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45,900 | 332 | 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.
|
45,901 | 332 | QUESTION:
-- the Northern Region is offering a modest amount
indeed compared to --
ANSWER:
2 per cent.
|
45,902 | 332 | QUESTION:
-- other Centres.
ANSWER:
Yes, region J was East Anglia for some reason.
I don't know why they didn't use optimal additive.
|
45,903 | 332 | 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?
|
45,904 | 332 | QUESTION:
Page 8, please.
ANSWER:
Yes.
|
45,905 | 332 | 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 to pick up the figures in
relation to cryoprecipitate at the bottom of the pa ge.
You say there:
98 "There has been no significant change in total
usage of this product."
Then we've got the figures from 1982 to '85.
The units showing a fall in '83, a slight rise agai n
in '84, and then a slight rise again or a further r ise
in '85. But not a huge variation.
ANSWER:
There was -- those numbers -- the differences in th ose
numbers are not significant. I mean, they are very ,
very small differences in the overall picture. And
I think even if you -- I did present a chart with s ome
other years -- and again, for quite a period we wer e
running along at around that ...[frozen screen]...
|
45,906 | 332 | 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.
|
45,907 | 332 | 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, probably due to a reduction in surgery on
haemophiliacs due to HIV/HTLV III positivity. It
99 seems likely that orthopaedic surgery will increase
again as arrangements are made to carry out surgery on
HIV/HTLV III positive patients."
Then we've got the figures for the Royal
Victoria Infirmary's cryoprecipitate use for that s ame
period, 1982 to 1985 and we can see there the reduc ed
usage. Then, if we just go a little further down t he
page, under the heading "Major Users of Cryo", we t hen
see the other users: Middlesbrough Group, QEH and
North Tees.
I'll come back and ask you a little more about
issues relating to the Haemophilia Centre in a litt le
while, Dr Lloyd.
Can I then, just in terms of an overview of the
Centre's work, pick things up with an inspection
report in 1989. NHBT0006234, please, Sully.
I'll just get my own copy.
So we can see the date of the inspection by the
Medicines Inspectorate was July 1989, so you were, by
this time, in post as director and we can see it's
a routine reinspection and the date of the previous
inspection was March 1987.
If we can go, please, to page 3, Sully. Under
the heading "Introduction", we can see here the mov e
has taken place:
100 "The Northern Regional Transfusion Centre is
housed in a purpose-built building, opened in 1985 ...
"The Centre serves a population of nearly
3.1 million over a wide geographical area, collecti ng
around 120,000 donations annually and employing
a staff of 220."
Then we have the staff list there set out. I'm
not going to go through the details of that.
If we go over the page, to page 4, we've got
a list of the products being produced as at -- for the
period April '88 to March 1989. Then, under the
heading "Inspection", I just want to pick up a hand ful
of points with you there. It says:
"There is a plasmapheresis clinic in the Centre
equipped with 8 Haemonetics machines, the donor pan el
currently numbering around 1000. However, apart fr om
very occasional walk-ins, normal donations are not
collected at the Centre and all normal donor sessio ns
are mobile. A visit was made to a mobile session h eld
in Whikham Community Association Hall."
Then the next paragraph tells us that:
"Donor records are not computerised, the 101
card system still being used", and there is then
a description.
Then the next paragraph:
01 "If a donor reports having had a recent illness
or course of medication, brief notes of this are
written onto a page of a duplicate notebook, alongs ide
the [donor] number, and at the end of this session,
this sheet, known as the 'Illness Sheet', accompani es
the blood to the Blood Components section, where it is
used to identify unsuitable donations."
Can you just tell us a little bit more about how
that latter procedure operated: the illness sheet a nd
identifying unsuitable donations?
ANSWER:
Sorry, I lost that little piece.
|
45,908 | 332 | 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:
Okay, this was the -- I mentioned this earlier in m y
evidence today -- that at the sessions there was
a book, as it mentions here, a duplicate book, and if
there was something that sort of fell outside the
normal or the -- that the clerk, who was clerking t hem
in wasn't, sure about, that information would be
written on the illness sheet, and if one of the don or
attendants or the team leader or, indeed, the medic al
102 officer at the session felt there was some piece of
information about which they weren't sure ...[froze n
screen]... written in this illness sheet, it came b ack
to the Centre.
Then every morning, the next morning after the
day's sessions, the illness sheets were passed to o ne
of the medical staff whose job it was to go through
all the illness sheet information, compare it to th e
known criteria for donation, in some cases to put t he
donation on hold while further enquiries were made of
the donor's general practitioner. Sometimes there' d
be, you know, if it was a more junior member of sta ff
doing it, they might refer it to perhaps myself or
Dr Collins.
So a decision was made whether or not that
donation was suitable. Sometimes the donation was
considered suitable for plasma but not for red cell s.
It varied. Unfortunately, there were -- it highlig hts
an issue that we tried to deal with later which was
that we were taking donations from people where we
weren't sure if their donations were going to be
suitable for full use, which we felt later -- when we
came to this issue, we tried to change that round a nd
say we shouldn't take a donation from someone unles s
we're sure that their donation is suitable for use.
103 But this is how it had worked for -- I mean,
that illness sheet book, that duplicate book, they had
been in use for years, and years, and years. That' s
how it worked.
|
45,909 | 332 | 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
hospitals. Telephoned orders are first noted onto
a piece of scrap paper and then transcribed onto
an official order form."
Then it goes on to talk about the orders being
put together, the donation numbers, et cetera, all
recorded manually "in the Blood Issues
Request/Despatch Book. There is a system of using
different coloured ink for each type of product but
this not always adhered to."
Then if we just go to the fourth paragraph, we
can see there it explains what happens with returne d
packs:
"... (of which there are many) are logged into
a Returns book ..."
Then it says:
104 "... the task of tracing the fate of
an individual pack would be extremely laborious and ,
in some cases, impossible."
Can I just -- again, this is obviously
pre-computerisation and we'll come on to the change s
that were made over the following years. The proce ss,
first of all, of dispatching products, leaving asid e
the milk run, which presumably was essentially a se t
of standing orders to different hospitals --
ANSWER:
Mm-hm.
|
45,910 | 332 | 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 he
Centre was -- you know, how much the Centre was
producing. So the ...[frozen screen]...
|
45,911 | 332 | QUESTION:
Sorry, Dr Lloyd, you froze again?
ANSWER:
-- throughout the day but also in the evenings -- y es.
|
45,912 | 332 | 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
05 described as the "milk run", although that's not
a phrase I ever heard any of our staff use. The
orders that came in for ad hoc were promptly,
dispatched whether it was during the day or whether it
was in the middle of the night. They didn't
specifically of their own give rise to shortages.
