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46,000 | 332 | QUESTION:
The general public sessions would take place in
village halls and community centres and the like; i s
that correct?
ANSWER:
That was the usual arrangement, yes.
|
46,001 | 332 | QUESTION:
Prior to the new centre opening in 1985, were blood
donor sessions ever held in the old centre?
ANSWER:
I don't think so. I don't think there was a facili ty,
168 a room in the old Centre that would take it but, no ,
I don't recall it.
|
46,002 | 332 | QUESTION:
Then once you had the new Centre, is it right that
there were some blood donor sessions that together
place in the new Centre but it wasn't a major part of
the Centre's use?
ANSWER:
No, it wasn't. The drawing has been shown as a don or
facility, a donor room was given over to
plasmapheresis, so we allowed -- I say allowed -- w e
accepted occasional walk-in donors who just thought :
well, here's the Transfusion Centre, I'll donate
blood. We would take their donations in the
plasmapheresis unit.
But we did hold some, sort of, full-blown
sessions by clearing out the dining room and using
that as a site, and we'd bring up a set of beds tha t
would normally be used on a mobile session and we'd
set up almost as though it was a mobile facility th at
happens to be in our building.
|
46,003 | 332 | QUESTION:
In terms of the geographical reach of the donor
sessions, is it right that the sessions took place all
over the area but there were fewer sessions in Cumb ria
because of, I think, transport and road links?
ANSWER:
Yes, yes. The road link from Newcastle into the
Cumbria area, even to Carlisle, remained sort of --
69 a city in that area -- was one road, the A69, and
a big stretch of it was not even divided. It was j ust
single track in each direction. And we ended up --
the arrangement was that the team would go out on o ne
day and then they'd be put up in a hotel, and then
they would run the session the next day and perhaps
stay overnight another night, do another session, a nd
then come back. So it was complicated. It was tim e
consuming. It was expensive. So the Cumbria area was
underserved.
|
46,004 | 332 | QUESTION:
You told us in your addendum statement that there w as
a satellite office in Middlesbrough, known as the
Teesside office. Did the donor sessions in that ar ea
take place at the Teesside office or was it a quest ion
of mobile questions going out from the Teesside
office?
ANSWER:
No, it was mobile sessions. The sessions essential ly
organised the same as the rest of the area, except
that the Teesside office did two things: one, it
looked after the donors in that area, parts of Nort h
Yorkshire, Durham and surrounding areas around
Teesside, Stockton -- anyway; and they also managed ,
as I mentioned, the voluntary team of donor attenda nts
from the British Red Cross and the St John Ambulanc e
Brigade, somewhat unusual, but interesting.
170 |
46,005 | 332 | QUESTION:
Then you told us in your main statement that you
thought there was an area just north of the Scottis h
border which was supplied by the Regional Transfusi on
Centre and you didn't recall any blood donor sessio ns
being held there but, in your addendum statement,
I think your recollection now is that you didn't
supply that hospital but you did hold donor session s
in that area; is that right?
ANSWER:
Yeah, I mean that's -- boy, I'm sorry, that's reall y
rusty. I think we did hold a session, perhaps in
Gretna. I really can't remember. It's so minor, i t's
a very, very minor issue. You know, we also crosse d
into the Yorkshire Region's area and supplied
a hospital. These are, in the big picture, very
minor.
|
46,006 | 332 | QUESTION:
Then, in terms of the general public sessions, were
they based upon donors being called up from the pan el
or were they drop-in sessions or was it a mixture o f
both?
ANSWER:
We called people to the general public sessions so
they were invited by letter. And so, you know, we had
statistics that showed, you know, how many people w e
invited, and how many turned up. We're very proud of
our statistics until we introduced a new computer
system and found out that, actually, there were qui te
171 a lot of walk-in donors that we hadn't invited turn ing
up. So it's interesting what you find out when you
start getting the information. But, yes, public
sessions were by invitation.
Industrial sessions were mainly the individual
companies organised, you know, who would come at wh at
time, and so we didn't actually send them out
individual letters, and you'll see that factor come s
into play when there was the -- when AIDS leaflets
were to be sent and distributed.
|
46,007 | 332 | QUESTION:
Then, if I can just ask you to look at one document
from 1988, NHBT0059596_001. So this is a meeting,
12 January 1988 at which you were present and this is
from the point in time at which you were a consulta nt
haematologist at the centre but not the director.
If we just go to page 5 and pick it up under
"Any Other Business", the second paragraph refers t o
you presenting the donor panel statistics for 1987.
You note there'd been a continued fall in the intak e
of blood and the number of new donors attending had
fallen still further. Relative decline in the valu e
of the publicity budget was also noted. Then there 's
a further discussion about rejection of donors.
Then if we go to the next paragraph, it says:
"Dr Lloyd pointed out that for the recruitment
172 of new donors we needed additional funding and this
had been requested in the short-term programme for
1988/89. He also felt that if any savings were to be
obtained from reorganisation within BTS then
a significant part of these resources should be
applied to the donor sessions to make them more
attractive. Some discussions followed on ways of
improving the appearance of donor sessions. It was
generally felt that the use of rather dingy church
halls left us with an image that was very similar t o
that seen in the 1950s. It was clear however there
was no easy answer to this problem as good quality
accommodation was extremely limited."
Then there's a later document, I won't go to it,
but there's an article from 1989 which quotes you
talking about difficulties in attracting donors giv en
the lack of standards.
Do you recall what was -- whether you were able
to do anything about the issue here of not being
attract donors because of -- well, described here a s
"rather dingy church halls" and not being attractiv e
accommodation or "good quality accommodation" to ho ld
the donor sessions in?
ANSWER:
I mean, we did make some changes in our donor servi ces
department, and tried to focus, get some people in to
73 focus on different types of sessions, so that they had
more chance of trying to get better accommodation. It
was certainly difficult. You know, we were competi ng
with other organisations. If you have an organisat ion
that wishes to use a nice community centre and they 're
going to use it once a week, then we want to come i n
on one of their days but only twice a year or four
times a year, it -- you know, it's a difficult issu e.
So you can't -- it's hard to get better
accommodation. It certainly was. Once you have th e
accommodation available to you, then you can perhap s
start trying to make the session run more effective ly.
But that's obviously another issue.
|
46,008 | 332 | QUESTION:
Do you know what consideration was given when the
general public sessions were being held to creating
opportunities for privacy, so that donors could spe ak
in confidence perhaps to the medical officer,
especially if they're being asked questions about
high-risk activities?
ANSWER:
No, it wasn't good. I think we used to use an area --
we had a screened area in our sessions, which wasn' t
sort of wonderful, but you could take the donor out of
the main area and into this -- an area with screens
around. I think it was sometimes used for someone who
wasn't feeling very well, as a recovery. And there
174 was also a screened-off area where they did some wo rk
on the bags after collection. So donors could be
taken out of the main area. Certainly not perfect but
they weren't being -- when you got away from the
initial questioning to go into something more
detailed, there was an opportunity to go to a sligh tly
more private area.
|
46,009 | 332 | QUESTION:
In terms of the workplace or industrial sessions on
which you've already told us the region was very
heavily reliant, was any consideration given to
concerns that a workplace donor might not be a trul y
voluntary donor because they may feel pressured to
give blood if their employers had arranged a sessio n?
