Cervical Cancer Inquiry Hearing Thurs 27 April
THURSDAY 27 APRIL 2000
THE HEARING RESUMED AT 9.30
A.M.
DR BOYD (On former oath)
XXD MS JANES
(continues)
Dr Boyd, just following on from where we
finished last night, I was puzzling overnight, we have in
the media at present the virus that’s infected the beehives
and we have the Ministry of agriculture and forestry who
have either themselves or contracted to carry out a random
audit of selected beehives in order to ascertain the extent
of the problem. Now, given that there were several
indictors of concern in relation to Dr Bottrill’s laboratory
starting firstly in 1989 with the general practitioner
indicating concern about lack abnormals reported over a
period of 3 ½ years, the visit two months later by the
visiting medical practitioner and the comments in relation
to firstly Dr Bottrill not wishing to increase his workload
and the now well known “laid back to the point of falling
over”, and if I can take you to your exhibit 26, this is in
1990, and obviously was the result of a survey of private
diagnostic medical laboratories and if I can turn you to the
third page in, that is Dr Bottrill’s response to the
questionnaire, and you’ll see on the bottom % of smears
being reported as abnormal and the response has just been
question marks. Did the Department of Health at that stage
particularly given the year earlier issues raised about the
lack of abnormals, was any action taken as a result of what
could only be seen to be an inadequate response or in the
kindest light a clear misunderstanding or inability to
answer the question – was that followed up by the
department.
MR HODSON: that question would need to be
put to the response from at least one other laboratory,
which is 2 pages down, which is if Dr Bottrill is inadequate
this is a complete failure
CHAIR: I see no reason why
Dr Bottrill can't be used as one example
MR HODSON: I
don't have a right to come back, but where the question is
coming from, counsel for the commission, it should be
complete.
CHAIR: if you are going to go beyond Dr
Bottrill, it may pay to break the question up.
MS JANES:
given the concerns raised in 89 with regard to abnormals and
the visiting practitioners report and a year later this
response to the survey which indicates either a lack of
understanding about what is required or an inadequate
response, did the department of health take any issue or
make any connection in relation to Gisborne laboratories at
this stage ..... to answer this first I would like to go
back to many brief of evidence where we described this
particular survey, which of course was being carried out to
fond out what information was available to the department at
that time to be able to build on, and I believe that that
was related in my previous evidence. As far as selecting
out any one laboratory for follow-up as a result of this,
the answer is no, and the reason is that there is
insufficient data and what the Ministry or department learnt
was that with handwritten records it was very difficult for
laboratories to provide back data over the years and that
was the main result of this survey was that you couldn't
carry out surveys of this type, using this particular
methodology. So it was not a statistically relevant survey,
it had no validity and the answer to your question is
clearly no, no one laboratory was selected out for further
investigation as a result of this inadq data.
Given
therefore that as my learned friend has pointed out there
were obviously misunderstanding or an inability to fill out
these forms, what steps were taken by the Department of
Health to make sure that meaningful and valid data was
available so that these necessary comparisons could be made
..... quite obviously the main one was to introduced a
cervical screening register where this data was collated,
regionally, and could be interpreted nation wide and not to
use the data that had been held in the laboratories
themselves.
But Dr Boyd we've heard over many days of
many expert groups and advisory
Committees that said the
register does not work until you can correlate the histology
and cytology. Was it reasonable for the department to be
placing reliance on the register at that stage, knowing that
the correlation did not occur until 1997 ..... I don't
believe that a register does not work without the linking to
cytology, obviously that was the aim and objective to link
the two, even though they weren’t to be on exactly the same
data base. And I believe it could be shown that collection
of data through the register can have great value and it’s
ridiculous to suggest otherwise
CHAIR: I noted you said
cytology, did you mean histology ..... yes, that would be –
cytology and histology to be linked, thank you ma'am.
MS
JANES: we know the histology data was being received in
hard copy from Ms Glackin’s evidence but her evidence also
was that there was no ongoing annual correlation being taken
with result to the cytology register. How then were those
quality measurements and correlation being undertaken .....
firstly, there was the expectations that laboratories would
form a relationship with their local colposcopists and
obstetrics and gynaecology surgeons and I think as has been
explained considerable times over, work was being done to
get the histology and the cervical cytology data linked, it
took longer than expected. This questioning started with
could you use the data that was held in the laboratory
itself and depend on that, and the answer came back this
was, to my mind, no.
So we've got this survey in 90,
which was intended to provide some measurement against which
laboratories could gauge their performance, but clearly that
the information that came back was inadequate, ..... that is
correct it was to give baseline data on cervical smears
because there were no national records kept up to that point
and it proved conclusively that you couldn't use the data
that could be provided by the laboratories from their day to
day work, particularly historically .
And then we had the
Norton review in 1993, which is at Ms Glackin’s exhibit 25,
volume 5, would it be correct to say this review was carried
as a result of the Department of Health indicating in 1992
that they would be providing the Programme Managers with
averages so that they could monitor their results in the
laboratories in their areas ..... I can't make that link
specifically, you may have found it somewhere in the
information. I can't at the moment make that link.
But
going to the Norton review, on p2, it’s an executive summary
of the results, are you aware what the Department of Health
did as a result of the Norton review of laboratories or was
it again just information that came into the Department of
Health and disappeared into the labyrinth ..... my exhibits
which include the minutes of the cytology liaison advisory
committee are quite clear about the discussions that the
national co-ordinator and the programme held with the
Advisory Committee about this report. I wouldn't describe
that as disappearing into a labyrinth.
On p2 it addresses
issues of internal/external quality control, and it
indicates 13 of the 18 community local laboratories, in
particular in the Royal College Quality Assurance programme
and 4 of the 12 hospitals. Did the department take any
steps, either to encourage or influence the other
laboratories to similarly participate in those programmes
..... my answers are going to sound somewhat repetitious but
this was written before June 1993, and it was the
expectation that the TELARC accreditation would be required
by which time all laboratories doing cervical screening for
the programme would be accredited and that would be an
expectation that they would undertake the external quality
assurance agreed. The standard at that time said there was
no perfect external quality assurance programme but firm
expectation that and encouragement to participate, so at
this stage again the dependence was on laboratories
preparing themselves for accreditation during the year
1993.
CHAIR: and was the Ministry aware that nothing
was happening in that regard ..... it’s hardly nothing, 13
out of 18, I guess was the report they got tat this stage
were already participating – it obviously wasn’t
complete
If the Ministry was relying on the TELARC
accreditation as the quality control measure and if it’s
expectation that all laboratories would become TELARC
accredited was not being met in 93 in the sense not all
laboratories were TELARC accredited then, why didn't the
Ministry direct that only TELARC accredited laboratories be
used to read cervical smears for the screening programme.
..... ma'am, they didn't require that up until July the 1st,
that would have been difficult if you accept one legal
opinion. After June 30th, from July 1 93 on, the funding
became a Regional Health Authority responsibility and of
course was being covered in the funding agreements although
we've learnt the funding agreements didn't carry on in the
same way. This was definitely a time of hiatus but it was a
time of changeover and one mechanism was not going to work
after June 93 anyway.
But the Department of Health and
then the Ministry would have been aware that it was going
through structural changes and therefore mechanisms would
have worked on wouldn't work under new changes. Why wasn’t
something put in place so that the accreditation happened
more quickly than it did ..... my answer, in hindsight, your
question should be posed the other way, mechanisms that
didn't work were being replaced – there was a very strong
expectation from government that mechanisms provide a funder
split would work much better because contracts would set out
the requirements and you didn't need change the law to
change things. So I guess that was the attitude at the
time, that mechanisms such as the Social Security Act which
had not given you a way to buy quality were being replaced
by something that did. We've seen that it took time for
this to bed down longer down than everybody would have liked
now, but that was not the attitude of the government towards
the changes in 93.
The contractual system being operated
would have involved the contracts going through negotiations
..... yes, which was much better than before, there was no
opportunity to negotiate.
As the Department of Health for
example if you take the amendment to the health act in 93
which provided power for an opt off register that was a
piece of legislation that the department was able to promote
and once passed it effectively allowed for an opt off
register didn't it ..... yes
And equally the department
could have promoted legislation once a decision was made to
run a cervical screening programme which would allow for
aspects of the programme such as quality control and any
other matters it was concerned to see implemented quickly
have a vehicle for doing so via legislation ..... again, I
think we've heard the evidence, the opt off legislation took
some years to come through it is not as easy as some people
might infer from your question, and any legislation is
possible, I can find no evidence that was sought at the time
and again I would have to say great expectation was put on
the replacement of old fashioned Social Security legislation
with something newer which allowed the person buying the
service or the representative of the Regional Health
Authority buying the service to closely relate with say the
laboratory or any other provider that they were actually
contracting with.
Given that there was this great
expectation that the new system would work better, who in
the Ministry was standing back monitoring the new system to
see that the great expectations would be met ..... that is a
very difficult one to answer, a system was set up to monitor
the performance of the Regional Health Authorities, we will
hear more about it, and obviously the different services
represented amongst the different branches of the Ministry
would be looking to see what was happening to the svce4 they
were involved with. Obviously it wasn’t going to just
suddenly appear before them within months as something where
they could see the dramatic changes. So it was done on a
full expectation that there would be improvements in the way
controls could be put on what was purchased
And that
quality was to be of a high order not matter what the health
service being purchased was
Is there a danger when there
is a number of players in a system more fragmented than a
centralised system that gaps will appear and therefore there
will be greater delay before there is a response to
expectations that are not being met ..... yes. I'm not sure
I should give opinions about the health reforms, there have
been a lot we have all lived through, so fragmentation was
actually one of the objectives was to break up a monophony
purchaser and introduce the element of competition into
health care services, but that was government’s intention,
and that was felt that you would get better volume of
service and better quality of service by bringing that
keenness into the exercise
When it came to the
laboratories reading the smears there was no element of
competent brought in, there was no requirement to tender for
contracts to read smears for the screening programme was
there ..... as it was, I think you will hear from the
Regional Health Authorities they rolled over the provisions
under the Social Security Act and their strongest indicators
of cstg for the first year were to reduce the colposcopy
waiting lists and increase the enrolment. Selected
indicators which were prioritised and the two important ones
they were to report against were those two.
MS JANES:
if one had grade one legislation because it was considered
important what time frame would it take for that to pass
through ..... legislation is so variable it has there are so
many factors involved, if its budget night it goes through
in 6 hours, if its anyone I'm interested in it takes 6 years
or more or never gets done. That’s the variation. That's a
fatuous answer to really say it is extremely variable, it
depends on the priority that government of the day can give
it and wish to give it and also what support there would be
in parliament without going through a select committee
process without calling for public consultation.
What
power did the Ministry have to influence the priorities of
government with respect of health and the National Cervical
Screening Programme ..... again that would vary at different
times with the seniority of the Minister who has a special
interest with the amount of interest and with the rest of
the legislative programme, and in this case health would
have been taking a major part of the legislative programme
with introducing the health reforms overall it would be only
conjecture as to where a specific piece about laboratory
service would fit amongst all that major health reform
legislation.
If there was general consensus on a
particular issue would that make it easier for the
government of the day to feel that that could e passed in
more haste than the 6 years ..... consensus amongst
whom
For instance on the issue of accreditation, on the
one hand you've got the Ministry and the Minister committed
to accreditation in the 91 policy to be effected by 93, and
you have the laboratories who have been advised of that
policy agreeing to the policy because they believe they have
been given sufficient time to implement and therefore it is
a fair pool. ..... you may well have to ask the
representatives of the private laboratories if that was the
case at the time.
There is a document which was notes of
a meeting of the private and community laboratories
indicating that they were so. I will try and find that
document ..... I'm not sure what the date was for that
meeting, and I'm not saying you're wrong, I don't know I can
confirm that in 1993, all the laboratories would say they
were at a consensus point. It’s a lottery which I'm not
prepared to bet on now
My concern is if we take the
proposition that the government of the day is committed to
accreditation by 93 and you have no conflict with the people
that is going to be imposed on and overlaid with that is the
concern with the restructuring taking place in 93 did it not
have been a reasonable step is that correct particularly
given that the other quality assurance measures were going
to take loner to implement that the government passed
legislation making accreditation compulsory for laboratories
that were to participate in the National Cervical Screening
Programme ..... I think it would take a better brain than
mine to put all those factors into a computer and bring out
an answer because I don't think my brain could, it obviously
wasn’t attempted at the time, there were lots of things
going on that you've listed, and I don't know what
weightings to give to all those factors.
The question is
why was the one simple thing that was readily achievable had
no conflict by either party involved not bedded in before
the Ministry felt that they lost control as a result of the
contracting to the Regional Health Authorities in 93 .....
are you defining legislation as a simple Act just done like
that
Can I put it to you it would have certainly taken
less time than the 6 years that it has taken for
accreditation to be compulsory for a regulation to have
been passed ..... well it wasn’t, and I don't see any
documents that suggest that any work was developed and it
was taken through the system.
CHAIR: is it correct to
say that, given the philosophy of the day, in terms of
relying on commercial arrangements between a defragmented
health system, that the notion of the Ministry using
legislation either primary legislation or subordinate
legislation was completely foreign to that philosophy and
wouldn't have been contemplated for that reason ..... again
I'm not able to say that that was the case. I can imagine
that you would have an extremely difficult job to put in
legislation about one piece of the health sector requiring
central controls of it when the philosophy of the day being
led outside the Minister of Health or Department of Health
by a health reform directorate responsible straight to
government was that the health department was not the
appropriate place to be having those controls. I wouldn't
have liked the job of pushing it through, I see no evidence
that anybody contemplated that or worked towards it.
MS
JANES: is it not the case that the department was actually
resistant to the idea of regulating laboratories at this
time, and I refer you to Ms Glackin’s volume 14, and the
meeting minutes of the Programme Managers on the 23 July
1992, about half way through the volume, the minutes
immediately prior are 4 December 1991. ..... I've got two
versions, done in different type face, but if it starts
laboratories and says that Cytology Advisory Liaison
Committee had requested regulating of laboratories, that’s
what it says, and that’s what it said the year before, when
of course already the TELARC requirement was there and was
in the policy and was known by all the laboratories. And by
then it was expected during the new year TELARC
accreditation would become a fact for all laboratories
working with the programme.
Given this expectation and
the reliance placed on that expectation, what was the
department doing to ensure the department was meeting that
expectation and adhering to the policy ..... I believe that
would be one of the reasons for the Norton Report, to see
just what activities were taking place in laboratories to
meet 4.1.4, is it, of the policy? Certainly, the department
did not go around to visit laboratories and audit them, so
they sought out information in the form of the laboratory
report from Valerie Norton.
But not all the laboratories
actually responded to the Norton review did they ..... no, I
believe that’s in the text, it doesn't – I'm not sure – no
they didn't all, and it was a questionnaire, 18 out of 19
community laboratories and I believe as we've already said
in evidence, we have searched, we have talked to the author,
the author’s manager at the time in the Christchurch unit
and the raw data is not available in archives and that’s New
Zealand archives, its not available in the Ministry’s
archives and it’s not held by the author and the unit of
course has closed down.
Is it not correct that the
ministry place such reliance on accreditation and their 99
policy for the reason that accreditation ensured that at
least once a year in a cursory manner and every 4 years a
full audit was carried out, that would actually ensure that
there were internal quality control processes within the
laboratories and also that there were satisfactory
participation in external quality programmes as well as the
normal certification management procedures in place. Would
that be fair as to such importance was place on
accreditation ..... I haven't seen it written down just like
that – that sums it up, yes, it was an example of the
optimum regultry model where the regulator, government, sets
standards, agreed with the industry being regulated, and the
industry itself contracts the auditors to provide the
assurance that they are in fact meeting those standards and
have the systems in place to continue to meet the standards.
So it’s descried as the optimum regulatory model which were
introducing into food, hospital licensing, and it was
obviously being used here in laboratory services.
So is
it also fair to say that as long as laboratories were
accredited the Ministry would have a degree of confidence
..... a degree of confidence only because I've already
agreed with Professor Duggan some days ago that just having
accreditation from a third party auditor cannot guarantee
safety or quality of service but it is a degree and a
significant degree of assurance.