What I can say is, and this is also touched on
in the records storage report prepared by the CMO
office, DHSS, and you have a copy of it, it's
a rambling report but it does say that hospitals th at
they went to often exaggerated the demand --
exaggerated their order because they knew that thei r
transfusion centre would issue less than the amount
they'd asked for. And that was absolutely classica l
of the Newcastle Centre; people ordered twice as mu ch
as they wanted, as they needed, because they knew
their order would get cut back, and then one day th ey
would make that large order and it wouldn't be cut
back, because there happened to be enough of it
around.
So it was a very poor system, a lack of
cooperation -- perhaps not cooperation, a lack of
understanding between both sides. And that was one of
the things we did try and change, was to say our jo b
is to issue what you asked for, not issue what we
106 think you should have.
So, yes, it was a difficult time, and it
required a lot of change to move from it.
Your other issue is -- that was brought up on
this is, of course, that everything was manually
recorded, and everything -- virtually everything in
that Centre was manual.
|
45,913 | 332 | QUESTION:
Then the paragraph I read out relating to returned
packs included the phrase in brackets "of which the re
are many".
ANSWER:
Yes.
|
45,914 | 332 | 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, I think, as
demand increased and supply didn't increase a lot, and
also with better arrangements between the Centre an d
the hospitals.
But if you go back into the 1960s and 1970s, you
see vast quantities of blood being returned from
hospitals unused. You know, thousands of units wer e
being returned unused, which was why the Centre spe nt
a lot of time collecting outdated plasma to be sent to
107 BPL in Elstree. So yes, there was a lot of ...[frozen
screen]... was the regular delivery runs, which
I think -- I only say I think -- well, particularly
for the hospitals outside Newcastle, were pretty mu ch
a fixed quantity of each blood group. To the exten t
that the delivery drivers sometimes had difficulty
delivering the order. Northallerton hospital, for
instance, I recall it was often mentioned that our
delivery to them they couldn't fit it in all into t he
fridge. So there was a big disconnect there betwee n
what we -- the Centre was doing and what hospitals
actually required.
|
45,915 | 332 | 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
computerised system, was that your experience on -- or
were there occasions when you did have to trace the
fate of packs and were unable to?
ANSWER:
We didn't have to trace packs very often. You know ,
if you go into the HIV era, the number of HIV posit ive
donations in the Newcastle -- for the Newcastle Cen tre
and its catchment area was very, very small. I don 't
108 recall not being able to trace it.
I mean, this is a report from an inspector.
What I would say is that although the Centre had an
incredibly manual system, it was a system that had
been in place, you know, from almost time immemoria l,
if I might say, and so people did know how to use i t.
It was slow. It was slow. I mean, it could
take you days to find out what had happened to
a donation. What we did have more of was donors wh o
would phone in after they'd donated, perhaps a week
later, and say, "Look, I've come down with a cold", or
something, and you would try and -- you needed to
retrieve that donation, which had been issued perha ps
in two or three parts to hospitals. It could take,
you know, a couple of days to actually trace that
going back through manual records.
But I think it was ...[frozen screen]...
|
45,916 | 332 | 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.
|
45,917 | 332 | 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 frequently they'd taken
place?
ANSWER:
No, I have no recollection of previous inspections.
The '87 one -- maybe I wasn't in the Centre but
I certainly don't recall it. And of course, we hav e
to recognise that this was at a time when the Healt h
Service operated under crown immunity, and therefor e
whatever the inspector might have said or might hav e
recommended, there was no sort of requirement on th e
centres for or their management, in this case the R HA,
to actually get things changed.
So yes, we do -- you know, it is -- I don't
recall them inspecting before, but obviously, as th ey
said, they had.
|
45,918 | 332 | 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.
|
45,919 | 332 | 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 Birmingham University Health Services Managem ent
Group to carry out an assessment of the management of
the Centre and develop a programme of predominant
development.
What had prompted you to ask for that
assessment, and what, again, in broad terms, was it
designed to address?
ANSWER:
Well, you have to understand that, you know, myself
and, you know, I had a medical training. None of m y
training included anything on how to manage, which
was, you know, a shame. And I became director quit e
suddenly. There was no opportunity to take any
additional sort of training courses. I started to
read quite extensively on how to manage, and
management issues, and I think together with my sen ior
managers we realised that we did need to improve wh at
we were doing. We needed to become more profession al
in how we operated and so the -- I had been to
a two-day -- a weekend course arranged for new
consultants, arranged by the Regional Health
Authority, presumably when I first became
a consultant, and they -- that little course was ru n
by the people from Birmingham University. And so
I sort of knew what sort of style they had, and fel t
111 that they might be able to help us and we -- I, in my
humble opinion, yes, it helped.
|
45,920 | 332 | QUESTION:
Now one of the --
ANSWER:
And if you want to know more about it --
|
45,921 | 332 | 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 donations for infectious disease s,
consolidated through the usage of a single
manufacturing system. Now, we'll talk about
hepatitis C screening and its introduction at a lat er
stage of your evidence probably tomorrow, but in br oad
terms what was this single system, and what was its
advantage in your view?
ANSWER:
Okay. Before we introduce that, we were testing --
you know, for hepatitis B and HIV, and there were t wo
different systems. So we were using completely
different mechanics, equipment, for each test. Tha t
gave rise to data transfer issues, so you now have to
develop two systems of data transfer, two systems o f
data validation, two systems of authorisation of th e
transfer of records into your main system.
112 You also have a training issue. You now have to
train your staff on two different systems. You hav e
to -- I mean, it goes on. I keep saying two. But
whenever you're using two different sets of equipme nt
it gives rise to a multiplicity of issues. You hav e
to do everything twice. Your quality control is go ing
to be different, your quality assurance programme f or
it is going to be different, your training is going to
be different. It makes it more difficult for staff to
change between one machine, one test and another.
So we moved to a single system offered by the
Abbott Plc, I think the official company we dealt w ith
was based in Germany, but it's an American corporat ion
and they produced equipment which had a much higher
level of automation than the equivalent other
companies offered. So it integrated a lot more of the
quality control into the system, automatic pipettin g
and delivery of samples.
But basically they're using the same system to
do different tests, and then the test results come
together, and they had one module which brought the
test results together, which allowed you to do one
authorisation process to release the results into t he
general computer system or wherever.