ANSWER:
Yes, I mean that's a valid concern. I don't recall
that we did anything to try to alter that. The don ors
in workplace sessions, I don't know how much in the --
they were put under pressure. It's hard to tell. You
know, perhaps some confidential surveys might have
been a good idea. But, yeah, there's always a risk in
any group, whether it's a family, you know, members of
the family or extended family donating, pressures
there. Pressures of work, certainly possible.
We never tried to pressure the workplace to,
sort of, push people into donating. It was very mu ch,
you know, you'd bring as many people as you can, bu t
175 if the numbers dwindle we're not going to sort of s ay,
"Hey, you must, must, must get more people!" But,
yeah, it's a valid concern, I agree.
|
46,010 | 332 | QUESTION:
Do you know whether, in the workplace sessions, aga in,
whether there were opportunities for donors to be a ble
to speak confidentially, again in the context of
discussions about high-risk activities in particula r,
it may be particularly problematic for a donor if
their colleagues are within earshot, to be candid i n
response to questions asked.
ANSWER:
You had the same physical set-up with the screened
area so that's sort of really as good as it got.
How close other donors would have been to that
would perhaps vary from session to session. You kn ow,
in some of the shipyard sessions, you could have
difficulty talking to people, they were so far away .
You know, a great big hall ...[frozen screen]... wh ere
the accommodation is certainly tighter. So -- but the
screened area, you know, was available. Not perfec t,
certainly.
|
46,011 | 332 | QUESTION:
Then I'm just going to ask you to look at couple of
the graphs you've exhibited to your statement on th e
donor numbers. If we start with WITN6935008, pleas e.
Oh no, sorry, my fault, Sully. I've given you
the wrong reference. WITN6935006, I meant to start
176 with, sorry.
So this gives an overall picture of donor
numbers from 1947 to 1994 in the region and we can
see, obviously, a significant increase overall, but it
looks like it remained relatively stable from reall y
the 1970s onwards, some increase when we get on to
1993, with a drop in '87 and, I think, '88 in
particular.
ANSWER:
Yeah.
|
46,012 | 332 | QUESTION:
Do you have any recollection as to what caused that
particular drop?
ANSWER:
Yes, I think there's another chart I've produced wh ich
shows employment rates. If you knew the north east at
that time, the number of shipyards closing down, yo u
know, steelworks closing down, steel fabricators, i t
was a very difficult time. We lost -- yeah, we los t
a lot of people. And it's very hard, if you lose y our
job, to bring yourself to come back and donate and do
something voluntary would be hard.
|
46,013 | 332 | QUESTION:
Then I won't go to the charts but there are two cha rts
which look at registered donors and industrial dono rs
and then the employment rates, and for the transcri pt
they're WITN6935008 and WITN6935009.
Can I then ask you little about the process for
donor screening. I'm going to start by asking you to
77 look at a national document, CBLA0002307, please.
Oh, no, that's not the document I had in mind at
all.
ANSWER:
Probably not.
|
46,014 | 332 | QUESTION:
Okay, let's try a different version. DHSC0046337.
Okay, so this is the 1985 version of the
"National Blood Transfusion Service Guidance for th e
Selection, Medical Examination and Care of Blood
Donors", and if we go over the page, we can see the re
it starts with a section on the "Selection of Donor s".
Now, Dr Lloyd, we've got a version from 1977,
a version from 1984. This one is 1985.
ANSWER:
Yes.
|
46,015 | 332 | QUESTION:
We've got later versions from '87 and 1990. Until you
introduced your own selection booklet, was this
the guidance that was used, do you think, some form
of -- one of the --
ANSWER:
Oh yes, yeah.
|
46,016 | 332 | QUESTION:
-- versions of this?
ANSWER:
I mean, this document is very familiar to me. I me an,
you could pull up several from different years and
they don't change a lot, but this was the base for the
selection of donors that we used. I mean, we didn' t
deviate particularly from this, it's just that we
tried to make something that was easier for our sta ff
178 to use so that they could be more effective in
selecting donors.
|
46,017 | 332 | QUESTION:
And if we go to the next page, please, this sets ou t
the questions that the donor session clerk should a sk
about medical history. And then we've got a number of
conditions listed. We can see AIDS would lead to
disqualification.
Blood transfusion in last six months is referred
to the medical officer. Can you recall what the
practice was in the Northern Region if there was
someone with a blood transfusion in the last six
months?
ANSWER:
Well, they would be deferred, as far as I can recal l.
For some reason I thought it was longer than six
months, but yes, we deferred blood donation within the
last six months. I see there in that document it
says, "Blood donation within 4 months",
"Action: Wait", which is don't take. In six months ,
presumably meaning between four and six months, "Re fer
to MO".
I'm not sure why there was that distinction
between four and six months. I'm not sure what the
logic behind that was. But this is the sort of
document we would have used, and so we would have
followed, you know, that instruction, "Refer to MO" .
179 |
46,018 | 332 | QUESTION:
Yes, if we go then to the bottom of page 6 because
you'll see it says, "See note ix", and then --
ANSWER:
Okay.
|
46,019 | 332 | QUESTION:
-- note ix is at the bottom of page 6:
"Transfusion of blood or blood products received
in the last six months."
Then it says:
"6 months minimum depending on nature of disease
or injury."
ANSWER:
Yeah.
|
46,020 | 332 | QUESTION:
In any event, if we then go back to page 4, please,
I just want to pick up a couple of other conditions or
situations.
So the third item down here is "Drug abuse ...
Disqualify." Can you recall what procedures were t o
try to assess whether somebody fell into that
category? Were there specific questions that were
asked or was it very much dependent upon that
information being volunteered?
ANSWER:
I don't think people are going to volunteer to answ er
and say, "Do you abuse drugs?" Looking back on thi s,
you think that perhaps the wording being used was n ot
really appropriate.
"Am I drug abuser? Oh no, but I did use drugs
once. You know, I did inject myself at that party. "
180 Is that person a drug abuser? Do they consider
themselves to be a drug abuser? So I think, you kn ow,
our wording is not that -- was not very good. I th ink
it changed later. But as to weeding out who might be
at risk, I don't think we -- we probably didn't do
a great job at it.
|
46,021 | 332 | QUESTION:
Then if we look further down the page, we've got:
"Hepatitis ... Refer to MO ... See appendix 1"
And we see the same at the top of the next page,
it says, "Jaundice ... Refer to MO ... See appendix
1".
If we just go to appendix 1, page 12, please.
So we can see it's the fifth paragraph down, headed
"Hepatitis".
ANSWER:
Yes.
|
46,022 | 332 | QUESTION:
"Individuals who give a history of jaundice or
hepatitis or in whose blood anti-HBs is present may be
accepted as donors providing they have not suffered
from jaundice or hepatitis in the previous
twelve months, have not been in close contact with
hepatitis or received a blood transfusion of blood or
blood products in the previous six months ..."