Given that you seem to
believe that the department did not have the ability to
legislate, which I would question because we have seen
superannuating go overnight, so where there is a will there
clearly is a way, putting that to one side if there wasn’t
the necessary commit to passing legislation for
accreditation was there not the alternative that in
providing contracts for the service of the programme that
the department could specify that only accredited
laboratories should qualify for reimbursmt under the
programme and I take you to Glackin 11, ..... first of all
before you do, laboratories were never reimbursed under the
programme with the Social Security Act, they were reimbursed
for providing cervical cytology as part of their
laboratory's services,
But we have seen under the Social
Security Act there was the ability to make it a condition
..... we have discussed that with a previous counsel, that
there was ability for the Minister to make conditions, that
would obviously have to be consulted upon, we agreed that
I could have drafted a discussion paper and a paper for the
Minister supporting that, knowing that was an ability under
the legislation, the answer has to be no, it was not done,
dependence was placed on the forthcoming TELARC
registration.
But we've seen that registration was not
forthcoming, would it not have been an alternative that
contracts would only be honoured or contracts were put in
place that only TELARC or some other accredited laboratories
should e entitled to participate ..... you're talking after
July 193 when contracts were to be managed y the Regional
Health Authorities
We've seen between the period 91 to 93
which is the period first set for accreditation to take
place that didn't happen for whatever reason, and no
legislation was put in place, and no regulation was put in
place despite the fact that there was no resistance from
either the laboratories or the Ministry, so if that was not
a viable alternative would it not have been cost effective
and efficient in the funding agreements that took place in
93 for it to be a condition that only accredited
laboratories be utilised for the cervical screening
programme ..... I'm going to say I don't know because I
wasn’t party to the funding agreements with the Regional
Health Authorities nor was I party to how best endeavours
got placed in there in many places and I'm not privy to how
the Minister at the time wished to set out those funding
agreements.
If I can take you to Ms Glackin’s exhibit 11,
volume 3, and the minutes of Cervical Screening Advisory
Committee held on 12 December 91, p2, the third paragraph
after “Matters Arising”, you've been and about the Rotorua
concern so we won't traverse that again, but if I can take
you to the second paragraph after the Society of
pathologists have recommended that the Rotorua registry
become TELARC registered, it says: “If the laboratory does
not … after 1993” ..... correct, that’s what it says. It
doesn't say who would enforce that or how it would be
enforced – I don't know who wrote this or who is being
quoted or if it – it is difficult to see how this would be
applied without all the qualifiers.
We have a range of
very sound expert recommendations contained in minutes and
reports ..... where is this a recommendation, it’s a
statement of a discussion and I'm not sure who said it or
how it’s reported, nor does it say how it would be
applied.
Clearly it was considered to be an option that
if a laboratory was not accredited after 93 that no further
smears should be sent to that laboratory. Could that not
have been adopted across the board by the Ministry – this as
an expert committee after all ..... but it’s not a
recommendation of an expert committee, you answered your own
question previously I believe by saying you would have to go
through the process of getting the Minister to put on a
condition of funding under the Social Security Act. I don't
see any reference to any of that here, and in some ways this
is like the reporting of this inquiry with the headlines
being based on a statement in a question from counsel not an
answer or the documents.
Putting the media to one side,
how did the Health Funding Authority or the Regional Health
Authority in 96 manage to put in place compulsory
accreditation when the Ministry was clearly not able to do
so ..... I believe you will have to ask them, I presume this
was contracting, working in the way that the 93 officials
would have expected it to work.
Why was that expectation
not in place for the 1993 contract round ..... it wasn’t and
I can't give you that answer
MR MURRAY: there is a
point that arose yesterday, but I think I should interrupt,
the question is being questioned about factual matters and
he is not a lawyer. It is fair to this witness that this
issue be identified.
CHAIR: I have difficulty in
understanding this point. What is of interest to the
Committee of Inquiry is whether the obligation was being
discharged and in what manner it was being discharged.
MR
MURRAY: there is an Act that has to be factored into this
line of questioning.
CHAIR: what is bothering the
committee is under the funding agreements it does say the
responsibility for the laboratories will remain with the
Ministry of Health and that is why the Ministry of Health is
still being and about this.
MS JANES: understanding
you are not a lawyer, your knowledge and understanding of
the functioning of the Ministry, was there any way that
accreditation which was both cost efficient and effective
given that other measures would take longer, was there an
availability to bed down that one quality assurance area
before control went to the Regional Health Authorities .....
you haven't asked me that before and the answer is I am sure
there was a possibility, and you did quote me previously as
saying we have no ability, that isn’t so. There was a
possibility, it was not used, and my feeling is that it
would have been extremely difficult but no one tested
it.
Given that there appear to have been a significant
number of concerns referred to the Advisory Committees over
a period of time, and in your evidence at p38 it goes
through the procedure for steps to be taken if there appears
to be inadequate performance. Was there a repository within
the Ministry of Health where all these strands, whether they
be from the local Programme Managers, the national
co-ordinator, the public as we've seen there was the letter
from Dr Hitchcock, there seem to be a plethora of places
where concerns channelled through the cervical screening
programme, where would they have ended up in such a way that
they could have been correlated and some action taken .....
I think p38 sets out the expectation at that time, the
national co-ordinator and Cytology Advisory Liaison
Committee as it Was then agreed that if the cervical
screening register identified a problem and I would take
that to be if there were identified problems with
laboratories from any other place than the register, that
first it would be with the national co-ordinator who it was
agreed would be discussing with the Chair of Cytology
Advisory Liaison Committee on a monthly basis at least
issues arising. They would decide whether to take it to the
committee for advice or I'm sure in some cases the national
co-ordinator would work on the advice of the chair of the
committee alone. So, yes, letters get addressed to
different people within the Ministry about the programme, my
perception is that they would have ended up in the hands of
the national co-ordinator who then, if it was a laboratory
issue, discuss it with the chair of the Advisory Committee
and the full committee if appropriate and the action would
be referred back to the Ministry or the national
co-ordinator for the Ministry because the Advisory Committee
would have had no disciplinary powers or no rule making
powers.
CHAIR: you mentioned p38 of what ..... I was
referred to p38 in my brief at the beginning of the
question.
MS JANES: you are correct that the Advisory
Committee’ had no disciplinary function, neither did the
national co-ordinator role have any disciplinary function.
Are you aware that the procedure for referral through to the
Ministry who was the only body certainly in 1991 to 1993
that had any ability to direct or enforce or take action,
was that procedure working in practice ..... there are
examples where the examples I've given, the information
certainly got to the national co-ordinator who certainly
sought advice from an expert in the field. So, there is
evidence there that it was operating. I wait for you to
find me one case where it didn't.
CHAIR: who between 90
and 93 had any disciplinary function in respect of the
programme ..... that’s over – it depends which service we’re
talking about and which sort of provider, if you start with
non-medical smeartakers they don't have a disciplinary
process but I would imagine there could be some pressure put
to no longer contract with them or to no longer use their
services. Medical discipline, there is a disciplinary
process and as counsel have pointed out there was the
ability for ministers to put conditions on but it was never
used over laboratories using cervical screening at that
time, but I said in my evidence on the first day, the threat
of non payment was always something it was believed kept
service providers in line, so that would have to be referred
to the Ministry itself over that period of time – it would
be referred to another branch of the Ministry. That would
apply to laboratories and doctors providing services under
the programme and obviously there would also have to be
thought about what are the controls over staff idn the
abnormalities running the cervical programme and presumably
if there was national concern over a particular Programme
Manager or their competence you would go to their employing
Area Health Board.
So the national co-ordinator had no
disciplinary function, did she ..... no, I believe she
employed a small number of staff of her own, over whom there
would be employee/employer controls – she didn’t have power
to discipline.
In terms of the cervical screening
programme as a whole there was no one person who had
disciplinary control over all aspects of the programme was
there ..... no.
And is it correct to say there was no one
entity that had disciplinary control over all aspects of
the programme ..... no, and that’s partly a factor of there
being no new service developed, this was built onto existing
services.
I think your answer is yes rather than
no.
MS JANES: but the national co-ordinator was charged
with identifying issues and potential problems and dealing
with them proactively, Ms Glackin’s tab 2, p3. but given
that she had no disciplinary function and the committees
had no disciplinary function it was reliant on some
communication taking place between either of those two
entities or individuals to the Ministry wasn’t it for
something to actually occur ..... if were talking the
national co-ordinator of course she, and it was always a
she, was an officer of the Ministry so it was a matter of
talking to the appropriate branch or section of the Ministry
if there was action to be taken about a funding issue an
issue of refusing payment or putting controls on a
laboratories services bought from them, and I see no
evidence that it got to that
Who in the Ministry would
she have referred those recommendations for non payment or
other sanctions to be imposed ..... first it would have been
the medicines and benefits section which was part of the
break up of my clinical services division, then that became
just the benefits section and medicines went off on their
own. There was a manager of a section which managed health
benefits over all that period of time.
Dr Boyd, the panel
asked yesterday about the incidence of cancer in the
Tairawhiti/Gisborne region at the period under review of the
inquiry. If I can just show you this media release. The
first paragraph indicates that the incidence of cervical
cancer in Gisborne was up to 40% higher than it was
nationally during the period being examined by an inquiry
into the pathologist Dr Bottrill. The second paragraph
indicates that in the same period, both Northland and Bay of
Plenty had a higher incidence of cervical cancer also. .....
no, than Gisborne.
And that raised the possibility that
the differences are due to the ethnicity of the local
populations and not the possible reading of thousands of
cervical smears. It further goes on in the bottom part,
that Dr Feek said that all three areas figures were affected
by the fact the cervical cancer rate amongst Maori women was
about double the rate in the general population. I just
want to refer you back to the laboratory comparisons that
were done in 1996, which is tab 29, but I actually want to
produce the full report that was done by the
Ministry.
CHAIR: what is the basis upon which the
newspaper article is being produced at the moment.
MS
JANES: the relevance being with the laboratory comparisons
the panel asked questions about the rate of incidence and
how comparable the statistics were given there may be
different socio economic, demographic and disease indicators
that had not been extrapolated and therefore the data was
not comparing like with like – to give an indication there
are areas where the prevalence of disease is higher than the
national average.
CHAIR: we need to be sure that the
statistics reported in the article are correct. ..... I
can't look at them and say whether they are correct, I can
report that after our briefs of evidence were written, I
believe, we in the Ministry pulled out from our national
health information service data for Nick Mailing to use, and
we provided him with the figures – whether they have to be
transposed correctly, it would take time to work out.
MS
JANES: perhaps the press release from the Ministry could
be provided.
CHAIR: the registry data is the best
data. You could ask Dr Boyd to comment on the statistics,
and if you are happy the press release could go in later
..... I think it was based on a press release – it must be
in written form somewhere.
MS JANES: do you believe it
would be your impression that the statistics for Northland,
Gisborne, Bay of Plenty figures provided in that article
would be based on those collated by the Ministry ..... that
would be m y expectation, and there are always a lot of
qualifiers that go out with incidence and death rates of one
disease in a small population such as Gisborne, Bay of
Plenty and Northland.
I understand that statistics may
not particularly be your background, but is it not correct
that in order for statistics to be meaningful a similar set
of assumptions would have to be applied and if there are
divergences between different regions they would need be
taken into account in order to make comparisons meaningful
..... they have to be taken into account by somebody reading
the numbers, they may not actually have been taken account
of in creating the numbers because the numbers are just
cases/hundred thousand, so some of those qualifiers have to
be on how you read the data, just as we were hearing about
the laboratory reports yesterday.
I reclctd one of your
answers to the panel questions on these laboratory
comparisons yesterday was that they compared like with like.
Is it your understanding, based on that answer, that
somebody within the Ministry actually collated the data with
similar regions and made the necessary adjusts to be able to
obtain an average, under tab 29, the larger series, the 96
full laboratory report. ..... I think I’d want to know what
it is you are asking, these are numbers of reports put out
by the laboratory and those there had to be work done on
those because there were duplicates in the register and
there was tidying up to be done of that data, however, they
don't relate to rates of disease/hundreds thousand of any
ethnic group or population nor do they draw a boundary
around a region in which the laboratory received the smears,
so all those things have to be taken into account when you
compare these results with those results.
I'm not a
statistician either but in trying to think through the
issues we understand that Gisborne has a higher rate of
incidence, there is a significantly higher proportion in the
region that are of Maori ethnicity and we understand that
they have up to a double rate of incidence of cervical
cancer, and we heard from Ms Glackin that in the early
stages in Tairawhiti it was the high risk groups that were
targeted on the opt on system. it seems to me that with the
combination of those factors, that there should be
abnormality readings in the higher of the national. Range,
not at the lower of the range, which is where Dr Bottrill’s
laboratory was reporting. Are you able to comment on my
statistical analysis, whether that is reasonable ..... I
heard you make one assumption which might alter the whole
thing, you made the assumption that targeting for the opt on
and I don't understand what that meant, certainly people
were targeted with advice about getting smears and were
sought to come to have smears from the high risk groups at
the beginning of the cervical screening programme . that
doesn't tell me that they necessarily opted on and got their
names on the register in those first years, you've made an
assumption, I don't know how you could verify it.
But
given that that was the evidence we heard, that they were
the individuals who were first targeted or invited to
participate in the programme ..... no, they were invited to
have a cervical smear and they were told about the programme
and the publicity was part of the programme, but there's
nothing to say that they then made a decision to opt on or
not opt on – you've made that assumption.
Given that we
have a region with the higher incidence and high Maori
population which has dlbed the incidence would it not be an
expectation that the reporting of abnormalities would be in
the higher range rather than the lower range ..... that is
certainly a reasonable assumption to make and it was obvious
to me that was the line of questioning before, but I am not
able to confirm who it was, which parts of the population
were the Maori chose to opt on or not, so you are making an
assumption, you are apparently asking me to confirm
something which seems reasonable, but that’s as much as I
can confirm.
CHAIR: as a public health specialist
having that information before you would you make that
assumptions yourself ..... it seems reasonable but there may
be other factors who attended, who opted on, but if there
was a higher incidence of disease amongst the people having
smears then certainly you would expect more positives and
its obviously fm the positives that you get the false
positives
So you would make the assumption but qualify it
with that additional knowledge that you didn't know at the
time the nature of the people operating on the scheme e
..... it may not be a big factor at all, it only came to me
when we thought about this overnight, but it’s not
necessarily an explanation and there will be more the
inquiries hears about false positives and also you have the
opportunity to speak to epidemiologists, particularly
Professor Skegg is interested in those people who develop
cancer of the cervix and follow them through
You would
make the assumption but it would be a qualified assumption
..... it would be qualified.
MID-MORNING ADJOURNMENT – 11A.M. TO 11.15A.M.
CHAIR: Dr Boyd, before the morning
adjournment when you were being questioned about the
incidence of disease in Gisborne at p637 of the notes of
evidence you were asked about the assumption that you would
make as public health specialist and I said to you “so you
would make the assumption … the scheme” and your answer was
“It may not be a big … overnight.” Could you tell me who
the “we” was ..... did I say we, if I did, that must have
the Royal “we” 0- no, I'm afraid I didn't discuss this issue
with any – no the rate of cancer I didn't discuss with
anyone, the laboratory results this morning I did discuss
with the author because the inquiry was wanting to know her
qualifications, so no I don't have any other expert or legal
advice on that. it says operating, but I am sure we were
opting on.
CHAIR: yes, you are quite correct.
MS
JANES: just concluding the questions in relation to these
comparisons, are you aware whether the person responsible
for collating the results of this review actually took into
account regions that had similar demographics, similar socio
economic profiles ..... not in compiling those results. It
was the matter more of getting the data correct about what
the laboratory had actually reported and that there was only
one report per case. So, no, it did not and quite clearly
in the results do not reflect any demographics offer the
region being covered by that particular laboratory
Would
it be correct to say no real meaningful extrapolatns could
be taken from the data ..... I don't believe that’s
reasonable to say at all. I think I pointed out yesterday
that the type of information continues, has continued to be
provided to laboratories and they themselves have, as part
of their analysis, looked at the populations they serve and
have been able to explain to their satisfaction to people
who might have questioned them, some of the variation for
their own laboratory.
PROFESSOR DUGGAN: this document
highlights variation in laboratory reporting between the
community and hospital laboratories ..... yes
And there
were questions from the Programme Managers with reference to
these variations ..... yes.