So it gave you a lot of advantages, not only in
13 mechanics of running it, the training staff
...[frozen screen]... run systems.
|
45,922 | 332 | 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 transferred out for use by the rest of the
system in ...[frozen screen]...
I have to thank the staff who worked there for
really bringing a lot of that to my attention, and
helping recognise that there were some good
alternatives out there.
|
45,923 | 332 | 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 predecessor. Dr Collins did app ear
to have difficulty with the Regional Health Authori ty
and her dealings with it. My understanding from
talking to somebody at the Regional Health Authorit y
was that they were to some extent unhappy that when
114 automated blood grouping was brought in, Anne Colli ns
would not reduce the staff commensurate with that
automation.
We had dozens of junior at the time called
technologists or technicians, which we didn't need
once it became automated in that particular
department. So I think there was sort of a little bit
of a stand-off about that. So I think, you know, s he
did have difficulties with her dealings with the RH A,
and I am sure we will come back to the RHA's view o n
plasma production later.
When I took over, I got along reasonably well
with the people at the Regional Health Authority,
initially the regional scientific officer, Mr
Geoff Whittaker and, as time went on, the Regional
Health Authority changed its -- you know, who I dea lt
with. I got moved to deal with somebody who dealt
with a number of regional services, Mr Tony Garland ,
I think. I'm not great on names. But I was sort o f
moved and I got along with them. I wouldn't say, y ou
know, that every communication was wonderful but, y ou
know, we got along quite reasonably and they did se em
to start responding to issues that we were able to
bring up.
And as time went on, I found that some of the
115 more senior staff at the Regional Health Authority,
particularly Liam Donaldson -- now, I think Sir Lia m
Donaldson, you know, he understood issues. He did.
He was -- he understood health care, and I found
that I was able to, you know, we did manage to get
things done. So it became a reasonable relationshi p.
In the early days there was -- as I mentioned in
my witness statement, there was a lot of detailed
stuff coming from some of the lower areas -- levels of
the Regional Health Authority. And some of that go t
pretty tedious, asking us to produce flowcharts and
I think something called a Gantt chart, all sorts o f
bits and pieces which really I felt weren't necessa ry
to the running of the Centre and weren't helping us to
move forward, and there was a lot of detailed stuff .
But as time went on, that became less, and part
of that was of course the move to separate us out i nto
a clinical agency of the Regional Health Authority.
|
45,924 | 332 | 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 h ave
been?
116 ANSWER:
It was.
|
45,925 | 332 | 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.
|
45,926 | 332 | 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 al
silence, and that there had been no discussion abou t
ending the meetings. So ...[frozen screen]... myse lf,
you know, my first meeting, I'm the junior, very mu ch
the junior, I'm sure I wouldn't have stood up --
I think you've lost -- I'm sure I wouldn't have --
|
45,927 | 332 | 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
17 served as ...[frozen screen]... Yes, I probably
acquiesced, let's put it that way.
|
45,928 | 332 | QUESTION:
We lost you a couple of times there, Dr Lloyd, but it
was clear, I think, what you were saying.
ANSWER:
Okay.
|
45,929 | 332 | 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 correspondence with the Nation al
Directorate, I think that speaks to the fact that I
did not have a very high opinion of that organisati on.
I felt that they were poor at making decisions. We
know from Dr Gunson's own statements that he felt t hat
he had no authority, and that's the case. He was
not -- the National Directorate wasn't set up to ha ve
a line of authority.
On the other hand, if you had recognised that,
you could have worked with people to get agreement,
and what we saw, as we mentioned earlier, as you
brought up earlier, there was the last of the Regio nal
Transfusion Directors meetings. And, in that -- in
dissolving that meeting, you removed a degree of
coordination which would have been possible, bringi ng
all the directors together with the national direct or,
119 and together with people from the Department of
Health, DHS, DHSS as what it was at different times ,
and a representative from the Scottish Blood
Transfusion Service.
And that is -- I mean that's mentioned by
Dr Ewa Brookes in her informal minutes of that meet ing
saying, you know, you may come to rue the moment yo u
agreed to this meeting ending.
So the National Directorate, to me, had ended up
severing certain lines of communication, so that --
I don't know how other directors felt but I felt th at
I was, sort of fed, you know, small snippets of
information and really didn't have a lot of input; and
sometimes that meant that you didn't understand the
context of some things that were happening.
So, yes, the National Directorate, to me, was
a poorly put together ...[frozen screen]... It coul d
have functioned a lot better within the confines of
what it was given. Sorry, I rambled a bit.
|
45,930 | 332 | 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 the Blood Transfusion Service in the
post White Paper Era", and it's dated on page 6 --
ANSWER:
Right.
|
45,931 | 332 | 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.
|
45,932 | 332 | 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 you refer to the National Directorate and
the CBLA and then, over the page, next page, you se t
out "A Proposal for the way forward". I'm not goin g
to through the detail of that but just pick it up a t
the "Summary", bottom half of the page:
"A re-definition of the role of the National
Directorate, with a clear brief to support the UK
Transfusion Centres and to provide cost effective
information, public relations and certain coordinat ing
functions is proposed."
Now, we know this isn't what happened and, in
due course, we have the National Blood Authority,
which I'll come on to in a couple of minutes, but w hat
was it that led you to advocate this redefined role
for the National Directorate? What were you hoping it
would achieve?
122 ANSWER:
Goodness, yes, I was obviously ...[frozen screen].. .
I was trying to look for something that didn't
require the National Directorate to be completely
brief, redeveloped. In other words, you didn't wan t
to have to go to the Department of Health and say, you
know, "Create a different beast". So what could th e
National Directorate do that would deliver, you kno w,
value to the transfusion centres? So I'm looking a t
certain things.
As an individual transfusion centre director,
I was obviously heavily consumed in running, you kn ow,
what was then a multimillion-pound operation. And the
amount of time available to do some of these things
was limited. So, you know, the time to travel to, you
know, international meetings and get a good
understanding of what was going on from around the
world, you know, that would have been something tha t
the National Directorate could have done because th e
National Directorate doesn't have to actually manag e
anything other than a handful of people in an offic e.
So I was looking for things that they could
deliver, which would help the Transfusion Services,
and so I think that's sort of where it -- where I w as
going. Gosh, it's a long time since I wrote this.
I don't know, is there anything else you'd like to dig
123 into on it?
|
45,933 | 332 | QUESTION:
No --
ANSWER:
Just to say, I was just flying a kite.
|
45,934 | 332 | 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 the NRBTS believes that strong local
management with local accountability provides the b est
option for the future. This option is outlined in the
section 'Preferred future management arrangements'.