As far as you can recall was that the practice
at the Northern Region, that someone with a history of
jaundice or hepatitis could donate if it was more t han
81 12 months ago? And subject obviously to the HBsAG --
ANSWER:
I mean, at that time, you know -- at that time I do n't
recall that we would have done anything other than
follow this. I certainly don't recall anyone sayin g
we should have a different arrangement. We
followed -- you know, in this case we followed thes e
guidelines as they came out every few years. Yeah.
I think that's -- I mean, I don't have documentary
evidence to say that we did anything different. So
yes, we would have followed this.
|
46,023 | 332 | QUESTION:
Then if we come to guidance produced by the Norther n
Region itself, if we start with NHBT0007497, we can
see a letter from you to Dr Gunson, January 1994
saying:
"I know you are now getting reasonably close to
producing the Selection of Donors booklet. I thoug ht
you might like to see the version we have introduce d.
The main aim in producing this booklet was to put a ll
the possible information together into one alphabet ic
section. This means staff are less likely to have to
jump from one section of the book to another", and so
on.
Then if we go on to NHBT0007498, we've got the
booklet or a version of it dated December 1993 --
ANSWER:
Yes.
182 |
46,024 | 332 | QUESTION:
-- so probably what you were referring to in your
letter to Dr Gunson?
ANSWER:
Yes.
|
46,025 | 332 | QUESTION:
If we go to page 5, we can see, under the heading
"Introduction", it provides:
"... the information required to assist staff of
the Northern Region Blood Transfusion Service in th e
process of selecting Blood Donors and Donations wit h
regard to both the safety of the donor and the safe ty
of the donations for transfusion and for further
processing into plasma derived products."
Do you know whether there have been any -- or
can you recall whether there was any earlier versio n
of a locally produced booklet or was this the first
time that one had been produced?
ANSWER:
I think this was the first one. It is marked as
Version 1. So I think don't think we produced an
earlier one of this. It took some time to produce
this and, as I say, it was part of our -- what we w ere
trying to do was make it easier for the staff to ge t
the information and use it. This was probably
introduced at about the same -- I think we introduc ed
the information on medication, might have been a bi t
earlier but, yeah, I don't think we did anything
separate prior to this.
183 |
46,026 | 332 | QUESTION:
Then if we look towards the bottom half of this pag e,
"Rationale":
"There are two major considerations with regard
to donating blood. These are:
"(i) That all care should be taken to protect
the voluntary donor from harm, and.
"(ii) That the blood or plasma collected should
be safe for its intended use.
"In addition to this it is the policy of the
NRBTS not to take donations of blood or plasma from
donors unless at the time of collection, it is
believed that the donation is suitable for use. It is
unethical to accept donations from donors in the
knowledge that the donation is unlikely to be used
because it does not meet specifications. Unusable
donations also represent waste of materials, money and
the time and effort of members of staff."
Had that always been the policy of the Northern
Region or was that a shift which you introduced?
ANSWER:
That was a shift. Perhaps not as massive as it loo ks
there. But we did collect ...[frozen screen]... it
was --
|
46,027 | 332 | QUESTION:
I'm sorry, Dr Lloyd --
ANSWER:
-- remember we had -- sorry?
|
46,028 | 332 | QUESTION:
You froze there for a moment. Sometimes when you
184 freeze I don't think we're losing what you're sayin g
but I think we might have done there.
ANSWER:
Okay.
|
46,029 | 332 | QUESTION:
So the last we heard was you said, "But we did
collect", and then we lost you.
ANSWER:
Okay, yes. We did collect donations that we couldn 't
use. Our statistics, as we gradually built up our
information systems in the centre, we realised that we
were taking a lot of donations that weren't either
being used at all, or were only being partially use d.
And we felt that was not good for the Centre and it
wasn't good for the ...[frozen screen]... medical
staff meeting, there was a question about someone w ho
was homosexual and, you know, should we take
a donation from them just, you know, so it looks ni ce
and then throw it away? Well, no, we shouldn't.
So it was a change. We were trying to do what
we said in this document and, obviously, we hadn't
done it before this time.
|
46,030 | 332 | QUESTION:
Then if we go to page 7, we've got the heading
"Medical Assessment":
"In practice it is impossible to perform a
complete medical and physical examination of every
prospective donor. A significant part of the
assessment procedure will usually rely on answers t o
85 simple standard questions relating to general healt h,
past medical history and medication. This is combi ned
with simple visual assessment of the donor and
selected testing of samples collected at the time o f
donation."
Then the next paragraph refers to donors
undergoing medical investigations. Then this:
"Where doubt exists, the donor should be
deferred and permission obtained to contact the
Donor's [GP] or other appropriate Medical attendant ."
Then:
"Any active and/or chronic disease which may be
transmissible, should be a reason for permanent
exclusion."
In terms of the "Where doubt exists, defer and
seek permission to contact the GP or other" --
ANSWER:
Lost you. In terms of these?
|
46,031 | 332 | QUESTION:
The paragraph which begins "Where doubt exists, the
donor should be deferred" --
ANSWER:
Yes.
|
46,032 | 332 | QUESTION:
-- was that a shift in policy at this time?
ANSWER:
I think we were moving more to excluding, if we wer e
in doubt, rather than collecting the donation and
perhaps following up afterwards. Now, in terms of the
safety of the blood we collect, you might argue tha t
186 that doesn't make a big difference, as long as you
have a doubt, and that is acted upon, donation is p ut
on hold, and then we follow it up. That's probably
not a dramatic change because we were all -- you kn ow,
we'd always done that. But what we're trying to do is
actually not take the donation in the first place.
|
46,033 | 332 | QUESTION:
We can take that down. Thank you.
What systems or processes did you put in place
to try and avoid donors whose donation might well e nd
up getting rejected from attending in the first pla ce?
How did you tackle that issue?
ANSWER:
I mean, two things. One is with a document like th e
selection document you've just seen, and working wi th
the staff to -- who went out and did this work, to try
to, you know -- when I started, there were very few
training sessions for anybody. So, you know, we
gradually introduced more training, gradually
introduced standard operating procedures, which sta ff
were required to read and understand and be shown t o
understand. So that we were trying to get the sess ion
staff to understand what we were trying to do as
an organisation.
So we did a lot more training and I think for
the first time we started having training sessions
back in the Centre for the medical officers. I don 't
187 recall that ever having happened in the past and so
now we were bringing medical officers in for --
whether it was a day or an afternoon, I can't
remember -- but we had training sessions. So we --
you know, trying to change the, sort of, attitude a nd
our approach, and it's very hard to know if we were
successful.
|
46,034 | 332 | QUESTION:
You talk in your statement about trying to ensure t hat
donors were informed about donation criteria before
attending, to avoid them wasting their time if they
turned out to be ineligible.
ANSWER:
Mm.
|
46,035 | 332 | QUESTION:
Was that done by sending out standard literature wi th
the call-up cards, then?
ANSWER:
Well, in one of my documents that I attached to my
witness statement, you'll see a leaflet that we
produced. You'll see it stands out. It's white wi th
a lot of red lettering on it and most of the text i s
blue with headings in red. I can't remember what
number it was but we produced -- that was one of th e
things we produced and sent out with all the call-u p.
