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Monday, 21 May 2012
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(10.00 am)
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MR MACAULAY:
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The next witness is
Charles Christopher Robertson.
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Good morning, my Lord.
MR CHARLES CHRISTOPHER ROBERTSON (sworn)
MR KINROY:
My Lord, before we begin, I wonder if I may make
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one thing clear, with your Lordship's permission, which
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is this: no-one should construe what I said on Thursday
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as implying a want of cooperation between HPS and GROS.
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I'm obliged.
LORD MACLEAN:
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MR KINROY:
Yes, my Lord.
The missing word is "a want of"
cooperation.
LORD MACLEAN:
Yes, that bothered me all weekend, actually,
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but that has been made clear.
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understood.
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I'm sure that is
Mr MacAulay?
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20
You will see from
the screen we are missing a word.
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Can you say that again?
Examination by MR MACAULAY
MR MACAULAY:
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Professor Robertson, are you
Charles Christopher Robertson?
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A.
Yes, I am.
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Q.
Could you tell the Inquiry what position you hold at
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present?
A.
I am a professor in the Department of Mathematics and
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Statistics at Strathclyde University.
Q.
I wonder if you could maybe adjust the microphone so
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that we can hear you?
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a look at your CV, which I will put on the screen for
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you.
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Perhaps I could ask you to have
This is INQ03900001.
If we look under the heading "Occupations and
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education", can we see that you graduated from
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Edinburgh University in 1976 with a BSc in Mathematics
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and Statistics?
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A.
Yes.
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Q.
You then have an MSc in Statistics from Kent University
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and then a PhD from the same university in 1980; is that
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correct?
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A.
That's correct.
15
Q.
I think we then follow through your employment history
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until 2002, where we can see that you became Professor
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of Public Health Epidemiology, Department of Mathematics
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and Statistics at Strathclyde University?
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A.
Yes.
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Q.
You also have a position, I think, in connection with
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Health Protection Scotland?
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A.
That's correct, yes.
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Q.
What is that position?
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A.
The job that I came back from Italy to was created by an
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agreement between Strathclyde University and Health
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1
Protection Scotland, and, effectively, Health Protection
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Scotland, at that time, paid half of my salary to
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Strathclyde University and I then worked as head of
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statistics at Health Protection Scotland from that point
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onwards.
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Health Protection Scotland by my time.
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Q.
So I'm fully employed by the university, and
If we turn to page 2 of the CV, you give us some details
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in connection with your current employment, and we can,
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I think, read that for ourselves.
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You then give some information about your research
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activities.
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application of statistics over a wide variety of
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disciplines; is that right?
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A.
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Essentially, it is in relation to the
Yes, I use statistical methods, statistical models, to
analyse data.
Q.
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Again, if the microphone could perhaps be brought closer
to you?
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LORD MACLEAN:
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A.
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MR MACAULAY:
Not every word is being picked up, you see.
I think my wife often says I don't speak properly.
Then you give some information towards the
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bottom of that page about your teaching, education and
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training.
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tell us that you have taught statistics at all levels,
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from introductory service courses through to
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post-graduate lectures; is that correct?
I think we can move on to page 3, where you
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1
A.
That's correct, yes.
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Q.
I think we can move quickly to cast our eyes very
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quickly over your publications.
If you turn to page 6,
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you mention two books for which you are jointly
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responsible; is that right?
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A.
Yes, two textbooks, yes.
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Q.
And chapters in books, you also give us a list of those.
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For quite some pages, you provide us with information in
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connection with published papers in assessed journals?
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A.
That's correct, yes.
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Q.
In relation to this Inquiry, then, Professor Robertson,
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could I ask you first to look at your report, and that
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is at EXP02840001.
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onto the system, so I will put it onto the viewer and
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get it on the screen for you.
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It doesn't appear to be coming up
We are looking at the frontispiece of your report,
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with the title "Statistical report on diagnoses of
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C. difficile and deaths among patients with
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C. difficile".
That's the title of the report?
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A.
Yes.
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Q.
If we turn to page 2, you provide, on that page and onto
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page 3 -- just keep page 2 on the screen for the
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moment -- an executive summary of what you say in the
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report; is that right?
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A.
That's correct, yes.
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1
Q.
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The main aims of the report, as you tell us in
paragraph 1, were what?
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A.
Am I supposed to read that?
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Q.
Just tell us in your own words, if you wish?
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A.
The main aims were to look at the -- as I saw it, to
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look at the variations in the rates of C. difficile over
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the wards in the hospital and over different time
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periods that were previously identified, and also to
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have a look at variations in deaths over the wards and
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over the time periods, using only data that were
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supplied to me by the Inquiry team.
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Q.
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with an Excel version of a timeline; is that correct?
A.
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So far as that's concerned, I think you were provided
Yes, I was provided with a file containing a lot of
data.
Q.
To look at the more relevant material, and I think that
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timeline we have seen in different forms, in charts,
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indicating when C. diff might have been in particular
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wards.
You had that sort of material?
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A.
Yes, I had data, yes.
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Q.
I think you also had data from the infection control
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database?
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A.
That covered a period prior to the Inquiry.
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Q.
Yes.
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A.
Yes, that was given to me later on.
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1
Q.
2
You also, I think, had a memory stick provided to you;
is that right?
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A.
Well, that's the same data.
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Q.
That's the same data.
I think, then, the way to
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proceed, rather than taking you through the detail of
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your report, is to invite you to give us a presentation
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that I think you have prepared, effectively setting out
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in that form what you have set out in the report; is
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that right?
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A.
Yes, that would be fine.
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Q.
Perhaps we can get the technology up and running, then,
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for that to happen.
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witness box and put on the screen and tell us what we
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are seeing?
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A.
Yes.
Okay.
Can you then manage this from the
Good morning.
What I propose to do here in
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this presentation is just to run through the main
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aspects of the analysis that I have in my report.
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There were many other analyses carried out which are
not in the slides here.
The outline of my presentation will be to run
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through the aims and methods, diagnoses and testing for
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C. difficile, and the purpose of this aspect was to see
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whereabouts C. difficile -- in which wards was
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C. difficile being reported and were the samples being
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taken from.
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Then we have a comparison of the rates of diagnoses
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in each of the different wards, essentially to try to
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see, were the rates higher in one ward relative to
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another ward, and then we use funnel plots to compare
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the wards.
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The next section looks at death rates.
Technically,
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it is the proportions of people who had C. difficile who
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died at various time intervals, and then I use data from
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Professor Griffin's report about the assignment or
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possible assignment of cause of death for a subset of
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the patients.
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The last three bits were in control charts,
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potential outbreak analyses and trends.
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essentially exploratory pieces of work.
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They are
The control charts, what we are looking for there
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is, if you used statistical methods which are currently
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used quite regularly in the health service to detect
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outbreaks, would they have detected anything happening
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in the hospital at that time?
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The potential outbreak analysis is to see, were any
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of the guidelines for potential outbreaks signalling or
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signalled -- did the guidelines signal at that time?
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The trends is a problematic analysis, but it is to
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look at what was happening in the rates of C. difficile
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prior to the Inquiry dates and post.
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But, as we will
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see, that is a comparison which is quite difficult.
We have already covered the main aims of the report,
so I'll move on to the next one.
The statistical methods that are generally used
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throughout this analysis is to look at the rate of
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occurrence of events, and that is either a rate per
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person, when it is strictly a proportion, or a rate per
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time period.
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comparisons as fair as possible, because the time
The reason for using rates is to make the
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periods are not of the same length, the wards are not of
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the same size and different numbers of patients are
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involved at different times.
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Sometimes we will use regression analysis and some
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statistical testing.
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to see whether or not there were differences between
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time periods, differences between wards and the analysis
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of rates is to see whether the rates in one period or in
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one ward are greater or less than in other periods.
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These are mainly based upon tests
For the death analysis, the important analysis is
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a time-to-event analysis, which takes into account how
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long patients are observed for, and that is technically
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known as a Cox regression analysis.
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standard methods for the analysis of such data.
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25
These are all
Now, the study periods were pre-defined before I was
involved in the analysis as January to June 2007, July
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to November 2007 and December 2007 to June 2008.
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informed that the latter period was the period under
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scrutiny.
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I was
The first of the periods, the January to June, is
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the period which is temporally most directly comparable
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to the main period of analysis.
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and, technically, it would have been better to go from
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December 2006 to June 2007, but we end up with --
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LORD MACLEAN:
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A.
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LORD MACLEAN:
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A.
It is not identical
June 2008?
No, I'm talking about the comparative group.
Oh, sorry.
So the comparator group is January to June 2007, which
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doesn't match for month the same period as the focus,
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which is December 2008.
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It is a small problem.
For the new diagnoses of C. difficile, and here
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there are two ways of looking at the data.
One is the
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ward that the sample has been collected from; the second
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way is the ward that the positive report of
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a C. difficile infection was returned to.
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generally, these are the same ward, in most cases.
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I don't know exactly the percentage.
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movement, admissions of patients and transfers of
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patients to another hospital, they are not necessarily
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the same.
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most of the results on the ward the positive result was
Now,
But due to patient
So I have looked at both, but I will present
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returned to, because that reflects whereabout in the
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hospital the hospital knew where the C. difficile
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infected patient was at the time of report.
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5
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So this is a descriptive analysis of whereabout in
the hospital C. difficile was reported.
Now, in order to do this, I had to make use of
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a convention which is used at Health Protection Scotland
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for the separation out of the first infection, which
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I call a positive first infection, which is the first
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positive test for C. difficile in the patient and, prior
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to that date, the patient may have had negative test
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results.
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Because patients were tested repeatedly in the
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hospital, what you find is that a patient with
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a positive test may have samples collected at a later
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date and still be positive.
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of using a period of 28 days clear of any positive
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result for saying there's been a new C. difficile
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infection.
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Now, this is the convention
So in order to achieve this, there has to be a clear
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period from the last positive to the next positive and
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the gap has to be at least 28 days, and that is
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a positive, subsequent new infection.
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If somebody is tested on a Monday and they are also
tested on a Thursday and both tests are positive, then
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the second test would be termed a positive continuation
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of a previous infection.
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that is adopted at Health Protection Scotland to try to
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distinguish new infections from continuations of
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previous infections.
This is the standard practice
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In this chart here, I present all the data that is
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available on new diagnoses, and in this chart, what we
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have got is the time along the X-axis from
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1 January 2007 to 30 June 2008.
On the Y-axis, we have
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the wards, and these are the wards that the positive
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result was returned to.
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The black dots refer to the first positive test, and
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the green dots refer to a new infection, a presumed new
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infection.
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sometime in March 2007, and that patient there is the
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same as one of the patients who has had a positive test
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at least 28 days previously.
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have to be in the same ward, so it could be this person,
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it could be that person.
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So the first green dot we see here is
They don't necessarily
The pattern that you see here is one of new
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diagnoses of C. difficile, certainly in ward 6, which is
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relatively continuous throughout the whole period, and
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also in ward 14.
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got -- tend to have a gap during the summer period.
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There are other wards which have
This is exactly the same plot of the same
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1
information, but now it's reflecting the ward that the
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sample was collected from, rather than the ward that the
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sample was returned to.
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ward -- the MAU ward appears as a sample collection, but
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not as one where the -- there's no reports, positive
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reports, back to this, because this ward here is
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a receiving ward.
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out.
What you see here is that the
So patients come in and are moved
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But, essentially, you have the same pattern of
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samples collected all the time and positive reports in
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ward 6 and in ward 14.
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gaps in these.
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Some of the other wards have got
So the summary from this descriptive analysis is
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that C. difficile is largely present throughout the
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whole period, and that's especially in wards 6 and 14,
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and also in ward 15.
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Now, this analysis doesn't take into account the
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size of the ward, how many beds are available or the
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occupancy, how many of these beds are occupied at
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a particular time.
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the results which are presented by ward of collection
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and ward of result, as I explained before, I'm generally
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using the ward the result was reported to.
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25
As there's little difference between
So most of the analyses I've repeated with the two
views, but in the presentation we will only look at the
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1
2
ward of report.
LORD MACLEAN:
Could I just ask you a question, and it is
3
going back a bit, but you don't have to.
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MAU --
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A.
6
LORD MACLEAN:
7
A.
8
LORD MACLEAN:
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Yes.
When the diagnosis was made, the person was
in the MAU; is that right?
A.
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LORD MACLEAN:
12
A.
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LORD MACLEAN:
14
A.
15
LORD MACLEAN:
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No, I have not -- I've gone the wrong way.
It is the other way.
It is not difficult to go back.
All right.
Here, this is where the sample was collected from.
Yes, but it is collected from somebody who
was in the MAU.
A.
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Collected from somebody in the MAU and then it is
reported to a ward, another ward.
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LORD MACLEAN:
20
A.
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LORD MACLEAN:
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This is an admission unit.
Yes.
So the person, I would assume, comes in with
C. diff.
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A.
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LORD MACLEAN:
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-- which is an admitting unit.
Yes.
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17
It is the
Yes, I would imagine so.
And then is put into a ward, having it?
patient has C. diff, it is diagnosed.
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The
It is confirmed?
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A.
Yes, I understand.
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LORD MACLEAN:
The patient is in the MAU and then the
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patient is sent to one of the other wards; is that
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right?
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A.
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LORD MACLEAN:
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A.
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9
Yes.
So these dots for the MAU --
These five dots here, one, I would imagine, would assume
that their source of infection was outside the hospital.
LORD MACLEAN:
10
A.
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LORD MACLEAN:
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MR MACAULAY:
Yes.
Then they are put into the system?
Yes.
Thank you very much.
Just to follow through his Lordship's
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thinking, the sample is taken in the MAU, but the
14
diagnosis will not be made until some time after that,
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and, by then, it may be the patient has been moved to
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another ward.
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A.
Yes, because there is generally a delay between the date
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of the sample being collected and the date of
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the report.
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be three or four days.
Sometimes it is one day, sometimes it can
21
Q.
Thank you.
22
A.
So in looking at testing, this is, again, a descriptive
23
analysis, and was looking to see whereabout testing for
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C. difficile took place, and was it localised to a few
25
wards or to specific wards with specific periods.
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1
Now, these graphs here, what I'm trying to do is to
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summarise quite a lot of information in one plot here
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for ward 14.
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throughout the 18-month period, and the data that were
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used for here are the laboratory data in the timeline
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data set which had all of the positive reports of
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C. difficile, together with a lot of data about the
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negative reports, patients who were -- had a sample
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collected and a sample tested, but the test result was
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11
I have organised it by testing by week
negative for C. difficile.
So these negative tests are indicated by the black
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bars, so here at the beginning of January there was one
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sample collected and reported in ward 14.
14
The points which were black on the previous graph
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are the red ones here.
These are the first notification
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in a patient of a C. difficile infection, and the amber,
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yellow/amber colour, is a positive test, which is
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a continuation of a previous positive test.
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have got -- this person here would be this one here, or
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it could have been this person on the same week.
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tests for the same person on the same week.
So what you
So two
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The green one is a subsequent or a presumed new
23
infection on someone who has previously tested positive
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for C. difficile, but this person need not be one of
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these two in ward 14 because they could have come from
15
1
2
one of the other wards in the hospital.
So what you see in this period here in ward 14 is
3
that seldom does a week go by without there being
4
a test.
5
a three- to five-week period with no samples being
6
taken, no tests, but in this period here, there's tests
7
every week, and what you have got here is, I think,
8
one -- that's going to be four positive reports to the
9
same ward in the same week at this particular time.
10
So in this period here, there's maybe
The next one is to look at ward 6, which, again, had
11
a lot of positive reports.
12
that there's a great deal of testing, much more so than
13
in the other one, but the same pattern of positive
14
results throughout and testing being carried out more or
15
less throughout the period.
16
17
What you see in ward 6 is
Ward 3, testing at least generally one test per
week, with positive results dotted around.
18
So, in summary, from the testing database it is
19
clear that there was testing for C. difficile throughout
20
the whole 18-month period in virtually all of the wards,
21
but especially in the three of the wards, 3, 14, 6, 5
22
and F, the ward 4 critical care unit and high dependency
23
unit, but even in wards with few cases, they were
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testing all the time, and there's the graphs for all the
25
other wards in the report.
16
1
So this presentation didn't take into account ward
2
size or occupancy, and wards 6 and 14, two of the ones
3
I presented, are actually two of the larger wards, so
4
you would expect more testing to be done there.
5
was slightly smaller, at 17 beds, and because of the way
6
the data were organised -- the critical care unit and
7
the high dependency unit were amalgamated -- they have
8
got about nine beds there.
9
Ward 3
So the next section of the report looks at the rates
10
of C. difficile, and here we are standardising -- oh,
11
that should be per thousand occupied bed days.
12
not going to be terribly important other than for the
13
magnitude, but the comparisons will be okay.
14
here is to see if there is any evidence that the rate of
15
new diagnoses varies over period or over ward.
16
It is
The aim
In this graph, what I have tried to do is to present
17
the timelines which were in some of the earlier graphs,
18
and this is for new infections, so it is either a first
19
infection or a presumed new infection in a patient who
20
had previously had an infection.
21
X-axis at January 2007, going through to June 2008, and
22
the vertical lines split the 18-month period up into the
23
three periods that we were looking at, with the January
24
to June 2007 here, the December 2007 to June 2008 here.
25
The horizontal dotted line is the average rate of new
17
It starts off on the
1
infections per week in the hospital over the whole study
2
period, and that stayed just about two per week.
3
What you see from this graph is that the thick black
4
line is the rate of new infection in ward 14.
These are
5
all on the same scale so that you are able to compare
6
where there are peaks of infection in different wards.
7
So what you see from the pattern in ward F is that,
8
generally, it is quite low, and there were two peaks:
9
one in about May 2007 and the second one in
10
about February 2008.
11
visible in the critical care unit at this time here.
12
Q.
13
Just for the notes, the "here" you are pointing to,
what, about March of 2007?
14
A.
About March, yes.
15
Q.
April?
16
A.
April, yes.
17
18
April.
You can see, again, it is not very clear,
but in ward 3, a peak pattern similar to ward F as well.
Q.
19
20
That peak here in ward F is also
And Fruin, just to focus on that, we can see a flat line
in to the very end?
A.
Yes, a very few cases, yes.
So, really, although there
21
are variations in the numbers of patients which are
22
reported, by and large, ward 14, ward 15, ward 5,
23
ward 6, there's not many evidence of large numbers at
24
one time, whereas in ward F, which is slightly
25
different, two clear peaks in ward F, and so, too, with
18
1
2
critical care unit.
In this analysis -- I go back, actually.
The next
3
part of this comparison was to try to use some
4
statistical modelling to see if there were any
5
differences in the rates comparing the three periods and
6
comparing these eight wards.
7
used for this was the Poisson regression modelling.
8
When we did this, there were significant differences
9
between the summer period, that's the July 2007
The technique that was
10
to November 2007 period.
The rates there were lower
11
than they were in the two kind of winter periods, but
12
between the two winter periods, the January to May 2007
13
and the December to June 2007 -- no, January
14
to June 2007 and December 2007 to June 2008.
15
getting confused because the December was in 2007.
I keep
16
There is no statistically significant difference
17
between the rates in these two periods, which means that
18
it is possible to combine these two periods together to
19
look at differences between the wards.
20
differences, then the differences between the wards
21
become apparent, and what you have is slightly higher
22
rates of C. difficile infections in ward 6 and ward F
23
and lower rates in Fruin, ward 5, ward 15, and these
24
have been previously pointed out.
25
When you do the
So in these plots -- and this is what makes the
19
1
interpretation quite difficult -- this is the rate over
2
the study period January to June 2007 and December
3
to June 2008, so ward 14, the rate was just under two
4
cases per week per thousand occupied bed days.
5
The horizontal line is what is called the
6
95 per cent confidence interval, and that is giving you
7
a range of values taking into account the variability in
8
the estimation of this rate.
9
the individual wards, their intervals overlap to some
10
extent, but what you have is a clutch of wards, ward 6
11
and ward F particularly, with higher rates at just
12
under -- between three and four cases per thousand
13
occupied bed days.
14
rates, at just above zero.
15
MR KINROY:
You can see, by and large,
Ward Fruin has got much, much lower
My Lord, I wonder if we might ask if it is
16
within the expertise of the witness to say whether the
17
difference between summer and winter might be explicable
18
by different prescribing patterns in these periods?
19
LORD MACLEAN:
20
A.
Is it seasonal, or is that just happenstance?
What is within my expertise is to talk about the average
21
rate in this period and its comparison with the average
22
rate in the January to June 2007 and the December 2007
23
to June 2008.
24
the source or any possible reasons for these
25
differences.
So we are talking about the average, not
20
1
MR KINROY:
My Lord, I think I am understanding from the
2
witness he is not able to posit reasons for the
3
statistical variations, he is looking purely at the
4
statistics and nothing else.
5
LORD MACLEAN:
6
A.
That's right.
Just to clarify that, the analysis of the -- this chart
7
here, which is looking at the wards, the rates by ward,
8
that is using data from this period here, the January
9
to June 2007, and the December 2007 to June 2008 period.
10
The summer period is excluded.
11
is excluded, because the rates in that period are lower.
12
The data for the summer
Now, the summary of these previous slides was that
13
ward F had two clear peaks.
14
ward 3, it is visible to some extent in ward 6.
15
The April peak is identified in the ward 4 high
16
dependency unit.
17
rates over the whole period.
18
between the three periods with the rates in the summer,
19
the July to November 2007, they are 45 per cent lower
20
than those in the first period, but there is no
21
difference in the rates in the two -- for the sake of
22
argument what I will call the two winter periods.
23
This peak is visible in
Wards 5, 14 and 15 have quite constant
There were variations
I then moved on to use a technique called funnel
24
plots, which are used quite heavily in the
25
Health Service now, to try to portray the variation that
21
1
you see among the wards in relation to what sort of
2
variability is anticipated because some of the wards are
3
larger, have got more patients in them and other wards
4
have got fewer patients in them.
5
see whether the variability in the rates might be as
6
a result of natural variation, which you would expect by
7
chance.
8
9
10
11
The aim of this is to
I looked at the three periods separately, and in the
next slide I will go on to explain in more detail what
funnel plots are.
If we take this funnel plot on the left here, this
12
is looking at the rates of C. difficile new diagnoses in
13
the period January to June 2007.
14
hospital, the average was 2.04 cases per thousand
15
occupied bed days.
16
represents the average over the whole hospital, at 2.04.
17
The X-axis on the chart is the number of occupied beds
18
in a ward at a particular -- in this period, January
19
to June 2007.
20
unit, which you see on the left-hand side of the plot,
21
had about 2,000 occupied beds in that time period.
22
is a smaller ward.
23
larger wards, have over 4,000 occupied beds.
24
is the rate of C. difficile infections.
25
Over the whole
The horizontal line on the graph
So the critical care unit/high dependency
It
Whereas wards 14 and 15, which are
The Y-axis
Now, the reason that the funnel plot uses the
22
1
occupied beds and the rate is, what we are looking for
2
is variability in the rates.
3
rates is inversely proportional to the size of the ward,
4
which gives you the number of cases that you are going
5
to get.
6
with a large number of patients in them, then the
7
precision in the rate is smaller(sic).
8
has got few beds in it, then the natural variability in
9
the rate is expected to be larger, and that is why the
10
funnel plot, if you look at the curved line at the top,
11
then the curved line at the top looks as if it is much
12
wider around about 2,000 beds than it is when you get up
13
at 4,000 beds.
14
anticipated variability.
15
Now, the variation in the
What that means is that, if you have got wards
In a ward which
This effectively gives you the range of
So what this is saying, if we look at ward 14 where
16
the rate is just slightly above 2, is, if the rate in
17
the whole hospital, in every ward in the hospital, is
18
identically the same at 2 per thousand occupied bed
19
days, then for a ward of the size of 14, you would
20
expect any value to be roughly between about 1, at the
21
lower limit, and about 4.3, at the upper limit.
22
23
24
25
Rates within these two ranges are what you would
expect with natural variability.