As well, you weren’t able to
tell me whether this variation was discussed by any of the
Advisory Committees or the professional associates of the
pathologists ..... I wasn’t able to point you to it I
believe that in discussions I've had with Programme Managers
and previous co-ordinators in the recent past are that these
results were taken to the - I think it was the cytology
Society where all the pathologists meet who are involved in
cytology – we don't have minutes of those meetings, but I
think that they were discussed in that forum. But they were
also provided to the laboratories for their own internal
use.
Yesterday you said to me that these documents would
be falsely reassuring to an individual laboratory, is that
correct ..... I think I would have agreed on something like
that, without the laboratory knowing or understanding its
local population.
What assurance does the committee have
that the laboratories do actually review these documents
within the context of these limitations of the design .....
I can't give you that, I think I have said everything I know
about how they’ve been used, so I can't give you the
reassurance you're looking for and I hope somebody else
would be able to who later appear before the inquiry.
I
would like to repeat that they can be falsely reassuring,
and in fact would you agree that they can be meaningless if
they are not critiqued within the context of their design
limitations ..... I defer to your judgement on that. I
guess in bringing them along I did not see the limitations
as you have seen them, but I will defer to your knowledge on
this, yes, if yes is the correct answer. So, yes, I agree
that yours seems a very well founded argument.
CHAIR:
the limitations were not expressed anywhere in any
communications to the laboratories were they ..... I can't
find any evidence of that, no.
MS JANES: you've
indicated that laboratories have received other comparisons
similar to the 96. how regularly were they receiving these
comparisons ..... Certainly I've been told that the more
recent ones are 6 monthly and I think I refer to this
somewhere in my brief of evidence that they caught up with
the time lag so that they were about 3 months behind when
they got their 6 month report in the more recent
times.
Would that be similar in form ..... I understand
the format’s similar, they aren't of course on our files and
that’s what I've been told
Who would have copies of the
performance comparisons generated since this 96 document
..... I believe they were sent out electronically, they are
part of the register, so that is where I’d expect them to be
with the current cervical screening register but they may be
in electronic form now and not hard copy to provide just
like that.
Is it the expectation that these are sent to
the laboratories and it’s very much at their discretion how
they apply the comparisons as a quality control mechanism
..... I think how it’s used currently would be better with
the people who are running the register at the moment,
certainly they are sent to the local Programme Manager and
obviously they would form the background of discussion at
Programme Managers meetings, but there's little in my
evidence to record that except the concerns that you've seen
and that have been referred to.
We've heard a lot about
the laboratory concerns that have been generated from
various parties involved or interested in the programme. Is
there any point where in the department there is a person or
a section who would have access to those concerns as well as
the statistical data that is generated so that there would
be comparisons capable of being made that may alert the
department to potential issues in laboratories servicing the
programme ..... up until the time that the Register was with
the department then the Ministry of Health it would
certainly be the register, the national co-ordinator and up
until 96 the cytology liaison advisory committee. After
that time I would think it would still be the national
co-ordinator and the manager of the Register as part of
running the programme.
And would the national
co-ordinator then have referred it to what department or
section in the Ministry if there were concerns to be
followed up ..... depends what the concerns are, but the
most likely one would be that up until 93 it could have been
one for funding, in which case it would go to the health
benefits section, after 93 it would go to - probably the
first call would be the relationship manager for the region
in which that laboratory was sited.
So would all this
information eventually be centralised somewhere ..... within
the cervical screening programme and on its files and in its
memory would be the central point. There isn’t another
Ministry section which is collecting information on all
points about cervical screening.
Was there not a problem
therefore, I understand there were, the staff turnover was
reasonably significant and resources were a problem. Is
that perhaps an issue as to why there was not the
institutional knowledge of concerns raised, ether about the
Rotorua laboratory in 91 and 93, or Dr Bottrill’s laboratory
in 89 and 90, to be able to make the necessary connections
for the alarm bells to be ringing and for some action to be
taken ..... I don't know I can answer that specifically yes
or not, there were staff turnovers, there is a filing
system, there is some continuity amongst the Programme
Managers and the other people that the co-ordinator relates
to, but it is always possible that staff turnovers can lose
you institutional memory.
You indicated yesterday that
quality mechanisms or quality assurance was a difficult term
to define. But would it not be fair, given all the expert
recommendations we were certainly able to extract several
principles of quality assurance – for instance did the
department agree that quality assurance would be provided
through provision of previous smear histories for
laboratories reading for the programme ..... having the
previous results available was considered an issue for
getting the best quality results from the reading of the
present smear, and I understand the availability of them to
the laboratory. If the woman has been on the programme,
then that availability has been there all along.
But
there was a problem with the 14 registers and a mobile
population ..... that certainly was a limiting factor on
somebody who had moved and whose own clinical notes hadn't
moved with them to the new general practitioner or
smear-taker who hadn't collected a full history before
sending the smear off to the laboratory. So that if they
didn't have the report it would be known where the report
could be found.
And would you agree that another quality
factor identified early by all experts and the committees
was the urgent priority of correlating the histology and
cytology which didn't happen until 1997 ..... throughout
that’s since long before the programme was established
that’s been seen as an important measure of the functioning
of the smear-reader.
And another aspect that was also
considered important by all of the Expert Group s and
committees was the need for accreditation because it takes
into external and internal quality control measures .....
again, that has been a long term issue, and so it has been
repeated by several committees right from the very early
meetings.
And the last plank of quality assurance that
was universally agreed upon was evaluation and monitoring
was it not ..... that’s more difficult to define, but yes,
any programme that’s set up should have some indicators of
its own performance and some targets which are within its
own control to meet. And those are quality
features.
Given the implementation of a programme such as
a National Cervical Screening Programme, how reasonable does
the Ministry believe it’s been, the time elapsed for each of
those 4 quality control planks to come into effect .....
regarding the last one, there were targets set on outcomes
from the programme and they’ve been more than achieved. So
that doesn't mean the service was of high quality in all its
features but targets were set for it and they were known
about and aimed for and they were exceeded. Regards TELARC,
I think we've heard considerable amount about the delays and
the expectations and how at each time the officials involved
and the people running the programme expected something to
happen and worked on that expectation and took much longer
than anybody would have envisaged for TELARC accreditation
to occur.
If we take each of those 4 quality assurance
elements as the 4 corners of the foundation of a house, and
given the length of time that it’s taken to implement them
and balance in implent in quality priorities, does it not
leave a shaky foundation for the implementation of the
programme until they came into place ..... if they were the
only foundations that – your analogy would be perfect.
Obviously there were some very good things and in some ways
the cervical screening programme has exceeded perhaps what I
envisaged in my expectations when I stopped having anything
to do with its implementation, so there are some very good
points, the enrolment numbers, the involvement of women in
this country, the high regard that the programme has had,
there are the reduction in incidence of the disease that the
programme was set up to reduce. Those are some features of
this house of yours as well that have to be taken into
account.
Thank you.
QD BY MRS BARRETT:
I would
like you to turn to your evidence, p22, about competent
personnel, paragraph 66, and it talks about smear-takers. I
want to address 66, 667 and mainly 67.1, and the paragraph
afterwards about the non-medical smeartakers and the lay
smear-takers and going into the medical practitioners. I
just wanted to know from the non-medical smeartakers that
are usually r/nurses, the NZQA accreditation in the course
is that part of their training when they are training as a
registered nurse ..... no, that’s some people have been
unhappy that I've used the term non-medical smeartakers and
not separated out nurses, but cervical smear taking is not
part of the undergrad training of a registered nurse, so
they are expected to take a course before being given a
number to be able to send their smears to the laboratory for
testing.
Has the panel got copies of the accredited
course, are they part of the Ministry’s exhibits ..... no I
don't believe the course material is
Is it massive .....
I guess because of that I can't tell you what size the
course material is, but I wouldn't expect it to be very
large because experience and training with a qualified
smear-taker and on the job training is an important part of
it.
It might be of interest madam chair that the panel
could have a copy of that ..... I will ensure that you get
the training material that a would be smear-taker would have
to go through.
Going to the lay smear-takers and there is
a vast difference between the non-medical and the lay
smear-takers, are you able to tell us what is the additional
training that lay smear-takers have to have, or do they have
any at all ..... I think that is up to the group which
employs them or contracts their group to decide what other
training is required in a general health context. In some
ways it is unfair to call those people as just lay because
they may be health workers with many years experience in
community health issues, but they may have no knowledge of
the cervix and how to take a smear, that’s the bit we want
to ensure they're trained on, the other training about the
health sector and health of women is not part of this
programme.
The last sentence of that paragraph says
clinical support from a local general practitioner … is
usually arranged by the local co-ordinator. Are you able to
tell the panel whether that happened ..... I can't give you
chapter and verse, I was told that’s what happens at the
local end, but no I can't be an y more definite than say I
have been told that and perhaps it would be something that
the Programme Manager co-ordinator that we intend to call
could elaborate on for you.
Going onto the medical
practitioners are you aware what amongst the vast amount of
paper that we have I had read somewhere where the medical
practitioners were not happy about not having non-medical
people and lay smear-takers. What is your view on that
..... there was definite resistance from individuals I don't
believe the medical associate or the college of general
practitioners ever came out with a policy statement, but I
was involved with setting up the pilot studies through union
health clinics and certain Maori health provider groups
before there was a cervical screening programme and there
was definite resistance to other people being involved in
smear-taking and some of the argument of course had to be
taken account of in the training programme because we have
heard that taking a cervical smear in itself is not
sufficient one should be able to describe the
characteristics of the cervix and be able to recognise
possibility of disease which should be referred on to a
qualified medical adviser. So they brought up the
individuals I talked to, the fact that other people did not
have the same training as they as a general practitioner had
had in identifying disease in that area.
It may be a
question that I could ask the Medical Council ..... you
could. Whether they would comment on the training of
knowledge of other people, I don't know.
It’s just that
the Medical Council is responsible for medical
practitioners, they monitor the profession, etc ..... they
will have an expectation as to what training in gynaecology
somebody should have before being fully registered as a
medical practitioner.
I want to compare the three
smear-takers in terms of I think the expectation of women
overall would be, that they would strive for excellence in
service of care. I want to go through those with you. can
we move on to paragraph 76 of your evidence. Under the Act,
1995, pathologists to hold a vocational registration are you
aware whether – is it your understanding all pathologists in
New Zealand have completed that training ..... this is under
– this applies absolutely to anybody who wishes to get on to
the register and become a pathologist after 96 when the Act
came into force. Before that, the Medical Council has
always had requirements that a pathologist must have had
training to a degree that satisfies the Medical Council
before they can put them on the register. If we take Dr
Bottrill as an example, his training would have been quite
some time ago but I believe the Medical Council at that time
would have had to look at his qualifications and the time
spent in training before they first put him on the Register
but it was obviously under an earlier legislation than this,
no-one could become a pathologist just by deciding to be
one.
So we won't be having any of the slip ups that we
have had in the past ..... I wish that was so. This is I
guess under the heading of general quality assurance and
entry into the profession is one quality assurance measure
continuing competence is another one, and the new
legislation has this provision which says that every
specialist in a specialty must recertify themselves every 5
years by proving that they’ve undergone some postgraduate
education and that they have achieved competence and
maintained it through that time. That’s new, it’s coming
into force, next year it will be fully in force the 5 years
in which doctors have had to show their competence and gain
the points required have been happening from 96 to the
present day and through until next year. So that will be
another step of improvement, but still no absolute guarantee
because it requires oversight from other practitioners,
behaviour and it does require the practitioner to recognise
faults in themselves.
Would the Ministry of Health be
putting any policy in place to make sure – you touched on
paragraph 78 as well in your answer, but would the Ministry
of Health be setting policy to make sure that that happens
or the Health Funding Authority ..... well, the policy was
set in drafting the legislation to make the Medical Council
responsible for seeing that doctors maintained their
competence and decide for – the Medical Council to decide
how this should be achieved. No, the Ministry itself is not
going to monitor individual doctors to see that the Medical
Council’s work has been achieved.
Paragraph 105 of your
evidence. The training of laboratory assistants. I was
going to ask is there a shortage but you actually answered
that a little further on in your evidence, but could you
tell us who is fulfilling that role now if there aren't
laboratory assistants in place in some laboratories at the
moment ..... I wouldn't want the stopping of the Central
Institute of Technology course to be represented as no
training for laboratory assistants, there still is a
qualification, but it’s a correspondence course and they sit
an examination at the end of a period of time. That is
still, there is training opportunity for laboratory
assistants, so they are fulfilling that role in
laboratories. We have heard indirectly that the Gisborne
laboratory did not employ a person in that laboratory
assistant role, and I don't know if there are other
laboratories which were in that same position or whether
that’s the case now. But if laboratory assistants weren’t
the primary smear-readers then a laboratory technologist
would have to be, and that is somebody with a university
qualification in laboratory technology, or as we've heard,
the pathologist, and there is also in the Acted an
opportunity for medical practitioners who are not registered
pathologists to also read smears without being under
supervision.
I want to actually take you to paragraph 106
of your evidence, part way through your evidence it actually
says – this is part of the Cytology Advisory Liaison
Committee August 94 meeting – that “these competencies had
been developed … laboratories” is there somewhere in your
evidence that those competencies are provided ..... it
appears not. It appears they weren’t – the draft was not
made as an exhibit. It was a draft, it was discussed at the
committee, the committee in the last committee meeting notes
I have seen still was recommending some changes, but the
final draft is now there as an exhibit and I would expect
that we could continue to search to find it. So, I will
undertake to have that provided if it can be found.
That
was my next question, whether you could make that available
to the committee ..... yes, I will make every endeavour
to
Are you able to tell us who in the Ministry of Health
actually did the competencies ..... I believe that it was
probably noted in the minutes, the person attending the
committee meeting, I got that impression, I’d have to refer
to the meeting of Cytology Advisory Liaison Committee and
Cervical Screening laboratory Advisory Committee meetings in
my volume 4. in any volume 4, tab 18, the draft agenda of
the Cytology Advisory Liaison Committee of Friday 19th
August 1994. there's a draft agenda, and attached to that
is a draft standards for cyto technicians, and attached to
that is the list of people who were involved in being
consulted in the preparation of the paper, and probably in
the minutes there would the mention of the person who pulled
it all together – Leslie Harwood is the name of the person
who pulled it all together.
CHAIR: I have 15 June 1994
and then I go to 20 September 1994. what is immediately in
front of your agenda of August 1994 ..... there's a service
agreement for the Cervical Screening Advisory Committee July
1994. I go 29 June 1994, my volume 4, tab 18. Leslie
Harwood was a Ministry employee, not in the cervical
screening programme but probably in our management support
area, pulled together the competencies and used the list of
people at the back for advice on the competencies
themselves.
MRS BARRETT: Leslie Harwood actually worked
for the Ministry of Health ..... I believe so. She wasn’t a
member of the committee and I believe she didn't work for
the cervical screening programme itself, but I'm not certain
about that. she was certainly a Ministry employee and it
was a document prepared with consultation with a
considerable number of people with knowledge in the
area.
To follow on about the Central Institute of
Technology course, I know somewhere in Ms Glackin’s evidence
she stated that the Ministry of Health serviced etc., did a
whole host of things, for the expert groups and the advisory
committees that the Ministry of Health had, is that correct
..... yes, of the ones I know best about, the cytology
advisory liaison committee actually was established outside
of the Ministry and after its first 2 meetings then the
Ministry provided secretarial services and travel expenses
and other needs of the committee. The Cervical Screening
Advisory Committee would have received that support all
along, the members in many cases would have provided their
services for little or no reward.
Can you then tell us in
the servicing role that the Ministry of health was
providing, in this case to Cytology Advisory Liaison
Committee, who in the Ministry of Health would have
negotiated the extra funding for the Central Institute of
Technology course ..... it would have had – the funding was
in the health development workforce fund which had its own
management within the Ministry, that would have had to have
been a decision taken at the very top level to put that much
funding aside, so the decision would have been made I'm sure
by the corporate management group. the decision was made
right at the time this would be for 3 years and the funding
would then come from like any other tertiary institution
funding, I can't give you the name of who did the
relationship with the Ministry of education to be able to
draft the papers to the Minister to advise what was
happening, but it clearly had to be written by somebody with
authority in the Ministry having gone through the issues.