And that --
You know, the thought process, if you've come to
a session it's taken you a long time, perhaps, to g et
there. You may be with a family member or a friend ,
188 and then we go into the peer pressure thing, and
you're presented with an AIDS leaflet at the sessio n,
that's a little bit late, a little bit harder to ge t
out. If you've had that in the privacy -- you know ,
a letter sent to you personally, you might be able to
make an informed decision prior to making -- going out
to a session. So try and give them more informatio n.
And it wasn't just about, sort of, the safety
issue it was also about looking after the donors an d
making things easier. There were a lot of simple
things where donors are not able to donate, so -- a nd
they only found that out after they'd come to the
session. So give them that information before the
session, it may save them the journey to a church
hall, which might be, you know, a few miles away. And
so it will save them time and effort and hopefully
mean that if circumstances change they'll be more
prepared to come back again.
|
46,036 | 332 | QUESTION:
The letter that you referred to that you exhibited to
your statement is WITN6935020.
ANSWER:
Yes.
|
46,037 | 332 | QUESTION:
It's not, I think, dated but I think it must be aft er
1989 because, if we just look at the letter on the
right-hand side:
"Dear Donor,
89 "On behalf of the Blood Transfusion Service in
the North East and Cumbria, I would like to take th is
opportunity to thank you for your willingness" --
ANSWER:
Yes, we put a date.
|
46,038 | 332 | QUESTION:
-- "to help us by donating blood.
"During 1989 there was an increased demand for
blood and blood components and I am very pleased to
say that many more donations of blood were given,
helping us to meet that need. This year it is clea r
that even more blood is being used and still more
donors will be needed."
Then the next paragraph talks about the value
placed upon the voluntary nature of the donation.
Then if we just go, next paragraph down:
"In this leaflet there is information about
donating blood which I hope you will find useful. In
particular it is designed to help avoid the annoyin g
situation where after going to a blood donor sessio n
you find that your donation cannot be accepted beca use
you may have taken some tablets recently, or perhap s
you have travelled to certain foreign countries
recently."
Then there's an opportunity to telephone
a number for further information, and then the next
paragraph says:
190 "... I hope that this leaflet will help you
avoid a wasted journey or a long wait at the sessio n."
I'm going to ask you separately about some
specific issues relating to the AIDS leaflets but, in
terms of this kind of letter, this personal letter
being sent out to donors, was this the first time t hat
this was done in 1990, probably, I think, or was th is
something that had been done earlier, do you know?
ANSWER:
Oh dear, I can't remember. I happen to have a copy of
this leaflet in one of my old files here. So, you
know, it sort of brought it back. But I can't
remember -- it's the sort of thing that we would
have -- we were trying to do. So I wouldn't be
surprised if we hadn't done it a little bit earlier
but, you know, 1990, did we do it before 1990
...[frozen screen]... first.
|
46,039 | 332 | QUESTION:
I'm sorry --
ANSWER:
-- given the timing -- and, oh --
|
46,040 | 332 | QUESTION:
We missed a bit there. So you said --
ANSWER:
Okay.
|
46,041 | 332 | QUESTION:
-- you asked the rhetorical question: did we do it
before 1990? Then we lost it for a few seconds.
ANSWER:
Okay. Looking at the timing and thinking back abou t
our thought processes of changing how we, you know,
dealt with donors, this is probably the first one w e
191 put out.
|
46,042 | 332 | QUESTION:
Then, if I can ask you to look at your statement,
WITN6935001, page 10. It'll be the bottom half of the
page, please, Sully, when we get to it.
So, in that long paragraph at the end, just over
halfway down, you say:
"In the past many donations were labelled for
'laboratory use' because of limitations in the
donation process."
What kind of limitations were you referring to
there?
ANSWER:
The donation process doesn't mean, in that context,
just putting the needle in the arm. It's the whole
process of the session, and selecting the donor and --
so it is the whole process. So -- and then it refe rs
to the fact that new documentation was produced to
support the clerical staff, providing clear
information.
So we -- this is part of this process: let's not
do what we did in the past and collect blood for wh ich
we really had no use.
|
46,043 | 332 | QUESTION:
We can take that down --
ANSWER:
It's not fair to the donors.
|
46,044 | 332 | QUESTION:
And then what, if any, systems were in place at the
Northern Regional service to ensure that a donor wh o
192 had been excluded from giving blood in your region
would not give blood in another region? Was there any
way of ensuring that?
ANSWER:
Oh no, no, I don't think so. If we excluded someon e,
I don't think there was any -- I don't recall sort of
a system of broadcasting that information to other
transfusion centres.
|
46,045 | 332 | QUESTION:
And do you recall any occasions in which your servi ce
was notified by another regional service of a donor
who'd been excluded? Or deferred?
ANSWER:
I do not recall that happening. It's a lot of year s
ago, but I don't recall it, no.
|
46,046 | 332 | QUESTION:
I just then want to pick up on a couple of what mig ht
be regarded as high-risk groups. So prison donatio ns,
first of all. If we look at NHBT0008628_001. This is
a document that was put up together for a Scottish
Transfusion Directors' meeting in September 1983. It
says:
"Telephoned survey ..."
ANSWER:
Yes.
|
46,047 | 332 | QUESTION:
"... of England and Wales Transfusion Centres
regarding use of prisons as a source of donor blood ."
ANSWER:
Yes.
|
46,048 | 332 | QUESTION:
I think this may have been an exercise undertaken b y
Dr Brookes, but I --
93 ANSWER:
I think it probably was.
|
46,049 | 332 | QUESTION:
And obviously it sets out the position in relation to
a number of regions. But if we go over the page, t he
second region is yours, Newcastle.
"Long ago stopped holding session is Durham and
Northallerton but continued to use an 'Open' prison in
West Cumberland which housed 'civil crime' prisoner s
(bigamy, fraud, etc).
"Latterly they had noticed an increase in
incidence of hepatitis B markers and discovered tha t
prisoners from Walton Jail (Liverpool) were being s ent
there for their pre-release 6 months.
"This session has now been dropped, so that
Newcastle now holds no prison sessions."
Now that's as at autumn 1983. Do you know
yourself how long before that this practice had bee n
dropped?
ANSWER:
No, I don't. I mean, I do -- you know, I recall, a nd
I think I said it in my initial witness statement,
that I thought we didn't hold sessions at prisons, in
my time, and I mean by that going back to 1981,
1980/81, when I first worked in the transfusion
centre. But then I saw this, and obviously it make s
it possible that we held sessions at that facility in
Cumberland after 1981, but prior to ...[frozen
194 screen]... Dr Anne Collins telling me that they had
stopped -- actually telling me this information: th at
they had stopped taking blood from prisons because of
the higher rate of hepatitis B markers. So she did
tell me that. And she would have ...[frozen
screen]... one maybe, you know, I can't be absolute ly
sure but it was in that early phase when I was firs t
starting working there, and I recall her telling me
about this.
|
46,050 | 332 | QUESTION:
We lost you for a couple of seconds, a couple of
occasions, Dr Lloyd. I'm just going to read back
broadly what you said and see whether we caught all
of it.
So you said it may be "possible that we held
sessions at that facility in Cumberland after 1981" .
Then you referred to Dr Collins telling you that
they'd stopped because of the higher rate of
hepatitis B markers.
