 I can't recall having any broader remit in terms of

5 advising junior doctors about length of prescription,

6 et cetera. I don't remember that.

7 Q. Did the position change after June 2008?

8 A. In terms of the pharmacy role -- remembering that

9 pharmacies -- resources were limited, and I don't think,

10 for example, they had a presence in all the acute wards

11 around that time. I think they would like to have had,

12 but I don't think they had the resources to do that. So

13 I can't actually remember what happened after 2008, to

14 be quite honest.

15 Q. I think earlier I took you to some of the prescribing

16 guidelines, and can I just, in light of one or two

17 points you made, put one or two further documents in

18 front of you? The first of these is INQ01300001.

19 This document is dated, as you can see,

20 January 1997. It runs on to perhaps four pages. We can

21 move on to page 2 and page 3. You will see there are

22 principles of antimicrobial therapy given in a box to

23 the left-hand side here. We can read the first

24 sentence:

25 "Antimicrobial agents should only be prescribed when

57

1 a patient's clinical condition indicates infection."

2 There are exceptions given to that. Then, finally,

3 page 4, where, again, there are guidelines given as

4 well. Do you see that?

5 A. Yes -- well, obviously, the section on the left is

6 partly obscured.

7 Q. Yes, it is. Going back, then, to page 3, the guidance

8 at 4 says:

9 "When the sensitivity pattern of an organism is

10 known, use an antibiotic with as narrow a spectrum as

11 possible."

12 That appears to have been guidance in January 1997.

13 Was this a document you were aware of?

14 A. Yes. This may have been the one I referred to earlier

15 that was in a card form that we kept in our pockets that

16 Dr Dancer was responsible for. I may be wrong about

17 that, but that looks very similar. But, yes.

18 Q. There is another one that I want to put to you as well,

19 and this one is at INQ01310001. This is headed

20 "Vale of Leven District General Hospital". If we move

21 on to the page -- I think it consists of four pages --

22 page 2 and then page 3, and you will see that on the

23 left-hand side of page 3 there is a similar box to what

24 we'd seen in the previous one, but this says

25 "Revised January 2000", so this is still at a time when

58

1 Dr Dancer is present.

2 A. Yes.

3 Q. Could this, again, be part of what Dr Dancer had been

4 involved in producing?

5 A. Yes, I think so.

6 Q. I think you told us earlier that this, in particular,

7 was something that you had with you, certainly leading

8 up to the time we are concerned with; is that correct?

9 A. Well, I think mine disintegrated a few years before that

10 point, but, yes, I had had it for a good number of

11 years.

12 Q. We talked earlier about the importance of C. difficile

13 as an important clinical diagnosis in its own right.

14 Looking to the treatment of C. difficile, I think we

15 have heard that, generally, a patient will be started on

16 metronidazole, all things being equal?

17 A. Yes.

18 Q. Once a patient certainly had been diagnosed with

19 C. difficile, would it be important to carry out

20 a clinical assessment of the patient?

21 A. Yes.

22 Q. What do you consider that should involve?

23 A. Regular examination of the patient and regular checks of

24 their inflammatory progress -- inflammatory blood

25 markers, and of course their physiological status.

59

1 Q. Just looking to the clinical assessment, would that

2 include an abdominal examination generally?

3 A. Usually.

4 Q. What about the use of stool charts at the relevant time?

5 Did you see stool charts as an aspect of management?

6 A. On occasion. On occasion.

7 Q. Were stool charts in place, so far as you could see, in

8 relation to patients that you were involved with?

9 A. For selected patients. Not in everyone with diarrhoea,

10 but certain patients.

11 Q. Would that be something that you would advise at the

12 time, or not?

13 A. In an ideal world, it would be best to have these

14 monitored in everybody who required it, but in a busy

15 acute medical ward, where nurses' time is of

16 the essence, I didn't insist on having everything

17 charted that one would normally wish to be charted.

18 I reserved my requests for those situations where I felt

19 it was necessary to be more thorough.

20 Q. What about the fluid management, then? I think we are

21 aware that, in patients with C. diff, fluid management

22 can be an important aspect of care. Is that right?

23 A. Yes, absolutely.

24 Q. What about the keeping of fluid balance charts, then,

25 for such patients?

60

1 A. Again, the rigour with which that would be done would

2 vary. Again, I would request more rigorous charting

3 where I felt it was necessary. But I didn't insist on

4 it in every case.

5 Q. If you had a patient who had had C. diff and, again, was

6 diagnosed -- or again developed diarrhoea, rather, would

7 that mean there would be a high index of suspicion that

8 this again was a relapse or a recurrence of the C. diff?

9 A. I think that would usually be the case.

10 Q. Would that demand starting treatment there and then, or

11 what would your practice have been?

12 A. Again, the situation would have to be assessed in each

13 individual case. I think, in general, one would wish to

14 assume that that was a most likely explanation, if it

15 was a relapse, and one would therefore isolate the

16 patient again, if that patient was out of isolation, and

17 one would check the stool sample.

18 The stool sample result should be back fairly

19 quickly and, depending on the clinical situation, one

20 could wait until that came back. But, of course, given

21 that they have already had an episode of C. diff, if

22 a stool sample comes back negative, one is left with the

23 quandary, what does one do then? The chances are, in

24 most situations, they would be recommenced on an

25 appropriate anti-C. diff antibiotic.

61

1 Q. What understanding, at that time, did you have of

2 the possibility of false negative results?

3 A. My understanding was that the tests we had were

4 reasonably good and that -- with an accuracy of about

5 85 per cent; in other words, a 15 per cent false

6 negative. So a result coming back would be reasonably

7 robust.

8 Q. So do I take it from that that you would proceed on the

9 basis of the result, or could the case be governed by

10 clinical signs?

11 A. Again, it depends on the clinical picture. If one's

12 suspicion of C. diff is fairly low and you get a result

13 back that is negative, I would probably be inclined to

14 move on to other explanations and investigate for other

15 explanations.

16 If my index of suspicion was higher, I would request

17 a second sample to be checked. Otherwise, in every

18 patient with diarrhoea, if one is checking two, three

19 times, it puts an onus on the lab. But obviously it is

20 the clinical situation that dictates what one would

21 normally do.

22 Q. If you had a patient who was confirmed to have C. diff,

23 what was your practice in relation to other antibiotics

24 that the patient might have been on at that time?

25 A. Again, the clinical situation dictates that. If

62

1 somebody is being treated for a serious infection and

2 develops C. diff in the course of that treatment, one

3 has to make a judgment as to whether to continue the

4 antibiotics as they are, change to something that is

5 perhaps a safer option, or even discontinue, and each

6 individual case has to be judged appropriately.

7 Q. Do I take it from that answer that you would review the

8 position?

9 A. I would review the position, yes.

10 Q. Just returning to the matter of the frequency of medical

11 review, I think you have given us information about your

12 own ward round commitments.

13 If you had a patient who contracted C. diff, would

14 you expect a doctor to review that patient on an ongoing

15 basis?

16 A. Yes. In the medical wards there would be a middle grade

17 and junior medical staff available during the weekdays,

18 from Monday to Friday, and I would expect all patients

19 to be assessed on a daily basis.

20 Usually, that would require leaving a note in the

21 case notes, and that would mostly be the case, depending

22 on the clinical situation. So I would expect some kind

23 of review every day, yes.

24 Q. What about your own involvement, if you had a patient

25 who became unwell? Would you review that patient

63

1 outwith your normal ward round commitments?

2 A. If alerted to a deterioration in a particular patient,

3 I would want to go and see that patient, and would do

4 so, depending on the situation. I may be happy to

5 accept the middle grade doctor's assessment at the time

6 and we would arrive at a programme of management for

7 that particular patient at that time. That might be

8 sufficient for me to leave off seeing the patient either

9 until my next formal ward round or at a time when

10 I could go and see the patient.

11 For example, not infrequently, middle grade staff

12 would come up to the endoscopy suite to discuss

13 a patient with me. At that particular time I couldn't

14 go down, because I was busy. I would give instructions

15 as to what should be done. They would report back to me

16 later on, perhaps, in the day and I would decide then

17 whether to go and see the patient after my endoscopies

18 or wait until, say, the following day.

19 Q. Do I understand from your answer that the alert would

20 come from the doctor?

21 A. Usually. If I had a patient that I'd received, say, and

22 I was concerned about them, then I would probably go

23 back the following day as well at some point, either

24 before, say, an endoscopy list or a clinic, or whatever,

25 or afterwards.

64

1 DAME ELISH: My Lord, I wonder whether my friend could

2 clarify whether or not in that circumstance, or similar

3 circumstances, would this witness have noted that

4 discussion in the medical records, if he'd been remote

5 from the ward at the time?

6 LORD MACLEAN: Would you?

7 A. Do you mean, having discussed it with the middle grade

8 staff, that they'd made a note in the notes pertaining

9 to that discussion?

10 DAME ELISH: Yes.

11 A. That would hopefully happen, but couldn't be always

12 relied on as happening, but usually one would expect to

13 see that in the notes.

14 LORD MACLEAN: But who would make the entry?

15 A. The doctor that I was discussing it with.


17 MR MACAULAY: Of course, you wouldn't be there to make the

18 entry.

19 A. I wouldn't be there, that's right.

20 Q. We have heard some evidence that there was a hospital

21 intranet in place at the relevant time; is that correct?

22 A. Yes.

23 Q. Did you make use of that facility?

24 A. I personally didn't use it. It required passwords and

25 it required a bit of time to get it kick-started into

65

1 operating for the individual operating it, so I relied

2 on the ward staff to use their codes to get it going.

3 Q. We have also heard some evidence about mortality audits.

4 Did you participate in these audits?

5 A. These took place on roughly a monthly or two-monthly

6 basis at our Wednesday -- no, our Thursday lunchtime

7 meeting for the medical unit, and was presented by one

8 of the FY1s. So I would be there if I could be there.

9 I think, as I explained yesterday, there were times

10 when I would have to go away early to start an earlier

11 endoscopy list than normal, but usually I would manage

12 to be there for most of the meetings.

13 Q. If we look at what documentation we have on this, it is

14 INQ03080001. You will see that this bears to be

15 a PowerPoint presentation, I think, and we see the date

16 is January 2008 and it was presented by Dr Mackay. Can

17 you remember if you were in attendance for this

18 particular presentation?

19 A. Well, I think I have read about this one from -- is it

20 Dr McCruden's evidence? I also personally don't

21 remember that particular one, because this is the one

22 where there were three cases of C. diff identified; is

23 that right?

24 Q. No, I don't think so.

25 A. Is it not?

66

1 Q. It was certainly reflecting on a month in which there

2 had been a number of C. diff deaths.

3 A. Yes.

4 Q. But I think, as Dr McCruden pointed out, audits were not

5 carried out on all the patients who died, for whatever

6 reason. What I want to ask you is whether at any of

7 the mortality audit meetings that had taken place in

8 this period there was a particular focus on C. diff

9 deaths?

10 A. I don't remember that.

11 Q. I think we heard from Dr Johnston that there was an

12 occasion when there were two cases presented at one of

13 these meetings where C. diff had been the cause of

14 death. That doesn't ring any bells with you, does it?

15 A. Again, that doesn't ring any bells with me. I may have

16 missed that meeting.

17 Q. I now want to move on, Dr Carmichael, to look at some

18 cases that you had some involvement in.

19 A. Okay.

20 Q. The first case I want to look at briefly, and this is

21 going back in time somewhat, is the case of John Miller.

22 I think you have a hard copy of the medical records

23 somewhere. The medical records are at GGC00590001.

24 Mr Miller was admitted to the Vale of Leven on

25 2 March 2007, and if we turn to page 13, first of all,

67

1 we see the admission date in the medical assessment

2 unit, and the presenting complaint is said to be a GP

3 referral with "?chest infection". If we turn to

4 page 15, do we see here that your name is mentioned as

5 the admitting consultant?

6 A. Yes.

7 Q. So was this a patient that came under your care?

8 A. Yes.

9 Q. If we turn to page 17, there is an entry for

10 2 March 2007. Is that your handwriting, Dr Carmichael?

11 A. Yes.

12 Q. What was the position, then, when you -- you have

13 provided quite a detailed note. What was the position

14 of this patient when you saw him? I think this was the

15 first time you saw the patient.

16 A. This was my first assessment of him. As stated, he was

17 a known prostatic cancer who had finished several

18 courses of chemotherapy a few months previously and had

19 developed what his GP called a flu-like chest infection

20 in January, which was treated with antibiotics by the

21 GP. But he never quite recovered from that. At least

22 that was the clinical impression, anyway. Although he

23 had no overt chest symptoms, he was still breathless,

24 more breathless than usual, on exertion.

25 He also had a painful right leg, and that had been

68

1 going on for some time. It was unclear what that was

2 due to. It had been particularly bad for a few days.

3 I wondered about a metastatic involvement from the

4 tumour as being a cause of that.

5 However, as you see there, I was obviously concerned

6 about a very marked elevation of his white cell count

7 and his CRP, which, as you know, is an inflammatory

8 marker. Although his temperature was normal, it was

9 evident that there was -- in his urine, he had blood,

10 protein and white cells, suggesting perhaps that he

11 might have an infection onboard.

12 So the acute, if you like, the initial need was to

13 try and establish if he did indeed have infection and

14 deal with it. We are dealing with a patient with

15 obviously significant health issues, and one is wanting

16 to not linger too long in dealing with an infection,

17 because their immune status is going to be affected by

18 that process of cancer and then the chemotherapy.

19 So, as you see there, I'm predominantly thinking of

20 a urine side of infection, but given the GP's story, and

21 a presumed reduced immunity, or a reduced resistance to

22 infection, one has to consider other options too.

23 Anyway, because of this I felt putting him on

24 co-amoxiclav after sending off cultures of urine and

25 blood, and so on, was an appropriate action to take,

69

1 pending further investigation.

2 Q. I don't think there is any criticism of that.

3 Am I understanding from what you said, then, that

4 certainly a urinary tract infection formed very much

5 part of your thinking at this time?

6 A. It sounded as if that was the most likely explanation.

7 Q. If we look at the results of the urine sample, I think

8 there are maybe two, at page 79, and also -- look, first

9 of all, at page 79. There is a specimen that was

10 collected on the 2nd, having been analysed. It doesn't

11 appear to have been received by the lab until the 5th,

12 according to what's noted here. Certainly on the

13 culture there was no significant growth noted. Do you

14 see that?

15 A. Yes.

16 Q. Just put that aside for the moment and look at the next

17 one, which is taken on 3 March. This is on page 78.

18 Can we see here that a coliform bacteria was isolated,

19 but that that was said to be resistant to co-amoxiclav?

20 A. That's right.

21 Q. Looking to that, then, should the antibiotic therapy

22 have been reviewed, particularly standing the suggestion

23 here that the bacteria was resistant to the co-amoxiclav

24 that had been prescribed on an empirical basis?

25 A. When that information became available, yes, but my

70

1 understanding was that the patient was transferred to

2 ward 5 after I saw him on 2 March and, unfortunately,

3 the juniors didn't take me to him when I did my ward

4 round that day -- that's 5 March, I beg your pardon,

5 when I did my follow-up ward round.

6 I think I heard about him being missed out late in

7 the day, and went to ward 5. Now, unfortunately, there

8 is no note in the notes -- in the medical notes to show

9 that that's the case, but it is noted in the nursing

10 notes.

11 Normally, I would have written in the case sheet,

12 but maybe it wasn't available for some reason at the

13 time. But at that time, certainly, the results of

14 the CSU were not back. I think I did request that they

15 try and find that. I think, from my understanding, the

16 results of both of these urine cultures didn't become

17 available to the ward until 12 March. That's my

18 understanding.

19 Q. That may or may not be correct, but certainly, on

20 12 March, you saw the patient, according to the clinical

21 notes.

22 A. Yes.

23 Q. If we turn to page 19, there's an entry by you on the

24 12th where you do say, "Stop the co-amoxiclav"?