It would become some part of the policy of the Ministry, it
wasn’t the cervical screening programme co-ordinator herself
I don't believe.
Its just that when we went to some of
the evidence, and I think it was some of the exhibits that
were provided, I'm not sure where, there was an actual
strong recommendation from the then Associate Minister of
Health of going to the Ministry education to negotiate I
guess funding for the Central Institute of Technology
course. I'm not sure about the logistics about govt and I
don't want to know about it either, and government agencies,
but if a Minister makes a strong stand like that I would
assume that she was very clear that funding would be
forthcoming for that course because she would have no doubt
spoken to the then Minister education if they spoke to one
another to actually negotiate that Central Institute of
Technology course don't you think ..... if you could take
that letter as being strong support, my reading of it is
that the decision was made at the beginning of the course
that after 3 years it would become part of the normal
tertiary system when time got near the Advisory Committee
recommended the course continue as is, the decision was that
the policy would not be changed and the Ministry would not
start funding the course beyond the 3 years, that had never
been the policy, and the decision at that point, if that was
government’s decision, the policy stood, then the Ministry
of Education and I think the letter advised that writing
support for the course to the Ministry of Education was the
correct thing to do – it didn't say “I am going to fund
it”; it said “I advise you to put your views to the
Ministry of Education.”
Do you think that the Ministry of
Health really stuck its neck out to make sure that funding
was available from the Ministry education – did the Ministry
do justice to it ..... that’s – I don't know the answer to
that. we've heard a lot about government policy and how it
should remain unless its changed positively, this clearly
government policy set out at the beginning. The Ministry
did not arrange with cabinet to overturn government policy
in that issue, and that’s as much as I can find. It would
have had to meant a change of policy for the Ministry to
come in again as the funder for a course which was not
proving to attract sufficient people to maintain
itself
Are you able to tell us whether in fact the
Ministry of Health had a good relationship with Central
Institute of Technology and NZQA as well ..... certainly the
person running the course at Central Institute of Technology
had or was a member of the Cytology Advisory Liaison
Committee I can see no evidence that there was any
disagreements amongst them. Obviously he would be a very
disappointed person when the decision was not made to
overturn government policy. I don't know how relationships
went well. I think I've seen his name amongst the
committees advised will be making submissions, but I haven't
spoken to him about this issue.
My last question, and you
kind of went over it a little bit yesterday, is in your
volume 5, tab 22, about off site home screening .....
yes.
Some of the – and its in reference to TELARC –
comments being made in there were reality for me as a lay
person. In terms of “the committee recognises that in … no
home screening … in this role.” What is your view about
that ..... it was inevitable that it was going to be phased
out and yes I did have some involvement before this time in
looking at home screening. Where I looked into it these
were extremely experienced, competent women who had been in
the workforce and then had home commitments and were doing
some of their work at home, unsupervised, and hopefully in
the quiet time at home when children were in bed asleep or
they weren't distracted, and their work of course was
checked to the same level as if they'd been in the
laboratory itself. And most of them came in or all the
people I talked to came into the laboratory one day a week,
for liasing with other staff members. That’s how it had
been for a considerable period of time. It was obviously
unsatisfactory, there had been considerable writing about
this in the American general media and it was going to be
phased out. The staff themselves wanted to keep working
that way rather than take full parental leave which wasn’t
probably reimbursed at that time. So it would have meant
losing skilled people from the workforce but it became
inevitable that it would happen.
Thank you.
QD BY
PROFESSOR DUGGAN:
Could we return to The flow diagram
in volume 3, the last page. This was how the group at the
National Cervical Screening Workshop envisioned the
screening programme ..... it appears so, yes. this may well
have been just one group who were there, but it definitely I
understand came out of the workshop.
Where in this flow
chart is the central co-ordinating office ..... yes, not
represented except as the Register, which in some people’s
minds could have been synonymous with a central
co-ordination of regional offices or it could be there was
an expectation that there would be one register for the
whole country at the time this was drawn. It doesn't say
national co-ordinator, it doesn't say 14 regional
registers.
Is it correct that this diagram was created
based on the World Health Organisation requirements for a
screening programme – this is 1988 ..... they certainly had
the material available to them – this was a workshop of
people with lots of interests. Which I said it was difficult
to achieve a consensus and different working groups drew up
different models of their particular areas of interest. And
this is put in for completeness, it doesn't make it a firma
recommendation for anybody, but the World Health
Organisation requirements you would have seen would have
been some of the background of the material they'd
had.
In the context of the programme over the last 10
years how much has been implemented of this flow diagram
..... implemented?
Or put another way, what is missing
..... what is missing from the current programme as it
stands today?
Right ..... there's been education, access
has been proved to be effective, smear-taking, there is
feedback to the providers of the service, smear-reading
occurs, and in TELARC accredited facilities, the results of
smear-reading go to the Register, the register is linked to
cytology to histology coming from colposcopy services.
Smear reports go to the women and to the provider – they go
to the provider with the expectation they would give them to
the women, the women are advised of recall times. Normal
results go back into the cytology register to be cycled
around at the recommended time, abnormals go for
investigation and treatment and what's missing in this
diagram I guess is a follow-up if there has been no
treatment after a period of time to get that women recalled
into the system, they leave that cycle with the dotted line,
if invasive cancer has required treatment the laboratories
are obliged to put the women on the cancer register and data
is correlated with the cytology register and the cytology
register itself does not consist of one box in total,
although it’s now an interconnected system. in those
respects, the circle’s have now at superficial reading the
circles are completed as is drawn there.
And when were
all the elements in place, what year ..... the histology and
Cancer Register linking to the main cytology group of
registers and the linking of the register were 96 for the
histology and cancer and later than that for the full
reconfiguration to get the cytology register fully linked
together – so 96.
96 with some elements, 97 ..... I think
that’s how the evidence has been given, yes.
is this the
usual period of time, i.e. 7 years, is that normal for the
establishment of a programme ..... I don't think there are
any other programmes similar to this to compare, breast
screening would be the nearest and that has been another
population based system, has had a long period of incubation
and development. So if I am to give an opinion, it’s an
unsatisfactory long time, but people have carried out their
continuous improvement that they were aiming for that has
been part of their being in the job I believe, so yes, it’s
a long time, too long in hindsight, but other programmes do
take time to bed down as well.
Other countries have put
an umbrella of organisation on elements of the cervical
screening that are already in place – for example the UK.
Do you know how long it took them to create a National
Cervical Screening Programme ..... no, I don't. I've
obviously read of problems and many problems of major
significance, but the time – no I don’t know – they haven't
achieved it yet by the sounds of it.
Is there a central
office now for the screening programme ..... yes, we have a
national co-ordinator and a manager of the screening
services within the Health Funding Authority who will be
giving evidence soon, I hope. But giving evidence with the
Health Funding Authority evidence.
And this individual
can give me the information about their function ..... yes,
Dr Peters has that role.
In your opinion is this a good
model for the screening programme, this diagram ..... the
diagram, yes, it’s what I understood was to be put in place.
So, yes I’d have to say yes. I can't see where I should be
adding things into it.
Yesterday we determined that the
cross symbols represented quality control ..... yes, that’s
what the page before it says. Points at which quality
control needs to happen and evaluation needs to happen, so
that’s outcomes in one or two places and points where one
can put in quality control
MR HODSON: at the bottom
left we've got the faintest outline of what the dagger
means, but there is no way to read it.
My description of
it, if there wasn’t, the page before mentions quality
control points at which you can make a difference by putting
in quality control measures or continuing to improve.
Do
you accept an organised programme should have a quality
assurance programme ..... yes, I think any project of this
magnitude and involving so many people should be developed
with a documented quality assurance procedure manual which
can be changed and which would have the philosophy and the
different roles of the different parties, how they can make
a difference, how they monitor, how their work impacts on
others. Yes, there should be a manual which should be
adhered to which contains all the elements of a quality
assurance programme
Based on what you say, is the quality
assurance programme the sum of the individual quality
assurance programmes of its components ..... I think yes the
daggers would mean that those are the points where
differences can be made and the major difference in total
would be the sum of those efforts.
Is there anywhere in
this diagram that you would add additional quality control
..... we haven't any feedback from the women involved, the
providers, and the Register itself doesn't have a dagger
attached to it, although the recall system that it runs
does, so within the whole register however that’s defined
should itself have a system that it is failsafe and is
producing the data correctly.
Is it correct to say there
is still work to be done ..... I would rather you ask the
current manager of the programme, I'm sure that there are
major continuing improvements that could be put into the
system,..... I don't think it is right for me to say how
it’s been managed over the last 2 years so I would prefer
you ask the current manager what improvements are planned to
be made.
In your brief of evidence you gave descriptions
on the qualifications and training of individuals involved
in cervical screening. However, I didn’t see similar
descriptions for individuals involved in the delivery of the
screening programme as defined by this diagram. ..... no I
agree that is absolutely correct. I found other than job
descriptions for the co-ordinator and I think a generic job
description perhaps for Programme Managers early on, then
there are no set and defined competencies that I could see
for people involved in running the programme within the
Ministry and then the Health Funding Authority and the
Regional Health Authorities before that.
In 90 when the
programme was introduced there wasn’t a culture of
smear-taking in New Zealand, is that correct ..... no I
don't believe that is correct. There was even a debate as
to whether introducing a cervical screening programme would
reduce the number of smears read in laboratories rather than
increase it, so it isn’t true to say there was no
culture,..... smears had been taking place and being read
from as far back as I can find in the files. In many cases
the wrong people were returning too often to have smears,
but it wouldn't be fair to say no culture of
smear-taking.
There is an exhibit, the Skegg workshop, I
think ..... that would be fairly early in my
volumes.
There were a variety of interested. stakeholders
at this particular meeting and I was concerned to read the
comments about primary care delivery, i.e. delivery of
cervical screening and the individual being recorded I
believe stated that this type of training was not being
provided in the undergrad curriculum, by the medical
curriculum ..... volume 2, tab 8, there certainly was a
real cross section of people there. The person most
possibly involved would be the Medical Superintendent of
National Women's at that time – I think she was there – p46
is the Medical Superintendent of National Women's –
obviously that was an area where cervical screening was
difficult in that there was some anti among the staff
there.
I think it comes under the education of
professionals, p36, then on p38 there is the education of
the general practitioners. I think what this meeting
highlighted was before the introduction of the programme
there was some discussion about the resource needs, the
training needs of the professionals and non professionals
for the delivery of this programme ..... yes.
And was
there any action based on these discussions before the
programme was introduced ..... no,..... I can't set out any
particular actions, the college of general practitioners was
involved, the educational institutes were – the two medical
schools that is, staff of the two medical schools were
involved, the needs of the programme were known but in fact
the cervical screening programme itself did not develop a
package for education of general practitioners about
cervical screening as far as I know.
Are current
graduates of the medical schools appropriately trained for
the screening programme ..... I would expect so, but I can't
define the amount of training that they have.
Who could
give me that information ..... certainly the first – to be a
general practitioner you go through the undergrad medical
training and then the expectation is you will do a register
post in general practice where there will be ongoing
training and cervical screening would be one of the
competencies expected, so I was thinking first the
undergraduate medical schools, but it isn’t them alone, it
would also be the training of the College of general
practitioners and I haven't got those at hand, we could find
for you what the universities have to say and what the
College of general practitioners have to say about their
training programme
You accept that the quality of the
programme is dependent on the sume of the individual
components ..... yes.
Thus each component of general
practice, colposcopy all needs to have quality control in
place .....– I agree they have to have their competencies
defined and trained up to them and maintain their skills and
be provided the educational material in which to refresh
their memory.
Is this currently happening in New Zealand
..... there is no monitoring of and no examination
requirements specific to cervical screening of the medical
practitioners involved. They are provided with education
material and my understanding is they are provided with the
undergrad training and it is part of the competencies
expected in general practitioner training. So I would
expect so, I cannot provide the documents to prove so.
I
note that in p28 of your brief, paragraph 87, that cervical
smear reading is a “regular … 1989”. And it states “it can
be carried out by a registered medical practitioner.” Does
that include individuals other than pathologists ..... yes
it does, that’s the way the law is written and has been
written, and I guess that’s why I brought it to the
attention of the committee, that’s how the law is written
and I guess that reflects the attitude that probably still
exists today in all medical specialities, having the
qualification makes you competent to do work that’s
medically related. You and I may not agree with that, but
that’s how that regulation has been written and that’s how a
lot of medical practice is carried out.
How would this
regulation drive with the need now to maintain competence
and recertification ..... I think I point out further on
that that – although that is still there in the regulations
the medical practitioner who is not a pathologist but
working in a laboratory – this is hypothetical, but under
the Medical Practitioners Act which came in subsequent to
this, they would be termed as a practising pathologist, so
they would have to work under the supervision of a
pathologist; the Medical Practitioners Act takes priority
of this particularly in the year 2001.
At the time the
programme was introduced in 90 how many individuals other
than pathologists who were medical practitioners were
reading smears ..... I don't know. And I suspect it was
probably none, but I don't know.
Are there such
individuals now ..... not that I know of. Again, I haven't
done a workforce survey to see. Every laboratory has a
supervising pathologist as part of its requirement, so those
individuals one would expect would be working under
supervision, but that’s all hypothetical, I don't know if
there are any.
Were obstetricians and gynaecologists
reading smears ..... not to my knowledge.
what is the
function of the laboratory assistant ..... in the case of
cytology they prepare slides and they are also primary
readers of cervical smears. So they are while undergng
their training they would be under full supervision, then
when they’ve passed their qualfctn they are primary readers
and there's a responsibility within the laboratory, as I see
it, and as I've read it, to define what is an abnormal they
must pass onto somebody more senior than themselves in the
laboratory. So, preparer of smears and primary
reader.
When the programme was launched in 1990, that was
around the time that there was the exposure in the USA abt
substandard cytopathology practice in 1998 ..... it was
around that time 98/99 when I was looking at home screeners
- that would have been associated with that whole time,
yes.
Did the implementation unit keep abreast of the
developments in the USA ..... I can't answer that, but
through their discussions with the Advisory Committee I
would assume that they did, yes.
They were aware that the
practice of cytopathology was suspect even in the USA .....
even in the USA. Yes, and the home screening and the high
throughput were all considered as being indicators of
potential poor practice, that’s why Cytology Advisory
Liaison Committee was spending quite a bit of time trying to
decide what was an appropriate number of smears for the
smear reader to read
This would be Between 98 and 80
which it was for New Zealand a planning period .....
yes
So this information was available to you – i.e.
laboratory practice may be less than perfect .....
yes
And you had numerous reports from a variety of expert
individuals and groups that laboratory practice may be a
vulnerable component of the screening programme .....
yes
When the visits of the Area Health Boards were
undertaken by the implementation unit, there was a meeting
with the local players, i.e. physicians and other personnel
..... certainly if the Gisborne one can be taken as an
example, yes there was a meeting with general practitioners
or a general practitioner representative who would have
represented the smear-takers at the time, met with the
pathologist, I think they particularly met with the Area
Health Board people who were going to be running the
programme locally and they may well have arranged who came
to the meetings on that day.
Also there was a survey of
laboratories to determine the number of smears ..... that
was the one we looked at this morning as to whether
laboratories could provide the information about the number
of smears they were reading and the type of results that
they had sent out.
Also at that time there was the 86
document on guidelines for cytopathology practice .....
that’s correct, the New Zealand version authored by 2 out of
the 3 pathologists on the Cytology Advisory Liaison
Committee
So everybody was aware of the needs for
quality control, the negative outcome and bad media if you
don't have quality control, is that correct ..... that’s
correct, and that’s why fairly early on they were developing
the standards which were to be used by TELARC and the two
pathologists.
We are still in the period 89, the dvlptmt
and planning period. If all of this was known, why when the
survey of the laboratories was conducted, why wasn’t their a
survey of the practices at the same time ..... I don't know
the answer, that survey was, I'm sure, part of the planning
process to see how data could be collected, so the person
doing that had one particular task, as I would see
it.
Although quality control is one component in the
laboratory of a successful screening programme it was
recognised before you implemented the programme it was a
critical component ..... yes.