ANSWER:
Mm-hm.
|
46,051 | 332 | QUESTION:
Then you say you can't be sure but it was in that
early phase when you first started working there an d
you recall her telling you about this.
So is it right to understand it's in the 1980/81
period that is your best recollection of when she t old
you this?
195 ANSWER:
That's my best recollection. I sort of feel that i t
was something that she told me early on, certainly
when I was still a registrar, or locum registrar. So
it's the '80/81, possibly '82, but I sort of feel t hat
it was probably in the earlier part because I do
recall, you know, this thing: we don't do sessions in
prisons anymore. And that came from other people a s
well.
|
46,052 | 332 | QUESTION:
You tell us in your statement this, you say:
"I recall from informal discussion with staff in
the Centre that it was known that prisoners were gi ven
privileges for donations such as cigarettes. This
went against our policy --
ANSWER:
Yes.
|
46,053 | 332 | QUESTION:
-- of not offering inducements to donate."
ANSWER:
Mm-hm.
|
46,054 | 332 | QUESTION:
Were you being told or led to understand that that was
something that was being given out by the Transfusi on
Service or by the prison?
ANSWER:
I mean, first of all, that was not -- those session s
weren't occurring at the time. This was a historic al
information. But those -- the cigarettes were give n
out, as far as I -- you know, they were given out b y
the prison staff. We didn't -- unless I'm extremel y
mistaken, we didn't supply cigarettes. But I think
196 the prisoners would get a benefit of some cigarette s
for donating. And that came from the prison.
|
46,055 | 332 | QUESTION:
And then do you recall whether the Northern Region
collected blood from military institutions, barrack s
or Air Force bases or the like?
ANSWER:
Yes, we did. I'm pretty sure that we went to
Catterick barracks, near Northallerton, actually in
north Yorkshire. And we also went to a small --
I think it was -- I can't remember if was run by th e
Royal Navy or the Royal Air Force, a munitions depo t
in the Carlisle area. So we certainly did those tw o.
The munitions depot would have been a slightly
different beast to the Catterick garrison, but yes, I
believe we did.
|
46,056 | 332 | QUESTION:
And were there any US bases where donation sessions
were held?
ANSWER:
No, as far as I -- well, I know we didn't do any
sessions at US bases, and I don't know that there w ere
any US bases in our region. There might have been an
Air Force base and some facilities around the North
York Moors, but no, we didn't do any sessions at US
bases.
|
46,057 | 332 | QUESTION:
Can you recall whether any active consideration was
given to the position of those donating at military
sessions, that, again, they may not be truly volunt ary
97 or it may be even more difficult for them to admit to
high-risk activities than it might be in other
settings?
ANSWER:
Yeah, yeah. Yes. No, I don't think we did give
consideration to it. I don't recall us discussing
that. So yes, they -- you know, "You, you and you
will donate today". It's certainly possible.
|
46,058 | 332 | QUESTION:
And then you referred earlier to the position of
people coming along with family members to donate a nd
the difficulties that might arise there.
ANSWER:
Mm-hm.
|
46,059 | 332 | QUESTION:
I just want to pick that up by reference to a docum ent
you exhibited to your statement, WITN6935018.
Some notes, I think authored by you, headed
"Transfusion - Do We Have Any Choice?" I'm going t o
come back to what you say elsewhere in this documen t
tomorrow, but if we just turn to page 4, halfway do wn
the page it says:
"This leaves two more areas:
"Predeposit and something that I have not
mentioned before - Directed donations."
Then you say:
"Directed donations are those made by family or
friends for a patient. This sounds like a good ide a.
My 'brother', 'sister', 'aunt', 'uncle', 'best
198 friend', 'neighbour' cannot possibly be at risk of
HIV/Hepatitis/Venereal Disease etc, hence much safe r
than the blood donor."
Then if we look in the next -- sorry, at the
bottom of the page. You say:
"... Voluntary donors are safer."
This is the last three lines:
"Family members who are not volunteer donors are
therefore ordinary members of the population with
a higher risk of HIV infection and other infections ."
We haven't, I think, with other witnesses,
discussed this particular category of potential
donors, the directed donation. What was your think ing
here?
ANSWER:
I mean, these were just notes I made for myself rea dy
to give a talk at a hospital -- at a hospital I--
anyway. Um, my thought process, as you see there, it
can't -- you know, "Someone in my family can't
possibly be at risk". You sort of have this innate
feeling that your family and friends must be, you
know, very good, very clean living or whatever. An d
so if you -- and this was very much about directed
donations not going to an ordinary voluntary sessio n.
|
46,060 | 332 | QUESTION:
Yes.
ANSWER:
So it would be nice to -- you know: let's get our
199 family to donate for another family member or for
a friend in hospital, so we direct the donations
because they must be safer. And I was saying: well ,
no, there's not really any evidence that they're
safer. And in fact they may be less safe because t hey
are under social pressure, as you've alluded to in
other cases, they're under social pressure to donat e.
So I -- perhaps around that time directed donations
was something being talked about, so I thought it
would be a good thing to bring up in a talk.
|
46,061 | 332 | QUESTION:
I want to then pick up the issue of AIDS. How and
when, as far as you can recall, did you first becom e
aware of AIDS and it's potential transformation
through blood or blood products?
ANSWER:
It's hard to remember when. I mean, you know, duri ng
training, you know, you read a lot so you know that
there's a problem. And, you know, I recall reading
the -- the earliest journal articles talking about
this new disease, that something was happening. So ,
you know, we're going back to the very early days o f
this, because I recall these articles and they're
saying, "Well, we don't know what's causing it".
There were even people saying with haemophiliacs it
might be due to some odd change in the constitution of
Factor VIII by fractionation which is impairing the ir
200 immune system.
So I've been aware of transmission certainly
since, you know, some of those early articles start ed
to confirm out in the States.
|
46,062 | 332 | QUESTION:
Again, putting it back in the context of your own
career, you were in that period, 1982 through to sa y
1984, that was your I think senior registrar traini ng
when you were doing the rotation between the differ ent
hospitals?
ANSWER:
Mm-hm.
|
46,063 | 332 | QUESTION:
So do you recall any sense in the haematology
community at that time any particular sense of urge ncy
or concern about the potential threat that AIDS pos ed?
ANSWER:
Goodness. Um ... I don't recall that terrific sens e
of urgency. I mean, I recall seeing some of the fi rst
haemophiliacs who were exhibiting signs and symptom s
associated with AIDS when I was at the RVI. So, yo u
know, people -- we knew there was -- this was going
on, this was happening, but did we know it was
happening amongst non-haemophiliacs? People receiv ing
regular transfusions? No, I don't think we did.
It would have been unusual, because the number
of people we -- donors we picked up once we started
testing for HIV, the numbers were very, very small.
So the likelihood of this being an issue that was
01 being brought to people's attention on a regular
basis, with people getting it from transfusion in t he
Northern Region was low. We knew about it from oth er
regions, and certainly I don't think there was
a terrific -- I don't feel a terrific sense of urge ncy
amongst the general transfusion population -- you
know, haematologists. But you should ask them.
|
46,064 | 332 | QUESTION:
And just in terms of seeing haemophiliac patients w ith
early signs at the Royal Victoria Infirmary, again,
just trying to put that in a chronological context,
you told us earlier that you thought your RVI
placement was the third of the three.
