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QUESTION: Yeah, "Percentage of Red cell products issued", and we see there, with the exception of region J, which is apparently not offering any -- 7 ANSWER: Yes.
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QUESTION: -- the Northern Region is offering a modest amount indeed compared to -- ANSWER: 2 per cent.
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QUESTION: -- other Centres. ANSWER: Yes, region J was East Anglia for some reason. I don't know why they didn't use optimal additive.
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QUESTION: Then I'll come back to how things changed in due course, Dr Lloyd, but I'm just trying to get a sens e of what things were like in the first half of the ' 80s through to sort of 1986 or thereabouts. Sully, could we go back, then, to NHBT0101332_045. ANSWER: What page would you like to look at on that?...
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QUESTION: Page 8, please. ANSWER: Yes.
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QUESTION: In this report, Dr Lloyd, I'm saying this for the benefit of others, really, you give a snapshot of t he position in relation to the range of different products used. I'm not going to go through the det ail of it but I mention that so that others listening c an look as appropriate. But I just wanted t...
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QUESTION: I'm sorry, you froze again, Dr Lloyd. The last we got was you said, "for quite a period we were running along at around that"? ANSWER: Around about 5,000. So it stayed at about that lev el over quite a long period of time.
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QUESTION: If we go to the top of the next page or the first h alf of the next page, we can see it says: "This, however, hides an underlying trend. The major users were the haemophilia units at Newcastle and Middlesbrough. The use of cryo at the [Royal Victoria Infirmary] fell significantly in 1983 and 1984, pro...
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QUESTION: So, in relation to the procedure described in that paragraph I just read out, the completion of the illness sheet and then its use to identify unsuitab le donations, how did that work in practice? Who woul d identify them as unsuitable and what kind of information would lead to that conclusion? ANSWER...
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QUESTION: Then if we can go to page 9 of this document, I jus t want to ask you about another aspect of the Centre' s operations. So under the heading "Despatch": "Orders for blood and products are generally telephoned in to the Despatch department but there is also a 'milk run' of set journeys to a number of h...
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QUESTION: -- to what extent were you able to deal with the ad hoc orders for blood and products being telephoned in or did it give rise to shortages? ANSWER: The telephoned orders, requests for blood, didn't specifically give rise to shortages. The shortages were more of a structural issue with the way that t h...
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QUESTION: Sorry, Dr Lloyd, you froze again? ANSWER: -- throughout the day but also in the evenings -- y es.
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QUESTION: Not your fault at all. You were telling us that it was a structural issue with the way the Centre was -- how much the Centre was producing. ANSWER: Yes, and so whether there was enough blood to, you know, fulfil the regular orders on what's here ...
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QUESTION: Then the paragraph I read out relating to returned packs included the phrase in brackets "of which the re are many". ANSWER: Yes.
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QUESTION: Is that accurate, and why were there many? Was tha t a feature of people asking for more than they neede d? ANSWER: I'm not sure I can give you a definitive answer on that. There certainly were many. The amount of bl ood that was returned to the Centre unused was considerable. It dropped off later,...
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QUESTION: And I know, Dr Lloyd, that you weren't involved in the formal hepatitis C look-back that was initiated in 1995 because that coincided with your departure fro m the Centre. But we can see here a reference to the difficulties in tracing the fate of individual pack s. Prior to the -- this becoming a fully ...
45,916
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QUESTION: I'm sorry, Dr Lloyd, we lost a few seconds again. You said it could take you a couple of days to trace going back through the manual records? ANSWER: Yes, and it was difficult, it was slow, and obvious ly, as it says there, extremely laborious. But it was possible.
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QUESTION: Now, we saw from the beginning of this document tha t there'd been an inspection in 1987. This was 09 a routine re-inspection in '89. Do you have any id ea whether there had been inspections in the first hal f of the 80s, and if so, how f...
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QUESTION: You tell us in your statement, it's WITN6935001, page 11, so it'll be on your screen, Dr Lloyd. You tell us there -- ANSWER: Okay.
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QUESTION: -- about the introduction of the Blood Management Computer Network System. I'm not going to ask abou t the details of that because you very helpfully set it out in your report, and the Blood Donor Management System, and then the CDIC. 110 At the bottom of the page, you explain that you asked Birmingh...
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QUESTION: Now one of the -- ANSWER: And if you want to know more about it --
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QUESTION: No, I think that's fine, thank you. We can take th at down, thank you, Sully. Your statement tells us you made a number of organisational changes to the Centre as director. I'll pick up one in relation to donor services late r but there's just one I wanted to pick up now. That was the testing of donat...