Why didn't anybody survey
the laboratories for their quality control activities .....
I don't know the answer. I do know that there was an advice
that was an advisory group that had been formulated on just
these issues about laboratory standards and laboratory
quality and how the programme would liaise with the
laboratories. That was done, but you are quite right, there
was no survey of laboratory quality control activities done
at that time.
Was it moral and ethical to put a national
programme on top of the structure that may not have been
perfect ..... those are very strong words for me to have to
use
As a physician can you answer ..... this is no
excuse. If you say there's no perfect health care system in
looking back there are many things that could have been done
differently I'm not sure that I would say that it is such
that it was totally unethical to use the existing services
which – I couldn't say it was unethical to use the existing
services, nor would I say it was immoral to do so.
But
the quality of the services at that time were not surveyed,
particularly laboratories but there were many other elements
of the programme that in all likelihood should have been
surveyed as well, do you agree ..... looking back, yes, but
again if this was a totally de novo service then there are
things that you would do differently. If you were adding
something to actually improve the outcome of what was
already existing, then I think that’s a different approach
that you'd take, and so counsel of perfection is to get
everything right before you start, but if it's already
existing and you're going to set targets for improving
what's already done you often build on the existing service.
I think that would happen again to some other improvements
that’s put into medical care in the country.
We have
heard from some of the testimony of the first 8 witnesses
that various elements of the programme may not have
functioned as well as they should have ..... in varying ways
for varying people, yes.
What may have been in place in
1998, i.e. not a perfect situation for piggy backing the
screening programme onto may still be in place today .....
that is possible when you look at competencies of people
involved, when you look at training matters, the council of
perfection might still apply to care and I think
unfortunately the histories we've heard show that there are
points of care there, maybe not directly related to the
cervical screening programme, which could have been done
better, I'm sure that will always be in the health care
system but we should hope to get things better and better
and better
When you implemented the programme in 1990 the
foundation may not have been perfect, is that correct .....
that is correct.
Was there some form of priority setting
meeting to guide the implementation of the various aspects
of the programme ..... I think we've heard the history and
in times there was different priority setting and the
biggest priority even right through to 1993 when it was
handover to the Regional Health Authorities was to increase
the enrolment of women from the higher risk groups and that
was classed as priority number 1 as I read it. Even to the
detriment of getting some of the infrastructure correct.
And that was - I believe that was a priority that was set
for the programme – it could have taken longer developing
than an infrastructure that had more control points, so
there were messages that were lots of recommendations but a
major priority of putting effort into education and
enrolment.
LUNCHEON ADJOURNMENT – 1.08P.M. – TO
RESUME AT 2.15 P.M.
PROFESSOR DUGGAN: Just before the
last break we were discussing the piggy backing of the
programme onto the existing medical system. my question to
you now is, is it appropriate or was it appropriate to piggy
back the screening programme onto a medical system that was
not audited ..... I think it was at the time the option for
improving the medical service that was been provided because
there were so many components of the health care system that
are actually involved in the diagnosis and treatment of
people who had gone through the cervical screening
programme, so yes I believe it was appropriate at the
time.
And in retrospect ..... at the time of 1989 I
haven't got a picture in my mind as to how you would have
audited all those components of the service, what standards
would have been there to have been followed by all parts of
the health care system which are involved in women being
examined and treated for cervical conditions. You would
have to have put in a system of auditing, really the whole
health care system
So you had no doubts about the quality
of the medical system ..... no I wish that was true. I had,
from being part of it and being in the disciplinary
committee, doubts about the health care system and always
being able to deliver what's required, and I still have.
Obviously in retrospect one would have liked to have seen a
programme that’s completely freshly designed and had all
those components built into it. I haven't got that picture
of how that could have been done at the time.
So you had
some doubts about the medical system but still the piggy
backing occurred, is that correct ..... I'm being much more
general, because cervical screening programme and the
treatment services that follow on involve so many different
parts of the health system I say I have doubts about whether
health care can always provide the safety that’s required.
I also do not quite envisage how at that time all audits of
all parts of the health care system involved could have been
put in place.
If I understand your position correctly,
you received complaints with reference to other areas of
medical practice ..... yes, from my role before joining the
Ministry, from within the Ministry, and in my role now, yes,
I hear of complaints. I have to help investigate or hear
about. Things that have gone wrong in the health care
system and produce press releases and so on which
regrettably tell people that things go wrong in the health
care system and there isn’t complete audit in what is
delivered in health care.
Are the numbers of complaints
re laboratory practice high low or medium ..... I believe
there've been very few about laboratory practice generally,
and they seem to have been at the earlier part of the
cervical screening programme, there isn’t a continuing list
of complaints and I haven't heard of any in the last few
years. So, I tried to work this out, looking at the
proportion of money spent on laboratory services, the number
of people involved, I don't think the complaints I've heard
about of laboratories make that a riskier service than other
health care services overall.
How would the number of
complaints compare to the number of complaints with
reference to family practice ..... the Health and Disability
Commissioner who handles most of the complaints these days,
has done since 1996, reports that general practice provides
by far the biggest number of complaints about health care
services. It’s a guess.. I've read the figure, something
like 75% or more sticks in my mind.
Would you mind going
to volume 4 of your exhibits, a letter dated July 5 1995
from Canterbury cervical screening programme – Val
McKliskey, who is the manager of Canterbury. This is a
letter re atypical smear results and the first sentence
“recently a general practitioner contacted me … had not
shown up for 2 years for any follow-up.” Do you know if
this matter was discussed ..... as it’s in amongst the
agenda papers. My concern is, based on the evidence of
some of the first 8 witnesses, such a scenario occurred.
And this is a letter from 1995 that actually documents such
concern from the Programme Manager ..... hmm. Yes, it’s
whether you are asking where this was then discussed, and
I'm not sure that I can give you the reference in the
minutes at the moment.
You would agree it’s an important
issue ..... yes. I do agree. I would have hoped that it
was the sort of thing that was disdfcusd at the Programme
Manager’s meeting as well, but that will take a fair bit of
thumbg through to find
What is the liability of the
register and the recall system of the general practitioner
in this scenario ..... legal liability? I'm not sure that I
can answer that question.
Ois there an ethical
liability ..... well, anything that is a complaint should be
followed up, and if there has been an error, then people
should be informed that there's been an error re their care
and corctv measures put in if its shown there's something
wrong with the system. these are my views. What I can't
in this particular case can't tell you just how it was
followed up and what was done at the time.
I think the
committee would like to know to what degree the Register
goes in order to ensure that letters that they sent out
actually get to the women and if there is no action on that
letter what is the next step ..... yes, and I think the
issue of letters that are sent out and what happens at the
steps would be better answered by the co-ordinator manager
person who’s going to come along. Obviously processes did
change through the time of the programme, as improvements
were put in – I'm not able to specify – it would be
conjecture – we can provide the material through the
Programme Manager.
I did ask Ms Glackin this question,
perhaps I can ask you the same, do you know how effective
your letter recall system is ..... personally I don't, so I
haven't got anything in front of me as documents to refer to
that would give you an answer, and that would be again a
better answered properly rather than me making
guesses.
This letter from the Programme Manager might
indicate that the recall system was not effective ..... yes,
I personally don't understand why the Programme Manager
would have to write a letter, I would have thought this
would be something found out about and discussed between the
co-ordinator and the Programme Manager so that it would
appear the first that’s heard of it is a letter when I
understood them to be in easy contact of each other, but
that’s again my view, I do not know what happened in this
particular circumstance.
Could we turn a few pages, 14
pages, to another letter from Di Cook to Dr Clint Teague on
19 June 1995. ..... this is from Healthcare Otago on behalf
of local Programme Managers for that part of the South
Island.
The first paragraph goes on to say “the local
Programme Managers … than usual.” ..... yes, that’s what it
says.
And she asks if the committee would consider this
problem. Do you know if this problem was referred to the
Advisory Committee ..... it’s headed at the top
“correspondence Cervical Screening laboratory Advisory
Committee meeting 26/7/95”
My reason for bringing this
forward is that in some of the early witnesses we may have
had situations such as this ..... hmm. The notes of the
meeting of that data don't include reports on a discussion.
If I understand how the registry works, the smear would
go to the pathologist who has not seen the cervix or the
women and would be reported as normal if there were no
abnormal smears ..... yes
And the management
recommendation could either be repeat at the next screening
interval which n may be 3 years or maybe altered if she had
some prior abnormality ..... yes, that’s what I
understand
However the smear-taker – I'm not sure if the
smear-taker can alter the management recommendation based on
their assessment of the cervix and the report and if they
alter it how is the register informed of this change in
management ..... yes, and I again am not able to tell you
exactly – I know this did come up as a problem and I have
actually discussed it a little while back with Di Best as
she is now, and again the better answer for this would come
from the people who are operating the programme itself right
at the moment. I would be guessing, I haven't got the
documents.
So this scenario that we heard earlier in this
inquiry has been documented here in 95 as a concern of the
Programme Managers and I'm not sure if it has been referred
for discussn any polace else ..... yes, and that will I'm
sure be answered for you. I've looked at the minutes of the
meeting following, there is no note in the min but people
involved will be able to tell you if it was. I know that
the smeartakers, the general practitioner, obstetrician can
obviously override because it isn’t the register which
recalls the woman in the first instance to give them their,
if it’s a normal smear, to advise them about returning, the
Dr could always override that. what we really want to know
is whether in overriding it, if that’s Dr contacted the
Register the register has a system to amed what's written in
there from the Bethesda code. I can't give you the
answer.
Who can gifgve me the answer ..... I believe the
witness to be called, who has been a programme co-ordinator,
Programme Manager.
Thank you very much.
QD BY CHAIR:
Dr Boyd if you could please turn to your volume 4,
part-way in there are the minutes of Cytology Advisory
Liaison Committee for 17 November 1993. ..... yes.
If
you could go to p6, please. At the bottom of the page there
is a heading “histology” ..... yes
Tina Handisides was
teeling Cytology Advisory Liaison Committee that there were
probvs of implementing histology as the wording of the
legislation was less than perfect – would that be the
amendment of the health act 93 ..... I'm sure that would be
the case.
She continues she …. To amend the legislation
but she stressed that little …the new legislation … very
slow.” Is that a fair description of what the political
will is at the time in respect of anything to do with the
programme ..... I think it would be totally unfair to
generalise anyhg to do with the programme, this was one
person’s opinion and may be at that time it had as much
value as my previous comment about time spent with
legislation.
Well It had taken until 93 to arivfe at the
legislation which allowed for the opt off programme had it
not ..... well, that was the date that the health act was
changed and that included the opt off and the histology
requirement.
Because there had been concern about doing
that without legislation in place because of patient
confidentiality, is that not so ..... that was one of the
reasons I understand, it was a very big issue at that
time.
And had it to your knowledge come to light that the
legislation might in fact be less than perfect in allowing
those events to occur ..... sorry, can you ask that question
again.
Did you know at the time that others within the
Ministry thought the legislation was less than perfect
insofar as it would allow the comparison of histology and
cytology ..... no I wasn’t aware of that, and certainly see
this as comment with some agreement from the chair of the
committee involved, but this is after the event. No, I'm
not aware whether these were expressed before the
legislation was put through or drafted.
Well after the
legislation was passed were you at the time aware that there
were persons, includilng Tina Handisides and Clint Teague
who were findiong problems with the legislation in terms of
its workabty to allow comparison of cytology and histology
data ..... no personally I wasn’t aware at all, it was
obvslyu discussed in the right forum and the decision was
made by the committee that there should be they should
advocate a change in the legislation and I know no more than
what's written here
Dol you know if there was a further
change to the legislation ..... my understanding is no there
was not.
Can you offer comment on why it is that Tina
Handisides would have said that there was little political
will to amend the legislation ..... no, I
can't.
Continuing with this issue of cytology and
histology, could you turn to your brief firstly at paragraph
36, paragraphs 1, 2 and 3. at paragraph 123.2 it lists one
of the advantages … quality assurance: ..... yes.
Would
you turn to paragraph 129 of your brief, there is mention
there of the Cytology Advisory Liaison Committee meeting and
Janet Phuah’s paper “data … to asses potential cytology and
histology within New Zealand.” Firstly, do you agree with
the comments in Janet Phuah’s paper ..... their comments on
her paper?
Yes ..... this was the comments of an expert
Advisory Committee about the paper?
Yes. ..... reading
through this I was surprised that a committee of experts
themselves couldn't find an expert who would be able to
fulfil that role, but the committee of experts has made it,
and I can offer no opiniono whether they were
right/wrong
If they were of that view, how would it
affect the advantge listed in 123.2 of your brief of
evidence ..... I read it and I wasn’t there, so I wasn’t
party to the discussion, I read it as being they were more
concerned putting this data together would either discredit
the programme as a whole or it would in fact give wrong
information about one area v another or about the national
figures. Having thought about it I still believe it would
be possible and very important to correlate one laboratory’s
work with particular women who had had a smear read at that
laboratory and their future care and diagnosis, but I seem
to read it as saying they were worried that the statistics
as a whole would give a wrong impression and if used as
generally published data about the programme as a whole or
specific laboratories. That’s my reading of it.
Do you
see it as having any detrimental impacted on quality
assurance or not ..... collecting the data and correlating
them I believe would have improved quality assurance in each
of the laboratories that it was applied to. We seem to have
agreed that’s the expert opinion through and through. So it
would improve quality assurance but I was interested. in
seeing this comment that they had doubts, maybe the
discussion I've had with Professor Duggan about the other
reports could maybe shed some light on why they felt that
you can't just take these figures and publish them without
looking at all the different correlations.
If you would
stay with volume 4 and the Cytology Advisory Liaison
Committee meetings of 17 November, p5, you will see under
the heading “TELARC”. You will see imemdly under the bullet
points confirmation as at that time there were 22 registered
laboratories ..... that’s what it says.
You would have no
reason to doubt that ..... there are some many figures
tossed around in the last few days, again this is the issue
because wshe was coming to ttalk to them about cytology did
she mean 22 TELARC registered laboratories which are doing
cytology or not, and has it been recorded exactly what she
said.
I see immediately above she was asking Cytology
Advisory Liaison Committee if it was wiolling to …. For
histology and there is a series of issues which she deals
with criteria … relating to cytology. Would you not infer
from that that the 22 TELARC laboratories were those doing
cytology.
..... I would think so, different laboratories
would be doing the histology part, in hospital laboratories
which may not do any csrs, not quite as easy to say yes as I
would like.
It has appeared from the material that the
Health Funding Authority will be producing it wasn’t until
march 97 that the Midland Regional Health Authority signed
off contract with the laboratories which included
accreditation., would you consider that to be slow given
that as at 1993 there were 22 TELARC registered laboratories
available whose services could have been used ..... this
goes back to the putting the erspbty onto the new funder and
how it was in the funding agreements I did not know until
told yesterday that same bit of an extract from future
evidence that in fact Midland’s contracts with the
laboratories weren’t signed until more than 6 months later.
Do I consider that slow? I would – yes, I would, but I
don't know the circumstances around it, and I don't know
whether they had complied but the contract wasn’t signed, I
do know there was negotiations obviously between the
laboratories and the funder, this was a new system in
working where they could negotiate whereas before they had
representatives come to a Ministerial committee meeting. It
was a new system, I didn't think it would take that long
As a public health specialist it is a matter of
principle, if you were working in a health system where
health clvry was being managed by way of a contract base
system, would you not expect the party ultimately
responsible, who was startoing the ball rolling so to speak
– the Medical Officer of Health. with its contract with the
Regional Health Authority, would you not expect it to
include a requirement for quality control in its contract
..... yes, because they were to purchase quality and in
their contract was obviously the requirement for the best
endeavours for TELARC registration.
Under the funding
agreement I have noted best endeavours and reasonable
endeavours – do you I know hat those two terms mean .....
no, I would be guessing sitting here. That is the reason we
have arranged that someone can run the inquiry through that
process, how it was put in place, even perhaps the
prioritising that was expected, looking back you can't
imagine someone would be able to sign all contract on day
one and they had to roll over some parts until the contracts
were written.
