1 Wednesday, 22 February 2012
2 (10.00 am)
3 MR CHARLES KINLOCH (continued)
4 Examination by MR MACAULAY (continued)
5 MR MACAULAY: Good morning, my Lord.
6 Good morning, Mr Kinloch.
7 A. Good morning.
8 Q. Yesterday, you gave some evidence on how specimens would
9 be dealt with when they arrived at the reception area of
10 the laboratory, and clearly we are interested here in
11 faecal specimens that were being sent there for C. diff
12 testing.
13 I think yesterday you indicated that the reception
14 would not be available on Sunday because the laboratory
15 would be shut; is that correct?
16 A. Yes.
17 Q. Similarly, on Saturday, the reception would only be
18 available for a period on Saturday morning?
19 A. Yes.
20 Q. So I can be clear, that would be up to 11 o'clock in the
21 morning; is that right?
22 A. 12.30.
23 Q. When the stool sample arrived at reception, again
24 I think you mentioned yesterday that it would be
25 accompanied with a request form?
1
1 A. Yes.
2 Q. The request form, which was in two parts, would be
3 separated at the reception?
4 A. Yes.
5 Q. The front copy would be kept at reception; is that
6 correct?
7 A. Yes.
8 Q. And the back copy would go with the specimen to the
9 laboratory?
10 A. Yes.
11 Q. Can I just understand, then, how the top copy is dealt
12 with at reception? I think I understood from you
13 yesterday that the information, or some of
14 the information, on the top copy would be input into the
15 LIM system?
16 A. Yes, the top copy is placed in a box to enter the
17 patient demographics and the test request by the
18 MLA staff and specimen reception.
19 Q. The bits of the request form are separated?
20 A. Yes.
21 Q. The top copy is not there and then dealt with, but it is
22 put into a box?
23 A. Yes.
24 Q. I'm interested in this, whether the date on the
25 microbiology report that would ultimately be produced,
2
1 the date of receipt, would reflect the actual date of
2 receipt at reception?
3 A. It would almost always reflect the date of receipt, yes.
4 Q. Would there be occasions when it would not?
5 A. Yes.
6 Q. That is just what I want to explore with you. I think
7 this is something you touch upon in your supplementary
8 statement that you have given to the Inquiry: how could
9 it be that the actual date of receipt would not then be
10 on the report?
11 A. The date of receipt that is put into the LIM system is
12 the default date that the computer generates. The
13 possibility that, if the specimen was not entered into
14 the LIMS on that day but the next day, it would appear
15 to be received a day after the date it was received.
16 Q. How could the situation arise that the top copy would
17 not be dealt with until the following day?
18 A. The specimen reception was a multidisciplinary specimen
19 reception. We shared it with biochemistry and
20 haematology. The haematology and biochemistry took
21 priority over microbiology to enter the patients' data
22 and their test requests. This is because their
23 analysers had to be -- had to have the patients'
24 demographics for it to work.
25 Q. So, as you have explained, the top copy would be put in
3
1 a box. Would it be in that box with other request forms
2 that had been sent to the laboratory?
3 A. The box of discipline-specific areas.
4 Q. I see. So would the boxes that represented the other
5 disciplines, then, as you have indicated, take priority
6 over the faecal sampling?
7 A. On the first day, yes.
8 Q. Would there be particular days of the week when this
9 could occur?
10 A. Yes, Monday.
11 Q. It may be obvious, but can you explain why that would be
12 a problem on the Monday?
13 A. Possibly the build-up of specimens from over the
14 weekend.
15 Q. Were you aware, then, that a date was being put into the
16 system for the date of receipt which did not truly
17 reflect the actual date of receipt?
18 A. I was aware that on occasion that did happen, yes.
19 Q. Was it something that you had raised with the people
20 involved in that part of the operation?
21 A. It was discussed, yes, but I accepted that, because the
22 actual test took longer than three days to process,
23 a day's delay would not affect the outcome of the test.
24 Q. Sorry -- yes. Are you talking here about the C. diff
25 test?
4
1 A. No, I'm talking about the enteric pathogen testing.
2 Q. So far as the C. diff test was concerned, I think you
3 told us yesterday you would expect a turnaround on the
4 same day as the sample was received?