In the critical care unit, where the observed rate
is just under 3, but if it was the same as the hospital
23
1
average of 2, then, because it is a smaller ward with
2
fewer beds, then any rate between about 0.8 and about,
3
say, 5.3 would be within the natural variability in
4
these rates.
5
Now, what this is saying in the left-hand side is
6
that, with the exception of ward 15, and given that the
7
average is 2, then the rates of new diagnoses of
8
C. difficile are within the realms of natural variation
9
that you would expect for wards of these size in that
10
hospital.
11
Ward 15 has got a lower rate than you would expect
12
by chance.
13
Now, I haven't presented the results in the graph
14
for the summer -- they are in the report -- but they are
15
essentially similar to the January to June period.
16
MR KINROY:
My Lord, with some diffidence, I wonder if we
17
need a correction -- I suspect we don't; I suspect
18
I have just misunderstood, but I see at page 23 the
19
professor said:
20
"What that means is that, if you have got wards with
21
a large number of patients in them, then the precision
22
in the rate is smaller."
23
Perhaps we could just check that that is what he
24
25
means?
A.
Yes, I have explained it in terms of variability, that
24
1
the variability -- so the precision -- yes, did I say
2
the precision is smaller?
3
MR KINROY:
4
A.
5
MR KINROY:
6
A.
7
LORD MACLEAN:
8
A.
9
Yes.
I think I should mean precision is greater.
Yes.
Variability is smaller.
What does "precision" mean in that context?
Well, "precision" means, in the context, if I go back to
this slide here, where we are looking at the confidence
10
intervals, now, in a ward where -- if the confidence
11
interval width is very large, then we talk about
12
"imprecision".
13
talk about high precision, so more precise.
14
If the interval is very small, then we
So precision and variability are inversely related.
15
LORD MACLEAN:
16
A.
Yes.
I will take it upon myself to look at this page and make
17
sure that it is correct.
18
we are on the right-hand side of the plot, the precision
19
is greater, the variability is less.
20
But, as I explain it now, when
If we move on to the second of the funnel plots,
21
covering the period December to June 2008, in that
22
period the average number of new infections is slightly
23
greater, at 2.26, compared with 2.04, but that
24
difference wasn't, in statistical terms, a significant
25
difference.
What you have got here is that the Y-axis
25
1
again gives the rate.
2
scale, because of the difference in the occupied beds.
3
On the X-axis, the occupied beds is on a slightly
4
wider -- and that is a reflection that this is covering
5
an extra month of data rather than in the first period,
6
which is six months, the second period is seven months,
7
so the occupied beds for wards 14 and 15, you see that
8
they are a good bit above 4,500, whereas in the first
9
plot they were just above 4,000.
10
It is on not quite the same
That reflects an extra
month's worth of data.
11
The interpretation of the funnel plot is the same,
12
that, if the average in the hospital, at 2.26, applied
13
to every single ward, then you would expect all of -- or
14
you would expect 95 per cent of the wards to lie between
15
the two limits.
16
outside it and ward F and ward Fruin are slightly below
17
it.
What you see is that ward 6 is slightly
18
What that indicates to me is that there's been some
19
evidence that there's more variation among the wards in
20
this period and ward 6 is identified as a ward with
21
slightly higher rates than you would expect, whereas
22
another two wards have got lower rates than you would
23
expect.
24
25
MR MACAULAY:
Just to go back to the graph on the right, you
have Fruin, and the next number, is that 5?
26
I think you
1
said F.
2
A.
Ward 5.
3
Q.
Just on the left-hand side, Fruin doesn't feature at
4
5
all?
A.
There is a little note that says there are no cases in
6
Fruin, so it would be way down below the axis.
7
Technically, I would have gone from zero upwards.
8
9
So the summary of this analysis is that there was no
evidence in the first period that any ward had
10
substantially higher rates with regard to the others,
11
and in the last period, it seems as though ward 6 had
12
slightly higher rates, ward 5 and ward Fruin had lower
13
rates, and assuming that the analysis -- or the model on
14
which the analysis is based, and there is no reason to
15
doubt this at this particular time, then all that this
16
is saying is there might be more variability among the
17
wards in the second period than could reasonably be
18
attributed to chance variability.
19
20
21
These types of plots are used as a means of
identification of areas of potential for investigation.
In this part of the analysis, we go on to look at
22
deaths and the proportion of people who died.
23
associated, again, with the same idea of seeing, is
24
there any evidence that there is variation over wards
25
and variation over periods?
27
This is
1
With the data that was available to me, there were
2
130 patients who had a new diagnosis of C. difficile
3
over the 18-month period, and for 80 of these, there is
4
a record of the death.
5
needs to be clear that we need to establish the periods
6
over which the deaths have been recorded and the source
7
of these figures.
8
a 65 per cent -- or 61.5 per cent of the patients died,
9
and this is a measure of the precision ranging from
10
Now, I think at this stage it
The death rate, the 80 over 130, is
53 per cent to 70 per cent as the confidence intervals.
11
Now, of the 80 per cent of patients who died,
12
25 per cent died within six days of the confirmed
13
diagnosis being reported to the ward --
14
LORD MACLEAN:
15
80.
A.
17
LORD MACLEAN:
18
MR MACAULAY:
20
It is just
It is not a per cent, is it?
16
19
But it is not per cent, is it?
25 per cent of 80.
I see, yes.
I think you did say 80 per cent.
In fact, it
is 80 patients.
A.
Eighty patients, okay, sorry.
And 50 per cent of
21
the patients who died, died within 17 days; 75 per cent
22
within two months; and 90 per cent within four months.
23
There were three deaths on the day of report and seven
24
patients died before the report was notified as coming
25
back to the ward, and the gaps were three days, three
28
1
2
with a gap of two days and three with a gap of one day.
MR KINROY:
My Lord, may we ask if the professor knows if
3
these were all deaths within the hospital or if some of
4
those were deaths after discharge?
5
LORD MACLEAN:
6
A.
Yes.
This is what I was alluding to, that the source of
7
the deaths needs to be checked, because it is not clear
8
that they were all deaths within hospital or deaths out
9
of hospital.
10
11
They were just people who have had the
C. difficile and whether or not they died.
LORD MACLEAN:
12
Mr MacAulay, that should be known, though,
shouldn't it?
13
MR MACAULAY:
14
LORD MACLEAN:
15
MR MACAULAY:
Yes.
I'm thinking of Professor Griffin's work.
You can correct me if I am wrong, you are not
16
looking here to deaths caused or contributed to by
17
C. diff; you are just looking at deaths in patients who
18
had C. diff at a point in time?
19
A.
Yes, this is deaths in patients who had C. difficile.
20
Professor Griffin's report refers to the period
21
December 2007 to June 2008.
22
Q.
23
But he's also making a link between C. diff and the
death?
24
A.
Yes.
25
Q.
Whereas this analysis does not make that link?
29
1
A.
That does not make that link, but there still needs to
2
be the question.
3
not the patients died in the hospital or whether they
4
died outside the hospital, then that would need to be
5
established, but this is only saying these patients had
6
C. difficile and, for 80 of them, there is a record that
7
they have died.
8
MR KINROY:
9
If it is important to know whether or
My Lord, it might help if we can label this.
it correct to label this "All-cause mortality"?
10
A.
11
LORD MACLEAN:
Yes.
It is important to understand that, on these
12
figures, the death is not related to C. diff,
13
necessarily; is that right?
14
15
16
Is
A.
Yes, it is any death.
Technically, if someone had a car
accident, that would be related as a death.
This table here summarises by the ward that the
17
sample positive result was reported to and by the ward
18
that the sample was collected from over the whole
19
18-month period.
20
So the first level here is ward 3, and there were
21
20 reports of positive C. diff infection, new reports,
22
to ward 3, and of these 20 patients, 14 of them died.
23
Now, the total here, at the very bottom, you will
24
see that there are a total of 117.
25
from the 130 on the previous slide, because this is only
30
That is different
1
looking at when the positive result was reported to one
2
of the wards in the hospital at that time.
3
In terms of the ward that the sample was collected
4
from, then we have got a total of 118 people, and the
5
difference is because there is some -- in the records
6
there is a note of where the sample was collected from,
7
but not where the report was sent to, or it could have
8
been that the patient's sample was collected in the
9
Vale of Leven and they had been transferred to another
10
11
hospital in the interim.
In terms of the percentage of people who died, then
12
we have got 62 per cent here, and the purpose of this is
13
amalgamating the data over the whole period, not making
14
any restrictions on the length of time from diagnosis
15
until death, to accumulate all the information on the
16
deaths and to look to see whether or not there was any
17
evidence that the percentage of people who died, did it
18
vary over the wards?
19
Now, what you can see is that it does vary greatly,
20
but that because they're based on very few samples, the
21
confidence intervals which relate the precision are
22
very, very wide indeed.
23
So if you take a look at the ward with the
24
highest -- the smallest rate, which is ward 5 here,
25
where two patients out of the nine died, then the
31
1
confidence interval is going from 2.8 up to 60: very,
2
very wide.
3
two patients here, so we will go to the next one,
4
ward 15, where there were 11 diagnoses reported here and
5
ten of those patients died, so 90 per cent died, but the
6
precise is so small, it's very imprecise, that the
7
confidence interval is going from 59 to nearly 100.
8
If you take at the highest end -- it is only
So if you look at the smallest rate, it is going
9
from 3 to 60 and from the highest, from 58 to 99.
10
imprecision means it's very, very difficult to see
11
whether or not there are any differences among the wards
12
in terms of the percentage of patients who died.
13
This
So there is no statistical evidence of differences
14
among the wards here and, similarly, if you look at the
15
ward that the sample was collected from, then you get
16
enormous variation, and that is a function that,
17
although there are a lot of people here, 33 in ward 6,
18
from a statistical perspective, these are relatively
19
small samples and the study -- this does not really have
20
sufficient information to discriminate between these
21
wards.
22
LORD MACLEAN:
23
24
25
Could I be clear: when you say "who died", is
that the same basis as in the previous chart?
A.
Yes, this is all-cause, and it can be any cause of
death.
It is any length of time as well.
32
1
LORD MACLEAN:
2
A.
3
LORD MACLEAN:
4
A.
Yes.
Any length of time?
We will come on to that later.
Oh.
This was the same idea, but looking -- rather than
5
comparing the wards, we are now trying to compare the
6
periods.
7
the hospital, 31 deaths, 58 per cent.
8
in the third period, December 2007 to June 2008.
In the period January to June, 53 reports in
It is 65 per cent
9
Because these are based on slightly larger numbers,
10
the precision is much -- is better, but still there are
11
no significant differences here.
12
take into account the length of time, but it is not
13
fantastically important in terms of the analysis because
14
of the accumulated period since this analysis was done
15
and the length of time in order to follow up the
16
patients.
17
Again, this doesn't
I added into the presentation as a result of
18
a question I got to look at 30-day mortality.
Although
19
I had done it, it's not in the report.
20
making a fixed period from the date of the diagnosis to
21
the date of death and, again, this is all-cause
22
mortality.
23
a surrogate for dying with an infection or dying as a --
24
as an infection, but it is just a surrogate.
25
you know that the time period for the follow-up is
This here is
Thirty-day mortality is often used as
33
But here
1
exactly the same on every patient.
2
Again, what you have got is -- the reason for doing
3
this as a secondary is that the number of deaths is
4
smaller, because you have got a shorter follow-up,
5
but -- and so the lack of precision is greater, and what
6
you have got here is, again, there is no evidence of any
7
differences between the wards in this analysis.
8
Similarly, when you look at the time periods, the
9
pattern of the percentages is almost the same as the
10
previous two slides ago.
11
the percentages is much lower.
12
in the December to June period, whereas in the all-time
13
it was 65 per cent.
14
mortality, there is no difference between the periods
15
and no difference between the wards.
16
The magnitude of
This one is 40 per cent
So, again, looking at 30-day
Now, this analysis does not take into account
17
anything other than period and ward, and it was focused
18
solely on all-cause mortality.
19
table was seeking to put together the report by
20
Professor Griffin, where he identified whether or not
21
C. difficile was a contributory cause to the analysis.
22
I think the assignment is slightly --
23
LORD MACLEAN:
24
A.
25
This analysis in this
Yes, it is.
If we go through the table in detail for ward 3, ward 3
had eight patients in total, and eight were alive at the
34
1
end of the study.
2
of the people who died, C. difficile was not
3
a contributory cause and in five of them C. difficile
4
was a contributory cause, according to
5
Professor Griffin.
6
eight patients there.
7
This is the full time period.
So the five plus one plus two is the
The per cent where C. difficile is a contributory
8
cause is the five divided by the eight, 62.5.
9
is the alignment down here.
10
In one
So that
Again, you see that -- a great deal of imprecision
11
in the estimates and there is no evidence that there is
12
any differences between the wards when you look at this
13
analysis.
14
Now, it is much smaller numbers here, because we are
15
only looking at the period from December 2007
16
to June 2008, whereas the previous tables looked at the
17
full 18-month period.
18
Now, in all of this comparison on looking at
19
descriptive comparisons of the differences between the
20
ward, what was not taken into account was anything
21
associated with the patient, such as their age, their
22
gender, comorbidities, other infections that they might
23
have had, instructions on their health records.
24
there is limited data available to me, but such as there
25
was -- and this is the main analysis that I did -- was
35
Now,
1
to take into account the length of time a patient was
2
followed up and, adjusting for the age and gender, then
3
there was no evidence that there was any variability
4
over the three periods in the hazard of dying, nor was
5
there any evidence of any variation over the wards in
6
the hazard of dying.
7
Cox regression analysis, which takes into account the
8
survival time, it takes into account age and gender.
9
This analysis was based upon the
Now, it does not take into account comorbidity,
10
which, if such data were available to me, I would have
11
used to see that.
12
But, essentially, what you have got is that there is
13
nothing which is making any adjustment which will mean
14
that there is any difference between the wards in terms
15
of the hazard of dying at a particular time or over the
16
periods.
17
This is where we start in the analysis looking at
18
a kind of "what if" scenario.
19
used to see whether or not there's any evidence that our
20
system is out of control.
21
statistical methods to routinely look at data to try to
22
monitor whether or not there is a larger number of cases
23
in the hospital at a particular time.
24
25
These control charts are
You are looking to use
Now, the analysis is not the same sort of analysis
which is done prospectively.
36
It is important to realise
1
that this is a retrospective analysis, and we'd be using
2
data which would not be available to the staff if they
3
were doing it prospectively, because in a retrospective
4
analysis you have a lot of time to look back and
5
correctly assign the dates and the times afterwards.
6
So what I have tried to do here is, because
7
the December 2007 to June 2008 is the main period,
8
I have used the initial period as the training period
9
and looking at the second period here.
I will go on to
10
describe in the control chart exactly what we are trying
11
to do here.
12
funnel plots, and what we have got is a situation -- is
13
that, in the period January to November 2007, there were
14
an average of 1.69 new diagnoses per week in the
15
hospital, and that is what that horizontal line along
16
here is showing you.
17
In many respects, they're similar to the
Now, the two dotted lines, there's a dotted line at
18
zero, which is the smallest you can have, and there's
19
a dotted line at about 5.6.
20
is the upper control limit and the area between the
21
lower control limit and the upper control limit gives
22
the range over which you would expect the rate -- the
23
number of new cases per week to vary, assuming that the
24
rate of 1.69 was valid in this period.
25
Now, the dotted line at 5.6
So, effectively, you wouldn't be surprised if you
37
1
got one new case a week, two new cases, three, four or
2
five new cases per week.
3
six or seven new cases per week, then using the
4
statistical control mechanism, that would signal that
5
perhaps you've got more cases per week than you would
6
expect by chance at that time.
7
If in the situation you got
The normal procedure in these things would be to go
8
and investigate possible reasons for that, and the
9
purpose behind this analysis is just to see, if these
10
were available at the time, what might have happened in
11
the hospital had they been used, and what we have got
12
here is that, in a period in the week beginning
13
21 January, there would be a signal and, again, in the
14
week beginning 28 April, there would be another signal
15
in that period.
16
With statistical control charts, it is important
17
that the target or the average is correct.
This is just
18
an illustration of what might be happening with
19
a routine use of these.
20
the upper limit would be higher and you would have less
21
signals.
22
limit would be lower than the 5.6, and you would end up
23
with more signals.
24
thing to do and in this analysis, just for illustration,
25
I have used the average from the previous period.
If the target was higher, then
If the target was lower, at 1, then the upper
So setting the target is a difficult
38
1
I was talking about the baseline to use.
The
2
conclusions from the chart were unchanged from using
3
the January to June period as the baseline, where the
4
average was slightly higher.
5
I think it is important to stress that, because this
6
analysis is retrospective, this doesn't mean this is
7
what the hospital would have seen had they been doing it
8
prospectively, because the dates would have been
9
slightly different.
10
MR MACAULAY:
11
We are moving on, I think, to another topic;
is that correct?
12
A.
Yes.
13
Q.
We tend to have a break at about this point in time in
14
the morning.
15
might be an opportune point to have a short break.
16
LORD MACLEAN:
If we are moving on to a new topic, this
I just wanted to ask you -- I'm trying to
17
grasp the difference between looking at it
18
retrospectively and looking at it prospectively.
19
you explain to me the difference?
20
A.
21
Could
I have had the luxury of looking at these data over
a long period of time.
22
LORD MACLEAN:
23
A.
Yes.
What I mean by "prospectively", is, because the reports
24
are coming back at a -- when it is happening
25
prospectively, everything is live and you are not always
39
1
sure exactly of the validity of the data.
2
thinking about is that these would be done in
3
a particular week using the data from the previous week.
4
If you have got a situation where lab reports are in
5
flux between a laboratory and a ward, then, at the time
6
the analysis is done, they may not have arrived at the
7
ward, so they're not counted, and then, when you do the
8
analysis in the subsequent week, what you see is that
9
they have arrived subsequently.
10
So what I'm
So it is possible, when you're doing it
11
prospectively, that because of the movement of the data
12
around, at the time you decide to do it, say on a Monday
13
morning, then you haven't got everything in from over
14
the weekend, and so you end up not -- in the case --
15
with the seven above the limits.
16
prospectively, you might find five.
17
LORD MACLEAN:
18
A.
19
back again, you say, "Oh, we had seven".
LORD MACLEAN:
21
A.
Actually, it was seven and not five.
Yes, not five.
When you run these things prospectively,
there is always a slight difference.
23
LORD MACLEAN:
24
now.
25
I see what you mean.
Then, when you go to the next week to do it and you look
20
22
So when you do it
Thank you very much.
(11.17 am)
40
We will have a break
1
(A short break)
2
(11.40 am)
3
MR MACAULAY:
I think, Professor, you were going to move on
4
to that section of your presentation headed "potential
5
outbreaks of C. difficile"; is that right?
6
A.
Yes, that's right.
7
Q.
Again, if you can perhaps move on from there.
8
A.
The data which I had in the timeline data set gave the
9
dates of the report of each positive laboratory test to
10
a ward.
It also gave details of dates of patient
11
admissions, dates of patient movement from one ward in
12
the hospital to another ward of the hospital, dates of
13
patient transfer from -- either from one hospital into
14
the Vale of Leven or from the Vale of Leven out.
15
that data, I was asked to try to recreate the pattern of
16
C. difficile within the wards in the hospital during
17
that period.
From
18
The reason for doing this was to try to see if there
19
were any dates when it was possible that an outbreak may
20
have occurred.
21
which I was given, about whether or not there is
22
a potential outbreak.
23
not possible from the data that is available to me to
24
establish when these guidelines were -- well, when
25
a situation in which there were two or more cases or
There were, in existence, guidelines,
There were two guidelines.
41
It is
1
three or more cases actually occurred, because, as you
2
can see, the guidelines specifically ask about that they
3
may be due to a known or unknown infectious agent
4
identified in healthcare premises, and also the
5
gastrointestinal are three or more cases with two or
6
more episodes of vomiting or diarrhoea.
7
Now, the information that I have would not allow me
8
to say that there were two or more episodes of
9
unexplained vomiting or diarrhoea.
10
So all that can be done here is to look at the
11
potential: is there a possibility that there were, at
12
a particular time in a ward, three or more cases of
13
people with C. difficile reported to that ward and, at
14
the lower level, two or more cases in the ward.
15
In order to make any use of this data to address the
16
question for potential outbreaks, we need to make
17
assumptions about the movement of patients throughout
18
the hospital, so we are assuming that the data in these
19
databases are correct.
20
possibly be absolutely correct, because there are people
21
who are in the hospital with no date of admission, there
22
are people who have moved around -- it has been noted
23
that they have arrived in one ward but not noted that
24
they have left another ward.
25
data which make this a tentative analysis.
Now, I know that they can't
42
So there are gaps in the
1
Furthermore, it is necessary to make an assumption
2
about, if someone is diagnosed with C. difficile, how
3
long do they have it?
4
how long they have it, but in consultation with the
5
Inquiry team, we arrived at the figure of seven days as
6
what I would use for the main analysis, but I have moved
7
it from anywhere from three to ten days, I have also
8
done it for one day only as well.
9
Now, I am not qualified to say
Because of this -- difficulties in the data, this is
10
tentative, it is fraught with difficulties and
11
I consider it quite weak.
12
I have got a few slides showing what I mean by patient
13
trajectories to try to illustrate it.
However, the analysis --
14
So in this example here, we have a patient who is --
15
there's a report on the first day that they are positive
16
for C. difficile and they have no subsequent positive
17
test.
18
C. difficile on this date for seven days.
19
a simple case of the same patient remaining in the same
20
ward.
21
Then that patient is assumed to be positive for
That is
The second example is a patient who has a positive
22
test here on day 1, but on the third day there's another
23
positive test, and so the seven-day period carries on
24
from this positive test.
25
assumption, this one.
It is not a terribly important
43
1
Here is a patient who died or was transferred out on
2
the fourth day, so they only contribute four days to the
3
count.
4
Here we have a patient trajectory where the patient
5
moves, so first of all the patient starts off in ward A
6
and is there for three days, and on the third day they
7
are transferred to ward B, so they count partially in
8
ward A on the third day and also in ward B, and on the
9
seventh day they finish being assumed positive for
10
C. difficile.
11
Here is a more complicated process, of a patient
12
moving from ward A to ward B and then having another
13
test at this particular time and being moved back and
14
dying on the same day that they have moved back.
15
can have quite complicated trajectories like this.
16
So you
When you put all of these together, and this is the
17
example for a ward trajectory, so Patient A is a patient
18
who was in the ward for three days post-diagnosis and
19
then was moved out to another ward and then moved back
20
on the sixth day, and finished on day seven, and
21
patient -- the second patient was positive on day 3 and
22
died on the fifth day, so they only have five days of
23
C. difficile positivity, and then, when you add the two
24
together, you find that this day there was one positive
25
patient, one here, there were two positive patients in
44
1
the same ward on the same day, one, one, again, two
2
there and two there and then zero positive patients
3
there.
4
So it is trajectories like these that are used to
5
build up the number of positive patients in a ward at
6
a particular time.
7
is subject to the very big assumption that it is seven
8
days post-infection that you have C. difficile, and
9
I have changed that at various times.
You have to bear in mind that this
It is also
10
subject to all the ward patient transfer data being
11
totally accurate.
12
So when you put all of this together, and for the
13
patients, the 130 patients, who are positive at least
14
once during the whole period, then this is -- along here
15
it is each single day in the period from January 2007
16
to June 2008 and, if the line is along the zero point on
17
the number of cases, then that means there are no
18
positive patients in the hospital at that particular
19
time.
20
What you see is that by counting up the periods
21
along the horizontal line at zero, what you find is that
22
in 29 per cent of the whole period there are no
23
C. difficile cases in the hospital at that time.
24
is assuming seven days post-diagnosis.
25
That
If you decrease this to three days or one day, then
45
1
2
you will increase this percentage.
What you have got here is that, by looking at the
3
trajectories, you find the period in April with the kind
4
of peak here, another one over here, but, largely, what
5
you have got is about one or two patients per day, and
6
these are consistent figures that we have picked up
7
throughout the report.