I've referred you to those Cytology
Advisory Liaison Committee minutes in 93 when there was
reference there to TELARC accreditation. I note also in the
96 policy document which appears at volume 1 of your
exhibits, at p20, this document is dated June 96, I note at
p20 under the heading “quality …. Screeners” it says “to be
eligible …or an equivalent aqcredn authority.” That is the
first time in the Ministry’s documents that I have seen it
stated as a simple request rather than a reasonable
endeavours, but yet again I would ask you to comment on the
fact that although the policy document says that
accreditation was required in June 96 in the case of Midland
it did not occur until February/march 97. do you have any
comment on that ..... that was what I was answering before,
I didn't know it would have taken that long, I don't know
what their priorities were or how much negotiating they were
doing about the contract of which this may have only been
one part, so slower than I would have expected looking back
on it but I did not know at the time, did not know until
yesterday.
Could you go please to volume 13 of Ms
Glackin’s evidence at tab 72. this is a question I asked Ms
Glackin and she said you would be best to answer it.
Firstly you will see the 93/94 funding agreement. If you
move to 94/95 funding agreement, go to p74, if you look at
10.3 you will see there that the Regional Health Authority
is to purchase cervical screening services and it said in
the second sentence “this programme … 1991 policy for
National Cervical Screening.” ..... yes.
Do you accept
then that under this funding agreement it was based upon the
agreement being consistent with the 91 policy ..... yes, I
do, as redrafted in 93, because the original 91 one should
be completed by 93 in it. Yes, overall, yes, the same
policy with those minor alterations.
And if you could,
just keeping that in front of you, then go to the policy
document, volume 5, tab 15 – the original document – reprint
February 93 ..... that is correct.
And if you could go
please to p5. if you look under the heading “laboratories “
– paragraphs 4.1.2, 4.1.3, 4.1.4 ..... yes.
Just keeping
those in front of you, the final document I would like you
to go to is volume 13, tab 71, the Cytology Advisory Liaison
Committee submission on the programme policy dated June 94
..... yes.
Could you turn to the second page in you will
find the heading “laboratories” and this is comment on the
paragraphs in the policy, they marry up together, if you
look at the comment in Cytology Advisory Liaison Committee’s
submission in 4.1.3 you will see that Cytology Advisory
Liaison Committee is saying “The Ministry of Health will be
responsible for confirming … 4.1.4” ..... yes.
And if you
continue reading you will see it says “the committee
believes the paragraph should remain the same … in 4.1.2
should be substituted” ..... yes.
You will be able to see
what those rqarmts are by looking at the policy document
which you'll have in front of you as well. Cytology Advisory
Liaison Committee continues “The reason the Ministry of
Health … accreditation … by TELARC.” ..... yes.
Firstly,
do you know whether or not the change suggested by Cytology
Advisory Liaison Committee was followed up and put into
place ..... well, obviously not in that form, because this
is a submission on what new policy should contain and the
new policy came out in 96, as we've heard, and it isn’t
exactoy the wrodg they recommended at the itme. The
philosophy is the same because the requirement is it is on
to the health authority that they see that laboratories are
TELARC accredited. It seems pretty pointless to have 2
bodies to do the same confirming thing.
In terms of the
funding agreements of 94/95 that was operating on the basis
it was to be consistent with the 91 policy wasn’t it .....
that is correct.
And under the 91 policy it was the
Ministry who had the responsibility of carrying out the
criteria set out at 4.1.4 wasn’t it ..... it was confirming
that laboratories complied with 4.1.4. obviously, it was 0-
nop I don't know o bvsly – it seem to me at the time having
TELARC accreditation would comply and just confoirmg that
one would be one thing, the other thing those laboratories
not TELARC acrdd at that time the wording would be the mniny
go around to do an audit of their own. We have heard the
Ministry did not have that capabitlty and did not do it and
put all its sstore in meeting the policy as soon as it
thought it was able to do so in meeting TELARC registration
and we have hard many times over how long that took.
You
agree with the Cytology Advisory Liaison Committee vew that
the Ministry didn't have the expertise to perform its
functions under 4.1.,4. at that time ..... we have had to
have bought in expertise, created auditors for laboratories
which had never been our function and so we didn't have the
capacity to do that work competently.
It would seem then
that under the documentation which found its waya into the
Regional Health Authority agreement for 94/95 that the
Ministry was under a rsp bty in terms of those legal
documents which it in fact was not able to discharge, is
that correct ..... yes that is correct.
And also is it
fair to say that because under the funding agreement the
responsibility was placed on the Ministry it would unlikelky
that any other party to the funding agreement we carry out a
responsibility which in terms of the funding agreement oit
was under no obligation to carry out ..... that was the
confirming that the laboratories complied with those
particular criteria. There was still their best efforts in
getting them TELARC registered.
Putting that aside, in
terms of carrying out the criteria under 4.1.4 any party to
the funding agreements that didn't under the agreement have
that as an aobligtn would not be likely to carry out that
task would it ..... of audointg the laboratories itself, I
don't know that the Regional Health Authorities or the
Health Funding Authority had capacity to audit laboratories
and who audits the auditors in that case.
So is it
correct to say the Regional Health Authority and the Health
Funding Authority would not be likely to take on a task
which under the terms of the funding agreement were placed
on the Ministry of Health ..... that is the auditing of the
laboratories correct, which is not otally exclusive from
using best endeavours to get the laboratories TELARC
accredited to those standards
Are you able to comment on
how it is that the ninny allowed
Funding agreements to be
funded in such a way when responsibility was placed on it
when it practice it did not have the means to do so ..... it
has to be personal opinion and it would the 91 policy was
soundly based on at the time when it was written I think
there were so many things going on health reforms that
somebody used a shorthand process or a shortcut process to
roll over a previous policy document when some of the wrodg
was probably not relevant, knowing that the Ministry was
putting all its store on the TELARC accreditation. I
believe a mistake was made in what was put up to the
Ministry about rolling over something when there was no real
capacity to carry that out. There was an expectation it
would be corrected very early on – in 94 the consultation
was well underway what should be in the new policy
documents. With hindsight we can say how stupid to think
all that would happen soon when in fact it took until
96,..... but that wsasnt the attitude of the people working
at the time.
I note in terms of the funding agreement for
95/96 that replicates the wording in the 94/95 funding
agreement in terms of the responsibilities of the Ministry
..... for this particular issue, yes.
And I note in the
funding agreements you've made reference to the Regional
Health Authority attempting to ensure that the laboratories
are TELARC registered, the wording used is actually
reasonable endeavours, not best endeavours ..... yes.
I
am aware those two phrases are used in the fiudning
agreements, do you know who would have chosen to use the
phrase r/endeavours rather than b/endeavours ..... no, I
don't. it was obviously that was what was negotiated
between the ninny obh of the Minister and the health
authorities
Who themselves wrote this part. They
were given the Minister’s wishes to explain it in general
terms, they created an agt that they felt they could live
with which met the min’s wishes, and it was legal argument
between the Minister and the Ministry and the Regional
Health Authority which was then to do contracting with that
money.
I note it appears in volume 14 there are Cytology
Advisory Liaison Committee minutes of 23/24 July 92 and as
erlyu as that it is said that under the new system of
Regional Health Authorities and CHEs that the market “and
Programme Managers .. for smear-reading.” ..... that never
became aprogm role because the funding authority took that
role on. There was considerable discussion and that whole
health reform is a very interesting letter what the
competitive edge hasn’t been discussed here so far, the
original plan was there should be private health care plans
to complete with the government’ health funding agencies to
really make this a copjmetive health care system where you
could chose where your health care $ were going to be spent
for you, so your money could be directed to a private health
scheme or government and you would pick the best one for
yourself. That was in 199l2
In terms of the belief in 92
that competition would allow Programme Managers to chose
laboratories for smear-reading that never translated into
the benefit of choosing only TELARC accredited or any other
type of accredited laboratory until late in 96/97 did it
..... no and it never became a role of a Programme Manager
either. So you are quite correct in that. the opportunity
was there if Regional Health Authorities had grasped it,
that was I guess up to them, that was their r/endeavours and
I guess we are taking it for granted all the other Regional
Health Authorities are the same as Midland and I'm not sure
that I know that is the case.
Did the health reforms of
93 create a great deal of pressure on the Ministry in terms
of its ability to discharge other functions such as the
screening programme ..... yes, there were staff who were
deputed to the health reforms and so some of the better
brains were put to that work and there were other
disruptions to management level and there was uncertainty.
But I don't know that the actual membership of the cervical
screening programme was altered and I don't know that
running the day to day operation was affected by that
preparation for the health reforms. we have discussed
whether legislation would have been easier to pass –
requiring to go through the House - I don't know there was
any effect.
Could you turn to Ms Glackin’s exhibit 088,
one of the separate ones. If you turn to p55, the last
paragraph, letter from the Minister of Health to Ms Betsy
Marshall and you will see in the last paragraph the Minister
says “a number of areas within the Ministry … overcome.” Is
the ministers statement there a fair statement ..... I
accept I must not disagree with minister’s past or present.
I said I didn't know that they were afectged. Reading that
I don't know how the health reforms directly involved the
co-ordinator position being vacant, but if that’s what was
written that must be so.
While you have that document in
front of you, if you would turn back to p46 at the top right
hand corner. This is a letter from Cytology Advisory
Liaison Committee to the then Minister of Health dated 5
March 95, page number 46, you will see reference to the
World Health Organisation identifying strong national
co-ordination … programme – reference to the department’s
new role, and it suggested that responsibility of providing
co-ordination may be inconsistent with the department’s
primary role of providing policy advicing and funding health
purchases. Do you agree there was that inconsistency .....
this is before the change on 1 July that was seen definitely
within all government circles as being a role that the new
department when it became a Ministry would have a much
lesser role in the health sector.
And do you accept the
Cytology Advisory Liaison Committee view expressed in this
letter that “the department’s new role would be inconsistent
with what the World Health Organisation has identified as
essential for an effective screening programme.” ..... yes,
this was the view offer the members of the committee about
what they saw happening around them, and yes they foresaw
problems.
In the next paragraph it says “recently we were
told that the department has been instructed … purchased by
Regional Health Authorities.” I would like you to comment
on how accurate is that first sentence in the second
paragraph ..... I don't know the accuracy, I wasn’t there –
I didn't hear that myself at the time. By the time it had
got to the committee it would have gone through several sets
of ears and/or hands, so it may not be a true representation
and it doesn't say who instructed the department. There was
a health reform directorate which was setting the proposed
path. There were nministers but it doesn't say who
instructed the department. So,m I'm not sure the accuracy.
Obviously the funding agreements as we found di take
precedence over what the programme and its Advisory
Committee s would have liekdd see happen and obviously I
believe took precendec over a government policy written
pvsly by the Associate Minister. that is what happened. It
looks like Cervical Screening Advisory Committee were almost
predictding that that’s what would happen.
The statement
that the department had no power to ensure local
co-ordination of a programme was puchd by the Regional
Health Authorities did that reflect the department’s view on
what power it had to insist what Regional Health Authorities
did in relation to purchas of hlth services from other
providers ..... I think that somewhat understates things.
It again does depend what can be put into the purchase
agreement. You could say that the department or the
Ministry to be could have tis ideas what the Regional Health
Authority should do but unless its in the purchase agreement
then it can't be enforced and that does refer back to some
of the other exhibits you gave me where each funding
agreement tends to role over the one before and I understand
it became more difficult to change the funding agt, you had
to go through a convoluted pathway to change the funding agt
because people in the department wanted to change different
things and the Regional Health Authorities were finding they
were being besiedged by potential changtes. Many of them
may h ave been with the best intentions but so if this
reflects the view that we in the cervical screening
programme and the Ministry staff who work with us wish this
to happen but we don't have the ultimate poer to make it
happen because that is the nministers’p funding agt that’s
correct.
From the perspective of a public health
specialist do you find the ability to implt health policies
being dependent on contractual negotiations with another
body and that other body’s willingns to agree to implement
the policy a cumbersome way of clvrg health services .....
it is a difficult way if you have bright ideas about what
should be changed, because or if you have ideas about what
are the highest priority and they don't coincide with other
people’s view of the highest priority.
Is it correct that
as from 93 96 during that period if the Ministry of Health
found itself dependent on the willingness of Regional Health
Authorities to agree to perform certain requirements in the
funding agreements that the Ministry being in that situation
was the result of a politicl decision to structure the
health service in that way ..... yes there were some
situations which it was a disadvantage to have it structured
that way. History will have to weigh up whether there were
other advantages from that came about through efficiencies
or the imposition of quality we may never have got to where
we are with the cervical screening programme if those
reforms hadn't come in and altered the old Social Security
legislation, hadn't altered several other things. So it
hasd to be weighd up and that’s for ahistorian to really
decide whether it provided an impetus of immpmt in many
other fields but some missed out.
To the best of your
knowledge, under the system in 93/96, had the Ministry
reserved to itself a power that it could use if necessary to
require Regional Health Authorities to perform certain tasks
..... if we had done that would it have been better are you
saying/
Did you do that ..... well, certainly not in
relation to cervical screening and it wasn’t within the
terms of the reforms to and in fact to require Regional
Health Authorities to do things outside the funding
agreements takes a Ministerial directdn which has a
constitutional pathway of its own.
There has been a lot
of discussion about TELARC. If you could please look at
volume 2 of the exhibits which Mr Mules is to produce, tab
27 – a collection of letters written to Mr Mules – one from
Medlab Hamilton, about accreditation, and this is just the
comments on TELARC “It is true … audits”. in sofar as
providing an audit of a labs work does TELARC go far enough
..... I believe that TELARC accreditation is a valuable
indicator of the laboratory’s capacity to do what it sets
out and offers to do. It doesn't give a total assurance
that there will be 100% accuracy or that the patient’s
safety is always guaranteed.
PROFESSOR DUGGAN: does it
assure accuracy to a certain standard ..... it asures that
the standards are there and are known by the staff and that
there is a checking system which will pick up some
inaccuracies, but cannot garnatee to pick up all of them –
no it dsnet guarantee 100% acurancy. I don't think any
auditor could do that because someone could come to work one
day incapacitated and try to work and could make
mistakes.
So that I can be clear on this, TELARC reviews
laboratories and checks performance against a set of
national standards ..... no, my understanding and I also
understand that TELARC itself is going to appear before the
committee, but my understanding of auditing generally is
they look to the processes to see are the appropriate
standards available in the service bg auditied – a
laboratory – are the standards there, are they known by the
stdaff, is the work pfd to those standards, what checking is
there done in the laboratory to see that that’s the case,
what are the processes and that includes what are the
competencies of the setaff doing the work, which should be
within the manual, the quality manual of the laboratory, and
then look at the equipment, look at the general suroundoings
and make comments sometimes they are comments for
improvement to bring you pu to auditable standard, other
comments must be “does not meet standards at all.”
TELARC
does not look at the results of the internanl quality
control ..... that’s where I'm not absolutely sure. They
were to be provided with even the documents that go to the
laboratory that they're going to audit. As far as their
comparison lf laboratories results they would want to see
exnmples of how this material is used, but no they don't go
rechcecking slides or checking work to see that it is 100%
accurate or apply their own accuracy, they what to see that
the tools are there and being used in the
laboratory.
Besides the data generated by laboratories by
the registry, laboratories generate other data out of their
ointernal quality control methods ..... yes. such as a
moisrdg is picked up by the more senior person it was
referred to or picked up during the 10% screening or ztype,
I'm quite sure the TELARC process wants to know when that
information was found what was done with it, what is your
system, did you then do a more intensive re-screening on
that particular inedivd, what's the evidence they went for
reeductn, what are your processes, were they put in place
when you did find an error within your system or a failing
within your system. that doesn't mean that they re-read the
slides again as some poelple think that is what auditn is
about.
But TELARC would look at the 10% re-screening for
example ..... certainly yes I would hope but much more than
that, they would want to know what is your system of
rescreening, show us it it is working, show us some
documents of your most recent series, show us what you did
about that, did that comply with what you set yourself as
targets.
Each laboratory sets its own targets for false
negatives ..... they I believe they set their target as to
what is an abnormal which then gets passed on. I can't
answer that question specifically – I guess they use targets
in a more quality assurance role, you've picked me up on
something – I don't know whether they do or don't.
TELARC
will be able to give us information on this ..... what they
would look for in that area and what they would expect to
see and I'm sure the pathologists would be able to answer
that as well.