25 A. Yes.

71

1 Q. Do you consider it would take as long as that for

2 a result?

3 A. It shouldn't have. I would have thought that the junior

4 staff would have made a point of finding out what the

5 results were, because, after all, this was ten days

6 later.

7 I think the results actually did come back to the

8 ward after that ward round, because I have not mentioned

9 them in this note, so I didn't actually know the

10 results, but he'd already had co-amoxiclav for ten days,

11 so it was appropriate to stop it then.

12 Q. I suppose then there are a number of points we can look

13 at. If we go back to the lab report on page 78, this

14 was the specimen that was received by the lab, according

15 to the document, on the 5th, and this is the result that

16 tells us that the bacteria was resistant to the

17 co-amoxiclav.

18 Had that result been available timeously in the

19 ward -- let's assume for the moment it wasn't before the

20 12th -- would that have resulted in a review of

21 the antibiotic treatment?

22 A. Most certainly.

23 Q. Would you say that it would have resulted in the

24 stopping of the co-amoxiclav --

25 A. Yes.

72

1 Q. -- and considering other therapy if such as required?

2 A. Yes.

3 Q. You have indicated yourself, looking at the record, the

4 note on page 19, for the entry you have made for the

5 12th, if we go back to that, that you think that the

6 report of the specimen had not been made available to

7 the ward by this time.

8 A. Yes, and I don't really understand why it would take so

9 long to get back to the ward. After all, it was signed

10 off, I think, on 5 March, and that is a whole week to

11 get back to the ward. So I don't understand that. That

12 doesn't make sense to me.

13 Q. Would you have expected a junior doctor, not having seen

14 the result coming in, to have chased it up?

15 A. I would have hoped so, but obviously it didn't happen.

16 I should say that, as well as not taking me to see the

17 patient on the 5th, my next ward round should have been

18 the Thursday following that, which I think is the -- is

19 that the 9th or the 10th? I should have seen the

20 patient then as well, but, again, I wasn't taken to see

21 the patient. So I was unable to exhort staff to look

22 for that result, or these results.

23 Q. Would it be fair to say here, then, Dr Carmichael, that,

24 in the whole circumstances, the patient would appear to

25 have been on a course of co-amoxiclav for longer than he

73

1 should have been?

2 A. Yes.

3 LORD MACLEAN: When you get a lab report which says report

4 on a certain date, what does "reported" mean?

5 A. I think that means it's been seen by the microbiologist

6 and signed off, so it would be copied to the ward,

7 a hard copy would be sent to the ward, that would be the

8 form of communication.

9 LORD MACLEAN: Did you find out if it had been?

10 A. That's what I'm saying, the hard copy arrived in

11 ward 5 -- I presume it was ward 5 -- on 12 March. That

12 is what I understand to be the case. Reading the

13 nursing notes, that would appear to be what happened.

14 MR MACAULAY: Remind me, when you first saw Mr Miller, was

15 that in ward --

16 A. It would be ward 3, presumably. Was it ward 3?

17 Q. That's the male receiving, the male acute ward?

18 A. Yes.

19 Q. We don't know, but the report might have been sent to

20 ward 3?

21 A. It's possible it went back to ward 3.

22 Q. In any event, it should still have been known before you

23 stopped the antibiotics after about ten days or so?

24 A. Yes. Now, as I say, on the 12th, when I saw him,

25 I didn't have these results, even though they came back

74

1 later that day, but what I was concerned about, as well

2 as him being on co-amoxiclav for ten days, was that his

3 white cell count and CRP were rising, despite that. So

4 it wasn't working anyway.

5 Q. No. Remind me, what day was it that you saw him in

6 between? It was the 5th, wasn't it?

7 A. The 5th, yes.

8 Q. If we look at the nursing notes, then, on page 87, there

9 is an entry there at 1700 in the second column:

10 "Seen by Dr Carmichael. X-ray organised for

11 tomorrow. Required to go to X-ray in the morning", and

12 so on.

13 So there is no reference there to the antibiotics?

14 A. No. By that stage, it is only three days -- two or

15 three days into the admission.

16 Q. If you send a sample off, like we have here, a urine

17 sample, when do you consider that you should have

18 a report back?

19 A. I would have felt two or three days -- three days

20 probably. Three days would be a reasonable timeframe

21 for the result of a culture to be available.

22 Q. Are these results that could be accessed on the hospital

23 intranet?

24 A. I don't think microbiology results were, but I could be

25 corrected on that; certainly not initially.

75

1 Q. We have also heard about a SCi system.

2 A. Yes.

3 Q. Do you know if they could be accessed on that system?

4 A. I'm not entirely sure about that.

5 Q. Can we leave Mr Miller's case aside, then? I will just

6 check to see that I don't have any other questions for

7 you in connection with that case.

8 A. Okay.

9 Q. I think there had been questions submitted on behalf of

10 the patients and families. I don't know whether they

11 are still live or not.

12 MR PEOPLES: No, my Lord, I think we have covered the areas.

13 MR MACAULAY: Similarly, my learned friend on behalf of

14 the MDDUS had submitted some questions.

15 DAME ELISH: I am content they have been covered.

16 MR MACAULAY: They have been covered, okay.

17 Can we move on to look at another patient, and

18 that's Elizabeth Rainey? The medical records for

19 Mrs Rainey are at GGC00480001. Mrs Rainey was admitted

20 to the Vale of Leven on 26 November 2007. If we look at

21 page 68 of the records, do we see here, Dr Carmichael,

22 the date of admission that I have just indicated and you

23 are designated as the admitting consultant?

24 A. Yes.

25 Q. Was this a patient, then, that was admitted under your

76

1 care, at least for part of the time?

2 A. Yes.

3 Q. I think also Dr Johnston was involved with this patient;

4 is that right?

5 A. I think so.

6 Q. If we turn to page 69 -- you can perhaps cast your eyes

7 over the admission, the clerk-in admission note,

8 page 69. There is an entry:

9 "FY1 oncall: asked to start co-amoxiclav."

10 Do you see that note? I think it is just before

11 your own entry.

12 A. Yes, okay.

13 Q. Can you tell us what the thinking was there for the

14 co-amoxiclav? I appreciate you hadn't actually seen the

15 patient at this time?

16 A. Not at that point, no. Well -- I'm just trying to

17 assess what the notes were. The sum-up doesn't

18 mention -- the impression says, "Anaemia and

19 dehydration", but it doesn't mention concerns about

20 infection.

21 Q. If we look at the note just above the note that mentions

22 the co-amoxiclav, the heading "Plan" indicates what is

23 proposed, and one of the proposals is for a urine

24 dipstick in ward and chest X-ray.

25 A. Yes.

77

1 Q. So far as the prescribing of the co-amoxiclav at that

2 point in time, is there any reason given as to why that

3 was the decision?

4 A. Not that I can see. I can only assume that the urine

5 dipstick and chest X-ray may have influenced that

6 decision to ask the FY1 to write up for co-amoxiclav.

7 Q. Should we have had some reason given as to why that

8 was --

9 A. There is no documentation of that.

10 Q. But you see the patient, I think, the same day; is that

11 correct?

12 A. That's correct, yes.

13 Q. That's your entry?

14 A. Yes.

15 Q. I think under reference to your diagnosis, you say:

16 "Possible infection. UTI most likely."

17 Is that right?

18 A. That's right. I think what we see here, what I have

19 documented here, is that there was a mild elevation of

20 white cell count, CRP and urea, and that the patient has

21 expressed difficulty passing urine, blood pressure is

22 down a bit, perhaps she's a bit dehydrated. That would

23 explain the elevated urea. And possibly infection is

24 onboard, with the urinary tract being the most likely.

25 Q. So by now, you'd have become aware that the co-amoxiclav

78

1 had been prescribed, and looking to your own assessment,

2 then, would you consider that to be an appropriate --

3 A. Yes.

4 Q. Although no reason has been given, would it be

5 appropriate, looking to your own diagnosis?

6 A. Again, I have not recorded this, but in the MAU she was

7 found -- a urine analysis in the MAU showed there to be

8 white cells, blood, protein and nitrites in the urine,

9 compatible with a urinary infection. As I said, the

10 patient had expressed difficulty passing urine and

11 I felt, given her frailty and concerns about her general

12 health, we should treat her.

13 The problem was complicated by the fact that she did

14 have a history of previous chest problems, including

15 a left lobectomy, a left lower lobe lung lobectomy, and

16 had been shown to have some crepitations at the left

17 base on examination, even though the chest X-ray itself

18 I think didn't reveal any definite evidence of

19 infection. There was a possibility of chest infection

20 and/or urine infection.

21 So the co-amoxiclav covered both options, really,

22 even though a urine infection seemed the more likely.

23 Q. Then if we look at the lab result from the urine

24 specimen that was taken, and we go to page 144 of

25 the records, if you have that, we can see here that the

79

1 collection date is 26 November, received by the lab on

2 the 26th and the formal report is on 28 November.

3 Do we note that coliform has been isolated,

4 resistant -- sensitive to trimethoprim, but in relation

5 to co-amoxiclav there is some resistance; do we see

6 that?

7 A. I haven't actually found it.

8 Q. It is page 144.

9 A. It is not marked on this as 144. Anyway, I think I can

10 manage without it. I have my own notes.

11 Q. It is on the screen.

12 A. I beg your pardon, so it is. As you will see, there are

13 two coliforms isolated. One was a significant growth,

14 the first one, number one, is a significant growth of

15 greater than 100,000, and it is sensitive to

16 trimethoprim and co-amoxiclav.

17 The second one is a nonsignificant growth, so if it

18 was an isolation on its own, we would not consider that

19 as diagnostic of a urinary infection.

20 I felt the co-amoxiclav covered the significant

21 infection and, given our concerns about her chest, that

22 we should stick with the co-amoxiclav.

23 DAME ELISH: My Lord, on this particular point, my learned

24 friend raised the issue of the chest infection.

25 I wonder if this witness could be asked, from his

80

1 clinical experience, does a developing chest infection

2 always appear patent in the X-ray?

3 A. No.

4 MR MACAULAY: You do see the patient on 29 November, and

5 that is on page 70 of the records.

6 A. Yes.

7 Q. Do you mention the antibiotics here, or not?

8 A. No.

9 Q. I don't think so.

10 A. No.

11 Q. I think what you have said is that you did address this

12 and you consider that the co-amoxiclav should be

13 continued; is that right?

14 A. That is right. I'm not sure when this result became

15 available.

16 Q. If we go back to the --

17 A. In fact, it was not back on that ward round. So

18 I didn't have that result then. It was available the

19 following day. The result was available the following

20 day.

21 Q. The co-amoxiclav, in fact, if we look at the Kardex, at

22 page 154, you can see that the co-amoxiclav is started

23 on the 26th and is continued, I think, through to

24 4 December. That is a period of about nine days.

25 A. The actual prescription is for between seven and eight

81

1 days. It is seven and two-thirds', if you like,

2 prescription, basically.

3 Q. The point has been made that because the coliform was

4 completely sensitive to trimethoprim, it would have been

5 better to have moved from the broader-spectrum

6 antibiotic to the narrower-spectrum antibiotic, in the

7 circumstances of this case?

8 A. Well, as I said earlier, my judgment was that

9 co-amoxiclav sufficiently covered the responsible

10 organism in the urine, and also would have covered any

11 respiratory issue as well.

12 Q. When did you form that judgment, if the result wasn't

13 available on the 29th? If you go back to page 70, we

14 see your entry for the 29th, where I think you thought

15 the result may not have been available at that time?

16 A. That's right. Even if it had been, I would have wanted

17 the patient to have been on a slightly longer course of

18 antibiotics than just for a urinary infection, given the

19 concerns about the chest.

20 Q. But you next see the patient, I think -- and you can

21 correct me if I am wrong -- on 3 December, if you turn

22 to page 72.

23 A. That's correct.

24 Q. What was the position at this time in relation to the

25 antibiotics? Have you noted that --

82

1 A. I haven't made any comment on the antibiotics at that

2 point.

3 Q. On page 73, there's an entry by the SHO, where we read

4 in the last line just before "Plan":

5 "On day 8 Augmentin - stop now."

6 A. Yes. Whether I made a comment on my ward round the day

7 before or not, I don't know, but I haven't made any note

8 of that.

9 Q. In any event, as I understand your position, you are

10 defending the continuation of the co-amoxiclav,

11 notwithstanding the result of the lab?

12 A. I'm defending the use of it to cover a chest infection

13 as well, which, in a frail, elderly patient, we would be

14 monitoring her blood to see if she was responding to

15 this. I think a seven-day course I would have been

16 happy with. I think probably stopping it about that

17 point, though, would have been appropriate.

18 Q. The reason for that, if we go back to the specimen at

19 144, is, as I understand it, you are pointing out that

20 for the co-amoxiclav, although it is resistant to

21 coliform number 2, if I can call it that, it is minor

22 compared to its sensitivity to the other coliform; is

23 that right?

24 A. Yes. The important coliform, it is sensitive to that.

25 Q. Although we see from this that trimethoprim is sensitive

83

1 to both?

2 A. Agreed.

3 LORD MACLEAN: I take it that if the patient had suffered

4 only from a possible UTI, and you know the coliform has

5 been identified, you would have changed to trimethoprim?

6 A. Yes.

7 LORD MACLEAN: And you didn't, because you were concerned

8 about the condition of her chest?

9 A. I was concerned that there might well be infection going

10 on in her chest as well.

11 LORD MACLEAN: Did you actually follow that through, the

12 possible chest infection?

13 A. Well, the difficulty is how you prove such a thing if

14 the evidence for it is limited. I'm afraid this is

15 where clinical judgment comes into managing patients.

16 One doesn't always have the evidence that one would

17 desire to have before making decisions.

18 LORD MACLEAN: You were covering both conditions?

19 A. I was covering both possibilities, yes.

20 LORD MACLEAN: Possibilities?

21 A. Yes.

22 MR MACAULAY: Did you ever establish whether there was, in

23 fact, a chest infection?

24 A. I can't say that we ever did do that. I think we

25 probably didn't. But, then, given that we were treating

84

1 it, one would hope it would go away, so if it wasn't

2 obviously present to begin with, it certainly wasn't

3 going to be present later on, because I think her

4 inflammatory markers did fall quite quickly with the

5 co-amoxiclav, so whatever infection was present

6 responded to the co-amoxiclav.

7 Q. I will just check to see whether or not I have any

8 further questions to ask you about this particular

9 patient.

10 LORD MACLEAN: She did have a urinary tract infection,

11 though?

12 A. She did.

13 LORD MACLEAN: So that wasn't a possibility?

14 A. That was a definite.

15 LORD MACLEAN: That was an actuality.

16 A. Yes.

17 LORD MACLEAN: It is the chest infection that was the

18 possibility?

19 A. It is the question of whether she also had a chest

20 infection, yes. In somebody who is otherwise healthy

21 and without any other comorbidities and not unwell, one

22 would probably just plump to treat the urine infection

23 in isolation, even if one thought one heard a few

24 crepitations in the chest X-ray, and just see how it

25 went. That's a possibility.

85

1 But in the frail elderly, one is dealing with

2 a particularly vulnerable individual and one wishes to

3 be sure that one has covered all the relevant options.

4 MR KINROY: My Lord, I wonder if we might explore the

5 possibility that, for the very reason that the frail

6 elderly are more likely to need a broad-spectrum

7 antibiotic, the frail elderly are also the patients most

8 exposed to the risk of contracting C. diff?

9 LORD MACLEAN: Do you really want to ask that question?

10 MR KINROY: I think I do, my Lord, because it appears to be

11 a matter of balance and necessity that a younger,

12 healthier patient is less in need of a broad-spectrum

13 antibiotic.

14 LORD MACLEAN: The question can be asked, but the answer

15 might be less comfortable for you.