Central coordination is available through a small
organisation operating on behalf of Regional
Transfusion Centres."
Then the next paragraph:
"It is accepted that the strongly independent
stance that we would like to take, whilst possibly
appropriate for ourselves will not be suitable for
a number of Transfusion Centres. It is also accept ed
that BPL requires more support to survive."
Then if we just keep the whole of it on screen,
Sully, I think it's fine.
The next paragraph:
124 "We have assessed various options against the
standards that we believe appropriate for
a Transfusion Service in the United Kingdom ..."
You refer to a proposal put forward by the
Transfusion Centre Directors and Managers. Then yo u
say:
"The NBA proposal as presented in the
consultation paper does not meet our criteria on a
number of important points. These are amplified in
the section 'Perceived problems in the NBA proposal '.
It does however address the national co-ordination
question, the need for a national image for the NBT S
and the link between the NBTS and BPL. We therefor e
support the formation of an NBA but believe it shou ld
be in the form of revised proposals from the
Transfusion Centre Directors & Managers."
I'm not going to go through the whole document,
Dr Lloyd, but can you tell us essentially what it w as
that you were proposing and why you were not
supporting the idea of an entirely National Blood
Authority, essentially a single transfusion service ?
ANSWER:
Yes. As I said in that document, you know, what we
were proposing may not have been entirely appropria te
for every transfusion centre. I'm certainly aware
that quite a number of transfusion centre directors
25 strongly wanted a central service -- organisation.
I guess I had found that I had a really good
group of staff in the Transfusion Centre, at many
levels, and we were able to work together to make
changes. And we could make them quickly. Relative ly
quickly. Some of them we could make very quickly.
So you can get things done with a good
management team and good staff. You can get them d one
locally. Once you become national, particularly in
the early years, you've got an enormous task to try to
bring disparate organisations together. And certai nly
from my point of view, and it's mentioned elsewhere ,
I didn't really want to be in a position of just be ing
told what to do.
You know, one was aware that the NBA changed
some of things we did quite quickly, perhaps stupid
things -- changing telephone systems, you know ...
which removed direct outside lines into our dispatc h
department, apparently. And I quote that from some one
who worked there after I left.
You know, so I'm not a lover of big
organisations, I have to say. I'm not a lover of t he
big bureaucracy. So yeah, I pushed for something t o
keep us independent, but not ...[frozen screen]...
standards. How you meet them doesn't matter. It's
126 meeting the standard. And if you can meet that
standard, or exceed it, then that's good. So it's not
saying, "Let's just forget about standards and we'l l
do our own thing", it's, "We'll do our own thing an d
meet what is appropriate."
So yeah, you see me being pretty clear on
(unclear).
|
45,935 | 332 | 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 witness statement, that I didn't want to stay in
that position for too long. One of the reasons for
that was that I had met a number of other transfusi on
centre directors, and sort of felt that perhaps, yo u
know, they'd started off with great ideas and, and so
on, but had rather stagnated, and I didn't want to let
myself get into that position.
So once, you know, by the time the NBA came into
...[frozen screen]... so the combination of my own
idea, that I didn't want to stagnate, and the fact
that the NBA would really take away my ability to g et
things done that I wanted to do, and I'd be subject to
127 an organisation, this sort of rather unknown
organisation, you know, yes, that gave me the impet us
to put my CV, my résumé out there.
|
45,936 | 332 | 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 you have any recollection of what Dr Jones'
approach to treatment or treatment philosophies wer e,
based on your own very short time there?
ANSWER:
Yeah, very short time. I mean he was a great advoc ate
for home treatment. And having, you know, knowledg e
of what haemophilia had been like for individuals
prior to the availability of factor concentrate and
then prior to the move to home treatment, you reali se
that home treatment offered a terrific -- potential
terrific improvement to life. Now we know what
happened.
But just the very fact of -- you know, he wanted
patients to live a more normal life, if they could.
So yes, home treatment was, I think, the bedrock of
what was done at that Haemophilia Centre. But
128 I didn't have time to go into, you know, what his
philosophy was and how long he'd gone down that pat h.
So I -- and after that, it becomes hearsay.
|
45,937 | 332 | 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 were
some sub-centres but I don't even really know how t hey
were staffed or managed. It did seem to be that
Newcastle was the -- you know, the Centre that mana ged
and offered management to patients in the whole
region.
|
45,938 | 332 | 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 commercial
concentrates. That was all dealt with directly by the
Newcastle Haemophilia Centre; is that right?
ANSWER:
...[Frozen screen]... Haemophilia Centre and their
pharmacy organisation. We did not order, choose,
supply any of those commercial products.
29 |
45,939 | 332 | 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 Centre?
ANSWER:
Yes. Without going too much into semantics, when w e
say "supplied", I mean that was just an issue of --
a matter of transferring the product. We had, you
know, we had a truck that went down to Bio Products
Lab, BPL, with plasma, it came back with finished
product, the Factor VIII was put into refrigeration ,
and then it was for the Haemophilia Centre, the RVI ,
you know, to collect that product.
I don't recall them actually ever ordering it.
They didn't sort of say, you know, "Can you supply us,
you know, ten boxes", it was a case of "We've got t he
product from BPL, come and get it".
|
45,940 | 332 | 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 ... As I only bec ame
130 Director/General Manager in late 1988 my involvemen t
with, and hence knowledge of, certain aspects of th is
Litigation is limited."
You then refer to having gone a through large
quantity of files created by Dr Collins and some fi les
dating back to Dr Murray, and you say:
"... clear from my examination of the files that
very little was put to paper by the previous Direct or,
or if it was, no copies now exist at the Transfusio n
Centre."
If we go to the next page, there is a heading at
the top of the page, "BTC Responsibilities in Relat ion
to the Haemophilia Centre":
"The Transfusion Service responsibility to the
Haemophilia Centre in this Region is little differe nt
to its responsibility to any other Health Service
Department or Unit. We provide, within our
capabilities, the products that are requested by th e
Haemophilia Centre. Some of the products we provid e
are locally produced, including cryoprecipitate and
individual packs of fresh frozen plasma.
"As far as the supply of Factor VIII and
Factor IX are concerned, we have acted purely in
a handling intermediary position between the Blood
Products Laboratory at Elstree and the Haemophilia
131 Centre. Because we have a vehicle travelling to
Elstree carrying raw plasma to that factory, and th e
van is then returning to Newcastle, we bring back a ll
the Factor VIII and Factor IX allocated to the
Northern Region and then despatch it to the
Haemophilia Centre. At various times we have held
some of this product in stock, awaiting instruction s
from the Haemophilia Centre to have it sent across.
