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45,809 | 326 | QUESTION:
I think that would be
a
fair reading of
the document
,
sir
. It's certainly
a
conclusion you
could
reach.
It
is clear
, however,
that there was an issue
about donors who self-
ex
cluded from donating and
wouldn't then become known to the blood services
subsequent
ly.
Dr Hewitt has raised this point in her
witness statement and
I'm sure we will explain that at
143
a
later point
,
but I
raise
it
now simply so that I can
take you,
sir
, to the minute of
a
meeting of the
expert advisory group on AIDS of 26 November 1985.
The document is DHSC0001736. So it's
26 November 1985
.
And if we turn to the final page,
page 12
, under
the
"
Agenda item 16 Any Other Business
"
we see
:
"
Dr Tedder
,
on behalf of
Dr
Contreras asked
clinical members whether they would consider asking
sero
-
positive patients as
a
matter of routine if they
had donated blood since 1978 and where blood had been
donated
,
if they would refer their patients to the
Regional Transfusion Centre in order that recipients
of donations could be followed up."
So we see him asking
,
and
it
appears at that
stage unresolved
,
whether
those
who were identified as
being HTLV-III positive should be asked about having
given blood so that
a
look-back process could be
followed in relation to them as well.
We have identified a number of examples of
the
notification process and the look-back process
operating as expected
from
those meeting minutes
,
but
I want to just look at one particular example now
.
CBLA0000010_209, please.
It's
a
letter from October '84 from the deputy
144
medical director of the Wessex Regional Transfusion
Centre to
Dr
Snape
:
"
To confirm Dr Smith's and my own telephone
calls to you within the last day or
two
. We have been
informed that one of our male donors has been admitted
into
a
Bournemouth hospital; the clinical diagnosis
is
,
almost certainly
,
AIDS."
Then he gives the details of his previous known
donations
,
and we can see that the first one
:
"
Donation not used
.
Time expired plasma pooled
and sent to BPL
..."
The second
:
"
Whole blood donation sent to one of our
Portsmouth hospitals not returned
..
.
"
Third
:
"
FFP sent to BPL
[
giving the batch and pack
number
].
Plasma reduced blood sent to one of our
Portsmouth hospitals
and
not
returned
..."
Then fourth
:
"
Plasma separated and frozen.
"
This was
a
very recent donation.
It
indicates at
the end
of the letter:
"Regarding Donations
2
and 3
. We are
not
getting in touch with
the
clinicians involved until
the diagnosis is
confirmed
."
9 November 2021
45
But the
indication is that
they have --
or one
might read the letter as suggesting they have
identified who the clinicians for those patients are
and once
--
if the diagnosis is confirmed
,
then
they
would be getting in touch with the clinician.
This is then picked up in a further subsequent
report
.
Apologies
,
sir,
if I can just take
a
moment.
Yes
,
a
fuller report of the incident was
prepared in October
--
later
,
in October 1984
.
DHSC0001111
.
If we can
start
at page 2
,
please.
Yes.
We see on this page
a
note of the
"
Donor
condition
and
products affected
",
but if we then
go
on
to the second page, the next page, the third page of
this document
,
we see under the heading
"
2
.
Actions
to secure/recall implicated products
",
and we see
that
:
"
Dr Smith
(
Wessex
)
was informed of
[
the
]
implication of
[
the batch
]
...
and was asked to recall
all vials including any held by patients for home
therapy.
"
Dr Napier
...
was unavailable but Mr Booth
...
was informed
...
and was asked to recall all vial
s ...
including home therapy issues
.
146
"
Both telephone conversations were confirmed in
writing
..."
It
goes on to explain that various batches were
then held pending investigation
.
Then on the next
page
,
we have
a
record of the results of the
Factor VIII recall and we can see that 400
vials were
despatched to Cardiff
,
broken down in that
way:
150
were held at the RTC
;
in relation
to
Heath Park
101 out of 150 were recovered
;
Morriston 51 out of 60
were recovered
;
Carmarthen
,
36 out of 40
.
So
:
"
A
total of 338 vials was recovered
; 9
patients
received the batch
.
"
And we get similar information in relation to
Wessex.
We then have
a
note under
"
Follow-up
actions
":
"
Dr
Smith ...
was asked to report any plasma
from
this
donor despatch
ed to BPL
(
or PFL
)
within the
last
5
years. Dr Smith was also asked to
determine
whether the donor had a history of attendance
at local
special clinics more venereal disease.
"
Then
,
finally
,
there are
,
on the last page
,
observations on the incident and there's just one
paragraph that I think is worth highlighting here
,
and
that's paragraph 5.3
:
"
The appearance of this donor at three different
147
Centres within two years clearly underlines
a
fundamental problem when carrying out
follow-up
of
donor incidents of this sort. Surely central
co-ordination of donor records is unavoidable."
That's the view of Dr Snape.
Before we leave that document, I just want to
highlight the second page
,
with the heading of the
report
,
so that the next document makes
sense.
It's
noted that it's
a
summary report on the recall of the
batch HL3186
,
and we see this picked up again in the
document CBLA0000010_202.
This is
a
letter in 1988 from Dr Craske to
Dr Lane dealing with batch HL31
8
6
,
and the second
paragraph
:
"
The
follow-up
we were doing
eighteen
months ago
of this incident was bedevilled at that time by the
reluctance of Haemophilia Centre Directors to cause
,
what they considered
to
be
,
an
unnecessary worry to
their patients
,
so that a follow-up of the
recipients
who received this product
has not
been carried out in
the formal sense."
There then was reference to
a
paper that had
been published and Dr Lane's letter had prompted
Dr Craske to reopen the enquiry. Unfortunately
,
at
this point
,
we have not been able to trace that letter
148
from Dr Lane. Efforts are ongoing but
,
in the four
th
paragraph of this letter
,
Dr Craske says:
"
Your
letter prompts me to re
-
open this enquiry
,
as we
[
don't
]
know the
outcome of patients who
received this and other batches which may have been
contaminated
with HIV
. I
will consult my
files
and
let you have
a
report as to
what is
known at the
present time."
The point raised by Dr Craske in relation to the
Haemophilia Centre Directors is
a
point that's raised
also by Dr Rejman in 1992. He had prepared
a
memo to
Mr Canavan. It's
a
memo dated 6 February 1992
,
DHSC0002585_004.
We can see on the second page of
the me
mo that
the context of
it
is about financial assistance and we
can see that in paragraph 7
.
But the paragraph I want
to draw your attention is paragraph 4 on the first
page
,
which notes that
:
"...
I think
it
is important to remember what
happened to the original
'
look-back
'
pilot suggested
by
EAGANSWER:
There was considerable resistance from some
Consultants to inform recipients who might
be at risk
of HIV, and various reasons were put forward
for this
including (i)
not being of any benefit to a patient
who was likely to die from his primary disease in the
9 November 2021
49
near future and (ii)
the distress that could be caused
to
a
patient
or
his family of knowing that he was
infected with HIV
,
when he was actually dying of
another disease. There was also opposition from
some
local ethical committees
on similar grounds.
It
is
possible that the
prospect of financial gain may make
'
look-back
'
easier on this occasion."
So it's noting
,
in this context in relation to
blood transfusion in tissue
recipients
that
Dr Rejman's understanding at that time was there had
been resistance in relation to informing recipients of
their risk of HIV.
The question of the reluctance of clinicians is
also highlighted in two further documents
,
one of
which is more contemporaneous. It's December 1985
from
a
consultant -- between
--
sorry
,
let me start
again.
It's
a
document
,
a
letter
,
from 1985 between two
consultant haematologists
,
which gives us some
indication of at least what one person's view was
in
addition
to what
we
have
already noted.