16 MR KINROY: Well, we are here to get the truth, my Lord.

17 A. I think this is the tension one has to deal with between

18 treating the vulnerable patient, but yet running certain

19 risks of other effects from that. I think that has

20 always been present. It comes into the definition of

21 side effects from treatment, if you like. Yes, the

22 elderly are perhaps more susceptible to these kind of

23 side effects, including predisposition to C. diff.

24 MR MACAULAY: I don't think my learned friend Mr Peoples has

25 any questions that I have not already covered. I don't

86

1 know if Dame Elish has any particular points.

2 DAME ELISH: The first point, my Lord, number 20, I would

3 like that to be put, because it raised a criticism which

4 was made on the basis of the diagnosis of the UTI.

5 LORD MACLEAN: Just the UTI?

6 DAME ELISH: Number 20.

7 MR MACAULAY: The point I have been asked to put to you is

8 this: did Dr Woodford -- it was Dr Woodford who gave

9 evidence in connection with this particular patient --

10 omit reference to difficulty in passing urine and

11 urinalysis in the medical assessment unit in his

12 observations regarding urinary tract infection? The

13 reference I have been given for that is page 65.

14 So the point is: did Dr Woodford omit reference to

15 difficulty in passing urine and urinalysis in the MAU in

16 his observations regarding UTI?

17 I have been told to look at page 65. I, myself,

18 didn't see any reference to that on page 65.

19 A. Is it page 65 of his report?

20 Q. No, it is page 65 of the records.

21 A. Are we looking for the result of the urinalysis?

22 Q. Yes. Is that here? There is nothing for urinalysis on

23 the screen. It may be the wrong page, of course.

24 A. Perhaps the next page?

25 DAME ELISH: This is a page the doctor has referred us to,

87

1 my Lord.

2 MR MACAULAY: I think what Dr Woodford was perhaps saying

3 was that there was -- well, the question is: has

4 Dr Woodford omitted reference to difficulty in passing

5 urine and urinalysis and MAU in his observations

6 regarding UTI? Which I took to mean that there was some

7 reference which had been omitted by Dr Woodford. I may

8 be wrong about that.

9 A. Sorry, I have a reference here 185. I'm not sure which

10 one that is. That is maybe Dr Woodford's statement.

11 Yes, the bottom right.

12 Q. What are we looking at, Dr Carmichael?

13 A. "Urinalysis". Underneath "Urinalysis" you see written:

14 "Ketones/leukocytes, blood, protein, nitrates."

15 That is a urinalysis.

16 Q. That is the nursing assessment?

17 A. Yes.

18 Q. Is there anything in the MAU assessment?

19 A. Can we just go back to that document?

20 Q. Page 65.

21 A. That is part of the MAU assessment, I think, admission

22 assessment. I may be wrong about that, but I think that

23 was carried out in the MAU. I may be wrong about that,

24 but I think so. Unless it was carried out in the ward

25 after she was admitted from MAU. It is either one or

88

1 the other.

2 Q. I don't think Dr Woodford was criticising the diagnosis

3 of urinary tract infection. I may be wrong about that.

4 You have looked at his report more recently than I have.

5 I think he questioned the diagnosis of chest infection.

6 A. Right. I can't remember.

7 Q. Particularly, he questioned the continuation of

8 the broad-spectrum antibiotics, standing the lab report,

9 which I have taken you through.

10 LORD MACLEAN: I have great difficulty in understanding

11 this, because you did have a urinalysis which showed

12 a particular coliform, which indicated that she was

13 suffering from a urinary tract infection, and you did

14 also note she had difficulty passing urine.

15 A. That's right. I think she had symptoms and she had

16 a positive urinalysis and eventually, yes, a positive

17 culture.

18 DAME ELISH: My Lord, that is precisely the point. I'm

19 grateful. There was an observation, as I understand it,

20 by Dr Woodford to the effect that there may not have

21 been the basis to justify the diagnosis of a UTI at that

22 stage, and the doctor had been concerned to ensure that

23 the Inquiry was aware of the basis of that diagnosis.

24 I think it has now become clear.

25 LORD MACLEAN: Have you any comment to make on that?

89

1 I don't.

2 A. I don't think -- Dr Woodford didn't note the symptoms or

3 the urinalysis result, I think, in his assessment.

4 I think that is the case.

5 LORD MACLEAN: Which urinalysis? The final one?

6 A. The initial. He didn't note the results from the

7 initial urinalysis or the fact the patient was having

8 some urinary-type symptoms in his assessment of our

9 decision to put the patient on antibiotics.

10 MR MACAULAY: I think his particular point was, particularly

11 after the lab report had come through, that co-amoxiclav

12 should have been reviewed.

13 A. As --

14 Q. You have given your explanation for that.

15 A. Yes.

16 MR KINROY: My Lord, may I respectfully ask for a correction

17 or an amplification? I now see why your Lordship's view

18 was that the question I asked might produce an

19 uncomfortable answer, but that was not what I intended.

20 I don't think it was what I asked. I am also aware

21 there is a problem of amplification from this side of

22 the hall. But, my Lord, I think the question I asked

23 was eventually met with an answer which exhibits

24 correctly what I did ask, rather than what the

25 transcript records.

90

1 What I intended to ask, and I think I did ask, is

2 this: I wonder if we might explore the possibility that,

3 for the very reason that the frail elderly are more

4 likely to need to be given a broad-spectrum antibiotic,

5 the frail elderly are also the patients most exposed to

6 the risk of contracting C. diff.

7 And for one reason or another, the words "to need"

8 are not in the transcript at page 85.

9 My question, my Lord, had been: there are good

10 reasons why the frail elderly are in need of

11 broad-spectrum antibiotics in a way that younger, fitter

12 patients are not, but the paradox is that there is

13 a risk then of them contracting C. diff.

14 LORD MACLEAN: Mr Kinroy, I think we understand that.

15 MR KINROY: That is all I need to know, my Lord.

16 LORD MACLEAN: Dr Carmichael replied to that. Didn't you?

17 MR KINROY: I'm sorry if I have laboured under

18 a misapprehension unnecessarily.

19 LORD MACLEAN: Let me see if I can summarise his answer, if

20 I have got it correctly. It is this: that is part of

21 the judgment that a clinician has to exercise in

22 determining which is the appropriate drug to prescribe,

23 because, on the one hand, you have got a greater risk in

24 the frail and elderly of the possible development of

25 C. diff, but, on the other hand, you have got to try to

91

1 cope with the existing condition which he is trying to

2 treat, which in particular in this case was a possible

3 chest infection.

4 Now, does that correctly summarise your position?

5 A. Admirably.

6 MR KINROY: I was worried unnecessarily, my Lord, but I'm

7 glad to know that.

8 DAME ELISH: There are no further questions, my Lord.

9 MR MACAULAY: The next patient I want to take you to,

10 I think again quite briefly, is Mrs Chandayly,

11 Dr Carmichael. The medical records for Mrs Chandayly

12 are at GGC00090001.

13 So far as Mrs Chandayly was concerned, I think the

14 Inquiry have looked at two admissions that she had to

15 the Vale of Leven Hospital, and I think that you were

16 only involved in the first of these admissions, which

17 was on 17 March 2008.

18 Perhaps just to focus on that, if you turn to the

19 records at page 10, I'm looking at the immediate

20 discharge letter, but do we see that it's stated that

21 she was admitted on 17 March, she was discharged on

22 4 April and that you were designated as the consultant?

23 A. Yes.

24 Q. Was this a patient, then, that was admitted at that time

25 under your care?

92

1 A. Yes.

2 Q. Perhaps I can take you to the clinical notes. If we are

3 looking at the medical assessment unit note on page 30,

4 can you help us as to what the background was to the

5 admission?

6 A. Right. Written by the nursing staff there, "Dizziness

7 and rectal bleeding" -- sorry, hold on:

8 "GP referral. Anaemia. Feeling dizzy. Having

9 rectal bleeding."

10 Q. If we move on to page 31, do we note towards the end of

11 this part of the note that it is questioned whether she

12 has a UTI and an MSSU has been sent; is that correct?

13 A. "MSU sent as leukocytes in urine", white cells in urine.

14 Q. So looking to the reasoning, then, as to why a urinary

15 tract infection was suspected, what was the basis?

16 A. Well, as well as leukocytes, if you look down at the

17 bottom right, the urinalysis result is tagged on there.

18 Q. Yes.

19 A. It is leukocytes, protein -- I think that is really it.

20 There is no blood mentioned, I don't think, is there?

21 Q. If we look, then, at the Kardex, page 198, do we note

22 that the trimethoprim has been started on the date of

23 admission on 17 March?

24 A. Sorry, I missed that.

25 Q. My reading is that the antibiotic, the trimethoprim, has

93

1 been started on 17 March --

2 A. Yes.

3 Q. -- which is the date of admission. So presumably on the

4 basis of the suspected urinary tract infection?

5 A. Yes.

6 Q. If we then look at the lab report and turn to page 91 of

7 the records, we see here the specimen collected on

8 17 March, that's the date of admission, received by the

9 lab on the 17th and formally reported on the 18th. What

10 would you take from this report?

11 A. Well, it was a negative culture.

12 Q. Should that have impacted upon the continuation of

13 the antibiotic therapy?

14 A. When the result was available, perhaps so, remembering

15 that this lady, as well as having these -- the

16 leukocytes and protein in her urine, she had a raised

17 white cell count and a raised CRP, as documented by

18 myself on my admission note on 17 March.

19 Q. So far as the focus on the urinary tract infection is

20 concerned, it is a negative result, so how should that

21 have impacted upon the management, then?

22 A. That culture is negative. Again, it depends on how

23 strongly one suspects a urine infection, because one

24 cannot -- as we have seen already, or perhaps it is

25 still to come, you can have two urine samples sent one

94

1 day after the other and one negative and the other

2 positive, so nothing is absolute. That particular urine

3 culture was negative and, yes, it does raise the

4 probability that she did not have a significant

5 infection, but she did have evidence suggestive of an

6 infection onboard.

7 Q. I think later -- and we'll look at this -- she started

8 on co-amoxiclav, but if we put that aside for the

9 moment, if we go back to the Kardex, then, page 198,

10 first of all, I think if we look at the guidelines,

11 would the normal practice be to place a patient on

12 trimethoprim for three days?

13 A. That would be usual.

14 Q. If we look here, the trimethoprim certainly seems to

15 have been continued through from 17 to 22 March, so that

16 is, what, three or four days longer than the normal

17 period?

18 A. She's had a total of five days' treatment.

19 Q. What is the position here? Are you saying that the

20 trimethoprim should have been reviewed, then, after the

21 negative result?

22 A. Yes.

23 Q. And was it, can you tell me?

24 A. I'm not sure.

25 Q. If we look at page 35 of the records, we have your own

95

1 note on the 17th, which is the date of admission, when

2 I think you have indeed noted that the trimethoprim has

3 been started; is that right?

4 A. Yes.

5 Q. Then if we move on to page 36, we have another entry,

6 I think by you, on the 20th, 20 March; am I right in

7 that, or am I wrong?

8 A. Yes.

9 Q. That is your handwriting. Are you able to say from that

10 whether the urine specimen result has come through or

11 not?

12 A. There is no indication of that, I don't think.

13 Q. Would you note, normally, if you had receipt of the

14 result?

15 A. That would be -- well, if it was back in the case notes,

16 I would be aware of it, yes.

17 Q. If you had been aware of it on the 20th, would you have

18 stopped the antibiotic?

19 A. I think I probably would have.

20 LORD MACLEAN: Well, you would have, wouldn't you, because

21 there is no reason to continue it, is there?

22 A. Most likely not. We never use the words "Yes,

23 definitely" or "No, definitely"; it is a question of

24 balance. As I said earlier, nothing is 100 per cent

25 accurate, and a urine culture that is negative one

96

1 minute could be positive another time very soon

2 afterwards.

3 MR MACAULAY: You haven't noted that you have.

4 A. I haven't noted it.

5 Q. What we do see in the next entry for the 22nd is that

6 the ST2, on the right-hand side, has plainly looked at

7 the result, seen there was no growth and has switched

8 the treatment to co-amoxiclav; is that right?

9 A. That's right.

10 Q. So what we don't know here, again, is how long it took

11 for the result from the lab to get to the doctors.

12 A. It would appear to be probably after my ward round on

13 the 20th, yes.

14 Q. Although, if we go back to the report itself on page 91,

15 we have noted your ward round was on the 20th. The

16 report certainly seems to have been printed on the 18th,

17 so there seems to be a lag in time between that and --

18 A. Remembering it takes at least 24 hours for a culture to

19 take place, that is actually quite a quick turnaround.

20 Q. So your position is that the result wasn't available, in

21 any event, you would say, when you saw the patient on

22 the 20th?

23 A. Correct.

24 MR MACAULAY: My Lord, that may be an appropriate point to

25 have a break for lunch.

97

1 LORD MACLEAN: Very well. 2 o'clock.

2 (1.00 pm)

3 (The short adjournment)

4 (2.00 pm)

5 MR MACAULAY: Good afternoon, my Lord.

6 Good afternoon, Dr Carmichael.

7 A. Good afternoon.

8 Q. Before the lunchbreak, I had been looking at the case

9 records for Mrs Chandayly. One further point in

10 relation to that case. If we go back to page 36 of

11 the medical notes, GGC00090036, we had noted before the

12 break that, certainly as at 22 March, the doctor is able

13 to note the urine culture that had been taken on

14 admission, and he or she switches the antibiotic to

15 Augmentin. What I want to ask you is, what was the

16 thinking here?

17 A. Well, by this stage, the patient had become pyrexial.

18 She was apyrexial, I think, on admission, and her

19 temperature rose above normal from about the 18th to the

20 25th and reached a peak of 38 degrees Centigrade on the

21 19th, I think, between the 19th and the 23rd. So her

22 temperature was up reaching a maximum of 38.

23 In view of that -- I think the chest X-ray also

24 showed some basal changes, perhaps related to infection,

25 not definitively, but there were changes there and, in

98

1 view of that, it was felt that the spectrum of cover

2 should be widened to include a chest infection, hence

3 the co-amoxiclav.

4 Q. Should the length of the course have been specified at

5 this time, or not?

6 A. I think certainly a time for review of it, yes.

7 Q. If we look at the Kardex on page 199, can we see that

8 the Augmentin -- it is the third entry from the top --

9 is started on 22 March and, as far as I can make out, it

10 continues through to 31 March; is that correct?

11 A. Yes. Slightly over nine days' treatment.

12 Q. Do you have any comments to make on the length of

13 the prescription here?

14 A. I'm just trying to catch up with my own recollection

15 from the notes. The first time I think I was aware of

16 her being put on co-amoxiclav was when I reviewed her on

17 the 28th, perhaps -- no, that's not true, I beg your

18 pardon.

19 Q. There is certainly an entry by you, on 28 March, at

20 page 38 in the records.

21 A. Yes, my focus on the 28th was on the colonoscopic

22 findings and, in my review of the notes in the Kardex,

23 I may have missed that she was still on co-amoxiclav.

24 It was an opportunity to stop it that I didn't see.

25 I think the next time I did see her, on the 31st,

99

1 I realised she was still on it and it was stopped then,

2 I think.

3 Q. Yes, that's correct. Can I then see if I have any

4 further questions to put to you?

5 In connection with Mrs Chandayly, I have been asked

6 to put this to you, and that is in relation to the

7 evidence of Dr Reid. The question is, in his report and

8 his evidence, Dr Reid indicated that he does not

9 consider there to have been clinical indication for the

10 prescription of trimethoprim. We have looked at that.

11 You don't agree with that, as I understand you? You

12 think there was --

13 A. The prescription of the trimethoprim?

14 Q. Trimethoprim, yes.

15 A. I think there was reasonable indication to put the

16 patient on that.

17 Q. There was a trimethoprim alert, I think?

18 A. There was, indeed. But the patient -- sorry.

19 Q. Sorry, carry on.

20 A. The patient had been commenced on trimethoprim when

21 I saw the patient for the first time, and I was aware,

22 I think, of the alert, but she didn't actually appear to

23 have suffered any problem from that. I felt if, by the

24 time the second dose was due, there were no problems,

25 then she could continue on it.