As mentioned elsewhere, there have been times when it
has been necessary to remind the Haemophilia Centre
that supplies of NHS Factor VIII are available and
awaiting collection."
Just pausing there in relation to that last
sentence, Dr Lloyd, you refer in your statement to
Dr Collins showing you boxes of Factor VIII in
a walk-in fridge that Dr Collins told you the
Haemophilia Centre was reluctant to take; is that
right?
ANSWER:
Yes, that's correct, and I think you have also
supplied a document which is a letter from Dr Colli ns
to Dr Jones, in which I think she uses the phrase
"embarrassingly large supply that hasn't been
shifted".
|
45,941 | 332 | QUESTION:
Yes and we well just look at that --
ANSWER:
(Overspeaking)
132 |
45,942 | 332 | 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.
|
45,943 | 332 | 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 document, that the Transfusion
Service's understanding was that the Newcastle
Haemophilia Centre used, to a very substantial exte nt,
commercial concentrates; is that correct?
ANSWER:
As far as I know, they did. We know, and I'm sure
we'll get into this at some stage, there was very
limited supply of BPL Factor VIII. It would not ha ve
met the regional demand, particularly once you star t
a fairly aggressive home treatment policy. But,
despite that, you know, there were still -- obvious ly
there were still some products not getting used
immediately. So yes, they used a lot of commercial
33 product -- concentrate, and you see that in other
documents that have been submitted.
|
45,944 | 332 | 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 has, since the 1970s, been produced
by the Blood Products Laboratory at Elstree in
quantities less than those required for the treatme nt
of the haemophiliacs in this country. The level of
shortage in each region has varied because of the
supply of raw plasma, from which Factor VIII is mad e.
As mentioned elsewhere, I believe that this Region
took a decision in the 1970s to purchase Commercial
Factor VIII rather than invest in the transfusion
centre, with a view to producing more plasma."
Can you recall, Dr Lloyd, what the basis was for
your understanding that there had been a positive
decision by the Regional Health Authority, I assume
it's the Health Authority you're referring to there ,
to invest in --
134 ANSWER:
Yes.
|
45,945 | 332 | 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 some of the documents that you
now have given me access to over decisions by the
Regional Health Authority.
So I am here, I think, pretty much quoting the
view that came from my predecessor without having s ort
of hands-on evidence to support that -- those
statements.
|
45,946 | 332 | 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.
|
45,947 | 332 | 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.
|
45,948 | 332 | 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 observations or any
reflections of your own based on your conversations
with her.
So if we go to page 4, please, thank you.
If we pick it up halfway down the page:
"A further difficulty arose from the
arrangements which were made from about 1980 onward s
with the distribution of Factor VIII. The system
introduced at that time was known as the 'pro rata'
arrangement, by which [RTCs] were intended to recei ve
back amounts of blood products in proportion to the
amount of blood plasma sent by Regional Transfusion
Centres throughout England and Wales. Because some
Regional Transfusion Centres, such as the Leeds
Centre, sent a disproportionately large amount of
blood plasma, the northern transfusion service 'los t
out', even when the amount of blood plasma sent to
Elstree increased."
Do you have anything or any particular insight
into or understanding of what Dr Collins had in min d
136 there, this sense that the pro rata system somehow was
stacked against the Northern Region in some sense?
ANSWER:
Well, not particularly against the Northern Region, it
happen to act against the Northern Region.
If you look at some of my -- one of the charts
I presented in my witness statements showing the
pro rata distribution of products in general to the
Northern Region, it shows that over a period of
a number of -- I think it was actually only couple of
years this data relates to, I just didn't happen to
have a larger range of data, but you can see that i n
that chart that the amount of plasma being sent to BPL
from the Northern Region stayed the same, but the
amount of product that came back diminished.
And that was a fact -- that's how the pro rata
system worked. You took the total quantity supplie d
by all transfusion centres and you, you know, divvi ed
it up, accordingly -- the production accordingly.
So if some centres produce more but others stay
the same, the ones who stay the same are going to g et
less product back. And that's what Dr Collins is
referring to here. And as I say, I did produce
a small chart showing that in operation.
|
45,949 | 332 | 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:
"It became apparent that there was a preference
at the Haemophilia Centre for commercially produced
Factor VIII blood product for the following
reasons ..."
Then she sets out three: solubility, allergic
reactions, and a more attractive presentation of
commercial Factor VIII.
ANSWER:
Mm-hm.
|
45,950 | 332 | 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 him .
I mean, I was certainly aware, because whilst I was
a senior registrar at the Royal Victoria Infirmary, we
often treated haemophiliacs who came in after hours
when the Haemophilia Centre wasn't open, and we use d
the product that was allocated, you know, for that
patient. If that patient was on a certain commerci al
product, that's what we used.
138 And it's true, the commercial Factor VIII was
more easily soluble. In other words you could put the
distilled water in -- I think it was distilled
water -- into the vial, and dissolve it much more
quickly than you could the BPL product. So I
actually, you know, have experienced that.
I don't know really enough to say about the
allergic reactions, the rate of those. But, you kn ow,
obviously Dr Collins had some knowledge of that. B ut
I don't know what specifically Dr Jones was saying
about that. But, you know, it is the case that tha t
product, the BPL product, was less easy to use, and it
wasn't presented, if you like, in a nice package. It
didn't come with its -- with everything together. So
a little more difficult to use.
|
45,951 | 332 | 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.
|
45,952 | 332 | QUESTION:
It's addressed to the parents of a boy with
haemophilia.
ANSWER:
Mm-hm.
139 |
45,953 | 332 | 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-specific cryoprecipitate", did
that take off? Was that something that was done, a nd
had it ever been contemplated before this?
ANSWER:
I don't recall it being done at other times. You
know, I read this letter and it -- you know, it
obviously brought the issue back to mind, but it
wasn't something that I was aware of as a -- certai nly
wasn't a major component of what we were doing in t he
transfusion centres. We were obviously prepared to do
it, but I don't recall it becoming a frequent --
certainly not a frequent issue. We might have done
others but I -- honestly, I'm sorry, I can't rememb er
now.
|
45,954 | 332 | 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 treatment.
140 So I don't know what discussions took place to come to
this conclusion. So I'm sorry, I can't help you
further on that one.
|
45,955 | 332 | 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 you make in your witness statement.
So the first document is DHSC0002247_077. This
is a letter dated 18 October 1984 from the regional
general manager at the Northern Region Health
Authority to the Department of Health. We can see
it's headed "Supply of Plasma to the Blood Products
Laboratory".