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QUESTION: I'm sorry, Dr Lloyd, we lost you again. So we last had it when you said it gave you a lot of advantages, not only in the mechanics of running it, the training of staff ... ANSWER: And things I've already mentioned. So the quality control and the single authorisation of results bef ore they're transfe...
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QUESTION: Can I then ask you a little about the relationships that you had with other bodies and organisations. So first of all, relationship with your Regional Healt h Authority. How would you characterise the relationship that you had or, to your knowledge, yo ur predecessor had? ANSWER: I'll start with my p...
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QUESTION: Now, in terms of relations with other directors of Regional Transfusion Centres, you were present at w hat turned out to be the last Regional Transfusion Directors meeting in January 1989. It wasn't clear to me whether it was also your first meeting as a Regional Transfusion Director, I think it might...
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QUESTION: So your first last and meeting, and I won't display the minutes because we've looked at them on a numbe r of occasions but you'll recall, and you note it in your statement, it suggests that the decision to disband the meetings was unanimous. Your recollection -- ANSWER: Yes.
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QUESTION: -- I think, is different? ANSWER: Yes, recollection is always a tough thing. Sometim es you recall what you want to recall. But I do note the informal minutes of that meeting, I think, produced by Dr Ewa Brookes, which said that the announcement or the decision to end the meetings was met by univers a...
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QUESTION: I can hear you. ANSWER: I'm sure I wouldn't have stood up and said, "No, do n't do this" because, you know, I was -- (a) I wouldn't have got anywhere because everyone else seemed to b e okay with it and, yes, I was very junior, in terms of the number of years that all -- most of the others had ...
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QUESTION: We lost you a couple of times there, Dr Lloyd, but it was clear, I think, what you were saying. ANSWER: Okay.
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QUESTION: Dr Lloyd, your arrival as director largely coincided with the creation of the National Directorate. What was your experience of the Natio nal Directorate and its ability to coordinate or take decisions? ANSWER: Well, if you look at some of the documents that hav e been submitted in my correspondenc...
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QUESTION: That's quite all right a bit. I want to ask you to look at a document which was produced by you in March 1991, so approximately three years into the life of the National Directora te, NHBT0001864. So the document should be on your screens, Dr Lloyd. It's "Framework for a National 120 Directorate of th...
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QUESTION: Yes, we're on the right page but we need the bottom half of the page. Yes, so "The Authority for a National Directorate". 21 ANSWER: Oh okay.
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QUESTION: You say: "At present the National Directorate is officially working to a brief dating from 1998. Th at brief is out of date ..." Then skipping over a couple of lines: "It's long term role appears uncertain unless a clear role can be developed that fits with the current White Paper philosophy." Then y...
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QUESTION: No -- ANSWER: Just to say, I was just flying a kite.
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QUESTION: We know there was then a consultation on forming a National Blood Authority, and there's a response to that consultation by the Northern Region Blood Transfusion Service at DHSC0004584_039. If we go to the third page, under the heading "Introduction" picking it up in the third paragraph : "In essence t...
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QUESTION: And I understand from your statement that the establishment of the NBA in the form it ultimat ely took was a factor in you deciding to leave your pos t and move on to pastures new? ANSWER: I have to put it in context. When I became directo r I had said to myself, and I think I've written that in my w...
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QUESTION: Now I'm going to ask you next about the relationshi p with Haemophilia Centres. Just before I ask you about that from your perspective as director of the Regional Transfusion Centre, can I just come back to the short period of time you worked at the Haemophilia Centre during yo ur registrar years. Do yo...
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QUESTION: One of the documents in the 80s tell us -- tells us that the haemophilia patients in the Northern Regio n area were all managed from the Newcastle Centre rat her than their own more local unit. Do you have any knowledge as to why that was the case? ANSWER: I really don't, no. I mean, I know that there...
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QUESTION: Now I'm going to look in a moment at a letter that you wrote at the time of the HIV litigation, but before we do that, just in broad terms, as I understand the position, in relation to commercial concentrates, t he Regional Transfusion Service had nothing to do with the ordering or stocking or supply of...
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QUESTION: In relation to the NHS concentrates, the BPL products -- and we'll explore issues of plasma supp ly a little later on -- but, as I understand it, the Regional Transfusion Centre did have a role there, in the sense it received those products from BPL, and it supplied those products to the Haemophilia Cen...
45,940
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QUESTION: If we look then at the letter from the time of the HIV Litigation, TYWE0000064, please, Sully. If we go t o the second page, it's a letter from you to a Mr Sla ck of Crutes Solicitors, heading "HIV Litigation", you say: "Attached is a fairly brief set of answers to the questions put by you recently ......