100

1 Quite often, these alerts are false alerts.

2 Q. Indeed. Can we leave that aside and move on to the next

3 patient? That is Mrs Shaw.

4 LORD MACLEAN: Sorry, could I ask you what you meant in your

5 answer about an alert?

6 A. Potential drug sensitivity, drug reactions, a patient

7 having, say, a rash or being sick or something like that

8 with a drug before.

9 LORD MACLEAN: Thank you.

10 MR MACAULAY: The medical records for Mrs Shaw are at

11 GGC00510001. Mrs Shaw was admitted to the Vale of Leven

12 on 19 January 2008. If we turn to page 75 of

13 the records, can we see that we see the date of

14 admission, and can we also note that you were designated

15 as the consultant in charge of the case?

16 A. Yes.

17 Q. Was Mrs Shaw under your care, at least for a period of

18 time during the Vale of Leven admission?

19 A. Yes, yes.

20 Q. At the time of admission, then, I think we see on that

21 page we are looking at that there may have been -- there

22 is reference to diarrhoea, reduced mobility and

23 dehydration; is that right?

24 A. That's right.

25 Q. If we turn to page 76, at least what was being

101

1 considered at that point -- I think we see this halfway

2 down -- is that she may have had C. difficile; is that

3 what we understand from that entry?

4 A. Yes, that's right.

5 Q. She certainly seems to have been clinically dehydrated

6 at this point?

7 A. Yes.

8 Q. She's seen by you, I think, the following day, if we

9 turn to page 77 of the records.

10 A. That's right.

11 Q. This is for 20 January. What was your conclusion,

12 having examined her?

13 A. That she had a short -- she had a one-week history of

14 diarrhoea, following on from amoxicillin being

15 prescribed by her general practitioner for a chest

16 infection. She'd had diarrhoea for three days before

17 admission. High inflammatory markers, high temperature,

18 white cell count.

19 There were other things as well, however. She was

20 also hypoxic, ie, her oxygen concentrations were down,

21 suggesting perhaps some kind of respiratory issue.

22 There was blood and protein in her urine, and I felt we

23 should culture urine, stool and blood, and even sputum,

24 perhaps, but that wasn't available, while treating her

25 for a suspected C. diff infection. By which stage, she

102

1 was on metronidazole, of course.

2 Q. Did you consider that she was rather unwell at this

3 time?

4 A. I have got down here "As she is reasonably stable, await

5 cultures". So I didn't think she was -- I thought she

6 was stable. She wasn't well, but I didn't think she was

7 unstable. She was obviously reasonably settled in the

8 ward at that point.

9 Q. I think the testing that was carried out for C. diff

10 produced a negative result, if we look at page 201 of

11 the records.

12 A. That's right.

13 Q. Can we see that the specimen that was collected on

14 admission, which was received by the lab on the 21st,

15 was negative?

16 A. Yes.

17 Q. At that time, I think, as we discussed, that would tend

18 to suggest to you that C. diff was not the appropriate

19 diagnosis because you weren't looking at false negatives

20 at that point?

21 A. Well, it certainly suggested we should look for other

22 explanations.

23 Q. If we turn to page 86 of the records --

24 MR KINROY: Sorry, my Lord, have I missed something? I no

25 doubt have. I am surprised by the suggestion that the

103

1 witness was not looking at false negatives at that

2 point. I understood he was aware that the toxin test

3 was not entirely reliable.

4 A. As I said before, my understanding of the test we were

5 using then was that it was 85 per cent accurate, so the

6 chance of a false negative was relatively low, but not

7 negligible, obviously.

8 My suspicions of that lady were that there were

9 probably other things going on. She was covered with

10 metronidazole at that time, although I think it was --

11 the oral was stopped, but then she was commenced on

12 intravenous metronidazole with, I think, another

13 antibiotic when we concluded that she was septic. So

14 she was covered for C. diff anyway for most of the time.

15 Q. Then if we move on to page 86, an entry for 26 January,

16 I think by a junior doctor. Do we read about halfway

17 down the entry the reference to:

18 "Fluid balance chart not up to date. Abdomen

19 distended, tender to touch."

20 Is that what's been noted at that point?

21 A. Yes.

22 Q. Then if we move on to page 87 --

23 DAME ELISH: Sorry, my Lord, I just wonder -- I hesitate to

24 interrupt here -- if my learned friend wishes to go back

25 to 24 January, when the colonoscopy was carried out.

104

1 MR MACAULAY: Yes, I can do that. You carried out

2 a colonoscopy, I think; is that correct?

3 A. That's right.

4 Q. I'm just looking for the reference.

5 DAME ELISH: If it assists, it is GGC00510138.

6 MR MACAULAY: Let's put that on the screen, then.

7 A. As I said earlier, I was suspicious of other

8 explanations and felt an urgent colonoscopy was called

9 for, given the predominance of her abdominal

10 presentation and, on colonoscopy, I found severe,

11 extensive ulceration in the colon and rectum.

12 Q. What you say in the report is:

13 "The appearance is in keeping with extensive, severe

14 Crohn's disease."

15 A. I think that was probably the most likely explanation.

16 Now, I should qualify that by saying, normally in

17 Crohn's disease, one gets what we call "serpiginous"

18 ulceration, ie, sort of long, snake-like ulcerations --

19 not exclusively.

20 That degree of ulceration I previously had only

21 really seen with the likes of Crohn's disease. Now, as

22 you realise, the histology results eventually came back

23 suggesting it was more likely to be ischaemic colitis

24 and not Crohn's disease. I had never seen such

25 extensive ulceration with ischaemic colitis before and

105

1 hence I felt Crohn's was the most likely one.

2 Q. If we turn to page 141 for the pathology report, is this

3 the report you had in mind?

4 A. Yes.

5 Q. Does it tell us in the last main paragraph:

6 "The appearances are not specific but are considered

7 to favour ischaemic colonic ulceration ... There are ...

8 no diagnostic features which would particularly point to

9 Crohn's disease."

10 A. That's right.

11 Q. I think by the time this report had come through,

12 though, Mrs Shaw had been transferred to the

13 Royal Alexandra Hospital?

14 A. That's right.

15 Q. I think that's where I was going to take you first,

16 because she was remitted for surgical review; is that

17 correct?

18 A. That's correct.

19 Q. She was transferred back to the Vale of Leven on

20 8 February and we can see that if we turn to page 88 of

21 the records.

22 A. That's when she was transferred to Paisley. I have

23 a wee note "Transferred back", yes, that's right.

24 Q. There's a note for the 8th that she's transferred back

25 to the Vale of Leven?

106

1 A. Yes.

2 Q. If we look at the clinical notes at around this time,

3 then, if we turn to page 122 of the records, can we see

4 here that the note made by the ST1 who saw her was that,

5 if you look towards the bottom, she was to receive

6 intravenous ceftriaxone for her chest?

7 A. Yes.

8 Q. If we turn to page 123, we have a note by yourself on

9 11 February where you instructed the stopping of

10 the intravenous antibiotics?

11 A. That's right.

12 Q. What was the thinking here?

13 A. Well, by that time, the repeat inflammatory markers were

14 back and seemed to be satisfactory, so given that she'd

15 already had lots of antibiotics in Paisley, I felt she

16 didn't require any more at that time.

17 Q. Was it appropriate, do you consider, to have had the

18 intravenous ceftriaxone prescribed on the 8th?

19 A. Well, when she was seen, she had some evidence of

20 crepitations in her lung fields, as noted by the SHO,

21 and Dr Al-Shamma, who was the admitting consultant at

22 that point, felt that it was appropriate.

23 Q. During the time of this admission, she did test positive

24 for C. diff, if we look at page 193. We can see there

25 was a specimen collected on the 18th, received by the

107

1 lab on the 19th, and that was a positive result?

2 A. This was towards the end of her stay in the Vale, again,

3 the second stay. By this stage, she had had two

4 negative C. diffs in the Vale and I think two negative

5 C. diffs in Paisley. She developed diarrhoea, I think,

6 on the 18th, ie, the day this was sent, and the day

7 before she was transferred back to Paisley.

8 Q. Was she still under your care at this point?

9 A. Yes.

10 Q. As you mentioned, the day after this, on 19 February,

11 she was transferred back to the Royal Alexandra

12 Hospital?

13 A. That's right.

14 Q. She died the following day, on 20 February?

15 A. That's right.

16 Q. Just focusing, then, on the medical management, and

17 I just want to put to you the specific points that have

18 been raised, and you may have seen this yourself from

19 the report by Dr Jones, I think, in this case. One of

20 the points I think he makes is that he considered there

21 was inadequate monitoring of the colon on the abdominal

22 X-ray and, in particular, that there was a lack of early

23 recognition that the colitis was ischaemic.

24 Do you have any comments to make on that?

25 A. Well, it would not have been possible to have made

108

1 a diagnosis of ischaemic colitis until the biopsy

2 results came back and that, of course, as you know, took

3 several days. I think it was the 31st of the month that

4 the results came back from the pathologist, by which

5 time she was already under the surgeons.

6 Before she was transferred to Paisley that first

7 time, I think that was the 28th, I had requested -- this

8 was on the Friday, I think -- that an urgent surgical

9 opinion be sought, and in the meantime they keep on eye

10 on the patient, including daily X-rays of the abdomen to

11 check for evidence of colonic dilatation.

12 Q. Was that something you had requested to be done and --

13 A. I had requested that on -- if you look at 085, my note

14 there.

15 Q. Is that your note for --

16 A. That's the Thursday, the day before the Friday. My

17 standard ward round day.

18 Q. On 24 January?

19 A. 24 January. Near the end of that, I have in brackets:

20 "Do daily abdominal X-rays."

21 I'm mainly concerned about the possibility still of

22 inflammatory bowel disease, but obviously severe

23 inflammatory bowel disease, which is another cause for

24 toxic dilatation of the colon.

25 Q. Were the daily X-rays carried out?

109

1 A. I can't see any evidence of that.

2 Q. Would that have made a difference?

3 A. It's difficult to judge that. Put it this way: she went

4 to Paisley; she was already on broad-spectrum

5 antibiotics for intraabdominal sepsis; and she settled

6 down there without any major change, I think, in her

7 management. So as far as I can gather, the treatment

8 she was getting was being effective.

9 Q. Up until that time, were you proceeding on the basis

10 that she had extensive Crohn's disease?

11 A. Indeed.

12 Q. The X-ray programme that you thought had been put in

13 place, might that have clarified the position?

14 A. The X-ray would have alerted us to the possibility of

15 her developing a toxic dilatation. If, indeed, it had

16 been Crohn's disease, she was already on intravenous

17 steroids with a view to settling that down. That is

18 a condition that requires close monitoring, toxic

19 dilatation.

20 Q. That's what you envisaged?

21 A. That's what I was trying to make sure did not happen,

22 that it did not go undetected.

23 Q. If the X-rays would have alerted you to the possibility

24 of the development of a toxic dilatation, that might

25 have prompted --

110

1 A. Well, the surgeons should have been involved at that

2 stage, should that have been the case, but I had already

3 asked for an urgent surgical opinion anyway.

4 Q. The prescription of steroids, then, how would that

5 impact upon what may possibly have been the development

6 of a toxic dilatation?

7 A. That, if it was due to inflammatory bowel disease,

8 Crohn's disease, et cetera, that would have hopefully

9 prevented that happening.

10 Q. But if it's ischaemic colitis?

11 A. Ischaemic colitis, no. As far as I'm aware, steroids

12 are not significantly effective in that condition.

13 DAME ELISH: My Lord, I wonder if my learned friend could

14 perhaps just clarify with the witness if it is correct

15 that he, in fact, went on leave on Friday, the 25th?

16 A. Yes.

17 MR MACAULAY: Is that the position?

18 A. I was on annual leave for a week at that point, which is

19 one of the reasons I wanted to be sure that surgical

20 involvement was arranged, and I think a written request

21 was faxed to the surgical secretaries the following day,

22 on the Friday. I think the usual channel of referral

23 was through the surgical secretary, because it was quite

24 difficult to trace where the individual surgeons were at

25 any one time in Paisley.

111

1 Q. You have looked at the records and, so far as you can

2 see, the programme of X-rays was not put in place?

3 A. As far as I can judge. I haven't seen any evidence of

4 that.

5 Q. The use of steroid treatment --

6 A. But can I say, if these were done, they may have gone

7 with the patient to Paisley, so it is quite possible

8 such X-rays could have -- well, I'm trying to think by

9 that stage -- they would have likely have been hard

10 films in the ward.

11 Q. Although, would one expect to see some reference in the

12 records?

13 A. One would normally expect to. That doesn't always

14 happen.

15 Q. The use of steroids, just to go back to that, would the

16 steroid treatment then mask the effect of the ischaemic

17 colitis?

18 A. The ischaemic colitis, probably not. I think with the

19 ischaemic colitis, what happened was that it led to her

20 bowel becoming infected and her developing

21 intraabdominal sepsis. The antibiotics would treat

22 that. That was the crucial thing to treat at that time.

23 The steroids would have no positive effect on that;

24 possibly a negative effect.

25 Q. Another point I want to pick up, on the patient's

112

1 return, then, to the Vale of Leven on 8 February, if we

2 turn to page 124 of the records, there is a note there

3 by you, I think, on the 14th; is that correct?

4 A. Correct.

5 Q. You have noted:

6 "Diarrhoea since yesterday."

7 A. "Once yesterday".

8 Q. "Once yesterday". Thank you. What was your thinking

9 here in relation to her bowel disease? Did you know by

10 now that it was not Crohn's disease?

11 A. We knew by now that it was not Crohn's disease, that it

12 was being accepted as ischaemic colitis, and that,

13 indeed, while in Paisley, she had settled down. By time

14 she came back to us, she was still settling, but that's

15 the way things were going. So noting she had had

16 diarrhoea was to say, "Well, is this the bowel playing

17 up again?", but it was only one episode of diarrhoea

18 that was recorded in the nursing notes.

19 Q. We then see an entry in a ward round on 15 February

20 where there is some mention of ischaemic colitis, "Not

21 for surgical treatment". Do you see that?

22 A. That is indeed the case.

23 Q. Then the next entry is on 18 February, when there

24 appears to be a three-day gap where there is no medical

25 review. Do you consider, looking to the problems this

113

1 patient was having, whether or not there should have

2 been a medical review during that period?

3 A. By this stage -- I'm just consulting my notes -- when

4 she came back from Paisley, she was still somewhat

5 dehydrated, and we put her on intravenous fluids for

6 a few days, and gradually weaned her off these. She

7 was, by that stage, off fluids, eating and drinking, and

8 starting to mobilise, and the priorities then seemed to

9 be that she was heading for rehabilitation.

10 Over that particular weekend, there were no clinical

11 concerns. Her nursing observations, her physiological

12 observations, were entirely normal, I think; her MEWS

13 scores were zero over that weekend; there were no

14 clinical concerns.

15 Q. So you're content to say that --

16 A. Yes, as far as I'm concerned, there was no need for her

17 to be reviewed specifically over the weekend. She was

18 not highlighted as being a cause of concern.

19 Q. If I go back, perhaps, finally, with this patient, to

20 the lab report that had been obtained earlier in

21 relation to the C. diff specimen, page 201, we see that

22 according to what we read, the specimen was collected on

23 the 19th at 1700 hours and received by the lab on the

24 21st at 1439. That is what is noted on the document.

25 That is a period of about two days?

114

1 A. I think this highlights the problem of these dates and

2 what they actually mean. We actually had the result

3 phoned back to the ward on the 19th, so we knew the

4 result before she went to Paisley. So that date of

5 being received is meaningless, it would appear. That is

6 presumably the case with many of the other samples.

7 Q. I think what we have been looking at is the date the

8 ward was aware in many of these cases. So whatever the

9 date may be on the specimen, if the ward is aware before

10 that, then we can ignore the date on the specimen?