8
9
In this graph here, it is simply a representation of
the same data but on a ward basis.
What I have tried to
10
identify with the black spots are periods when there
11
were two patients in the ward on the same date, and
12
a red spot corresponds to three or more patients in the
13
ward on the same date, again, subject to this assumption
14
of seven days post-diagnosis for being C. difficile
15
positive.
16
What you can see there is that these potential
17
outbreaks only occurred in wards 3, 6, 14, 15 and
18
ward F, and the three -- there's only a -- these
19
periods, these number of days, so nine days for ward F
20
over the whole period, one for ward 15, seven days for
21
ward 14 and five days for ward 6, and these are
22
identified by these red spots at that particular point.
23
So the wards which are not identified here never had
24
any potential outbreaks, according to the loose
25
interpretation of the definition.
46
1
If we reduce the length of time to three days, then
2
what is going to happen is that the number of black
3
spots is going to reduce, because it is harder to have
4
a potential outbreak, and the number of red spots is
5
going to reduce as well.
6
That's just saying that, even with a three-day
7
period, then you still pick them up, and even if you
8
went down to one day, ie, reports on the same day, there
9
was one episode in ward 14 when this happened -- I think
10
11
17 April 2007.
So this analysis I think is very sensitive to the
12
assumptions and the data quality that is available.
13
is an investigation to see whether or not there were
14
times when potential outbreaks occurred.
15
go to the -- I have used "favourable".
16
not the right word.
17
period post-diagnosis for C. difficile, that's saying
18
you have only got it on the day you tested positive for
19
it, then there is one day when you have three cases in
20
the same ward at the same time.
21
It
Even when you
It is perhaps
Even when you go to the lowest
The last part of the analysis was again carried out
22
at the request of the Inquiry team, and I think this
23
analysis is very subject to ascertainment bias, which
24
I will talk about.
25
in September 2006, mandatory reporting of C. difficile
The reason for this bias is because,
47
1
among people over 65 started in Scotland, and that will
2
have had an impact on the number of cases being reported
3
centrally to Health Protection Scotland.
4
not have had an impact on the number of cases being
5
picked up and reported locally in the hospitals.
6
It may or may
The other source of ascertainment bias is that
7
there's been a lot of investigation in the hospital
8
laboratory data in the period January 2007 to June 2008
9
through the analyses that I have done, and from the
10
database which is prior to that, from 2006 to -- sorry,
11
2003 to 2006, I haven't done any -- there has been no
12
looking in the hospital records in detail and looking at
13
the laboratories that I am aware of, so there is
14
a potential for this ascertainment bias, which means
15
that, because the data in January 2007 to June 2008 have
16
been looked at in a great deal of detail, you are going
17
to pick up more cases, ones which might have slipped
18
through if they existed in a previous time.
19
I think I have said virtually everything in this
20
slide before.
So the mandatory reporting came, case
21
definitions, rules for finding patients, rules for
22
reporting them, so the reporting practices prior
23
to September 2006 may not be comparable with the
24
reporting practices after that period.
25
makes the interpretation of the data I am about to show
48
This is what
1
2
quite problematic.
This is looking at the rate of new cases per month.
3
Ideally, it would have been better to look at this per
4
occupied bed day, as was done in the period January 2007
5
to June 2008, but I didn't have the bed day data for all
6
of the months in the period down from 2003 to 2006.
7
So, again, we have, in the data that is presented
8
here, the number of cases that are reported, and so, in
9
2003, you have got 18; 23 cases in 2004; going up to
10
figures we have seen before of 53 cases in the January
11
to June 2007.
12
13
14
Now, this is the first ever case of report.
not using a new episode.
It is
It is the first ever case.
So the rate of cases or new reports per month is
15
around about 1 to 2 to 3 in the earlier period.
16
six-month period here it is eight cases.
17
six-month period at the end it is 8.2, and four cases in
18
the summer period July to November 2007.
19
In the
In the
The confidence intervals for the rate are presented
20
as well, and you can see that these intervals don't
21
overlap at the period from 2003 to 2006.
22
all below 3.9, whereas here they are above six in both
23
of these cases.
24
25
Then they're
So looking at this data as a whole, what you see is
that they're over the period here, in 2003 to 2006, then
49
1
there is evidence that the rates of C. difficile were
2
increasing.
3
experienced in all hospitals in Scotland.
4
about the magnitude of the increase, but similar
5
patterns.
I believe that this is the same as
I don't know
6
This figure of 4 that crops up in this period
7
of July to November is actually quite consistent with
8
the trend that has appeared in this period here.
9
two figures here, the 8 in the January to June and
These
10
the December to June, are not consistent with the trend,
11
and there's an increase there.
12
looking at that, it is how to interpret that, and it is,
13
frankly, very difficult to interpret this, because you
14
know there has been this mandatory reporting which may
15
have had an impact at that time and there's also these
16
issues about ascertainment practices.
17
all I want to look at.
18
However, when we are
So that is about
In the report I have looked at other data in the
19
same connection, but it is always -- it is not
20
particularly consistent.
21
If I go to the summary of all the points I wanted to
22
make in the analysis, I think there are data issues.
23
For me, I had to make a large number of corrections to
24
the data, and these are things which happen when you use
25
hospital record databases, in that not everything is
50
1
totally consistent.
There are simple things, like
2
spelling mistakes, which don't really matter to somebody
3
who is looking at them, so for a woman called Anne, if
4
she's down in one data set with A-N-N-E as her name and
5
in another data set it is A-N-N, then it is difficult
6
for me to link them, but actually they are referring to
7
the same person, and when an observer looks at them and
8
says, "Annie Smith" -- I don't think there is an
9
Annie Smith -- and I find records for Anne Smith,
10
A-N-N-E Smith, then a person would know they are from
11
the same person, but a computer programme, when I am
12
trying to link them together, won't know they are from
13
the same person.
14
So I had a lot of going through the data to correct
15
these typographical slips that crop up, because the
16
database wasn't set up for a rigorous analysis of
17
the type that I was expecting to carry out.
18
The patient movement data may not be complete, so
19
the impact of that is that, in the outbreak analysis, if
20
there is a report of a positive C. difficile case in
21
a ward, then I would say for the next seven days there's
22
a C. difficile person in that ward.
23
further information, I would assume that person has
24
stayed in that ward, but it is quite possible that the
25
person had been moved a ward and there had been no
51
If there is no
1
record of it.
2
back in again and no record of it.
3
magnitude of this.
4
think it is probably terribly much.
5
They could have been moved out and moved
I don't know the
I suspect there is some, but I don't
It is not clear that in the trend analysis, which is
6
the last analysis I presented, the database had all the
7
cases of C. difficile prior to 2007.
8
been cases that have occurred in the hospital but
9
weren't reported because the criteria for reporting
So there may have
10
changed with the mandatory introduction of C. difficile
11
reporting to Health Protection Scotland there.
12
For the cases that C. difficile is present
13
throughout the whole period, particularly in wards 6, 14
14
and 15.
15
infections in ward 6 and ward F, but no major difference
16
between these two periods January to June 2007
17
and December 2007 to 2008.
18
From the slightly higher rates of C. difficile
The funnel plot analysis suggested to me that there
19
was slightly more variation amongst the wards in the
20
later period 2007 to 2008.
21
For the deaths, there was no particular evidence
22
that the proportion of patients who died varied
23
significantly over the wards, and this analysis took
24
into account the age distribution in the different
25
wards.
52
1
So the patients in the database who had C. difficile
2
were generally quite old patients.
Their median age was
3
about 79.
4
slightly over the wards, but not terribly much over the
5
wards.
6
over the wards, then there is no evidence that -- the
7
proportion of patients who died in the wards.
8
seems that the ward where you were first tested positive
9
or the ward where the report was made didn't play a lot
It ranged from about 36 to 96.
It varied
Even taking into account this variation in age
So it
10
of importance into survival from that -- or survival
11
with the infection.
12
That analysis doesn't take into account everything
13
that could have been taken into account.
In a sense, it
14
would be better to take into account other comorbidities
15
that the patient had, because the more comorbidities
16
a patient has, the chances of survival might be lesser.
17
So it would be possible to improve this, but it is
18
unlikely to suggest that there were significant
19
differences over the wards, even if you did that.
20
There was no evidence that the proportion of
21
patients who died varied over the three periods.
22
From a statistical perspective, there are 130
23
patients there, but because they are split over a number
24
of wards, within each ward there is relatively few, and
25
you don't pick up statistical significance because of
53
1
a lack of power to do so.
2
the order of magnitude 20 per cent more cases in order
3
to have statistical power to pick up differences of
4
the size that exist.
5
There would need to be of
I think, even allowing for all the caveats in the
6
data, and because there is an instance of three reports
7
on the one day to the one ward, it seems likely that
8
there will be occasions when these guidelines for how
9
the outbreak potentially occurred -- but that doesn't
10
say that an outbreak has definitely occurred, only that
11
there are three or more patients with C. difficile in
12
a ward at the one time.
13
The trend analysis shows that over the period 2003
14
to 2006 the rate of C. difficile in the hospital was
15
increasing.
16
that trend in January to June 2007 and December 2007
17
to June 2008, but this interpretation of why that has
18
happened is really difficult because there was an
19
unknown impact of the reporting and an unknown impact of
20
ascertainment bias.
21
22
There were more cases than predicted by
That is all I need to say.
LORD MACLEAN:
You said the unknown impact of reporting.
In
23
relation to at least the January to June 2007 period and
24
the December 2007 to June 2008, how does that affect the
25
figures?
54
1
A.
If I go back to the -- because I find it easier to try
2
to explain this by looking here, at some time here,
3
between these two periods, mandatory reporting came in.
4
LORD MACLEAN:
Actually, I think, subject to what any of
5
the parties say by way of submission, our concern has
6
been less with what preceded these periods, the three
7
periods you were talking about, even accepting that
8
reporting became different in 2006.
9
system of reporting was in full swing, I assume.
10
11
right?
A.
Am I right?
By 2007, that
All
Am I wrong?
It is not something I have looked at, as to how --
12
I mean, I know it was supposed to
13
start September/October 2006, so there are three months
14
for it to --
15
LORD MACLEAN:
All right.
I can see there may be
16
a difference between the period from 2003
17
to September 2006, but then our remit, actually, begins
18
in January 2007.
19
A.
Yes, this is this period only.
20
LORD MACLEAN:
So assuming, which may not be a correct
21
assumption, that the new system of reporting was in
22
operation from January 2007 and ran all the way through
23
to June 2008, what difference does it make?
24
25
A.
In this period here, you're assuming that you have got
the same pattern, so the comparison of the 8 with the 4
55
1
2
with the 8 should be unaffected by this.
LORD MACLEAN:
It is not the same pattern.
It is the same
3
system of reporting.
4
understanding why the system of reporting should make
5
a difference in this period, by which, of course, you
6
know I mean January 2007 to June 2008.
7
A.
I just have a little difficulty in
If I was only looking at the period, which I did
8
initially, January 2007 to June 2008, that is
9
post-reporting, you don't need to worry about it.
10
LORD MACLEAN:
11
A.
12
13
Thank you.
I am only raising it so that people don't overinterpret
the change from 2003 to 2006.
LORD MACLEAN:
I can see that.
That seems to me to be made
14
out, actually.
15
changes, then you're reporting on different things --
16
not different things, but you're reporting in a
17
different way.
18
reporting in the period which is entirely relevant to us
19
was the same, was consistent, I should say.
20
A.
21
22
25
I have to assume that the system of
Yes, I would hope it was consistent in the hospital over
that whole period.
LORD MACLEAN:
23
24
Because, when the system of reporting
Yes, I would assume so.
In which event,
these figures are there.
A.
Yes.
Certainly the 8 and the 4 and the 8 are what comes
from the data that was given to me.
56
That is the cases
1
per month.
2
I have reported them as cases per thousand occupied bed
3
days.
4
LORD MACLEAN:
5
In the period that we are concerned with, you
get the peaks as well.
6
A.
7
LORD MACLEAN:
8
A.
9
10
In previous reportings of the same figures,
Yes.
They are there.
There was a greater rate -- these peaks were picked up
in the analysis when I was looking at wards.
MR MACAULAY:
I think through your presentation you have
11
covered what you have set out in your report; is that
12
correct?
13
A.
I hope so.
14
Q.
It is the case, I think, Professor, that questions have
15
been intimated on behalf, in particular, of patients and
16
families, and also the Greater Glasgow Health Board.
17
Quite a number of questions, in fact.
18
A.
Yes.
19
Q.
I think -- you can correct me if I am wrong -- you have
20
had the opportunity of looking at these questions.
21
A.
Yes, I have looked at them.
22
Q.
You have also prepared written answers to the questions?
23
A.
Yes, I have.
24
Q.
I think on that basis, I will work on the basis that the
25
written answers will be circulated to the core
57
1
participants and I needn't take you through them.
2
thank you very much for that.
3
MR KINROY:
So
My Lord, may I sound a word of caution here:
4
some of these questions may not be particularly amenable
5
to being dealt with via correspondence.
6
a certain fluidity and flexibility that is helpful in an
7
oral examination of some of these issues.
8
9
There is
I suspect, from what we have heard from the
professor today, he has already looked at the questions
10
and worked them into his answers, and I suspect there
11
will be no practical difficulty about his written
12
answers in this case.
13
witnesses, it might be better, I respectfully suggest,
14
for them to address questions from the parties orally.
15
It would all depend on the precise matter.
16
LORD MACLEAN:
But in the case of other
My Lord --
It is a difficult one to decide, of course,
17
Mr Kinroy, as you know.
18
asking more questions in the light of the answers.
19
MR KINROY:
20
LORD MACLEAN:
21
22
There always is the route of
Yes, indeed, my Lord.
I take it you have not felt at a disadvantage
thus far, have you?
MR KINROY:
My Lord, I should frankly say I have not had
23
a chance to look at some of the written answers we have
24
had in the past from experts.
25
else to do.
There has been too much
We urgently need to do that, but of course
58
1
there are many things we urgently need to do.
2
far so good, I think, yes.
3
MR MACAULAY:
4
But so
I don't think my learned friend is taking any
issue then with this process with this witness.
5
LORD MACLEAN:
6
MR MACAULAY:
7
LORD MACLEAN:
Yes.
Nor is anybody else.
No.
Which means you are free to go, and with our
8
thanks, because that was a very clear exposition of
9
these figures, I have to say.
10
to be so comprehensible, actually.
11
A.
12
LORD MACLEAN:
13
14
Thank you very much.
And it certainly was comprehensive, too.
Thank you very much.
A.
You're welcome.
15
16
I didn't quite expect it
(The witness withdrew)
MR MACAULAY:
17
My Lord, the next witness I would like to call
is Professor Paul Martin.
18
PROFESSOR PAUL MARTIN (sworn)
19
Examination by MR MACAULAY
20
MR MACAULAY:
21
A.
I am, yes.
22
Q.
Can you perhaps tell the Inquiry what position you hold
23
24
25
Are you Paul Martin?
at present?
A.
My position at present, as of 1 May, is Interim Deputy
Principal at the University of the West of Scotland.
59
My
1
substantive post, from which I am currently seconded, is
2
Vice Principal (International) and Executive Dean of
3
Education, Health and Social Sciences at the same
4
university.
5
Q.
I want to look at your CV, and I think we will have to
6
do that through the viewer.
7
screen for you.
It will come onto the
Do you have a copy of that yourself?
8
A.
It is here, yes.
9
Q.
We are now looking at the front page.
If we turn to
10
page 2, towards the bottom you set out your
11
qualifications.
12
began your career, really, within the nursing
13
profession?
Can the Inquiry understand that you
14
A.
Yes.
15
Q.
You became a registered nurse in 1982; is that correct?
16
A.
Yes.
17
Q.
You set out there your qualifications and your honorary
18
award.
19
If we turn to what is page 13 of the document, and
20
if we look towards the top of the page, if I can just
21
pick it up from here, can we see that, from April 1999
22
to June 2002, you were Executive Director of Nursing and
23
Professions Allied to Medicine at Renfrewshire and
24
Inverclyde Primary Care NHS Trusts?
25
A.
Yes.
60
1
Q.
If we then move on to page 11, here, just above halfway,
2
do we note that, from July 2002 to August 2004, you were
3
chief executive of Highland Primary Care NHS Trust?
4
A.
That's correct, yes.
5
Q.
Then if we take it from there, if you turn to page 6, do
6
we note here towards the top that, from September 2004
7
to February 2009, you were chief nursing officer?
8
A.
9
Yes.
I just wonder, for completeness, I was, for
a period, chief executive of NHS Orkney and chief
10
executive of Highland Primary Care, but at this point
11
I was now appointed as chief nursing officer.
12
Q.
You set out your duties in that particular post.
13
I think it is in relation to this that we are
14
particularly interested in in relation to your evidence.
15
A.
Yes.
16
Q.
What were your duties, then, in that particular post?
17
A.
Specifically, the role of the chief nursing officer is
18
to provide advice to ministers in respect of health
19
policy, with regards to the nursing contribution to that
20
health policy and, indeed, to carry responsibility for
21
a portfolio defined by the now director-general of
22
the health department.
23
Q.
24
25
We have heard from Dr Woods already.
the same department; is that correct?
A.
Yes, I reported directly to Dr Woods.
61
You and he were in
1
Q.
2
Was it from that post that you took up your present
position?
3
A.
Yes, on 1 March 2009.
4
Q.
Can I ask you to perhaps have close to hand your
5
statement, and that is at WTS01670001.
If we just look
6
at paragraph 4, I think you set out there what your
7
responsibilities were.
8
A.
Yes.
9
Q.
As you indicated, it was to provide advice to the
10
Scottish ministers on all matters relating to nursing,
11
midwifery and allied health professions?
12
A.
That's correct, yes.
13
Q.
On page 2, you devote some time in your statement to
14
telling us about the HAI Task Force.
Can you just give
15
us some background into that?
16
formation of that Task Force was announced
17
in November 2002 by the then health minister; is that
18
right?
First of all, the
19
A.
Yes, that's correct.
20
Q.
What was your involvement?
21
A.
I wasn't involved at that time, because I was not in the
22
department until 2004.
23
led by the chief medical officer, who was
24
Mac Armstrong.
25
Q.
The Task Force at that time was
You did become involved with the Task Force?
62
1
A.
Yes, I became involved as chair -- well, sorry, as
2
cochair of the Task Force from my appointment
3
in September 2004 until the end of March 2005, when
4
Dr Armstrong retired, and then it was agreed that
5
I would, as CNO, take responsibility as chair of
6
the Task Force from April 2005.
7
Q.
8
9
Can you just assist the Inquiry and perhaps give us some
understanding of what the aims of the Task Force were?
A.
The Task Force was set up as a reflection at a policy
10
level of the understanding of the growing challenges
11
around healthcare-associated infection.
12
particularly and specifically around MRSA, but not just
13
MRSA.
14
infection prevention and control and all that goes with
15
that.
16
a group of key interested parties and experts, we would
17
inform and develop better policy at a national level on
18
the back of the creation of the Task Force.
19
I think
It recognises -- recognising the challenges of
It was thought that, if we could pull together
If it's useful, I think in the minutes of
20
the Task Force in March 2006 the role of the Task Force
21
is quite clearly set out in those minutes.
22
23
24
25
Q.
Could I just ask you to slow down a little bit so that
the transcriber can note what you have to say?
Did the Task Force set out, then, to produce
different programmes over the years?
63
1
A.
Yes.
There were action plans put in place that were
2
developed in consultation with key players, such as now
3
QIS, NHS Education for Scotland,
4
Health Facilities Scotland and the service, as well as
5
specialist advisers or advice from medical directors,
6
nurse directors, directors of public health.
7
phase of the Task Force, if you like, was accompanied by
8
an action plan that was negotiated and then ultimately
9
agreed by ministers.
So each
10
Q.
Where was the membership of the Task Force drawn from?
11
A.
It was drawn from a wide range of parties that we
12
thought could help inform our thinking, so we had
13
representatives from what you would perhaps describe as
14
stakeholders, which I have touched on, medical
15
directors, nurse directors, directors of public health,
16
the chief executives group, there were representatives
17
from the public, there were representatives from the
18
Consultant Microbiologist Society: a whole range of
19
different key players that we thought could contribute
20
to the debate about the direction of the HAI agenda and
21
the policy that we would develop on the back of that.
22
Q.
So do I take it from that that the membership would be
23
drawn, for example, from health boards across the
24
country?
25
A.
Generally, people who were employed in health boards,
64
1
but wouldn't necessarily be representing a health board
2
as a member of the Task Force.
3
Q.
Was it as a result of the work of the Task Force, for
4
example, that the mandatory surveillance of C. diff was
5
introduced?
6
A.
Amongst other things, yes.
7
Q.
What about the establishment of the C. diff reference
8
9
laboratory?
A.
Was that part of the Task Force?
Absolutely, yes.
That was in recognition of some of
10
the challenges around specimens, for example, being sent
11
to laboratories in Wales.
12
Q.
What about organisations such as Health Protection
13
Scotland?
14
organisations?
15
A.
Would the Task Force liaise with these
Yes, absolutely.
Health Protection Scotland were one of
16
the key organisations represented at the Task Force and
17
providing advice and support to the ambitions and
18
actions of the Task Force.
19
like, provided the science, in the loose term of
20
the word, the science behind the decisions that the
21
Task Force would take forward.
22
They, in many ways, if you
The Task Force, in effect, would agree policies that
23
were built from the main players, and HPS would be the
24
main player in terms of the technical and clinical
25
policies to do with HAI.
NHS Education, for example,
65
1
would be the lead player in developing educational
2
programmes for the Task Force.
3
Q.
Again, if I can remind you just to slow down.
4
A.
Sorry, I was born on the east coast and brought up on
5
the west coast, so the speed of my speaking is a mix of
6
both.
7
Q.
Can I ask you to look at this document, if you could
8
look at GOV00710052.
We are looking here at a document
9
with the title "The Healthcare Associated Infection Task
10
Force: report on the Scottish Government's two HAI
11
programmes between January 2003 and March 2008".
12
would be familiar with this document?
You
13
A.
Yes.
14
Q.
Were you chair of the Task Force when --
15
A.
At that time, yes.
16
Q.
-- this was produced?
17
A.
Yes.
18
Q.
What was this document designed to do?
19
A.
The document was really to try to pull together the
20
outcomes of the two action plans that had been in place
21
during that period, and to capture progress, if you
22
like, against those particular actions.
23
It also helped to draw a line between the completion
24
of the 2006/2008 action plan and the new action plan
25
that was to be delivered thereafter.
66
1
Q.
So if we turn to page 59 of the document, there is
2
a heading "Description of the main areas of HAI work",
3
and we are told:
4
"This section of the report provides an overview of
5
the most significant areas of work completed by the HAI
6
Task Force over the last five years."
7
I think we then read that one of the first areas of
8
work for the Task Force was the development and
9
publication of the NHS Scotland code of practice for the
10
management of HAI and hygiene?
11
A.
That's right.
12
Q.
Was that in 2004?
13
A.
Yes.
14
Q.
We will look at that in a moment, and that goes on to
Let me just check.
Yes.
15
say what the purpose of that was.
The next section is
16
dealing with antimicrobial prescribing; is that correct?
17
A.
Yes.
18
Q.
Was there also an initiative in 2005 in particular in
19
that connection?
20
A.
Yes, as part of the action plan.
21
Q.
If we go back to the second paragraph, with the heading
22
"Implementation and performance", do we also read there
23
that there is reference to funding to support the role
24
of the infection control managers and nurse consultants
25
who continue to play a key role in tackling
67
1
healthcare-associated infections?
2
for these particular posts an important aspect of
3
the Task Force's work?
4
A.
Yes.
So was the support
The Task Force would take the opportunity where it
5
was introducing an element of its work, perhaps even in
6
year -- or where it was an additional cost, perhaps, to
7
the boards, the Task Force, through ministers, was
8
allocated an amount of money that it could then issue
9
out to boards in the context of the action plan.