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QUESTION: Yes and we well just look at that -- ANSWER: (Overspeaking) 132
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QUESTION: -- TYWE0000015_002. If we just zoom in on the text , please, Sully. It looks like it's 26 August 1983 but I'm not 100 per cent sure. ANSWER: Yes, that's what I thought.
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QUESTION: It's from Dr Collins. Thank you, Sully, I think that's right. It's from Dr Collins to Dr Jones: "Dear Peter "We have an embarrassingly large supply of BPL Factor VIII in stock. How about it?" It would appear from what you -- from what Dr Collins related to you, I think, and what you relate in this do...
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QUESTION: If we go to the next page of this document, just pi ck up an answer you gave to one of the questions. So it's TYWE0000064, and it'll be page 4, please, Sull y. So paragraph 5 says: "To what extent were there shortages of Factor VIII?" This, as I understand it, was part of your answer. "Factor VIII h...
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QUESTION: -- commercial concentrates rather than rebuilding t he transfusion centre? ANSWER: Okay, at the time I wrote that, I would have been fairly heavily influenced by comments made by my predecessor, Dr Anne Collins, because I wrote that before I was director, and I would have had -- I wouldn't have seen s...
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QUESTION: And I should say, I'm not going to go to it now, si r, but we do have a draft statement from Dr Collins produced I think, again, for the purposes of the HIV litigation. ANSWER: Yes.
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QUESTION: I won't take time with it now, but for the transcri pt it's TYWE0000022. I may come back to it in the cou rse of Dr Lloyd's evidence. But we do have Dr Collins' s input there. ANSWER: Yes. I have read that.
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QUESTION: There are a couple of comments that -- actually, 135 having said we won't look at that document, I'm goi ng to suggest that we do. Sorry, Sully, could we have TYWE0000022. So this is the draft statement from Dr Collins. I just want to pick up on what she says at pages 4 to 5 and then ask if you have any...
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QUESTION: I'll certainly come on to some of the charts that you've produced, Dr Lloyd, in the course of the 37 afternoon. Then if we just go to the next page, page 5, so still in Dr Collins's statement, picking it up in t he second paragraph she says...
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QUESTION: Now that's what Dr Collins was saying. Do you have any direct evidence or information of your own as to what might have been the preferen ce of Dr Jones for commercially produced Factor VIII product? Is it something you ever discussed with h im? ANSWER: I mean -- no, I don't think I discussed it with...
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QUESTION: And then just before we move more generally to issu es relating to plasma supply, whilst still on the topi c of haemophilia treatment, can I ask you to look at NHBT0078890_022. When it comes up, Dr Lloyd, you'll see it's a letter from you. So it's dated 13 November 1986. ANSWER: Yes.
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QUESTION: It's addressed to the parents of a boy with haemophilia. ANSWER: Mm-hm. 139
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QUESTION: And it refers to the possibility of collecting plas ma from the parents to provide cryoprecipitate for treating their son. Now I'm not going to ask you anything about the individual family concerned, but just as a broad topic, this idea of what I think you refer to in yo ur statement as "family-specifi...
45,954
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QUESTION: Do you know whether what had triggered this possibl e arrangement was concern about viral infection, or whether it was unrelated to that issue? ANSWER: No, I don't know. I didn't deal with the parents, and certainly, you know, it was Dr Jones who worked wit h the parents to get a suitable means of tre...
45,955
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QUESTION: Thank you. We can take that down, Sully. I'm going to ask you now to look at three documents, all of which, I'm afraid, predate your t ime as director, but they're three short documents relating to issues of plasma supply and meeting targets, and so on. Then I want to ask you about s ome observations ...
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QUESTION: It says this: "Your letter dated 10 August 1984 on this subject was discussed by the Regional Health Author ity at its recent meeting when commitment to achieving the target for this Region was reaffirmed but only a qualified assurance with regard to timing could b e given in the light of additional ca...
45,957
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QUESTION: Then I'll just pick up two other documents, they're not, I think, the one you're referring to, but I'll try and find the reference to that later. So the second is a letter from Dr Collins to the DHSS, May '85, DHSC0002269_021, so 1 May 1985, head ed "Plasma Procurement for BPL": "I am sorry for my late re...
45,958
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QUESTION: Then I think we see that perhaps most starkly in th e 144 third letter I wanted to ask you to look at briefly , it's TYWE0000051_004. It's almost illegible but I' m going to read it out. It's Dr Collins to Dr -- ANSWER: Dr Jobling.
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QUESTION: -- Jobling, a pathologist -- ANSWER: Jobling.