11 A. Yes.

12 Q. I'm just looking to see where the entry is to tell us

13 that the ward was aware on the 19th.

14 A. Right.

15 Q. If we look at page 97 of the nursing records.

16 A. I find it on page 113 -- oh, no -- oh, yes, that's

17 right.

18 Q. I think that is the wrong timeframe. That is February.

19 A. Oh, I beg your pardon.

20 Q. If we look at page 97 --

21 A. Am I in the wrong place? Right, okay.

22 Q. I, myself, hadn't noted that it was noted on that date.

23 A. Sorry, I thought we had jumped to the second admission.

24 I beg your pardon. So this was the admission --

25 Q. My note is, if we turn to page 102, there is a note in

115

1 the nursing records for the 24th of the result. Yes, if

2 you look at the 24th between 6 am and 11 o'clock,

3 halfway down, "Patient C. diff negative".

4 A. Right. I think that pertains to that first sample on

5 the 18th.

6 Q. In the clinical notes at page 79, on the 22nd, there is

7 a reference to C. diff negative.

8 A. That's right.

9 Q. I think you may have confused February with January when

10 you gave your earlier answer.

11 A. I did, sorry, apologies.

12 Q. But looking to that sort of delay, if you have

13 a specimen collected on the 19th and the result is not

14 available until about the 22nd, if we go by the clinical

15 notes, do you see there is a delay?

16 A. There appears to be a delay in getting a negative result

17 back, certainly.

18 Q. I want now to see if there are any points I have to take

19 from you under reference to this patient from, first of

20 all, the patients and families and, again, my learned

21 friend Mr Peoples can indicate if there are some further

22 questions here that he would like me to pursue?

23 MR PEOPLES: My Lord, I wonder if my learned friend could

24 pursue question 1(c) in terms of the effect of delay on

25 the risk of false negatives, and also perhaps just to

116

1 get a more specific position on the evidence of Dr Jones

2 which was given in 3(b) and (c). I think he's dealt

3 with it in part, but I'm not sure whether we have

4 a complete answer to that and, also, section 5, dealing

5 with death certification, there is an issue there as

6 well raised by Professor Griffin.

7 MR MACAULAY: The first point I have to raise with you is in

8 connection with the stool sample in fact we have been

9 looking at, the one that was collected on 19 January.

10 In January 2008, were you aware of the possibility of

11 a C. diff result being a false negative?

12 A. Sorry, say that again?

13 Q. It is really the second part of the question, but this

14 is the introduction to it.

15 In January 2008, that's the time of the specimen,

16 were you aware of the possibility of a C. diff result

17 being a false negative?

18 A. Well, I was aware of the possibility.

19 Q. Were you aware that delay in sampling increased the risk

20 of false negatives?

21 A. A delay in testing the sample, yes, not -- yes, a delay

22 in testing the sample. But I'm not aware that there is

23 such a delay in these samples being tested. From what

24 I have gathered, the confusion seems to arise from the

25 lab system, as to when they record they receive the

117

1 specimen, and that, I think, is the confusion.

2 DAME ELISH: I think, my Lord, on this particular point, my

3 learned friend can confirm -- what I understood the

4 witness said earlier was that priority was given to

5 telephoning positive results in terms of the hierarchy.

6 A. That's right, yes. Positive results would be phoned to

7 the ward. Negative results would probably, as you quite

8 rightly say, be allowed to drift through the system.

9 MR MACAULAY: I think it is more the delay in transport that

10 the question is focusing on.

11 A. I realise that. I think the confusion is that the lab

12 system records specimens as being received at a date

13 that probably bears little relationship to when they

14 actually were received.

15 Q. We can't say in this particular case whether the date is

16 right or wrong?

17 A. I think that is the case and I think I have jumped the

18 gun a bit, but I think the sample that ended up being

19 positive was phoned back that day, but I think -- as

20 I say --

21 Q. That was later on in February?

22 A. Later on, yes.

23 MR PEOPLES: My Lord, I wonder if it could be put this way,

24 that leaving aside the question of the reliability of

25 the date of receipt, if a sample remains in a ward for

118

1 perhaps more than 24 hours, would that increase the risk

2 of a false negative unless it was stored in particular

3 conditions? I think that is the point I was trying to

4 tease out of the question.

5 A. I think you have had more reliable advice on that than

6 mine, but the answer must be yes.

7 MR MACAULAY: The next question I have been asked to put to

8 you is this -- we may have touched upon this, but this

9 is looking at a quotation from the evidence, and I will

10 read it out to you -- do you have a copy of these

11 questions in front of you?

12 A. Yes.

13 Q. It is page 2 of the questions on behalf of the patients

14 and families. In his evidence on Day 51, Dr Jones gave

15 the following evidence:

16 "Question: Moving on, then, to page 12 of

17 the report, you begin by saying that Ms Shaw died from

18 a potentially preventible cause. Can you just elaborate

19 upon that?

20 "Answer: Yes, ischaemic colitis can be managed in

21 different ways. It is possible to intervene and prevent

22 death. The sepsis, from which she eventually succumbed,

23 was not adequately treated in its early phases and there

24 is a good evidence base that suggests, when sepsis

25 occurs, it has to be managed very aggressively.

119

1 Otherwise, the outcome is very less favourable.

2 "So I think there are two things: first of all, the

3 issue of management of ischaemic colitis; and the

4 second, the management of the physiological

5 deterioration. I think the latter of these is probably

6 the more important, in that there was a completely

7 suboptimal reaction to her deterioration."

8 The question is, do you accept that here?

9 A. In part, because I think Dr Jones misinterpreted some of

10 the recordings, should I say. On the ward round of

11 the 18th, that would be the Monday morning, I think --

12 the page eludes me just now.

13 Q. I can help you with that. The page, I think, is -- are

14 you now in February or January?

15 A. I think he's referring to the second admission.

16 Q. Yes.

17 A. So I think we are talking of 18 February, yes.

18 Q. That is page 124 of the records.

19 A. Yes, bottom of the page:

20 "Ward round ST1."

21 That was my Monday morning ward round. I would have

22 been wanting to see Mrs Shaw on that ward round, but she

23 apparently was busy with the physiotherapist, who

24 probably also had her case sheet with her at the time.

25 By that stage, as I said, over the weekend, the

120

1 assumption was that she was remaining settled and was

2 awaiting rehabilitation in care of the elderly and,

3 although I didn't see the patient, I was told there were

4 no new issues, and that's the note that the ST1 has put

5 down on the case sheet when it was available.

6 I asked on the ward round that her inflammatory

7 markers be rechecked because they were slightly up the

8 previous week. They had never quite settled down and

9 I felt we should continue to monitor the situation.

10 Now, it was the afternoon of that day that she

11 suddenly seemed to change. I think her blood pressure

12 fell quite markedly that afternoon. I think later on

13 she developed a pyrexia. The nursing staff alerted the

14 FY1 to this, and the FY1, at the bottom of that page,

15 has recorded that blood cultures were obtained.

16 Q. So that's the background to that, is it?

17 A. That's the background to that. Now, unfortunately, as

18 I'm sure you're aware, the page of nursing notes

19 relevant to the dates between the 14th and that part of

20 the 18th, that page is missing. That would have been

21 very useful to have seen that, actually. But that

22 appears, to my mind, to be the sequence of events, that

23 she was okay in the morning and seemed to go off in the

24 afternoon, developed a pyrexia by, I think, early

25 evening. Blood cultures sent then. Her blood pressure

121

1 came up without, I think, any significant intervention,

2 but it didn't come up to normal, it came up to about 95

3 systolic, having fallen to about 80-ish. That's my

4 recollection, anyway.

5 Q. She must have deteriorated very quickly, then?

6 A. She must have deteriorated very quickly, yes.

7 Q. Because I think she had died by the 20th.

8 A. By the following day, it was realised that she was

9 unwell and they did aggressively resuscitate her then,

10 with fluids, and so on. I'm sure you're coming on to

11 that, though.

12 Q. The next bit is this, that Dr Jones went on to say:

13 "Question: What do you say should have been done at

14 that point in time?

15 "Answer: The issue of response to somebody who is

16 becoming septic is to intervene aggressively with

17 massive fluid replacement, appropriate antibiotics,

18 usually central monitoring, very good fluid balance and

19 usually escalating to a high level of care, probably an

20 HDU setting, to give a better chance of outcome.

21 "As we have seen, she was becoming increasingly

22 acidotic with a very high serum lactate. That shows

23 a fair amount of her body was not getting enough oxygen.

24 In that situation, her outcome was always going to be

25 poor."

122

1 Do you accept that analysis?

2 A. I do. I think, in a case like this, obviously you want

3 to intervene as quickly as possible, and there were

4 early signs that something was going wrong the previous

5 afternoon. The FY1 most likely, or the nursing staff,

6 should have alerted the middle grade SHO to the

7 situation.

8 Q. Did that happen?

9 A. I don't think so. As I say, the notes are not there to

10 clarify that.

11 Q. What Dr Jones is postulating is an aggressive

12 intervention with massive fluid replacement, and so on,

13 and I don't think we see evidence of that?

14 A. Not on that day, but the following day we do. And she

15 responded very well to that, in fact.

16 If I can go on, on the 19th, about midday, the

17 patient was put on rapid intravenous fluids and her

18 blood pressure quite rapidly came up to 125 over 75

19 after, I think, just one bag of saline, so that's really

20 not an awful lot of resuscitation to get her blood

21 pressure back up. She continued on that. I think she

22 was on her fifth bag of saline by the time she left to

23 go to Paisley in the mid-evening.

24 It is not a vast amount of fluid to have given to

25 get her blood pressure back up again, but, nonetheless,

123

1 I agree it would have been better to have done it

2 earlier.

3 Q. The missed opportunity was on the 18th?

4 A. You could say -- did it make any great difference to

5 outcome? I suspect not, actually. I suspect not.

6 Because she did respond to that. The likelihood is that

7 she would not have been transferred to Paisley until the

8 next day, I suspect. I suspect that would have been the

9 case, anyway.

10 Q. The other point I have been asked to raise with you

11 relates to death certification. The patient, of course,

12 died in the Royal Alexandra Hospital.

13 A. Yes.

14 Q. If we look at the death certificate, at SPF00320001, we

15 can see in section 7 that she died on 20 February 2008

16 in the Royal Alexandra Hospital and the causes of death

17 are given as septic shock and fulminant colitis.

18 The point I have been asked to raise with you is

19 whether you agree with Professor Griffin that C. diff

20 was an underlying cause of death?

21 A. Well, that's a difficult one, I find, quite honestly.

22 This lady had, obviously, severe, very severe, ischaemic

23 colitis that should have been treated surgically when

24 she went to Paisley the first time, but the patient

25 refused surgery, as you know.

124

1 I think that was a missed opportunity, really. That

2 was the time to have dealt with this. When she went off

3 again -- and, of course, the initial illness was due to

4 sepsis related to that ischaemic colitis, which

5 responded to antibiotics then.

6 When she went off the second time, I can only assume

7 the same is true again, that she went in -- she

8 developed sepsis again.

9 Now, the question is whether that sepsis was

10 entirely due to C. diff, partly due to C. diff or

11 C. diff was just an innocent bystander, and I don't

12 really know the answer to that. All I can say is that

13 she'd been checked for C. diff numerous times up until

14 that last day, and the last day is the only time that we

15 get a positive result back.

16 I think if this lady had not had C. diff, she would

17 have died from her sepsis secondary to her ischaemic

18 colitis, so I have a difficulty putting C. diff down as

19 the cause of death.

20 Q. What about a contribution to death?

21 A. Yes, in part II, certainly. Part I, I would have

22 difficulty with that, simply because it would then be

23 seized on as being the cause of death. I think if

24 C. diff had not been there, the likelihood is that this

25 lady would have developed further sepsis.

125

1 Q. If I can just see if there are any further questions on

2 behalf of the MDDUS for this patient?

3 DAME ELISH: My Lord, the first four questions can be

4 omitted. They have been covered. I think part of some

5 of the other questions have also been covered, but there

6 may be an element of the question which has not been.

7 MR MACAULAY: One of the next questions then is question 54,

8 if you have a list there: please explain the decision to

9 commence intravenous hydrocortisone and whether you

10 agree with the observation by Dr Connor that

11 hydrocortisone therapy could make the clinical condition

12 deteriorate by depressing the body's natural defences

13 against C. difficile.

14 A. As with all treatments, there are pros and cons and,

15 yes, a potential side effect from steroids is, indeed,

16 that it might suppress the immune system's response to

17 other situations. But at the time, that seemed the

18 appropriate thing to do. I think it would be the thing

19 I would do again in that situation.

20 Q. I think what you are saying is that the steroids could

21 depress the immune system --

22 A. Could do.

23 Q. -- and make the infection much more severe and

24 aggressive?

25 A. Given that she was on steroids on the first occasion

126

1 when she settled with intravenous antibiotics, I think

2 it's a hypothetical situation that's been raised,

3 because, in fact, she settled down despite being on

4 steroids then.

5 Q. I think you also said that this would have worsened her

6 condition and made her more susceptible to C. diff

7 infection, for the reasons I think you have indicated?

8 A. All I can say is, when she came back to the Vale the

9 first time, by the time she had been with us for, say,

10 four or five days, her inflammatory markers were settled

11 pretty well. She, herself, was seen to be over whatever

12 had been happening before that time and we were

13 considering rehabilitation. So, again, I can't discount

14 the fact that steroids might have had some delayed

15 effect --

16 Q. Was she on steroids at that time?

17 A. I can't remember. Have we got the drug Kardex?

18 Q. What would you require to look at? Would it be the

19 Kardex?

20 A. All the Kardexes I think ended up in Paisley, didn't

21 they? Let me just check.

22 Q. Was this being given intravenously?

23 A. Yes. My recollection is that she came off the steroids

24 in Paisley, but I may be wrong about that.

25 Q. We have, I think, an intravenous chart on page 267, if

127

1 that is of any help to you. Have you got that?

2 A. Yes.

3 Q. GGC00500267.

4 A. These are the once onlys. I think that was earlier on.

5 On the next page, page 269, is when she was given the

6 steroids and I see these are discontinued on the 31st

7 when she's in Paisley.

8 Q. That's the second entry, then?

9 A. The hydrocortisone, that's right.

10 Q. That suggests she wasn't on steroids, then, when she

11 returned to the Vale of Leven?

12 A. Yes. So she came back -- they were discontinued in

13 Paisley, yes.

14 Q. The other point I have been asked to put to you on

15 behalf --

16 A. Can I just add to that, that being the case, that was

17 19 days prior to -- 18 or 19 days prior to her going off

18 again. I think any effect from these steroids would

19 have gone by that stage.

20 Q. The next question I have been asked to put to you by the

21 MDDUS is this: do you agree with Dr Connor's conclusion

22 in his report that more attention should have been given

23 to the possibility and reasons for a potential false

24 negative in the earlier specimens?

25 A. Well, as I have already said, when she presented on the

128

1 first occasion, my feeling was there was more going on

2 than just -- well, it just didn't ring true as just

3 being a simple C. diff situation. The test was negative

4 for that. I looked for other explanations and I found

5 other explanations.

6 Q. But, in any event, she was treated with metronidazole?

7 A. And indeed she was covered with metronidazole.

8 Q. Question 55: Dr Jones in his report suggests that (a)

9 repeated transfers between the Vale of Leven and RAH

10 sometimes without handover did not help the continuity

11 of care. Do you make any comments on that?

12 A. I'm not quite sure what he means by that.

13 Q. The lack of early recognition that the colitis was

14 almost certainly ischaemic was not helped by the

15 expressed certainty that the colonoscopy appearances

16 were those of extensive Crohn's disease?

17 A. Granted.

18 Q. Neither the nursing staff nor senior medical staff

19 responded appropriately on 18 February and the decisions

20 by the very junior medical staff were simply inadequate.