ANSWER:
Yes.
|
45,956 | 332 | 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 capital and revenu e
resources required and more particularly the need t o
41 build up the number of plasma donors in the Region.
In this latter connection, the recent closure of
factories in the Region has had a considerable effe ct
on the ready availability of blood donors."
So I appreciate you wouldn't have seen this
letter at the time, Dr Lloyd, and, indeed, it doesn 't
even appear to have been copied to Dr Collins. But it
suggests an in-principle commitment to meeting the
targets and, presumably, the ultimate objective of
self-sufficiency but not an equivalent guarantee of
being able to do so. Is that, more broadly, a fair
reflection of your understanding of the position at
around this time, and the position you then inherit ed
later in the '80s?
ANSWER:
Yes, I think so. I think there's another document
also from the Regional Health Authority probably fr om,
was it the Regional Director of Resources, which
I think may have followed up this letter, which you
also, you know -- I didn't see at the time, which
gives it perhaps a little more background to it. B ut,
yes, my understanding was that we're not going to p ut
a lot of money into the Centre. It's going to be
expensive. We have limited resources, and so, at t he
moment, yes, we'll -- when you read it, you say: ye s,
well, we -- we'd like to go along with you, but
142 actually we're not going to. Haha.
That's what it appears to say. And the little
bit about the closure of factories, and so on, is j ust
a little bit of icing on the cake to try to show th at,
you know, it was going to be difficult.
|
45,957 | 332 | 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 reply to your letter re
Plasma Procurement for BPL. The matter was raised at
the recent [Regional Health Authority] meeting,
members being advised that additional finances woul d
be required for the proposed plan and that informat ion
was still being collected.
"I am therefore not in a position to assure you
yet of any increased supply from this region.
"The new Transfusion Centre building should
become available later this year, thus resolving on e
constraint upon us. The proposal being considered
comprises a small increase in routine blood donatio ns,
use of SAG-M for a proportion of donations and the
shortfall being made up by plasmapheresis.
143 "I will let you know when any agreement is
reached."
So it would appear that Dr Collins is
effectively awaiting approval from the Regional Hea lth
Authority to take the steps outlined, fairly modest
steps, potentially outlined in the third paragraph of
her letter.
ANSWER:
Yes, yes. She wasn't -- she felt, you know, she
couldn't -- you couldn't -- you can't spend money t hat
you don't have, you know, you don't have the author ity
to. And so the two things there, the bags containi ng
the optimal additive, SAG-M, were more expensive an d,
of course ...[frozen screen]... expensive operation .
There was a small plasmapheresis centre in the new
building with a small number of units. We saw that in
the Medicines Control Agency Inspection Report
earlier, where I think they mentioned eight
Haemonetics machines, although that might have been
a little bit later than this.
Yes, it was the next year, wasn't it, that
report.
So she had -- she couldn't go ahead with some of
the things that she would have liked to have done
because she didn't have the funding to do it.
|
45,958 | 332 | 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.
|
45,959 | 332 | QUESTION:
-- Jobling, a pathologist --
ANSWER:
Jobling.
|
45,960 | 332 | QUESTION:
-- at the Preston Hospital, and it's December,
9 December 1985, I think.
ANSWER:
Yes.
|
45,961 | 332 | 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
number of units, as they are correcting this."
So again, I think it's fairly obvious what
Dr Collins is saying in the first main paragraph
there: insufficient funding for self-sufficiency.
ANSWER:
Yes.
|
45,962 | 332 | 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 plasma
targets", and you identify three points there:
"Prior to 1985 -- limited and outdated
facilities", which you've already told us about in the
course of your evidence.
ANSWER:
Yes, yes.
|
45,963 | 332 | 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.
|
45,964 | 332 | 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 what I said before -- the Centre seemed to
think, at least its laboratory staff at that time - -
not later, but at that time -- seemed to believe th at
what the hospitals needed was whole blood and that' s
what we were going to give them. And the -- we did n't
fractionate -- sorry, not factor -- we didn't separ ate
a lot of the whole blood into components as we shou ld
have done and, of course, you couldn't put it into an
146 optimal additive because we didn't have the bags an d
the money to, you know, buy them.
So that's definitely what I was talking about
and that's what I'm talking about here.
|
45,965 | 332 | 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.
|
45,966 | 332 | 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 referring to
earlier.
ANSWER:
Yes, it is.
|
45,967 | 332 | 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.
|
45,968 | 332 | 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?
ANSWER:
Yes. Yes, I mean, you're talking about a close
to 50 per cent reduction in products sent back to t he
Northern Region from whatever BPL was producing at the
time. And the Northern Region hadn't done anything
other than stood still. The rest of the world had
moved on.
|
45,969 | 332 | 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 plasma
being dispatched to BPL over that period.
ANSWER:
Yes.
|
45,970 | 332 | 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 change in plasma production was to
go full force into plasmapheresis, as the way some
other centres had done -- Leeds has been mentioned
148 before. But once I got into the job, you know,
I realised that we had a terrific opportunity to
separate a lot more blood, and instead of sending o ut
whole blood, we would produce products where we wer e
able to salvage the -- remove the plasma for this
purpose and send the hospitals either concentrated red
cells or we'd reduce that, or we sent them somethin g
in an optimal additive. So we did change our view.
We ran a small plasmapheresis operation within
the Centre. We were able to do that with very litt le
extra cost because we had the facility. We still
had -- we had the machines there, and ... you know, it
needed a bit of staffing and organisation. And tha t
produced about 4 tonnes of plasma per year througho ut
this period.
So the bulk of this change is just by changing
the amount of blood that is processed and how we
processed it. So one of the things we did was we
organised meetings with the haematologists and thei r
senior blood bank staff from across the region, and
they all came to the Centre for a day, and we were
able to present information showing them how much
whole blood they were using and how that compared t o
the rest of the country, how much whole blood was
being returned unused, and we initiated a discussio n
49 with them. And I have to say they were extremely
cooperative. I mean, you know, the haematologists
across the region understood that whole blood is no t
a good product to use, you know, generally. A few
specific cases, maybe ...[frozen screen]...
concentrated red cell products, and using plasma
products and so on as needed was something they
recognised. And they were able to change and deal
with their staff and surgeons, anaesthetists and so on
at the hospitals, and allow this change to happen.
And I think we did it in two stages. We sort of se t
a target and then we went to a second stage after
a further meeting and said, "Well, can we reduce th is
further?" And they said yes, of course. And by th e
end of that period, whole blood was a rare beast.