5 A. Yes.
6 Q. Do you accept that to have a report produced that
7 indicates a particular date of receipt which is not
8 correct is somewhat misleading?
9 A. Yes.
10 Q. If we look at your supplementary statement, and we have
11 that at WTS02170001, and if we turn to page 7 of
12 the statement, you are looking here at a laboratory
13 request -- this is at paragraph 35 -- that you have been
14 referred to for one of the patients, Mrs Chandayly.
15 What you say is:
16 "I note that the specimen is recorded as being taken
17 from the patient on 20 April at 0500 (a Sunday).
18 According to the resulting laboratory report, the
19 specimen was not received by the lab until 21 April."
20 You say:
21 "This specimen will only have been received by the
22 lab on the Monday when the lab was open again. The top
23 copy of the lab request form would go into the box in
24 the specimen reception to be 'test requested' and the
25 patient demographics entered on the system by specimen
5
1 reception. In that box there will also be request forms
2 for biochemistry and haematology."
3 Just on that, I understood you a moment ago to say
4 there would be separate boxes, in fact?
5 A. No, it was the same box with separate dividers.
6 Q. I see. You go on to say:
7 "There would be a lot of forms to be processed on
8 a Monday following a build-up over the weekend. I had
9 also agreed that biochemistry and haematology forms
10 could be processed first at specimen reception as those
11 departments needed the patient demographics to be put on
12 the system so that they could carry out their work."
13 Moving on to paragraph 36:
14 "With regard to the date of receipt entered on
15 Ms Chandayly's laboratory report, that is the default
16 time and date given on the LIM system. This default can
17 be changed on the system but tended not to be.
18 Therefore, this entry would reflect the time and date
19 that the specimen was entered on to the LIM system and
20 not the time and date of actual arrival at specimen
21 reception or when it was received by the lab on the
22 first floor."
23 I think the point on that particular case was that
24 there was an entry in the nursing notes which recorded
25 notification of the actual positive result on 21 April,
6
1 which didn't seem to coincide with what was on the
2 report; is that right?
3 A. Yes.
4 Q. So this was your explanation as to how it came to be, in
5 this particular case, that there was this discrepancy?
6 A. Yes.
7 Q. Was there any system of date stamping the request forms
8 when they came to reception?
9 A. No.
10 Q. Did that remain the position --
11 A. No.
12 Q. What happened after June 2008?
13 A. The actual time and date was recorded in a book until
14 the scanner system was inputted into the lab, which was
15 around June, I believe, where the forms were scanned
16 after they had been -- the specimen and form had been
17 brought into the lab.
18 Q. Just so I can understand that, do you think, first of
19 all, that this change in the procedure happened in
20 about June 2008?
21 A. No, it actually happened after the accreditation visit,
22 because that was one of the non-compliances.
23 Q. I think the accreditation visit that we have seen
24 reference to was in September 2007.
25 A. Yes.
7
1 Q. So sometime after that?
2 A. Sometime after that.
3 Q. Was it in response to that that that happened?
4 A. Yes.
5 Q. Had it happened, had that change to the process
6 happened, before June 2008?
7 A. Yes.
8 Q. Are you able to assist us when that did happen?
9 A. No.
10 Q. Just so I understand the change, then, the change was
11 that the actual time and date would be recorded in
12 a book held at reception; is that correct?
13 A. Yes.
14 Q. Until the request form was being dealt with?
15 A. No.
16 Q. You put the date and time in the book at the reception.
17 What then happens to the request form and the specimen?
18 A. What happens is, the specimen comes into the specimen
19 reception --
20 Q. Can you bring the microphone a bit closer to you,
21 please.
22 A. The specimen comes into specimen reception. The
23 specimen and the form are matched together. A number is
24 put on the specimen, a laboratory number is put on the
25 specimen and put on the form. They were pre-printed
8
1 numbers. Then there were extra numbers on the row.
2 A number was put into a book, and against that book --
3 against that number, a time and date was recorded.
4 Q. Was this then in response to the inspectors focusing
5 upon the problem that we have been discussing up until
6 now?