So the
10
infection control managers and the funding of nurse
11
consultants, the funding of the local hand hygiene
12
coordinators, et cetera, were examples of where the
13
Task Force would release funding to the boards to enable
14
them to move on that initiative without any barriers,
15
such as local finance, for example.
16
MR KINROY:
17
18
My Lord, I wonder if we might ask, was that full
funding or partial funding?
A.
We issued an amount to the boards, so for the ICMs, if
19
I remember correctly, it was 40,000 to each of
20
the mainland territorial boards and 20,000 to the island
21
boards.
22
I think that was for the boards to determine based on
23
the grade of the person that they appointed.
24
25
Q.
Whether that covered the full cost or not,
If we look at the code that was mentioned there,
GOV00090001 -68
1
MR PEOPLES:
My Lord, I wonder, before we go on, if the
2
witness could indicate whether funding was provided for
3
infection control managers as well as the posts that
4
he's mentioned?
5
A.
6
LORD MACLEAN:
7
A.
8
9
Yes.
Yes, because you mentioned ICNs, didn't you?
Sorry, it was infection control managers that I was
referring to in terms of the 40,000 and the 20,000.
MR MACAULAY:
I think now we have on the screen then the
10
code of practice that is mentioned in the document we
11
have just looked at; is that correct?
12
A.
Yes.
13
Q.
We see that is dated 2004?
14
A.
2004.
15
Q.
If we turn to page 7 of the document -- perhaps before
16
we look at the detail of that, was this seen as an
17
important document?
18
A.
Absolutely.
This was what you might describe as the
19
foundation.
Infection prevention and control and the
20
management of HAI has been an issue for centuries within
21
health systems, so to describe this as being the
22
foundation is maybe a bit grand, but in terms of modern
23
policy in Scotland, this was the foundation of modern
24
policy, in terms of the management of HAI in Scotland,
25
and it set out quite clearly the expectations from
69
1
a policy perspective of the NHS system, the boards now,
2
around what they were expected to have in place within
3
their local systems.
4
Q.
If we turn to the page I have taken you to, page 7, it
5
is just below halfway.
6
"It is crucial":
7
It is the paragraph beginning
"It is crucial that everybody is responsible for the
8
effective implementation of the code of practice."
9
Is there then some reference to the infection
10
control team, the infection control committee, the risk
11
management committee or structure and designated senior
12
manager with overall responsibility for risk assessment
13
and management processes relating to decontamination,
14
infection control, medical devices, management and
15
cleaning services, and does that final bit, in
16
particular, focus upon what we refer to as the infection
17
control manager?
18
A.
19
20
Yes, this was the beginnings of it, as referred to
in the previous HDL in 2001.
Q.
21
22
Yes.
What was the infection control manager's role seen to be
then?
A.
In respect of the infection control manager, their
23
responsibility was effectively to manage or to oversee
24
the systems and processes around infection control; to
25
make sure that they were working effectively and
70
1
2
delivering to the correct quality.
I don't know if it would be useful, your Lordship,
3
if I could take some other analogy not to do with the
4
health system to explain what we meant by the infection
5
control manager role?
6
If we were to step into, say, a factory environment,
7
in a factory environment, we would have production lines
8
that we would be producing goods -- widgets, or
9
whatever, it doesn't really matter -- and within that
10
production line you would have a production manager who
11
would be operationally responsible for the delivery, the
12
flow, from the beginning to the end; they would manage
13
the staff, they would set the duties, they would make
14
sure everything was happening at the right time, so
15
that, at the end of the day, a widget was produced.
16
Sitting alongside that, you are likely to have
17
a quality assurance manager.
18
manager's role would be to check the systems and
19
processes were working, not to manage the system, but
20
just to make sure that the system was working and to
21
make sure that the quality, if you like, was right.
22
they would be checking that the right things were
23
happening at the right time, they would be applying
24
tests to the system, to make sure that it was working in
25
the right way, and they would be dipping in and plucking
71
That quality assurance
So
1
out a widget every now and again to make sure it was
2
being delivered to the right quality.
3
Now, I think in very crude terms, that describes
4
what we were expecting of an infection control manager,
5
that they would not necessarily operationally manage the
6
infection control system team, but they would be
7
managing or, if you like, overseeing the processes,
8
making sure that the right policies were being applied,
9
making sure that everything was contemporary and up to
10
date and making sure that the quality of the infection
11
control systems was of the highest standing.
12
There are two aspects, I think, that it is important
13
to be clear on that would make that work.
14
infection control manager needs to be visible, needs to
15
be integrated, needs to be known, needs to be part of
16
the system, not separate from the system.
17
One is the
The other is, continuing the factory analogy, the
18
production elements, in this case the infection
19
prevention and control services, would need to have
20
clear structures, would need to know who was in charge,
21
would need to know what the roles and responsibilities
22
were, and if the two of those were working well
23
together, then the added value of the infection control
24
manager's role was that you would have ongoing quality
25
assurance of the system.
72
1
Q.
Just to pick up the point you make about clear
2
structures, would the infection control manager have
3
responsibility for ensuring that there were clear
4
structures in place?
5
A.
That would be part of their responsibility.
They would
6
be about ensuring that the structures were clear, not
7
for setting the structure; that would be the
8
responsibility of line management.
9
advising on the structure, they would be advising
But they would be
10
whether their views were such that the structure was
11
working appropriately and delivering what it was set up
12
to do, and, I have to say, in the context of
13
the infection control manager, because this was crucial,
14
the infection control manager had to have unfettered
15
direct access to the chief executive and the board, and
16
that was crucial.
17
raising an issue or alerting the board should something
18
be of concern to them.
19
Q.
20
Nothing could get in their way of
Before I pick up one or two points you have made, can we
just look at the relevant documentation first of all?
21
A.
Yes.
22
Q.
Let's go back to 2001, when I think the post was
23
originally --
24
A.
Envisaged.
25
MR PEOPLES:
My Lord, I wonder before we go on, in his last
73
1
answer, the witness talked about the infection control
2
manager ensuring the structures were clear, not
3
responsibility for setting the structure, which would be
4
the responsibility of line management.
5
could perhaps just expand a little on what the
6
difference is, what setting the structure is in the
7
context of this?
8
LORD MACLEAN:
9
A.
I wonder if he
Yes.
The establishment of management and leadership
10
arrangements within any organisation ultimately rests
11
with the chief executive of that organisation, or the
12
person who sits at the head of that organisation.
13
have a responsibility to ensure, in my view, having been
14
a chief executive, that those lines are clear and that
15
people understand how those lines work.
16
They
So within the line, there would be somebody who will
17
be the director, for example, or the line manager or
18
a direct worker, if you like.
19
clear and explicit.
20
So that line has to be
The infection control manager will advise on whether
21
or not that system looks as if it will deliver the
22
infection control outcomes or the control and management
23
of the system.
They won't manage it specifically in
24
that instance.
So they act as an adviser to the chief
25
executive.
74
1
MR MACAULAY:
If I can look at some of the documentation,
2
first of all, before we develop this, if you could look
3
at GOV00440006.
4
9 February 2001.
5
this the document that set out initially the role of
6
the infection control manager.
7
A.
We are looking here at a letter dated
Can we see this is HDL(2001)10.
Yes, I think further on it begins to identify what
8
responsibilities at that time were envisaged of
9
the post.
10
Q.
Was
If we turn to page 8 of what we have on the screen,
11
I think it is the section that begins about a third of
12
the way down from the top:
13
"Chief executives of NHS Trusts should ensure that:
14
"1.
A senior manager (ie either a member of
15
the Trust board or directly accountable to a member of
16
the Trust board) is designated as having overall
17
responsibility for risk assessment and management
18
processes relating to decontamination, infection
19
control, medical devices management and cleaning
20
services."
21
That was the original structure.
22
A.
Yes.
23
Q.
Did that change?
24
A.
In essence, it remains the same, but if we were able to
25
go to the HDL that issued the allocation, which I think
75
1
2
is HDL(2005).
Q.
I will put that on the screen now: GOV00440001.
This is
3
the letter dated 19 July 2005, and this is the one that
4
sets out the funding; is that correct?
5
A.
Yes.
You will see at paragraph 5 there there is
6
reference to the 2001 HDL, and that was to try to ensure
7
there was continuity between one HDL and the other.
8
always, where possible, when issuing further guidance,
9
try to refer back to the previous guidance to ensure
We
10
continuity so that people were clear that, when we were
11
setting the context of the ICM and releasing the money
12
to the system, reference should always be made back to
13
the original HDL in 2001.
14
Q.
15
LORD MACLEAN:
16
A.
I think later on --
If we turn to page 4 -Sorry, what does HDL stand for?
Health department letter.
Sorry, it changes all the
17
time, from health department letter to chief executive
18
letter, to ... it is the same thing, in essence.
19
MR MACAULAY:
On the page we have on the screen, for the
20
funding letter, that was a letter that you, yourself
21
wrote; is that right?
22
A.
That's correct, yes.
23
Q.
If we move on to page 3, first of all, this letter --
24
again, I think you are one of the signatories to this
25
letter?
76
1
A.
Yes, that's correct.
2
Q.
This begins by saying:
3
"This letter reiterates and updates the main
4
responsibilities of chief executives and infection
5
control managers ..."
6
A.
That's right.
7
Q.
If we turn to page 4, at paragraph 6, does that set out
8
the responsibilities of the infection control manager?
9
A.
Yes.
Paragraph 6 and paragraph 7, yes.
10
Q.
For example, at 7, we are told:
11
"The ICM will be responsible for:
12
"Coordination of prevention and control of infection
13
throughout the board area.
14
"Delivery of the board approved infection control
15
programme in conjunction with the infection control
16
committee ..."
17
For example, the second-last bullet point:
18
"Challenging non-compliance with local and national
19
20
protocols and guidance ..."
A.
Yes.
Sorry, part of the rationale also for not
21
necessarily tying the infection control manager into the
22
operational -- day-to-day operational management of
23
the infection control system was to make that part
24
easier, if you like.
25
are an operational manager, to stand up and say, "Well,
It can be very difficult, if you
77
1
I maybe got this wrong".
2
in their role, because they are looking across the whole
3
system and they have, or need not have, line management
4
control, can more easily have an overview of that and
5
can step to the side and go straight -- you know, either
6
challenge the infection control team themselves or, as
7
we have said, go directly to the chief executive and
8
raise those issues there.
9
Q.
The infection control manager,
If we look at another letter, this is at GGC16000002, we
10
are now looking at a letter I think written by yourself.
11
This is dated 12 December 2007.
12
A.
Yes.
13
Q.
This letter, in the final section, is asking each board
14
to confirm that an infection control manager is in post?
15
A.
Yes.
16
Q.
Was that a pre-condition of funding?
17
A.
It was a pre-condition of funding.
I think we actually,
18
if I remember correctly, asked boards to make sure there
19
was job descriptions or role profiles in place as well.
20
21
Q.
You say:
"As a condition of ongoing funding, each board is
22
asked to confirm that an ICM is currently in post.
23
Please, could you ..."
24
Turning on to page 3:
25
"... therefore write to confirm the position and
78
1
submit a copy of the current ICM job description to
2
Callum Percy ... by Friday, 25 January 2008."
3
I think if you move on to the fifth page of
4
the document, can we see that the response to that
5
letter appears to have produced this job description we
6
have here?
7
A.
8
9
10
That's my understanding, yes.
That is a copy of the job
description for the infection control -LORD MACLEAN:
A.
What is the date of this?
I'm not sure of the specific date that that was
11
returned, but they all had to be in by the end
12
of January 2008.
13
MR MACAULAY:
If we turn to page 4, there seems to be a copy
14
of a letter that seems to confirm that the infection
15
control manager is Mr Walsh:
16
"Please find attached, as requested, a copy of
17
Mr Walsh's job description."
18
We don't have a date there.
19
A.
No.
20
Q.
The deadline was 25 January 2008?
21
A.
Yes.
22
Q.
If we go back to page 5, then -- have you had an
23
opportunity of looking at this job description?
24
A.
I have, yes.
25
Q.
Can you tell me, does it comply with the thought process
79
1
as to what the infection control manager's functions
2
were to be?
3
A.
Yes, broadly.
4
Q.
If we look at, for example, "Job purpose", the
5
second-last paragraph:
6
"Provide strong strategic leadership on
7
healthcare-associated infection control issues across
8
NHS Greater Glasgow and Clyde and he/she will have
9
overall responsibility for creating a culture of
10
effective practice to ensure that infection control is
11
everyone's business."
12
13
What do you understand by that?
A.
Well, in real terms, this means that the infection
14
control manager -- this is my interpretation; I'm sure
15
Greater Glasgow and Clyde will be better able to answer
16
the question than I.
17
looking for the infection control manager to oversee the
18
infection control challenges and processes within the
19
board at a strategic perspective, to make sure that
20
there is a strategy in place that identifies how the
21
board will prevent and control infection and will grow
22
within the context of this an understanding throughout
23
the organisation that infection control is everybody's
24
business.
25
My understanding is they are
If we looked at that "everybody's business"
80
1
perspective, that's from the chief executive to whomever
2
it is, the part-time domestic or nursing auxiliary, and
3
to the patients and the public, and it is a phrase
4
I think that is used in the code and I think it is also
5
a phrase that is used in the 2001 HDL.
6
get across this principle that everybody had something
7
to do with the infection prevention and control agenda.
8
Q.
9
It was trying to
In the next paragraph we read that the job purpose also
includes:
10
"Through leadership and programme monitoring, he/she
11
will ensure the development of robust systems ..."
12
A.
Yes.
13
Q.
Picking up what you said earlier about structures, do
14
you see this as going beyond the terms of
15
the correspondence that we have looked at?
16
A.
No, not in my view.
Part of the processes around
17
infection control would include having robust systems in
18
place.
19
individual wards or community teams in community
20
settings, systems for reporting, systems for outbreaks
21
response, systems for intervention.
22
that this, in my view, would be -- I would consider this
23
to be part of the infection control manager's
24
responsibilities as we defined them.
25
Q.
For example, being able to be alert to issues in
So, no, I think
Similarly, if you turn to page 6, then, there's an
81
1
organisational chart which I will look at in a moment.
2
But the role of the department heading, then, we read:
3
"The infection control manager of the NHS board has
4
the overall responsibility for management process and
5
risk assessment relating to infection control including
6
the issue of antibiotic-resistant infections."
7
Again, then, do you see that as reflecting the
8
thought process that was in the correspondence?
9
A.
Yes.
10
Q.
We look at the organisational position where we see the
11
infection control manager and the nurse consultant.
12
Within the infection control team, then, we know that
13
you would have an infection control doctor, for
14
example --
15
A.
Yes.
16
Q.
-- and infection control nurses.
17
A.
Yes.
18
Q.
Can I just understand how it was envisaged that the
19
20
infection control team would be managed?
A.
In many ways, that was a decision -- it is an
21
operational decision that would be the responsibility
22
for the board.
23
we gave, and I think if you were going back to the role
24
of the chief executive in previous correspondence that's
25
been up on the screen, it would be quite clear that it
What we were clear in any guidance that
82
1
was the chief executive of the board's responsibility to
2
ensure that management systems and processes were in
3
place and not directly and specifically the
4
responsibility of the infection control manager.
5
So, as a department, we would not prescribe what
6
that would look like because every board would be
7
different.
8
size of Orkney and a board the size of Greater Glasgow
9
and Clyde and the structure of their infection control
You could have, for example, a board the
10
systems and teams and the responsibilities and where
11
they would sit, whether they would be single
12
responsibilities or singular responsibilities for an
13
infection control doctor, or joint with other
14
responsibilities would be dependent on the context of
15
the organisation.
16
So, from a department's perspective, it was not seen
17
clearly that -- it was not seen as our role to prescribe
18
structures for boards.
19
That is their responsibility.
Here, however, you can see that the infection
20
control manager, as per the guidance, has direct access
21
to the chief executive and, also, within Greater Glasgow
22
and Clyde they have identified an additional board
23
member to have responsibility for infection control in
24
this context, such as the medical director.
25
If you went back to my own career, when I was the
83
1
nurse director in Renfrewshire and Inverclyde, I carried
2
those responsibilities for infection control and for HAI
3
in that Trust at board level.
4
Q.
So can I understand it, then: if there were to be
5
a management issue and the infection control manager
6
became aware of that management issue, are you saying
7
that his route would be to the chief executive and then
8
for the chief executive to sort it out?
9
A.
The infection control manager can step across and speak
10
to, say, for example, the infection control doctor or
11
the infection control nurse or nurse consultant.
12
cannot be resolved to his satisfaction, then he has
13
direct access to the chief executive, yes.
14
LORD MACLEAN:
15
to --
16
A.
17
LORD MACLEAN:
18
A.
19
MR MACAULAY:
If it
And thereafter it is for the chief executive
Thereafter, it is for the chief executive to resolve.
-- sort it out?
Yes, yes.
Do I understand from what you have said that
20
it would be your expectation that, initially, the
21
infection control manager would try to sort it out
22
himself?
23
A.
Yes, yes.
If he was unsure or uncertain or thought that
24
a part of the system, perhaps, was not working, then
25
I would expect the infection control manager to have
84
1
a discussion with the team or with the doctor or with
2
the line manager, the service director, if you like, and
3
if that could not be resolved or he continued to be --
4
he or she continued to be unhappy, then they had direct
5
access to the chief executive.
6
So you could have a situation where the infection
7
control manager, hypothetically, was asking for
8
something to be done and line management was saying,
9
"No, I'm not going to do that".
If the infection
10
control manager thought that the risk was such that the
11
patients would be exposed, then they could go straight
12
to the chief executive and report their concerns, and it
13
then became the responsibility of the chief executive to
14
resolve the matter.
15
Q.
16
The other aspect of policy I think we saw when we looked
at the code was in relation to antimicrobial practice.
17
A.
Yes.
18
Q.
That was one of the main areas that was being addressed
19
by the Task Force?
20
A.
The Task Force, yes.
21
Q.
Antimicrobial practice was something that had been
22
looked at, really, over a considerable period of time.
23
A.
Over a long time, yes.
24
Q.
For example, we won't dwell on it, but if you have
25
GOV00360072, I think we are here looking at a Scottish
85
1
action plan that I think dates from 2002; is that
2
correct?
3
A.
That's correct.
4
Q.
That was before your time, obviously.
5
A.
Yes.
But I think also, before that, antimicrobial
6
prescribing had been a key concern, certainly across the
7
clinical and health systems, in particular, I think,
8
around microbiology, with the growing evidence of
9
multidrug-resistant pathogens.
10
Q.
If we now look at GOV00360001, we are looking at
11
a letter that, again, I think you are one of
12
the signatories to; is that right?
13
A.
That's correct, yes.
14
Q.
Can we see this is dated 5 September 2005.
15
16
Perhaps you
can tell us, what is the intention behind this letter?
A.
This is really, again, setting out to the service the
17
continued focus on antimicrobial prescribing and, in
18
particular, the responsibilities of boards to ensure
19
that within their systems they had appropriate
20
antimicrobial prescribing policies in place; that staff
21
who were prescribing were alert to those policies; and
22
that appropriate education was in place to support the
23
delivery of those policies.
24
25
Q.
I think attached to the letter, if we turn to page 3, do
we see the document that was produced by the Task Force?
86
1
A.
Yes, that's correct.
2
Q.
I think, if we turn to page 5, can we see that this
3
document was published in August 2005?
4
A.
5
LORD MACLEAN:
6
7
How many years were you chief nursing
officer, again?
A.
8
9
2005, yes.
I was chief nurse from 1 September 2004 until the end
of February 2009, so four and a half years.
MR MACAULAY:
If we turn to page 9 of the document, it is
10
the last main paragraph, where we can read what is being
11
said is:
12
"In Scotland, there are a number of challenges
13
related to antimicrobial prescribing facing hospitals.
14
These have been recognised by the Scottish Executive
15
Health Department ..."
16
They give a number of examples:
17
"Evidence of wide variation in antimicrobial
18
prescribing policies and practice.
19
"Concern about insufficient regular liaison between
20
microbiologists, clinicians and pharmacists."
21
And concern about inadequate supervision of,
22
I think, junior doctors.
23
24
25
These were some of the concerns?
A.
Yes, these were some of the concerns that the framework
was seeking to identify, heighten and then begin to deal
87
1
2
with, yes.
Q.
If we turn to page 12, under recommendation 3, which is
3
dealing with hospital structures, was one of the policy
4
goals that there be an antimicrobial management team
5
formed by health boards?
6
A.
Yes, in each health board, the requirement was, within
7
the framework, to develop an antimicrobial team, to both
8
develop good practice, ensure that was implemented and
9
monitor its effectiveness across the system.
10
Q.
Perhaps to move quickly on to page 17, was audit and
11
auditing of prescribing practice also seen as one of
12
the policy goals?
13
A.
Yes, audit would be seen, in the context of a policy
14
such as this, as an integral tool, in terms of
15
the boards then being able to understand whether their
16
local application of the policies was having an effect,
17
or the desired effect.
18
Q.
Perhaps one final point from this document, if you turn
19
to page 23, there is a heading towards the bottom, at
20
1.2, "Prescribers' adherence to guidelines", and then
21
there is a list of auditable standards which should be
22
met by prescribers.
23
(iv), for example, evidence of an assessment of
24
severity, and so on.
25
standards which those prescribing the antibiotics should
If you just look at (i) through to
Can you help with this: were these
88
1
2
meet in relation to what records were kept?
A.
Well, both in terms of what records were kept and in
3
terms of understanding what a doctor would need to take
4
cognisance of.
5
a qualified prescriber, so there is a bit of hesitancy
6
here, but in terms of the context of this, you would
7
expect a doctor to reflect on these four points before
8
they prescribed.
9
the prescription, but also in terms of what a doctor
You have to recognise I'm not
So it's both in terms of the audit of
10
would consider before they prescribed any medication in
11
the context of infection.
12
Q.
13
This list is described as a list of auditable standards.
Does this envisage that an audit would be able to see --
14
A.
Would be able to see that.
15
Q.
-- whether the standards were being followed?
16
A.
Yes, and, therefore, the normal recourse to gather that
17
18
information would be through clinical records.
LORD MACLEAN:
19
20
Remind me -- I have been told this,
actually -- what is an alert antimicrobial?
A.
There are alert and non-alert.
So where there is an
21
alert antimicrobial, it is where it is used in
22
a particular and specific -- or for a particular and
23
specific reason, and you would seek not to use it unless
24
you were absolutely clear that you were needing to use
25
it for that purpose.
89
1
LORD MACLEAN:
2
A.
3
Why is it called "alert"?
Because you need to be alert to whether or not you are
going to prescribe it or not.
4
LORD MACLEAN:
5
A.
Is that because of its potential effect?
Because of its potential effect or the potential for
6
its -- again, this is reflecting the ongoing
7
understanding of drug-resistant pathogens.
8
got to reflect whether or not you would prescribe it or
9
not prescribe it in the context of this particular
10
patient.
11
think twice.
12
LORD MACLEAN:
13
A.
14
MR MACAULAY:
15
Just be careful, is what it is saying, or
Make sure it is appropriate.
Think twice.
My Lord, that might be an appropriate point to
stop for lunch.
16
LORD MACLEAN:
17
(1.00 pm)
18
Thank you.
2 o'clock, please.
(The short adjournment)
19
(2.00 pm)
20
MR MACAULAY:
21
So you have
Good afternoon, my Lord.
Good afternoon, Professor Martin.
Before lunch, we
22
had looked at the antimicrobial policy that was issued
23
in 2005.
24
was the establishment of an antimicrobial team; is that
25
correct?
I think we saw one of the key elements of that
90
1
A.
Yes.
2
Q.
Did you have in mind any timescale within which such
3
4
a team would be formed by health boards?
A.
I don't think at the time we prescribed a timeframe,
5
but, generally, when we issued guidance to the boards,
6
we expected them to respond fairly quickly to that
7
guidance.
8
Q.
9
10
within your knowledge as to what the response was?
A.
11
12
In relation to this particular issue, is it or is it not
Across the boards, I wouldn't be able to say accurately
across all of the boards.
Q.