It
is
NHBT0011051_01
0,
where it's noted that the screening
process had started and it was agreed that
if
any
positive donor was found their previous donations
would be traced. One such donation had been
150
highlighted to them and
,
in the middle of the second
paragraph
,
this haematologist indicates
:
"
I personally am not quite sure what the
Transfusion Service hopes to achieve by this
type
of
follow-up
but
I am
told
that
it would be helpful if
you
could
find out who received the donation an
d
in
form the Consultant in charge of the patient of this
finding. I have to ask you to
ensure
that the
recipient is not told because the worry inflicted on
the
poor
recipient would be out of all proportion to
the possible risk."
We then have an
epidemiological study that was
being run from 1986 from Bristol and there are
a number of documents from that epidemiological study
that I want to
go
to now.
The first is DHSC0002480_047. This is
a
letter
from Dr Wallington
,
who was running the study
,
to his
colleague
,
setting out the nature of the study that
was being proposed. It's
a
letter that went to the
Regional Transfusion
Centre
Directors and
it
explained
the need for further research. If we look at the end
of the first page
,
we can see that he notes the
following:
"Some patients will have been infected by
transfusion in this country
,
but as yet they have not
151
been identified. Most of these will not belong to the
high
risk
groups and will
therefore
provide
an
opportunity to study how this virus spreads
,
if at
all
,
outside of the h
igh
risk groups.
It
can also be
argued that these people and their close contacts
should be identified and counselled for their own
sakes. As you know
it
has been agreed
that
an
attempt
be made to identify and study these patients and their
household contacts."
He then notes that
:
"
The project will be co-ordinated
from
Bristol
but is totally dependent on considerable work on the
part of each Regional Transfusion Service and other
health service staff who will have
to
be
contact
ed
at
the regional level
."
He goes on towards the end of the letter to say
:
"[He
looks
]
forward to receiving details of both
donors
and
patients whose permission we have to
contact
.
Perhaps we could start with
enquiries based
on the donors picked up by
screening since last
October 14
th,
there are also
instances
in which
patients infected by blood transfusion have brought
the problem
to
light and
a
donor can be found by back
tracing."
The
focus of the study is set out rather more
152
clearly in a letter to Dr Gunson in May
19
87. The
document is NHBT0004202.
It
is the first paragraph
where you see him set out
the
point of the study:
"
As
you
know
it
has been agreed within the NBTS
that an
attempt be made to identify, help and
investigate patients who have received transfusions
which might have infected them with HIV
,
also where
necessary their household contacts."
If we turn the page, he sets out
,
in the second
paragraph
,
what he terms
"
Task
Two",
the
"
Yellow
sheets
",
which are the recipient tracing and study
,
and he says:
"
... I have
been questioned much more vigorously
on the ethics of this part
of
the study than on Donor
tracing
,
people have been very worried about the idea
of approaching blood recipients
a
proportion of whom
will be well and unsuspecting with such
a
dread
diagnosis and even more in doubt about investigation
of household contacts. Opinion has been changing
rapidly and most people now believe that infected
persons should be identified whenever possible for
public health reasons. As this part of the study will
undoubtedly prove controversial I think colleagues in
Haematology should be fully informed before being
presented with notification of
a
donation thought
to
9 November 2021
53
be
infectious."
So what I would suggest this document highlights
is that there clearly was an
ongoing controversy about
whether recipients should be informed of the risks
,
as
we
saw
in earlier documents.
Then what we have -- sorry
,
sir
. The next piece
of correspondence that we should
go
to is
a
response
from Dr Wallington to Dr Gunson in 1991.
What appears
to
have
happened is that concerns
were raised in January 1991 by Dr Contreras that
nothing had been heard about the study despite her
sending
a
lot of data
,
and what we then have is the
response from Dr Wallington in relation to that.
The document is NHBT0004810
.
What
Dr
Wallington says in the second paragraph
is:
"I think that Marcela
's [
Dr Contreras'
]
letter
expresses
a
reasonable concern. I have
so
far
received data on 84 donors on the comprehensive
questionnaire that she mentions
.
North London and one
or two other Regional Transfusion Centres including
the Manchester Centre have continued to send in
completed forms. Certain Transfusion Centres have
never sent them. Scotland has never participated
apart from
a
few forms from Edinburgh."
154
Then
there is
some
discussion of other data
gathering exercises
that had taken place
,
and towards
the end of the letter he says:
"I think at this stage we should abandon
the
study
as
I
do not
think
that we will
learn more from
it that is not being learnt from other
data gathering
efforts."
Then the final page:
"As
you
are well aware the look
back element of
this study never got off the ground
,
people were
simply unwilling ..."
Exactly what they were unwilling to do
,
whether
it was the participation in the study or undertaking
some element of the look
-
back
process
is unclear from
the
letters, and
that is something we will need to
explore further.
But
it
perhaps suggests that there were
difficulties in the
--
both
--
there was controversy
in relation to informing recipients and there was
difficulties in obtaining data
from
transfusion
centres of exactly what was
being
done and who had
been traced.
The difficulties
with look-back exercises are
also exemplified in a study
by
Dr Hewitt
,
Dr Moor
e
and
Dr Bar
b
a
ra which
was
discussed at the
IV
International
155
AIDS conference
in June 1988
in
Stockholm. The
reference is NHBT0057880.
We see here the
"
Objective
",
which was
:
"
To trace past recipients who might have
received blood components infectious for HIV.
"...
Donations were traced for
3
categori
es
of
donors
:
(
i
) current donors found positive for
anti-HIV
,
(ii) ex-donors reported positive
,
(iii)
donors implicated in cases of transfusion-transmitted
HIV.
Hospitals
were notified of involved blood
components, traced their
fate
and blood samples were
obtained
from
living recipients wherever possible.
"
Results. Previous donations had been given by
9 of 17 current donors,
4 ex-donors
and 2 identified
as anti-HIV positive through infected recipients. Of
44
blood components made, 6 were unused, 9 not
traced
by the hospital and
4
incorporated in plasma
pools for Factor VIII. Of recipients who could be
traced
;
11 were
deceased
, 8 were not infected, 3 were
anti-HIV positive and 4 were not tested. Seven
recipients were notified as infected. In
2
cases
donors were implicated
, 2
cases
could
not be solved
despite contact
of
all available donors
,
1
could
not
be
pursued due to inadequate hospital records and
2
are incomplete.
156
"
Conclusions. These investigations are
time-consuming. Hospital records are often deficient.
The benefit produced by these enquiries has been
little
,
but 3 blood recipients have been identified as
seropositive and spread to
their sexual partners
possibly averted."
That's
obviously
an extract of
a
conference
paper that was given
,
but
it
gives us some indication
of the conclusions of the work in relation to that
material.
We have
a
further report by Dr Hewitt from 1993
,
DHSC0006351_032 in tab 107.
At DHSC0006351_32
,
if we start on page 1.
So we can see there the date
it
was received by
CDSC
,
in July
19
93
,
and then if we
go
over the page we
have the
"
Abstract
",
which indicates the
"
Objective
",
which was
:
"
To study the transmission of HIV by blood
donated
from
individuals
subsequently
identified
to
be
infected with HIV
.
"
And
the
"
Design
"
of the study
,
it was
a
:
"
Retrospective study of previous donations
from
individuals
subsequently
identified as infected with
HIV. Investigation of donations from individuals
believed
to
have
transmitted HIV infection by
9 November 2021
57
transfusion. Investigation of donations transfused to
recipients later found
to
be
infected with HIV
.
In
whom the only identified risk for infection was blood
transfusion.