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QUESTION: -- at the Preston Hospital, and it's December, 9 December 1985, I think. ANSWER: Yes.
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QUESTION: She says: "I must point out that the Regional Health Authority does not fund this service to be self-sufficient in plasma products." Then she says: "However -- there has been recently a shortfall in supplies of processed material from BPL, and we will now be able to let you have a small additional num...
45,962
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QUESTION: So those letters really then lead, I think, to some observations you make in your witness statement, Dr Lloyd. So if we could have on screen, please, 45 Sully WITN6935001, and we go to page 39. So paragraph 29 says "Barriers to achieving p...
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QUESTION: Then "The Centre's belief that a large proportion o f whole blood was required by the hospitals it supplied", is the second bullet point. ANSWER: Mm-hm.
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QUESTION: Does that take us back to the issue you referred to earlier about the very substantial proportion of bl ood or -- or products being supplied in the form of who le blood rather than, for example, the use of the red cells and SAG-M? ANSWER: Yes, yes. I mean, when I started -- as I'm just reiterating wha...
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QUESTION: Then the third bullet point, "Prior to 1988 the RHA 's approach to funding plasma collection", and that's really the point that emerges from the corresponden ce we've just looked at; is that right? ANSWER: Yes, yes. Yes.
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QUESTION: Can we then just look at some of the graphs that you've exhibited to your statement. If we start wi th WITN6935013, so this is the supply of fresh frozen plasma from the Northern Region to BPL, 1981 to 198 5. Can you just -- well, I think this is probably one of the pieces of information you were refer...
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QUESTION: The amount in terms of volume supplied remains relatively static during that period. There are increases and decreases year in, year out -- ANSWER: Yes.
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QUESTION: -- but there's not a huge difference. But the percentage, in terms of the percentage contributed by all centres, we can see significantly reduces over that period, which results, under the pro rata system, 147 with a Northern Region receiving less by way of BPL factor concentrates; is that right? ANSWE...
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QUESTION: And then, if we turn to WITN6935003, we have, I thi nk, now, information about the same thing, in the sense it's plasma dispatched to BPL. This is purely relating to the Northern Region. And it's now for the period from the '85/'86 to '93/'94, and we can see a very significant increase in the amount of ...
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QUESTION: We'll look at a handful of further documents, Dr Lloyd, but essentially, how was that achieved, t hat increase? ANSWER: Okay. My -- if I may start with what I was thinkin g at the beginning of that period, perhaps just befor e I became director, which was that probably the only way to get a major chan...
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QUESTION: If we look at one further graph on this topic, WITN6935002. This is, I think, a visual depiction of what you've just told us. So percentage of red cells issued as whole blood -- ANSWER: Correct.
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QUESTION: -- for the period '85/'86 to '93/'94, and we can se e its decline too, as you just indicated, and there being a tiny proportion, if any, being issued by th e time we get to '93/'94. ANSWER: Mm.
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QUESTION: Is there any reason why this could not have been do ne significantly earlier than it was? ANSWER: Oh, it could certainly have been done earlier. I m ean as I said, when I -- just before I started as director, my views were different. I didn't really appreciate the extent of what we could do. It did t...
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QUESTION: You told us a few moments ago that when you started out as director, at the forefront of your thinking had been using plasmapheresis more. I'm not going to g o to the document because you've explained what happe ned in relation to that, but for the transcript there w as a report which you produced in ar...
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QUESTION: -- which you produced relating to plasmapheresis donations, which is WITN6935012. We can see from this an increase in plasmapheresis donations again over the period 85/8 6 to 93/94. So would it be right to understand altho ugh this wasn't the central plank of your strategy for increasing the supply o...
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QUESTION: And I think we can get a snapshot of the plasmapheresis facilities at NHBT0003365. This is a short note from Dr Gunson, 14 August 1989, "Notes on Visit to Northern RTC". He discusses issues relating to the plasma targets and the core records in the past of the fir st section. And then section 2, "Plas...
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QUESTION: Then if we look at WITN6935024. Now this is just on the topic of autologous transfusion. I don't think we need to l ook at anything other than the first paragraph, which explains that there's a: "... pre-deposit Autologous Transfusion service for hospitals within the Northern Region. This service is p...
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QUESTION: We can take that down, thank you, Sully. ANSWER: We should have done more earlier.
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QUESTION: That leads neatly to my next question for you, whic h was about your understanding of hepatitis. Before we 156 look specifically at non-A, non-B hepatitis, if you can go back to your training years in the 1970s, Dr Lloyd, what can you recall being taught about th e risks associated with blood and blood ...