I mean, less -- well under 1 per cent of our output
was whole blood.
So most of this was done by working with the
hospitals, with people who understood, you know,
transfusion and blood banking.
And we also changed our manufacturing techniques
to allow us to produce more plasma per pack. We
became probably the biggest user of an automated or
semi-automated system for separating blood, the
Optipress system from Baxter Corporation, which
150 allowed us to eke out, you know, that extra 10, 20m l
of plasma from a lot of the products we produced, a t
the same time as improving the quality of the produ ct.
So it was a multifaceted change, but it was done wi th
very little in the way of capital investment.
|
45,971 | 332 | 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.
|
45,972 | 332 | 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.
|
45,973 | 332 | 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
take a year before I -- well, before I really got i nto
it. So yes, it could have been done. Of course it
could have been done. Newcastle was -- even before we
151 moved to the new centre, we were at the top of the
league table of producing whole blood. So other
centres were able to reduce it, reduce the use of
whole blood, so there's no reason why we shouldn't.
I would say that I think, and I don't have
terrific information, the Northern Region probably had
fewer haematologists in post, particularly outside
the -- you know, a couple of the bigger centres, wh ich
would have made it more difficult to do. You know,
you need a good haematologist, with good transfusio n
knowledge, who can talk as an equal to the surgeons
and the anaesthetists about this. So yes, we could
have started -- it could have been started earlier.
It would not have been as easy for me to do at this
time with so many haematologists in post.
|
45,974 | 332 | 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 around I think 1988,
which is at NHBT0001580, which had a proposal at th at
time for increasing plasmapheresis.
If we just go, however, to the graph --
ANSWER:
Correct, yes.
152 |
45,975 | 332 | 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 of plasma, nonetheless you we re
able to achieve a significant increase in
plasmapheresis collection?
ANSWER:
Yes, yes. We got us a small plasmapheresis unit, g ot
some great staff together to run it, and got it up
quite quickly to producing the 4 tonnes, and we sor t
of left it at that, because we seemed to be able to
produce plasma from other sources. And plasmaphere sis
plasma is more expensive. The physical location
within the Transfusion Centre had originally been
designed as a location for blood donor sessions, so
we -- with a very small pheresis section at the far
end of it, with room for two machines, I think --
I think that was in the original plans drawn up by
FaulknerBrowns. So we did a bit of a remake, turne d
it over to plasmapheresis, and then somewhere in th e
middle of that, with a lot of help from the staff
running that unit, we remodelled it to increase its
efficiency, using some ideas that they came up with .
53 |
45,976 | 332 | 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, "Plasmapheresis", we can
see:
"2.1 Plasmapheresis centre in RTC.
"2.2 Eight machines in operation."
He gives then details of the staffing.
And then 2.4:
"Currently there are 1000 donors on the panel
which have been recruited in the last six months."
Prior to the new centre being opened in 1985,
would plasmapheresis have been possible in the old
Regional Transfusion Centre?
ANSWER:
I don't think so. I mean that facility was crammed ,
physically not set up for this. I'm trying to
think -- I'm trying to reimagine the building. I
really cannot think of anywhere in that building wh ere
you could have set up plasmapheresis. You know, yo u
might have built another shed, another hut, in the
grounds and used it as a plasmapheresis centre but not
154 in the existing structures. I don't think so.
|
45,977 | 332 | 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 provided on request and aims to ensure t hat
any patient due for planned surgery and for whom th ere
is a likelihood that blood will be required will be
able to benefit from [it] ..."
Was there the potential for any wider use of
this, as a method of collection?
ANSWER:
Yeah, autologous is an interesting topic. I think --
and there is some documentation earlier than this d ate
where I actually sort of say I don't think it's rea lly
a very good idea -- or not that it isn't a good ide a,
but it probably isn't necessary from a safety point of
view. Perhaps by this time I was -- I'd got to
a point where, "Mm, perhaps I shouldn't be quite so
sure of myself."
And there were patients and their physicians --
sorry, their doctors, who really felt that they wan ted
their patients to have autologous transfusion for - -
155 particularly for planned surgery. So we were
fortunate in being able to offer it. It was a smal l
operation. But I was very concerned that if
autologous transfusion was carried out locally with
poor control, you had the risk of blood going to th e
wrong person or not being stored properly, not bein g
labelled properly, and that would negate the benefi t
that autologous transfusion was bringing to you.
So we did offer it. It didn't have a great
uptake. I think it's -- at the end of the contract
there's a list of hospitals who that used it in the
previous year and I can't remember if it's six in t his
document or nine. But, you know, it's a small numb er
and a small number of units. But it was an option for
people, and, you know, once you've realised --
particularly once you start thinking beyond HIV, th en
autologous certainly makes more sense. If you only
think of HIV, then, because of the very low inciden ce
in the Northern Region, it was hard to make a case for
it. But certainly with non-A, non-B, and then hep C,
the balance does, I think, change.
|
45,978 | 332 | QUESTION:
We can take that down, thank you, Sully.
ANSWER:
We should have done more earlier.
|
45,979 | 332 | 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 transfusion, in
particular the risks of viral transmission?
ANSWER:
I trained at the Royal Free Hospital which was the
centre of liver disease treatment and investigation .
So we knew a little bit about it. I was, I think,
aware that there was a problem with patients
undergoing cardiac surgery. There was a big cardia c
surgery unit in the south of England, in Hertfordsh ire
perhaps? I can't remember now.
So we were aware of a problem but at what point
between -- you know, during my training I became aw are
of that, I'm not sure. It sort of sits somewhere
back -- at the back of my mind that there was this
issue. So yes, there was -- I had some understandi ng
and then, obviously, as I went through my --
particularly my senior registrar training, where I had
to read extensively on transfusion issues, it becam e
much more apparent.
|
45,980 | 332 | 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 why that
might be the case not limited to, but including, vi ral
transmission.
ANSWER:
Mm-hm. Okay.
|
45,981 | 332 | 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 registrar.
I don't think -- it wasn't a terrific sort of --
I don't sort of see that message up on the chalkboa rd:
it's dangerous. Certainly, it was being used
relatively freely, and we were still seeing units
being given -- you know, single unit transfusions, and
the like. So I don't think there was quite as stro ng
an emphasis as Dr Contreras showed where she was
teaching students. So perhaps not as significant, no.
|
45,982 | 332 | 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 came from the
States, and certainly was aware that there were a l ot
158 of differences in the way that, you know, donations
were collected in the States, the separation betwee n
the voluntary side, under the umbrella of the ABB, and
the commercial side. So you got a sense that maybe
we're not in as bad a position as they are. And of
course, we probably weren't, but it wasn't -- it
wasn't a panacea. We weren't wonderful, by a long
way.