"
Then if we
go
down to the
"
Results
":
"Five
HIV infected recipients were identified
,
who had not previously been known
to
be
infected.
In
addition,
the RTC became aware of
2 recipients
known
to
be
anti-HIV positive but previously unreported.
All infected
in
the
recipients were transfused before
19
85 with unscreened blood or components. Of the
possible transfusion-transmitted HIV infections
,
one
third were considered not due to transfusion
,
one
third thought likely
(
without the identification of
a
culprit donor
)
and 5 donors were identified as
likely to have been responsible for
6
reported cases.
One case
could
not
be
investigated through lack of
records and one is still under investigation."
What we note in the
"
Conclusions
"
are that
:
"
Investigations failed to reveal any infection
arising after screening of blood donations commenced
in 1985
[
in this study
]
. Overall
,
42
%
of
identifiable
recipients
died within
6
months of transfusion.
Eight
of 32
...
living recipients were infected with HIV and
5
of these were newly detected through the
158
investigation. Laboratory record keeping was
generally
deficient prior to
1985
;
accurate recording
of transfusion details
in
patient medical records
remains
a
conspicuous problem up to the date of the
report. The investigation confirms
the
exceedingly
small chance of transmission of HIV by transfusion of
screened blood and blood components
...
"
So
,
again
,
something that was highlighted in
relation to early jaundice enquiries
:
the difficulties
in relation to both laboratory record keeping and
patient medical records
and
the
challenges that that
gives
rise to in a look-back process.
It's
perhaps instructive to go into the detail
of this study in relation to one element and that's
internal page 11.
Under the heading
"
Discussion
":
"
The investigation of possible
transfusion-transmitted infection is extremely
laborious and time-consuming. Investigation must be
both thorough and methodical. This involves work for
the
RTC
, hospitals,
General Practitioners
and FHSAs.
Meticulous checking of the records at the RTC and
hospital laboratory is necessary to
ensure
that the
relevant donation is traced to the correct recipients
and recorded in the patients' medical notes.
It
is
159
not uncommon to find that
a
hospital laboratory has
records of issuing
a
donation for
a
particular
recipient, but the medical notes contain no
information about the donations transfused. Such an
omission
obviously
leaves room for doubt when
investigating possible cases of
transfusion
transmitted infection. Hospital
laboratory record
keeping has
generally
much improved
since the Health Circular relating to Record
Keeping
and Stock Control
...
On
the
other
hand
, audits of
blood transfusion practice continue to show gross
deficits in the recording of information in medical
notes.
"
The
majority of cases of transfusion
transmitted HIV infection arise from blood
transfusions given in 1982-1984. As record keeping
was not satisfactory at that time, and
usually
related
to non-computerised systems,
it
can often be difficult
and time-consuming to retrieve information within the
RTC, in the hospital laboratory and in the medical
records department. Further
more
, recipients can be
difficult to trace if no longer under hospital care.
In many instances, recipients have moved home and are
no longer registered with the General Practitioner
caring for them at the time of transfusion. As
160
contact is made first through
a
doctor
a
significant
amount of time is spent in correspondence with FHSAs
,
to trace
the appropriate GP. Sometimes the RTC has
written to five or six doctors in an individual case
(haematologist, surgeon,
physician, referring
physician GP
)
without any of them
wishing
to take
responsibility for notifying the recipient. Not only
does this cause extra work
,
but
it
considerably delays
the investigation. On occasion several reminder
letters have been necessary before the RTC has been
supplied with relevant information. The period
between initiation and completion of an investigation
can be as long as one year. The more distant the
transfusion
,
the longer the investigation will take."
If we
go
to the next paragraph and just pick
it
up half
way
through:
"
It is
of continuing concern to the BTS that
there
is
no mechanism for checking whether
a lapse
d
donor has
subsequently
been reported as HIV positive
through the confidential reporting system operated by
the Communicable Disease Surveillance Centre
.
The
failure
of
professionals to ask individuals diagnosed
as infected with HIV about prior blood
donation and
then
to notify the RTC also leads to missed
opportunities to identify all recipients infected with
9 November 2021
61
HIV by transfusion
.
"
So that was the discussion of Dr Hewitt in the
study -- sorry
,
Dr Hewitt in 1993.
The final point I want to picked up in relation
to the HTLV-III look-back is the issue of donors who
didn't
subsequently
return to give blood and the
difficulties that that appears
to
have
raised and the
documents in relation to that that have been
identified.
If we
could
start with NHBT0099107, please it's
a
letter from 9 August 1991 from Dr Hewitt to
a
consultant paediatrician and if we pick up the third
paragraph
:
"
Our usual practice in reports of possible
transfusion transmitted HIV infection is to institute
a
search for the records of the relevant donors. This
we have done. As
you will
know
,
routine screening of
blood donations for evidence of HIV infection did not
start until 1985. It was in September 1983 that the
Department of Health issued advice about the exclusion
of certain individuals from blood donation who might
be at risk of HIV infection.
It is
likely that once
we have traced the donors involved in
[
X
]
's case
,
we
will
find that
a
proportion have donated since 1985
and will
therefore
have been tested for anti-HIV. Our
162
problem is what to do about the rest.
It is
possible
that one or more of the donors ceased donating before
1985 in response to requests from the Blood
Transfusion Service to self-exclude from blood
donation. In these cases, especially if we have no
recent record of an address, attempts a
t
contact with
these ex-donors have been singularly successful. We
will
,
however,
examine our
records
then
determine
what
action is necessary."
|
45,810 | 326 | QUESTION:
A.ANSWER:
SIR BRIAN LANGSTAFF: |
45,811 | 326 | QUESTION:
SIR BRIAN LANGSTAFF:ANSWER:
MS FRASER BUTLIN: |
45,812 | 326 | QUESTION:
MS FRASER BUTLIN:ANSWER:
SIR BRIAN LANGSTAFF: |
45,813 | 327 | null |
45,814 | 328 | QUESTION:
And that was the worry
?
"ANSWER:
Yes.
" |
45,815 | 328 | QUESTION:
Was the
worry directed at economics
or safety
or
a
com
bination of both?
"ANSWER:
For us
,
safety was paramount: we wished to
48
minimise exposure of patients to commercial
concentrates
.
" |
45,816 | 328 | QUESTION:
Does the article bring that out?
"
ANSWER:
Probably
not as clearly as
it
could, although
I should say we were writing against the background
of
the
[
World Health Organisation
]
recommendations of
1975. This is
a
very important document which
I suggest you read."
Then he sets out the WHO declaration
and then
continues:
"The article to which you refer picks up from that
point and attempts to address some of the consequences
of these WHO recommendations in the context of
factor VIII concentrate.
"
|
45,817 | 328 | QUESTION:
What was the reaction
from
within the
profession
to
that article?
"
ANSWER:
I cannot honestly say. As far as
I am
aware
-- virtually zero, at least outside the
Scottish
Health Service.
"
|
45,818 | 328 | QUESTION:
A
voice in the wilderness?
"
ANSWER:
Perhaps, but at that time there wasn't
a
satisfactory forum in which
a
corporate reaction
could be generated."
Then the question is put about self-sufficiency in
Scotland
:
10 November 2021
9
"...
was Scotland self-sufficien
t
in AHF
?
"
|
45,819 | 328 | QUESTION:
Insofar as you were not self sufficien
t
between 1975 and 1983, where were you buying your
commercial factor VIII concentrate?
"
ANSWER:
Yes, but this purchasing exercise was
,
as in
England and Wales
,
the responsibility of local Health
Authorities,
[
Haemophiliac
]
Centres, hospital
pharmacists
,
et cetera. We
(
the SNBTS
)
were not
directly involved.