21 I think we have covered that.

22 A. We have covered that. Going back to the first point,

23 ischaemic colitis, there are very few treatments for

24 that. Really, it is surgery. Now, surgery was not

25 going to happen until the results of the biopsies came

129

1 back. So even if I'd queried it -- and it may have been

2 in my mind at the time because the ulceration was not

3 entirely typical of Crohn's disease. Even if I had

4 queried it at the time, I think it would not have

5 changed what happened thereafter.

6 Q. Another point raised is that the repeated transfers --

7 certainly we know there was the transfer from the Vale

8 to the Royal Alexandra Hospital and then a transfer back

9 subsequently. The point is whether the quality of

10 communication between the two was appropriate?

11 A. I think -- I'm not sure if this is the patient that I'm

12 thinking of. Did we get -- I don't think we got any

13 communication back from the surgeons with the patient,

14 just the notes.

15 Q. I think we heard some evidence from Dr Herd yesterday

16 that in particular instances that seemed to happen?

17 A. I'm afraid that did happen not infrequently.

18 Q. This is question 58, because I think I have covered 57

19 already: Dr Jones made the point in his report that the

20 rise in the MEWS score to 3 on 18 February and the rise

21 to 5 on the 19th did not correspond to the medical note

22 written on the 18th, where it stated "No new issues"?

23 A. As I have already clarified, that has happened before

24 the MEWS of 3, which was in the afternoon. Up to that

25 point, her MEWS over that weekend had been zero.

130

1 I think that's the case. From recollection, it was

2 zero.

3 Q. The point about the prescription of the metronidazole,

4 and we can see this in the medical records at page --

5 the reference I have been given is 155.

6 A. I don't understand why Dr Jones felt there was only one

7 dose given, because I can see two marks on that

8 particular page for metronidazole, and that was my

9 understanding, that she had two doses of metronidazole

10 before she was transferred to Paisley.

11 Q. We can see that for ourselves, I think.

12 A. I don't quite understand why it says only one. I don't

13 know where they got that from.

14 Q. We'll perhaps just check that that's what he said, but

15 if that's what he said, we can see for ourselves that

16 that is not correct.

17 A. That is indeed what he said.

18 DAME ELISH: If it assists, I think my friend has it at

19 Day 51, page 85.

20 MR MACAULAY: We can check exactly what he said. If that is

21 what he said, we can see for ourselves he wasn't correct

22 in that. That's correct, isn't it, Dr Carmichael? Are

23 you looking for where that was said?

24 A. I thought you were, sorry.

25 Q. We will look for it. You are right: if that is what he

131

1 said, he is wrong and you are correct, because we can

2 see that for ourselves.

3 A. Indeed.

4 Q. I have also been asked to ask you, why would the Kardex

5 for the Vale of Leven appear in the Royal Alexandra

6 Hospital notes?

7 A. Well, we shared Kardexes. Basically, we had the same

8 format of Kardex so that -- to facilitate this kind of

9 situation where patients were transferred back and

10 forth, so the Kardex would go with the patient.

11 Q. The final question I think I have to put to you is, do

12 you accept the evidence of Dr Jones --

13 DAME ELISH: I think this question has been answered.

14 MR MACAULAY: It has, thank you.

15 MR KINROY: My Lord, I wonder if I might be allowed to ask

16 one question to do with death certification? If I may,

17 the evidence was that Dr Carmichael accepted that

18 C. diff should have been down in part II of the death

19 certificate as a contribution to death.

20 The question is: is Dr Carmichael saying that, but

21 for the C. diff illness, Ms Shaw would not have died

22 when she did?

23 A. Well, that is a question I can't really answer, but in

24 my opinion, I think C. diff could possibly have had

25 little role in the final episode. It was part of

132

1 the picture, but not the whole picture. The sepsis was

2 probably a combination of all the bugs that were around

3 her gut at the time getting into her blood system.

4 MR MACAULAY: Would the final answer depend on whether the

5 other results were false negatives or not?

6 A. Well, this is it. We had no evidence of C. diff up

7 until that very last day. I think the likelihood, given

8 her initial presentation that she was at risk of this

9 happening again -- and indeed it did happen again,

10 quicker than we would have thought likely. Now, the

11 role of C. diff in that, as I said earlier, I have

12 difficulty answering that, but my feeling is that, if

13 C. diff had not occurred, the likelihood of this

14 occurring was very real.

15 Q. The next patient I want to look at with you is

16 Mrs Fitzsimmons. Again, this patient had a number of

17 admissions, I think, Dr Carmichael, but the relevant

18 one, as far as you're concerned, was one on

19 27 March 2008. If we turn to page -- the medical

20 records are at GGC00190303. Can we see here that, at

21 the time of this admission, you were designated as the

22 admitting consultant?

23 A. Yes.

24 Q. Was the patient then admitted under your care at about

25 this time?

133

1 A. Sorry, I'm just trying to find my place in my own notes.

2 Yes.

3 Q. If we move on to page 305, I think, do we have a note by

4 yourself on 28 March?

5 A. Yes.

6 Q. Just looking to the final section of that note, what was

7 the plan at that point?

8 A. Let me just gather my thoughts. This was a lady who had

9 quite a number of issues: previous right hemicolectomy

10 for diverticular disease many years ago; chronic

11 pancreatic insufficiency with secondary diabetes from

12 that; diabetic retinopathy and nephropathy, that's

13 damage to her eyes and kidneys from the diabetes;

14 chronic obstructive airways disease; and, in the lead-up

15 to this admission, I had seen her twice because of

16 concerns about her liver, and investigations, including

17 ultrasound and CT, had shown that she had cirrhosis of

18 the liver and secondary ascites, that's fluid within the

19 peritoneal cavities, due to that. So this was a lady

20 with a number of problems.

21 Q. What was your plan, then, at this time, as to how she

22 should be managed?

23 A. She was frail and not able to look after herself. She

24 came in with several weeks of poor appetite and

25 increasing weakness and off her feet since her care

134

1 package had been removed in the week or two prior to

2 that, I think.

3 My assessment of her was that she was dehydrated,

4 wasted and had evidence of crepitations in the lung

5 fields and oedema of her tissues, perhaps partly due to

6 a very low albumin level, which itself was probably

7 a combination of poor nutrition and her liver disease,

8 which -- the liver makes this albumin, and a liver that

9 is chronically scarred is unable to do so, so readily,

10 anyway.

11 So the priorities were rehydration at the time.

12 Q. I think you have noted rehydration, and also you wanted

13 some physiotherapy input as well; is that right?

14 A. That's right.

15 Q. If we move on to page 15, to 31 March, where I think you

16 have seen the patient again -- is that correct?

17 A. Page 15?

18 Q. Page 315, rather.

19 A. Oh, yes. Indeed.

20 Q. Can we see here that you consider that she's still

21 dehydrated; is that right?

22 A. Yes. She was a complicated lady to look after, and the

23 nursing staff were concentrating and controlling

24 her diabetic status and giving her glucose to cover her

25 insulin needs, et cetera, because she wasn't taking much

135

1 orally. That was to the detriment of giving her saline,

2 which was also required.

3 Q. This is all towards rehydration?

4 A. This is all towards rehydration and repleting the saline

5 that was deficient in the body. She required saline as

6 well as dextrose -- well, the emphasis --

7 Q. Just to move on to the next entry, then --

8 A. Okay.

9 Q. -- the same day there is an entry by an ST1 doctor,

10 suggesting there was a raised white cell count and CRP,

11 and she's for empirical Augmentin. Is that what we see?

12 A. That is the case, yes.

13 Q. Can you say what that -- we see the inflammatory

14 markers, but can we see from this what the thinking was

15 as to what the source of the inflammation might have

16 been?

17 A. Well, obviously they haven't made any specific reference

18 to a source of infection, but the worry was that this

19 represented her infection. There is no mention of urine

20 analysis or examination of the chest, et cetera.

21 Q. So there have been some reference to potential sources?

22 A. I would have thought that.

23 Q. But you then, I think, the following day, carried out an

24 examination. If we turn to page 237 of the records, we

25 are looking at a gastroscopy report; is that correct?

136

1 A. That's correct, yes.

2 Q. What did you ascertain from this examination?

3 A. That she had a severe fungal infection of

4 the oesophagus.

5 Q. Did you then prescribe some medication for that?

6 A. Yes, fluconazole.

7 Q. Would you have expected the antibiotics that had been

8 prescribed previously to have been reviewed?

9 A. To have been reviewed, did you say?

10 Q. Yes.

11 A. The antibiotics prescribed on the 31st?

12 Q. Indeed, yes.

13 A. Well, at that point, at endoscopy, I wouldn't have been

14 concentrating on that aspect of things, so I don't think

15 I became aware that she was on antibiotics until,

16 presumably, the following day, 2 April, page 316.

17 Q. On page 316, you have seen the patient, that's the entry

18 towards the top of the page; is that correct?

19 A. Yes.

20 Q. Did you review the antibiotics that the time?

21 A. Well, I have made no reference to that, have I? So

22 I can't be sure when I became aware that she was on

23 these antibiotics. I should have reviewed the Kardex at

24 that stage.

25 Q. If we look at the Kardex, page 719, we can see that

137

1 she's on the co-amoxiclav from the 31st through to

2 about -- is it 6 or 7 -- 8 April?

3 A. I think I became aware of her antibiotics on the 3rd,

4 the following day, because I have asked for repeat

5 inflammatory markers, to see if, indeed, she has

6 evidence of infection, ongoing infection.

7 Q. Should the antibiotics have been continued for that

8 length of time?

9 A. Well, this is now -- depending on the cause, that's

10 roughly a seven-day course. Depending on what the

11 explanation was, it might have been appropriate, but of

12 course, we are not sure here what is going on, what the

13 potential source of infection is supposed to be. It has

14 not been clarified by the juniors as to what they put

15 the patient on the co-amoxiclav for.

16 Q. That's one of the difficulties. We don't know why it

17 was prescribed in the first place?

18 A. We don't know why, no, I accept that.

19 Q. If we look at page 537, because there was a urine sample

20 taken on the 27th, can we see that that is the position:

21 collected on the 27th, received by the lab on the 28th,

22 reported on 1 April and that candida species was

23 isolated. How does that fit into the antibiotic

24 therapy?

25 A. The antibiotics do tend to encourage the growth of

138

1 fungus in urine cultures. So if you have been on

2 antibiotics for a while, you get a secondary growth of

3 fungus. It doesn't necessarily mean to say that that is

4 a clinically important thing to find, but obviously, if

5 it is left untreated, it could lead to problems.

6 Now, this lady was already on treatment for candida

7 anyway, so it probably didn't really matter that much.

8 Q. But this would not be a basis for continuing with

9 antibiotics?

10 A. Certainly not. No, no, the very opposite. The

11 antibiotics -- apart from -- the fluconazole would treat

12 that, but not the co-amoxiclav. The very opposite: the

13 co-amoxiclav would encourage that.

14 Q. So should the co-amoxiclav then have been stopped?

15 A. It was, in fact, eventually stopped, was it not? I'm

16 not sure when this result came back to the ward.

17 Q. The dates --

18 A. I eventually stopped the antibiotics on the 7th --

19 Q. Yes.

20 A. -- when I next saw her. I expected the juniors to have

21 reacted to the repeat inflammatory markers before that

22 stage, I think, but that had not happened.

23 Q. The other point about Mrs Fitzsimmons' case relates to

24 the prescription of clarithromycin. If you turn to

25 page 323 of the records, we have an entry for 15 April.

139

1 I think the plan is to add clarithromycin to her current

2 therapy; is that correct?

3 A. I think that's the case.

4 Q. Can you say what this was for?

5 A. To backtrack a bit, again, the juniors had commenced her

6 on co-amoxiclav on 9 April, on the basis of -- let me

7 just get this right. I think what happened was further

8 monitoring of her CRP and white cell count showed these

9 were drifting back up again and, having been settled

10 down, the CRP was back up to 65 and the white cell count

11 up to 14.5 on the 9th, and I think because the chest

12 X-ray on that day had suggested possible chest

13 infection, the juniors had commenced the patient back on

14 co-amoxiclav.

15 Q. If we look at the clarithromycin, then, what we see is

16 there is a reference to "Complaining of very vague

17 symptoms, appears very depressed".

18 A. Yes, that's right.

19 Q. That wouldn't be a basis for starting an antibiotic?

20 A. Certainly not, but the inflammatory markers and the

21 chest X-ray findings were what precipitated that being

22 recommenced. I think I became aware of that on

23 14 April, that she was on co-amoxiclav, so I requested

24 that further monitoring of her CRP and white cell count

25 be done with a view to discontinuation if these were

140

1 settled again, but the following day, as you quite

2 rightly say, the junior has again had concerns about the

3 patient not settling down, the examination of the chest

4 again showing what I presumed were a worsening of

5 the crepitations in the lungs, as far as the junior was

6 concerned, at any rate, and, therefore, a feeling that

7 the co-amoxiclav was not fully covering the situation

8 and that the patient -- the doctor added in

9 clarithromycin at that point.

10 Q. I suppose the short point is, do you consider that was

11 appropriate standing the clinical findings, or not?

12 A. It is debatable. I stopped them on the 17th.

13 Q. You did, indeed.

14 A. I think I felt that they were no longer necessary. By

15 that stage, she had had two days of clarithromycin only

16 and eight days of co-amoxiclav.

17 Q. You took the view at that time, certainly, that the

18 treatment should not continue?

19 A. Yes.

20 Q. Can I see if there are any additional questions that

21 I require to put to you? I don't know if my learned

22 friend Mr Peoples is insisting on all his questions or

23 not.

24 MR PEOPLES: My Lord, I think the only point might be about

25 clarithromycin, (c)(iii), to complete the picture.

141

1 I also note that on the entry for 15 April,

2 Dr Carmichael -- there was a discussion with him,

3 according to the junior doctor's note. I'm not sure if

4 that was covered. I think it is point 3 in the plan.

5 It may be "to discuss" rather than a discussion?

6 A. Sorry, which page?

7 MR MACAULAY: If we go back to page 323, there is

8 a reference at the bottom of the page to "Discuss with

9 Dr Carmichael - possibly psychogeriatric" -- that's not

10 to do with the antibiotics, it's to do with --

11 A. This was, I think, "psychogeriatric referral".

12 Q. That doesn't mean it has happened because it is under

13 reference to "Plan".

14 A. No, this is a note of things to do: should the patient

15 have a psychogeriatric referral? Presumably because of

16 this recording of her mood being very low. Now, I can't

17 remember if that was discussed at that time or not.

18 Q. The one point I have been asked to raise with you

19 relates to the actual administration of

20 the clarithromycin, and if you turn to page 531 --

21 MR PEOPLES: Sorry, I think the numbers are transposed.

22 I think it should be page 135, sorry, GGC00190135.

23 LORD MACLEAN: Do you think we could continue with this

24 after tea?

25 MR MACAULAY: Yes, my Lord, I think we can have a break now.

142

1 LORD MACLEAN: What is progress like?

2 MR MACAULAY: I have to finish off some further questions on

3 behalf of the health board and the MDDUS, and then

4 I will be finished with Dr Carmichael.

5 LORD MACLEAN: All right.

6 (3.16 pm)

7 (A short break)

8 (3.40 pm)

9 MR MACAULAY: Dr Carmichael, I am going to put some

10 questions to you on behalf of the health board. The

11 first question I want to put to you is this: is it

12 possible that there was a transition from active

13 treatment to palliative care which went unrecorded in

14 the notes of any patient of yours?

15 A. Not to my knowledge.

16 Q. I think it is right to say that you haven't seen any of

17 the GP records for the patients whose care is in

18 question here?

19 A. No.

20 Q. Can you exclude the possibility that in such cases the

21 patient suffered from C. diff illness or diarrhoea in

22 the six months preceding that patient's admission?

23 A. Sorry, can I ...?

24 Q. Can you exclude the possibility?

25 A. No. No.

143

1 Q. Can you exclude the possibility that in such cases the

2 patient was prescribed antibiotics in the three months

3 preceding the admission?