But insofar as Greater Glasgow and Clyde would be
13
concerned -- well, perhaps I can put this document in
14
front of you.
15
is headed "Antimicrobial management in Greater Glasgow
16
and Clyde hospitals: response to increased incidence of
17
HAI (June 2008)".
18
You will see this
We read there:
"The NHS Greater Glasgow and Clyde antimicrobial
19
management team was established in June 2007 ..."
20
And there is reference to the document we have been
21
22
It is at GGC13550001.
looking at.
A.
What about that sort of timescale?
I think the timeframe in which the board established the
23
AMT is a question, really, you would need to ask them.
24
My view is that that is perhaps a little longer than we
25
would have expected, but the reasoning for that would be
91
1
2
explained by the board.
Q.
We have looked at two principal policy documents, and
3
also the materials related to the setting up of
4
the infection control manager.
5
infection control manager, you did seek to get some
6
feedback --
In relation to the
7
A.
Yes.
8
Q.
-- and we have looked at that.
9
A.
Yes.
10
Q.
What about these other policy initiatives?
How would
11
you monitor if boards were picking up the policy and
12
doing something with it?
13
A.
Yes.
Generally, the policy would be issued, and
14
particularly with something like antimicrobial
15
prescribing, given its centrality to infection
16
prevention and control.
17
at the chief executive's meetings to encourage them to
18
establish the teams.
19
We would also have raised this
I think the other areas would be through monitoring
20
by organisations such as NHS Quality Improvement
21
Scotland, and we would be asking the boards, in terms of
22
their local delivery plans, which I think Dr Woods had
23
explained to the Inquiry in terms of each individual
24
board requiring to have a local delivery plan in
25
response to the HEAT targets.
92
So we would be looking
1
for reference of the antimicrobial prescribing teams in
2
the feedback from the boards.
3
I think, as a generality, where we thought boards
4
were not perhaps moving as quickly as we would expect,
5
then we would play in.
6
freeing up some resource, because, often, policy
7
initiatives didn't come in at the beginning of
8
the financial year, boards would have committed all of
9
their resources, so quite often we would, as we did with
Maybe the concern was about
10
the ICMs, release some funds.
11
2008, we released some funds to support the development
12
in each of the boards of an antimicrobial prescribing
13
pharmacist.
14
I think actually, in July
I think I personally and professionally am
15
challenged by any board's reluctance to take this
16
forward, in the main, because not only is good
17
prescribing practice good clinical practice, so it
18
should be done for that reason, but good prescribing
19
practice in the context of antimicrobials is what you
20
would describe as a "spend to save".
21
to invest in additional pharmacy support, but the
22
pharmacy support would then identify practice that
23
needed to be reviewed, inappropriate practice, patients
24
that were on medication for too long -- antibiotics or
25
others, but in this case antimicrobials, and would -93
So you might have
1
Q.
If you could slow down, please.
2
A.
Sorry.
And would reduce that.
So, in effect, if you
3
are not motivated by the clinical and patient safety
4
issues, then you would be motivated by the ability to
5
save some money in this context.
6
So I was always a bit -- I found it difficult to
7
understand why some boards didn't push ahead with this
8
initiative, both from a clinical and from an economic
9
perspective.
10
LORD MACLEAN:
11
A.
What is a HEAT target?
A HEAT target is the performance targets that were
12
established for boards.
13
access and treatment.
14
LORD MACLEAN:
15
MR MACAULAY:
It is health, efficiency,
Thank you.
We see, if we go back to the document on the
16
screen, in fact, it reminds us that the policy in which
17
you said the creation of an AMT, antimicrobial team, was
18
a key feature was dated September 2005.
19
A.
Yes.
20
Q.
But the NHS Greater Glasgow and Clyde team was not
21
established until June 2007.
22
boards, that's, what, more than 18 months down the line,
23
do I take it from what you have said that you would not
24
have any mechanism of knowing whether Greater Glasgow
25
and Clyde had in fact implemented that particular
94
Leaving aside other health
1
2
policy?
A.
Not in the context of the policy that we put forward.
3
It wasn't a requirement for the boards to report back to
4
us that they had established the teams.
5
less, through the provision of the framework and the
6
policy, requested that the boards put that in place, and
7
normally we would expect that to happen fairly quickly.
We had more or
8
Q.
What timescales would you normally have in mind?
9
A.
Well, again, you know, the issue in terms of the context
10
of the board, but they would need to perhaps identify
11
and then recruit to a lead doctor; they may also have to
12
identify and recruit to a lead pharmacist post; and/or
13
identify and recruit to a lead microbiologist.
14
It depended on -- it would depend on whether they
15
were setting the team up from the existing resources in
16
the board or adding to it.
17
in the board, it could, and should, happen fairly
18
quickly.
19
people to posts, then it could take a little longer.
20
Q.
If it was existing resources
Obviously, if they were having to recruit
Was there any mechanism whereby the board would be held
21
accountable to your department for not implementing
22
a particular policy?
23
A.
The process for accountability would be through the
24
annual reviews that were held with each of the boards,
25
and each of the boards would be asked about their
95
1
delivery of infection control and prevention --
2
infection prevention and control arrangements, and any
3
policies that had been issued by the HAI Task Force and
4
other departments across the Scottish Government Health
5
Department.
6
Q.
Would your department then become aware, at the time of
7
the annual review, that a particular policy had not, in
8
fact, been put in place?
9
A.
Only if we specifically asked that question, and I can't
10
say whether we specifically asked a question around
11
antimicrobial prescribing at the Glasgow --
12
Greater Glasgow and Clyde annual review at that time.
13
MR KINROY:
My Lord, I wonder if we might, given the prime
14
importance of the policy -- is it likely that the health
15
department would have failed to ask about that?
16
A.
17
MR MACAULAY:
18
A.
19
LORD MACLEAN:
20
21
I would have thought it unlikely.
Unlikely they would have failed to ask.
Did you actually, as a matter of policy,
check by asking questions?
A.
22
Not in respect of every policy that we issued or every
part of guidance.
23
LORD MACLEAN:
24
A.
25
Unlikely it would be asked?
How did you make the choice?
We would identify the ones where -- well, sorry, we
would normally use the HEAT process for that.
96
One of
1
the challenges in the health system in Scotland
2
previously to the HEAT targets was that there was --
3
I will get the name wrong -- a performance assessment
4
framework in place.
5
performance in that, that boards -- it set up
6
effectively a massive bureaucracy and more time was
7
being spent tracking the indicators than was being
8
spent, one could argue, in the delivery of care, and
9
certainly more resource, we thought, was being tied into
There were so many indicators for
10
that.
11
that down to as tight a set of HEAT targets as we could.
12
So, when we created the HEAT targets, we pulled
I think the Inquiry is aware, your Lordship, that
13
these annual reviews were hosted by the minister in the
14
days of Andy Kerr, and then by the Cabinet Secretary in
15
the days of Nicola Sturgeon, and they would have as much
16
a conversation with the chair and the chief executive
17
and the representatives of the board as they would
18
sitting down with a whole host of tick boxes.
19
through that that the Cabinet Secretary would secure
20
assurances for herself that HAI was high up on the
21
agenda of the board.
22
MR MACAULAY:
It is
Just so I can be clear, are you saying it is
23
likely that the position of the antimicrobial team would
24
have been discussed at the time of the annual review
25
next following upon the time the policy had been issued?
97
1
A.
I would have thought so, but without actually going back
2
and reading the letter and the notes, the minutes, of
3
the annual review, then I'm not able to say with
4
confidence.
5
Q.
6
Did there come a time when health boards generally were
told to have this team in place?
7
A.
Yes.
That was, in effect, the 2008 letter --
8
Q.
I see.
9
A.
-- where it became clear that not all boards had
10
embraced -- in particular, not so much the antimicrobial
11
prescribing teams, but it became clear that boards had
12
not necessarily embraced the importance of
13
the antimicrobial pharmacist and the advice and support
14
that they could give to clinical practice.
15
Q.
If I can ask you to look at this letter for me, it's to
16
be found at GGC14420004.
You will see,
17
Professor Martin, that this is a letter that was issued
18
by yourself.
19
A.
Yes.
20
Q.
It is dated 8 November 2007.
21
It is addressed to the
chief executives of the boards?
22
A.
Yes, that's correct.
23
Q.
Can you tell me what the thinking behind this letter
24
25
was?
A.
There were, in the main, two drivers for the issuance of
98
1
this letter.
One was -- and I think we can reference
2
that back to the minutes, the October minutes, of
3
the Task Force -- the recognisance of the Maidstone and
4
Kent report, which was published in October 2007 and was
5
discussed at the Task Force and it was thought
6
appropriate to ensure that boards were -- their
7
awareness of HAI as an issue was heightened and their
8
responsibilities were stressed; the other was that it is
9
not particularly unusual to see an increase of incidence
10
of HAI over the winter months, due to the clinical
11
complexities of the patients that present, the
12
throughput of patients, the winter season, if you like,
13
and, again, it was thought appropriate, before that
14
fully kicked in -- that period fully kicked in, to
15
remind boards of their responsibilities to ensure that
16
infection prevention and control sat at the heart of
17
what they did and that their systems and processes were
18
robust and in place.
19
Equally, as you will see, there were key contacts in
20
line with the Watt matrix, and that was really just
21
reminding boards that we, in the department, needed to
22
be alerted appropriately if an outbreak, as defined by
23
the Watt matrix, occurred.
24
25
Q.
We need to look at the last main paragraph.
last sentence, where you say:
99
It is the
1
"With this in mind, I would urge you to ensure that
2
your board undertakes an immediate and thorough review
3
of its local infection control policies to help minimise
4
the risk of any outbreaks occurring."
5
What would your expectation be as to what response
6
7
there would be to that statement?
A.
Yes.
We would expect, and did expect, the chief
8
executives and the boards through the infection control
9
committees and, indeed, through their clinical
10
governance machinery to do a review, to make sure that
11
the systems and the processes were in place, that
12
policies were in place, that staff in all of
13
the settings knew how to respond if there were issues
14
raised, education was happening, et cetera.
15
the actions that you would expect you would see within
16
the codes.
17
So all of
If you were to take the code, in effect, and set
18
that down in front and just go through the pages of
19
the code and say, "I have done that.
20
this.
21
policies, systems and processes of infection prevention
22
and control in the boards.
23
Q.
I know I have got
I have done that", so effectively an audit of the
You have mentioned the chief executive.
No doubt the
24
direction would come from him.
25
infection control manager to be involved in this review?
100
But would you expect the
1
A.
2
Yes, that's why I think the letter -- is it not copied
as well to --
3
Q.
It is copied to.
4
A.
Copied to.
5
Q.
So it is to chief executives, and you include the
6
infection control managers?
7
A.
Yes.
8
Q.
Perhaps I can take you to another letter, again by
9
yourself, at GOV00210001.
We are looking here at
10
a letter dated -- it is February.
We don't have an
11
actual specific date in February.
It is February 2008.
12
Again, it is addressed in particular to chief executives
13
and infection control managers; is that correct?
14
A.
That's correct, yes.
15
Q.
This is your letter again, I think?
16
A.
This is my letter again, yes.
17
Q.
The second paragraph, if I can just take you to that --
18
perhaps I could ask you this: what triggered this letter
19
at this time?
20
A.
21
22
Can you tell me?
I'm just wondering if this was actually issued in 2008
or 2009?
MR DEWAR:
23
I think, Mr Chairman, we understand that the date
on that should be 2009.
24
A.
2009, I think it was, yes.
25
MR MACAULAY:
So you think this is February 2009?
101
1
A.
I think it is February 2009, yes.
2
LORD MACLEAN:
3
A.
Why do you say that?
It's my recollection that we issued a letter --
4
the November 2007 letter.
Then, if I'm clear in my
5
mind -- I think I am -- we issued a further letter at
6
the same time in 2008, and then this followed up in 2009
7
as a specific template for the reporting.
8
you go further down, attached to this is a specific
9
template for the reporting of incidents, and this was
I think if
10
about making sure that, from the department's
11
perspective, we were getting the right information.
12
MR MACAULAY:
13
Yes, the template is on page 2, is it, of
the letter?
14
A.
Yes.
15
Q.
If we look to that.
16
Is that the various contact
numbers?
17
A.
Yes.
18
MR DEWAR:
Again, if it is of assistance, the reason why we
19
think that it is 2009 is that there is another version
20
of this letter on the database, and I can give the
21
reference: GOV01040001.
22
that version of the letter to get the correct date.
23
24
25
MR MACAULAY:
It may be worthwhile to look at
We now have it on the screen and we can see
the date is 19 February 2009.
MR PEOPLES:
We can leave that aside.
My Lord, I wonder if the witness can say
102
1
whether this was a response to events at the
2
Vale of Leven?
3
A.
I think it reasonable to say that it was a response to
4
the events at the Vale of Leven, as well as other
5
incidents that were and had happened between the
6
Vale of Leven and that date.
7
8
I think you will see -MR KINROY:
My Lord, do we know what the other incidents
9
were?
10
LORD MACLEAN:
11
A.
Sorry, you wanted to say something.
If you go down to appendix 2, you will see that there
12
is, beyond just the contact numbers, actually
13
a reporting framework that identifies for boards what
14
information they are asked to submit when referring an
15
issue.
16
LORD MACLEAN:
17
A.
18
MR MACAULAY:
19
20
Appendix 2.
Page 3 is the Watt Group matrix I think,
appendix 1.
A.
21
refers to "At appendix A you will see".
MR MACAULAY:
23
A.
25
Then page 4.
I think, if you go back to the body of the text, it
22
24
Could we look at page 2?
Right.
If we go back to page 1.
It is:
"The risk management and communications criteria",
detail published in the report -- sorry:
103
1
"A template for reporting incidents/outbreaks ... is
2
provided in appendix 2.
3
we would expect to be provided at time of reporting."
4
LORD MACLEAN:
5
MR KINROY:
This is the minimum information
Mr Kinroy?
I understand the witness to say that there were
6
other incidents of concern between the Vale of Leven
7
outbreaks and the date of the letter, 19 February 2009.
8
I wonder if it was germane to know, at least in outline,
9
what these incidents were?
10
LORD MACLEAN:
11
MR MACAULAY:
What do you think?
We are not really looking at other -- other
12
than, of course, the Ninewells experience, which we'll
13
look at separately.
14
LORD MACLEAN:
15
MR KINROY:
Well, the Ninewells --
I should just explain, my Lord, I think if it
16
had been perhaps, for example, to do with
17
recommendations the Inquiry might make, it might be
18
germane to know, if recommendations are to be made, what
19
their effect is likely to be and, to some extent, these
20
episodes after the Vale of Leven might have a bearing on
21
that.
22
LORD MACLEAN:
23
24
25
Oh, the episodes at the Vale of Leven, yes,
but you are asking about the others.
MR KINROY:
I am saying, my Lord, the episodes after the
Vale of Leven might have a bearing on the efficacy of
104
1
2
steps taken to avoid further outbreaks.
LORD MACLEAN:
3
4
our remit.
MR MACAULAY:
5
6
I have a feeling that is a little bit beyond
Yes, once we go down this route, it is
difficult to know where to stop.
LORD MACLEAN:
In fact, when it comes to recommendations, we
7
will have to be very careful that we are not suggesting
8
things that are already in place.
9
have to try to do the best we can on that, if we do make
10
11
recommendations.
MR MACAULAY:
12
13
So we are going to
Did you say a moment ago that there was an
equivalent letter to this in 2008?
A.
14
I'm afraid I have in my mind, but I don't think we can
find a letter.
15
Q.
I see.
Because I don't think we have seen it.
16
A.
I have in my mind, yes, but if there is no record in the
17
system, then that probably raises questions about my
18
recollections of issues at the time.
19
LORD MACLEAN:
20
A.
21
A letter similar to the one in 2007.
But this doesn't
refer to that.
22
LORD MACLEAN:
23
A.
24
LORD MACLEAN:
25
You mean a similar letter in 2008?
It doesn't, does it?
No.
You would expect the heading to be, "I wrote
to you on 8 November 2007 and then again on", whenever
105
1
it was, and it is not there.
2
A.
It is not there.
3
MR MACAULAY:
Moving on to a separate topic, then,
4
Professor Martin, and if I can take you to your witness
5
statement, first of all, WTS01670001, and if we turn to
6
page 6, you make some comments there about the hand
7
hygiene campaign.
8
A.
Yes.
9
Q.
You say there that this became what you describe as
10
11
a key issue?
A.
Yes, absolutely.
Hand hygiene is central to any
12
infection prevention and control system or process, no
13
matter the bug or the infection, and, indeed, I would
14
consider it in any guise good professional practice,
15
clinical practice.
16
Q.
If we look at, I think, one of the documents you are
17
responsible for, it is at GOV00420001, I think we are
18
looking at a letter written by yourself, being addressed
19
to chief executives and also infection control managers;
20
is that correct?
21
A.
Yes.
22
Q.
Amongst others?
23
A.
Yes.
24
Q.
Was this then to do with the hand hygiene campaign for
25
Scotland?
106
1
A.
Yes.
What we were doing was confirming that there would
2
be a public media campaign, as it states at the first
3
bullet point, to be launched in January, I think it was,
4
the middle of January, 12 January, I think the campaign
5
eventually started, and that we would be running at the
6
same time a campaign which would highlight the issues of
7
hand hygiene with patients and the staff.
8
Q.
Funding would be provided for the campaign and was?
9
A.
Yes, funding was provided from the Task Force funds for
10
11
the campaign.
Q.
I think it was about GBP2 million.
Was this simply to do with the washing of hands, as
12
opposed to facilities in which you could wash your
13
hands?
14
A.
Yes.
This particular exercise was about alerting
15
people, if you like, highlighting the requirement for
16
clean hands, for all of us, not just staff, but for
17
patients and the public as well.
18
Q.
In relation to the Vale of Leven, for example, this
19
would presuppose that they had adequate facilities for
20
hand washing?
21
A.
Yes.
For hand washing, yes.
22
Q.
The other point I want to take you to in your statement
23
is at paragraph 32 on page 8.
24
talking about the reporting of C. diff cases; is that
25
correct?
Paragraph 32.
107
This is where you are
1
A.
Yes.
2
Q.
Were you involved in that action?
3
A.
That was part of the Task Force's action plan for that
4
5
period, yes.
Q.
If we look at this letter, then, it is GOV00430001, we
6
are looking at a letter dated 10 July 2006 addressed, in
7
particular, to chief executives, and I think you were
8
also one of the core signatories to this letter; is that
9
right?
10
A.
I am, yes.
11
Q.
This is dealing with, we see, a revised framework for
12
national surveillance of healthcare-associated infection
13
in Scotland and, if we turn to page 2, is this the
14
letter that makes it clear that surveillance of C. diff
15
was to become mandatory from 1 September 2006?
16
A.
Yes, and that that would ultimately lead to a reporting
17
of the outcome of that surveillance in a public way
18
nationally.
19
Q.
20
If we look then at the table, we see the mandatory data,
and here we are focusing on Clostridium difficile.
21
A.
Yes.
22
Q.
Now, "Action required":
23
"Put surveillance systems in place."
24
Can I just understand what you meant by that?
25
A.
It is probably a question that colleagues from HPS could
108
1
answer more accurately than I, but what we were looking
2
to do was to make sure that boards had applied, as was
3
touched on in the earlier evidence, the definition of
4
C. difficile, that they were -- had identified and were
5
using the appropriate mechanisms for gathering
6
specimens, et cetera, and were linking their labs
7
together in such a way as the information could then be
8
gathered and submitted to HPS for them to interpret on
9
a national basis.
10
Q.
11
Then, if we look at the final paragraph, we read:
"We encourage NHS boards to comply with NHS Quality
12
Improvement Scotland standard for surveillance within
13
the infection control standards.
14
structures should be in place for alert organism
15
surveillance, alert condition surveillance and
16
surveillance of HAI outbreaks with reporting according
17
to the existing SSHAIP HAI outbreaks protocol in all NHS
18
directly managed beds within NHS boards."
19
20
As a minimum,
Can you just interpret that for me?
A.
In many ways, that was really about -- what we were
21
saying was that we had identified what were the
22
mandatory organisms that boards would report and we
23
would report, if you like, produce reports, on
24
a national basis.
25
be alert to, however, and the risk is that, if we say
That wasn't all that boards needed to
109
1
you only look at MRSA, you only look at C. diff and you
2
only look at two surgical site infections, for example,
3
that that is all the board has concentrated on and,
4
clearly, that is not the environment within which -- the
5
context within HAI happens in real life.
6
So our challenge to the boards, in terms of putting
7
this forward, was to remind the boards of the importance
8
to look at all organisms.
9
organisms that they needed to be alert to, and these are
10
identified here, but that boards had an eye to the whole
11
system, not just the part that was mandatory.
12
Q.
There were particular
What would your expectation be, then?
What response
13
were you anticipating that a board would make to that
14
last comment?
15
A.
That they would just do that, that they would check the
16
systems that they had in place, they would understand
17
what their local surveillance arrangements were, that
18
they would have, in inverted commas, triggers, so that
19
they would know when an outbreak was occurring, and that
20
they would act if and when an outbreak occurred in line
21
with the protocols.
22
LORD MACLEAN:
23
A.
24
LORD MACLEAN:
25
What is SSHAIP?
I knew you were going to ask me that.
There is no point in reading acronyms if one
doesn't know what they are.
110
It may not matter at all.
1
MR MACAULAY:
2
A.
3
LORD MACLEAN:
4
A.
5
6
Programme.
Right.
There is another one to
add to the list of acronyms, which one will treasure.
MR KINROY:
We might require an expert witness, my Lord, for
the acronyms.
LORD MACLEAN:
11
12
Scottish ...?
Scottish surveillance of healthcare-associated infection
LORD MACLEAN:
9
10
Of healthcare-associated infection in Scotland.
programme.
7
8
I think it means Scottish surveillance --
It might be an idea.
It would be a short
session, but useful.
MR MACAULAY:
This point that we see in this letter was
13
being made, I think we see from the date of the letter,
14
in July 2006, in relation to surveillance structures.
15
A.
Yes, this was the issuance of the letter, yes.
16
Q.
I think another area that you were involved in was the
17
Cleanliness Champions programme; is that correct?
18
A.
Yes.
19
Q.
I think we have heard about this already, but since
20
I think it came within your jurisdiction, what was the
21
thought process with that?
22
A.
The Cleanliness Champions programme, I think, was part
23
of the first action plan in 2002, and the thinking was
24
around creating a cadre of staff.
25
be clinical staff or, indeed, infection control
111
They didn't need to
1
qualified staff; they needed to be staff who were
2
willing to participate in the Cleanliness Champions
3
training and to take on the role about promoting good
4
practice and challenging poor practice in and around the
5
health systems.
6
So they could be -- I think, if I remember
7
correctly, one of the examples we used to use was the
8
Cleanliness Champion -- or one of
9
the Cleanliness Champions in Lothian was a nursing
10
auxiliary, and she did a tremendous job, along with her
11
colleagues, in promoting and challenging, and one of
12
the examples was used by a clinical colleague -- I'm
13
straying a little, but just as an example -- where the
14
medical consultant had placed their case notes on top of
15
the clinical waste bin and they were pulled up about how
16
appropriate that was or was not, and, you know, the
17
Cleanliness Champion had said, "Well, I hope you don't
18
mind me raising it with you", and the consultant rightly
19
had said, "Absolutely, you are doing your job.
20
what the role is about.
21
what is good practice and challenging poor practice".
22
In 2005, I think it was March 2005, in discussion
That is
It is about reminding us of
23
with the nurse directors, we identified that that would
24
be a good leadership example if all of the G-grade,
25
which are the ward sister charge nurse colleagues in the
112
1
health systems, if they were trained as
2
Cleanliness Champions as well.
3
in the HDL at that time that the G-grade staff became
4
Cleanliness Champions.