"
|
45,820 | 328 | QUESTION:
Would you know where they bought from?
"ANSWER:
They would buy from the identical sources our
friends in England and Wales
--
primarily the
[
USA
],
because
,
to the best of
my
knowledge
,
this was the
primary source in those days."
Then you see
a
reference,
sir
,
to
the
conversation
with Ross
,
that's Graham Ross.
|
45,821 | 328 | QUESTION:
Can I read to you part of Graham Ross'
s
note arising out of your telephone conversation with
him on 28 November 1989 and ask you to say whether or
not
it
accurately reflects your views
...
"
Then the quote is:
"Appointed Medical Director of
[
SNBTS
]
in 1979.
At no time during the period he held that position did
he make any offer to Elstree to process English
or
Welsh plasma nor was he involved
,
to his knowledge
,
in
any discussions on that matter."
Then the question is posed:
"
Is
that
right
?
"
ANSWER:
Yes and no
.
As we began to develop our own
self sufficiency programme in Scotland
,
some time in
the early 1980s
it
became clear to us that our friends
South of the Border were in serious difficulties and
this had arisen because they had accepted that their
laboratory at Elstree would be inspected. We
understood
it
had been inspected and found
to
be
in
some difficulty.
It
became clear
to us that,
if
we
10 November 2021
3
operated our facility 24 hours a day, 7 days a week
[
so this returns to the shift work at PFC
],
we
could
take some pressure off our friends in England. There
would be two requirements: first,
a
modest expenditure
on increased accommodation for what we call
'
finishing
'
...
Secondly, we required permission
from
the Government to allow us to introduce
a
shift
working system. We had been anxious to introduce such
a
system since our Centre had been commissioned in
19
75
because
the
technology we had installed was quite
unique.
It
had been designed to run 24 hours
a
day,
7 days a week with a computer
looking after
it
."
Then he provides
a
little more detail about
that
,
and then the last sentence of the paragraph on
the screen:
"My predecessors had been very distressed when
the final message
came
through that we would not
required to fractionate for the
north
of
England
but
for Scotland only."
So that's going back to the earlier
period in
the 19
70s. Then he says:
"I can well remember the resultant
disappointment of my then senior colleagues because it
was thought sensible
to
have
two
major
fractionation
centres in the UK -- prima
rily
for strategic supply
54
reasons and co-ordinated research and development. My
pre
decessors decided they would not change the
engineering system as such and so that potential
capacity remained in place but all
the
associated
'
downstream
'
facilities -- packaging
[
et cetera
]
were
scaled down very substantially. When we
came
to the
1980s and were looking at our plans for self
sufficiency
and
,
as our staff had gained confidence in
running
the CVSM system
,
we were
keen
to introduce
a
shift system. One
way we thought we could get it
was to offer
our English friends some help because
,
at
that time
,
they were in
some
difficulty. We did not
offer to sell products -- we
hadn't
enough plasma in
1981 for Scotland. What we offered was our
fractionation capacity. I don't think we should
delude ourselves that if
it
had come
to
pass it would
have solved all the problems in England and Wales.
Moreover
,
we didn't do the final sums and
,
at least
initially
, the assistance would have been directed
towards
albumin production only. We communicated our
thinking to our
employing
authority, the Common
Services Agency in Scotland. I was not
,
as far as
I can recall
,
involved in direct communications with
Elstree."
Then he is asked:
55
"
And we
are
talking about 1981?
" |
45,822 | 328 | QUESTION:
A
total
lack of meaningful infrastructure?
"
ANSWER:
Yes."
Then if we just
go
over the page
,
a
couple of
final passages in this, the second paragraph down is
a
question about importing American concentrates and
58
what is said is this:
"
It
has
been said to us by
a
virologist
that
this was dirty blood
--
a
sewer of
viruses. Was that
a preception [I think that must mean perception] of
American concentrate in the Scottish Transfusion
Service over that period?
"
|
45,823 | 328 | QUESTION:
And this risk had long been recognised?
"
ANSWER:
Yes."
So there Professor Cash's views recorded in
1990
,
touching on both issues of risk and on matters
of self-sufficiency in both Scotland and England.
With apologies to everyone for depriving them of their
tea and coffee for ten minutes, perhaps we
could
take
the break now
.
|
45,824 | 329 | null |
45,825 | 330 | QUESTION:
Thank you. When do you say they made
their
final decision
as
it
were
to
go
ahead?
"
ANSWER:
July 1990
,
subject to
a
pilot trial."
Then
,
if we
go
over to page 53
,
if we pick
it
up
at 2610
,
or 2609:
"
|
45,826 | 330 | QUESTION:
So when did you say
a
decision in principle
was made
?
"
ANSWER:
I said the decision in principle that we
must test was November 1989."
Then at 2615
,
the judge says:
"
I
have three dates
on
Dr Gunson's evidence
:
November 1989
,
in principle; July 1990,
go
ahead
subject to the pilot trial; November 1990, final
decision.
"
Mr Brown: I am content with that summary,
my Lord."
Dr Gunson
,
as the witness
,
doesn't intervene and
60
say no
,
no, that's wrong
.
So it's
a
little bit
difficult to follow his evidence but my understanding
of that is that that is what his evidence was in terms
of the
major
milestones.
So
,
just for reference, that meeting in
July 1990 -- we don't need to turn
it
up -- is
PRSE0000976
.
|
45,827 | 330 | QUESTION:
Who phoned whom?
"
ANSWER:
I think I phoned her.
"
|
45,828 | 330 | QUESTION:
And
the
gist
of
your
discussion was?
"
ANSWER:
It
looks as
though
we
are
going
to have
a
problem completing these tests by
1st
July
,
perhaps
we ought to consider
a
later date
,
and I suggested
1st
September
,
to which she
agreed, and
sent
a
memo
to
Dr Metters, who was her chief,
because she
-- it
was
she I was discussing
it
with because
she was
on
holiday at the time."
Then the
judge
says.
"
There are two
decisions there then, Dr Gunson.
I want to be clear about this. There are two
decisions. The
first decision is:
it
is an essential
precondition of starting routine screening that there
be prior tests on about second generation equipment;
12 November 2021
9
secondly, consequent
upon
that,
it
is decided to
postpone
from
1st
July to
1st
September.
"Now you have told
us about the
second decision
,
but who took, and how and when, the first decision,
which
does not
appear, as
you have told us
,
either to
have
been the express subject of discussion at either
of those two meetings?"
The answer:
"
It
came
I think
also
in that discussion I had
with Dr Pickles
,
how advisable it would be
,
and
I think it then got to essential;
it was sort of
drift."
So that's what he says in evidence
,
but of
course
,
having looked at the minute of the March
1991
ACTTD meeting
,
that doesn't quite --
|
45,829 | 330 | QUESTION:
Let us assume that that body had
arranged
to meet immediately after this very important
conference. Can we assume that, please?
"
ANSWER:
Yes.
"
|
45,830 | 330 | QUESTION:
Let us also assume that before
Rome
we in
this
country had done what the French had done and had
run some extensive pilots?
75
"
ANSWER:
Yes. May I
say,
France was really the only
country that reported at Rome
to
have
done that.
"
|
45,831 | 330 | QUESTION:
I understand that, but you were
striving,
as your statements of objectives make
s
plain
,
to
maintain the high
est
standards
and
ensure
the
maximum
safety. So I am imposing
upon
you your own standards
,
Dr Gunson. Let
us
assume
first that the
Committee had
met
immediately after this very important conference
;
secondly that we had done
some extensive pilots before
that conference
; third
that Dr Cash
and
Dr Gillon had
got their act together about drawing up donor
counselling
and
documentation; fourth that people like
Dr Lloyd had approached their local funders
to say,
'We
will need some money'; fifth,that everyone had
said, 'Well,
we
will
have
to wait for the excise
licence
,
the export licence
,
but we do not have wait
for
FDA approval
'
; and
sixth, and
this is the one
where we will perhaps part company and I identify
it
for you, Dr Gunson, everyone had been prepared to say
,
'
We think
there
is
a
confirmatory test just on the
horizon.