ANSWER:
Mm-hm.
|
46,065 | 332 | QUESTION:
So would that have been around 1986, then, that you
were there?
ANSWER:
Um ...[frozen screen]... '86, I'm trying to --
I honestly, you know, my -- one of the things I fou nd
about this whole business is that I have difficulty
putting things into sort of chronological order, an d
I do find at times that I am not quite sure. So
I wouldn't like to be sure but I, you know, as you
said, I believe my RVI placement was the third of f our
in that block so it would have been in the latter
part. So you're probably about right.
|
46,066 | 332 | QUESTION:
Then perhaps just one more document before we finis h
202 for today, WITN6935027. These are handwritten note s.
Are they your handwritten notes?
ANSWER:
They are indeed.
|
46,067 | 332 | QUESTION:
They're remarkably legible, in that case:
"The Acquired Immunodeficiency Syndrome and the
Human T-Lymphotrophic Leukaemia Viruses.
"Notes made at a symposium held at the London
School of Hygiene and Tropical Medicine on
3rd April 1985. With some additional material from
a Brief review published in Blood, February 1985, a nd
the Interim guidelines from the Advisory Committee on
Dangerous Pathogens."
So it looks, Dr Lloyd, as though you attended
this symposium in April 1985. Can you recall what
prompted you to attend?
ANSWER:
This was a major issue -- I mean, AIDS -- and so, y es,
I wanted to go to this. It wasn't just a, sort of,
a routine one of the conferences coming up.
I certainly wanted to go to this. It was -- and as
you can see -- I mean, what you see here, I only
reproduced a couple of pages, the first and last, a nd
perhaps the one in the middle. It was a longer
document and I took a lot of notes.
|
46,068 | 332 | QUESTION:
If we go to the second page, there's a heading, nea rly
halfway down, "Mode of Transmission", and then the
203 second paragraph under that records:
"The transmission by blood or blood products is
now well documented, and this includes 'needle stic k'
injuries in staff handling infected materials,
intravenous drug abusers sharing needles and patien ts
receiving blood or certain blood products. It appe ars
that Human Albumin Solutions (PPF) do not transmit the
virus, nor do intramuscular preparations of
immunoglobulin. Factor VIII concentrate is known t o
transmit HTLVIII, and one case is documented of
a patient who had received only UK produced
[Factor VIII] concentrate developing AIDS."
Then if we just go to the next page, it's the
last long paragraph --
ANSWER:
You can see there's a lot of pages -- a lot of page s
missing. I think that has "Page 12" at the top.
|
46,069 | 332 | QUESTION:
It does.
ANSWER:
I didn't attempt to reproduce the whole thing.
|
46,070 | 332 | QUESTION:
It says:
"Prospects for limiting the spread of the
disease including encouraging homosexual men to lim it
the number of partners they have, to use condoms, a nd
presumably once known to be HTLVIII antibody positi ve,
to refrain from sexual contact."
Then you go on to talk about the implications
204 for transfusion:
"For blood transfusion, all donations should be
screened for HTLVIII antibody -- as tests are now
available, although not yet as commercial kits.
Potential donors from risk groups must be excluded as
far as possible. Effective literature and advertis ing
campaigns should be used. All plasma for processin g
should be tested and treatment of finished products
should be carried out to render the product
non-infective. Heat treatment of [Factor VIII]
concentrate may render the product non-infective, b ut
at the cost of a 50% reduction in potency and a
resultant increase in [cost]."
So do you recall anything more in relation to
that symposium, any further discussions about the
implications for blood transfusion and the measures
that should be implemented in the Transfusion Servi ce?
ANSWER:
No, I don't. I mean, I have the document, and if y ou
want to see my whole document, I'm quite happy to s can
it and let you read it. But now, off the top of my
head, I can't remember all the other things that
were -- that I wrote. But, obviously, this sort of
colours your -- informs your view of the issues,
certainly. I mean, we can see that we've got
a problem.
05 |
46,071 | 333 | QUESTION:
Now yesterday we had looked at your notes from
that April 1985 symposium on AIDS, where you outlin ed
some of the measures that might need to be consider ed
by the Transfusion Service. Before we look at thos e
measures, just one other matter relating to a respo nse
to AIDS that I wanted to ask you about.
In 1983/84/85 you obviously weren't based at
the Centre. Do you know, either from discussions w ith
Dr Collins or discussions with Dr Peter Jones or
through any other route, whether Dr Collins was eve r
asked to increase the production of cryoprecipitate at
that time?
ANSWER:
Right. Production of cryoprecipitate was very much on
a -- it's a daily decision. Although it's a frozen
64 product, you can store it, so you look at how much you
have in your store, and you decide whether or not t o
produce more. You don't necessarily produce it eve ry
day. You would hopefully -- you would tend to do
a run, particularly in the old centre, where the
production was in a different building. But there was
no -- there's no problem in producing more
cryoprecipitate, it's not a difficult thing to do.
Once you're set up to produce it, you know, you can
turn the tap on. You can say: today, instead of
making just plain FFP for clinical use, fresh froze n
plasma for clinical use, we'll make cryoprecipitate .
And so you can do a run of another hundred that day if
you so wish.
So as far as I'm aware, we never -- we just
produced, the Centre -- in Anne Collins' day, the
Centre just produced enough cryoprecipitate to be s ure
that there was product on the shelf for when it was
requested.
So if we were asked for more, then yes, we would
produce more. It wasn't a big issue.
|
46,072 | 333 | QUESTION:
But as far as you know, and it may be you simply do n't
know, was a request -- any particular request for m ore
as a response to the threat of AIDS in that early
period, do you know whether that was ever made to
5 Dr Collins?
ANSWER:
I don't recall her ever saying that she had receive d
a specific request. We've seen some of my data tha t
shows that the amount of cryoprecipitate going to
the RBI and therefore the Haemophilia Centre was
actually going down a little bit. But they could h ave
requested more. We obviously had the product.
|
46,073 | 333 | QUESTION:
Thank you.
Now I want to move, then, to the donor leaflets
introduced in 1983. Again, I'm very conscious that
you were not in post at the Centre at that point in
time, but I'm going to ask you to look at a couple of
documents in any event.
If we start with NHBT0020668.
So, Dr Lloyd, this was a letter sent by
Dr Wagstaff from Sheffield, 6 July 1983, to his
Regional Transfusion Director colleagues, enclosing ,
over the page, what was intended to be the final
version of the AIDS leaflet for national use.
ANSWER:
Yes.
|
46,074 | 333 | QUESTION:
Again, I'm not going to go through the detail of th e
leaflet.
Now, that was early July 1983. The Inquiry
knows from other evidence that the Department of
Health became involved and the final leaflet was on ly
66 issued at the beginning of September.
And we'll just look briefly at that for the
benefit, really, of those watching. BPLL0007247.
There we have the national leaflet from
September 1983.
Do you know, either from your later involvement
or, again, from conversations with Dr Collins, whet her
in Newcastle any earlier leaflet of Newcastle's own
devising was introduced, or whether Newcastle waite d
for the national leaflet?