5
So we made a requirement
That was followed on, then, by -- again, to try to
6
encourage boards to pick up the mantle -- although
7
I have to say the nurse directors had accepted all of
8
this in discussion with them -- we, again -- or I,
9
rather, issued a letter offering funding to boards of
10
about GBP200 per Cleanliness Champion trained between
11
the period of November 2005 and the end of March 2006,
12
and that was really just to encourage boards to move
13
staff through the training, so that, if there was an
14
issue of staff being blocked because of replacement or
15
whatever, that really couldn't be used as an excuse.
16
Q.
Can I then move on to the position after it became
17
apparent that there may have been a problem with
18
C. difficile in the Vale of Leven Hospital and your
19
involvement in that?
20
statement, at paragraph 35, I think what you begin to
21
tell us is that, when matters came to a head, you were
22
actually on annual leave; is that correct?
If you turn to page 9 of your
23
A.
Yes.
24
Q.
Did you then become involved in the aftermath?
25
A.
Yes.
On my return from annual leave, because of my
113
1
portfolio lead, I took over responsibility for leading
2
the department's response to the issues raised by and
3
through the Vale of Leven outbreak.
4
Q.
If we perhaps look at this document, INQ02880001, this
5
is really a -- this is minutes of a meeting that was
6
held obviously to discuss the independent Inquiry that
7
was being set up, and we will see this was held on
8
Thursday, 26 June 2008.
This was after you returned?
9
A.
Yes.
10
Q.
If we turn to page 2, the third paragraph, you are
11
minuted as highlighting a number of concerns which had
12
become apparent over the last few weeks:
13
"These included issues around communication,
14
timelines, autonomy and leadership, identifying cases
15
and missing trends."
16
Are you able to elaborate upon what you are dealing
17
18
with there?
A.
Yes, my recollection is that this was a reflection of
19
the feedback that I had received from Dr Woods and from
20
the HAI policy team, which was -- prior to me returning
21
from leave, obviously, there had been contact and
22
communication between the department and the board, and
23
these were the kinds of issues that were being raised at
24
that time, issues around communication from the board
25
perhaps to the department and between, timelines weren't
114
1
entirely clear to us at that point in time, and the
2
issues of autonomy to act from the board's perspective.
3
So that was, as it says here, a reflection of
4
the discussions, the briefing I had received on my
5
return from leave.
6
LORD MACLEAN:
7
The HAI policy team, is that the board's
policy team, or was that --
8
A.
No, that would be the department's policy team.
9
LORD MACLEAN:
10
A.
11
MR MACAULAY:
12
The department's policy team?
The department's policy team, yes.
In not the next paragraph but the paragraph
after that, it has been minuted:
13
"NHS Greater Glasgow and Clyde had a very effective
14
surveillance system in place which the board had begun
15
to implement within the Clyde area in May 2008.
16
implementation of this system identified the concerns at
17
the Vale of Leven Hospital."
18
Leaving that last sentence aside, what did you
19
understand then was the position with regard to
20
surveillance in the Vale of Leven at this time?
21
The
A.
I think we probably had -- I certainly had limited
22
understanding of what surveillance was like at the
23
Vale of Leven.
24
understanding that Greater Glasgow and Clyde had begun
25
to introduce a process of local surveillance based on
What the first sentence refers to is our
115
1
things like statistical process control charts and were
2
able to identify in other hospitals within the board
3
area where there were concerns and we in the department
4
had in effect benefited from that, where the board had
5
alerted us to the risks of breaking of trigger points,
6
if you like, in other hospitals, and just as an
7
example -- I can't remember the specific infection that
8
was reported, but around about the Vale of Leven
9
incidents and the reporting, we received a report from
10
Greater Glasgow and Clyde to do with a risk that had
11
been identified in one of the wards in the
12
Victoria Infirmary.
13
because they knew that in a particular ward in a big
14
hospital something was not quite right, and they were
15
addressing that, so the report identified the actions
16
that they were taking.
17
For us, that was reassuring,
What we understood was that the board were committed
18
to the rollout of that approach across the board, they
19
were managing the rollout of that approach across the
20
board, they had not yet, though, applied that approach
21
in the Vale of Leven Hospital.
22
Q.
The next document I want you to look at, still looking
23
at the events after this came to a head, is at
24
GOV00710004.
25
(ninth) meeting of the Healthcare Associated Infection
We are looking here at the "Emergency
116
1
Task Force".
2
the HAI Task Force meeting, and it was an emergency
3
meeting because you were looking at the Vale of Leven?
4
A.
This was held on 4 July 2008.
So this was
Yes, by that time, obviously, we knew about the
5
Vale of Leven.
We had put in process the independent
6
review.
7
to the chief executives reminding them of their
8
responsibilities.
9
meeting, I think it was the end of June, and we had
I had spoken -- Dr Woods had issued his letter
I had spoken to the chairs at the
10
called an urgent meeting of the HAI Task Force, one, to
11
brief them on what had and was happening and, two, as
12
you will see later in the minutes, to have a discussion
13
about what their reflections were, given what they knew
14
about what had happened at the Vale of Leven.
15
we were circumspect in terms of what we shared.
16
Q.
17
Obviously
If we turn to page 5 of the minutes, I think -- you
chaired the meeting, I think.
18
A.
Yes.
19
Q.
You have set out at 2.1 what the purpose behind the
20
meeting was; is that correct?
21
A.
Yes, that's correct.
22
Q.
If you turn to page 6, 2.7, what is noted is this:
23
"Concerns were raised that although good guidance
24
was available for NHS Scotland, the tools for
25
implementation were not always available or in place."
117
1
2
What does that mean?
A.
I think this was a reflection of the general discussion
3
that was happening in the Task Force, because, as the
4
chair, I wanted the Task Force to contribute to the
5
department's thinking and what we might put in place
6
with regards to any actions or requirements of
7
the boards after the independent review, and I think the
8
reflection coming back from the Task Force members was
9
that we had issued a lot of good guidance, good robust
10
guidance, to NHS Scotland and, as it states here, that
11
the boards were not always necessarily picking up that
12
guidance timeously and applying it rigorously.
13
My point was to remind the Task Force that HAI was
14
central, as I have stated, to both the minister and to
15
the Cabinet Secretary's policy agenda for health, and
16
was one of the key issues raised with boards at the
17
annual accountability reviews.
18
Q.
19
If we go to your statement, WTS0167004, you make an
comment at paragraph 14 where you say:
20
"There was a shift from policy development to
21
supporting policy delivery in the second plan."
22
I think you have raised this yourself.
We have seen
23
that policies were developed and issued to boards, and
24
here we are focusing upon Greater Glasgow.
25
A.
Yes.
118
1
Q.
It is the monitoring of the implementation of the policy
2
that I want to ask you about again.
3
are meaning here, that there is a shift from just simply
4
issuing policies to having a more hands-on involvement
5
in how the policies are implemented?
6
A.
Is this what you
The approach that we were taking was, again, that we
7
would -- if we issued a policy, for example, around hand
8
hygiene, we would also, where possible, issue some
9
resource to support the implementation of that policy.
10
So we didn't just issue the policy and say, "There you
11
go, get on with it", we issued the policy with some of
12
the levers that helped the delivery of that policy.
13
you would perhaps include a whole raft of measures
14
around C. diff that are identified in the minutes of
15
the Task Force from March 2006 right the way up to and
16
including this, the emergency meeting, and indeed
17
thereafter, where what we were doing was saying,
18
"C. difficile is an issue in Scotland and indeed beyond,
19
and here are some of the policies and levers that we
20
require to address that".
21
So
Some of that was around mandatory reporting, some of
22
that was around the creation of the reference lab, some
23
of that was around the issuing of money to support the
24
infection control managers.
25
So the department is careful not to get too involved
119
1
in what would be delivery or operational matters.
2
is not their responsibility.
3
necessary to lever some change, then we would do so as
4
appropriate, and the performance management -- I would
5
go back to the performance management sat around the
6
local delivery plans of the boards and the annual
7
accountability reviews.
8
Q.
9
That
But where we thought it
We have seen in a number of the documents reference to
robust surveillance, or words to that effect, in
10
relation to, for example, C. difficile.
I think what
11
you are saying is you leave it to the board to follow
12
that through on the ground.
13
A.
Yes.
14
Q.
You would not then be involved?
15
A.
As a department, and certainly not as a Task Force, we
16
would not follow that through into the operational
17
delivery of that; not generally.
18
LORD MACLEAN:
When you use the word "robust", which is
19
currently used quite a lot, actually, certainly in these
20
documents, I suppose you mean it will stand up, stand
21
the test of time, do you?
22
A.
Yes.
23
LORD MACLEAN:
24
A.
25
LORD MACLEAN:
As opposed to a weak policy --
Yes.
-- a robust policy?
120
1
A.
Yes.
Well, the robust policy as well would be
2
a reflection of the evidence base that built that policy
3
up, and that is why, on occasions -- I use an example
4
where you may want to come on and talk to me about the
5
issuance of what I described as C. diff policy bundle
6
in September/October 2008, so this was the guidance
7
around C. diff.
8
up over time, and what we were seeking to do, certainly
9
from a Scottish perspective, was not issue bad policy.
10
So we would take the time to do literature reviews, to
11
check out the science, if it was a science-based policy,
12
to understand the implications, so we would consult with
13
the policy in draft with the boards to see whether or
14
not there were any barriers to delivery, if you like,
15
and that would make the policy more robust.
16
The policy around that would be built
So in robust terms, we would have done the best that
17
we could, given the individual context and the
18
circumstances of each policy, to test that it could be
19
delivered by a board.
20
MR MACAULAY:
Can I take you to paragraph 40 of your
21
statement on page 10?
22
surveillance.
This is within the context of
What you say there is that:
23
"NHS Greater Glasgow and Clyde had a programme in
24
place to introduce statistical process control charts
25
across its area."
121
1
You go on to say:
2
"I think it would have made a difference with the
3
C. diff outbreak at the Vale of Leven Hospital if the
4
SPCCs had been in place earlier.
5
at the Vale of Leven was less than adequate.
6
had been in place earlier, it would have made them more
7
sensitive to what had been happening within the
8
hospital."
9
10
The local surveillance
If SPCCs
What is your basis for making these points?
A.
I think there are two bases: one around the statistical
11
process control charts allow boards down to ward or
12
clinical area to very obviously track the occurrence of
13
infections within their area, whether it is C. diff or
14
MRSA or SABs in general.
15
control chart allows you to track that trend, if you
16
like, over time, and to do that quite obviously within
17
a clinical area.
18
Using a statistical process
So it is not unusual, for example, under the
19
Scottish Patient Safety Programme, for wards or clinical
20
areas to have charts on the wall, either of the duty
21
room or, indeed, of the corridor of the clinical area,
22
that say, "Here is where we are with infections" or
23
"Here is where we are with" -- and take nosocomial
24
pneumonia, or something, or ventilator-associated
25
pneumonia, "Here is where we are" and track, quite
122
1
obviously and openly, the period between an incident
2
being reported and the next one.
3
we received earlier sets that out.
4
Indeed, the evidence
What it also does is it quite clearly identifies the
5
expected norm for a clinical area, and, therefore, the
6
ward or the clinical area can then track whether or not
7
they are within the norms, and we had that example this
8
morning.
9
Q.
If I could just interrupt you there, I am more
10
interested in what makes you say it would have made
11
a difference in this particular case.
12
A.
Sorry, I understand.
Sorry.
Because they would have
13
known, if they'd used that, the evidence would have been
14
clearer to them, it would have been more obvious to
15
them, I think, and they would have recognised that there
16
were certain areas within the hospital that required, at
17
the very least, a look-see.
18
Q.
And "they", who are the "they"?
19
A.
They would be the infection control teams, the ward
20
sisters and charge nurses and ultimately, through
21
reporting, all the way up to the board, if an
22
investigation, there's something significant identified.
23
So it would at least have made the wards and the
24
infection control teams alert to the visibility of
25
the C. difficile across the hospital areas.
123
1
Q.
We understand they did have a T Card system which would
2
give you a snapshot at different points in time as to
3
what the position was?
4
A.
Yes.
5
Q.
You're aware of that?
6
A.
Yes, but I think the review team, Professor Smith's
7
review, did identify that perhaps that system was less
8
than adequate in terms of facilitating the ease of
9
understanding of what was happening in wards and across
10
a clinical area.
11
around the system and to identify what the whole
12
hospital looked like was difficult using the T Card
13
system.
14
Q.
So the ability to track patients
Can I move on to something different to that?
Again, it
15
is still looking to events after the problem was
16
apparent, and this is at GOV00330001.
17
We now have on the screen, Professor Martin,
18
a letter addressed to Mr Divers, the chief executive of
19
Greater Glasgow and Clyde, dated 22 August 2008.
20
this is, I think, a letter written by yourself?
Again,
21
A.
Yes.
22
Q.
What was the purpose behind this letter to Mr Divers?
23
A.
As the letter refers, on 7 August, when the Cabinet
24
Secretary was launching the independent review report,
25
prior to the formal publication and the media and press
124
1
conference that happened around that, the Cabinet
2
Secretary met with the relatives of the incident -- of
3
patients involved in the incident and talked them
4
through, as I understand it -- I wasn't at that meeting,
5
as I will come on to explain -- the contents of
6
the report and what that meant and what her response was
7
going to be.
8
At the same time as Dr Woods and the
9
Cabinet Secretary were meeting with the families, I was
10
meeting with Mr Divers as the chief executive of
11
the board and other members of his team, and I was
12
issuing him with the specific action plan for NHS
13
Greater Glasgow and Clyde in response to the independent
14
review team's report.
15
I think, as I stress in my statement, the approach
16
to this was really quite unusual, and I think that is
17
also reflected in my comments thus far to the Inquiry.
18
The department would not normally be that command
19
and control or interventionist or prescriptive in our
20
actions.
21
Q.
22
23
That is the point I was going to raise with you.
Is
this an example of being hands on?
A.
Yes.
But we would not normally do that.
But in this
24
situation, it was considered to be so important that we
25
would not negotiate with the board what we were asking
125
1
them to do, so they did not see the action plan in
2
advance, we did not ask their views.
3
with it and they were told it was non-negotiable and
4
they had to get on with it and that we would then
5
monitor them at regular intervals until the action plan
6
was delivered.
7
MR KINROY:
We issued them
My Lord, I wonder if we might enquire if there
8
was a separate action plan for boards in Scotland
9
generally, but equally requiring certain things to be
10
done by all of them?
11
LORD MACLEAN:
12
A.
Yes, was there?
Yes, there was.
There was also, at the same time,
13
a specific action plan for Greater Glasgow and Clyde,
14
and at the same time there was the table which is headed
15
up "General Actions", which effectively was what we
16
thought needed to be taken forward by Greater Glasgow
17
and Clyde and all other boards in response to the
18
independent review team report as well.
19
LORD MACLEAN:
20
21
22
23
What was specific to Greater Glasgow and
Clyde, though?
A.
What was in their action plan was specific to
Greater Glasgow and Clyde.
MR MACAULAY:
I will put that on the screen so we can see.
24
It is at page 3 of the document.
25
directed, as you indicated, to Greater Glasgow and
126
We can see this is
1
Clyde.
2
For example, the second box:
"Infection prevention and control policies to be
3
reinforced and compliance monitored and audited at the
4
Vale of Leven."
5
You have given a completion target date for that
6
7
action.
A.
Yes.
Some of the target dates are particularly tight,
8
because, in my view, the board -- boards, if you look at
9
the broader action plan, should have had these in place
10
11
anyway.
Q.
12
What about page 4, under the heading "Facilities".
It
is the second box:
13
"The board to review isolation facilities at the
14
Vale of Leven maximising access."
15
Had you been made aware as to what the position was
16
with isolation facilities?
17
A.
Yes.
18
Q.
What was your understanding?
19
A.
That they were extremely limited and at times difficult
20
to access for patients who may have required or
21
benefited from isolation.
22
Q.
The proposed completion/target date for this, I suppose,
23
review and then maximising access, what did you envisage
24
was going to happen here?
25
A.
I think the board had already identified an action plan
127
1
that they were going to take forward as part of their
2
internal processes that showed a reconfiguration of ward
3
areas.
4
follow that through; we were expecting them to, where
5
they could, identify further isolation facilities and to
6
make sure that those facilities were managed in an
7
appropriate way by the hospital managers who were on --
8
who could be on duty at any point in time.
9
So we would expect -- we were expecting them to
That, you know, perhaps meant taking wards down and
10
putting up fairly temporary separations.
11
to be -- you know, as long as it complied with the
12
appropriate building regulations, it didn't need to be
13
a huge build programme, and I think, to be fair, the
14
board had an understanding of what it could do within
15
the constraints of the fabric of the building.
16
Q.
It didn't need
The final point I want to take you to in this document
17
is on page 5.
18
and it is -- I'm interested in the second box, where we
19
read:
20
It is under the heading "Surveillance",
"Board to carry out epidemiological review of cases
21
between December 2007 and June 2008."
22
With a completion date for September 2008.
23
A.
Yes.
24
Q.
What was envisaged here?
25
A.
The issue here was that we remained -- and I think,
128
1
again, that was highlighted this morning -- unclear as
2
to what the epidemiological profile of the patients were
3
in the Vale of Leven outbreaks or incidents, and so we
4
were unclear about, you know, the kind of aspects of
5
comorbidity that may have influenced the vulnerability
6
of a patient and their susceptibility to C. difficile
7
and may have influenced, for example, the treatment
8
plans and packages put in place by the clinical teams.
9
So we were looking for the board, and I think the
10
board were committed to doing this, supported by, if
11
I remember correctly, colleagues from Health Protection
12
Scotland, to undertake a review of that evidence and
13
identify whether or not there were particular challenges
14
around the presentation of the patient group that had
15
been caught up in this period.
16
Q.
Did you see the review of cases?
17
A.
I can't remember, I'm sorry.
18
Q.
Do I take it that such a review was carried out?
19
A.
Yes.
My understanding is it was, but I wouldn't be able
20
to quote the outcomes to you.
21
actually to speak to HPS, they would be able to give you
22
that information.
23
24
25
Q.
I think if you were
The other document, perhaps just to identify it since
you mentioned it, is GGC14470001.
MR KINROY:
My Lord, I wonder, before we go to that, could
129
1
we clarify whether the board attended diligently to what
2
was required of it by the specific action plan for it?
3
A.
Yes.
I mean, I have to say that I found absolutely no
4
resistance from the board to either the approach that we
5
took as a department or, indeed, to the willingness to
6
learn lessons.
7
For my view, I am clear that the board, particularly
8
Mr Divers, was focused on resecuring, if you like, or
9
securing a future for the Vale of Leven Hospital and for
10
re-establishing the confidence of patients, staff and
11
the local community in the functioning of the hospital.
12
There was no resistance at all to what we asked him to
13
do.
14
LORD MACLEAN:
15
In the circumstances, that's not surprising,
is it, frankly?
16
A.
No.
That is an observation your Lordship can make.
17
LORD MACLEAN:
18
to --
19
A.
20
LORD MACLEAN:
I'm being unkind.
But the reality was he had
Yes.
-- and show willing too, because it was
21
a pretty parlous -- that is a pretty neutral word --
22
situation that the Vale of Leven had got itself into.
23
24
25
A.
I think in some situations where things like this
happen, organisations can be defensive.
LORD MACLEAN:
Oh, yes.
130
1
A.
I think, when we see the reports from down south, for
2
example, we saw organisations that resisted an
3
understanding and acceptance of what was going on within
4
and through their organisation.
5
experience in my dealing with Greater Glasgow and Clyde.
6
LORD MACLEAN:
That was not my
It wouldn't have been very profitable to have
7
been obstructive or reluctant, would it?
8
it is true that they were anxious to get it right.
9
A.
Yes.
But, I mean,
The phrases were "No more excuses" and "This is
10
not negotiable.
11
language which was used, which was very, very unusual
12
from the department's perspective.
13
MR KINROY:
You will do this".
That was the
My Lord, I wonder if we could perhaps develop
14
that?
Would it be correct to imagine that was
15
a cultural phenomenon of being unwilling or reluctant to
16
accept what was going on, or, at the other extreme,
17
being non-defensive and keen to learn?
18
LORD MACLEAN:
19
A.
Do you want to offer on that?
I'm not sure that I can add.
My statement, which
20
perhaps should be reassuring, is that the board
21
approached this in a positive and responsive and
22
responsible light.
23
LORD MACLEAN:
24
A.
25
MR PEOPLES:
Yes, and they were very cooperative too?
Absolutely.
My Lord, the witness did in fact say that one
131
1
of the phrases used was "No more excuses".
2
based on something that had previously happened in
3
Greater Glasgow in relation to this area?
4
A.
Was that
No, this was a general observation that, in terms of
5
the reluctance, if you like, or the, at times,
6
difficulty in having policies implemented, that's where
7
that was coming from.
8
and get this done".
9
MR MACAULAY:
So "No more excuses, just get on
The general action plan, I was just going to
10
quickly take you to that, is at GGC14470001.
I think we
11
have it on the screen.
12
that you made reference to when responding to my learned
13
friend Mr Kinroy a little while ago?
Was this the general action plan
14
A.
Yes.
15
Q.
This was to apply to across Scotland?
16
A.
Yes.
17
Q.
If I could take you to page 5, I think here, just to
18
touch upon something you said earlier, in the box
19
"Policies and procedures", can we see that a number of
20
documents were to be issued in that connection, and in
21
particular a C. diff care bundle was one of the topics?
22
A.
Yes.
This action plan was really a reflection from
23
discussions within the department with the HAI policy
24
team and checking and testing that we did with the
25
Task Force.
What we were looking to do was to see, as
132
1
I have touched on, whether or not there were particular
2
actions or lists of actions that we would expect each
3
board to do, so that we were minimising -- sorry, we
4
were acting with Greater Glasgow and Clyde specifically
5
around the incident, but we were seeking to minimise the
6
risk of this happening anywhere else in Scotland, or
7
something similar to it, and these were the actions that
8
we thought needed to be taken forward.
9
So in reference to the policy and procedures, that
10
was around Health Protection Scotland in effect pulling
11
together policies and procedures that were in part
12
available, so the CDAD care bundle was being piloted, as
13
I understand it, if I recollect correctly, in
14
Greater Glasgow and Clyde and one other health board --
15
I want to say NHS Ayrshire & Arran, I think it was --
16
and the C. diff check list was there as well, framework
17
for local surveillance would be developing from what was
18
there before, and antimicrobial prescribing was
19
effectively bringing that into the context specifically
20
of C. diff and referencing out to the appropriate
21
frameworks that existed at that time.
22
So, you know, I think, like other countries in the
23
UK, we were seeking to pull together a package of
24
policies, but most of these policies already existed in
25
one shape or form.
133
1
Q.
2
The antimicrobial prescribing policy, we have seen
material going back to the early 2000s, 2002?
3
A.
Yes.
4
Q.
The C. diff care bundle, why wasn't that in place
5
6
before June or July 2008?
A.
In terms of the C. diff care bundle, what we were doing
7
was piloting that in board areas to see whether or not
8
it was fit for purpose and see whether or not it
9
actually helped to support and form and influence
10
practice, and that would be normal, in the context of
11
issuing a care bundle.
12
There were some challenges, I think, around the
13
taking forward of the care bundle, and I don't know if
14
your Lordship wants, but if you look to the minutes,
15
I think it is May, of the HAI Task Force of 2008, you
16
will see there was a discussion around the C. diff care
17
bundle and, effectively, myself and the Task Force
18
saying, "Well, this may have been the time we were
19
introducing the Scottish Patient Safety initiative in
20
Scotland", which is a care bundle approach, it is
21
a particular approach to the promotion of patient safety
22
which requires a particular methodology.
23
Q.
Just to stop you there, do I take it, though, that
24
essentially the production of the care bundle, for
25
example, was really something that was, in large
134
1
measure, motivated by the Vale of Leven problem?
2
A.
No.
3
Q.
So it had been there before?
4
A.
Yes.
5
Q.
When had it first been mooted as something that would
6
7
be -A.
I think, if you go back, it was certainly mooted for
8
about -- it would probably be -- let me see in the
9
Task Force minutes.