7 A. Yes.
8 Q. Just to be clear as to what happened before the change
9 in the procedure, then --
10 MR PEOPLES: My Lord, before we go on, can Mr Kinloch advise
11 us whether this book would still be available? Because
12 if it related to the relevant period and gave the actual
13 time and date of receipt, it might be the best evidence
14 of when that happened.
15 A. I cannot.
16 LORD MACLEAN: You don't know?
17 A. I don't know.
18 MR MACAULAY: Nor do you know when the change in the
19 procedure took place, but I think you are saying, are
20 you, that the change did take place before June 2008?
21 A. Yes.
22 DAME ELISH: Sorry, my Lord, I had understood that at one
23 stage they moved to a scanner system and that this was
24 an interim measure until the scanner was introduced. Do
25 we have any indication as to when the scanner, the
9
1 automated system was introduced? That might be helpful.
2 LORD MACLEAN: Do you know that?
3 A. I would guess it would be June 2008.
4 LORD MACLEAN: What, the scanner?
5 A. The scanner was introduced. But I'm not entirely sure.
6 MR MACAULAY: I just now want to be absolutely clear, then,
7 as to what information would be input at reception and
8 taken from the top copy of the request form. So if we
9 look at one of the request forms we looked at yesterday,
10 it is at GGC23460059. I think this is the top copy for
11 Mrs Thompson's request form. You mentioned the input of
12 the demographics, and I think you meant by that the name
13 of the patient and the date of birth; is that correct?
14 A. The method for entering demographics is actually into
15 the CHI number. This brings up the patient on the
16 screen if they have previous records.
17 Q. Just to be clear about that, what you call the CHI
18 number, we can see that, "CHI", and the number after
19 that?
20 A. Yes.
21 Q. So you put that in and that brings up the patient's --
22 A. It brings up the patient's demographics. So that is
23 entered, the lab number is entered, which is on the
24 right-hand top corner.
25 Q. Is that the E number, is it?
10
1 A. The E number, that's the lab number. The "E" indicates
2 that it's an enteric specimen. Then the test request is
3 entered -- sorry, the source is entered after the
4 patient's demographics.
5 Q. You mean the source, the ward number?
6 A. The ward and the requester. The specimen number is
7 entered, then the test request is entered. The "S" on
8 that form is the state of the stool. That means the
9 stool was soft. "FC" is "faecal culture group" and the
10 "ICDT" is "Clostridium difficile test".
11 Q. What about the date and time of specimen, then? Is that
12 entered into the system?
13 A. No.
14 Q. If we look at --
15 A. Sorry, sorry, yes. Sorry, I'm getting date of specimen,
16 date received confused. The date of specimen taken is
17 entered into the system.
18 Q. If you look at --
19 A. Then there's a date received.
20 MR PEOPLES: My Lord, before we go on, could the witness
21 just simply indicate what "ICDT" stands for?
22 A. "Investigation C. difficile toxin" and "FC" means
23 "faecal culture".
24 MR MACAULAY: If we look at the lab report that was
25 generated following upon this test, that's at
11
1 GGC00540078, we can see here that this relates to
2 Mrs Thompson, that it is a positive result.
3 A. Yes.
4 Q. It is addressed to ward 6. Do I take it that is because
5 the person inputting the information at reception has
6 inputted ward 6?
7 A. Yes.
8 Q. We see Dr McCruden's name -- perhaps we can have the
9 request form next to the report, GGC23460059.
10 If we go back to the lab report, we see
11 Dr McCruden's name, as we see also on the request form,
12 and then, focusing on the dates, we see on the report
13 the date collected is the 16th. If we go back to the
14 request form, can we see that that accords with the date
15 on the request form?
16 A. Yes.
17 Q. We then go back to the report. Can we see that the date
18 of receipt is 16 January as well?
19 A. Yes.
20 Q. Is that right? If the 16th was, in fact, a Wednesday,
21 then is it likely that the date of receipt that's been
22 entered would be the true date of receipt?
23 A. Yes.
24 Q. Then we see the date of the report, being 21 January.
25 Would that part of the document be input by the
12
1 scientist who dealt with the specimen?
2 A. No, it is automatically generated when the report is
3 printed.
4 Q. I see.
5 MR PEOPLES: My Lord, before we go on, if my learned friend
6 is finished, there is reference in the printed report to
7 a laboratory reference number ME454723C, which is not
8 the same as the reference on the request form. Why has
9 that changed?