It
is desirable but
it
is not necessary
to
have
on the same day
'
. If I make all those
assumptions
,
we
could
have started
,
could
we not
,
at
the turn of the year
?
"
ANSWER:
With those assumptions, yes."
76
He then goes on to give some evidence in
relation to FDA approval
,
which I think we've looked
at and then if we pick
it
up, please, at page 27
,
at
the bottom of page 27, Mr Brown
,
1344:
"The only other matter that you identify
,
making
all the assumptions I did about the best will in the
world and moving
forward and trying to maintain the
obligations
you set yourself, subject to the need or
the desirability for
a
confirmatory assay, one could
have introduced
it
at the turn of the year?
"
|
45,832 | 330 | QUESTION:
We have looked at why they
could
not.
It
is questions of funding
,
good
will
,
matters
of
that
kind
.
They have most
move
d earlier.
"
ANSWER:
Building
,
possibly
.
"
MR JUSTICE BURTON
:
What do you mean
'
if
',
because you are the
man
who would know
?
"
|
45,833 | 331 | QUESTION:
Sticking with England and Wales
,
if at any
rate that is the figure you have, about how many
donors does that represent?
"
ANSWER:
Something in the order or 1.5 to
1
.6 million.
" |
45,834 | 331 | QUESTION:
Just one other general question
:
what is
132
the broad turnover in the donor population? How many
donors do you lose
a
year?
"
ANSWER:
From retirement
, illness, donors moving
from one venue
to another
,
it
is something in the
order
of
12 to 15 per cent per year.
"
|
45,835 | 331 | QUESTION:
People just
getting busier
and
--
"
ANSWER:
And
stopping
, yes."
Then if we
go
,
please
,
to NHBT0000146,
it
is at
page 95, this is Dr Gunson giving evidence on
24 October 2000
,
and if we
go
to the bottom of that
page
,
he is still being examined
-
in
-
chief
,
at this
stage
,
by his counsel Mr Underhill
:
" |
45,836 | 331 | QUESTION:
What you say in paragraph 20 is that the
blood
sup
ply within the service was
a
constant source
of concern and during the period with which we are
[
go
over the page
]
concerned here
,
you spent several hours
most days
ensuring that blood supply met demand
throughout the country.
"
Is that an exaggeration?
"
A
.
No,
it is
not an exaggeration at all.
I spent
a
long time
, and
so did many other members of
the
staff at the Directorate
,
trying to
locate
centres
who
could
supply
blood
to other centres
,
where there
was
a
shortage
."
So we know here that he's talking about
11 November 2021
33
post
-
creation of the National Directorate
:
"
The critical day
,
I
have
to tell you
,
in the
week was Friday
,
when most of
our
time was spent on
this activity
,
and it was made more difficult because
even those centres who had
a
good stock of blood did
not particularly want
to
give
it
away
,
in case they
had emergencies they were unaware of come in during
the weekend and they
could
find themselves then short,
so
it
took
a
great deal of persuasion to obtain
agreement to transfer blood from
,
say
,
Sheffield to
London.
"
Q
.
Yes.
"A
.
But the London centres all had
difficulties
,
virtually
,
on
a
daily basis
,
particularly, I have to say, North London, where they
have to
supply
a
large number of teaching hospitals."
Then the last passage,
sir
, is NHBT0000148_001
,
and this is evidence given on Thursday, 26 October
,
you can see at the top there
,
and this is during
cross-examination.
If we go to page 5
,
he gives some evidence about
the supply in Manchester. If we go down to
line 226 --
in fact,
221
,
we had better start
at
the
question. Halfway through line 223:
"
...
just give us
a
feel for how you say the
134
problem of supply was between these years
1987 and
1991
,
that sort of period?
"
ANSWER:
W
ell
,
between 1987 and 1988 I was the
director of the centre in Manchester and I was not the
national director.
Therefore
I just ran
a
transfusion
centre like my colleagues. We had considerable
difficulties at certain times of the year,
particularly during the school
holidays and
particularly around Christmas time, when we had
a
significant drop in donors, and it was always
extraordinarily difficult then to catch
up and
there
were several instances during that period, 1987/1988,
that
hospitals had to cancel routine surgery because
there was insufficient blood
available and this got
into the
press
on a number
of
occasions."
Then he says:
"When I became the National Director
,
I
established this system
of
having
--"
Then there's
a
discussion about when that was
and he says
down
at 243:
"I established
a
system where
by
each transfusion
centre sent me their stock levels for that day and any
requests that they had for shortages of
blood
and
we
then
,
in the National Directorate
,
endeavoured to
supply this blood
from
other centres and indeed from
135
Scotland as well.
"
|
45,837 | 331 | QUESTION:
Were you successful during that period?
"
ANSWER:
During that period we were extremely
successful. There was not
,
I do not think
,
one
critical
report in the
press
during the whole of the
periods until 1993."
Sir
, then can we turn now to DHSC0002195_044
.
This is
a
document
--
I think this is the document we
just looked at
.
|
45,838 | 332 | QUESTION:
Dr Lloyd, can you see and hear me?
ANSWER:
I can. There is a slight delay in your voice but,
yes, I can hear you clearly, thank you.
3 |
45,839 | 332 | QUESTION:
I'm going to start by just getting an overview of y our
medical career. You took up your first house offic er
post in 1975; is that right?
ANSWER:
That's correct, yes.
|
45,840 | 332 | QUESTION:
Then, between 1975 and 1979, you had various house
officer and senior house officer posts with no
particular emphasis on haematology or transfusion?
ANSWER:
That's correct.
|
45,841 | 332 | QUESTION:
Then, in 1980, you had your first placement at the
Northern Regional Transfusion Service from 1980 to
1981, as a locum registrar; is that right?
ANSWER:
That is correct, yes.
|
45,842 | 332 | QUESTION:
What led you to that post?
ANSWER:
I was following what would be considered a traditio nal
medical career, working my way up the ladder, I gue ss,
and at that time working in neurology at Newcastle
General Hospital, I felt that a career in what one
might call the traditional medical format was not f or
me. I watched some of my colleagues trying to move
through the grades doing research jobs, for which t hey
were neither qualified nor interested, and I decide d
to look for something different, and it was very mu ch
by chance that I came to the Blood Transfusion
Service.
|
45,843 | 332 | QUESTION:
In the course of the year or so that you were there ,
74 at that stage, you spent, I understand, some time i n
each department of the Centre and you've explained you
would review donor information and also you became
involved in blood banking and component production and
the introduction of automated blood grouping, among st
other tasks?
ANSWER:
Yes, that's right. I can't remember the exact mome nt
when we started work on the automated grouping. It
might have been while I was still in the locum
position it might have been after I obtained
a substantive registrar position. But it was about
that time we were trying to move from manual
operations to a little bit of automation.
|
45,844 | 332 | QUESTION:
Then from 1981 to 1983, you were a registrar in blo od
transfusion and haematology and, as I understand it ,
that involved receiving training and experience in
haematology, pathology and microbiology at the Free man
Road Hospital; is that right?
ANSWER:
Yes, and some clinical biochemistry. So it was all
the pathology departments in a big general hospital .
|
45,845 | 332 | QUESTION:
You also, during that period, had a secondment to P HL;
is that correct?