4 A. No.

5 Q. Is it possible that in some cases, at least, the

6 patient's susceptibility to contracting C. diff

7 infection was caused by antibiotic prescribing in the

8 community?

9 A. It's possible.

10 Q. Is it the case that, quite often, elderly patients with

11 a urinary tract infection do not have the classic

12 symptoms of that?

13 A. Indeed.

14 Q. Is it the case, quite often, the most obvious clinical

15 sign of that infection in an elderly patient is

16 confusion?

17 A. That is one of the symptoms that can occur.

18 Q. If you had encountered systematic and material delays in

19 the testing of samples, would you have done something

20 about that?

21 A. Yes.

22 Q. Did you?

23 A. No.

24 Q. Was there a common background rate of unexplained

25 diarrhoea for norovirus infection on wards at the same

144

1 time as C. diff that would have the potential to make it

2 difficult to suspect a false negative on clinical

3 grounds?

4 A. I don't recall at the time. If it had been the case, it

5 would have certainly made it more difficult.

6 Q. This is a quote from the statement given by Dr McCruden:

7 "There was a general awareness in the profession

8 that C. diff numbers were rising. This is based on

9 discussion with colleagues from elsewhere, and not just

10 based on the Vale of Leven. We thought that it was the

11 same picture that was being seen in other sites across

12 the UK."

13 Did you share that awareness?

14 A. Yes, I have already alluded to that.

15 Q. Was there, and does there remain, a background rate of

16 C. diff infection in every hospital?

17 A. I think that is the case, yes.

18 Q. Does that mean that it is virtually impossible to

19 guarantee that there will be no patient in the hospital

20 suffering from C. diff infection?

21 A. It will be impossible to guarantee that, mmm-hmm.

22 Q. Do you agree or accept that the practical issue is

23 detecting in the hospital suffering from C. diff

24 infection when the incidence of C. diff infection

25 exceeds the unavoidable background rate?

145

1 A. I would imagine it is very difficult to be aware of that

2 without input from infection control, yes.

3 Q. That is what the statistical process charts are designed

4 to do; is that right?

5 A. Yes, I really meant -- yes, yes. Surveyance.

6 Q. If it was the case that, at the time, you and your

7 colleagues believed that there was an increased

8 incidence of C. difficile infection nationally, which

9 you might have expected to see reflected in the

10 background rate, then might that have played a part in

11 camouflaging that there was actually a C. diff infection

12 outbreak in the hospital?

13 A. Very much so.

14 Q. Dr McCruden, I have another quote from him to put to

15 you:

16 "Dr Andrew Seaton came to speak to the medical staff

17 as a group at the Vale of Leven, having met with me

18 beforehand. He gave a presentation on very recent

19 experience of beneficial changes in prescribing in

20 C. diff cases. Protocols then became available

21 around June 2008 in terms of prescribing in order to

22 reduce the incidence of C. diff and terms of treating

23 identified cases. I was not part of the AMT as such.

24 I was there to be persuaded by the new evidence and, in

25 response to this evidence and Dr Seaton's

146

1 recommendations, I, along with my Vale of Leven

2 colleagues, agreed to mandate junior staff to follow

3 these protocols."

4 Do you agree with this account?

5 A. Yes.

6 Q. Were you also persuaded by the evidence that Dr Seaton

7 presented?

8 A. Yes.

9 Q. If that is so, does this reflect that there was not

10 unanimity within the medical profession at the time

11 about how, in prescribing antibiotics, to balance the

12 risk of the patient contracting C. diff infection

13 against the risk of delaying treatment or other

14 bacteriological infections from which the patient was

15 already suffering?

16 A. I'm not quite sure I follow that.

17 Q. If so, this account reflects that there was not

18 unanimity within the medical profession at the time

19 about how, in prescribing antibiotics, to balance the

20 risk of the patient contracting C. diff infection

21 against the risk of delaying treatment of other

22 infections from which the patient was already suffering?

23 A. Yes.

24 Q. It would have been quite improper for the board to deny

25 to doctors their proper discretion in which antibiotics

147

1 to prescribe?

2 A. Yes.

3 Q. Changing in prescribing practice desired by the board

4 required to have an evidential basis of which the

5 doctors had to be informed?

6 A. Yes.

7 Q. They then required to be persuaded that it was

8 professionally proper to change their prescribing

9 practices as the board desired?

10 A. Sorry?

11 Q. You then had to be persuaded --

12 A. Yes, yes.

13 Q. -- that it was professionally proper?

14 A. Yes.

15 Q. You and your colleagues required to consent to these

16 changes in prescribing practices for themselves and for

17 your junior doctors?

18 A. Yes.

19 Q. Changes in prescribing practice desired by the board

20 could not necessarily, depending on what was in issue,

21 be effected quickly?

22 A. That is true.

23 Q. If you had been systematically hindered by the quality

24 of nursing of your patients, would you have done

25 something about that?

148

1 A. Yes.

2 Q. Was the quality of nursing adequate?

3 A. It was indeed.

4 Q. Do you consider that more single rooms would have

5 avoided the outbreak occurring?

6 A. I can't possibly claim that. It certainly would have

7 helped.

8 Q. Finally, in relation to these questions, do you consider

9 that you have prepared appropriately to give your

10 evidence to the Inquiry?

11 A. Yes.

12 Q. I am now moving on to conclude the questions I have been

13 asked to put to you on behalf of the Medical and Dental

14 Defence Union for Scotland. There are a number of

15 general questions, first of all --

16 DAME ELISH: I have indicated to my learned friend, my Lord,

17 the first 17 do not require to be asked.

18 LORD MACLEAN: What about the others? How many others are

19 there?

20 DAME ELISH: Unfortunately, my Lord, there are several. I'm

21 just wondering, the witness having been here all day,

22 whether or not it is appropriate to embark, because

23 I think the one in particular which relates to

24 William Hunter could take some time.

25 LORD MACLEAN: I realise that is coming.

149

1 MR MACAULAY: I will press on and see how we get on and try

2 to get you finished, Dr Carmichael.

3 Generally, in relation to the provocation -- the

4 relationship between provocative antibiotics and

5 C. diff, has there been a variety of studies over

6 a period of time which have come to different

7 conclusions on that?

8 A. I think that the answer to that must be yes. It is

9 a difficult area, trying to decide which antibiotics

10 carry the biggest risk. A lot of the studies done are

11 largely dealing with observational data, which is

12 notoriously suspect and rather weak in terms of basing

13 one's conclusions on. This has been true, as I think we

14 are aware here, of PPIs, for example.

15 Some of the experts maintained that PPIs were

16 accepted as being detrimental to the development of

17 C. diff. There is no consensus on the role of PPIs.

18 For every study that suggests PPIs are bad, there are

19 studies that suggest there is no problem, and the

20 consensus at the moment is that the jury is out, as they

21 say, on PPIs.

22 The same can be said, to some extent, with a lot of

23 the antibiotic-related studies. They are observational.

24 Some are better done than others. The problem is trying

25 to relate the findings -- eliminate as many confounders

150

1 as possible, ie, other factors that would appear to make

2 that particular antibiotic look bad when, in fact, it is

3 not the case. I think that is what has bugged a lot of

4 us over the years.

5 I don't want to spend too much time on it, but I do

6 want to plead the case for the poor old co-amoxiclav,

7 which has been --

8 LORD MACLEAN: Before you deal with co-amoxiclav, I don't

9 think you really mean to say, do you, that PPIs are

10 accepted as being detrimental to the development, you

11 mean the opposite?

12 A. The opposite. I think the jury is out as to what the

13 role of PPIs is.

14 LORD MACLEAN: In the development of C. diff?

15 A. In the development of C. diff, yes.

16 LORD MACLEAN: Now co-amoxiclav.

17 A. Sorry about that, my apologies.

18 Co-amoxiclav, as I said earlier, my feeling about it

19 was that it was intermediate in risk. I think that is

20 the case with a lot of the experts as well. But the

21 feeling in the Scottish and Glasgow protocols is that

22 they are lumping co-amoxiclav together with the

23 cephalosporins and the fluoroquinolones as being bad.

24 I'm not sure that is fair, personally.

25 The Americans -- very rarely do you even see

151

1 co-amoxiclav mentioned in their list of suspect drugs.

2 I prepared a one-sheet A4 summarising two studies done

3 that I think are relevant, and I am not sure -- has that

4 been submitted, do you know? Is it available?

5 DAME ELISH: It has been submitted, my Lord, to the Inquiry.

6 A. Is it available to put on the screen? It is called "Low

7 risk of co-amoxiclav" --

8 LORD MACLEAN: Has it?

9 MR MACAULAY: If it has been submitted -- I don't have it to

10 hand. Perhaps my learned friend can --

11 A. I can speak to it. I will keep it as simple as

12 possible.

13 Q. If it hasn't been submitted, we can get a copy of it.

14 Can you give me the title of it?

15 A. There are two papers. The first -- well, I can't

16 actually give you the titles because I haven't actually

17 recorded the titles. One was published in the Journal

18 of Hospital Infection 2009 by Sundram et al from the

19 Royal Surrey County Hospital. Basically, it was looking

20 at antibiotic resistance to various ribotypes of

21 C. diff, including the 027, which of course is the one

22 that we are dealing with here primarily.

23 Basically, what it's showing is that for 027 in

24 particular, whereas the cephalosporins and ciprofloxacin

25 had almost -- well, 95 per cent resistance -- sorry, the

152

1 027 was 95 per cent resistant to the cephalosporins and

2 the ciprofloxacin, that figure for co-amoxiclav was only

3 15 per cent, very near the 2 per cent for vancomycin,

4 which, as you know, is the treatment for C. diff, and

5 metronidazole which was zero.

6 So co-amoxiclav appears, in this study at least, to

7 carry a fair degree of sensitivity regarding C. diff.

8 In other words, C. diff should be suppressed by it, not

9 encouraged by it. That is one study; okay?

10 Q. And the other one?

11 A. The other study follows on from the Quebec outbreak in

12 2003. This is a study published in 2005 in the New

13 England Journal of Medicine, a big study.

14 Basically, it's looking at the risks of various

15 different antibiotics primarily to do with the 027.

16 This was an outbreak where 84 per cent of the cases were

17 due to 027, and it was 1,700 patients that were

18 reported. Whereas the odds ratio for cephalosporins and

19 fluoroquinolones was nearly 4, and the higher you go the

20 higher the risk, that for the beta-lactamase inhibitors,

21 ie, including co-amoxiclav, was virtually 1, 1.2, and 1

22 is no effect, basically.

23 What the study was basically saying, as far as they

24 are concerned, co-amoxiclav was not a risk for the

25 development -- or a very minor risk for the development

153

1 of C. diff. So these are just two studies. There are

2 many other studies. I am just pointing these two out,

3 just to highlight the fact that there is a lot of

4 uncertainty around exactly what is going on, and it is

5 probably not just one antibiotic, it is the whole

6 climate of what has been happening that has led to this

7 problem.

8 So that is really all I want to say about

9 co-amoxiclav. Made in Scotland, but that's not why I'm

10 saying it.

11 LORD MACLEAN: I have a little difficulty in understanding

12 one of the statements which you have taken, obviously,

13 from a paper: the 027 ribotype was 95 per cent resistant

14 to ciprofloxacin and cephalosporins?

15 A. Yes.

16 LORD MACLEAN: Resistant?

17 A. That means it would not be suppressed by the

18 cephalosporins or the ciprofloxacin and, therefore,

19 whereas other bacteria would be suppressed by these

20 antibiotics, they would then be allowed to flourish in

21 the gut. That is why these antibiotics are a danger --

22 were a danger for the development of C. diff, because

23 the 027 ribotype was resistant to their effect.

24 LORD MACLEAN: But I thought we were looking at C. diff

25 being caused by?

154

1 A. Indeed that is the case, but it is an indirect cause.

2 These cephalosporins and fluoroquinolones would suppress

3 the other bacteria in the gut, and, therefore, allow the

4 resistant bacteria to take over, to colonise the gut,

5 and that particularly is the case with C. diff. So it

6 is an indirect effect of not suppressing the C. diff.

7 LORD MACLEAN: I see that. Thank you very much.

8 MR MACAULAY: Can I then move on to look at the individual

9 cases that are left that I need to raise some questions

10 with you? The first of these is Mr Hunter,

11 William Hunter.

12 If we turn to the medical records at GGC00280013.

13 I think we see that you were the admitting consultant;

14 is that correct?

15 A. Yes, that is correct.

16 Q. If we turn to page 17, can we see that there is a note

17 in your handwriting at the top of the page?

18 A. Yes.

19 Q. The point that I have been asked to put to you at this

20 point is whether you can explain why the note is

21 undated. That is the first part of it. Are we to take

22 it there is a page missing? I don't know whether that

23 is going to be the explanation or not.

24 A. That is the conclusion I have come to. I remember

25 Mr Hunter well. Other patients, I have perhaps a hazier

155

1 memory for, but Mr Hunter sticks in my memory. He was

2 a gentleman with mental health problems who came in

3 shortly after an admission to Paisley where he had been

4 treated for pneumonia with a cephalosporin. He came in

5 with C. diff diarrhoea, basically. The diagnosis was

6 made more or less on arrival.

7 But he refused intravenous access throughout the

8 whole of his admission. He allowed blood tests when he

9 arrived at the MAU, and I think on one other occasion,

10 a couple of days later, a few days later, but he did not

11 allow any IV access for treatment at all during the

12 course of his admission, which was very frustrating and

13 distracting as far as I was concerned.

14 Now, this first note, obviously one can never say

15 "always", but as far as I'm aware, I nearly always dated

16 my notes. There is no date to this note. I have

17 written his name at the top of this sheet and not put

18 the date in. I do recollect there being issues that

19 I spent some time deliberating over on that first day

20 that are not in this note. I think there is a bigger

21 bit missing, and this is just the final bit of the note.

22 Q. If you go to the previous page, on page 16, and we put

23 them both together --

24 A. Well, this page -- as far as I can gather, the note

25 above the final note pertained to the patient in MAU

156

1 before arrival in the ward.

2 Q. We see the date at the bottom of page 16 is 18 February;

3 is that right?

4 A. That's right.

5 Q. The next date we see, if we leave aside your entry, is

6 19 February.

7 A. That's right.

8 Q. So we have your entry in between, with no date.

9 A. Now, I would have seen -- the patient was admitted in

10 the morning, I think came into MAU in the morning; is

11 that right?

12 Q. If you turn to page 13, we see --

13 A. 11 am, yes.

14 Q. -- the admission date.

15 A. I will have missed him in the morning ward round and

16 seen him in the late afternoon ward round, around about

17 4.30 or 5 o'clock. This note on the previous page at

18 the bottom by the FY1 is dated -- is timed, I beg your

19 pardon, as 11.15. I think that's right. Is that right?

20 Q. Yes, that looks like 11.15, if you turn to page 16.

21 A. I think so. Just when the patient refused bloods. Now,

22 there is nothing happened after that, at least there are

23 no notes for that, but yet, the patient had had an ECG

24 and a chest X-ray carried out while in MAU and these

25 would then have been available to the ward staff, and

157

1 I think I would have expected some notes from the ward

2 staff regarding these.

3 Certainly I remember the chest X-ray being available

4 and remember the background to his admission and the

5 admission to Paisley. In Paisley, he was admitted, as

6 I say, with a pneumonia.

7 Q. Can I just ask you to slow down, Dr Carmichael?

8 A. I beg your pardon. I think I remember getting

9 information that, during that admission, he was

10 significantly hypotensive for a period of time and that

11 his sodium was very low. These were pertinent to this

12 admission as well. His blood pressure was low, and his

13 sodium was low.

14 My feeling -- I'm sorry, just to backtrack, the

15 chest X-ray that was available also for this evening

16 ward round showed evidence of congestion of the lungs,

17 fluid in the lungs. My feeling was -- again, just to

18 further elaborate, his mental health problems were such

19 that he was on an antipsychotic drug called risperidone.