It is unclear as to whether TELARC uses the
results of certain performance indicators in its
registration process ..... it’s uncertain exactly how they
apply them at the moment.
CHAIR: if you could turn to
Ms Glackin’s volume 3, tab 11, a Cervical Screening Advisory
Committee meeting of 12 December 91 – if you go to the
second page under matters arising, you will see the
reference there to Dr Teague following up a complaint about
quality of smear reading at a laboratory ..... right.
And
it seemed that the New Zealand Society of pathologists at
the time in 1991 were supportive of a scenario occurring
where if the laboratory complained about .. TELARC
registered that the cervical smears taken as part of the
national programme would not … after 93.” ..... yes. that
was the statement, and that was obviously the expectation
based on the 91 policy.
Is there any reason why this
couldn't have been put into action ..... I guess we go
around the circle again. This was his expectation in
91based on the policy written in 91. by the time it camne
to 93 the responsibility became that of the Health Funding
Authority – the Regional Health Authority as from 1 July and
the government policy of 91 appears to have been overwritten
by a purchase agt signed by the Minister in 93 that then
required reasonable endeavours for TELARC acrdn and funding
which had been the tool for cervical smears going to
laboratories at that time. It was jno longer the
responsibility of the then Ministry of Health.
Given that
it seems that in 91 the Society of pagists would have
supported an approach where someone who wasn’t accredited by
93 no longer got cervical smears from the programme to read,
why wasn’t a tougher approach taken by that I mean there
doesn't seem to have been any factors which would have made
it dflct for the Minister of Health and the Regional Health
Authorities to have taken a tougher approach with
laboratories who owerent accredited after 93 ..... ik don't
want to be picky but you have made an assumption, it’s in
the same paragraph. You have assumed that the next
statement is that of the Society of pathologists, it may
well have been but I can't say that it was.
Certainly it
seems that this approach was supported by Dr Teague wasn’t
it ..... certainly and he was as you know was a member of
both committees and was an adviser right the way through
fgor the Ministry and so he was aware of what the
department’s expectation was in 91, i.e. no TELARC
registration, no cytology.
From your knowledge at the
time, were the laboratories resistant to compulsory
accreditation in order to be able to read smears associated
with the programme ..... there's little in the evidence to
suggest that there was reluctance, but obviously we did have
a quotation about costs resources, time in previous
XXN.
It’s just that it’s difficult to see, given that
there seems to be little evidence in the documents so far of
a strong resistance by laboratories to compujlsory
accreditation in order to get contracts to read srs for the
programme, it’s dfcltd to see why the requirement of the 91
policy ultimately with the new health service was changed to
one of being rsble endfvrs to have laboratories accredited
..... I couldn't agree more. It’s not in any of the
evidence that I could put forward. and nor is there
evidence as to whether there really was resistance, whether
some laboratories did not wish at any time to be involved
with TELARC.
As a public health specialist given the
senarioi that I've just outlined what conclusions would you
dcraw from that as to the wililngns at the tme to impose
compulsory controls on laboratory accreditation ..... at the
time this was written, which is 91, compulsion was implicit
in the policy and it was fully expected that given the 2
years this would be in place. So therefore there was no
need to put some other belt and braces type legislation
through, came 93 when there was still half a year to go and
it was handed over to the Regional Health Authorities that
obviously no legislation was drafted as you've already
elicited and it was part of the funding agreement as we've
gone through before.
F m youe expertise as a public
health specialist are you able to draw any conclusions from
why it wouldn't have been made a greater priority in the
funding agreement given the scarcity of evidence to suggest
the laboratories w3ere strongly resistant to accreditation
being compulsory ..... no, I'm not able to decide how things
were prioritised as to what must be in the funding
agreement, what must have indicators. I have said some
points did have indicators, the enrolment of women and the
colposcopy waiting times, these were seen as critical for
the success of cervical screening but why this particular
one wasn’t given the same priority is not something I can
tell you about why.
Thank you.
PROFESSOR DUGGAN:
If you could go to p29 of your brief, paragraph 94, the
item with reference to the laboratory assistants. The
laboratory assistants do primary screening, is that correct
..... yes.
How much of the primary screening in New
Zealand is done by the laboratory assistants ..... I can't
answer that question, I don't know.
Could you speculate
..... no. that’s another thing I'm not allowed to do, but in
this one I would be jmisleading you. my ethics doesn't
allolw me to speculate.
This group of individuals work
under the supervision of the medical laboratory technologist
scientific officer or medical practitioner ..... yes there
is that word seitnifc officer in there, I'm not sure any
more sieitific officers have been trained. I couldn't find
much about them. They are very similar to the medical
laboratory tecnololgists degree course people. They are
more highly trained than laboratory assistants.
This
group receives certictn from the New Zealand institute of
medical laboratory science ..... yes.
Are they then
members of that national Society or do they have a national
body ..... again, it’s something I can't answer
specifically. They are not a registered health profession
like the tecnologists are. Tecnologists are rgd health care
providers by having their own piece of legislation so they
have greater indemnity powers and it’s not for me to give
you oa lecture on ACC and the no faults insurance scheme but
they are covered under medical misadventure for the ACC
insurance scheme. Laboratory assistants are not. So they
are not a registered profession, so that’s a legal standing.
Whether they have a body of their own to represent themn I'm
not quire sute. Certainly they have representatives at our
meeting but whether they have a professional body of their
own I'm not sure.
Are they then required to maintain
comptence ..... the laboratory which employs them would be
is expected to maintain their competence but no there is no
legal requirement for them personally to maintain their
competence to stay on a register because they're not on a
register.
Are there national competency standards for
this group ..... there are the competency standards for
laboratory assistants that we discussed earlier that were
drafted to be sent to laboratory managers and again I would
expect it to be part of the TELARC auditing to see that
there are ways of maintaining the competence of the staff
from [pathologist down to laboratory assistants so there is
no central governmental requirement on an individual
laboratory assistant to set what their coipmetence level is
there is a requirement through the TELARC registration that
their staff maintain competence and that they provide them
the ways with which to do it.
Is the remuneration level
in terms of % and cents of the laboratory assistant equal to
the tecnolgoist ..... I'm not it’s not. There's no set pay
scale as most of this is private laboratories but we can
make an absolute certainty that the degree course people
would get higher salary because part of their job is to
supervise the laboratory assistants so it would fllow that
they are on a higher salary.
Is there any conern in the
medical practice that primarty screening to some degree is
done by this group ..... not that I know of, in that that’s
the system that I know has operated and yes, I'm not in a
position to know whether that’s different to other
countries or other cervical screening programmes that the
next step up is the degree decrease technologist who does
see themselves as having a supervisory role, not necessarily
of other degree decrease people but also of laboratory
assistants.
MR HODSON: re the paper produced by Ms
Janes. GRB/MOH/ 048
MR CORKILL: when this document
was sent to myself and counsel assisting the names were
deleted. Any use this document might have is compromised by
not knowing a) the identify to the laboratory or b) the
region from which it comes. I would like to raise this issue
with the committee and with the Ministry to ensure that the
full schedules are available to the committee so that its
value can be properly assessed.
MS SCHOLTENS: as far as
the information being presented to the inquiry, we are in
the inquiry’s hands, in terms of the Official Information
Act we thought it prudent to approach the material in this
way. Because the association of community laboratories may
have something to say about it.
Mr COLLINS:
Without
knowing the identify of the laboratories, I can't take any
instructions .
MR HINDLE: the document is current as at
1996 and I have to say I have some sympathy without knowing
what the names of the laboratories are. The information is
really of some historic value – I support the submission
made by Mr Corkill on this issue.
MS SCHOLTENS: my
understanding this information came straight from the
register and laboratories are compelled to provide it. I
understand that the Ministry were making enquiries of each
laboratory to ascertain to whether they had any objection to
the information being made available and obviously if it’s
going to be of assistance I could find out where that
process is up to and advise Mr Collins.
CHAIR: I am
reluctant to require it to be distributed without hearing
from the laboratories.
MID-AFTERNOON ADJOURMENT
4.10P.M. TO 4.25 P.M.
MS SCHOLTENS: I am reliably
advised that there are at least 2 laboratories that were
very concerned that this sort of information might be made
public, the potential for misunderstanding that goes with
it, and thinking that point through a little further,
certainly I think there would be some hesitation in putting
it out in the public domain as is.
CHAIR: the document
was first sought to be introduced by Ms Janes, so given that
she hasn’t produced it, if I could outline the basis for why
she is producing it we can work from there.
MS JANES:
Twofold: one because the statistics were falsely reassuring
because there was no comparison with like regions with like
regions in relation to demographics and socio economics.
The second basis is that document is the only document which
would enable the committee to address terms of reference 3
which is was the Gisborne laboratory issue an isolated case.
Mr COLLINS: Can I suggest that the question of
individual laboratories be deferred. I understand the
Ministry has raised with the individual laboratories
specifically whether or not the individual laboratories
consent to this information being made available, and until
we understand the results of that inquiry it would be
premature.
CHAIR: We will accept provisionally the
sanitised document, Mr Hodson can XXN on that. it seems
from what I have heard from Ms Janes that we could get away
with identifying regions rather than naming laboratories.
It would be subject to strict suppression orders that the
information will not go any further than that.
Dr Boyd,
earlier on you were asked about the information provided
concern drb’s laboratory and you described that information
as falsely reausring and I think you agreed with Professor
Duggan earlier today that the information was not meaningful
..... without all the qualifiers that could be put to it and
Professor Duggan presented some with great
clarity.
Looking at that document now, once the regions
and the names of the laboratories w3ere available, what
would you say about the quality of that data, would it still
be subject to the same limitation ..... what applied to Dr
Bottrill would certainly apply to all the other
laboratories, the same qualifiers, and there may be others –
I happen to be privy to the letters to the two laboratories
I know of who opposed the release of their names. Their
view was similar to Professor Duggan’s but they certainly
would want it to be known that there were qualifiers you
should use before comparing one laboratory against
another
And It would be correct for the committee to
uplift what you said in respect of the questions about the
Dr Bottrill information and impose that on what you might
think of the information relating to all the laboratories in
that document ..... it would apply to each and every
laboratory noted in here.
XXD MR HODSON:
This
document shows the analysis performed by the register from
some 30 laboratories relating to their screening to 30 June
94 ..... that is correct.
Of those 30 laboratories 20 are
community laboratories and 10 are hospital laboratories and
in my questioning I will disregard the 10 hospital
laboratories.
Of the 20 community laboratories Dr
Bottrill appears, or Gisborne appears, and it’s easily
identifiable because it is the only one that read 1.2% of
the national smears. His reporting rate is 0.6% ..... if
that’s the same as int he evidence I presented.
What this
document shows is that 5 other laboratories had a reporting
rate of 0.6% or less ..... having looked at these before I'm
sure you are right, yes.
And taking those 5 plus Dr
Bottrill making 6 laboratories, they covered 1/3rd of all
the smears reported in that period . ..... I’ll take your
maths as correct.
Dr Bottrill has come under very heavy
criticism because the Sydney re-read of his smears came up
with 3.73% high grade – i.e. 6 times the rate found by Dr
Bottrill. My question is: have the laboratories which also
had a rate of 1/6th of the Sydney rate or an even smaller
fraction been identified in the context of excluding or
establishing the possibility that those populations are at
risk to the same degree as Gisborne women or more .....
there's one bit of that question I'm not sure about and
that’s the 1/6th Sydney rate, you were quoting that as a
Sydney rate for smears collected in this Tairawhiti region,
obviously the other laboratories were slides taken in other
regions. I'm not quite sure on that part of the question,
but I have answered you before that the Health Funding
Authority has had the responsibility for looking not only at
the re-reading of the smears from Tairawhiti but also
looking at ways in which you can judge the effectiveness and
the quality of work from other laboratories. I've been
party to their informing the Minister of what they were
doing and their progress but I have no written reports
because their work isn’t completed yet.
What happened in
Gisborne, based on the Sydney results, has been presented as
a serious public health risk to the women of Gisborne.
Isn’t it desirable that the risk be dealt with as a matter
of high priority ..... I believe it is being dealt with a
matter of high priority and the report will be made
available tot this inquiry as soon as it is complete.
Incomplete reports are not helpful to the public confidence
or in fact to the women themselves who've had smears.
The
same comment could be made about Gisborne laboratories, but
would you accept in the documents so far made available to
the inquiry there is no indication of it having been dealt
with throughout 99 ..... that is correct because the
Ministry has not been the party dealing with it, it’s a
health funding issue to be doing the investigation of what
we've heard described as terms of reference 3 for the
inquiry. The Health Funding Authority did want to know are
there risks that the same might have occurred in other
areas, and obviously re-reading smears might be one way of
doing that work but there are other ways of assessing the
quality of the work and much better you hear from the public
doing the work.
The social demographic profile of the
community would be relevant. Is it not part of the
Ministry’s functions to monitor a public health concern of
this nature and be aware of what is being done ..... yes it
is. It is certainly more the role of working with the
Minister to see that the work is done in the most effective
way within the min’s portfolio and clearly it was agreed by
the Minister and the two government agencies involved that
that work be carried out by the organisation which currently
has the cervical screening programme within its
mandate.
I pointed out at least 3 times that there is no
indication that this issue has ever been raised with the
Minister ..... yes, you have said that, and I think
certainly – I don't know why there is no particular document
there. I believe that the work being done by the Health
Funding Authority is not secret but it is equally not useful
until the results are known and then critiqued.
Is it
fair to say that exactly the same comment can be made about
the criticisms and general descriptions of the work of Dr
Bottrill ..... I believe very similar comments could be made
about you shouldn't judge something until you have all the
information. And that I hope is what the inquiry is going
to develop for us.
Thank you very much Dr Boyd.
MR
MURRAY: I think it would be helpful to the inquiry that
the importance of that topic is not overlooked, the Health
Funding Authority is doing a great deal of work and it is
not going to be productive for us to come to the inquiry
with that evidence – the work is being done, it will be
briefed before July and it will be of assistance.
CHAIR:
we will accept this document provisionally now and later we
may replace it with a document more informative. Perhaps if
we could revisit that issue on Tuesday morning. – GRB/MOH/
048.
DR BOYD RE-EXAMINED BY MS SCHOLTENS:
Dr Boyd,
can you turn to your volume of exhibits 5, document 26, my
learned friend Ms Janes took you to this exhibit this
morning and asked you a number of questions about the survey
that your evidence refers to this being an extract from
..... yes
Can you confirm from the cover letter 4 May 990
that this is a request for information carried out in 1998
..... yes, that’s what the author of the letter which went
out to the laboratories certainly put.
And at tab 27 do
you understand that to be tables prepared from the
information received from both the 88 and 90 surveys ..... I
think that is the case.
And your evidence is that those
figures did not necessarily provide meaningful information,
I think in particular table 8, the % of smears reported is
inadequate ..... yes, I was loathe to give an opinion, but I
do not believe that this data, knowing how many laboratories
did not respond or found it difficult to provide the
information, I do not believe this was adequate for doing
the sort of assessment that people may wish to apply to say
the 1996 document we've just talked about.
The next
reference to statistic information of this nature is in the
first statistical report which is Ms Glackin’s exhibits
volume 6, tab 26. ..... yes I have that
Can you first
confirm that this is the next collation of statistical data
that we have a record of ..... yes.
And the data
apparently runs to, from the foreword, up to May 1992 .....
yes.
And do you know the qualifications of the authors
..... two of them, yes. Brian Cox was a member of the
Cervical Screening Advisory Committee and an author of
several of the documents that we have already presented as
exhibits and I s an epidemiologist at that time working with
Professor Skegg in his unit in Dunedin and Clint Teague is
Dr Teague the pathologist on the Cytology Advisory Liaison
Committee and was an adviser to the Ministry.
I want to
take you to where the statistical report is discussed by
Cytology Advisory Liaison Committee, your volume 4, tab 18.
Could you find the minutes for 10 April 1992. ..... I have
it.
Can you turn to p7 of those minutes. The item which
is marked B national cytology register statistics, does that
appear to be – read that to yourself, does that appear to be
a discussion about this statistical information prepared for
this report ..... yes the timing is right for discussing, I
think, a draft of that statistical report and two of the
authors certainly were present.