And so you saw that. It then gradually, you
know -- there wasn't a -- one of the documents that
has been presented to me was a journal article whic h
studies non-A, non-B in the States, I think, in --
certainly in two areas: Texas and New York, I'm not
sure.
Anyway, it's an article that you presented.
And, you know, you read that article and you see
people have taken care to develop a study over a lo ng
period of time, they've got good information, they' ve
used an independent panel to assess the recipients of
blood to see if they had hepatitis and whether it w as
significant, and they were able to test large numbe rs
of donations that went to these patients, and they
used some fairly sound statistical analyses which
showed that there were, you know, the link between the
blood and the hepatitis and the patients, you know,
159 there was a link. It was statistically significant .
I don't recall seeing that sort of information
coming out in the UK. We had some studies but they
were underpowered. They weren't powered to give us
the real knowledge we needed. And they didn't make
that firm link with patients who were getting
hepatitis. So my knowledge of it, sort of, develop ed,
I think, relatively slowly, and so I got to a point
where I -- and I put it in my witness statement -- you
know, should we have been doing ALT testing, for
instance? Yes, I think we should have been. Was
I standing up there shouting from the rooftops, say ing
should we do it? No, I wasn't, and probably should
have done more. But, yes, it took the UK -- for so me
reason, the UK seemed to have this attitude that th is
was not a serious disease, and we didn't need to do
much about it.
We've seen documents, articles, which seemed to
imply that it's not a cost effective thing to do.
There's a lot of information about, oh well, we're
going to lose too many donors. Well, heck, that's the
transfusion centre's job, is to replace the donors
with safe donors. That was what we should do and, you
know, if we lose 1,000 donors we can replace them.
You take the Northern Region, we lost thousands and
160 thousands of wonderful donors because the factories ,
the shipyards, the steelworks, closed down. We los t
those donors, but we made them up. We made up more
numbers from those losses than we would have had to
have made up from starting the ALT testing. You kn ow,
we should have been there.
As to its severity, I didn't do a lot of work
clinically to actually see it, and obviously you'll
read it, but I was very surprised by Dr Gunson's
comment around the time of HCV introduction saying
that non-A, non-B or hepatitis C, this hepatitis wa s
not a significant disease. I mean that really
surprised me, even then.
|
45,983 | 332 | 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:
No, sorry. Sorry, can I -- can you --
|
45,984 | 332 | QUESTION:
Yes?
ANSWER:
Sorry, can you clarify that? You said hepatitis C
testing.
|
45,985 | 332 | QUESTION:
B, hepatitis B.
61 ANSWER:
Oh B, oh yes.
|
45,986 | 332 | 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 I just point out, sorry. Please note that that is
not his correct name, that is an error on that lett er,
it is Dr Kesteven with a K. But anyway, thank you
Patrick Kesteven, yes, I do recall this.
|
45,987 | 332 | QUESTION:
Thank you. Yes, so you'd obviously been asked
a question about the position in 1974?
ANSWER:
Mm-hm.
|
45,988 | 332 | 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 the donor population.
Can you recall what had prompted that enquiry?
It looks as though it may have been a case of someo ne,
a recipient, getting hepatitis B.
162 ANSWER:
Yes, I -- no, I've read this letter. I can't remem ber
what the -- you know, what letter was sent, you kno w,
came through or question was sent to me about this.
I mean, you look at that, and say maybe Patrick was
being asked to, you know, make a witness statement
for, you know, for litigation. But it goes back, y ou
know, obviously a lot of years. But no, I don't
recall. I'm sorry.
|
45,989 | 332 | 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]...
|
45,990 | 332 | 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
bottom of page 6, you -- and this was about Dr Jone s
again and his choice of commercial produced
Factor VIII. So you've said:
"As I understand it, the reasons why Dr Jones
163 may have preferred commercially produced Factor VII I
were ..."
Then we've seen two of the points already
discussed, the reactions --
ANSWER:
Yes.
|
45,991 | 332 | 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."
ANSWER:
Yeah.
|
45,992 | 332 | 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 saying that? It was
probably -- and I only say probably -- from discuss ion
with Dr Collins about this. But I don't have any - -
I don't think I had anything really firm that I
could -- now that I could say that's why I said tha t.
And I don't think I can really, you know, say much
164 more on that point.
|
45,993 | 332 | 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 blood and regu lar
blood products, and I don't recall having to do any
hepatitis B, you know, look-backs. I might be wron g.
And probably the cases of hepatitis B in the
haemophiliac population, one suspects that, you kno w,
that was more an issue with the fractionators rathe r
than the Centre. And obviously the Centre produced
the plasma but the fractionators converted it into the
finished Factor VIII, Factor IX.
So I would imagine that the haemophilia
population who developed hepatitis B, that informat ion
would have been sort of fed back to the -- to, say,
BPL or, if they received commercial product, to the
commercial people, manufacturers, and so you may ha ve
seen a difference in hepatitis B rates between the two
groups. But I wasn't a -- certainly not party to t hat
information.
|
45,994 | 332 | 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 upon whether a clinician who had
a patient who might have a case of
transfusion-associated hepatitis, whether they
happened to tell you?
ANSWER:
Yeah, I don't think there was any sort of proper
set-up -- a sort of -- there wasn't like a sort of
a document that said, you know, "You will inform us ".
So I suspect that it would have been very ad hoc .
And it's quite possible that, you know, they
just -- if it was a non-A, non-B hepatitis, then,
well, you know, there's was no point in telling the
Centre because they're not testing for it. And, yo u
know, it is something that could have been done but
no, we didn't do it. But there was certainly non-A ,
non-B hepatitis around, and you saw that in one of the
documents that was presented which references an
article by another Dr Collins, at the Freeman
Hospital, Dr Collins and James and a couple of othe rs,
who actually followed up a number of cardiac surger y
patients who developed hepatitis.
So it was around, and I don't recall that
information sort of flowing back into the Centre.
166 |
45,995 | 332 | 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.
|
45,996 | 332 | 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 --
|
45,997 | 332 | QUESTION:
-- can you hear me now?
ANSWER:
-- but I can't hear anything.
|
45,998 | 332 | QUESTION:
Dr Lloyd, can you hear me now?
ANSWER:
I can hear you clearly, sorry for the interruptions .
|
45,999 | 332 | 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 right?
ANSWER:
Yes, correct.
|
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