ANSWER:
Yes, I went to the Public Health Laboratory Service ,
which had laboratories actually based in the same
building as the Transfusion Service in Newcastle, a nd
75 that was mainly to look at virology.
|
45,846 | 332 | QUESTION:
You also, during this period, had a further period of
time at the Regional Transfusion Centre; is that
correct?
ANSWER:
Yes, that's right. It was officially a rotation, s o
I came back into the transfusion centre.
|
45,847 | 332 | QUESTION:
Can you remember of that period '81 to '83, can you
remember approximately when you were back in the
transfusion centre, which year it was?
ANSWER:
It was likely at the end of that rotation, so proba bly
1983. I think I would have started off the rotatio n
by going to the Freeman hospital, and then coming b ack
to the transfusion centre at the end of the period.
|
45,848 | 332 | QUESTION:
You tell us in your statement that your time at the
haematology department at the Freeman Road Hospital
provided insight into hospital blood banking, use o f
blood products and clinical issues arising from
transfusion. What kind of issues arising from
transfusion do you recall encountering during that
period of your work?
ANSWER:
Well, the Freeman Road Hospital housed Newcastle's
cardiothoracic unit, so there were a lot of patient s
receiving fairly high volume transfusions and plate let
transfusions and support for their coagulation stat us.
So the issues that arose, we would see quite a lot of
76 patients with non-specific reactions to transfusion ,
raised temperature, perhaps rigors, and so on. So
there would be some investigation to make sure ther e
wasn't an obvious serological reason for it but
I don't recall any other really major issues.
I think we had one case of a major transfusion
reaction and, I think -- and I really only think --
that that was a case of a unit of blood being
incorrectly -- being given to the incorrect patient
and caused a major reaction.
So we saw some serious things. I do not recall
anything that was related to non-A, non-B, for
instance, but then that's -- I don't think people w ere
looking as hard for it as they might.
|
45,849 | 332 | QUESTION:
We'll come back to that at a later stage of your
evidence, that issue.
ANSWER:
I'm sure.
|
45,850 | 332 | QUESTION:
1983 to 1987 you were then a senior registrar in
transfusion and haematology, spending time in each of
the three main teaching hospitals in Newcastle. So
would that be Freeman Road, Newcastle General and t he
Royal Victoria Infirmary?
ANSWER:
That's correct.
|
45,851 | 332 | QUESTION:
You had a period at the Haemophilia Centre, the
Newcastle Haemophilia Centre, at this time. Can yo u
7 remember which year that was?
ANSWER:
No, I can't now. It would have been at my -- towar ds
the -- in the latter half of that period, because
I think I started at the Freeman Hospital then the
Newcastle General, and then the Royal Victoria
Infirmary, and it was while I was at the Royal
Victoria Infirmary that I would have had a period
working in the Haemophilia Centre. So yes, towards
the -- in the second half of that period.
|
45,852 | 332 | QUESTION:
How long, very roughly, were you at the Haemophilia
Centre?
ANSWER:
Very roughly -- very hard to remember now -- probab ly
four weeks. I doubt whether it would have been
longer. There were so many other things to fit int o
that period of time.
|
45,853 | 332 | QUESTION:
And you had then also during this period of your wo rk,
a further period at the Regional Transfusion Centre ?
ANSWER:
Sorry, you froze then but I think you were asking i f
I had a further period at the transfusion centre?
|
45,854 | 332 | QUESTION:
Yes.
ANSWER:
And that's correct, yes.
|
45,855 | 332 | QUESTION:
And you did the second part of your MRCPath exam
having done the first part earlier in the 1980s.
ANSWER:
Yes, yes.
|
45,856 | 332 | QUESTION:
Then in 1987 you took up a post as a locum consulta nt
78 haematologist at the transfusion centre, and then
June 1987 to October 1988 you were a consultant
haematologist at the transfusion centre.
ANSWER:
Yes, that's right.
|
45,857 | 332 | QUESTION:
What, in broad terms, did that role as a consultant
haematologist entail?
ANSWER:
I had obviously -- sorry, I shouldn't say obviously .
I had quite a number of -- I spent quite a lot of t ime
with interactions with the individual haematologist s,
particularly when products were requested. It was not
unusual for there to be shortages of platelets,
particularly, and so we'd be discussing how --the
condition of the patient, their platelet counts.
I also looked at information from donors. At
the blood donor sessions there was a book which was
used to make notes about any particular donor. If
there was something that the clerical staff or the
nursing staff felt warranted further investigation,
a note would be made and each day that list would b e
looked at and I took my turn at doing it and someti mes
would discuss with others who were doing it what wa s
found, were the donations that they had made suitab le
for use? And obviously in some cases we felt unabl e
to use them.
I also became perhaps more involved in
79 management than would be normal for that position,
including sitting as the Centre's representative on
union negotiations with staff over changes that we
were hoping to make.
|
45,858 | 332 | QUESTION:
And then November 1988 you became the director of t he
Northern Regional Transfusion Service. I think you r
title at that point --
ANSWER:
Yes.
|
45,859 | 332 | QUESTION:
-- was medical director and then later became chief
executive?
ANSWER:
I think I was medical director and general manager.
Excuse me. Sorry, this is a problem I have.
I was director and general manager from the
beginning. It was some years later that we
...[frozen screen]...
|
45,860 | 332 | QUESTION:
Sorry, you froze then, Dr Lloyd, and we lost the
last --
ANSWER:
Sorry.
|
45,861 | 332 | QUESTION:
No, no, not your fault at all. We lost the last bi t
of your answer.
ANSWER:
Yes, I was medical director and general manager fro m
the beginning, and then it was several years later
that we reorganised a bit and I became just the chi ef
executive. We also of course at that time, around
that time, were able to appoint a new consultant to
80 become the head of our medical services.
|
45,862 | 332 | QUESTION:
And when you took up the role as director in
November 1988, your predecessor Dr Collins moved to
the clinical haematologist role; is that right?
ANSWER:
That's correct, yes.
|
45,863 | 332 | QUESTION:
I want to ask you next a little about the Centre, i ts
facilities and its arrangements. I've just mention ed
Dr Collins, that was Dr Anne Collins, and prior to
her --
ANSWER:
Yes.
|
45,864 | 332 | QUESTION:
-- appointment, it was Dr Sheila Murray. Who was
director; is that right?
ANSWER:
That's right. I met her on one occasion in 1980 ju st
as the transfer from herself to Dr Anne Collins too k
place.
|
45,865 | 332 | QUESTION:
In broad terms, what was the geographical reach of the
Northern Regional Transfusion Service?
ANSWER:
It had a very wide geographical area to cover, one of
the largest in England and Wales, with some large
areas of low-density population and a few very high ly
dense pockets of population. So it covered -- it
actually took in a little piece of North Yorkshire,
which was not part of the Regional Health Authority 's
remit, the Northern Regional Health Authority's rem it.
It then, from there, went up to the Scottish border
1 and, across to the west side, it took in most of
what's now called Cumbria. We did a little bit acr oss
the border and I think we sort of snuck into Gretna ,
but we did not -- there was a small area of south
Cumbria which we did not cover. Transport links we re
very poor and it was covered by the sub-centre at
Lancaster.
|
45,866 | 332 | QUESTION:
Now the centre which you first worked at in 1980 wa s
based in the Institute of Pathology in Newcastle
General Hospital, and I think had been since the
1950s.
ANSWER:
Yes.
|
45,867 | 332 | QUESTION:
Can you describe to us the facilities there and how
adequate or otherwise they were for their purpose.