I think if you went back as far as
10
certainly nine months before, I think, when we had
11
commissioned it from HPS, they would develop a care
12
bundle.
13
Q.
Would that be sometime in the latter part of 2007?
14
A.
Yes.
It will either be June or October 2007, I think,
15
in the Task Force minute meetings you will find it
16
there.
17
Q.
So it was being discussed then?
18
A.
Oh, yes.
19
20
Yes, it was part of HPS's work plan to develop
a care bundle.
I think -- you know, I don't know if it's -- if it
21
would be reassuring, your Lordship, to go through the
22
Task Force minutes, because -- but I don't want to hold
23
you up if you have already been through that, but the
24
Task Force was quite clear that C. diff was one of its
25
priorities.
It was identified in the 2006/2008 action
135
1
plan at 14.4 that HPS would be taking forward
2
interventions to support the reduction in C. difficile
3
and, you know, I can cite in the minutes of each --
4
virtually each of the Task Force meetings thereafter
5
reference specifically and directly to the actions
6
around C. difficile.
7
It was very much sitting at the heart of
8
the importance at a policy level, certainly, within the
9
HAI Task Force.
10
11
MR MACAULAY:
My Lord, that might be an appropriate point to
have a break.
12
LORD MACLEAN:
13
(3.20 pm)
Yes.
14
We will have a short break.
(A short break)
15
(3.35 am)
16
MR MACAULAY:
Before we had the break, we were looking at
17
the general actions that were proposed by the
18
department.
19
Can we go to page 6 of the document?
20
reference to policies and procedures, the first action
21
listed is:
If we go back to that, please; GGC14470001.
Here, under
22
"Clostridium difficile root cause analysis tool to
23
be developed and used by boards to investigate adverse
24
outcomes including death."
25
The Inquiry has heard some evidence about this
136
1
approach.
2
that was not being used in Scotland?
3
A.
4
Do we take it from this that this was a tool
I was not aware that it was used as a matter of routine
across boards when incidents like this happened.
5
Q.
Was there any reason why that was so?
6
A.
I honestly -- I don't know.
I don't know whether it was
7
a tool that was sort of being used or not, but it was
8
not used.
9
Q.
10
11
Had there been any policy issued to indicate that this
approach would have been --
A.
12
We hadn't issued any policy from our perspective within
the department, no.
13
LORD MACLEAN:
14
A.
It was being used in England, was it?
My understanding was that a process like this was one of
15
the recommendations that came out of the -- I think it
16
was the Maidstone and Kent review as well, to encourage
17
the use of -- well, to get to the detail, to get to the
18
root -- basically, that's what it's called, what it
19
is -- of what the issues were and are as they presented,
20
and so the outcome here was for Health Protection
21
Scotland to develop a similar tool for Scotland.
22
MR MACAULAY:
Would it be right to say that when the report
23
into the Maidstone and Tunbridge Wells Inquiry was
24
available and, indeed, also the Stoke Mandeville report,
25
that these would be reports that your department would
137
1
be taking particular cognisance of?
2
A.
Would be looking at, yes.
3
Q.
Do I take it, then, that this particular tool was just
4
5
something that had not been focused on?
A.
It wasn't something that we had focused on in respect of
6
the reports.
We had looked at the other issues,
7
obviously, around environment and staffing and
8
antimicrobial prescribing.
9
construct of our code in respect of the management
We had looked at the
10
arrangements, et cetera, that were in place.
11
broad headings of both reports, we were fairly
12
comfortable that we either had policies in place or were
13
developing policies.
14
So the
I think if we reflect back on the emergency meeting
15
of the Task Force, this was one of the points that was
16
brought out in the general discussion there, that it may
17
be useful for us to have a tool of this kind in
18
Scotland.
19
Q.
So we tasked HPS with taking that forward.
You mentioned one of the meetings in relation to the
20
C. diff bundle, I think, earlier.
If you could look at
21
HPS01130001, we are looking here at the eighth meeting
22
of the Task Force.
23
you were chairing this meeting?
This is dated 27 May 2008.
Again,
24
A.
Yes.
25
Q.
If we turn to page 5, at 6.5 there's a presentation on
138
1
Clostridium difficile update which wasn't on the agenda.
2
So this was ad hoc?
3
A.
Yes, this was ad hoc.
We thought it was important to
4
get an update from HPS and from the surveillance lab and
5
Dr Eastaway came forward to do that presentation.
6
Q.
7
This is before you were aware of there being a problem
in the Vale of Leven?
8
A.
Yes.
9
Q.
Then, is it here that we see in the third bullet point
10
reference to:
11
"HPS have developed a care bundle on the Clostridium
12
difficile-associated disease.
13
about the possibility of too many bundles being
14
introduced too quickly.
15
CDAD was such an important and high-profile issue that
16
it is important to introduce the bundle as quickly as
17
possible."
18
19
Concerns were raised
However, it was agreed that
Is that what you had in mind earlier when you -A.
Yes, that is right.
I think if you were to go back, in
20
terms of the minutes in previous meetings, you would see
21
the discussions that were happening between the
22
Task Force and HPS from the beginning of the development
23
bundle and the piloting of it to this stage, where we
24
were now seeing that we had the Scottish Patient Safety
25
Programme in place.
The reference here was that the
139
1
Scottish Patient Safety Programme works through
2
a process of care bundles, and there was a slight delay,
3
I think, as we -- we didn't want to introduce two
4
separate approaches, because that could lead to
5
confusion, so HPS were tasked with negotiating with the
6
Scottish Patient Safety Programme and making sure that
7
what we introduced was appropriate and consistent with
8
their methodologies.
9
I think what this notes here is that the Task Force
10
felt that we had probably given enough due regard to the
11
timing of the introduction of the patient safety
12
programme, and we should just push ahead with the
13
introduction of the care bundle.
14
Q.
15
16
Was the trigger for this one of the Inquiries south of
the border, or was it some other source?
A.
The management of patient safety challenges has
17
increasingly, over probably the last five years -- well,
18
sorry, I'm forgetting the timeframe.
19
years previous, if not ten years, the emergence of
20
patient safety as a concept and process more formally
21
than it had been described before had come forward, and
22
the Institute of Health Improvement from Harvard
23
University had been commissioned to take forward
24
a Scottish-wide Scottish Patient Safety Programme.
25
At that time, five
That approach then allowed for what's described as
140
1
a care bundle approach, so you are clear about what you
2
do, say, in the care of someone having an intravenous
3
infusion, a cannula inserted; there is a process that
4
the nurse or the doctor, or whoever, would follow to
5
minimise any risks associated with cannulation,
6
particularly around infection.
7
So the care bundle approach is that approach.
It
8
tells you what to do -- or, sorry, it doesn't tell you.
9
It maps out what you should do in a particular situation
10
or clinical presentation or clinical task.
11
Q.
If I take you back to your statement --
12
MR DEWAR:
My Lord, I wonder if I may just add one further
13
reference on a particular point Counsel to the Inquiry
14
is dealing with to add or project backwards in the
15
timescale: if the witness is referred to GOV01220001,
16
which is a previous minute of a meeting of the
17
Task Force, there is a specific reference to care
18
bundles in the context inter alia of C. diff at
19
paragraph 3.4 on the third page, and it may be that that
20
is at least one of the references that the witness was
21
referring to.
22
MR MACAULAY:
23
24
25
I will take you to that.
Is that the
paragraph you had in mind?
A.
Absolutely.
If you look at the process here, what it
describes was the process that we put in place when we
141
1
launched the second action plan, the 2006/2008
2
Task Force action plan.
3
would be what's called a project initiation document for
4
care bundles, and the project initiation document was to
5
help us manage the impact of the demands from the
6
Task Force on its key supporters, if you like, HPS, so
7
that we were clear what HPS were being asked for, they
8
were clear with us, any resources they required to take
9
that forward were also identified.
We put in place that there
10
So you will see here that we have talked about
11
central line insertions, central line maintenance,
12
ventilator-associated pneumonia, peripheral vascular
13
catheters, surgical site infection,
14
C. difficile-associated disease and hand hygiene.
15
these were all care bundles that were being developed by
16
HPS.
17
Q.
This is June 2007?
18
A.
June 2007, yes.
19
Q.
Again, perhaps you can give me an understanding of
So
20
the time frames these matters take, because we see
21
in May 2008 that, nearly a year later, the care bundles
22
are still not ready for production?
23
A.
Yes.
I think if you were coming forward to the June
24
meetings and to the October meetings of the same year,
25
you would see that the introduction of the Scottish
142
1
Patient Safety Programme to Scotland and the
2
methodologies that that brought with it had caused
3
a delay in the development of this particular approach
4
to care bundles.
5
delivering this than we had hoped we would be, so that
6
we didn't create confusion in the service by issuing
7
a care plan bundle using one methodology and then care
8
bundles coming out through the Scottish Patient Safety
9
Programme using a different methodology.
10
Q.
11
12
So we were perhaps slower in
As at June 2007, what was the expectation as to when the
care bundle would be put in place?
A.
We would have expected them to be in place -- I think it
13
says here -- at the end of 2007 for piloting -- sorry,
14
I think I said Ayrshire & Arran earlier on.
15
Forth Valley.
16
and Clyde are piloting the care bundles at present".
17
So, even at the time of that meeting, the care bundles
18
were already out there being tested.
19
rolled out across the whole of Scotland.
20
LORD MACLEAN:
21
22
It's
"NHS Forth Valley and NHS Greater Glasgow
They just weren't
Where was the piloting going on, as far as
Greater Glasgow and Clyde is concerned?
A.
It would be -- that would be a question for HPS and for
23
the board.
24
or clinical settings they were being piloted in.
25
MR MACAULAY:
I am not sure of which particular hospitals
You say here -- it says in the minute that
143
1
"NHS Forth Valley and NHS Greater Glasgow and Clyde are
2
piloting the care bundles at present", but it doesn't
3
tell us in what hospitals.
4
A.
No.
5
Q.
I think we know they weren't being piloted in the
6
Vale of Leven, because we have seen the medical records.
7
A.
Yes.
8
Q.
If we go to your statement again, WTS01670011,
9
paragraph 42, that's the paragraph I think where you
10
discuss your involvement with, in particular, Mr Divers
11
and the action plan, the specific action plan, that you
12
put in place for Greater Glasgow and Clyde; is that
13
correct?
14
A.
Yes.
15
Q.
You say:
16
"It was made clear that implementation of the action
17
plan was non-negotiable."
18
Were you satisfied, by that I mean was your
19
department satisfied, that each of the proposed elements
20
of the action plan were actually followed through and
21
put in place by the board?
22
A.
Yes.
What we did was we tracked the actions with the
23
boards.
We met -- I think it ended up being monthly --
24
with the boards formally -- sorry, with Greater Glasgow
25
and Clyde board formally to identify where they were
144
1
with progress against particular time frames for the
2
actions, and we were content that they were moving
3
forward with the actions that we had prescribed for them
4
within those time frames.
5
I think, if I remember correctly, the independent
6
review team follow-up report also acknowledges that
7
Greater Glasgow and Clyde had moved forward with the
8
particular actions prescribed to them.
9
Q.
And implemented these actions?
10
A.
Yes.
11
Q.
I raised earlier with you the board's carrying out of an
12
epidemiological review of cases.
Although you,
13
yourself, may have no recollection of that, are you
14
saying that that was implemented?
15
A.
As far as I am aware, yes.
16
Q.
I think one of the other results of the Vale of Leven
17
situation -- you can correct me if I am wrong -- was, at
18
least in part, the creation of the Healthcare
19
Environment Inspectorate; is that correct?
20
A.
Yes.
21
Q.
Perhaps I can get you to look at -- we have a witness
22
coming from that organisation tomorrow, I think, but
23
just to get the background to this, if you could look at
24
INQ00880001.
25
We see here that this is a document with the title
145
1
"Inspection methodology.
Healthcare-associated
2
infection".
3
Healthcare Environment Inspectorate.
4
was set up in 2009; is that correct?
Can we see "HEI" at the top means
This organisation
5
A.
Yes.
6
Q.
The problems with the Vale of Leven, was that at least
7
8
part of the background to the creation of this body?
A.
9
Yes.
I should point out that, in the timeframe for the
issuance of this document, and indeed the formal
10
commencement of the Healthcare Environment Inspectorate,
11
I was no longer in post.
12
Q.
Yes, indeed.
13
A.
But the development of the guidance that then allowed
14
for the negotiation between the department and NHS QIS
15
to establish the Healthcare Environment Inspectorate was
16
developed as a response to the Vale of Leven in
17
particular, but also, again, to help to create, as
18
I think you have touched on, some evidence of
19
the quality of the impact of the work that the boards
20
were doing in taking forward cleanliness and infection
21
prevention and control.
22
Q.
Before the HEI came into existence, what system, if any,
23
was there to inspect hospitals, either announced or
24
unannounced?
25
A.
The system that we had in place rested with the Clinical
146
1
Standards Board for Scotland, and in this regard I think
2
they issued the first standards around infection control
3
in HAI in 2001.
4
Scotland merged into NHS Health Improvement Scotland,
5
and they were responsible for the development of
6
standards, their application across the boards and for
7
the review processes that went with those standards.
8
Q.
9
The Clinical Standards Board for
But prior to the creation of the Healthcare Environment
Inspectorate, was there any system whereby hospitals
10
could either be inspected on an unannounced or announced
11
basis, particularly in this context?
12
A.
In the context as described in the HEI inspectorate
13
remit, no; it was very much around the standards set out
14
by Quality Improvement Scotland.
15
agencies that have powers, such as the Mental Welfare
16
Commission, who can enter into a hospital, both
17
announced and unannounced, in respect of their
18
particular client and patient group, but the approach
19
that was taken here, proposed through the inspectorate,
20
was far more directional and obvious than would have
21
been the case with the Quality Improvement standards.
22
Q.
There are other
I think the Clinical Standards Board for Scotland, going
23
back to the early 2000s, did carry out an inspection
24
type of role?
25
A.
Yes, but very much announced and very much peer group
147
1
reviewed and very much from an improvement thinking
2
perspective, because I was one of the external reviewers
3
for the Clinical Standards Board for Scotland, so
4
I would visit other Trusts at that time to look at their
5
services, but I don't think even QIS would describe
6
themselves as applying those standards and/or their
7
overview of those standards in the same way as was then
8
implemented in the inspectorate's approach.
9
Q.
Was there then a gap in the system, in particular, the
10
lack of an inspection regime, prior to the creation of
11
HEI?
12
A.
I think that there was probably a weakness in the
13
system, that the inspectorate has helped to fill because
14
of its independent nature and because of its ability to,
15
as you said, visit unannounced, and I think that that is
16
reinforced by the fact that we established the
17
inspectorate, or ministers established the inspectorate,
18
at all.
19
Q.
20
21
Otherwise, there would be no need to do that.
What was the position in England, particularly following
upon the Stoke Mandeville report; do you know?
A.
Well, my understanding is that they would use the
22
Healthcare Commission as part of their, if you like,
23
policing of the system.
24
Q.
So there was an inspection regime for healthcare?
25
A.
There was.
That is my understanding.
148
Yes.
1
Q.
I think we have seen, when we have looked at the
2
documentation and the policies, that your department did
3
see infection prevention and control as an important
4
aspect of care?
5
A.
Yes, absolutely, and I think that came from the very
6
top, if you like.
There is absolutely no doubt in my
7
mind that the minister and then the Cabinet Secretary
8
saw HAI as one of their top priorities, and would make
9
that clear at, you know, every opportunity that it was
10
relevant to make it clear: at chair's meetings; at
11
annual reviews; at conferences; making resources
12
available to the Task Force for it to take forward its
13
work plan, both its general work plan and, indeed, the
14
investment in the MRSA screening approach, which was
15
a significant amount of money.
16
was clear that her officials were required to ensure
17
that HAI was top of the agenda as well.
18
raised at chief executives' meetings, nurse directors'
19
meetings.
20
Q.
The Cabinet Secretary
That would be
As we have seen from the documentation, it was the chief
21
executive who was to have ultimate responsibility for
22
healthcare-acquired infection?
23
A.
Yes, absolutely.
I think that is also reinforced by the
24
chief executives of the systems are required to sign
25
what is called a statement of internal control.
149
That
1
statement of internal control simply reaffirms, if you
2
like, as part of the annual auditing process, that they
3
have risk approaches and systems in place around the
4
governance requirements which, in the main, are
5
financial, clinical and staff governance.
6
So they sign each year to say, "I am confident that
7
8
I have risk processes in place in these areas".
Q.
9
It would be your expectation that health boards, and
particularly Greater Glasgow and Clyde Health Board,
10
would have put in place appropriate systems to manage
11
healthcare-associated infection?
12
A.
Healthcare-associated infection would be captured in the
13
clinical governance arrangements of the board.
14
a chief executive was signing to say they had effective
15
processes in place for clinical governance, in
16
particular the risk-based approaches to clinical
17
governance, in my view, they would be signing to say
18
they had appropriate mechanisms in place for HAI.
19
Q.
So when
It is my intention next to move on to questions that
20
have been intimated by families, the board and also on
21
behalf of the Scottish ministers.
22
There are quite a number of questions, my Lord.
23
I wonder if there might be some merit in saying to my
24
learned friends, if we were to adjourn now, could they
25
look at these questions and decide which questions they
150
1
are still insisting on?
2
LORD MACLEAN:
3
MR MACAULAY:
4
5
In light of the evidence given?
Yes, and perhaps let me know which questions
are still being insisted upon.
MR KINROY:
My Lord, I think we could save a lot of time if
6
I had a chance to reflect on this.
I hope to
7
considerably prune the questions for the witness.
8
MR MACAULAY:
That being so, my Lord --
9
MR PEOPLES:
I think I can take some out.
10
I don't know yet
how many, but I certainly can take some out.
11
LORD MACLEAN:
12
MR DEWAR:
13
You have some questions.
Likewise, I have some, my Lord, and some of these
are already been dealt with.
14
LORD MACLEAN:
15
MR MACAULAY:
16
LORD MACLEAN:
17
A.
18
LORD MACLEAN:
19
(4.04 pm)
Okay.
We will prune overnight.
There may be merit in that.
There may be some sense in adjourning now.
Are you all right for tomorrow morning?
Yes, certainly.
Tomorrow morning, 10 o'clock.
20
(The hearing was adjourned until
21
Tuesday, 22 May 2012 at 10.00 am)
22
23
24
25
151
1
I N D E X
2
3
4
MR CHARLES CHRISTOPHER ROBERTSON .....................1
(sworn)
5
6
Examination by MR MACAULAY ....................1
7
8
PROFESSOR PAUL MARTIN (sworn) .......................59
9
10
Examination by MR MACAULAY ...................59
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
152
NOTE (1)
for
GREATER GLASGOW HEALTH
BOARD
in
THE VALE OF LEVEN PUBLIC
INQUIRY
re.
THE EVIDENCE OF PROFESSOR
CHRIS ROBERTSON
In terms of the GUIDANCE ON WITNESSES AND TAKING OF EVIDENCE, Greater Glasgow
Health Board wishes the following lines of questioning to be put by Counsel to the Inquiry to the
witness Professor Chris Robertson:-
1. Would you agree that calculating mortality rates enables statistical comparisons for
specific morbidities to be made between cohorts?
To be honest I don’t really understand the relevance of this question and the subsequent 8 to my
report.
If you wished to compare mortality between two cohorts then you would use some form of
standardisation to compare. This is needed if the cohorts are of different sizes or observed for
different length of times. There are many other adjustments that might have to be made if the
distribution of important variables associated with the outcome varied between the two cohorts.
For example if one cohort was younger than the other.
2. Would you agree that in carrying out a mortality rate study it is crucial to compare like
with like, so that among other things, the period (“the mortality period”) over which the rate
is calculated needs to be the same in each study?
You need to compare like with like in all statistical testing and this is one of the biggest challenges
in observational epidemiological studies. Using the rates is one way of trying to ensure that you
are comparing like with like. If you are comparing events over a 6 month period with events over a
7 month period then some form of standardisation is required as the length of the time period is
not the same. So you could compare the events per month in each period or events per occupied
bed days and these should be comparable.
If there is a strong seasonal pattern to the event rate then the comparison is better if the two
periods refer to the same seasons. In the report it would have been better to compare Dec 2006
to June 2007 with Dec 2007 to June 2008, as the latter period was the one under focus. This
leaves a quandary as a result of the lack of availability of data for Dec 2006 as it was outside the
terms of reference. The comparisons of Jan-June 2007 with Dec 2007 to June 2008 were
standardised to occupied bed days, months, or proportions of patients and all of these should be
comparable
3. Would you agree that if the cohort to be studied is those who have died from a specific
morbidity, the criterion by which the cause of death (e.g. from CDI) is assessed needs to be
consistent?
Cause of death assessment should be consistent if possible if the reason for the death is
important. This will not always be possible if administrative death records are used. For example,
if cause of death for one half of the cohort was assessed by one person and another person was
used for the other half of the cohort then this would need to be taken into account in the analysis if
possible
4. Would you agree that a study of that sort (where all members of the cohort under
study died from the same illness) is known as an “attributable mortality study”?
I must confess this is the first time I have heard the phrase “attributable mortality study”. I am
more familiar with the phrase attributable mortality used in connection with a study comparing
matched cases and controls with an excess of deaths, for example, in the cases being attributed
to the reason the cases and controls differ.
I do not think that we have such a study here as not all cases with C. difficile died as a result of the
infection – see report by Professor G Griffin. To do the type of study I think you are asking about
would require patients who had a C. difficile infection and patients who did not have the infection.
I do not have any data on deaths among patients who do not have a C. difficile infection.
5. Is the reason for that because the death of each member in the group is attributed to
the same illness?
I am not sure of the relevance of this question in view of my answer to 4
6. Would you agree that one difficulty with attributable mortality studies is that there is a
variety of ways by which cause of death may be assessed, and some of those ways are so
imprecise or subjective that significant errors can come into the comparison between the
cohort and the control group?
Comparisons of two groups can still be valid even in the presence of imprecision provided there is
no systematic bias in the assessment of the endpoint.
7. Would you agree that the way to avoid this problem is to calculate all-causes
mortality?
With all-cause mortality it is known when someone is dead or not. There could still be a bias if
proportionately more individuals from one group are lost to follow up and so there is no information
on death.
8. Would you agree that an all-causes mortality study compares the number of deaths in
the cohort over a specified period with the number of deaths in a control group over the
same period?
To compare the numbers you would need to have the two groups of the same size and followed
up for the same time and the cohort and control matched on important variables associated with
the outcome. It is better to compare the rates – proportions dying within a certain period or rate
per month – as then you can use follow up periods of different lengths.
9. Would you agree that the mortality rate in an all-causes mortality study should be
statistically similar in the cohorts and the control group, if adjusted for sex, age and comorbidity, and if it is not, this suggests excess mortality?
I do not necessarily think that a difference in mortality rates necessarily means excess mortality,
though perhaps I am thinking of excess mortality in a specific sense – more deaths than would be
expected taking into account chance variability in the number of deaths.
Even adjusting for age, sex and co-morbidity need not necessarily give similar mortality rates
between two groups. This could happen because there is a genuine difference between the two
groups on mortality or also because there is another factor not included in the analysis which
varies across the groups and is related to mortality. The reason for the adjustment is to try and
correct for any imbalance among the two groups on factors which are associated with mortality.
10. You say in your conclusions at EXP08440030 that some of the problems with the data
may be “because the database created by the Vale of Leven Inquiry team was not set up for
a rigorous analysis as much information was contained within the same text entry field”.
What does that mean, in practice?
A lot of this is in page 5-7 of the report. The data file I was given had the patient identifier, event
details and ward information all in the same text field. In order to make this useful I had to search
through this text field to extract the relevant data. This text field was not in a standard format and
much of the separation of the items was on the basis of a number of spaces, sometimes brackets.
There were also a lot of typos. If the database was set up for a scientific study then each patient
would be assigned a unique identifier and the fields which were to be extracted from the data
would be identified and the values in these fields listed – there would not be free text fields which
had to be searched for the presence of key items of text.