20 This very often lowers blood pressure, it is

21 a well-recognised side effect of it. It is also less

22 frequently, but nonetheless has been recorded as

23 lowering sodium as well, in the blood.

24 So my feeling was, after assessing Mr Hunter, that

25 his low blood pressure was probably more likely related

158

1 to a combination of heart failure, a failing heart, and

2 his risperidone and less likely related to fluid

3 depletion.

4 My reason for downgrading the latter was that his

5 urea and creatinine on the blood sample checked in MAU

6 were entirely normal. I think anybody with significant

7 dehydration causing hypotension would have probably some

8 evidence of that in his blood tests, the urea

9 particularly would rise fairly quickly. It was entirely

10 normal.

11 Q. Can I just interrupt? You have moved on from the point

12 that I think you are making in relation to the specific

13 question I have asked you, which is whether or not there

14 is a missing page.

15 A. Yes, I have.

16 Q. Your note begins "diarrhoea for" whatever number that

17 is, is that six days, is it?

18 A. Ten days.

19 Q. You think you would not have begun your note in that

20 way?

21 A. I'm pretty sure I didn't. What I often did was, I would

22 hear the story from the juniors, read what they had to

23 say, whatever information was available. In a complex

24 case, before going to see the patient, I would often

25 start and make -- you know, note the things that were in

159

1 my mind at that time.

2 Q. And you would date it?

3 A. And the date would be first.

4 Q. And there is no date?

5 A. There is no date.

6 Q. Are you postulating that there is one page missing?

7 A. I am postulating there is a page missing. I wouldn't

8 imagine there is any more than one page missing, but

9 there is a page missing as far as I'm concerned, yes.

10 Q. You made some other points which I think you are going

11 to pick up once I go through the remaining questions --

12 A. I beg your pardon.

13 Q. -- about dehydration, and so on; is that right?

14 The next question I have been asked to put to you on

15 the previous entry that we have I think seen, there is

16 a reference to Mr Hunter refusing IV cannulation, and

17 the question is, how did that affect his treatment?

18 A. Well, it made it more difficult. We couldn't -- he only

19 allowed, I think, three blood tests during the whole

20 admission, or in fact two, because the last blood test

21 was done when he was in extremis. As I say, he didn't

22 allow any intravenous access otherwise. So we were

23 unable to monitor him from day to day in terms of blood

24 tests and unable to give him fluid that way as well. So

25 it did make it more difficult.

160

1 Q. Dr Jones said in evidence that he was of the view that

2 Mr Hunter ought to have been given a fluid challenge --

3 A. Well --

4 Q. -- once he allowed IV access.

5 A. I think Dr Jones misunderstood the comment. I think

6 I made it, so maybe I'm partly to blame. On page 018,

7 my note of the 21st. I have got, "Eating and drinking

8 okay. Allowing IV access". Now, I really just meant IV

9 bloods, you know, allowing a blood sample to be taken

10 off for testing. He was not allowing a drip to be put

11 up and left in situ.

12 Q. So that is how that is to be interpreted?

13 A. I think Dr Jones has misinterpreted that as meaning

14 continued IV access. He never allowed that.

15 Q. Dr Jones also, in his report, had described concerns

16 about the use of a fluid restriction regime in a patient

17 who was suffering from diarrhoea --

18 A. Yes.

19 Q. -- and the inadequacy of subsequent fluid resuscitation.

20 A. Yes.

21 Q. I think you want to respond to that.

22 A. I think, again, back to page 17, the bottom of it, the

23 junior has noted after my note -- no, hold on, it is

24 before that. I think, basically -- yes, that is the

25 one:

161

1 "Sodium 122 - fluid restriction."

2 That is certainly an appropriate response to

3 treating low sodium when it is due to too much water in

4 the system; dilutional hyponatremia is the term for

5 that. That was not the case here. So that was probably

6 not appropriate at that point. But, as I said earlier,

7 having established to my satisfaction that he was not

8 significantly dehydrated -- maybe minorly, but not

9 significantly -- and his low blood pressure was more

10 related to his cardiac condition and his risperidone,

11 I felt we shouldn't be overhydrating him because of his

12 heart, that we should be giving him sufficient fluid to

13 manage from day to day, and that is in fact what

14 happened.

15 Q. I think it is a point you have made already, and does it

16 also cover, in relation to the next question that

17 Mr Hunter had low blood pressure, was this the result of

18 dehydration or are there other causes? I think that is

19 what you have been telling me, that there was the heart

20 problem?

21 A. Yes, and the other factor, of course, is the fact he had

22 a C. diff infection, the toxic effects of which would,

23 to some extent, compromise his cardiac ability to pump,

24 so, again, that is another factor. I think that is why,

25 if I may go on, we see his blood pressure gradually

162

1 improving, certainly after a few days, such that, by the

2 end of the first week, I think, his blood pressure is

3 reaching more or less normal levels at some points, and

4 I think that is because, in part at least, he was

5 responding to the metronidazole for his C. diff

6 infection.

7 Q. Can you assist us, then: when was it that Mr Hunter

8 started on metronidazole? Do you need the Kardex for

9 that?

10 A. Yes, probably.

11 Q. Is that page 78?

12 A. Yes, we can see he started -- his first dose was midday

13 on the 18th, so more or less even before I saw him he

14 was on metronidazole. His first dose was before I saw

15 him, in fact.

16 LORD MACLEAN: I notice that you have got an entry,

17 actually, in that undated entry. When you say

18 "Metronidazole started".

19 A. An undated entry?

20 MR MACAULAY: We have to go back to page 17 for that.

21 A. Yes, "Started metronidazole orally", you are quite

22 right. He already had had his first dose before I saw

23 him that evening, that late afternoon.

24 LORD MACLEAN: It certainly puts that into context.

25 A. Yes.

163

1 MR MACAULAY: Moving on, then, to look at the next patient

2 to look at, and that is Mr Lynch, the question I have

3 been asked to put to you is this: it seems that

4 Mr Lynch's second positive C. diff result -- and if we

5 look at the records, perhaps put the records up, that is

6 GGC00370075.

7 So the question is that his second positive C. diff

8 result -- and we now have that on the screen -- was

9 printed on 24 March 2008 at the Royal Alexandra

10 Hospital. Given that Mr Lynch was reviewed by

11 Miss Chisholm, the consultant colorectal surgeon at the

12 RAH at her outpatient clinic on 25 March 2008, and she

13 made no mention of this positive result in her letter of

14 that review, do you agree with Dr Jones that the

15 decision-making episode occurred on 2 April, when you

16 saw the patient and said that C. diff cultures were

17 negative? Do you understand that?

18 A. I think I know what you are driving at, yes. When I saw

19 him on 2 April -- that was 11 days after discharge from

20 the RAH -- I had what I thought was the advantage of

21 having Miss Chisholm's discharge summary and covering

22 letter.

23 Q. Can we just look at that, then?

24 A. Yes, the covering letter particularly.

25 Q. Page 86. We are looking at the letter dated 4 April.

164

1 Is that the letter?

2 A. No. That's the clinic letter. The covering letter to

3 me following the discharge summary being done, so

4 it's --

5 Q. Is that page --

6 A. Not the review letter, but the one before that.

7 DAME ELISH: I think it is 004, my Lord. 360004.

8 MR MACAULAY: Page 4, then, of these records?

9 A. No.

10 DAME ELISH: There is another one which is also important.

11 MR MACAULAY: I think it is GGC00360004. Is that the letter

12 you have in mind?

13 A. There is a second page?

14 Q. Yes, if you turn to page 5.

15 A. I think Miss Chisholm sent me an accompanying letter

16 with that.

17 Q. What's the point you are making?

18 A. The point is -- can I quote from that letter? It is

19 what I had available at the time:

20 "(He (Dr Hislop) ..."

21 That's the consultant gastroenterologist who was

22 involved in the care of Mr Lynch in the RAH:

23 "He also recommended restarting methotrexate

24 injections after the C. difficile toxins were found to

25 be negative."

165

1 I took that to mean that they had been found to be

2 negative.

3 Q. So you were misled?

4 A. Yes, I assumed I was being told both tests were

5 negative. I knew -- I think Mr Lynch himself knew the

6 first test was negative. He didn't know the result of

7 the second test. I took that to mean they were both

8 negative. That aside, Dr Jones I think also suggested

9 that we should have checked his stool for C. diff again

10 when the patient was admitted, and in fact that did

11 occur. He had a further test carried out following

12 admission.

13 Q. What was the result of that?

14 A. I'm just trying to find out where it is. I think it is

15 360104.

16 Q. We can have that on the screen. That's the result of

17 the sample taken on 4 April?

18 A. That's right. After he was admitted urgently by myself

19 because he had ongoing diarrhoea.

20 Q. So we see it was collected on the 4th and this is

21 a negative result?

22 A. Yes.

23 Q. What you are saying, I think, as I understand your

24 point, is that you were misled in your interpretation of

25 the letter that was sent to you?

166

1 A. The letter following his first admission. Yes, that's

2 right.

3 Q. I have also been asked to ask you whether you would have

4 expected to be notified of the positive result obtained

5 at the RAH prior to reviewing the patient at your

6 outpatient clinic on 2 April?

7 A. I would have expected the laboratory at Paisley to have

8 notified either Miss Chisholm or the gastrologist or one

9 of their staff whether it came back positive, and that

10 that would have been relayed to us in one way or

11 another, yes.

12 Q. Had you known of the positive result, in your opinion

13 would that have changed the subsequent progress towards

14 colectomy?

15 A. It certainly would have instituted further treatment for

16 his ongoing C. diff infection. I expect it would have

17 simply delayed surgery, having said that, because

18 I think there was evidence from previous admissions that

19 Mr Lynch was heading in this direction anyway.

20 Miss Chisholm felt the same.

21 Q. The next patient, I have got one question for you in

22 connection with Mrs Valentine, and it is this: how would

23 the result of the colonoscopy and your finding of

24 C. diff be conveyed to the responsible clinician?

25 A. Right. At the time, after doing the procedure, I would

167

1 do the report on the computer in the endoscopy suite, so

2 a full report would go back with the patient to the ward

3 and the nurse who came up to pick the patient up would

4 be aware of that, and that information would be

5 available then to the ward staff and it was up to the

6 ward staff to notify the doctors of that.

7 Q. I think the last patient I have been asked to raise with

8 you is Mr Drummond. I will perhaps get the medical

9 records for him. His medical records are at

10 GGC00170001. It seems that you reviewed Mr Drummond on

11 21 April 2008. If we turn to page 34 of the records, do

12 we have there at the top of the page your note of that

13 review?

14 A. Which page are we on? Oh, yes, up here.

15 Q. Page 34.

16 A. 21 April. Yes.

17 Q. You started him on a course of ciprofloxacin; is that

18 correct?

19 A. Yes.

20 Q. In your entry I think you note the CRP was "185

21 yesterday". Is that what you have noted?

22 A. Right.

23 Q. That's the second line, I think.

24 A. Yes, it has risen to 250, I think it was up to, but it

25 had fallen back a bit.

168

1 Q. It has fallen a bit to 185?

2 A. Yes.

3 Q. Dr Sheridan had indicated that his CRP for 18 April and

4 the CRP for 20 April was 136. The result reports being

5 at pages 77 and 76 of the medical records. Perhaps we

6 can look at that. Page 77. That's the CRP, I think, of

7 185, is that right, that you have mentioned?

8 A. Yes.

9 Q. And page 76? We can put them both on the screen

10 together. We have a CRP of 136; is that right?

11 A. That's right.

12 Q. If you had known the CRP was 136 on 20 April, and we see

13 that from the date, as opposed to the 185 for 18 April,

14 and we see that from the date of the other report, would

15 this have affected your decision to start the

16 antibiotic?

17 Just to be clear, it seems that you had information

18 based upon a report relating to a specimen collected on

19 18 April and, on the basis of that, on 21 April you

20 prescribed ciprofloxacin, but there was another report

21 in relation to a specimen collected on the 20th, where

22 the CRP was less, at 136.

23 A. If I could take it further on from that, the CRP was

24 certainly falling and, had I realised it was falling

25 further, it might have well affected what I did, but if

169

1 I can take you on from that, on the day I saw the

2 patient, 21 April, it had fallen to 101, so it was

3 continuing to fall at that point.

4 Subsequent to that, it started rising again, to 129

5 on the 23rd. His white cell count, which had also

6 fallen to normal levels, I think -- I think it was 11.1

7 on the 21st -- rose to 15 on the 23rd and then 19.3 on

8 the 24th due to a neutrophilia, which is the white

9 cells, to do with infection, combating infection.

10 So looking at these figures to my mind suggests that

11 he was developing a recurrence of the infection that

12 a prolonged course of co-amoxiclav had only partly

13 treated. It wasn't fully sensitive to the co-amoxiclav.

14 Stopping the co-amoxiclav was appropriate because he'd

15 been on it for a long time, but the infection was

16 showing signs of recurring.

17 Now, had he not been commenced on ciprofloxacin,

18 I think that would very well have progressed from that

19 to a further, more severe relapse of the initial

20 infection.

21 As it happened, I imagine it was the ciprofloxacin

22 that seemed to curtail that, because the readings

23 thereafter steadily improved.

24 Q. I think the point that Dr Sheridan may have been making

25 was that, at the time the patient was reviewed, on

170

1 21 April, the CRP was falling and, indeed, by then had

2 fallen below the 185 to 136. If you just freeze the

3 frame there --

4 A. I fully accept that, and I fully accept that starting

5 ciprofloxacin on the basis of just the CRP results would

6 have been illogical.

7 Q. I think his position simply was that, in those

8 circumstances, he might have adopted -- he would have

9 adopted --

10 A. A wait and see.

11 Q. -- a wait and see approach.

12 A. And perhaps that could have been adopted, but I felt at

13 the time, seeing the patient as he was, I was unhappy

14 that -- I had a feeling that the infection was not fully

15 controlled by a long course of co-amoxiclav and felt we

16 should be covering the possibility of it coming back

17 again in somebody whom I felt, being 81 years old, could

18 ill afford to sustain a recurrence of that infection.

19 I think, as I said, the further results thereafter,

20 rising and then falling, supports that clinical decision

21 to put him on a different antibiotic.

22 LORD MACLEAN: As it turned out?

23 A. As it turned out. Good judgment, I thought.

24 LORD MACLEAN: It might be regarded as lucky judgment,

25 fortunate judgment.

171

1 A. Perhaps.

2 MR MACAULAY: I think I will leave that there, then,

3 Dr Carmichael, and I think that does conclude the

4 questions that I have been asked to put to you, and,

5 indeed, the questions I myself proposed to put to you.

6 Just to confirm with you that you have provided the

7 Inquiry with a statement as well; is that correct?

8 A. Yes.

9 Q. Is there anything further you would like to say to the

10 Inquiry in order to assist the Inquiry?

11 A. I think I've said all I have to say, other than just to

12 echo what Dr McCruden said regarding the abilities of

13 our nursing staff, our senior nursing staff. We were

14 very fortunate to have such dedicated, committed,

15 compassionate and able nurses like Lesley Fox,

16 Jane Searle, Liz Hunter, Susan Craig, Susan Scotland,

17 et cetera. I have nothing but admiration for all of

18 them.

19 MR MACAULAY: Thank you, Dr Carmichael.

20 LORD MACLEAN: Thank you very much indeed for coming and

21 giving such a full account of your patients. Some of

22 whom, of course, you do recall, obviously.

23 What are you doing in retirement?

24 A. Converting a coach house at the moment.

25 LORD MACLEAN: Sorry to keep you away from it. Tomorrow

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1 morning.

2 MR MACAULAY: Just to confirm with my learned friends, the

3 plan is to start with Dr De Villiers and it is not

4 proposed to lead Dr Dancer at this phase.

5 LORD MACLEAN: Tomorrow morning at 10 o'clock.

6 (4.30 pm)

7 (The hearing was adjourned until

8 Thursday, 2 February 2012 at 10.00 am)

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