ANSWER:
Yes, that building I believe was opened in 1956. O ne
floor was dedicated to the transfusion service and
that would have been at a time when there was very
little in the way of processing blood into componen ts,
and very little testing -- I think probably only th e
syphilis test -- and so there was not a lot of spac e.
By the time I arrived there, several things had
happened to that facility. The basement, which had
never been intended as a laboratory area, part of t hat
had been converted to make a facility for processin g
blood into components.
82 A second -- and it only came back to me the
other day -- there was a second laboratory annex,
a wooden structure, elsewhere on the site, Newcastl e
Hospital site, which was being used for the infecti ous
disease testing, at that time hepatitis B and
syphilis, but also had a facility for producing
cryoprecipitate.
Then there was a second hut which housed the
donor services department, where all the donor reco rds
were kept.
So when you look at it, it -- to me, even then,
it was a very old-fashioned set-up, a little bit so rt
of cobbled together with these sheds, these huts, a nd
the basement facility.
The laboratory equipment was generally old, and
laboratory benching -- by today's standards, you kn ow,
one would be horrified at the wooden benches and
people actually brewing up tea in a laboratory,
I recall.
The other facility was a garage housing the
vehicles. The vehicles were old, not in great
condition. Some of them the refrigeration systems
were very basic as well for transporting the blood.
So it was ...[frozen screen]... in the 1980s.
|
45,868 | 332 | QUESTION:
Again, I'm afraid we lost a few seconds then,
83 Dr Lloyd. You said it was, and then we missed
a little and then you said, "the 1980s".
ANSWER:
Okay. I think it was -- yes, I said something like :
it was pretty outdated, even by the standards of th e
1980s.
|
45,869 | 332 | QUESTION:
An adjective a use in your statement to describe it ,
in fact, is "Dickensian"?
ANSWER:
Yes, sorry about that. Yes, it was in some ways. The
thing that sort of struck me was that we would see
blood grouping being performed and the results were
transcribed by clerks sitting on high stools at woo den
benches with great big ledgers. The entries being
made in pencil, which of course would be a complete no
...[frozen screen]... after doing repetitive tasks,
which did give you that feel of a Dickensian office .
|
45,870 | 332 | QUESTION:
I'm going to ask you to look at a document with me,
Dr Lloyd, just so that I can pick up one point from
it.
Sully, can we have NHBT0101335_052.
ANSWER:
Sorry, can you say that number again?
|
45,871 | 332 | QUESTION:
NHBT0101335_052, it should come up on your screen.
ANSWER:
I was trying to pull it up, but a little too fast f or
me there.
|
45,872 | 332 | QUESTION:
Have you got it, Sully?
84 ANSWER:
No, say it again? 0101?
|
45,873 | 332 | QUESTION:
Sorry, we're just having to reload it on to
our system here, Dr Lloyd. NHBT0101335_052.
ANSWER:
052. Is that going to come up for me?
|
45,874 | 332 | QUESTION:
It should come up on the screen in front of you,
Dr Lloyd. Can you see it now? It should be displa yed
on the screen on which you're talking to me?
ANSWER:
Yes, it has. Okay. Right, I --
|
45,875 | 332 | QUESTION:
It should now be in front of you. So it's a letter --
ANSWER:
Yes --
|
45,876 | 332 | QUESTION:
I'll read it. My screen is not working,
although if everyone else's is, that's fine. I've got
a hard copy.
The paragraph towards the bottom of the page
beginning:
"Finally, the concept introduced" --
ANSWER:
Yes, I have it.
|
45,877 | 332 | QUESTION:
"-- that the Centre was designed and commissioned f or
200,000 donations per annum shows a lack of
understanding of current blood transfusion practice ."
This was the sentence I wanted to ask you about:
"The original submissions for this building of a
new Transfusion Centre was made in the 1960s, at wh ich
time 200,000 donations seemed appropriate. When th is
Centre was actually planned, transfusion practice h ad
changed dramatically, but to avoid major delays it was
decided not to make a new submission to the DHSS.
A decision was made to go ahead and build within th e
confines of the original schedule of accommodation. "
Now, as I understand it --
ANSWER:
Yes.
|
45,878 | 332 | QUESTION:
-- the service moved in 1985 to a new purpose-built
centre but do we understand from this that it was
a purpose-built centre based upon designs and think ing
86 from decades previously?
ANSWER:
No, that's not quite the case. I think in this
document and this paragraph, what I'm saying is the
Regional Health Authority to allow themselves to go
ahead and build a new centre at that time, what the y
felt was fairly quickly, they didn't want to go bac k
and make a whole new submission to the DHSS.
So they went ahead using the original envelope
of the submission, but what was produced internally
had no bearing on the original -- I never saw the
original submission, but the new building was, to m y
mind, well built. I thought the design was very go od.
There were a few little bits you could argue about
but, in general, it was well built, well designed.
The architects spent a lot of time on trying to
make sure that the flow of people and materials wit hin
the building were logical. They grouped department s
next to each other where material was required to m ove
between them. So, for instance, the donor services
department which didn't actually handle the physica l
-- you know, the material, the blood, was on an upp er
floor. The dispatch department was fairly close to ,
you know, the loading bay.
So my feeling was that it was well designed, it
was up to date and this particular phrase I can
87 understand does give a slightly strange impression of
the building.
|
45,879 | 332 | QUESTION:
We can take that down, thank you.
Do you have any knowledge of why, it apparently
having been identified in the 1960s, that there was
a need for a purpose-built proper centre, why it to ok
until the mid-1980s for that to be realised?
ANSWER:
No, I have no idea. The only thing that comes to m ind
is one of the documents that you submitted in that
final group was a document from Dr Sheila Murray to ,
I think, Mark Sackwood, the Chief Medical Officer a t
the RHA, in which she discusses issues of introduci ng
more plastic bags and producing more cryoprecipitat e.
So maybe that was a time when there was a sudden pu sh
to produce more cryoprecipitate and, also, you know ,
platelet transfusion was presumably starting to bec ome
a possibility, but maybe that was a bit later.
So it may have been, and I only say may have
been, that Sheila Murray was pushing for a better
facility to produce particularly cryo.
|
45,880 | 332 | QUESTION:
If I can ask you next to look at -- and again it
should, I hope, come up on the screen in front of
you -- TYWE0000052_005.
ANSWER:
I'll get that up for you. No, sorry it's not comin g
up on mine --
88 |
45,881 | 332 | QUESTION:
Don't worry, it should, I hope, come up on ours
shortly.
ANSWER:
-- and it hasn't come up on the screen yet.
|
45,882 | 332 | QUESTION:
Our document system is struggling today. TYWE --
ANSWER:
Yeah, I did -- yeah.
|
45,883 | 332 | QUESTION:
Dr Collins's letters.
ANSWER:
-- one of these poorly legible.
|
45,884 | 332 | QUESTION:
Yes, it is. I'll read out the relevant passages. So
it's from Dr Collins, it's dated 3 October 1986.
ANSWER:
Yes.
|
45,885 | 332 | QUESTION:
So, by this time, the service has moved into the ne w
centre. It's addressed to Dr Donaldson --
ANSWER:
Yes.
|
45,886 | 332 | QUESTION:
-- the Regional Medical Officer at the Northern
Regional Health Authority, and I'm just going to re ad
out the first four paragraphs.
"Dear Liam
"Your letter of 24th June requested
a comprehensive survey of modern Blood Transfusion
medicine, as well as complex information not readil y
available from our many complete but manual recordi ng
9 systems. Getting it out is very laborious.
"As you are aware, we are understaffed at senior
level and now have no purely scientific staff. Thi s
means that the increasingly complex clinical and
scientific problems have to be handled largely by
myself. Being virtually single handed during the
summer I have not had sufficient time to devote to
this report.