ANSWER:
Sorry, I've lost you: "or whether Newcastle was ... "?
|
46,075 | 333 | QUESTION:
Whether Newcastle introduced, as some centres did,
their own earlier leaflet or whether Newcastle wait ed
for this national leaflet to become available in
September?
ANSWER:
I'm certainly not aware that we issued anything
earlier. I can't say we didn't, but I personally a m
not aware of it.
|
46,076 | 333 | QUESTION:
And then I'm again going to ask you to look at
a document you wouldn't have seen at the time but i t
gives us some information about the method of
distribution of the leaflet deployed at Newcastle.
ANSWER:
Mm-hm.
|
46,077 | 333 | QUESTION:
CBLA 0001820, please.
This was a table compiled for the Advisory
67 Committee on the National Blood Transfusion Service ,
"AIDS leaflet - First six months experience".
ANSWER:
Yes.
|
46,078 | 333 | QUESTION:
And we just need to look at the entry for Newcastle at
the top of the page:
"Distribution Method
"With call-up cards
"Displayed on industrial sessions. Issued to
Citizens Advice Bureaux STD Clinics
"No. used 110,000,
"Stock 3,000"
Then we have:
"Donor Response, Effect on Attendance
"Nil. 2 or 3 resigned because of homosexual
relationships"
Then:
"Other Comments
"One donor [I think that should be] [thought] he
could contract AIDS from donation. 'Who is at Risk ?'
(final ..."
That might be "paragraph" or "part".
ANSWER:
Paragraph.
|
46,079 | 333 | QUESTION:
"... may be read as 'if you get jaundice you may [g et]
AIDS'. Majority don't know what Hepatitis B is."
So we can see there, I think -- please let me
68 know if this is your understanding, Dr Lloyd, three
methods of distribution there described.
In terms of the general public it would appear
that the leaflet was being sent out with the call-u p
cards, so donors could take a decision in advance
about not attending.
ANSWER:
Mm-hm. Yes.
|
46,080 | 333 | QUESTION:
And then in relation to the industrial sessions, wh ere
presumably the Centre wouldn't know who individuall y
would be attending, it was on display.
And then Newcastle then took a further step,
which is to provide the leaflet to local Citizens
Advice Bureaux and STD clinics. Was that still --
ANSWER:
Mm-hm.
|
46,081 | 333 | QUESTION:
-- the system of distribution with later versions o f
the leaflet when you came back to the Centre full
time?
ANSWER:
Yes, we sent out AIDS leaflets when they were chang ed,
so they went out with the call-up cards. They were
more like little cards than letters in the earlier
days. But yes, we sent out a new -- new versions a s
they became available, so we would do a new
distribution, but we still had the issue that at
industrial sessions, you -- we didn't individually
call up, the call-up was done within the factory or
9 office complex. So then it was a matter of just
displaying it at the clinic, which is not as good
a situation as providing it in advance, I have to s ay.
So yes, we continued to do this.
|
46,082 | 333 | QUESTION:
Now, we've -- the Inquiry has heard evidence from
the North London Regional Transfusion Centre about
an additional measure which they introduced, which was
the completion of a confidential exclusion
questionnaire which enabled the donor to, as it wer e,
save face, potentially, by ticking a box which mean t
that their donation might be used, for example, for
research, rather than for transfusion. Do you know
whether a system like that was ever in operation in
the Northern Region?
ANSWER:
Now, the confidential exclusion certainly rings a b ell
with me and I'm not sure now whether I'm just
remembering what North London did or whether it was
what we did. It is familiar but, again, I couldn't
tell you definitively that that's what we had on th e
session, I'm sorry.
|
46,083 | 333 | QUESTION:
If we then move forward to the point in time or
a point in time at which you're at the Centre, if w e
go to NHBT0118280, please. So this is a memo from
you, Dr Lloyd, dated 22 January 1987 to the session al
medical officers and the Regional Transfusion Centr e
70 medical officers?
ANSWER:
Mm.
|
46,084 | 333 | QUESTION:
"It may be necessary to explain the risk group in m ore
71 detail, but every care must be taken not to offend
donors. If the donor is suitable to donate, he or she
should be shown back to the Clerk.
"Donors who are not suitable to donate should be
offered further advice through an MO at the RTC."
Then if we just read paragraph (c):
"Donors who are in any AIDS risk group must not
be bled. Where there is any doubt about the risk t hey
should not be bled, but in either case, the potenti al
donor should be sympathetically dealt with and
arrangements made for an MO from the Centre to cont act
them, especially where doubt exists. Some donors m ay
not wish any further contact, and this should be
respected. A note giving details MUST be sent to
an MO at the Centre in a sealed envelope."
Now, obviously this memo has been prompted by
the specific issue of questions about visits to Afr ica
but if we can just go back and look at paragraph (b ),
please, Sully, thank you.
You're here emphasising that the medical officer
must ensure that the donor has read and understood the
AIDS leaflet or the AIDS poster; was that something --
a new requirement that you were introducing at this is
point in time or were you emphasising that which th e
MO should have been doing, in any event?
72 ANSWER:
Goodness. Um ... trying to recall. Reading, you
know, what I wrote, it doesn't look to me like I'm
introducing something new. I'm just reinforcing
an existing situation because of the -- particularl y
emphasising the change in risk areas, and I am not
sure if they'd all been included in the new AIDS
leaflet at that particular moment. I think there w as
some delay between recognising larger risk areas an d
actually getting that information into leaflets.
So, as far as I can see from the way I've
written this, I'm just emphasising, you know, what
we're already doing.
|
46,085 | 333 | QUESTION:
We can take that down, thank you, Sully.
Can I then move and deal very briefly with the
question of the introduction of screening or testin g
for HTLV-III or HIV, which was in October --
ANSWER:
I'm sorry, I lost you then.
|
46,086 | 333 | QUESTION:
Can you hear me again now?
ANSWER:
I lost you again -- could you say -- yes, if you st art
that question again.
|
46,087 | 333 | QUESTION:
Of course. I'm going to ask you very briefly about
the introduction of HIV screening at the Centre. M y
understanding from the documents and from your
statement is that you had no involvement, either in
the decision making regarding HTLV-III screening or in
3 its introduction at the Centre; is that right?
ANSWER:
Yes, that's correct.
|
46,088 | 333 | QUESTION:
Before I leave the issue of AIDS, Dr Lloyd, and com e
on to ask you about hepatitis C screening, I just
wanted to ask you about investigation of cases of
transfusion-transmitted or possible
transfusion-transmitted HIV. I'll do that by
reference to a document you've seen and talked abou t
in your statement. It's at DHSC0020840_041.
You can see, Dr Lloyd, this is a letter from you
to Dr Rejman at the Department of Health --
74 ANSWER:
Yes.
|
46,089 | 333 | QUESTION:
-- October 1992, and it concerned the Department of
Health's scheme of payments for those infected with
HIV through blood or tissue transfer. You refer to
a file relating to the transfusion of a particular
individual and, obviously, we're not going to menti on
that individual by name.
ANSWER:
Yes.
|
46,090 | 333 | QUESTION:
If I just read the first paragraph:
"No new information has come to light since the
original investigation. I enclose for your
information a copy of the report I wrote in 1986 wh ich
identifies the donations originally transfused to
[her] and the related investigations. One of the t wo
units transfused to [her] came from a donor who
subsequently donated and was found to be HIV Negati ve.