And it notes at the
penultimate paragraph on p7 that the document includes
statistics able to be collected on … of laboratories
nationally, and the committee discussed what should be done
with the individual statistics and the action to be taken
and who by … from the national statistics. Do you see that
..... yes.
And the emphasis, the minutes record, should
be educative rather than punitive approach to any outlying
laboratory ..... correct.
They also suggest they also be
produced every 6 months and initially be supplied
confidentially to each laboratory ..... yes.
And that
Cytology Advisory Liaison Committee have the ability …
consistently outlying ..... that is correct.
And then
there is a concern that the information not be published
..... that is correct.
And that seems to relate to table
6 ..... yes.
This discussion is in April 92 and the
report, the statistical report which we've just looked at
dated August 92 was released in August 93. can you confirm
that ..... yes I can confirm that's what it says on
it.
You were referred in XXN to a meeting of Programme
Managers in July 1992 where discussions about laboratory
statistics were raised and Gillian Grew was to provide
figures for Programme Managers do you recall that .....
yes.
Can I get you to turn up those minutes in volume 14
of Ms Glackin’s exhibits – somewhere near the middle – 23/24
July 1992 is the date of the meeting. The minutes are, I
think, 9 pages long and then there is an action plan .....
yes.
The second step is that the Department of Health
agreed to provide Programme Managers with the average
against which they should monitor the smear results from
laboratories ..... yes.
And then follows a discussion on
p1 of the minutes, Gillian Grew referring to Brian Cox’s
study ..... yes.
Is it fair to draw the inference those
that appear in the statistical report ..... yes, it is. I
understand that the statistical report’ was provided to
Programme Managers and that would seem a reasonable
assumption.
PROFESSOR DUGGAN: this is 92 you are
talking about
MS SCHOLTENS: yes.
PROFESSOR DUGGAN:
when there were 14 independent registries
MS SCHOLTENS:
that is right. There were 14 separate regional registers
when this first statistical report was produced Dr Boyd
..... It was discussed in 92, published in 93 and the time
it was discussed at Cytology Advisory Liaison Committee was
very similar to the time the Programme Managers meeting were
also discussing the same issue and they were promised the
data. This is the first statistical report of the
data.
So the Programme Managers are discussing this in
July 92 shortly after Cytology Advisory Liaison Committee
has looked after it. I now take you to where Cervical
Screening Advisory Committee has a look at this information,
and that is in Ms Glackin’s volume 3, minutes of 11 February
1993 – near the middle. Can you look at p2, item d,
statistical report ..... right.
And you see there that
the chair enquired about its release and we know it hasn’t
been released, reference it has been sent to the Programme
Managers, Sue reiterated that it should not be widely
released … summary statement … and also agreed that regular
statistical reports are required ..... Yes, that is
correct.
The figures in the statistical report in 92 –
perhaps if I could show you two documents before I ask the
question: I am really trying to follow the line of the
information that the register was producing and how it was
made available to those significant players in the
programme, hopefully it will become clear as we move along.
The one page document is an agenda for a meeting ..... I've
got lots of copies of a one page document, which means
counsel haven’t got any!!
The one page document you
have is an agenda for a National Cervical Screening
Programme laboratory meeting ..... yes, that’s what it’s
headed.
And dated 1 October 92 ..... correct
And does
that appear to be a Ministry file reference in the top
right hand corner ..... yes definitely a cervical screening
programme file number.
Number 5 on the agenda, laboratory
statistics generated by the National Cervical Screening
Programme followed by general discussion with Dr Teague’s
name beside that item ..... yes.
The next document again
does that have a Ministry file reference on the
top?
Agenda produced as GRB/MOH/ 049
The next document
is a Ministry reference ..... yes, on the same file
Does
that appear to be the minutes of that meeting .....
yes.
Do you note among those present M Bottrill .....
yes, I'm aware he was at the meeting, I haven't found it
yet. Yes, I do now, yes.
Can you turn to p18 of the
minutes, where we come to item 5 on the agenda, laboratory
statistics. I will just give you a moment to read the
minutes under that heading. ..... yes.
Would it be fair
to conclude that this meeting may be the result of the
discussion at the Cytology Advisory Liaison Committee
meeting that we referred to earlier on 10 April 1992 where
that committee discussed how one would deal with this sort
of information with laboratories when they discussed the
educative rather than punitive approach and how they might
deal with outlying laboratory issues – the first two
paragraphs of the minutes under heading 5 there seems to be
some consistency there with what was in the minutes .....
yes, you could draw that assumption. I don't remember
finding anywhere else a particular reason for the meeting
except there were some very important issues also discovered
about revised treatment protocols and revised Bethesda
coding so to bring this to all the laboratories involved
must have been a very useful exercise for the programme to
have them all together.
Can you produce that document,
please – exhibit GRB/MOH/ 050. Are meetings like that, to
your knowledge were meetings like that unusual ..... they
were certainly not a regular occurence to get all the
laboratory people and the committees and the cervical
screening programme staff including the contractor who was
working on the histology exercise all together in the same
room would be a major logistics exercise to get them there,
so not common at all.
Can I ask you to turn to the second
statistical report which is in Ms Glackin’s volume 7, tab
37, you have been referred before in evidence to the author
of this report, Maryann Linton ..... yes, that is correct
and I stood corrected as to who was the author
Have you
been able to find out her qualifications ..... I did rang
Marian Linton to find out the information and her
qualifications are BSc from Victoria University with the
third year papers in statistics, 12 years in the health
sector as a health data analyst, and she has attended
epidemiology course in Italy, I believe that would be post
doing this particular work and she’s still employed in that
type of work in the Ministry. I've described it as
demography and she said her role is mostly health data
analysis.
This report was published in October 1995.
would it have been usual to have been peer reviewed .....
yes, I'm sure it would have been and I do know that it was
also subject of a part of the meeting of the Cervical
Screening Advisory Committee where the author – two authors
of the first statistical report were present.
The
laboratory statistics that you produced before the
adjournment, or just after provisionally as your document
48, those statistics are based not he same data as this
second screening report – second statistical report .....
yes, it was the same author, using the same data base
And
its data to 30 June 94 in both cases the statistical report
and your exhibit 48 ..... correct.
I want to take you
briefly to where the second statistical report is discussed
by the expert committees, first to the general expert
committee, Cervical Screening Advisory Committee, that’s in
Judy Glackin’s volume 4, 1 August 95, 2/3 through, and the
heading is in a square box ..... 1 august 95?
Yes - page
3, heading “statistical report” Maryanne Linton joined the
meeting, Cervical Screening Advisory Committee … for the
next statistical report ..... yes
Tina Handisides the
coordinator at the time will send … of the statistical
report including the laboratory data for Cervical Screening
Advisory Committee … in writing .. 11 August .....
correct.
We don't have any further information about what
comments were made in the documents you've considered .....
no.
Then Cervical Screening laboratory Advisory
Committee in your volume 4, tab 18, the very last document
is the minutes of the meeting, the final meeting, 19 June
1996 ..... yes.
If you look at p7, item 11, national
laboratory results analysis ..... yes
Can you confirm
that this is a reference to the information that you've
tabled in the sanitised form as your exhibit 48 ..... yes,
the timing is right and yes I understand that to be a
discussion of all those reports from laboratories.
And
she is reported as saying she has done an individual …
analysis ..... correct.
And … was very useful .....
that’s what the committee said.
The data … as a quality
measure for laboratories ..... yes
And there is a record
that Maryann asked … format etc ..... correct.
TELARC
will be given the national … data.” ..... yes
TELARC will
be informed when the individual laboratory data has been
sent out ..... correct.
And the individual … with the
laboratories performance ..... that’s what was written in
the committee minutes, yes
This is what Cervical
Screening laboratory Advisory Committee envisaged would
happen with data of this type ..... yes
Then there's
reference to the information … internal quality measure to
TELARC .. and to the Ministry … to the attention of the
Regional Health Authority ..... that’s correct.
And this
initial document can be used as a benchmark .....
correct.
And the action was for the programme to forward
the information to the laboratories ..... that is
right.
And we know Ms Glackin advises that is what she
did ..... yes with a covering letter she signed.
I want
to turn to the issue of quality assurance in a more general
way, in particular the Ministry’s obligations under the
Ministry policy ..... yes.
In 91 and then 93 and then 96.
Your volume 4, 3 pages in on the very first meeting of
Cytology Advisory Liaison Committee on 18 April 89, there is
a reference to – the first 3 pages relate to terms of
reference. Dr Boyd can you turn to the last page of those
minutes, which is p5, agenda items for the next meeting, and
what Cytology Advisory Liaison Committee have proposed to do
there under paragraph A ..... yes, they were
”to look at
their meeting at quality control including a … presently
available in New Zealand and their usage, their developments
at present”
That was to occur at the next meeting. If
you turn over the page there is a reference to the meeting
being brought forward and you can see the explanation on the
second paragraph as to why that occurred ..... it was
brought forward at the behest of the Health Department.
“The department have requested the earlier meeting … before
the end of July.” And that was July 1989.
Can you turn
over 2 pages to the minutes of the second meeting on 18 July
89, p2, item 3, quality control. Can I just ask you to read
to yourself the minutes under heading three which continue
over on to p3. ..... yes.
Does that record advice being
sought by the programme from the expert committee about
quality control issues ..... yes, it does. It’s in a very
shorthand form and difficult to understand this long after
it was written, but yes definitely records the fact that we
already know that the department wanted committee to discuss
these issues and the issues are noted.
Would you agree
there are a large number of issues raised surrounding
laboratories ..... yes.
On p3, paragraph 3, there is a
reference to the paper on recommendations and quality
control produced by the Fitzgerald committee, can you
confirm that that is the document that you produced in your
papers in which Professor Duggan referred to yesterday as
the American paper ..... yes, I'm quite sure this is the
same document and I would point out the two authors of the
New Zealand version were both members of the Cytology
Advisory Liaison Committee and so they were part of this
discussion which said this paper should be modified and
taken bo the Cytology Society before its next meeting. And
it should also be made – “recommendations and standards …
and to TELARC.”
They wanted to do more with that paper in
terms of quality control ..... certainly they wanted to look
at it again and revise it before recommendations could be
made, for instance to TELARC about standards.
The next
document in your bundle is an agenda for the 4 May 90
meeting. ..... correct.
That’s followed by the minutes
which I think we've seen on p3 which set out the discussion
which ultimately found its way into the recommendations
published by TELARC in 1991 ..... that is correct.
MR
HODSON: the document I think we are presently looking at
is headed “Minutes of meeting 4 May 1990” and lower down it
says minutes of 18 July 90 were accepted as a true and
accurate account.
CHAIR: do we know the correct date
..... quite clearly the previous meeting had been held on 18
July 1989. the day and the month were correct.
MS
SCHOLTENS: so the minutes record on p3 and 4 the decisions
relating to quality control and at the foot of the reference
on p4 above the heading National Cervical Screening
Programme the action that was going to be taken was agreed,
do you see that ..... it was agreed that Clint Teague
prepare a draft submission to TELARC. Which
action?
That’s the one I'm referring you to ..... yes,
and the draft would circulated to members of the committee
prior to its submission to TELARC.
And just a further 3
pages over is a letter to TELARC, dated 15 August 990,
signed by Clint Teague, recording those matters ..... yes,
as I remember it was word for word or almost word for word
with those discussions .
Can you go back to the minutes
that precede that letter, p4 under the heading National
Cervical Screening Programme there is a reference under
“:circulation of slides” can you tell us what this is about
..... this of course is another quality assurance measure
where laboratories share slides amongst themselves and
circulate them. We've heard of the college of pathologists
programme, certainly there were more than one programme like
that operating in New Zealand in the late 1980s and into
1990 to my knowledge, and it was clear the cervical
screening programme was putting to the committee that this
was a good way of quality control and ensuring uniformity of
reporting.
Over the page, p5, there is recorded at the
top what the committee ultimately agreed it would recommend
to the programme ..... It was agreed “that the committee
would … using the Bethesda system in due course ..
registered. while the programme was saying circulating
slides was a good form of quality control the committee was
saying that a closest degree of uniformity could be obtained
through a uniform reporting system and TELARC
registration.
The use of the Bethesda system was taken up
by the programme as you've said before, that’s right .....
yes, and I think it was subject of discussion at that
previous meeting that we skimmed across.
From your
reading of the papers are you aware of the level of effort
that went into seeking to ensure uniformity of reporting by
laboratories, by the programme and its advisors ..... yes,
there was a considerable amount of effort put into one
ensuring that the Bethesda system was suitable and
compatible with the New Zealand laboratories and in trying
to persuade laboratories to all use this system as against
some of the other methods of reporting that they were using
at that time. And it definitely did become universal by the
time the programme was up and running.
Could you comment
on the importance of uniformity of reporting by the
laboratories ..... the Register would be impossible to
operate if it didn't have a common form of reporting from
the laboratory. So that these results could be coded.
Do
you know if this was easy to achieve, by this I mean
uniformity of reporting by the laboratories to the Register
..... I'm not sure how to answer that., there’s definite
resistance during 1990, but I'm not sure ii can answer just
how difficult it was.
Do you know if it was achieved
quickly ..... there must be an answer in my documentation, I
don't know what the answer is.
You think there may be an
answer in your documentation is a fine answer, Dr Boyd.
Then just under that reference is a heading “other external
quality control measures” can you just read that and let us
know what other advice was given by Cytology Advisory
Liaison Committee to the programme at this stage – the
minutes of 4 May 1990, p5, heading 2 ..... yes, that’s very
similar to the wording that ended up into the TELARC
document that was circulated to laboratories
The advice
to the programme was what ..... that the programme and
TELARC should be advised that participation in external
quality control programmes should be encouraged and before
that there were some comments on the fact that there was no
totally satisfactory programme of external quality
control.
I now ask you to stay with that bundle and go to
17 November 93 minutes, which madam chair took you to
earlier this afternoon, just before the middle, p5, item 8.
in your answers to questions from the chair you explained
that it appears a member of TELARC came to the meeting .....
that is correct
To request revised standards for
laboratories ..... yes.
This is in late 93 ..... yes,
that is correct.
Can you turn to p6, the TELARC has
indicated they would provide copies of other country’s
standards ..... yes
And then there is the agreement of
the meeting recorded, that they would developed min
standards ..... yes
Do you know what that means ..... I
think it goes possibly back to the very first page under tab
18 so we had the Royal College of Pathologists of
Australasia, the New Zealand Society of Pathologists, the
New Zealand society of cytology and the New Zealand
institute of medical technologists. They were the four
sponsor organisations at the beginning of the Cytology
Advisory Liaison Committee and there were representatives of
each of those bodies on the committee.
CHAIR:
whereabouts in volume 8 ..... the first page of 18 – the
terms of reference and it gives a history of how the
committee was formed, how it did its work, how it became
adopted by the Ministry.
MS SCHOLTENS: so at this stage
the Advisory Committee embarks on a revision of the 91
standards ..... yes, obviously agreeing that it needed
consultation throughout the sector, through the sponsoring
organisations.
The next document in the same volume is
minutes of 24 June 94. ..... 29 June.
Sorry, 29 June,
p3, recommendations for TELARC standards ..... yes.
You
see the agreement at that meeting that each person on the
committee prepare a different section and return them to the
Ministry of Health for collation and the topics have been
divided up between members of the committee ..... that is
right. Clint and carol had agreed to be the lead people and
they were splitting the work up amongst committee
members.
These minutes are 29 June 94. we know at the
same time as this the same committee was being asked to make
recommendations on the review of the cervical screening
policy. ..... yes.
Do you remember being taken to the
document recording their view on the review of that policy
..... yes.
That document is in Ms Glackin’s document 71,
do you recall that it was pointed out to you that there was
a decision in that effectively recorded in those
recommendations that there would no recommendation on
minimum numbers of screenings for laboratories ..... yes
that was pointed out in XXN previously yesterday I
think.
So that was about the same time, June 94 .....
yes, they were looking at rewriting the standards, also
commenting on the policy, recognised that the policy had
something about min numbers and they found it impossible to
come up with a number. That’s my summary of what I
saw.
THE HEARING ADJOURNED AT 6.00P.M., TO RESUME AT
9.30A.M.
FRIDAY 28 APRIL
2000