"However, Dr Lloyd has rejoined us on the Senior
Registrar rotation and is well experienced in the
workings of the centre from within and also as a us er
of the Service.
"I have discussed all these matters with him and
he has been working hard compiling this preliminary
report."
The question I want to ask you rising from this
document is really about the staffing situation by
this time, 1986, and you obviously then returned fu ll
time to the Centre in 1977. What do you recall abo ut
the staffing problems that Dr Collins is referring to
here.
ANSWER:
The problems, I think, were quite significant. Ann e
Collins, as the director, I don't think -- there wa s
no other full-time consultant. There was some
clinical assistants -- I think they called them
90 clinical assistant grade -- but their ability and
their knowledge range was extremely limited. So
really, she was working very much on her own. The
support from the others there at the time, the othe r
medical staff was really -- didn't touch on what
I would call significant clinical issues or the, so rt
of, management of the Centre.
So yes, she had a difficult time. Very little
support.
|
45,887 | 332 | QUESTION:
Then if we look at a report which may, I think, hav e
been the report produced that's referred to in this
letter. It's NHBT0101 --
ANSWER:
I can tell you, NHBT -- (overspeaking) --
|
45,888 | 332 | QUESTION:
-- 332_045.
ANSWER:
332 -- that is the one, you're correct.
|
45,889 | 332 | QUESTION:
Good. So hopefully it will come up on the screen
again in the not too distant future.
Yes, NHBT0101332_045. Thank you.
So we can see there a page which has various
sections set out. If we go over the page, we can s ee
section 1 is "Major products and services provided by
the Northern Regional Transfusion Centre", and then we
can see it's red cell products, fresh plasma produc ts,
time expired plasma, platelet concentrates, reagent s,
and then reference to the transfusion laboratory an d
91 antenatal laboratory.
ANSWER:
Yeah.
|
45,890 | 332 | QUESTION:
Then if we go to the next page, I wanted to ask you
about this next section. So headed "Whole Blood":
"This region has a relatively high demand for
whole blood. There are many periods during the yea r
when whole blood is not available in the quantities
requested, despite some whole blood being returned
'out-dated'.
"Reasons:
"(a) Previous patterns of use. Whole blood has
tended to be freely available.
"(b) Many surgeons and anaesthetists find it
easy to have whole blood available for operations.
Plasma blood is available in most cases.
"(c) Hospital blood banks maintain stocks of
whole blood for emergency use for major trauma and
massage haemorrhage."
Then there are "Comments", four comments:
"(i) Pressure of reduced whole blood supply will
force some change in use.
"(ii) Education at hospital clinical meetings
may help accelerate the changes.
"(iii) Changes in hospital blood bank policies
in consultation with clinical departments can reduc e
92 the level of requests.
"(iv) Optimal additive red cells provided
acceptable alternative to whole blood in most
instances."
Then you go on in the next part of the document
to talk about the optimal additive red cells.
What essentially was the issue here that you
were recounting in 1986 about the use of whole bloo d?
ANSWER:
Well, if you looked at the amount -- the percentage of
donations that we produced that were issued as
whole blood, it was high compared to other parts of
the country.
I had a chance to look at some figures from
elsewhere around the country so I was aware that we
were, if not at the top, very close to it. I think we
probably were the highest issuer of whole blood, an d
that sort of seems to go back -- when I was in the old
centre in the early part of the 1980s, the laborato ry
manager always pushed very hard for us to -- for wh ole
blood. To the extent that the Centre production st aff
were sometimes unoccupied because blood that was
expected to be converted was not being converted, i t
was being left as whole blood.
It was a strange situation. We were collecting
blood into multiple bag packs designed for producin g
3 multiple components, and yet we left it as whole
blood, clipped off the extra blood packs and threw
them in the waste.
So there is a long history in this Centre of
using whole blood, issuing it. And if you look at
that, the Centre really, I don't think, had an
opportunity to discuss these issues with the
hospitals. But also, most -- many to the hospitals
outside sort of the two bigger centres, sort of lik e
Newcastle, had no haematologist. The blood bank an d
haematology was operated by -- was overseen by
a pathologist. So that was not their specialty. A nd
there was a big push by Professor William Walker at
the Royal Victoria Infirmary to get haematologists
into all the hospitals in the region and that was
successful.
So it would have been hard to make a change at
that time and we were putting out lots of whole blo od.
A second point, and that comes up in another
article -- another document, is that -- and I think it
was from Anne Collins -- that we are trying to prod uce
blood -- optimal additives or sometimes referred to as
SAG-M, saline-adenine-glucose-mannitol, the optimal
additive, saying you don't give us -- you have the
money to produce this product on a regular basis.
94 This product is a good alternative to whole blood, but
if we can't produce it on a regular basis, on
a consistent basis, then the individual hospital us ers
are not going to change over to it.
So we had a sort of a little bit of
a chicken-and-egg situation there. And so yes, it was
a lot of whole blood, and the demand appeared to be
there but that's possibly because the education had n't
filtered through that whole blood is not a good
product for many patients.
|
45,891 | 332 | QUESTION:
Just picking up --
ANSWER:
I hope that answers your question.
|
45,892 | 332 | QUESTION:
Absolutely. Just picking up your reference to the
document from Anne Collins, CBLA0001800, please,
Sully.
This is a report by Dr Gunson. If we go to the
second page -- if we just go a little closer, pleas e,
Sully, into the table.
ANSWER:
I know the document.
|
45,893 | 332 | QUESTION:
So we've got the reference there: Northern Regional
Transfusion Centre:
"1984-5
"- Does not expect to separate more plasma than
1983/4. Cannot obtain finance for SAG(M)."
And then "1985":
95 "Has been unable to initiate discussions on
plasma supply with RHANSWER:
Could not in any case
increase supply in present premises. New RTC shoul d
open in 1985/6."
Then:
"Confidence ... in ... achieving target.
"Not hopeful of obtaining necessary funding."
|
45,894 | 332 | QUESTION:
So that would suggest --
ANSWER:
I'd say that -- if I might say, there is another
document where Dr Collins specifically mentions
the problem of erratic supply of optimal additive, or
SAG-M, so there is another document, and I'm sorry
I can't remember it, but I have seen it. So yes,
there's more than one reference to this problem.
|
45,895 | 332 | QUESTION:
And then if we pull up CBLA0002392.
ANSWER:
Oh, yes.
|
45,896 | 332 | QUESTION:
And if we could go to page 165, please, Sully.
This is a document you drew attention to in
a recent addendum to your statement, Dr Lloyd.
So we've got table 11:
"Number of units of red cell products made
in 1985/86."
Then if we look at the regions on the left-hand
side, as I understand it region B is the Northern
96 Region, is that right?
ANSWER:
In this table. It's different in different tables.
So you can't use B across everything.
|
45,897 | 332 | QUESTION:
Well, that's useful to know, thank you, Dr Lloyd.
And we can see there highlighted for us on the
screen the relevant figures, which show, if we look at
the figure under the heading "SAG(M)" a very --
ANSWER:
Compared to most of the other centres.
|
45,898 | 332 | QUESTION:
Exactly, a very modest use compared to the other
centres.
ANSWER:
You know, it's not only a modest use, it is --
emphasises the fact that you couldn't provide this
product on a regular basis. If you only make 2,000 in
a year, you can't offer it as an alternative to
whole blood.
|
45,899 | 332 | QUESTION:
And if we go two pages further on, please, Sully, t o
page 167.
This is the second table you referred into your
addendum statement, Dr Lloyd. Table 13. I think t his
is -- region B is still the Northern Region in this
table, and we can see there the percentage --
ANSWER:
Yes, a little group.
|
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