The other donation came from a donor who left our a rea
and to the best of our knowledge transferred into t he
West Midlands. At the time the Transfusion Centre
based at Birmingham had no record of this donor
donating and I have again checked with the Donor
Service Department at the Birmingham Transfusion
Centre and they still have no record of this
individual donating. Therefore this leaves the
possibility that this donation came from a donor wh o
75 was HIV Positive. On the other hand there is no
evidence to suggest that the individual is
infectious."
Then you refer to information relating to the
individual's husband, who had been a donor, and the
donation had been tested and was HIV negative.
If we go over the page, we can see this was your
report from, I think, 1986 where you set out the
donation history of the individual and then, as
I understand it, the investigations that were then
made in relation to those two donors. If we look a t
the bottom of the page, we can see in relation to t he
second donor, who had donated at a time when no HIV
testing was available, you record that:
"The donor has left the factory at which the
donations were made and has not replied to call-up
requests made in 1984 and 1985. One further reques t
to attend a donor session is being made ..."
Then you go on to set out over the following
pages -- I don't think we need to go through them - -
follow up of various other donations.
ANSWER:
Yes.
|
46,091 | 333 | QUESTION:
Do you recall whether this was the only such
investigation which you carried out or were there
others?
76 ANSWER:
I don't recall any others. You know, the Northern
Region didn't -- you know, had a very low incidence of
HIV positivity amongst blood donors. I think we're
talking perhaps about one in a year. So, on that
basis, the chances of a donation which was infectio us
for HIV but was negative by test is presumably less
than one per year. So it's not a common thing in t he
region and, therefore, I can understand that we, yo u
know, you're not going to have had many investigati ons
because there were very few infectious units at tha t
time.
So it doesn't surprise me that that's the only
one I recall.
|
46,092 | 333 | QUESTION:
Would we be right to understand this case may
illustrate the limitations of the investigations wh ich
you were able to undertake because, in relation to the
second donor, whose donation may have been the
infectious donation, you had no samples post the
availability of testing and you were unable to trac k
that donor once they'd left the area?
ANSWER:
Yes, we wouldn't have kept -- we didn't keep sample s
for later testing. And I think the donations, if
I recall from what I just saw, were from 1982.
|
46,093 | 333 | QUESTION:
Yes.
ANSWER:
So, no, we certainly didn't keep samples. We weren 't
7 testing for HIV in 1982. And as you've said, we
had -- there were definite limitations on how we
further explored the possibility of that individual
being HIV positive.
Looking back on it, I'm not really sure that
they were. It would have been a very -- pretty
unusual for 1982 in the region. Not unknown,
certainly not, but we didn't -- as you saw, we only
followed up to the one transfusion centre in the We st
Midlands that we thought the person might have
transferred to. We could, and perhaps should, have
circulated all the transfusion centres, both in the
UK -- in England and Wales and in Scotland. I don' t
think there was -- there certainly wasn't a system for
doing it, but when you look back you say: well, yes ,
maybe we -- (a) we should have done more, and (b), you
know, maybe there should have been a more formal
system that would have made it easier to do this.
|
46,094 | 333 | QUESTION:
Then if I just ask you to look at a reply from
Dr Rejman to you.
DHSC0020840_031.
So this is a response to you, 4 November 1992,
and Dr Rejman sets out in the second paragraph:
"It would appear that the donor who failed to
re-attend may be the cause of the HIV infection."
78 Then he goes on to set out a protocol agreed
with CDSC, and in the last paragraph he explains:
"We therefore agreed the following procedure, in
an effort to minimise the risk of any breach of
confidentiality concerning the donor."
And then we can see -- it essentially involves
contact being made with CDSC and then CDSC would
notify the Department but wouldn't notify the Regio nal
Transfusion Centre. We see that over the top of th e
page.
ANSWER:
Yes, yes.
|
46,095 | 333 | QUESTION:
Do you know whether anything further was done in th at
regard?
ANSWER:
As far as I know, this donor did not come up on the
panel, on the CDSC. I think Dr Rejman would have l et
us -- would have let me know, so I had no further
follow-up from this. I'm not quite sure how the
Department planned to deal with the information,
should it, you know, come to their attention. If C DSC
found that this person had been reported to them or
they had information that this person was HIV
positive, they were obviously prepared to send this
information in confidence to the Department, who
presumably would have some method of dealing with i t.
And given that there was, you know, a definite
79 drive to understand -- to find people -- find out h ow
people had been infected through transfusion, that
information would have had to have come back in som e
way, and I never had any -- I don't recall any furt her
follow-up on this.
|
46,096 | 333 | QUESTION:
So WITN6935001, please, Sully. Dr Lloyd's witness
statement's. And if we go to page 83.
So picking it up at the bottom of the page,
there's a heading "Surrogate testing for NANB", and
you say this in your final paragraph on that page:
80 "I did consider that surrogate testing might
have reduced risk, but the use of surrogate testing is
difficult in that there was no clear link between t est
results and infectivity. I was not opposed to
additional testing but it was not being put forward
for use in the UK and I acquiesced in this decision
given the weight of expertise in the Transfusion
Service on the topic."
And then the top of the next page, you say:
"To decide not to introduce surrogate testing
given the information on the reduction in non-A, no n-B
hepatitis in recipients was from my limited
perspective a decision not to apply a 'maximum safe ty'
ethos. I think that a substantive trial in the UK
would have provided a better basis on which to make
a decision. Data from other countries did not
necessarily apply in the UK and from what I have se en,
US data was also not current in terms of donor
screening and also due to the different blood
collection arrangements in the US.
"This was not a simple decision to make."
We have therefore that -- we have your evidence
yesterday, Dr Lloyd, that you think probably ALT
testing should have been introduced. The other for m
of surrogate -- the surrogate marker potentially in
1 relation to non-A, non-B hepatitis would be the
anti-HBc testing. I'll come back to the later
question of anti-HBc testing in relation to
hepatitis B in the 1990s.
ANSWER:
Yeah.
|
46,097 | 333 | QUESTION:
But in relation to anti-HBc testing either on its o wn
or combined with ALT testing as a surrogate marker for
non-A, non-B hepatitis, do you have any views on
whether that could or should have been introduced a t
some point in the 80s?
ANSWER:
That, yeah, that's a difficult -- we know from stud ies
that there was an overlap between those two tests,
that they weren't defining the same range -- the sa me
infectious nature of the donations. I didn't put t hat
very well.
So you've got two tests, neither of which
specifically identifies what became hepatitis C, bu t
both do pick up some of it and they pick up differe nt
sort of spectrums of it. From what I read, ALT was
probably more effective in doing that.
Oh dear, we've just lost -- I'm sorry, something
has happened at this end.
|
46,098 | 333 | QUESTION:
We can still see and hear you, Dr Lloyd. Can you s ee
and hear --
ANSWER:
You can?
82 |
46,099 | 333 | QUESTION:
Yes.
ANSWER:
But I've lost my screen completely. Ah, we're back ,
I'm sorry. I think an auto switch-off occurred.
|
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