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QUESTION: We heard evidence a few weeks ago from Professor Marcela Contreras and she told us of writ ing on chalkboards in the classrooms of medical student s the words to the effect "Blood can kill", and 57 obviously there may be a range of reasons ...
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QUESTION: Was that sense of needing to be aware of the danger s of the use of blood and blood products very much pa rt of the thinking at the Northern Regional Transfusio n Centre in the '80s or was it not? ANSWER: Ooh, I'm trying to think what it was like before I was director, when I was just around as registr...
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QUESTION: Then non-A, non-B hepatitis, can you recall, as it were, the evolution of your understanding of non-A, non-B hepatitis, both in terms of its incidence as a risk of transfusion, and as to its seriousness? ANSWER: Taking the risk of non-A, non-B, a lot of what I kn ew in the earlier days was material that...
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QUESTION: I'll pick up on some of those issues again tomorrow , Dr Lloyd, when we look in more detail at the introduction of hepatitis C testing. Hepatitis B. Now, obviously testing for hepatitis B had been in operation long before you joined the Centre. Can I just ask you couple of questions about -- ANSWER:...
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QUESTION: Yes? ANSWER: Sorry, can you clarify that? You said hepatitis C testing.
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QUESTION: B, hepatitis B. 61 ANSWER: Oh B, oh yes.
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QUESTION: I'm moving to hepatitis B, my apologies. So I just want to ask you a couple of questions in relation t o hepatitis B testing. If we go to NHBT0072680. Thi s is a letter you wrote in May 1992 to Dr Castervan a t the Freeman Hospital, and it looks like you've been asked a question about -- ANSWER: Can ...
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QUESTION: Thank you. Yes, so you'd obviously been asked a question about the position in 1974? ANSWER: Mm-hm.
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QUESTION: You say: "According to our records for the whole of 1974 we were still testing for Hepatitis B antigen using an electrophoretic method." And then you explain it was definitely less sensitive than the assay brought in in 1975, probab ly missing as much as 20 per cent of the hepatitis B positivity in th...
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QUESTION: When you first started work at the Centre in 1980, do you recall what form of hepatitis B testing was the n in use? ANSWER: No, I don't. I couldn't tell you what the technolo gy was. I mean I did go into that lab and see it bein g done but I can't remember the exact test that was ...[frozen screen]....
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QUESTION: Then if we could look at TYWE0000067, please. This is another letter to Crutes Solicitors, and it refers to you having returned a witness statemen t, which, if we go to page 3, we can see the statement . For present purposes I just wanted to pick up on something you say on page 7, but if we start at the...
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QUESTION: -- and solubility. Then over the page, (c) is about the characteristics of the commercial product, (d) abou t purity. It was (e) I wanted to ask you about. You say: "Dr Jones may have considered that the methods of testing for the presence of the Hepatitis B viru s were better in the United States." ...
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QUESTION: Now do you know where that thought came from? Was that your own thought you were attributing to Dr Jo nes or was that your understanding of his actual thinki ng? ANSWER: I mean, I say there "may have considered", so I can -- I don't recall Dr Jones ever saying that to me. Bu t what was my reason for...
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QUESTION: And do you recall whether -- at any point in the 19 80s or first half of the 1990s when you were at the Centre, do you recall any cases of transfusion-transmitted hepatitis B being drawn to your attention? ANSWER: I don't remember any. And I know we have two areas there. One is patients who received ...
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QUESTION: Then in terms of transfusion-associated hepatitis m ore 65 generally, so leaving aside whether it's hepatitis B or non-A, non-B hepatitis, was there a system for s uch infections being notified to the Centre or did it j ust very much depend...
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QUESTION: And if cases of hepatitis or transfusion-associated hepatitis were reported to the Centre, was there anybody or organisation to whom the Centre then had a reporting obligation, as far as you can recall? ANSWER: Not that I recall. No.
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QUESTION: Dr Lloyd, I'm going to ask you a little bit now about the arrangements at donor sessions. You tell us in your statement that the donor sessions - - ANSWER: Sorry, I don't have sound at the moment. I don't h ave sound at the moment -- should be all right --
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QUESTION: -- can you hear me now? ANSWER: -- but I can't hear anything.
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QUESTION: Dr Lloyd, can you hear me now? ANSWER: I can hear you clearly, sorry for the interruptions .
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QUESTION: Thank you. I'm going to ask you next about the arrangements for donor sessions and then look at questions relating to donor selection. You tell us in your statement that, in broad terms, the sessions historically could be divided i nto the general public sessions and industrial sessions ; is that righ...