11. You say in the executive summary at 11 that “11 .A tentative analysis of the number of
C. difficile patients in a ward on each day during the study period has suggested that there
are periods in wards 3, 6, 14, 15 and F when there were potentially 2 or more patients with
C. difficile at one time. Wards 6, 14, 15 and F all had periods with potentially 3 or more
patients with C. difficile on the same day.” Can you explain what analysis you made of this
question, and why it was tentative?”
The analysis is tentative because so many assumptions are made in trying to answer the question
– was there ever an occasion between Jan 2007 and June 2008 when the conditions for an
outbreak were satisfied. This question cannot be answered using the data available and all that
can possibly be established is if there were possibly 2 or more (or 3 or more) patients with C.
difficile in a ward on the same day and this is not the same as in the outbreak definitions. The
quality of the data about patient movement is not sufficiently robust for anyone to be absolutely
sure that a patient had been moved from or to a ward. Also there is the assumption about whether
a patient who was diagnosed with C. difficile and treated for 3 or 4 days still has C. difficile.
12. In this regard you say in your report (at EXP02840009) that your work looking for
possible clusters of clostridium difficile is the weakest section of the analysis and the one
which is most sensitive to the data quality. You say that “it was fraught with difficulties
because of the lack of absolute certainty in the data discussed above.” Can we take it that
you are not in a position to say which if any of the potential clusters you specify at
EXP02840009 and in Figures 13 and 14 actually occurred, on a balance of probabilities?
Not absolutely when there is an assumption of 3/7/10 days post diagnosis because of the potential
problems with patients’ movement. However if we consider only the date of report to the same
ward
There were 2 positive reports to ward 15 collected on 15/2/2007 and reported on 19/02/2007
There were 2 positive reports to ward F collected on 29/3/2007 and reported on 02/04/2007
There were 3 positive reports to ward 14 collected on 11/04/2007, 13/04/2007, 14/04/2007 and
reported on 17/04/2007
There were 2 positive reports to ward 6 collected on 07/05/2008, 08/05/2008 and reported on
09/05/2008
There were 2 positive reports to ward 14 collected on 12/06/2008, 13/06/2008 and reported on
16/06/2008
These 5 reports are based solely on the data available and do not use the time period of 3/7/10
days post diagnosis.
The 3 patients in 14 were all in the ward for the period 10/04/2007 to 23/04/2007. There was
another patient in ward 14 with a sample collected on 16/04/2007 and reported on 19/04/2007
13. Would you agree that the introduction of mandatory reporting in October 2006 must
have made a material difference to the completeness of data concerning the prevalence
and incidence of C. difficile from time to time?
Yes, I would expect so and this is mentioned in the report
14. Would you accept that this can make statistical analysis using data for a period which
includes time before October 2006 and time after it very difficult?
Yes, again in the report
Also it is not just the mandatory reporting which is an issue but the data throughout the hospital in
the period Jan 2007 to June 2008 has been looked at in a great deal of detail and the data prior to
this period has not been.
15. Is this what you are referring to in the executive summary at 11 when you observe as
follows:
Yes and also expanded in the last few paragraphs of the Appendix
16. At any rate, can you explain what you mean in that passage by “severe difficulties of
interpretation”?
There are alternative explanations which might be postulated for the different rates and it is not
possible to separate these out using an analysis of the data available.
One interpretation is that the high rate in Jan-June 2007 is a result of mandatory reporting
Another is that the trend is the impact of mandatory reporting
One thing which is clear is that the seasonal effects (spring, summer, autumn, winter) in the period
2003-2006 are not great and the differences between Jan-June 2007. July-Nov, 2007 and Dec
2007-June 2008 are greater that would have been expected by seasonal differences, unless the
impact of mandatory reporting had a greater effect in winter and spring than in summer and
autumn.
17. Can you explain how these difficulties operated in the statistical work you carried out?
There was no comparator data to look at the trends in more detail as this was not part of the remit
of the inquiry (as explained to me). One way to shed light on the potential impact of mandatory
reporting would be to take similar data from a variety of hospitals and look at the trends in new
diagnoses of C. difficile over time. The comparison would enable an estimation of the effect of
mandatory reporting in these hospitals and hence aid the interpretation of the data for the Vale of
Leven.
This comparison is not without difficulties also such as comparability of data and an assumption
that the effect of mandatory reporting is the same in all hospitals.
18. Might these difficulties apply to the work you refer to at 0284003 where you say “A
lower mean is used in Figure 1 I, where the centre line is based upon historical data from
2003 to 2006, and there are 7 weeks with a signal. This lower mean is based upon data
discussed in the Appendix which was gathered as part of a police investigation into the
number of cases of C. difficile at the Vale of Leven, using data from the Vale of Leven's
Infection Control Team's Access database, if these data are a true record of all patients
newly diagnosed with C. difficile during the period 2003 to 2006 then they can be used to
estimate an historical average. For the periods December to June each year from 2003 to
2006 the average number of new patients diagnosed with C. difficile was 0.504 which is
much lower than the 1.69 episodes per week in 2007”?
Yes. The aim of this control chart section was simply to see if there would have been a
mechanism for detecting an excess number of cases as mentioned in the report
The aim is to see if or when there would have been statistical evidence suggesting that there were
an exceptionally large number of C. difficile cases in any of the hospital wards.
19. It may be self-evident, but can we confirm that you were not able to analyse the
demographics of those patients in the period January 2007 until June 2008 who were never
tested for clostridium difficile with the demographics of those patients who were tested?
Yes – I had no data of patients who did not test positive for C.difficile.
20. Can you say what is the number of patients in the period January 2007 until June 2008
who were never tested for clostridium difficile?
No – I have data on 512 patients who were tested at least once. 130 tested positive at least once
and 382 always tested negative. Knowing the number of unique patients in the hospital over the
period would give the number never tested.
21. Would you agree that even where it is improbable that different rates of c.difficile
infection between wards were the product of natural variation, the difference may be
explicable by different patterns between wards of prescribing of antibiotics?
There are many possible explanations that I was not able to investigate – age, co-morbidities and
frailty of the patient among them. Certain types of anti-microbial prescribing may be an
explanation though this would need to be in the period prior to the diagnosis of C Difficile.
22. Would you agree that even where it is improbable that different rates of c.difficile
infection between wards were the product of natural variation, the difference may be
explicable by there being more pressure on isolation facilities in some wards than others?
As for 21, it would be speculation on my part to agree. If it was possible to identify for each ward
and for each day if there was pressure on isolation facilities then it would be possible to adjust for
this in the modelling.
23. We see mortality rate statistics in your report at EXP02840019-20. Are we correct to
understand that you did not use a fixed mortality period for this calculation?
The tables did not use a fixed period. The first data was supplied to me in April 2011, nearly 3
years after the last case. The last reported death was 2.6 years after first diagnosis. The cox
analysis censored follow up at one year so deaths after this time were not counted. Using various
censoring times down to 90 days yielded no changes to the interpretation of ward differences and
period changes. I chose to report all deaths rather than those within a fixed period as the time
period from final diagnosis to analysis was nearly 3 years and 75% of deaths occurred within 2
months of first diagnosis.
24. Do you agree that it would be possible to use the data you had to do a 30 day allcauses mortality study?
Yes – I had done so – see below. The conclusions were unchanged using 30 days, 90 days, 1
year. The shorter the cut off period the more deaths which are not used in the analysis and so
there is a balance between the number of deaths used and the cut off period. In the review of
whether or not C. difficile was a contributory cause by Prof Griffin there were 31 patients identified
and for 8 of then the survival time was greater than 30 days with a maximum of 7 months so using
only 30 days potentially misses deaths.
Ward Total
3
20
4
5
5
9
6
33
14
17
15
11
F
16
Fruin
2
HDU
4
MAU
Total 117
Ward of Diagnosis
Dead PointEst Lower
9
45.00 23.06
2
40.00 5.27
1
11.11 0.28
13
39.39 22.91
6
35.29 14.21
6
54.55 23.38
6
35.29 14.21
1
50.00 1.26
1
25.00 0.63
45
Ward Sample Collected From
Upper Total Dead PointEst Lower Upper
68.47
19
8
42.11 20.25 66.50
85.34
6
2
33.33 4.33 77.72
48.25
7
1
14.29 0.36 57.87
57.86
31
12
38.71 21.85 57.81
61.67
17
7
41.18 18.44 67.08
83.25
11
6
54.55 23.38 83.25
61.67
17
5
29.41 10.31 55.96
98.74
2
1
50.00 1.26 98.74
80.59
3
1
33.33 0.84 90.57
5
2
40.00 5.27 85.34
38.46 30.15 47.51 118
45
38.14 29.88 47.14
Total
Jan-Jun 2007
Jul-Nov 2007
Dec-Jun 2008
Dead
53
19
58
PointEst Lower
Upper
18
33.96
21.52
48.27
5
26.32
9.15
51.20
24
41.38
28.60
55.07
25. If you had done such a study, and wished to use it for comparative purposes, you
would have to make adjustments at least for sex, age, and co-morbidities?
Adjustment for age and sex was done in the analysis. Lack of co-morbidity information is a
weakness of the analysis in this report
26. You may be aware that in 2008 HPS published a report commenting on various data,
including mortality statistics?
Yes.
27. It would appear to be suggested in that report (Appendix 3 to the HPS report (at
HPS01570049) that in a mortality rate study the patient demographics for which there
should be an adjustment include the following:
Would you agree with that?
I believe that this is for the comparison of hospitals in the national data review. Total antibiotic
consumption in the hospital is not valid here though there might be an argument for using total
consumption by ward if available. If I had data on co-morbidities and deprivation I would have
used it also. The main conclusion from the analysis I did is that there are no great differences
between the wards and period in the hazard of dying among patients who had a diagnosis of C.
difficile. For the conclusions of this analysis to be invalid we would need to have comorbidity and
deprivation to vary markedly across the wards. It is unlikely that deprivation varies markedly over
the wards as the patients for all the wards come from the same catchment area. Co morbidity
might but is likely related to age.
28. Can we take it that your finding (7) (that there is no statistical evidence that the death
rate among c.difficile patients varies significantly over the 9 wards) means that it is
impossible to conclude from the data you used that there was a different standard of care
provided between wards for those patients who had contracted c.difficile?
Even if there was a difference you would not be able to conclude that the difference was
associated with the standard of care. The analysis I did does not shed any light on standard of
care
29. Can you confirm that you were unable to undertake a comparative analysis of the
demographics of those patients who contracted c. difficile and died the demographics of
those patients who contracted c. difficile and survived?
No, there was an adjustment based upon age and gender and neither influenced mortality rates
among those who had C difficile significantly. There is a trend for a greater hazard of dying with
increasing age, as you would expect. Gender had no influence
I interpreted the task to looking at evidence for differences between wards and periods adjusting
for the effects of age and gender and so reporting of age and gender differences was not required.
Looking at things the other way round and comparing the age and sex distribution in those who
had C difficile and died within 1 year compared to those who had C difficile and did not die within 1
year shows that those who died were older on average (median = 73 for those who did not die and
median = 84 for those who did die). There was no association with gender.
Questions on behalf of patients and families for Professor Chris Robertson
1. Your report (EXP02840001) is a statistical analysis of data supplied by the Vale of
Leven Inquiry team. Core participants were advised on Thursday 10 May 2012 at 16.50 (a)
that the Memory Stick Data referred to in the Appendix is data from the IC Access Database
and (b) that other data referred to earlier in your report “is based on the Inquiry timeline
information”. Core participants were advised, as is the case, that various timeline charts
are available on Lextranet and in hard copy. In the body of your report [at page 5] you make
reference to an Excel Spreadsheet prepared by the Vale of Leven Inquiry team containing
data taken from “hospital notes”. You state that data was received as “a long flat file.
(a)
What do you mean by “hospital notes”?
I only analysed data passed on to me by the Vale of Leven Hospital Inquiry Team. I was informed
that these data came from the patient records and hospital records which I have called hospital
notes as they were notes collected from the hospital
(b)
Are you referring to patient records?
Yes, I believe so. It is a combination of data available on the patients as well as data available
about the wards.
(c)
Are you referring to records kept by ICNs such as T-cards?
This would need to be established with the Vale of Leven Hospital Inquiry Team
(d)
Are you referring to other records, and if so, what type(s)?
This would need to be established with the Vale of Leven Inquiry Team
(e)
Are the “Excel Spreadsheet” and the “long flat file” the same thing?
Yes. I used the long flat file as a means of describing the organisation of the data passed to me
with everything in one file. An alternative would be to have a file for diagnoses, another one for
Deaths and so on linked by a unique patient identifier.
(f) Can we take it that it was not your idea to present the data in the form of “Event
Types”?
Yes – The structure of the data was decided before I was involved.
2. For each “Event Type” there is a count. Can you explain, using “ADMISSION” and
“BEDS”, how the counts of 269 and 4041 were arrived at?
These are simply a count of the number of different data records passed onto me. There were
269 records classed as a patient admission which give details of the dates and wards of
admissions of the patients who tested positive for C. difficile. I was always concerned that these
data may not be complete, i.e. there are some admissions not recorded, but had no way to check
this.
The beds data gives the total number of beds available on a particular day and the total number
occupied in a ward. These data would come from hospital notes as opposed to patient records.
3. What, for the purposes of the count under Event Type “DIAGNOSIS”, qualifies as a
positive diagnosis of C. diff ?
This was decided by the Vale of Leven Inquiry Team. From the records I have it is a lab reporting
a sample as positive for C. difficile to a ward. There is no source recorded for these data.
4. In particular, does the count include any entry in any “hospital record” that makes
reference to the words “C. diff positive” or some equivalent expression such as “CDT
+ve”?
This would need to be clarified with the Vale of Leven Hospital Inquiry Team
5. What for the purposes of your analysis, is the significance of the count number under
those event types upon which your analysis is based?
It shows the amount of data available to me in the categories previously decided by the Vale of
Leven Hospital Inquiry Team
6. On page 7 of your report, you refer to “Ward Occupancy Data”. Was that data
contained in the long flat file?
Yes
7. Do you know the original source of the ward occupancy data? [If the data used by you
is on Lextranet, it would be helpful if you could provide a reference number or numbers.]
There are 501 references to the source of the data. These all begin GGC242 followed by 5 digits.
8. Why under the head “New Infections and repeat infections” [page 7 of your report] did
you choose to use a time interval of 28 days?
I consulted with a colleague at HPS, Camilla Wiuff, on the convention used there on the definition
of a potential new episode of infection as opposed to a continuation of a previous infection. This
definition is used in the HPS Report on Review of Clostridium difficile Associated Disease Cases
and Mortality in all Acute Hospitals in Scotland from December 2007 ─ May 2008, published in
July 2008.
9.
Were you asked to use that time interval and if so by whom?
I was not asked to use this interval by anyone
10. Do you know whether that interval is wholly artificial or has some support in the
literature on the pathology of C. diff infection?
I believe it is a convention. It is certainly easy to investigate the sensitivity of the conclusions to
this assumption. There would be no impact on anything which is based upon an analysis of
patients as the date of first diagnosis was used.
If the interval was reduced, to 14 days for example, then the impact would be that there were more
subsequent diagnoses (65 compared to 25 with 28 days) and a smaller number of continuation
tests (59 compared to 99 with 28 days. The impact would be in the sections dealing with new
diagnoses, pages 10-19 and 22-26 where the number of new diagnoses would increase. The
ward comparisons would be relatively unaffected as the increased number of new diagnoses is
spread proportionately over all the wards.
11. For the purposes of your report, did you take as the date of a positive test (a) the date
of collection of the sample (b) the date on which the result was notified to the ICN or the
ward by the laboratory or (c) some other date?
For most of the analysis I used the date the report was notified to the ward as that represents the
time the ward had confirmation of C. difficile. In some analyses I used the date at which the
sample was collected
12. For the duration of the infection, you assumed a period of 7 days following
discussions with the Vale of Leven Inquiry team and infection control experts engaged by
the Inquiry. Can we take it that the data supplied did not include data on how long
individual patients were in fact symptomatic due to C diff infection?
There was some data on symptoms (Event Type – Symptomatic) but this only contained data for
60 of the patients – mostly those diagnosed in the period Dec 2007 – June 2008. Furthermore
these data seldom gave duration of symptoms. Mostly it was a note that the patient was
symptomatic on a particular day and so was not suitable for the analysis
13. In the main, do you use regression analysis?
Yes – or a variant of it
14. In essence, does regression analysis seek to establish whether there is a correlation
between phenomena e.g. examination scores and hours spent studying?
Yes – this is not a causal analysis and seeks to estimate the magnitude to the association
15. Does such an analysis assume that variable x (hours spent studying) comes first and
is considered independent whilst variable y (examination scores) comes second and is
dependent on x? In other words, knowing x will allow prediction of y or by changing x then
y is changed
It is not absolutely essential that the x variable precedes the y variable, for example you can use
height and weight recorded at the same time. Often regression models are used for prediction
and then the x variable will precede y.
16. Your report contains many references to “p” values. Can you explain what they are
and their significance?
A statistical significance test comparing proportions in two groups starts with the assumption that
two proportions are equal and the p value is the probability of obtaining the observed difference in
proportions in the data or a more extreme difference. The p-values lie between 0 and 1. If the p
value is very small then this is taken as evidence that the initial hypothesis of equality of
proportions is not supported by the data as an unlikely event has occurred. If the p value is large
then the data do not provide evidence to reject the initial hypothesis
If the p value is large this does not mean that there are no differences in the proportions.
Differences can exist but the study is not large enough to detect them. Correspondingly even if
there is no difference between the proportions a small p-value can be obtained by chance.
The main issue in the analysis in my report is that the comparison of the proportions and rates
over the wards is an analysis which does not have a great deal of power. The power of a test is
the probability the test will give a significant result (p-value < 0.05) given that differences in
proportions of a specified magnitude exist. For example, with one ward with 33 patients and
another with 20 the power to detect a difference in proportion from 0.6 to 0.7 is 0.10. To have a
high power in excess of 0.90 then the differences would need to be 0.6 to 0.97, i.e. only very large
differences can be detected with the small (from a statistical perspective) numbers of patients with
C. difficile per ward.
17. What is “funnel plotting”?
This is a method of presenting data, usually on rates or proportions, taking into account the natural
variability in the data. In the report I use a funnel plot to compare the rates of new diagnoses per
1000 occupied bed days over the wards. The wards are of different sizes and using the bed days
corrects for this imbalance. The variability of the rate is inversely related to the size of the ward
which means that in small wards the rate is estimated imprecisely relative to the rate in a large
ward. The curved lines in the funnel plot represent this variability (imprecision).
18. Did the data supplied to you demonstrate (a) that in a hospital with around 138 beds
there were 60 patients with a diagnosis of a new infection of C.diff between 1 Dec 2007 and
30 June 2008; (b) that 40 (67%) of these patient died; (c) that 31 (around 50% ) were deaths
associated with C. diff and (d) that 50% of the deaths occurred within 17 days of diagnosis?
There were 58 patients with a first diagnosis of a new infection reported in that period.
There were 60 patients with a diagnosis of a new infection reported in that period
40 of the 60 patients died up to April 2011. 38 died within 1 year of first diagnosis; 25 died within
30 days of first diagnosis and 22 died within 17 days (55% of those who died by April 2011)
Deaths associated with C. Difficile are in the report by Professor G Griffin – 31 of the patients who
died were assessed as C. difficile infection as a cause of death or contributory factor to death.
19. Does figure 12 on p27 of your report (EXP02840001) show that there may have been 8
patients in the Vale of Leven Hospital with C. diff infection at the same time in late April
2007, 6 patients at the same time in January 2008 and 5 patients in May 2008?
There may have been. The quality of the data available to me is not sufficiently high to be more
certain about this. Also this Figure on page 27 is sensitive to the assumption that a person who
has C. difficile has it for 7 days. If you reduce this to 3 days then there are 3 days when there may
have been more than 5 patients with C. difficile in the hospital – 17, 18, 19 April, 2007.
20. From your analysis of data relating to deaths amongst C. diff patients, do we take it
that there is no evidence that the “hazards of dying” were greater in any particular ward
during the relevant period (Jan 07 to Jun 08)?
Insofar as the analysis goes there is no evidence that the hazards of dying are different in the
different wards. However this did not take into account factors which might be associated with
death, such a co-morbidity, which might vary across the wards.
21. Are we correct in understanding that your analysis does not consider the relative risk
of dying (based on mortality rates) comparing Vale of Leven Hospital with, for example,
other acute hospitals in NHS GGC or throughout Scotland?
Yes – the only data I looked as was within the Vale of Leven Hospital.
22. One of your conclusions is that there is no evidence that mortality from CDAD was
higher in any particular ward in the period 1 Dec 07 to 30 Jun 08. Are we correct in
understanding that you carried out no analysis to determine whether mortality from CDAD
in that period was considerably higher compared to earlier periods?
That is correct. The only information I had about the possible association of the cause of death
with the C. difficile infection came from the report by Professor G Griffin and this only covered the
period Dec 01, 2007 to June 30, 2008.
23. In other words, is it correct to say that you carried out no statistical analysis to
investigate the temporal pattern of mortality from CDAD?
Yes
24. Is it correct to say that the quality of the data is a concern to you?
Yes. It was a concern to me that there were a great deal of typographical errors in the data
passed to me and this required a great deal of work to overcome. It is entirely possible that I have
missed some corrections.
The patient records may also be incomplete or contain inaccuracies. All of the records about
diagnosis and death have a date but there are instances where the ward the sample was collected
from or the result reported to are not known. With a great deal of investigation it might have been
possible to go through the records and correct this by considering the records on admission,
transfer and patient movement to try and establish where the patient was on a particular date.
There are also inconsistencies in these records also. Consequently I decided, in conjunction with
the Vale of Leven Inquiry Team, to analyse the data as reported, having corrected typographical
errors.
25. If there is a lack of certainty in the data that hinders reliable analysis and the data is
information that ought to be part of the patient record, does that indicate that the patients’
records were, in many instances, not properly kept?
I would not comment on this as I do not know the information which should be in the patient
record. In the course of my work I have analysed data from other hospitals using data taken from
patient records and have experienced similar issues with data.
26. If the data quality is a concern to you and the state of knowledge about the pathology
of C. diff is currently incomplete and, for these reasons, it is necessary to resort to
imputation and assumption as you do in your report, do you think much weight can be
attached to the results of the analysis?
The only imputation that I did was to impute the bed occupancy data for days when it was not
available. In the 8 wards with occupancy data imputation was used on 10% of days and this was
principally in the period Jul-Nov 2007. Imputation does not have a great deal of impact on the
conclusions and is only used for Figures 4-8 in the report.
I believe that the analysis is the main body of the report is reasonably robust to the assumptions
for the comparison of wards and periods. The main problems are on pages 26-28 and the
appendix and these are the two weakest parts of the analysis I carried out.
27. You are employed by HPS, one of the core participants. Prior to being instructed to
prepare this report did you have any involvement in the investigation of events at VOLH in
2007/2008?
I am employed by Strathclyde University, though HPS contribute to my salary through a
collaborative agreement with the university and I work at HPS 2 days per week. I was very
surprised to be asked to do this work as I thought that there would be a conflict of interest however
HPS were consulted by the Vale of Leven Inquiry Team and no conflict was identified.
In the analysis I only consulted colleagues at HPS to establish information of the 28 day period for
a new infection. Frankly I would have valued the ability to consult with colleagues in this analysis
but did not do so.
I was not involved in any investigation of the outbreak at VOLH in 2007/08. Undoubtedly I would
have given statistical advice if asked but do not recall any specific instances. I was involved in the
preparation of the HPS report in 2008 through advice and supervision of the study statistician, Dr
G Allardice.
I have not been actively involved in the submission of any materials to the Inquiry by HPS.
However, on 16th May 2012 was asked by HPS to help prepare their response to questions for the
Inquiry and have done so.
28. When setting up a local surveillance database for HAI (such as C.diff) do you think the
involvement of a statistician such as yourself would be desirable to ensure that relevant
data is included in an appropriate format?
Yes, but not only a statistician.