10 A. It is actually the same. The "M" and the "C" are
11 a computer-generated code. If you actually look, it is
12 E454723, which is the same number that's on the request
13 form.
14 MR PEOPLES: Sorry, I put that badly. I probably wanted to
15 know why the "M" and the "C" had been added.
16 A. It is to do with the way the computer works, the way the
17 LIM system operates.
18 MR PEOPLES: Perhaps I could just ask one more question:
19 does it signify anything?
20 A. No.
21 LORD MACLEAN: Not at all?
22 A. No. The only part you need is the E454723 to process
23 the specimen.
24 LORD MACLEAN: The "M" and the "C" don't stand for anything?
25 A. "M" means microbiology.
13
1 LORD MACLEAN: There you are. There's a start. What about
2 "C"?
3 A. I think it is a random-generated letter. I don't know,
4 in other words.
5 LORD MACLEAN: You don't know, yes. A random-generated
6 letter.
7 MR MACAULAY: Thank you for that explanation. Can I just
8 leave that aside for the moment and look at one or two
9 other aspects of what happened at the laboratory. Can
10 I take you, first of all, to this document, INQ01560001.
11 We are looking at a document that is described as the
12 processing of faeces for Clostridium difficile. Was
13 this a document that you were familiar with?
14 A. Yes.
15 Q. Does this give information in relation to the collection
16 and the type of stools that might be suitable for
17 C. diff testing?
18 A. I believe so.
19 Q. If we turn, for example, to page 7 of the document, at
20 the section "Specimen collection", 2.1, "Optimal time of
21 specimen collection":
22 "As soon as possible after onset of symptoms."
23 Would that really be something directed towards the
24 nursing staff rather than the laboratory staff?
25 A. Yes.
14
1 Q. Did you keep a copy of this document in the laboratory?
2 A. Yes.
3 Q. At 2.2, can we read that information is given as to the
4 correct specimen type, and then we read:
5 "Formed stools are unsuitable for investigation for
6 C. difficile. These should be rejected with the
7 appropriate comment appended to the report."
8 Did that happen on occasion? Did you require to
9 reject the specimens?
10 A. If the specimen had been requested to be tested by the
11 medical staff and it was formed, the test would be
12 performed.
13 Q. So you wouldn't reject it?
14 A. No.
15 Q. You would do the test?
16 A. If I had been requested.
17 Q. If I can move on now to look at another document, this
18 is I think the lab manual, which you will find at
19 GGC24480001, can we see that this document's date of
20 issue is 31 August 2007, and it bears to be the
21 laboratory manual? Was this the laboratory manual for
22 2007 to 2008?
23 A. Yes.
24 Q. At page 7, for example, we can see we are given
25 information about the laboratory hours. Just to pick up
15
1 a point from this morning, you said that the Saturday
2 service was up to 12.30. According to the manual,
3 I think we are told that a limited service is available
4 between 9 o'clock and 12 noon. So was it, in fact,
5 until 12.30 that the service was available?
6 A. There was always a BMS in the laboratory until 12.30.
7 Q. If we turn to page 41 of the manual, can we see here
8 that under the heading -- this is 4.6.3 -- "Faeces",
9 that, for Clostridium difficile, information is given in
10 relation to how the specimen should be submitted, and
11 also it is indicated that a specific request must be
12 made for this examination; do you see that?
13 A. Yes.
14 Q. But in practice, could there be situations where the
15 test would be carried out without a specific examination
16 being carried out?
17 A. Yes.
18 Q. If we turn to GGC28020001 -- perhaps we can put the
19 first page on the projector. We are looking at
20 a document that's headed "Enteric procedures". The date
21 is 12 September 2007, and it is the Vale of Leven. Were
22 you aware of this document at the time?
23 A. Yes.
24 Q. Was a copy of this kept in the laboratory?
25 A. Yes.
16
1 Q. If we move on to the page I want to turn to, and that is
2 at page 16, at 6.3 there's a heading "Supplementary
3 tests", and we can read that for C. difficile toxin:
4 "Samples are tested for the presence of C. difficile
5 toxin in the following instances: